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Biocidal Products Regulation

Active substance suppliers

If a company obtains a Letter of Access (LoA) to a dossier and submits the LoA to ECHA for inclusion in the list of relevant substances and suppliers under Article 95 of the BPR, does it have to pay a fee to ECHA?

Given the Agency's work required to analyse submissions for inclusion in the list of relevant substances and suppliers referred to in Article 95 of the BPR, it is appropriate to levy a fee for these types of submissions. The applicable fees are laid down in the Commission Implementing Regulation (EU) No. 564/2013 of 18 June 2013 on the fees and charges payable to ECHA pursuant to Regulation (EU) No 528/2012.

The amount of work required for such a submission will vary significantly depending on whether the person submits a letter of access or a new dossier, since, in the latter case, ECHA will have to check that the dossier complies with Annex II to the BPR or, where appropriate, Annex IIA or IVA to Directive 98/8/EC and, where relevant, Annex IIIA to that Directive.

Annex III of the aforementioned Commission Implementing Regulation (EU) No 564/2013 sets the applicable fees depending on the type of the submission under Article 95 of the BPR:

  • 2 000 EUR per submission of a letter of access to a dossier already found complete by the Agency or an evaluating competent authority;
  • 20 000 EUR per submission of a letter of access to part of a dossier already found complete by the Agency or an evaluating competent authority, together with complementary data;
  • 40 000 EUR per submission of a new dossier.

The text of the Commission Implementing Regulation (EU) No 564/2013 is available at:
http://echa.europa.eu/regulations/biocidal-products-regulation/legislation

Under the BPR, can I apply for approval of an active substance for which a non-inclusion decision has been taken under the BPD (Biocidal Product Directive)?
Yes, this is possible. Without prejudice to the transitional arrangements provided by the BPR, an application for the approval of an active substance/product-type combination can be submitted in cases where a non-inclusion decision had previously been taken under the BPD. 
 
Processes and timelines are set out in Articles 7 and 8 of the BPR. Please note that such cases are subject to the data protection period specified in Article 60(2) of the BPR (10 years). 
Company A is a participant in the Review Programme established under Article 89 of the Biocidal Products Regulation (BPR), and is listed as a substance supplier in the Article 95 list. Following a specific date, for example 1 August 2015, Company B, which is affiliated to Company A, takes over the role of substance supplier as well as the role of participant in the Review Programme, from Company A. How should these changes be formally recorded?

The companies need to submit a joint notification in accordance with Article 10(2) of the Review Programme Regulation (Regulation (EU) No 1062/2014) to update the identity of the participant. R4BP 3 does not currently include such a facility. However, the notification can be made using the following web form: https://comments.echa.europa.eu/comments_cms/BiocidesJoiningOrReplacingParticipants.aspx

If ECHA finds the notification to be compliant, the information in R4BP 3 will be updated accordingly. Following from this, Company B will be listed instead of Company A in the subsequent update of the Article 95 list.

What is the purpose of data-sharing?

As described in Article 62(1) and Recital 57 of the BPR, the legislator has placed a new objective which is "to minimise the number of tests on animals".

Hence the BPR sets now a specific obligation on the applicants to "share and not duplicate studies on vertebrate animals in exchange of equitable compensation." Data sharing increases the efficiency, reduces costs and reduces testing, in particular, on vertebrate animals.

In the context of Article 95, in light of the timeframe for submissions (inclusion on the list by 1/9/15 if the products are to remain on the market), the scope of mandatory data sharing is extended to certain non-vertebrate studies as concerns active substances in the Review Programme in order to allow applicants to prepare their submissions on time.

Which actors have data sharing obligation under Biocidal Products Regulation?

The BPR data sharing obligations apply to data owners and prospective applicants. A prospective applicant is "any person intending to perform tests or studies" (Article 62(2) and Article 63(1). Data submitters have the obligation to facilitate contacts between the prospective applicant and the data owner(s).

What must any person do if they need to perform tests or studies?

Any person intending to perform tests on vertebrates is required to first inquire with ECHA whether such tests or studies have already been submitted to a competent authority under the BPR or Directive 98/8/EC (the previous legislation).

Such an inquiry is optional in case of tests not on vertebrates.

If such tests or studies have been submitted, ECHA will provide the prospective applicant with the contact details of the data submitter. In cases where the data submitter is not entitled to negotiate access to the data, they are required to facilitate the contact between the prospective applicant and the actual data owner.

More information on how to inquire to ECHA (manuals and tools) is available on the ECHA website dedicated to BPR.

Where such an inquiry is made, and the studies have been submitted under either the BPR or Directive 98/8/EC, data sharing obligations apply.

If such tests do not exist and you would like to initiate them then as laid out in the introduction to Annex III to the BPR "The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set out in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out" (emphasis added). Therefore, we would encourage you to contact the Member State Competent Authority in charge of your application in order to discuss this test including potentially applicable additional legislative requirements.

 

 

 

What is meant by "compensation for Data Sharing"?

Following an inquiry and, according to Article 63(1) and (4), the parties involved must:

  • make every effort to reach an agreement on the sharing of the results of tests or studies requested (whether involving or not vertebrate animal studies);
  • ensure that the costs of sharing these tests or studies are determined in a fair, transparent and non-discriminatory way.

Further information is available in ECHA's Guidance on data sharing

ECHA will not determine what the compensation should be. The parties have the option of settling this matter before a national court.

How shall the negotiations be conducted?

The obligation to reach an agreement on the sharing of the results of the tests and studies requested is the exclusive responsibility of the negotiating parties which bear the obligation to make every effort to reach an agreement.

Negotiating parties shall consider the following in order to fulfil their data sharing obligations in a timely manner:

  • To ensure the sharing of the tests or studies, parties are encouraged to allow a reasonable time for the negotiations between their inquiry to ECHA and before the actual planned submission of the dossier.
  • The prospective applicant should define clearly the scope of the negotiations, by being explicit on the studies and tests requested (regarding vertebrate or non-vertebrate studies).
  • As it is the responsibility of the parties to make every effort, the argumentation against any claim or element of the negotiation shall be expressed between the parties; ECHA is never a party in the negotiations.
  • Both the prospective applicant and the data owner should be constructive, reliable and consistent negotiating partners, make sure to provide precise information and be proactive and transparent at all times in the negotiations.

More information is available in the "Key Messages" document in the BPR Data sharing web page.

What can a prospective applicant do if they do not reach an agreement to share data or costs with the data owner/submitter?

Where no agreement is reached during the negotiations, the prospective applicant can, as a last resort, inform ECHA of the failure to reach an agreement with the data owner on the sharing of the data or of its costs, at the earliest one month after the original receipt from ECHA of the contact details of the data owner (or data submitter). The prospective applicant shall also notify the data owner that they have informed ECHA. The ECHA data sharing dispute procedure should be initiated after all possible efforts have been made and the negotiations have failed. Having submitted an inquiry is the pre-requisite before lodging a data sharing dispute claim with ECHA, including in situations where the prospective applicant already knew the data owner(s) or where negotiations had already started before the entry in force of the BPR.

ECHA strongly recommends continuing the negotiations also after a data sharing dispute claim has been filed.

What if the negotiations have started before 1 September 2013?      

Under the previous legislation (Directive 98/8/EC), there was no mandatory data sharing obligation. The new obligation under the BPR cannot have retroactive effect, and ECHA cannot take into consideration what was discussed prior to 1 September 2013 in a data sharing dispute. Where negotiations started before the entry into application of the BPR, parties should identify the remaining points of disagreement and the points on which they have reached an agreement as of 1 September 2013. This can serve as a basis for the negotiations that must take place after 1 September 2013. It remains mandatory for "any person intending to perform tests or studies on vertebrate animals" to submit an inquiry to ECHA and to negotiate for at least one month after receiving the relevant contact details, before being entitled to submit a data sharing dispute claim. This applies equally to studies not involving tests on vertebrates under Article 95.

What is a reasonable time for the negotiations for data sharing?

The BPR requires as a minimum of 1 month (Article 63(3)) after the prospective applicant receives the name and address of the data submitter from ECHA. However, when submitting the data sharing dispute claim the prospective applicant and data owner have to demonstrate that they have made every effort and exhausted all possibilities in the negotiations.

How is the reference to Article 63(3) of the BPR in Article 95(3) to be understood? Does mandatory data sharing apply to all toxicological and eco-toxicological studies, as well as environmental fate and behaviour studies, including non-vertebrate studies?

In the event of a data sharing dispute claim under Article 63(3), ECHA can grant the prospective applicant permission to refer to vertebrate studies.

For the purpose of Article 95, and studies regarding an active substance in the Review Programme, the scope of the data to which ECHA can grant permission to refer in an Article 63(3) dispute is expanded to include non-vertebrate data on toxicological, ecotoxicological and environmental fate and behaviour studies. This facilitates applicants meeting the Article 95 deadline of 1/9/15.

Does the data owner have to share non-vertebrate data, if asked for it?

Article 63(1) states where a request has been made in accordance with Article 62(2) the prospective applicant and the data owner have to make every effort to reach an agreement. This applies also where the prospective applicant requested to share non-vertebrate data.

In the event of failure to reach an agreement, under Article 63(3), ECHA can grant the right to refer to non-vertebrata data where the request to share was made further to an inquiry under Article 62(2) and in the context of an Article 95 application concerning an active substance in the Review Programme.

Does the non-EU data owner have the obligation to share data?

The BPR data sharing obligation applies to data owners whether they are established in the EU or not. In most cases the data submitter will be based in the EU. The data submitter has the responsibility to facilitate contacts between the prospective applicant and the data owner.

Is the data sharing obligation limited to situations where the applicant's substance is the same as the one on which the tests were carried out?

No, the data sharing under BPR is not limited to the same substance. Technical equivalence is not a condition for data sharing under Article 62 and 63 of the BPR (in contrast to the same substance condition under the REACH data sharing provisions). For example, shared data can be used for bridging and read across.

In case of affiliates/multinational company, do all affiliates need to be listed or is it enough to have one legal entity on the list?

For the purposes of Article 95(2), as per the amendments introduced by Regulation 334/2014, the biocidal product can only remain on the market after 1/9/15 if either the product supplier or the substance supplier is on the list. Therefore not all the affiliates must be on the list. Only those who act as product or substance supplier and are not linked in the supply chain to the legal entity on the list would need to be also on the list.   

Where an alternative Annex II dossier is submitted for the purpose of Article 95, will there be a detailed review of efficacy data as already submitted by the existing participants?

The Article 95 compliance check on alternative substance dossiers is not a detailed review. For an alternative dossier submission, basic information on efficacy would be sufficient. Further information will be requested at the product authorisation stage.

Can you be listed on the Article 95 list for existing active substances after September 2015 if you submit a compliant application after that date?

Yes, applications can be submitted also after September 2015 and inclusion on the list will follow when the application is deemed successful.

However, the entity making biocidal products available on the market must ensure that the relevant substance supplier or product supplier is included on the list as at 1/9/15 or the products will need to be removed from the market from that date (until the substance supplier or product supplier is eventually included on the list).

How long does it take to be listed on the Article 95 list once a submission is made or the positive compliance check decision is taken? And how often will the list be updated?

An application must always be reviewed by ECHA. The time between submitting the application and being placed on the list depends on the type of submission (complete substance dossier, LoA or the combination of both), and, where relevant, the quality of the dossier submitted. For dossiers it might take several months but an application based on a LoA to a complete substance dossier should take less time to process. We will aim at updating the list on a monthly basis.

Is it enough if either the manufacturer of the active substance or the manufacturer of the biocidal product is on the list?

Either one is enough within a given supply chain, that is to say there must be a clear connection to the product made available on the market.

Where a product supplier is listed, will the source of the substance be made public?

No. The list will only contain the names of the substances, product type, names of companies and roles (substance or product supplier).

The source of the active substance in a biocidal product will become public when the SPC for the biocidal product is published by ECHA under Article 67(2) of the BPR.

Will trade names or qualities be given in the Article 95 list or how can a formulator be sure that its active substance is on the list?

Trades names will not be included in the Article 95 list. We advise you to consult your supplier to better identify the active substance you use in your product.

Can you make an Article 95 application providing a LoA to another full Article 95 dossier even if that had not been evaluated yet?

An application to be included on the Article 95 list can be made by providing a letter of access (LoA) to a "complete substance dossier". Where an alternative dossier has been submitted for Article 95 purposes, a second Article 95 application with a LoA to that dossier can be made as soon as the alternative dossier application fee has been paid. However, the LoA application can only be approved once ECHA has found the alternative dossier as compliant with Article 95(1) and therefore qualifying as a complete substance dossier.

Can non-EU companies be included in the Article 95 list?

No OR facility is provided for under the provisions of the BPR. According to Article 95(1), a substance supplier or product supplier must be established in the EU.

 

To ensure equal treatment, ECHA and the Commission have agreed that non EU participants in the Review Programme can be listed in the Article 95 list next to their EU representative. Non-EU manufacturers of active substances or biocidal products may also apply for inclusion on the Article 95 list via a representative based in the EU.

The non EU entity will be listed next to the name of their EU representative.

What are the obligations of the EU representative for Article 95 under the BPR?

Under the BPR, only EU companies fall within the definition of substance supplier or product supplier. The role of the EU representative has therefore been created to allow non-EU manufacturers to appoint an EU representative to apply for inclusion on the Article 95 list on their behalf. The list will display both the names of the EU representative and the non-EU supplier.

Unlike the ‘Only Representative' under REACH, the role is not associated with any specific regulatory obligations or responsibilities, and it was developed only for Article 95 purposes. This is also because the obligations under Article 95 are ultimately the responsibility of the parties making the biocidal product available on the market in the EU (Article 95(2)).

In summary, it is entirely up to the non-EU manufacturer to decide if it wishes to appoint an EU representative and who it wishes to appoint. The responsibilities of the EU representative would be set out in a contract with the non-EU manufacturer, and would normally include to make the application for Article 95 inclusion and, for example, further to a reasoned request from a competent authority, to provide it with the information and documentation necessary to demonstrate the role of the non EU company in the supply chain of a product made available on the market.

Is it possible for the same company to be listed on the Article 95 list as a ‘substance supplier' and as a ‘product supplier' for the same substance?

Yes, a company can have both roles, and if indicated in the application they can be listed for both roles.

How can a small company become listed as a "product supplier" if the active substance supplier is not applying to be included in the list of active substances and suppliers?

In this case an application can be made by the entity which manufactures the biocidal product or who makes it available on the market, for inclusion on the list as a product supplier. The applicant will need to submit either an alternative Annex II dossier, or obtain a letter of access to the Annex II data on the active substance. To receive the contact details of the data submitter of the Annex II complete substance dossier, the applicant should submit an inquiry under Article 62(1) of the BPR. For the purposes of Article 95 and active substances in the Review Programme, mandatory data sharing applies to vertebrate data and also non vertebrate data (toxicological, ecotoxicological, environmental fate and behaviour).

Would a submission made under the REACH Regulation satisfy the requirements of the BPR?

o, the BPR is a different regulation and a separate application needs to be submitted.

What if my application for inclusion in the Article 95 list is rejected?

ECHA will issue draft decisions on the applications and the applicant will have a possibility to update their application taking ECHA's comments into account.

If, after such update, the application is considered as non-compliant, the applicant will receive a communication in writing stating the deficiencies and reasons. The relevant person will not be included in the Article 95 list. A new application could be submitted to address the issues identified by ECHA in its decision. The rejection decision may also be challenged before the Court of Justice of the European Union (General Court).

What if ECHA does not manage to run the compliance check before 1 September 2015?

ECHA advises companies to submit their applications well in advance of 1 September 2015. Article 95(3) states that as of 1 September 2015, a biocidal product should not be made available on the market unless the substance supplier or product supplier is included on the list. Please note that Article 95 does not indicate any deadline for processing an application but ECHA will process the applications without undue delay through the compliance check as efficiently as possible.

Are the fees applied per dossier submitted or per number of product types (PT)s for which the listing has been requested?

Fees apply per dossier and active substance. Hence several product types can be indicated in one application.

Can an EU-based toll manufacturer sell an active substance or a biocidal product (consisting of, containing or generating that active substance) to customers in its own right?

Article 95 does not place any restriction on who can sell (make available on the EU market) the active substance. Therefore a toll manufacture is not prohibited by Article 95 from selling an active substance to a customer in its own right. Article 95(2) provides that a biocidal product may not be made available on the EU market unless either the substance supplier or the product supplier is on the Article 95 list. The responsibility falls on the first person making the product available on the market to ensure there is an appropriate listing among the actors in the supply chain. Where it is the toll manufacturer who manufactures the biocidal product (and who is not on the Article 95 list itself), it can sell (make available on the EU market) a biocidal product to a customer in its own right if the active substance is on the Article 95 list. The toll manufacturing contract would also be relevant as regards agreed conditions applying to the manufacture and supply by the toll manufacturer.

Can an EU-based toll manufacturer manufacture active substances for a supplier which is not on the Article 95 list?

Article 95 does not place any restriction on who can manufacture the active substance. Therefore a toll manufacture is not obliged by Article 95 to only manufacture an active substance on behalf of a substance supplier who is on the Article 95 list.

Is an EU-based toll manufacturer of active substances obliged to be on the Article 95 list?

Article 95 does not place any restriction on who can manufacture the active substance. Therefore an EU-based toll manufacturer of active substances is not obliged to be on the Article 95 list.

BPR General

When will the Union list of approved active substances be made publicly available?

The Union list of approved active substances mentioned in Article 9(2) of the BPR is publicly available on the website of DG Environment of the European Commission:
http://ec.europa.eu/environment/chemicals/biocides/active-substances/approved-substances_en.htm

ECHA maintains a similar list on its website:
http://echa.europa.eu/information-on-chemicals/biocidal-active-substances

Pursuant to Article 67(1) of the BPR, as amended by Regulation (EU) No 334/2014, approved active substances are added on this list from the date on which the Commission adopts an implementing Regulation providing that an actice substance is approved.

Should I register an active substance under the REACH Regulation?
Active substances which are on the Union list of approved active substances under the BPR (which includes those active substances included in Annex I to Directive 98/8/EC), or which are under evaluation in the Review Programme (Regulation (EC) No 1451/2007) are "regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product" (see Article 15(2) of the REACH Regulation). This only applies to approved active substances and "existing" active substances in the Review Programme, not to on-going evaluations of "new" active substances, or where the evaluation led to a non-approval decision, or to new active substances not yet submitted for approval. 
 
The exemption from REACH registration provided by Article 15(2) of REACH is extended by Article 57 of the BPR to also cover active substances manufactured or imported for use in biocidal products authorised in accordance with the BPR, Article 27 (simplified authorisation); Article 55 (by particular derogation) or Article 56 (research and development).
 
Accordingly, if an active substance is manufactured or imported without an intended and/or demonstrated claim of use in biocidal products, the registration obligations under REACH apply. If, on the other hand, the active substance is imported solely with the intended use and/or demonstrated claim for use as a biocidal product or to be incorporated in another biocidal product, the requirements of the BPR apply. This also includes the appropriate classification, labelling and packaging of the biocidal product in accordance with Article 69 of the BPR. 
 
Is a safety data sheet required for active substances and biocidal products according to the BPR?
The requirement to prepare a safety data sheet (SDS) for substances and mixtures according to Article 31 of the REACH Regulation applies for active substances and biocidal products. This is confirmed by Article 70 of the BPR. 
 
Note that an exposure scenario to be attached to the SDS would not be required for substances considered as registered, i.e. active substances which are included in the Union list of approved active substances (which includes those active substances included in Annex I to Directive 98/8/EC) or are under evaluation in the Review Programme (Regulation (EC) No 1451/2007) to the extent they are manufactured or imported for use in biocidal products only (see Article 15(2) of the REACH Regulation). For such substances no chemical safety report (CSR) is required according to REACH Article 14 and therefore an exposure scenario would not be required to be attached to the SDS.
 
Active substances which are not manufactured or imported only for use in biocidal products may require registration under the REACH Regulation. Where a CSR would be required according to Article 14 of REACH, an exposure scenario for all identified uses not covered by Article 15 (REACH) would be required to be attached in the SDS.
Do I need to submit a renewal of national authorisation in R4BP 3 if an application for national authorisation submitted via R4BP2 is under evaluation?
No. A renewal of national authorisation can only be granted for an existing authorisation. 
For an existing national authorisation, an application for renewal shall be submitted to the relevant Member State authority via R4BP 3.
 
For biocidal products that contain an active substance for which the approval will expire within 550 days and for which the national authorisation has not yet been granted, the applicant might have difficulties to submit an application for renewal in accordance with Article 31 of the BPR that states that applications have to be submitted at least 550 days before the authorisation expires. Since the applicant may have been prevented from applying for renewal for a reason that is not under its control, the applicant should contact the relevant MSCA to inquire if the application may still be accepted after the renewal deadline has passed.
 
Which active substances ('ASs') in a biocidal product containing more than one AS have to be approved before the product can be authorised under the BPR?
According to Article 19(1)(a) of the BPR, a biocidal product can only be authorised if all the ASs are approved for the relevant product-type ('PT'). 
 
However, a distinction is made between ASs contributing to the biocidal function(s) of the product and ASs which have no intended biocidal function outside of the product. The latter category are commonly called ‘silent ASs'; typically in-can or film preservatives aimed at preserving the biocidal product itself from bacterial deterioration. A biocidal product containing a so-called silent AS can be authorised under the BPR even before the silent AS has been approved. This is because the approval requirement under Article 19(1)(a) of the BPR should be read with the function of the product in mind. Given that silent ASs do not make any significant contribution to any of the biocidal functions of the product, similarly to non-active substances, their previous approval is not required. However, such ASs must be under evaluation at the moment of the application for product authorisation.
Do ecotoxicological and toxicological tests have to comply with the principles of good laboratory practice (GLP)?
According to point 6 of Annexes II and III to the BPR, ecotoxicological and toxicological tests should be performed in compliance with the principles of good laboratory practice or other international standards recognised as being equivalent by the Commission or ECHA. Note that for the time being, no 'other international test methods' within the meaning of point 6 of Annexes II and III to the BPR have been recognised by the Commission or by ECHA.
 
Further information can be found in the Guidance on information requirements for Biocides.
Is an annual fee payable to ECHA also for a Union Authorisation granted through the Same Biocidal Product regulation?

Yes, an annual fee is payable to ECHA also for a Union Authorisation granted through the Same Biocidal Product Regulation (Commission Implementing Regulation (EU) No 414/2013). 

What is the fee for Union authorisation of a same biocidal product application?

Fee payable to ECHA (ref. (EU) No 564/2013 – Biocides Fee Regulation):

A fee for “Union authorisation of a same biocidal product” is specified in Annex II, Table 1 of the Biocides Fee Regulation. Whether the application is for a product or for a whole family, the fee is the same.

In addition, there is an annual fee for all authorised biocidal products (single product and family) specified in Annex III of the Biocides Fee Regulation. It is applicable also to biocidal products authorised via the same biocidal product application.

A fee for “notification to the Agency of an additional product within a biocidal product family” is specified in Annex II, Table 1 and it is applicable also to families authorised via the same biocidal product application.

Fee payable to eCA:

Please note that the fees related to UA applications payable to the evaluating Competent Authority (eCA) may vary between the CAs and are established in the national legal acts of each MS. The applicant is responsible for checking and paying the specified amount of fees to the chosen eCA. For more information about the CA fees, the applicant should contact the CA or its helpdesk. The contact information for national helpdesks is available at: https://echa.europa.eu/support/helpdesks

Data Sharing

What are the data sharing requirements under the BPR?
Under the BPR, new studies involving vertebrate animals can be conducted only as a last resort and, therefore, mandatory data sharing applies.

Prospective applicants, intending to perform new tests on vertebrate animals, have an obligation to find out which tests and studies are already available, by submitting an inquiry through R4BP 3 to ECHA.

Prospective applicants may also inquire about tests and studies not involving tests on vertebrate animals. Accordingly, an inquiry is mandatory when the intention is to perform tests on vertebrate animals and is optional when the intention is to perform tests which do not involve vertebrate animals. An inquiry is also a pre-requisite before a data sharing dispute claim can be submitted to ECHA under Article 63(3) of the BPR (including in cases where the prospective applicant already knows the identity of the data owner).

Once a request for test data (on vertebrate animals or not) has been made to a data owner (or any data submitter that is entitled to negotiate on behalf of the data owner), the parties must make every effort to reach an agreement to ensure that the cost of sharing the information is determined in a fair, transparent and non-discriminatory way, in accordance with the provisions of Article 63(1) and (4) of the BPR. ECHA will provide the inquirer with the contact details of all previous data submitters, when tests or studies were already submitted to the competent authorities or ECHA in connection with an application under the former Directive 98/8/EC or the BPR. Where applicable, the data submitters are required to facilitate the contacts between prospective applicants and data owners.

Please consult the ECHA website on inquiry, available at: http://www.echa.europa.eu/ regulations/biocidal-products-regulation/data-sharing/inquiry and at:
http://echa.europa.eu/support/dossier-submission-tools/r4bp/submit-inquiry-share-data-active-substance

The data sharing obligation also applies to the inclusion in the list of relevant substances and suppliers under Article 95 of the BPR. Note that mandatory data sharing for the purpose of Article 95 extends to all toxicological, eco-toxicological and environmental fate and behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, including any such studies not involving tests on vertebrate animals.

Please consult the ECHA website on data sharing (and the related documents), available at:
http://www.echa.europa.eu/regulations/biocidal-products-regulation/data-sharing
How to get contact details of the substance/product supplier under Article 95 to ask for the LoA?

The provisional list of active substances suppliers contains the name of the company/companies that submitted the data. You may wish to contact them and to ask for a LoA: http://echa.europa.eu/information-on-chemicals/active-substance-suppliers

A prospective applicant can also turn directly to ECHA to get contact details to the data submitter(s) of an active substance or a biocidal product by making an inquiry as described below.

Any person intending to perform tests or studies (or asking for a LoA), for the purposes of an application under the BPR, is required to first inquire with ECHA whether such tests or studies have already been submitted to a competent authority under the BPR or Directive 98/8/EC (the previous legislation).

Such an inquiry is optional in case of tests not on vertebrates.

If such tests or studies have been submitted, ECHA will provide the prospective applicant with the contact details of the data submitter. In cases where the data submitter is not entitled to negotiate access to the data, they are required to facilitate the contact between the prospective applicant and the actual data owner.

Where such an inquiry is made, and the studies have been submitted under either the BPR or Directive 98/8/EC, data sharing obligations apply.

Such an inquiry must be submitted to ECHA through R4BP3.

After the inquiry has been assessed, the requester will be informed if such tests or studies have been submitted. ECHA will give the contact details of the data submitter to the applicant, and at the same time communicate the inquirer's contact details to the data submitter.This information will be retrieved from dossiers submitted under the BPD and the BPR. ECHA will not provide information on individual tests or studies.

Please note: Having submitted an inquiry is the pre-requisite before lodging a data sharing dispute claim with ECHA, including in situations where the prospective applicant already knew the data owner(s) or where negotiations had already started before the entry in force of the BPR.

In-situ generated a.s.

What data on precursors are expected to support the assessment of active substances generated in situ?

Guidance is under development and subject to consultation with the Member State competent authorities.

How can I prepare a dossier in IUCLID for the active substance and the precursor(s), including waiving of data?

To submit Annex II data for precursors for each precursor of an in situ active substance, you have to create a separate substance dataset in IUCLID.

Depending on the properties of a substance, you should use the corresponding dataset template in IUCLID for either a "BPR Substance of concern" (if the precursor is considered a substance of concern) or "BPR Basic information" (substance) to insert the required data.

If a study has been waived according to the specific rules for waiving data requirements in Article 21 of the BPR, then you must identify this in an endpoint study record.

For further information, see ECHA's Biocides Submission Manual Technical guide: using IUCLID MANUAL (Annex II) at the following link: http://echa.europa.eu/documents/10162/14938692/bsm_01_using_iuclid_en.pdf

How can I report the conditions under which the in situ generated active substances are created?

You need to provide a comprehensive description of the generation process. This should include the generation conditions as pH value, concentrations of the precursors and all parameters that impact the generation and reaction schemes of each single step in the chemical reaction from the precursors to the in situ generated active substance (i.e. including the active constituents and impurities.

Impurities may comprise by-products, unreacted precursors (starting materials) and constituents of secondary or incomplete reactions).

You should report this information under the section "2.8 Method of manufacture" of the data package on the active substance generated in situ, i.e. in the respective "BPR active substance information" dataset template in IUCLID.

How can I derive reference specifications and reference sources (technical specifications)?

You can normally derive the reference specification from the five-batch analysis. However, for in situ generated active substances, reliable analytical information might not be achievable. Therefore, you should calculate the concentration of each constituent (active constituent, impurities) in a stoichiometric way based on the precursors and their applied concentrations.

This calculation should indicate the chemical species and their concentrations generated in situ, but it cannot be regarded as the reference specification of the active substance. The specification will be defined through the composition of the precursors.

You should report this information under Sections 2.9 and 2.10 Specification of purity and identity of impurities of the data package on the active substance generated in situ, i.e. in the respective “BPR active substance information” dataset template in IUCLID.

A five-batch analysis is not required for the in situ generated active substance if the generated substance is not stored or isolated. However, for the precursors, certificates of analyses might be acceptable.

If the in situ generated substance is stored, even for a short time, sampling seems to be possible and therefore a five-batch analysis has to be provided. (ref. Section 2.11 Analytical profile of Annex II to the BPR.)

 

Is a risk assessment for the precursors needed or is hazard assessment sufficient for the precursors?

Both risk assessment and hazard assessment are required for precursors.

Further guidance is under development.

 

Do I have to assess the efficacy of precursors?

You have to provide the efficacy data for the active substance generated in situ. Depending on the system, you could approach assessing the efficacy in different ways. The manufacturer of the in situ generated active substance is best placed to provide ways of demonstrating the substance efficacy. That includes, for example, testing on the pure active substance together with evidence that a corresponding concentration is achieved with the in situ generation system.

This further implies that you have to provide information on the storage stabilities of the precursors necessary to generate the in situ active substances.

Do I need to assess the substitution and exclusion criteria for the precursors?

According to the competent authority meeting document (CA-Nov15-Doc.5.5), only the properties of the in situ generated active substance are considered to define whether the exclusion, substitution and Annex I listing criteria are met during the approval process. However, please note that an in situ generated active substance includes active constituents and impurities, where impurities may comprise in situ generation reaction by-products, unreacted precursors (starting materials) and constituents of secondary or incomplete reactions.

Link to CA-Nov15-Doc.5.5
https://circabc.europa.eu/d/a/workspace/SpacesStore/a0cb1d57-9287-4cd2-975e-e473b411cb5f/CA-Nov15-Doc.5.5%20-%20Final%20-%20Classification%20and%20in%20situ%20generated%20AS.doc

What needs to be classified?

As the harmonised classification plays a key role in assessing the exclusion or substitution criteria, the active substance generated in situ must be classified. 

A harmonised classification will be proposed by the evaluating competent authority (eCA) on the in situ generated active substance.

When the eCA considers that it has appropriate information on the precursors, they may also submit a CLH dossier for the precursors to ECHA to establish or amend the harmonised C&L. This can later help in the product authorisation stage, and could be important for product authorisation. (See competent authority meeting document CA-Nov15-Doc.5.5)

Warnings resulting from the classification of the active substance generated in situ should be added in the instructions of use accompanying the products placed on the market, i.e. the precursors.

Link to CA-Nov15-Doc.5.5

https://circabc.europa.eu/d/a/workspace/SpacesStore/a0cb1d57-9287-4cd2-975e-e473b411cb5f/CA-Nov15-Doc.5.5%20-%20Final%20-%20Classification%20and%20in%20situ%20generated%20AS.doc

Parallel Trade

Is a parallel trade permit an authorisation for a biocidal product?
A parallel trade permit is not an authorisation for a biocidal product. As clarified under Regulation (EU) No 334/2014 (amending certain provisions of the BPR), a parallel trade permit functions as a derogation to Article 17 of the BPR – the product authorisation requirement. 
 
According to Article 53 of the BPR, a parallel trade permit allows the holder of the permit to make available on the market and use a biocidal product in a Member State (Member State of introduction), if the biocidal product is authorised in another Member State (Member State of origin) and if the biocidal product is identical to a biocidal product already authorised in the ‘Member State of introduction' (the reference product). 
 
The competent authority of the Member State of introduction has to examine whether the two biocidal products are identical in accordance with the legislation and may request information from the Member State of origin. 
 
 
Review programme

What happens if the withdrawal (by all the participants supporting the active substance/product-type combination) takes place after the evaluating Competent Authority (eCA) has submited the draft Competent Authority Report (CAR) to the applicant?

The decision making process continues on the basis of the draft CAR (i.e. BPC opinion) and there will be no opportunity for anyone else to take over the role of participant.

When will the Article 95 list be updated following the joining, or replacing of one of the participants by mutual agreement?

Updates of the Article 95 list are foreseen to take place once a month. ECHA intends to take all changes within that month into account.

When will the Article 95 list be updated following the notification to take over the role of participant?

Article 95 only applies to "relevant substances" i.e. substances for which the application for approval of the active substance has been submitted and validated by the evaluating Competent Authority. Therefore, following the submission of a compliant notification to take over the role of participant, the Article 95 list will not be updated until the evaluating Competent Authority has validated the active substance application (which can be over two years later).

Who can submit notifications?

Any natural or legal person can submit a notifications to take over the role of participant.

Do you need to make separate notifications per active substance/ product-type combination, or can one notification cover for several product- types? Do companies need to pay the notification fee for each PT?

The notification can be for one active substance in one or more PTs. The notification fee is per notification of an active subsance and covers all PTS notified. The fee is then deducted from the active substance approval fee.

Will a notifier (under Article 17) be reimbursed the fee that it had paid, if the notification is rejected?

It is the responsibility of the notifier to provide all the necessary data. If the data is not complete (following one request for additional information) the notification will not be compliant. A recovery of fees is not provided for in the legislation.

Can a group of companies (e.g. a taskforce) submit a joint notification?

Yes, a group of companies (e.g. a taskforce) can submit one notification. The active substance will become relevant for Article 95 when the application for approval of the active substance is submitted and validated by the eCA. The companies which apply jointly for the approval of the active substance will then appear on the Article 95 list individually.

From which evaluating Competent Authority (eCA) should I get the agreement to evaluate my application?

If no eCA is mentioned in Annex II of the Review Programme Regulation (EU) No 1062/2014 for the active substance/product-type in question, the applicant may choose any competent authority, as defined under Article 81 of the BPR, that would agree to evaluate the application for approval.

When submitting a notification to take over the role of participant for a substance which is on part 2 of Annex II of the Review Programme Regulation, is it necessary to provide evidence that the substance is an exisiting active substance?

Part II of Annex II of the Review Programme Regulation lists review active substances that are no longer supported which means that these substance are existing active substances (on the market on 14 May 2000). The notification for taking over the role of participant for these substances does not require evidence that the substance is an existing one.

How do you submit a Declaration of Interest to notify an active substance/product-type for inclusion in the Review Programme (Article 15 of the Review Programme Regulation)?

Declarations of interest need to be submitted via the ECHA webform under "new combinations of  substance/product-types in the Review Rrogramme" http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance 

Simplified authorisation

How can a company request an amendment of Annex I of the BPR?
The European Commission has adopted an Implementing Regulation (Commission Implementing Regulation (EU) No 88/2014) specifying the procedure for amending Annex I of the BPR. It clarifies the procedure to be followed when an application is made to include a substance in Annex I.The regulation confirms that the application follows the procedure of Article 7 of the BPR.
 
The data requirements for the inclusion of an active substance are given in Annex I to Regulation (EU) No 528/2012.
 
You can find the Implementing Regulation at:
 
How much are the fees for the simplified authorisation procedure according to the provisions of the BPR and how can a company apply for it?
A simplified authorisation can be requested as of 1 September 2013 if the conditions in Article 25 are satisfied. The fees applicable for the dossier evaluation depend on the competent authorities selected by the applicant for the evaluation process as described in Article 26(2) of the BPR. 
 
Note that the Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 concerns only the fees and charges payable to ECHA pursuant to Regulation (EU) No. 528/2012. 
 
The format acceptable for the submission of a simplified authorisation is a IUCLID file submitted through R4BP 3. Applicants are requested to use the general template for product authorisation by filling in only the relevant parts described under Article 20(1)(b).
 
Treated articles

How to comply with the BPR for placing on the market treated articles which have been treated with, or include, biocidal products containing active substances?
According to Article 58(2) of the BPR, only treated articles that have been treated with or include biocidal products containing active substances included in the list drawn up in accordance with Article 9(2) (Union list of approved active substances) for the relevant product-type and use, or in Annex I, and any conditions or restrictions specified therein are met can be placed on the EU market. The active substances included in Annex I to Directive 98/8/EC have been transferred to the Union list of approved active substances as of 1 September 2013.
 
The BPR also requires that the person responsible for the placing on the market of such a treated article shall ensure that the treated article is labelled when: 
 
1. a claim that the treated article has biocidal properties is made
2. it is required in the conditions of the approval of the active substance contained in the biocidal product used to treat the article
 
The label shall provide the information referred to in Article 58(3) of the BPR and needs to be easily understandable and visible for consumers.
 
More information on treated articles can be found in the ‘Note for Guidance on Frequently asked questions on treated articles' available on the ECHA website at:
 
Note that Article 94(1) of the BPR (amended by the Regulation (EU) No. 334/2014 of 11 March 2014) seeks to allow the placing on the market of articles treated with biocidal products containing active substances which, albeit not yet approved, are being evaluated, either in the context of the work programme referred to in Article 89(1) of the BPR or based on an application submitted by 1 September 2016 pursuant to Article 94(1). 
 
The text of the Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 (BPR) concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market, is available at:
Is my product a treated article, a biocidal product or neither?
The decision on whether a product is a biocidal product, a treated article or neither will always have to be taken case-by-case, considering all properties and functions, as well as the intended use of an article. 
 
A claim, for instance that an article itself is protected by a biocidal treatment, is likely to be considered a claim about a biocidal property rather than indicating a biocidal function, and is unlikely to drive a decision that the article would be considered a biocidal product. 
 
Member States may request the European Commission, according to Article 3(3) of the BPR, to take a decision on whether a product is a biocidal product, a treated article or neither. 
 
More information on treated articles can be found in the Note for Guidance on Frequently asked questions on treated articles available on the ECHA website at:
 
The guidance includes a decision tree which may help deciding whether an object treated with or intentionally incorporating one or more biocidal products is a treated article, a biocidal product or neither.
Does the BPR foresee transitional measures for the labelling and information requirements for treated articles?
The BPR does not foresee transitional measures for the labelling of treated articles. This means that all treated articles placed on the market from 1 September 2013 onwards have to comply with the labelling and information requirements set out in Article 58(3) and (4) of the BPR. It has to be noted that the provisions of Article 58(3) and (4) concern the ‘placing on the market', and not the subsequent supply, of the treated article, and that there is no mandatory labelling of all treated articles already present in the supply chain on 1 September 2013. 
 
It must be emphasised that the aim of the legislator when imposing a labelling requirement for treated articles is to enable consumers to make informed choices, facilitate enforcement and provide an overview of their use. It is for the person placing the treated article on the market to make sure that this aim is respected while fulfilling the labelling requirements for treated articles.
Does Article 95 of the BPR apply to treated articles, i.e. can a mixture or article only be treated with or intentionally incorporate a biocidal product containing an active substance if the supplier has submitted a dossier or a letter of access to ECHA?

The requirements of Article 95 do not apply to active substances used only in treated articles governed by Article 58 of BPR. Article 95 applies only to active substances placed on the EU market in biocidal products, or with the intention of being used in biocidal products.

CLP

Annex VI to CLP

Where can I find the updated version of Table 3.1 of Annex VI to CLP?

The European Commission issues Adaptations to Technical Progress (ATPs) to the CLP Regulation, which provide updates to the harmonised classification and labelling in Table 3.1 of Annex VI to CLP. The updated version of this table is included in the Classification and Labelling Inventory managed by ECHA. 

ECHA has prepared an unofficial excel table containing all updates to the harmonised classification and labelling in Table 3.1 of Annex VI to CLP (http://echa.europa.eu/information-on-chemicals/annex-vi-to-clp).

The table should be used for informative purposes only as it could contain inconsistencies with the legally-binding entries in Annex VI to CLP as published in the Official Journal of the European Union (http://echa.europa.eu/regulations/clp/legislation).

What should you do where you have to use a harmonised classification which is marked as minimum classification in Table 3.1 of Annex VI to CLP?

In order to take full account of the work and experience accumulated under DSD, all previously harmonised DSD substance classifications were translated into harmonised CLP classifications. For substances with harmonised classifications for the hazard classes acute toxicity and STOT (repeated exposure), minimum classifications were assigned. These minimum classifications take account of the fact that the exact translation of the DSD criteria into the CLP criteria was not possible, based on the lack of available data.

 

Manufacturers or importers must apply at least this minimum classification (marked with an asterisk), but must classify in a more severe hazard category when they have further information, e.g. in the form of an LD50 value, which shows that a more severe category is more appropriate. 

Can a manufacturer, importer or downstream user submit to the Agency a proposal to introduce additional harmonised classification and labelling elements to an existing entry in Part 3 of Annex VI?

Yes. A manufacturer, importer or downstream user can submit a proposal to introduce additional harmonised classification and labelling elements to an entry in Part 3 of Annex VI to CLP directly to the Agency. A condition for submitting such a proposal is that the additional harmonised classification and labelling elements concern a hazard class or differentiation not yet covered by the harmonised classification of the substance in Part 3 of Annex VI. The procedure is described in Article 37(2) of CLP.

Where a change to the existing harmonised classification and labelling elements of a substance in Part 3 of Annex VI to CLP is proposed, the manufacturer, importer or downstream user must submit the proposal to a competent authority of a Member State in which the substance is placed on the market (Article 37(6)).

When a manufacturer, importer or downstream user has new information which may lead to a change of the existing harmonised classification and labelling of substances regulated under the Biocidal Products Regulation (EU) 528/2012 (the BPR) or under Regulation (EC) No 1107/2009 on plant protection products (the PPPR), they must act according to Article 37(6) CLP.

As harmonised classifications in Annex VI are binding for the endpoints covered in the entry (except the minimum classifications (section 1.2 in Annex VI to CLP) indicated by the reference * in Table 3.1), it is not possible to use a different classification and labelling from a harmonised one until an ATP amending it has been published. 

If a substance is subject to harmonised classification, do I have to classify it for the hazards which are not covered by the entry in Part 3 of Annex VI?

Yes, you do. A substance, which is listed on Annex VI, must be classified in accordance with the entry in Part 3 of Annex VI. Furthermore, the manufacturer, importer or downstream user of such a substance has to carry out a self-classification in accordance with Title II for those hazard classes or differentiations where no harmonised classification is contained in the entry in Part 3 of Annex VI. For example, a substance may have a harmonised classification for acute oral toxicity, but not for acute dermal toxicity. This means that a supplier would have to explore, using the information available, whether the classification criteria for acute dermal toxicity are fulfilled, and classify accordingly. For harmonised classifications referring to the aquatic hazard classification acute or chronic category 1 where no M-factor appears on Annex VI, the classifier must set an M-factor.

Self-classification may entail new testing for those physical hazards where no harmonised classification exists and where, pursuant to CLP Article 8(2), adequate and reliable information is not available.

Classification

If a substance did not meet the classification criteria under the Dangerous Substances Directive, is it therefore also not classified under CLP?

A substance may be classified under CLP, even though it was not under the DSD. For a range of hazards, the classification criteria have changed, e.g. for many physical hazards where the test methods which determine the classification criteria are often different from those of the DSD. For other hazards, the applicable concentration limits for taking into account the classification of its constituents, additives and impurities contained in the substance have changed, e.g. for the irritation and corrosive hazards. This means that where there is no reliable test information on the substance as a whole and the bridging principles cannot be applied, use of the calculation rules using concentration limits may lead to a classification under CLP, even though the same substance was not classified under DSD.

May a supplier use data which is available in open literature, e.g. from the internet, online databases, for the purpose of physical hazard classification under CLP?
Yes, he may, provided the data is reliable and adequate for the purpose of hazard classification. Further to this, available studies should be sufficiently documented to assess their quality and adequacy.  
 
The physical hazards of substances and mixtures should be determined through testing based on the methods or standards referred to in part 2 of Annex I to CLP. These methods can be found for example in the UN Manual of Tests and Criteria, which is normally used to classify substances and mixtures for transport:http://www.unece.org/trans/danger/publi/manual/manual_e.html.
However, testing is not mandatory in cases where adequate and reliable information from reference literature or databases is already available and where the substance to be classified and the substance described in the reference are comparable with regard to homogeneity, impurities, particle size etc. 
 
Open literature or databases often use secondary data sources. When such data is used, the original source should be cited and checked by an expert. This should involve the check that there is sufficient documentation to assess the suitability of the test used, and that the test was carried out using an acceptable level of quality assurance. Useful data compilations containing physicochemical data are listed in section R.7.1.1.2- 'Available information on physicochemical properties' of the Guidance on information requirements and chemical safety assessment on ECHA's website.
In a case where the classification for physical hazards depends on the particle size of a substance, will a supplier have to classify for all particle sizes?

No, this is not necessary. A supplier will only have to classify the substance in the form that is going to be placed on the market and in which it can reasonably be expected to be used.As the particle size may have a significant effect on the test result, it should be explicitly specified in the test report for the relevant hazard what the particle size is. This does not mean that several classifications have to be performed in order to cover different particle sizes of the same substance. It means that the classification based on the particle size that is placed on the market has to be provided. In cases where several particle sizes are placed on the market or where the particle size may be altered during transport or storage, a worst-case approach should be used. This would normally imply using the classification based on testing the smallest particle size that could occur.

If particle size is relevant for classification and safe handling and use, this should be mentioned in the Safety Data Sheet. Information on deviating classifications due to different particle sizes should be mentioned in the Safety Data Sheet as well.

In relation to the determination of the aspiration hazard of paints and varnishes: how to convert the viscosity derived from flow time measurements using a flow cup at 23°C ± 5°C according to ISO 2431 into the kinematic viscosity of the paint or varnish at 40°C?
Under CLP, the classification criteria for the aspiration hazard require the determination of the kinematic viscosity while the viscosity based on flow time is not part of the classification criteria. ISO 2431 contains correlations between flow time and kinematic viscosity. However, there is no general correlation describing the temperature dependence of the viscosity, and expert judgement is necessary.
What are the quality requirements when testing for physical hazards?

According to Article 8(5) of the CLP Regulation, where new tests for physical hazards are carried out for the purposes of this Regulation, they must be carried out, at the latest from 1 January 2014, in compliance with a relevant recognised quality system or by laboratories complying with a relevant recognised standard. The provisions of that Article are further detailed in section 2.1.5 "Quality" of the Guidance on the Application of the CLP criteria. According to the Guidance, even though the quality requirement does not become immediately effective, it is highly recommended to do so if reasonably possible. In general, the following alternative strategies can be pursued:

1. Compliance with the principles of good laboratory practice (GLP) (as formerly required by the DSD).

2. Accreditation according to EN ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories" (a relevant recognised standard).

3. Other internationally recognised standards of comparable scope.

Any testing organisation that carries out physical hazard tests for classification purposes can therefore choose how to fulfil the quality requirements of CLP.
When classifying and labelling substances that are included in Annex VI to the CLP Regulation, do I need to consider any impurities that might be relevant to classification as stipulated in Article 11(1) CLP?

Yes, you do. As stated in section 1.1.1.4 of Annex VI to the CLP Regulation, impurities are not normally mentioned in Annex VI to CLP entries unless they contribute significantly to the classification of the substance. This means that the entry in Annex VI to CLP relates normally to the toxicity of the "pure" substance and impurities have not been taken into account. Therefore, if the substance placed on the market contains an impurity not specified in the corresponding entry in Annex VI to CLP, the presence of classified impurities must be taken into account for classification purposes in accordance with Article 11(1) CLP. 

As of when did the deletion of Note H in the second ATP to CLP apply to entries in Tables 3.1 and 3.2?

The Commission Regulation (EC) No 286/2011 (second ATP to CLP) entered into force on 19 April 2011. In accordance with Article 3 of this ATP, Note H is no longer applied to entries marked with the Note from 1 December 2012.

Does Article 37(6) of CLP apply to companies that possess information which obliges them to divert from the minimum classification indicated in Annex VI?
No, where a minimum classification is given in Table 3.1 of Annex VI to CLP there is no need to submit a proposal amending a harmonised classification to a Member State competent authority in accordance with Article 37(6) of the CLP Regulation in order to apply the more stringent classification.
 
For certain hazard classes, including acute toxicity and STOT RE, Table 3.1 of Annex VI to CLP gives a minimum classification, indicated with an asterisk. For such a minimum classification, a more severe classification shall be used when the conditions described in section 1.2.1 of Annex VI to CLP are fulfilled (Guidance on the application of CLP criteria, section 1.1.10). According to the Guidance, section 1.7.2.1, the minimum classification should only be used if no additional hazard information is available. Thus, a company must assess all information and apply a more stringent classification if appropriate and record the decision basis. A company applying a more stringent classification has therefore classified the substance in agreement with the harmonised classification in Part 3 of Annex VI to CLP.
Is it possible to ‘waive' a classification by assuming that there is no exposure based on the identified uses or uses advised against communicated in the safety data sheet under REACH?
No, this is not possible. The classification of hazards is only dependent on the intrinsic properties of a substance or mixture and exposure shall not be taken into account. 
 
The hazards of a substance or mixture are communicated in the supply chain via the label elements and classification/labelling in the safety data sheet. The necessary risk management measures further down the supply chain are based on that information. ‘Waiving' a classification would interrupt that flow of information down the supply chain. Therefore, it is not possible to waive the requirement for classification based on assumed lack of exposure. 
 
It should, however, be remembered that the form and physical state of a substance or mixture need to be considered in the framework of the hazard classification, in accordance with Articles 5 and 6 of the CLP Regulation.
Do suppliers have to comply with the harmonised classification and labelling (C&L) of a substance in Annex VI to CLP before the application date indicated in the respective adaptation to technical progress (ATP)?

A new or revised harmonised C&L of a substance set out in Annex VI to CLP must be applied from the date specified in the respective ATP, although suppliers may use this classification before that date.

In cases where a supplier decides not to apply the harmonised C&L of a substance before this date, the question arises whether they should nevertheless take into consideration the opinion adopted by the ECHA Risk Assessment Committee (RAC) on the harmonised C&L for that substance in the self-classification of a substance or mixture.

When suppliers consider the self-classification of their substance or mixture before placing them on the market (Article 4(1) of CLP), they must identify and examine all available information (Article 5 of CLP). The classification must reflect the latest scientific knowledge (Articles 5(1)(d) and 15 of CLP). During the transitional period for compliance with a new harmonised C&L for a substance, the RAC opinion for that substance should be considered as the latest reliable scientific evidence that should be reflected in the self-classification of the substance or mixture, unless the supplier has other scientific evidence that differs from the RAC opinion and leads to a different conclusion.

If the C&L of a substance is already harmonised in the same hazard class, compliance with the existing harmonised C&L is legally required until it is formally changed in an ATP to CLP. The new harmonised C&L may be voluntarily applied as soon as the respective ATP enters into force. At the date of applicability, as provided for in the respective ATP, the suppliers are obliged to comply with the new C&L.

Must you re-classify and label your biocidal product when there is a change in harmonised classification?

Yes, the classification and labelling (C&L) of biocidal products needs to be updated in line with the change in harmonised classification within the timelines specified below. If the C&L of a substance in the product is already harmonised, compliance with the existing harmonised C&L is legally required. The new harmonised C&L may be voluntarily applied as soon as the respective ATP enters into force. At the date of applicability as provided for in the respective ATP, the suppliers are obliged to comply with the new C&L.

Further to this, Article 30(3) of CLP states that the label of a biocidal product should be updated in line with the requirements of the biocidal products legislation. The Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products gives the authorisation holder 12 months after implementation of the change to notify the updated hazard and precautionary statements to all the Member States in which the product is authorised or, where relevant, ECHA (see Annex, Title 1, Section 2).

Should extreme pH be considered when classifying a mixture for skin corrosion/skin irritation or eye damage/eye irritation when it contains an Annex VI substance with a specific concentration limit (SCL) for that endpoint?

It is assumed that pH has been taken into account when setting an SCL for a substance for skin corrosion/skin irritation or eye damage/eye irritation.

When a mixture only contains one corrosive or irritant ingredient (acid or base) with an SCL, the mixture should be classified according to this SCL even if the pH of the mixture is extreme. However, the SCL reflects a situation where the mixture does not contain any other ingredient that might affect the classification for that endpoint. If other ingredients in the mixture affect the irritant/corrosive properties, this has to be taken into account.

If a mixture contains any other substances than the one with an SCL, which may affect the corrosive or irritant properties of the mixture, the SCL may not determine the classification of the mixture. Such ingredients can be surfactants, other acids or bases, which either themselves possess corrosive or irritant properties or may be expected to affect the corrosive or irritant properties of the substance with the SCL, for example, by increasing the permeability of the skin. In that case, the classification should be based on the pH value of the mixture, unless consideration of the acid/alkali reserve suggests that the mixture may not be corrosive, and data from in vitro tests confirm that classification as corrosive is not justified. Classification based on the pH value of the mixture may lead to a more severe classification than if based on the SCL. A more severe classification may also result when either the additivity rule (Tables 3.2.3 or 3.3.3 of Annex I to CLP) or non-additivity rule (Tables 3.2.4 or 3.3.4 of Annex I to CLP) applies.

Can the bridging principle "Review of the classification where the composition of a mixture has changed" be applied where the identity of the hazardous constituents (ingredients) of a mixture change?

No, the bridging principle "Review of classification where the composition of a mixture has changed" can only be used for mixtures containing the same constituents (ingredients). It is only the concentrations of the hazardous constituents (ingredients) and not the constituents themselves that are permitted to change, within the ranges specified in Table 1.2 in Part 1 of Annex I which applies Article 15(2)(a).

How can I determine the aspiration toxicity of a mixture based on its components?

Where the aspiration toxicity of a mixture is based on its components, two conditions need to be met.

Firstly, a mixture must contain a total of 10 % or more of a substance or substances classified in Aspiration Toxicity Category 1.
Secondly, the kinematic viscosity of the mixture must be at or below 20.5 mm2/s, measured at 40°C (point 3.10.3.3.1.1 of Annex I to CLP).

When these conditions are both met, the mixture must be classified in Aspiration Toxicity Category 1.

When deciding on the classification of aerosol mixtures concerning health and environmental effects, does the propellant have to be excluded?

Yes, the propellant has to be excluded, provided that it does not affect the hazardous properties of the aerosol mixture and there is scientific evidence available that shows the aerosolised form is not more hazardous than the non-aerosolised form.

The aerosol bridging principle, set out in Annex 1.1.3.7, requires the aerosol form of a mixture to be classified in the same hazard category as the non-aerosol form of a tested mixture. The bridging principle does not apply to the CMR hazard classes.

However, a similar approach should generally be used where methods, other than bridging principles, are applied for the classification of mixtures, especially for mixtures containing CMR substances. Where the calculation method includes the propellant, this results in a dilution effect of CMR substances, which is not in line with the general approach taken in CLP concerning CMR substances in mixtures. Further, this would not reflect the actual hazards of the mixture, as it is placed on the market, since the propellant normally evaporates.

It is therefore recommended to exclude the propellant for the identification of health and environmental hazards of aerosols provided that it does not affect the hazardous properties of the aerosol.

In practice, this means that, for example, when considering the classification of an aerosol, where the non-aerosolised form of a mixture contains 1.2 % of a carcinogen (Carc. cat. 2), this should be included in the classification of the aerosol regardless of the amount of propellant added. So, where a mixture consists of 33 % propellant and 67 % non-aerosolised form, which nominally would bring down the concentration of the carcinogen to 0.8 %, the mixture would still be classified.

In a cement mixture, the concentration of chromium (VI) is reduced to below 2 mg/kg (0,0002 %) to meet the conditions of the restriction on the placing on the market and use of cement and cement-containing mixtures in entry 47 of Annex XVII to REACH. Should the mixture be classified as skin sensitising (H317)?

No. Soluble chromium VI causes the sensitising effect of cement or cement-containing mixtures. Chromium (VI) compounds generally are classified as Skin sens 1, and therefore the classification limit for mixtures containing these substances is 1 %. When the concentration of chromium (VI) is reduced to below 2 ppm (0,0002 %) of soluble chromium (VI) of the total dry weight of the cement, the concentration limit for classification as sensitising is unlikely to be reached and thus the hazard statement H317 would not apply.

It should be noted that the cement mixture containing below 0,0002 % soluble chromium (VI) of the total dry weight of the cement would also not be subject to the labelling requirement set in point 2.3 of Part 2 of Annex II, regarding the statement EUH203. 

Please note, however, that if reducing agents are used then the packaging must include the information on the packaging date, the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to keeping the content of soluble chromium VI below 0,0002 %.

Hazard communication with means other than labelling

What kind of information must be provided in an advertisement for hazardous substances according to CLP Article 48?
CLP Article 48(1) outlines the information which must be provided in an advertisement for a substance classified as hazardous. The advertisement shall contain the hazard class and/or the applicable hazard categories, as appropriate, e.g. acute oral toxicity category 3.
What kind of information must be provided in an advertisement for mixtures according to CLP Article 48(2)?

CLP requires that where a member of the general public can purchase a mixture without first seeing the label, and where that mixture is classified as hazardous or contains a hazardous substance as referred to in CLP Article 25(6), then the advertisement for that mixture must mention the type or types of hazard as indicated on the label.

The type of hazard is best specified by providing the relevant hazard statements, including the supplemental hazard statements as referred to in CLP Article 25(6). It is also recommended that the hazard pictograms and signal word are mentioned, where appropriate, to alert the reader to a potential hazard.

For sales to the general public, it is not sufficient nor relevant to refer to a safety data sheet containing this information.

Can transport labels be included in Section 2.2 of the SDS?

No, Section 2.2 of the SDS is intended only for supply (CLP) pictograms, which are described in Annex V to the CLP Regulation. The transport labels can be included in Section 14 of the SDS (see also Annex II to REACH).

Where the inner packaging of a chemical product requires a tactile warning to be fitted, does the outer and intermediate packaging also require a tactile warning?

No, only the inner packaging is required to be fitted with the tactile warning. 

The technical specifications of the tactile warning are given in EN ISO standard 11683 (section 3.2.2.2 of Annex II to CLP). The ISO standard states that ‘... the tactile warning shall be placed on the packaging and not on any secondary packaging, such as cardboard box protecting a glass bottle, so that it can be felt prior to fully opening the package'. The warning shall also remain tactile during the expected period of use of the package under normal handling conditions. 

Thus, the ISO standard provisions aim to ensure that when handling a chemical product the person who has a visual disability is aware of the danger. The ISO standard refers to ‘primary packaging', which can be understood as ‘inner packaging' in CLP terminology.

Outer and intermediate packaging may be fitted with the tactile warning but this is not obligatory.

Does the scope of Article 48 of CLP include internet sales through websites and web shops?

Yes, a web page can be regarded as an advertisement in the scope of Article 48. Hazard information must be provided in this type of advertisement for classified and labelled substances, in accordance with Article 48(1). 

When a member of the general public can conclude a purchase of a mixture online, without first having sight of the label, the information required by Article 48(2) must be provided. 

How should the meaning of “general public” be understood in the context of Article 48(2) of CLP?
The term "general public" is understood in this context to mean anyone who is not buying the chemical for their professional activities. This would be equivalent to ‘consumers’ in the context of this provision.
Industry roles under CLP

What roles and obligations do re-fillers have under CLP?

Re-fillers are downstream users of substances or mixtures whose use is limited to transferring substances or mixtures supplied to them from one container (or packaging) into another. Re-fillers are therefore not obliged to classify in accordance with Title II of CLP, but may also take over the classification derived in accordance with Title II already by another actor in the supply chain provided the re-filler does not change the composition of the substance or mixture that is being refilled. In any case the re-filler has to ensure that the labelling and packaging is in accordance with CLP. This can mean that the original label must be replaced by another one. For example, when the contents of a 200 l drum is decanted into 25 ml bottles, the new label should be in line with the small packaging exemptions, unlike the original bigger one which required full labelling.

Note that re-fillers established within the EU who are supplied with substances or mixtures by an actor outside the EU are considered to be importers under CLP, unless they can benefit from the provisions foreseen for re-importers, see Q&A 168. This means that they have the obligation to classify these substances and mixtures and to notify relevant substance information to the Classification and Labelling (C&L) Inventory.

What roles and obligations do re-importers have under CLP?

According to CLP Article 2(19), a re-importer is considered a downstream user. Re-importers are therefore not obliged to notify to the C&L Inventory or to classify in accordance with Title II of CLP, but may also take over the classification derived in accordance with Title II already by another actor in the supply chain. In any case the re-importer has to ensure that the labelling and packaging is in accordance with CLP.

Note that for a re-importer to be considered a downstream user certain conditions have to be fulfilled. First, the re-imported substance must have been registered before it was exported from the EU. In addition, the substance must have been re-imported within the same supply chain. Third, a re-importer needs to be able to show that the re-imported substance is the same as the one that was originally exported. Finally, the re-importer must also be able to show that he has been provided with the respective information in accordance with REACH Article 31 or 32.

When any of the conditions mentioned above is not fulfilled, the re-importer is considered an importer. This means that he has the obligation to classify these substances or mixtures and to notify relevant substance information to the C&L Inventory.

Do distributors have to classify under CLP?

A distributor is a natural or legal person established within the European Union, including a retailer, who only stores and places on the market a substance, on its own or contained in a mixture, for third parties. Distributors are not obliged to derive the classification of the chemicals they place on the market. In contrast to other suppliers, distributor (including a retailers) do not have to classify their substances and mixtures, but may take over the classification that was derived in accordance with Title II of CLP by another actor in the supply chain. Typically, the respective classification is made available on a Safety Data Sheet.

The same derogation is also granted to a downstream user as long as he does not change the composition of the substance or mixture supplied to him.

Note that distributors established within the EU who are supplied with substances or mixtures by an actor outside the EU are considered importers under CLP. This means that they have the obligation to classify these substances and mixtures and to notify the relevant substance information to the C&L Inventory.

Is an establishment which is recovering a substance obliged to classify and notify it to the Classification and Labelling Inventory?

Under CLP, recovered substances and mixtures will normally have to be treated in the same way as other substances and mixtures under CLP. This means that they have to be classified in accordance with Title II of CLP and the substances have to be notified to the C&L Inventory, unless the establishment undertaking the recovery (manufacturer of the recovered substance) has already submitted a registration under REACH and included the information necessary for a notification. If the establishment undertaking the recovery can rely on the exemption from the REACH registration provisions for recovered substances pursuant to REACH Article 2(7)(d), it would still have to notify the recovered substances to the C&L Inventory, in accordance with CLP Article 39(b) and 40.

When classifying under the CLP Regulation, the establishment undertaking the recovery may take over the classification already derived in accordance with Title II of CLP by the registrant of the same substance, if this is appropriate. When notifying in such cases to ECHA, it is recommended to retrieve the classification and labelling information provided earlier by the registrant of the original substance from ECHA's Classification & Labelling Inventory and agree to it.

Do professional and industrial end users have obligations under CLP?

No, they do not. They are considered to be end users of the substances and mixtures supplied to them as long as they do not place the substances and mixtures on the market. Examples of professional users are cleaning personnel, painters or craftsmen who use e.g. paints, lime or cleaning agents in the context of their professional activity. Industrial users may use substances or mixtures supplied to them as processing aids which are not consumed by the industrial activity, e.g. surface cleaners prior to electroplating or users of lubricants for chainsaws. Formulators of mixtures are not considered as end users, but rather as downstream users of substances and mixtures.

Professional and industrial end users are required to respect the information on the label and on the Safety Data Sheet supplied to them. Further to this, they have to comply with the downstream user obligations set out in Title V of REACH on the safe handling and use of substances and mixtures.

Note that end users established within the EU, who are supplied with substances or mixtures by an actor outside the EU, are considered to be importers under CLP. This means that they have the obligation to classify, label and package these substances and mixtures and to notify relevant substance information to the C&L Inventory.

 

Labelling

Is the number of hazard statements on the label limited?

The number of hazard statements on the label is in principle not limited, as they will normally have to reflect all hazard classifications of a substance or mixture. The only exception is for evident duplication or redundancy.

Is the number of precautionary statements on the label limited?
In contrast to the number of hazard statements, the number of precautionary statements is limited on the label. The general rule is that no more than six precautionary statements shall appear on the label unless they are necessary to reflect the nature and the severity of the hazards. Advice on the selection from more than 100 different precautionary statements is given in the Guidance on labelling and packaging available at:
Is a label which is designed in accordance with legislation of non-EU countries implementing the GHS accepted in the EU?

In the EU, only those labels, which comply with the CLP rules, will be accepted. This means that the provisions that are laid down in Title III of the CLP Regulation and the details regulated in its Annexes I – V must be respected. However, many aspects in relation to the arrangement of labelling elements and in relation to supplemental labelling information are at the discretion of the supplier of the hazardous substance or mixture.

Is it mandatory to include the hazard and precautionary statements together with their codes on the label?
No, it isn't. CLP Articles 21 and 22 require that the statements as such are put on the label, in accordance with the wording provided in Annex III and Annex IV, Part 2. The codes corresponding to these statements are not required for the label, but are not explicitly excluded. It is up to the supplier to decide whether he will include the codes on the label as well.
When preparing hazard labels, the pre-printing of the diamond form may result in labels where not all diamonds are filled with hazard symbols. Would such empty diamonds be allowed on labels of hazardous substances and mixtures?

It is acknowledged that mass pre-printing of labels is current practice in industry. This means that the label background is printed first before it is overprinted with the specific label information in a second step. In cases where this two-step process leads to a situation where only a few hazard pictograms are needed for the label, one or more pre-printed diamonds may have to be left empty or, alternatively, be blacked-out in a second step.

Although CLP does not explicitly forbid the use of blank or blacked out diamonds on the label, Article 19(1) requires suppliers to include relevant hazard pictograms on the label which are intended to convey specific information on the hazards concerned. Furthermore, Article 25(3) requires that any information which goes beyond the mandatory label elements; must not contradict or cast doubt on the messages provided by the latter.

Therefore, due to the current lack of suitable printing techniques afforded by SMEs, it may not always be possible to only include hazard pictograms that fulfil these conditions. This means that any blank or blacked out diamond(s) should be seen in the light of this provision. In cases where empty diamonds are unavoidable, it is recommended to cover them up with a solid overprint, which blacks them out completely and thereby avoids the impression that relevant hazard symbols may have been left off the label through a printing mistake.

 

Do active substances, plant protection products and biocidal products have to be labelled in accordance with CLP?

Yes, they do. Active substances, plant protection products within the scope of Regulation (EC) No 1107/2009 or biocidal products within the scope of Regulation (EU) 528/2012, which are classified as hazardous, must bear a CLP label including the relevant hazard statements, precautionary statements, signal word and pictograms.

In addition, the label of a hazardous plant protection product must also display the statement EUH401 ("To avoid risks to human health and the environment, comply with the instructions for use"). However, in relation to any other aspects of labelling, the provisions of the respective regulations apply, e.g. for the update of a label of a plant protection or biocidal product, see CLP Articles 15(5) and 30(3). Further information can be found in the Guidance on labelling and packaging in accordance with the CLP Regulation available on the ECHA website at http://echa.europa.eu/guidance-documents/guidance-mainly-for-industry-use

Note that an active substance can also be placed on the market for non-pesticidal or non-biocidal uses. In these cases, the labelling provisions set out in CLP Title III apply in full. This means, for example, that the update of the relevant label has to follow the provisions of CLP Article 30(1) and (2).

Is a supplier always required to provide their contact details on the label?

Yes they are. CLP Article 17 (1) (a) states that the name, address and telephone number of the supplier(s) must be included on the label. Furthermore, as stated in Article 4 (4), a supplier must ensure that a hazardous substance or mixture is labelled and packaged in accordance with Titles III and IV of the CLP Regulation, before placing it on the market.

In principle, there can be more than one supplier of the same hazardous substance or mixture in the supply chain at the same time. This can be the case, for example, when a hazardous substance or a mixture containing hazardous substances has been supplied to a distributor, who then supplies it to third parties. If the distributor then changes the packaging to such an extent that the label elements set out in CLP Article 17 have to be displayed differently than on the original label/packaging supplied, then the contact details of the distributor should be added to or replace the contact information of the previous supplier. In this scenario, the distributor has taken on the responsibility for repackaging and re-labelling of the substance or mixture.

If distributors do not change the packaging or labelling, then they do not need to add their contact details to the label nor replace the contact information of their supplier. The distributors may however do so if they wish to.

When a supplier changes the languages(s) displayed on a label, they become responsible for the correct translation of the label content. Thus, they should add their contact details to the contact details of the supplier who issued the original label.

 

May non-EU hazard information be included on the label along with CLP labelling elements for substances placed on the EU market?

CLP Article 25 introduces the concept of "supplemental information", which is intended to incorporate additional labelling information 'over and above' that listed in CLP Article 17 (1) (a) to (g). Any non-EU hazard information included along with the CLP label elements may be considered as supplemental information and placed alongside the CLP labelling elements so long as it does not contradict or cast doubt on the validity of the information required by CLP Article 17 (1) (a) to (g), nor makes it more difficult to identify such information. This can only be determined on a 'case-by-case' basis depending on the information being proposed by the importer. Additional guidance on supplemental labelling information can be found in Section 4.8- 'Supplemental labelling information' of the CLP labelling and packaging guidance available on the ECHA website at http://www.echa.europa.eu/guidance-documents/guidance-on-clp.

When designing a label, what are the requirements regarding dimensions and make-up of the hazard pictograms, to be used on the label?

The general rules for the application of labels are outlined in CLP Article 31. For the hazard pictograms, as detailed in CLP Article 31 (4), the provisions of Annex I, Section 1.2.1, to CLP and Annex V to CLP shall apply. According to Annex V to CLP, hazard pictograms shall have a black symbol on a white background with a red frame wide enough to be clearly visible. Hazard pictograms shall be in the shape of a square set at a point. Each hazard pictogram shall cover at least one fifteenth of the minimum surface area of the label dedicated to the information required by CLP Article 17 (as defined in Table 1.3 in Section 1.2.1.4 of Annex I, 2nd ATP to CLP). Where a supplier chooses to use a label that is larger than the minimum dimensions for a certain capacity of the package, it is not necessary for the size of the pictogram also to be increased, provided it covers one fifteenth of the relevant minimum dimensions and remains proportional to the size of the packaging. The minimum area of each hazard pictogram shall not be less than 1 cm². Note that the size of the pictogram relates to the dimensions of the pictogram itself, and not to the size of the virtual square where the pictogram is embedded. Further guidance can be found in Section 5.2- 'Size of the label and of the label elements' of the Guidance on labelling and packaging in accordance with the CLP Regulation available on ECHA's website at: http://www.echa.europa.eu/guidance-documents/guidance-on-clp.

If a substance or mixture is produced exclusively for the non-EU market, does it need to be labelled in accordance with CLP before export?

The CLP Regulation does not require the labelling of substances or mixtures that are only exported and that, within the EU, are only subject to transport operations. It is necessary to take worker health and safety considerations into account during the production packaging and storage stages, to ensure that these substances and mixtures are handled safely.

However, the PIC Regulation ((EU) 649/2012) concerning the export and import of hazardous chemicals (which implements the Rotterdam Convention within the EU) requires that all exported chemicals are classified, labelled and packaged in accordance with the CLP Regulation, the Plant Protection Products Regulation ((EC) No 1107/20), the Biocidal Products Regulation ((EU) No 528/2012) or any other relevant EU legislation, unless those provisions would conflict with any specific requirements of the receiving countries. Further information can be found in sections 4.1 and 6.10 of the Guidance for implementation of the PIC Regulation.

The labelling and packaging requirements for hazardous transported goods are laid down in the respective transport legislation, based on the UN Model Regulations.

Should substance names used on the label be in the official language(s) of a Member State?

Yes, they should. It should be kept in mind that labels are meant for health, environment and consumer protection, thus they must be understood by the users of the products. According to 17(2) of CLP, the label must be written in the official languages(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise. 

Therefore, the translated names of substances listed in Part 3 of Annex VI to CLP or in the C&L Inventory need to be used in the Member State(s) where placed on the market unless the Member State(s) provides otherwise. The public C&L Inventory does not contain translations for substances that do not have a harmonised classification of the Annex VI entries.

Do containers used for the transport of bulk chemicals (e.g. portable tanks and trailers) meet the definition of a package and fall within the remits of CLP Article 33(3) and as a consequence should they be labelled accordingly?
CLP Regulation is not applicable to transport of dangerous goods by air, sea, road, rail or inland waterways, except for the labelling requirements set out in CLP Article 33. Article 33(3) CLP states that single packages that meet the labelling provisions set out in the rules on the transport of dangerous goods shall be labelled both in accordance with CLP Regulation and the transport rules.
 
As CLP does not define what constitutes a 'single package', for the present purposes the definition of 'single package' is taken from the rules on the transport of dangerous goods. The rules on road, rail and inland waterway transport are implemented in Europe by Directive 2008/68/EC. From Annex I, Annex II, and Annex III to Directive 2008/68/EC and the definitions of the ADR it can be inferred that packaging (e.g. boxes, drums and jerry cans), large packaging and IBC are considered to be packaging for transport purposes in the context of CLP Article 33(3) and therefore both a CLP and transport label are required.
 
In contrast, tanks, bulk containers and freight containers are not considered packaging or single package according to Directive 2008/68/EC and the exclusion stated in CLP Article 1(6) may be considered fully applicable during the transport activities. 
When is it relevant to allocate the supplemental hazard statement EUH029 - "Contact with water liberates toxic gas" - to a substance or mixture?

According to the criteria given in section 1.2.1 of Annex II to CLP, the hazard statement applies to 'substances and mixtures which in contact with water or damp air, evolve gases classified for acute toxicity in category 1, 2 or 3 in potentially dangerous amounts, such as aluminium phosphide, phosphorous pentasulphide.' No further criteria or guidance are provided as to when this hazard statement should be assigned and no appropriate test methods are indicated. It is recommended that any amount of acute toxic category 1, 2 or 3 gas emitted triggers the inclusion of EUH029. It is thus also recommended to add this sentence to each substance or mixture that releases a toxic gas when in contact with water.

 

Are there any exemptions in the CLP Regulation for chemicals supplied in very small quantity packages, when they are considered to present a very low risk?

No. Substances or mixtures under the scope of the CLP Regulation can not be exempted from the classification, labelling and packaging requirements regardless of how low the risk is estimated to be and regardless of the size of the packaging. However, certain derogations apply for labelling of small packagings according to Article 29 of CLP.

May a supplier put the name, address and phone number of another supplier on the label?
Yes, they may. Private labelling is commonly used by industry whereby products are made by a contract manufacturer under licence using different brand labels for different suppliers. Although the CLP Regulation does not explicitly refer to private labelling, its provisions apply in this case. 
 
In accordance with Article 17(1)(a) of the CLP Regulation, a substance or mixture classified as hazardous and contained in packaging shall bear a label including, among others, the name, address and telephone number of the supplier(s). Based on this provision, it is possible to place the name, address and telephone number of more than one supplier on the label. The contact details of any supplier in the supply chain are allowed to be included on the label. More information can be found in the Guidance on labelling, section 4.1, and in the CLP FAQ on labelling (unique ID 242).
 
The responsible supplier should be able to provide additional information in the language of the country where the product is placed on the market.
If a mixture contains more than four substances contributing to the classification of the mixture, which substances should be identified on the label?

Article 18(3) of CLP provides that the identity of all substances in a mixture that contribute to the classification of the mixture in certain hazard classes must be given on the label. A maximum of four chemical names are to be included, unless more are needed to reflect the nature and severity of the hazards.

There are no strict rules on how to decide which substances should take precedence to be named on the label, but the following may help in the selection.

For non-additive health hazards (e.g. germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation and specific target organ toxicity categories 1 and 2), all ingredients which are present in the mixture above the generic or specific concentration limit should be considered as "primarily responsible for the major health hazards" within the meaning of Article 18(3)(b) CLP and included on the label.

For the additive health hazards mentioned in Article 18 (3)(b) CLP (e.g. acute toxicity, skin corrosion, serious eye damage, specific target organ toxicity category 3 and aspiration hazard), all ingredients which are present in the mixture above the generic or specific concentration limits should be included on the label. However, where there are several ingredients contributing to classification for one hazard endpoint, only the ingredients primarily contributing to the classification, for example, those closest to the GCL or SCL, need to be included on the label, and thus the names of other ingredients with limited contribution to the classification are not required.

In addition, specific labelling rules apply to mixtures containing skin and respiratory sensitisers. See Annex I Table 3.4.6 and Annex II, point 2.8.

Are CLP pictograms required when outer packaging is marked with the ‘limited/excepted quantity marks' according to the rules on the transport of dangerous goods?

No, they are not. Article 33(1) of CLP outlines that when a package consists of an outer and an inner packaging, together with an intermediate packaging, and the outer packaging meets the labelling provisions in accordance with the rules on the transport of dangerous goods, the hazard pictograms required by CLP do not need to appear on the outer packaging.

For the purpose of CLP, transport labelling is considered to include the limited/excepted quantity marks (chapters 3.4 and 3.5 of the UN Model Regulations for the transport of dangerous goods).

This is explained in the Guidance on labelling and packaging in accordance with the CLP Regulation (chapter 5.4) that states that labelling in accordance with CLP is required only when neither:

  • 'normal' transport labelling elements, nor
  • other transport labelling elements such as the ‘limited/excepted quantity marks', the mark for environmentally hazardous substances or elevated temperature marks are needed on the outer packaging.

This means that limited/excepted quantities are considered as transport labelling and therefore CLP pictograms are not required when those limited/excepted quantity marks are carried on the outer packaging and the pictograms depicting the same hazard do not need to appear twice. CLP labelling may however be used, if desired according to Article 33(1) of CLP.

When must the precautionary statement P501 be included on the label of a substance or mixture supplied to the general public?

The precautionary statement P501 with appropriate specification of where to dispose of the content/container (e.g. public waste disposal or recycling facility), in accordance with the applicable regulation, must be included on the label of any substance or mixture supplied to the general public if the substance or mixture is classified in the hazard classes and categories listed under P501 in Table 6.5 of Annex IV to the CLP Regulation.

When does an imported substance or mixture need to be classified and labelled in accordance with CLP?

Suppliers of substances and mixtures classified as hazardous according to CLP must label them in accordance with CLP before placing them on the market. 

A supplier is any manufacturer, importer, downstream user or distributor placing a substance on the market on its own or in a mixture. Import is considered to be placing on the market (Article 2(18) CLP). Therefore, an importer (supplier) importing (placing on the market) substances or mixtures will have to label them according to CLP. Imported substances and mixtures require CLP labelling, even if the importer and the user are the same legal person.

Where importers make use of a distributor, the importers may not pass this labelling duty to their distributor. The substance/mixture being distributed should be correctly labelled by any supplier (including the importer) in the supply chain.
An importer is not required to classify, notify or label its substances/mixtures in accordance with CLP if the following conditions apply (note that they apply cumulatively):

  • the substances/mixtures are under customs supervision;
  • there is no treatment or processing activity;
  • one of the three following (not cumulative) conditions apply: the substances/mixtures are (a) in temporary storage or, (b) in a free zone or free warehouse with a view to re-exportation or, (c) in transit.

In customs terms, transit means both internal and external transit. In case of doubt, it is recommended to contact the customs authorities, to clarify the applicable customs rules established by Regulation (EU) No 952/2013 on the Union Customs Code.

Is the labelling and packaging of a hazardous chemical product compliant with the conditions of Article 35(2) of CLP if it contains elements such as pictures of fruit or other food products, or a colour, shape or design that attracts children?

No, it is not. A hazardous chemical product that is subject to labelling and packaging under CLP must not be confused with a food, medicinal or cosmetic product. For example, a prominent picture of a fruit on the label or packaging can create confusion for the consumer and increase attractiveness to children. Other elements, such as the bright colour, the shape and design of the packaging or the consistency of the chemical may also create a resemblance with food products or with toys.

A hazardous chemical product must not attract the curiosity of children, but apart from children, other vulnerable consumer groups also exist and need to be considered. Therefore, the packaging of a hazardous chemical should not be of a shape or design that, for example, a visually impaired person could confuse with food.

What is the interplay between CLP and TPD regarding the classification, labelling and packaging of e–liquids?

E-liquids for electronic cigarettes are regulated by the Tobacco Products Directive (TPD, Directive 2014/40/EU). The TPD requires Member States to ensure that electronic cigarettes and their refill containers are only placed on the market if they comply with the TPD and with all other relevant Union legislation (Article 20(1)), including the obligations under the CLP Regulation.

Under CLP, the classification, labelling and packaging of an e-liquid is the responsibility of the formulators or importers of the liquid. Under TPD, they must also submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. This notification should include the classification of the mixture in accordance with CLP. 

The TPD sets its own labelling requirements for the unit packets of electronic cigarettes and refill containers (TPD Article 20(4)). In addition, the refill containers must also be labelled and packaged in accordance with CLP if the e-liquid is classified as hazardous. In that case, the unit packet must have a CLP label, with TPD-related information as supplemental. Overlapping information only needs to be indicated once: for example, the list of all ingredients required by TPD vs the list of ingredients contributing to classification under CLP.

It should be noted that the TPD provides that the nicotine content must not exceed 20 mg/ml and only ingredients that do not pose a risk to human health in heated or unheated forms may be used in the nicotine-containing liquid. However, other components of e-liquids have also been identified as hazardous and need to be considered in the classification and labelling of the e-liquid. 

According to TPD, electronic cigarette devices and refill containers have to be child- and tamper-proof, protected against breakage and leakage and have to have a mechanism that ensures refilling without leakage (Article 20(3)g).

A refillable electronic cigarette device that is empty when placed on the market is not subject to the labelling obligations under CLP, as the hazards are dependent on the contents of the refill container.

What are the labelling and packaging requirements for candles under CLP?

Under CLP, candles are regarded as mixtures. Therefore, if a candle is classified as hazardous or where CLP Article 25(6) applies, then the candle must be labelled and packaged in accordance with CLP before placing it on the market. 

An open container of glass or aluminium foil or an openwork paper box are not considered as packaging in the context of CLP Article 35. A candle in such a container, must still be supplied in packaging that complies with the CLP requirements, with the label firmly affixed to one or more surfaces of the packaging immediately containing the candle, and positioned horizontally on the side of the packaging, so that it can be easily read. 

For small candles, certain labelling exemptions may apply, in accordance with CLP Article 29. 

Should mixtures which were already placed on the market before 1 June 2015 and are still in stock after 1 June 2015 be re-labelled according to CLP?

After 1 June 2017, all mixtures placed on the market must be classified and labelled in accordance with CLP. This means that also mixtures which were already placed on the market before 1 June 2015 and are still in the stock of any supplier in the supply chain must be re-labelled in accordance with CLP.

 

Notification-Classification and Labelling Inventory

Which substances have to be notified to the Classification and Labelling Inventory?

The following substances will have to be notified to the C&L Inventory, irrespective of their quantities:

  • Substances which are subject to registration under REACH (= one tonne/year) and placed on the market. This includes substances on their own, substances contained in mixtures and certain substances contained in articles where REACH Article 7 provides for their registration. Notification of these substances is not necessary where a manufacturer, importer or Only Representative (OR) has already registered the substance with the classification and labelling according to CLP when its notification in line with CLP Article 40(1) is due. In particular, notification is not required of the importers covered by a registration that has already been done by an OR on their behalf. However, importers will have to notify a substance within one month of its placing on the market where the OR has not yet submitted the registration.
  • Substances classified as hazardous under CLP and placed on the market irrespective of tonnage. This includes substances which are classified as hazardous under CLP, but which are exempted from registration, e.g. polymers referred to in REACH Article 6(3); and
  • Substances classified as hazardous under CLP and present in a mixture above the concentration limits specified in Annex I to CLP, which results in the classification of the mixture as hazardous, and where the mixture is placed on the market.

According to CLP Article 40, only manufacturers of substances and importers of substances or mixtures have the obligation to notify. Therefore, it is only the importer who has to notify a substance contained in a mixture to the Inventory, where the substance is hazardous or subject to registration.

 

Would only substances manufactured or imported in quantities of one tonne or more per year be subject to notification?

No, according to Article 39(b) of the CLP Regulation, the requirement for notification to the Inventory includes all hazardous substances within the scope of CLP, either on their own or contained in a mixture above legally defined concentration limits, and which are imported or manufactured and placed on the market within the EU. In other words: the requirement for notification goes beyond substances manufactured or imported in quantities of one tonne or more per year.

Is it necessary to notify to the Inventory a non-hazardous substance that is also registered under REACH?

Yes, it is. Article 39(a) of CLP states that "substances subject to registration in accordance with Regulation (EC) No 1907/2006" fall within the scope of the C&L Inventory when they are placed on the market. Therefore, this applies to substances subject to registration under REACH and placed on the market, regardless of whether they are hazardous or not. Where a substance is not classified, the "not classified" option should be selected in IUCLID 6 dossier, or in REACH-IT C&L on-line wizard when notifying it to the Inventory.

However, if the substance is not subject to registration and does not meet the criteria for classification as hazardous there is no notification obligation. It is noted that where a substance has not yet been registered, the registrant/notifier should notify according to the provision of CLP Article 40(3) since notification is independent from the registration deadlines (see also FAQ ID = 209). Note also that if a company has already submitted a registration dossier for the substance including the classification and labelling in accordance with CLP, the same company does not have to submit a separate notification to the C&L Inventory.

What is the deadline for notification to the Classification and Labelling Inventory?

The deadline for notification to the Inventory is one month after a substance has been placed on the market.

The one-month period has to be calculated from the date a substance is placed on the market. This also applies to substances which had been placed on the market before 1 December 2010, but which were not placed on the market on 1 December 2010, but only again afterwards.

For example, you as manufacturer or importer placed a substance on the market on 8 November 2010, then you stopped for a while, and later resumed your activity on 1 February 2011. In this case, the obligatory one month notification deadline fell one month after the resumed activity and your notification was due on 1 March 2011.

 

Do I have to notify substances that are classified for a physical hazard and contained in a hazardous mixture?
Yes, you do. CLP Article 39(b) refers to all hazards. This includes notification of a substance classified for a particular physical hazard and contained in a mixture whenever the mixture is placed on the market and needs to be classified for a physical hazard due to the presence of that substance. It should be noted that the physical hazard class to which the mixture belongs could be different from that of the substance(s) causing the hazard. Expert judgment should be sought in case of doubt.
CLP refers in its Article 40(1) to a "group of manufacturers or importers". Is this the same as a SIEF?

No, it is not. The term "group" is not defined under the CLP Regulation, in particular it does not equate to a Substance Information Exchange Forum as defined under REACH. Nevertheless, SIEF members can decide to notify to the C&L Inventory as a group. The identity of each member of the group should be specified in the notification.

The term "notification" has been used in various contexts in the EU chemicals legislation. What is the difference between a notification under Directive 67/548/EEC, a notification under REACH, and a notification under CLP?

Under Directive 67/548/EEC, notification was related to new substances. The notification process referred to was the submission of a dossier containing relevant information on a new substance (i.e. a substance placed on the market in the EU after 18 September 1981) to the competent authority of a Member State. The amount of information required depended on the quantity in which the substance was placed on the market. The notification requirement for new substances under Directive 67/548/EEC was replaced by the registration requirement under REACH after its entry into force.

The use of the term "notification" under REACH refers to three different obligations: 

  • the obligation to provide basic information to the Agency on substances in articles, under Article 7(2). 
  • the obligation to provide basic information to the Agency on those substances that are exempted from registration for five years because they are manufactured or imported for the purpose of product- and process-orientated research and development, under Article 9(2). 
  • the obligation for downstream users to inform the Agency when using a substance that is on the Authorisation List (Annex XIV to REACH) based on an authorisation granted to an applicant up their supply chain, under Article 66(1).

Finally, "notification" under CLP relates to the C&L Inventory established by the Agency. Manufacturers and importers are required to submit information on the classification and labelling of substances placed on the market to the Inventory, regardless of their quantities, in accordance with CLP Article 40. The Inventory is a database that was originally introduced by the REACH Regulation; it did not exist under the previous legislation. 

Who must notify to the Classification and Labelling Inventory?
Both manufacturers who place a hazardous substance on the market and importers of a hazardous substance will have to notify the classification and labelling of the substance to ECHA. This applies to substances on their own or contained in a hazardous mixture above a relevant concentration limit, which results in the classification of the mixture as hazardous, and irrespective of the quantity placed on the market. The obligation to notify will also apply to manufacturers and importers placing on the market a substance that is subject to registration under REACH, regardless of the classification. A separate notification is not required where the same information (i.e. the classification in accordance with the CLP criteria) has already been submitted as part of a registration under REACH by the same manufacturer or importer. If the registration dossier does not contain that information, it needs to be updated with the CLP information without undue delay. Notification can also be done by a group of manufacturers or importers.
Who is not expected to notify to the Classification and Labelling Inventory?
Downstream users, including formulators of mixtures, producers of articles as well as distributors of hazardous substances and mixtures do not need to notify to the C&L Inventory. This is because the notification of the respective substances should already have occurred at an earlier stage in the supply chain.
 
Importers of articles are also exempted from the obligation to notify the substances contained in imported articles in all cases where registration of these substances is not required, in accordance with REACH Article 7.
 
Natural or legal persons that manufacture substances, formulate mixtures or produce articles outside the EU cannot notify a substance to the C&L Inventory.
 
Only Representatives (OR) established under REACH only have a formal role when submitting the information which is needed for notification to the C&L Inventory as part of a registration dossier. The CLP Regulation does not foresee a formal role for an OR. However, it is accepted by ECHA that third parties are taking care of the submission of a notification on behalf of a group of manufacturers or importers which they represent. If such a solution is used, the submitting entity must be able to document that it has been mandated to act on behalf and in the name of the manufacturer(s)/importer(s) that are part of the group and that the manufacturer(s)/importer(s) acknowledge that they remain solely and fully responsible to fulfil all their obligations associated with the notification
Can Only Representatives who have been appointed under the REACH Regulation notify to the Classification and Labelling Inventory?
The CLP Regulation does not foresee a formal role for an OR. However, Only Representatives (OR) appointed under REACH may submit the information needed for notification to the Inventory as part of a REACH registration dossier. They may also submit separate notifications to the Inventory where they are notifying on behalf of a group of importers. Such a group notification should be done using REACH-IT. Contrary to the role of an OR under REACH, where such a solution is sought the importers will still remain responsible for the information notified to the Inventory. The submitting entity must be able to document that it has been mandated to act on behalf and in the name of the manufacturer(s)/importer(s) that are part of the group and that the manufacturer(s)/importer(s) acknowledge that they remain solely and fully responsible to fulfil all their obligations associated with the notification.
For substances with REACH registration deadlines in 2018, is it necessary to notify a substance to the C&L Inventory before the registration deadline?

Yes, it is. Notification is independent from the REACH registration deadlines. A substance, either on its own or contained in a mixture, must be notified to the C&L Inventory within one month of the first time the company is placing it on the market. Notification can be done using any of the notification tools available at: http://echa.europa.eu/support/dossier-submission-tools/reach-it/notification-to-the-cl-inventory

What substance identity information is required for notification to the Classification and labelling Inventory?
The substance identity information required for notification to the C&L Inventory is set out in CLP Article 40 (1) (b); it includes the items listed in point 2.1 to 2.3.4 of Annex VI to REACH. In order to ensure proper identification of a substance, the provided information on substance identity should be consistent and unambiguous.
 
For example, in the case of a multi-constituent substance, the concentrations of its constituents should ideally add up to 100%. The identifiers provided by the notifier (i.e. IUPAC name, EC number, CAS name and CAS number) should also be consistent and they should refer to one substance.
 
For the purpose of notification of an imported substance either on its own or contained in a mixture, the importer should contact his non-EU supplier(s) to find out as much as possible about the identity of his substance.
 
Further guidance on the information required for the identification of substances is provided in the document Guidance for identification and naming of substances under REACH as published on the ECHA) website under http://www.echa.europa.eu/guidance-documents/guidance-on-clp
Is analytical information such as HPLC data, gas chromatograms or a description of the analytical method required for notification to the Classification and labelling Inventory?
The following substance identity information is not required for the purposes of notifying to the C&L inventory: spectra, HPLC (high-pressure liquid chromatography) data, gas chromatograms nor a description of the analytical methods used for the identification of the substance and its possible impurities and additives. This is in contrast to the registration requirements under REACH where this information is required.
When notifying a substance to the Classification and Labelling Inventory, do its constituents, additives and impurities also have to be notified separately?
No, they do not. Constituents, additives and impurities of a substance do not need to be notified individually, even if they are hazardous and contribute to the classification of the substance. This is because they are included in the definition of a substance, pursuant to CLP Article 2(7): 'substance' means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. However, if these impurities, additives or constituents are also marketed as separate substances, these will of course have to be notified.
 
IUCLID 6 allows the indication of the presence of any impurities and additives necessary to preserve the stability of a substance as well as their contribution to a classification of the notified substance in section 1.2.
Can a company appear in more than one group of manufacturers/importers?
Yes, this is possible. A company may appear in more than one group of notifiers provided the substances being notified are different.
How should aqueous solutions of substances be notified in accordance with Articles 39 and 40 of CLP?

By definition, a solution composed of two or more substances is a mixture, see CLP Article 2(8) and REACH Article 3(2).

Therefore, substances contained in aqueous solutions should be notified to the C&L Inventory under the conditions of CLP Article 39(a) or (b) when they are placed on the market.

However, certain diluted acids and bases may be listed with the notation "%" in Annex VI to CLP. Such entries are treated as substances and should be notified as such to the C&L Inventory under the conditions of CLP Article 39(b) when they are placed on the market. In these cases, the harmonised entry as listed in Annex VI and any self-classifications for the hazard classes or differentiations not covered by this entry, if applicable, should be notified.

 

Does a manufacturer or importer have to notify substances listed in Annex VI to CLP?

Yes, he does; substances listed in Annex VI have to be notified in accordance with CLP Article 40 if placed on the EU market. Where a particular hazard class or differentiation is harmonised through Annex VI, this classification has to be used when notifying the substance. It is noted that for substances with a minimum classification in Annex VI, the notifier must classify in a more severe hazard category where he has further information which shows that this is more appropriate (see also QnA 260).

For non-harmonised hazard classes or differentiations of substances listed in Annex VI to CLP, the manufacturer or importer should self-classify the substance and introduce the resulting classification and labelling in his notification to the C&L Inventory, according to Article 4(3) of CLP. In case he concludes that the substance should not be classified for these hazard classes or differentiations, the reason should be given in accordance with Article 40 (1) (d) of CLP.

Where a notifier proposes to apply a different non-harmonised classification and labelling for a substance than that which has already been submitted to the Inventory by another actor, the notifier has to provide a reason for his classification as part of his notification to the Inventory.

 

In relation to non-harmonised classifications, is it possible to notify a classification to the Inventory, which differs from already existing entries on the Inventory for the same substance?

Yes, it is. On the C&L Inventory differing classifications for the same substance can have different reasons, e.g. different impurity profiles. In other cases, notifiers or registrants may have reached a different classification for the same substance due to interpretation differences in the process of evaluation of available data or in the application of the classification rules for CLP.

However, Article 41 of CLP requires notifiers and registrants to make every effort to come to an agreed entry for the same substance, unless a justification (e.g. impurity profile) can be provided for deviating classifications.

Once a substance has been notified to the C&L Inventory, will manufacturers or importers still have to notify the same substance although it is already on the Inventory?
Yes, they will. A notification must be made by each legal entity that places the substance on the market. Nevertheless, manufacturers or importers may prefer to notify as a group where only one notifier introduces the notification in REACH-IT on behalf of the other notifiers while introducing the identity of the latter as well.
 
In addition, if you are using the online REACH-IT tool for the submission of a notification and: a) the substance has already been notified by other manufacturer or importer and; b) you consider the displayed C&L for that substance appropriate, you can just tick the box "I agree" and the relevant fields of your notification dossier are automatically filled in.
Does the notifier have to give the reason for no classification according to CLP Art. 40 (1) (d) in cases where classification for an endpoint is excluded by definition?
Yes, he does. Notifiers, i.e. manufacturers and importers, will always have to provide a justification for "no classification". In line with the principles applied in the Submission Manual - How to prepare registration and PPORD dossiers, available on the ECHA web site at: https://echa.europa.eu/manuals
 
"The reason for no classification should be selected according to the following principles:
- "data lacking" should be selected if you do not have relevant data or other adequate and reliable information that can be compared with the classification criteria; 
- "inconclusive" should be selected if you have data or other information but which is not reliable (e.g. data of poor quality) or if you have several equivocal study results or information. The available data/information cannot be regarded as a firm basis for classification; 
- "conclusive although insufficient for classification" should be selected in cases where a substance is tested with the appropriate high quality study or where other high quality information is available.
 
It is also pointed out that there are certain 'classification waivers' in CLP:
- if a substance is classified for skin corrosion cat.1, it does not need to be classified for serious eye damage (but not vice versa),
- if a substance is classified for certain physical hazards, it does not need to be classified for certain others,
- if a substance has a particular physical state, e.g. it is a gas, it does not need to be classified as an oxidising solid or as corrosive to metals.
 
In case of such classification waivers you should select "conclusive, but not sufficient for classification" as a reason for no classification. 
 
Note that one reason must be selected where a particular classification is not provided. It is up to the company to decide which reason to select. In case you do not fill in any reason for "no classification" in IUCLID 6, the dossier will fail the TCC (technical completeness check).
What is the difference between the labelling information required for a notification to the C&L Inventory under CLP and for a registration under REACH?

Pursuant to CLP Article 40(1)(f), a notification to the C&L Inventory should include the applicable CLP hazard pictograms, signal words and hazard statements as well as any supplemental hazard statements set out in sections 1.1 and 1.2 of Annex II to CLP or provided in Part 3 of Annex VI to CLP.

For a registration, the same CLP labelling elements as for a notification to the Inventory should be given. In addition, the registrant is requested to provide the relevant precautionary statements. When considering all identified uses covered in the registration dossier, more than six precautionary statements may be necessary to reflect the nature and the severity of the hazards. This reflects the provisions of Section 4 of Annex VI to REACH as amended by CLP Article 58(11).

CLP Article 28(3) states that not more than six precautionary statements shall be given on the label, unless necessary to reflect the nature and the severity of the hazards. Since for many hazardous substances, the number of precautionary statements that can be assigned based on the classification of the substance will exceed the specified number of six statements, the manufacturer or importer will have to select them from those set out in the tables in Annex IV to CLP, in line with CLP Articles 22 and 28.

Does a notifier have to pay a fee when notifying to the Classification and Labelling Inventory?

No, he does not. The submission of a notification to the C&L Inventory is free of charge. Similarly, there are no fees for an update or transfer of the notification.

Would a company with subsidiaries in two Member States have to notify a substance twice, when it manufactures it in both Member States?

Yes, it would. As both subsidiaries are separate legal entities, each legal entity would have to notify the substance separately if in both cases it meets the criteria for notification in accordance with Articles 39(a) or (b) and 40(1) of CLP. Alternatively, both subsidiaries (as legal entities) may prefer to notify as a group of manufacturers. See also Q&A 29.

Would only substances manufactured or imported in quantities of one tonne or more per year be subject to notification?

No, according to CLP Article 39(b), the requirement of notification to the C&L Inventory includes all hazardous substances within the scope of CLP, either on their own or contained in a hazardous mixture above defined concentration limits, and which are imported or manufactured and placed on the market within the EU. In other words, the requirement for notification applies irrespective of the tonnage manufactured or imported per year.

Is it required to update the C&L notification every time new information relevant for classification becomes available or are companies allowed to wait until they register the substance?

When preparing for the REACH registration of substances which have previously been only used for R&D purposes in amounts below one tonne per year used under strictly controlled conditions, potential registrants must collect available data, determine if relevant existing information is in line with Annex XI to the REACH Regulation and develop a testing programme. During this period, there is a high likelihood that the classification of the substance will change.

Article 15(1) of the CLP Regulation obliges manufacturers, importers and downstream users to assess new information "without undue delay". Article 40(2) of the CLP Regulation further requires C&L notifiers to update their C&L notification "when, ---, a decision to change the classification has been taken".

ECHA recommends that the potential registrant carefully considers, on a case-by-case basis, when to update the C&L notification. Factors to be taken into consideration could, for instance, be additional time needed until the registration dossier is submitted, potential impact on the safe uses of the substance and practical consequences of revising the safety data sheet and labels. Companies should also keep all documentation available and consult the relevant authorities of their Member State.

Is it possible to flag confidentiality of certain information when notifying to the C&L Inventory?
Yes, it is. Manufacturers and importers can flag confidentiality of the IUPAC name when notifying certain substances to the Inventory. The substances for which confidentiality of the IUPAC name is possible are those listed in Articles 119(2)(f) and (g) of REACH, i.e.
- non-phase in substances,
- substances only used as one or more of the following:
- as intermediates,
- in scientific research and development,
- in product and process orientated research and development.
 
Where confidentiality of the IUPAC name is flagged when a substance is notified to the Inventory, the IUPAC name will not be displayed on the public part of the Inventory on ECHA's website. Where the IUPAC name has already been claimed confidential under a registration of the substance and ECHA has accepted the justification, the confidentiality claim will automatically be valid for the Inventory as well.
How do I flag confidentiality of the IUPAC name for an eligible substance when notifying it to the C&L Inventory?

The confidentiality flag of the IUPAC name should be flagged when creating an online or IUCLID C&L notification.

  • set a confidentiality flag for the IUPAC name of the substance by ticking the appropriate box;
  • attach a justification, including a clear indication whether the substance ranks among those referred to by REACH Article 119(2)(f) and (g), and
  • introduce an alternative name which would be disseminated on the public part of the

    Inventory instead of the IUPAC name. To derive an alternative name, he should apply the rules set out in Part B of Annex VI to Directive 1999/45/EC (Dangerous Preparations Directive).

    Notifiers are requested to provide all three elements for flagging confidentiality.

Is it necessary to pay a fee for flagging confidentiality?

No, it is not. Manufacturers and importers who flag confidentiality of the IUPAC name for a substance referred to by REACH Article 119(2)(f) and (g) do not have to pay a fee when notifying it to the Classification and Labelling Inventory.

What is the meaning of "placing on the market" in the context of CLP?

Placing a substance or mixture on the market under CLP means supplying or making the substance or mixture available to third parties, whether in return for payment or free of charge within the territory of the EU Member States and those EEA countries which have implemented the CLP Regulation.

In addition, import is deemed to be placing on the market and is defined as the physical introduction of a substance or mixture into the customs territory of the EU and those EEA countries which have implemented the CLP Regulation.

In relation to notification, placing on the market is a pre-condition. Substances which are referred to in CLP Article 39 have to be notified to the C&L Inventory if they are placed on the market. However, no notification is required if the information mentioned under CLP Article 40 has already been provided as part of a previous registration or notification by the same notifier.

The notification deadline is dependent on the date on which the substance is placed on the market. When a substance is placed on the market it must be notified to the C&L Inventory within one month.

In relation to import, the one-month timeline is counted from the day when the substance or mixture is physically introduced into the customs territory of the EU Member States and those EEA countries which have implemented the CLP Regulation. 

Must a manufacturer or importer do physical hazard testing for classification purposes for substances not included in Annex VI to CLP or for substances included in Annex VI, but not classified for a specific physical hazard, and for which no adequate and reliable information is already available for the physical hazards?

According to CLP Article 40 (3), substances placed on the market on or after 1 December 2010 must be notified within one month after their placing on the market. In addition, CLP Article 4 (1) stipulates that the manufacturer or importer must classify their substances in accordance with Title II of CLP before placing them on the market.

Furthermore, CLP Article 8 (2) requires that for the purposes of determining whether a substance entails any of the physical hazards referred to in Part 2 of Annex I to CLP, the manufacturer or importer must perform the tests required in that Part, to allow classification of the substance, unless adequate and reliable information is already available.

Therefore, manufacturers and importers are required to perform physical hazard testing so as to classify their substances not included in Annex VI to CLP, or included but not classified for a specific physical hazard, and to notify this classification to ECHA within one month after their placing on the market.

However, substances may be placed on the market in very small quantities only (e.g. the quantity of a substance used in R&D (Research and Development)). These quantities may not be sufficient for the testing of physical hazards. When there is no adequate and reliable information already available on the physical hazards of these substances, it may not be feasible and/or proportionate for the manufacturer or importer to perform the tests required in Part 2 of Annex I to CLP. In those cases physical hazard testing should not be required. Nevertheless, every effort should be made to assess the physical hazards using any available theoretical methods e.g. UN test methods screening tests, along with expert judgment, and the most severe of the resulting classifications should be applied. Finally, as it is explained in FAQ ID=186 for R&D substances in particular, if neither test data are available nor any other adequate information indicates that a substance should be classified, a notification to the C&L Inventory is not required.

How do I notify to the C&L Inventory a specific form of a substance when there is already a harmonised C&L for the same substance in another form in Annex VI to CLP?
When a notifier is using the REACH-IT online tool to notify a substance already listed in Annex VI to the CLP Regulation, the C&L online functionality will automatically display the harmonised C&L without considering the potential form of the substance being notified.
 
Harmonised classification has to be respected and a notifier should not modify any of those harmonised hazard classes/differentiations. Nevertheless, in some cases, the classification of a substance has been harmonised only for a specific form (e.g. for zinc the harmonised entries refer to the powder or dust form and not to the massive form). In this situation, the substance may be self-classified in a specific form that is different from the form in Part 3 of Annex VI to CLP for some or all hazard classes or differentiations. The self-classification shall be based on the available data for that specific form. 
Can the C&L notification number be used to identify a substance when searching the public C&L inventory?
No, a substance can only be identified by searching either with the CAS number, EC number or the substance identity. The C&L notification number can only be used by the notifier via REACH-IT.
Does the notification number received when a substance is notified to the Classification and Labelling Inventory need to be communicated through the supply chain (SDS, label, etc.)?
No, manufacturers or importers do not have the obligation to inform downstream users that they have submitted a notification to the C&L Inventory. Furthermore, there is no need for downstream users to receive confirmation from upstream suppliers that substances have been notified to the C&L Inventory in order to continue the use of the substances in their own products. Similar to the REACH pre-registration number, the C&L notification number is for internal use for the importer/manufacturer as receipt/proof of notification. It does not need to be communicated to the DU/distributor.
 
A notification number cannot be considered as an identifier according to Article 18 CLP and it is not the inventory reference number published in the C&L Inventory.
Are importers obliged to submit information on the impurities/additives of an imported substance in a mixture to fulfil the notification obligation under Article 40 (1) of CLP?

No, they are not. When a substance is present in a mixture, and the importer does not know whether it has been added as a substance as such or whether it is a constituent (additive/impurity) of a substance in the mixture, then that component must be notified if it meets the criteria in Article 39 of CLP. However, when the importer of a mixture has information that a substance present in the mixture is a constituent (additive/impurity) of another substance in the mixture, then the fields on impurities and additives can be filled in.

How should a group of manufacturers/importers for the purpose of notification to the Classification and Labelling Inventory be set up?

ECHA's REACH-IT system will offer the possibility of creating a group of manufacturers or importers (hereinafter referred to as "M/I Group"), in accordance with CLP Article 40(1). The concept "Group of MI" is not further defined in the CLP. Such a group can, for example, be a corporate company with different legal entities or a SIEF. It is nevertheless important that the members of an M/I Group are all manufacturers or Importers.

When an M/I Group notification is submitted in REACH-IT, the identity of each member should be specified in the notification by indicating the name of the M/I Group at the time of dossier submission. If the membership of the M/I Group is updated by adding a new member, then the new member will automatically be considered as having submitted the notification(s). It is noted that updating a notification made by an M/I Group is possible only by the group leader who has carried out the M/I Group notification. The group leader shall be careful to indicate the name of the M/I Group every time he is updating the notification (otherwise the updated notification will be considered as having been made on behalf of the group leader only).

It is stressed that if the group leader who has carried out the M/I Group notification submits a registration dossier for the same substance, the group is removed from the notification and the other group members are obliged to notify again. For this purpose, one of the M/I Group members has to create an ECHA account in order to become the new group leader. The original group leader can make a legal entity transfer of the notification to another member of the group before or after he submits his registration. A legal entity transfer warrants that the group notification is retained in the REACH-IT.

Poison Centres

Where can I find Q&As on submission of emergency information for the use of Poison Centres?
Information on the obligations related to Article 45 and Annex VIII to the CLP Regulation is available at https://poisoncentres.echa.europa.eu/questions-and-answers
Public Classification and Labelling Inventory

What is the Classification & Labelling Inventory?

The Classification & Labelling (C&L) Inventory is a database which contains classification and labelling information on substances notified under Regulation (EC) No 1272/2008 (the CLP Regulation) and registered under Regulation (EC) No 1907/2006 (the REACH Regulation). It also contains the list of legally binding harmonised classifications (Tables 3.1 and 3.2 of Annex VI to the CLP Regulation). It is established and maintained by ECHA.

The C&L Inventory serves multiple purposes:

- It is a tool for hazard communication and a source of basic information on substances placed on the market which meet the criteria for classification as hazardous or are subject to registration, for suppliers of substances, the general public and Member State Competent Authorities (MSCAs);

- It reveals differences in the classification and labelling of the same substance applied by different suppliers, thus pointing to the need for further discussion among companies to explore the reasons for differences and/or agree on the correct classification, evaluation needs or the need for a legally binding harmonisation of a particular classification and labelling of a substance;

- It is an important tool for hazard communication and risk management, e.g. when MSCAs assess the need for potential authorisations and restrictions of hazardous substances under REACH.

What is the content of the public Classification and Labelling (C&L) Inventory?

Article 42 of the CLP Regulation and Article 119(1) of the REACH Regulation stipulate which elements of a notification should be publicly accessible in the Classification and Labelling Inventory.  These consist of certain elements of the substance identity and all classification and labelling (C&L) elements.   The EC name and number of all notifications for EINECS substances and, wherever possible, all other substances in the EC inventory, are published.  In addition, when a substance is classified in certain hazard classes referred to in Article 119(1)(a) of the REACH Regulation by at least one notifier then the C&L elements are published from all notifications for that substance.  The IUPAC name is only published from notifications classifying in the hazard classes referred to in Article 119(1), however.

Flags in the Public C&L Inventory also indicate whether the displayed classification and labelling is derived from a joint submission in the REACH registration process and in the future agreed entries between the notifiers according to Article 41 to CLP will be flagged.

The information published in the C&L Inventory is not reviewed or verified by ECHA or any other authority and can be changed without prior notice. ECHA does not guarantee the correctness of the information published in the database as it is automatically disseminated from the notifications and registration dossiers.

What is NOT in the Public C&L Inventory?

The Public C&L Inventory does not contain contact details of notifiers or registrants, as this is not foreseen in the CLP Regulation. In order not to disclose confidential business information, no detailed information on impurities or additives is included in the Public C&L Inventory either. In addition, notifiers and registrants have the possibility to claim the IUPAC name confidential (further information on how to flag the IUPAC name confidential can be found in the manual Dissemination and Confidentiality under REACH Regulation). If so, it will not be included in the Public C&L Inventory.

Furthermore, IUPAC names of substances from notifications which do not classify in one or more of the hazard classes stipulated in Article 119(1)(a) of REACH, are not included.  If no substance identifier (EC name or number, IUPAC name, CAS no etc.) can be published, the notification cannot be displayed in the public inventory.

How can I search information in the Public C&L Inventory?

The Public C&L Inventory provides for multiple search options based on both substance identity and classifications. If one is interested in a particular substance or group of substances it can be searched using the full or partial EC name, the name as contained in Annex VI of the CLP Regulation, the IUPAC name or the full or partial EC, CAS or Annex VI Index numbers.

For ease of use, the classifications have been separated into physical, health and environmental hazard classifications and the user can choose either the abbreviated hazard class and category codes (e.g. Acute Tox. 4) or the hazard statement code (e.g. H302).  Combining the substance identity and classification elements will further refine the search results.

The search results are provided based on substances. By selecting one substance from the results, the user is guided to a summary page listing first the harmonised entries (if any) and then the aggregated classifications from the notifications. A further selection of a particular aggregation will provide the detailed view of the aggregated notification.

ECHA has noticed that in individual cases a wrong substance name has been supplied by notifiers with their notification. As ECHA displays the information as provided in the notifications, without verification of the accurateness of the data, this may result in spurious results when searching by substance name, as a seemingly unrelated substance could be displayed in the results. In such cases, it is advised to use the second page view where all published IUPAC names are listed, to identify whether the initially displayed name was incorrect. The grouping of substances is based on numerical identifiers and is not affected by inaccuracies in the substance name.

Are notifications for the same substance grouped? If so, what aggregation rules are applied?
The notifications for each substance are grouped together based on numerical identifiers such as EC or CAS numbers, where they exist. For display purposes, identical classifications are aggregated and are displayed as one entry. The number of notifications behind each aggregated classification is also indicated. The aggregation is done automatically based on both classification and labelling elements. Different states/physical forms and different reasons for no classification have not been considered during aggregation. Those differences, if any, are reflected in the detailed view of the classification entry.
I have notified a substance but cannot find it in the Public C&L Inventory. What could be the reason for this?
If you have just recently submitted your notification it will be included with the next data refresh of the Public C&L Inventory. A time-stamp on the search page indicates when the last refresh was made. Furthermore, ECHA only publishes those substances that are either in the EC inventory or have been notified as hazardous (according to Article 119(1) of REACH) by at least one notifier. Should your substance not be included in the above, ECHA cannot display a suitable substance identifier and the notification is not displayed.
Can you confirm that details such as molecular formula, structural formula, and molecular weight will not be visible to the public when the substances are notified to the C&L Inventory?
ECHA does not publish information submitted with C&L notifications which is not referred to in Article 119(1) of the REACH Regulation.
Can I use the list number of the substance to search in the Public C&L Inventory?
No, you cannot. During pre-registration ECHA has automatically assigned list numbers to substances not yet listed in the European Inventory of Existing Commercial Chemical Substances (EINECS), the European List of New Chemical Substances (ELINCS) and the No-Longer Polymers (NLP) list. These automatically assigned list numbers during (pre-) registration have no formal status and thus will not be published in the C&L Inventory. The only numerical substance identifiers that can be used to perform a search are official EC and CAS numbers and the Annex VI Index number (for substances with a harmonised classification and labelling).
Can the C&L notification number be used to identify a substance when searching the Public C&L Inventory?
No, a substance can only be identified by searching either with the CAS number, the official EC number, for substances with a harmonised classification and labelling the Annex VI Index number, or the substance name, while the C&L notification number can only be used by the notifier via REACH-IT.
Why are there differing classifications for the same substance?

One main aim of the inventory is to promote uniform classification of substances. However, it is to be expected that, initially, for many substances different classifications will have been notified. Some of these can be explained by technical errors made during the notification process (e.g. not assigning all labelling elements correctly) or slight differences in seemingly identical notifications (e.g. affected organs or route of exposure differs). However, notifiers can also disagree on the classification of a substance based on different interpretation of scientific studies or different access to those studies. In any case, notifiers have the legal obligation to make every effort to come to an agreed entry to be included in the inventory and inform ECHA accordingly (see Article 41 of the CLP Regulation).

There can also be different legitimate reasons why notifications for the same substance have different classifications. Different compositions or impurity profiles often lead to different classifications and the physical state and form of a substance is often very important when the hazards of a substance are assessed. The Public C&L Inventory displays the notified state and form but does not contain any information on composition or impurities.

Can I use the classification and labelling information published in the public C&L Inventory to choose a ‘correct’ classification?

The public C&L Inventory displays the notified classifications as they are reported to ECHA. No verification of the content is performed by the Agency. The notifications should therefore reflect the situation on the market. While notifiers have an obligation to undertake all efforts to come to an agreement on the classification for their substance, many may legitimately differ based on e.g. impurities or composition. This may not be immediately apparent in the public C&L Inventory. We encourage all users to discuss their concerns with their suppliers should they have any but there will be no single "correct" classification identified and highlighted by ECHA. However, the public C&L Inventory will indicate where a legally binding harmonised classification is included in Annex VI of the CLP Regulation and where the classification of a substance is the result of a joint registration under REACH. 

How can companies get in touch with each other and when will they be able to do so? Would notifiers be put in touch with others if there is a disagreement over the classification?

In accordance with Article 41 of the CLP Regulation it is the responsibility of the registrant(s) and notifier(s) of the same substance to make every effort to come to an agreed entry included in the Public C&L Inventory. However, ECHA has received millions of notifications for more than 100,000 substances for the C&L Inventory. Thus, the process of agreement for such a large number of notifiers and substances will be long and requires the active involvement of all parties concerned.

Is it possible to delete a C&L notification from the inventory when a company ceases manufacture or import?
Cease of manufacture or import does not automatically mean that a substance is no longer on the market. However, ECHA is currently investigating the possibilities of being able to indicate the submission date or when the notification has been updated for the last time in the public C&L Inventory. This information may allow concluding on the actuality of the classification and labelling information for the substance displayed in the Inventory.
Is the harmonised list according to DSD criteria (Table 3.2 of Annex VI to CLP) in the Public C&L Inventory?

The classification and labelling of harmonised substances according to the DSD criteria (Table 3.2 to Annex VI of CLP) is included in the C&L Inventory.  The DSD classification of each harmonised substance can be found directly underneath the CLP classification.  We have also included the categorisation of harmonised substances according to the Seveso II Directive.

Why are the precautionary statements not published?
Pursuant to Article 40(1)(f) of the CLP Regulation, a notification to the C&L Inventory should include the applicable CLP hazard pictograms, signal words and hazard statements as well as any supplemental hazard statements set out in sections 1.1 and 1.2 of Annex II of CLP or provided in Part 3 of Annex VI to CLP. ECHA does not consider precautionary statements as part of the classification and labelling within the meaning of Article 119(1) of the REACH Regulation. In addition, the provision of precautionary statements is not compulsory in C&L notifications. Furthermore, the precautionary statements are not listed in the tables with harmonised classification and labelling.
Some aggregated notifications have no classification elements visible while others are labelled "not classified". What is the difference between these?

When notifiers wish to notify a substance for which they believe no classification is required, they can tick the appropriate tick-box (labelled "not classified"). In this case, no further details on the classification and labelling of the substance are needed. The C&L Inventory displays these notifications with the label "not classified" and the third page view is disabled. Some notifiers have submitted notifications with no C&L elements but which the tick-box "not classified" was not ticked. For these notifications, ECHA cannot verify whether their intention was to submit no classification or whether the notifier simply forgot to add the C&L elements. These notifications are therefore displayed separately.

Will I have the possibility to download my search results from the C&L Inventory?

Yes, there is a possibility to download and export the search results in excel or csv format.  No classification and labelling information can be downloaded.

How can I use my search results from the C&L Inventory?
Reproduction or further distribution of search results may be subject to copyright protection. Please note that using this information without obtaining the permission from the owners of the respective information might violate the rights of the owner. ECHA is not responsible for any copyright or other infringements that may be caused by you using the information.
Request for use of an alternative chemical name

What fees are payable for requests for use of an alternative name?
A manufacturer, importer or downstream user of a substance in a mixture may submit a request to the European Chemicals Agency, hereinafter 'the Agency', to use an alternative chemical name on the label and in the safety data sheet. Such requests under Article 24(1) should be accompanied by a fee. The level of the fees collected by the Agency, as well as the rules for payment are determined by Regulation (EU) No 440/2010 of 21 May 2010 on the fees payable to the European Chemicals Agency, are pursuant to Regulation (EC) No 1272/2008.
When diluting a substance in water, can we consider the result of this dilution as a mixture and, as such, to fulfil the conditions of Article 24 (1) of the CLP Regulation allowing submission of a request to use an alternative chemical name?
According to CLP Article 24(1), a request to use an alternative chemical name on the label and on the safety data sheet refers to a substance in a mixture where the substance meets the criteria set out in Part 1 of Annex I to CLP.
 
When a substance is diluted with water, the water can be separated from the substance without affecting the stability or changing the composition of the latter, see CLP Article 2(7). Consequently, the diluent water must be considered as a substance on its own. When a diluent is mixed with another substance, a mixture in accordance with the definition set out in CLP Article 2(8) is generated.
 
Thus, a substance which is diluted in water and which meets the criteria set out in part 1 of Annex I to CLP is eligible for a request for an alternative chemical name according to CLP Article 24.
What is the purpose of requesting an alternative chemical name for a substance contained in a mixture?
If disclosing the full composition of a mixture on the label or in the safety data sheet would put the confidential nature of your business at risk, you can request permission to use an alternative chemical name for a substance in the mixture, in line with the provisions under Article 24 of the CLP Regulation. You can submit the request to ECHA for substances that fulfil the criteria set out in section 1.4.1 of Annex I to CLP. If ECHA accepts the request for an alternative chemical name, the name will be valid in all EU Member States and the alternative chemical name can be used on the label and in the safety data sheet of the mixture.
How can I request the use of an alternative chemical name for a substance contained in a mixture, in accordance with Article 24 of the CLP Regulation?
A request for the use of an alternative chemical name, according to Article 24 of the CLP Regulation, can be submitted to ECHA by submitting a IUCLID 6 dossier in REACH-IT by using the ‘Alternative chemical name request’ functionality.
How to submit a dossier
Scope and exemptions under CLP

Will radioactive substances and mixtures have to be classified or notified under CLP?
No, they will not.Radioactive substances and mixtures within the scope of Directive 96/29/Euratom are exempted from the scope of CLP. The reason for the exemption is that this legislation already lays down provisions for the protection of workers and the general public arising from ionising radiation, so there is no need to apply CLP in addition.
Will a non-isolated intermediate have to be classified and notified under CLP?
No, it will not. As long as an intermediate falls under the definition of REACH Article 3(15)(a) concerning non-isolated intermediates, it is exempted from any obligations under CLP.It must be noted, however, that quantities of the same substance may be used in other operations or under other conditions than mentioned in this definition, which would imply that those quantities cannot be regarded as "non-isolated intermediate", but rather as a substance that may be placed on the market. Only the quantities of the substance used under the conditions qualifying it as a "non-isolated intermediate" are exempted from CLP. For the remaining quantities, the relevant requirements under CLP must be fulfilled.
Do "new" substances notified under Directive 67/548/EEC (NONS) have to be classified, packaged and labelled in accordance with the CLP criteria and notified to the Classification and Labelling Inventory?

Yes, substances notified under Directive 67/548/EEC (NONS) need to be classified, labelled and packaged in accordance with the CLP Regulation.

These substances are regarded as registered under the REACH Regulation. Therefore, their classification and labelling information must be included in the C&L Inventory. After a registration number has been claimed by the NONS notifier, the respective registration dossier must be updated with the CLP classifications without undue delay, and a separate notification to the Inventory is not required.

For NONS notified below one tonne under Directive 67/548/EEC and for which no tonnage band update has been done, a separate notification to the Inventory will have to be submitted if the substance is classified as hazardous and is placed on the market. So, if the annual volume of the NONS substance remains below one tonne, the company must submit a C&L notification. When the annual volume has reached or exceeds the one tonne threshold, an update in the form of a registration dossier is required. 

Will waste have to be classified and notified to the Classification and Labelling Inventory?

No, it will not. Waste as defined in the Waste Framework Directive 2006/12/EC is outside the scope of CLP. Waste is any substance or object which the waste holder discards, or intends or is required to discard. This may be waste from households (e.g. newspapers or clothes, food, cans or bottles) or from professionals or industry (e.g. tyres, slag, window frames that are discarded).

As waste is not considered to be a substance, mixture or article under CLP, waste treatment operators are not considered as downstream users. At the same time waste treatment operators will not receive Safety Data Sheets on how to handle a substance or mixture during the waste phase. As long as residues from waste treatment operations are waste, i.e. they are disposed of (e.g. land-filled), they do not fall under the scope of CLP. However, residues which are recovered as substances or mixtures do fall under the scope of CLP.

Will medicinal products need to be classified and notified to the Classification and Labelling Inventory?
Substances and mixtures which are in the finished state and intended for the final user and which are medicinal products within the scope of Directive 2001/83/EC on the Community code for medicinal products for human use, or veterinary medicinal products within the scope of Directive 2001/82/EC on the Community code relating to veterinary medicinal products are on the whole exempted from the provisions of the CLP Regulation, i.e. they do not have to be classified, packaged, labelled and notified to the C&L Inventory.
 
However, in cases where a manufacturer or importer supplies substances and mixtures, e.g. active pharmaceutical ingredients (APIs) or excipients, that are not yet in the finished state, this manufacturer or importer will have to classify, package and label these substances and mixtures in accordance with CLP. In addition, if these substances are placed on the market, they will also have to be notified to the C&L Inventory.
 
The exemption from the provisions of the CLP Regulation does not distinguish between active and non-active pharmaceutical ingredients: it applies to any substance or mixture used in medicinal products, e.g. excipients, which is in the finished state and intended for pharmaceutical use.
Are medicine tablets in a drum being sent to the EU for packaging considered to be "in the finished state and intended for the final user" and therefore exempted from Article 1(5)a of the CLP Regulation?
Yes they are. According to Directive 2001/83/EC on the Community code for medicinal products for human use, medicine tablets are medicinal products and exempted from the provisions of the CLP Regulation if they are in the finished state. The finished state of the medicinal product relates to the substance or mixture and not to its package since re-packing the tablets does not alter the substance/mixture.Bulk tablets that will not be altered after having been produced are therefore considered in the finished state intended for the final user. Therefore, it is neither necessary to classify, label and package these bulk tablets according to CLP nor to notify them to the C&L inventory.
 
However, it will be necessary to take worker health and safety considerations into account to ensure the safe handling of these bulk tablets during the transfer and packaging stages, until they reach the final user in the appropriate package with appropriate safe use instructions.
Will medical devices need to be classified and notified to the Classification and Labelling Inventory?
Substances and mixtures which are medical devices as defined in Directives 90/385/EEC and 93/42/EEC and which are invasive or used in direct physical contact with the human body, as well as those covered by Directive 98/79/EC, are exempted from the provisions of CLP on the whole if they are in the finished state and intended for the final user:
- Substances and mixtures covered by Directive 90/385/EEC that are invasive or used in direct physical contact with the human body would include cochlear implants, implantable cardiac pacemakers, implantable defibrillators and implantable nerve stimulators,
- Substances and mixtures covered by Directive 93/42/EEC that are invasive or used in direct physical contact with the human body would include sutures, catheters, stents, balloon catheters and wound dressings and
- Substances and mixtures covered by Directive 98/79/EEC would include reagents for diagnostic of Hepatitis C and HIV, self-diagnosis devices for the measurement of blood sugar and IVD Analysers.
 
As the substances and mixtures mentioned above are exempted from the provisions of CLP, they do not need to be classified, packaged, labelled and notified to the C&L Inventory. However, for substances that are manufactured or imported in volumes of at least 1 tonne per year, either on their own or contained in a mixture, the obligation to classify (but not label, package and notify) may still arise from REACH because such substances would have to be registered.
Do cosmetic products have to be classified and notified to the Classification and Labelling Inventory?
Similarly to other substances and mixtures referred to in Article 1(5) of CLP, which are in the finished state and intended for the final user, substances and mixtures in the form of cosmetic products as defined in the Cosmetic Products Regulation (CPR, Regulation No 1223/2009) are not covered by the provisions of CLP. However, for substances that are manufactured or imported in volumes of at least one tonne per year, either on their own or contained in a mixture, requirements for classification (but not labelling or packaging) may still apply under REACH, as such substances may need to be registered.

Substances or mixtures intended for use in cosmetic products, but which are not yet in the finished state or intended for the final user, are covered by the provisions of CLP. Therefore, the suppliers of these products must classify, label and package them accordingly.

Furthermore, these manufacturers or importers are obliged to notify the relevant substances in line with the provisions on notification to the C&L Inventory, unless they have already registered the substance under REACH.
Do I have to notify explosive articles to the Classification & Labelling Inventory?
If you are a manufacturer or importer of an explosive substance (explosive according to the CLP criteria) that will be incorporated into an article at a later stage you do need to notify that substance. However, you do not have to notify explosive articles.
Must the classification and labelling of polymers be notified to the Inventory?
A polymer is a substance and must be notified on the basis of Article 39(b) and 40(1) of the CLP Regulation if it fulfils the criteria for classification as hazardous and it is placed on the market.
Will substances and mixtures used in scientific research & development have to be classified and notified under CLP?
Both substances and mixtures used in scientific experimentation, analysis or chemical research are exempted from the obligations of CLP as a whole, provided they are not placed on the market and they are used under controlled conditions in accordance with Community workplace and environmental legislation. However, as soon as substances and mixtures used in scientific research & development (R&D) are physically made available or supplied to another legal entity, for example by sending samples from a university to another research institute or by importing such samples, this is considered as "placing on the market" (see CLP Article 2(18)). In this case CLP requires the supplier or importer to classify according to the available information, to label and package the sample of a hazardous substance or mixture according to CLP and to notify to the C&L Inventory the substance(s) contained therein if it/they meet(s) the criteria for classification as hazardous on the basis of available information.
Should companies notify substances used in the early stages of scientific research & development (R&D) to the C&L inventory?

Quantities of substances used in R&D are by definition smaller than 1 tonne per year and are therefore not subject to registration under the REACH Regulation. If the substance used in R&D is hazardous and placed on the EU market, it, however, needs to be notified to the C&L inventory notwithstanding its volume.

According to Article 5(1) of the CLP Regulation, manufacturers, importers and downstream users shall identify the relevant information for the purpose of determining whether the substance entails a physical, health or environmental hazard.

If neither test data are available nor any other adequate information indicates that a substance should be classified, a notification to the C&L Inventory is not required. If sufficient information is available to classify, and the substance is placed on the market, and hence when the notification to the C&L Inventory is necessary, the IUPAC name of substances used in R&D can be kept confidential as set out in the Practical Guide No 7: How to notify substances in the Classification and Labelling Inventory (see also Q&A 226, 227, 228). If further information becomes available that leads to a change of the classification, the C&L notification has to be updated (see also Q&A 224).

Is it necessary to notify substances to the C&L Inventory that are exempted from registration under REACH?

Yes, it is, under the conditions of CLP Article 39(b) and 40(1): where a substance is exempted from registration under REACH, CLP requires it to be notified to the C&L Inventory if it is classified as hazardous and is placed on the market either on its own or contained in a hazardous mixture above specified concentration limits.

Examples are hazardous substances that are recovered in the EU and that are exempted from registration under REACH Article 2(7)(d). Also, it should be noted that when substances covered in Annexes IV and V of REACH fulfil the criteria of classification they must be notified. 

On the other hand, substances which are exempted from registration under REACH and which are not classified as hazardous and placed on the market do not have to be notified to the C&L Inventory.

Will alloys have to be classified, labelled and notified under CLP?
Alloys are considered as special mixtures under the REACH and CLP Regulations. Alloys as well as their components need to be classified and labelled in accordance with CLP. The components of an alloy will have to be notified if they are hazardous and contained in an alloy above specified concentration limits, in accordance with CLP Article 39(b).
 
In relation to classification for the aquatic hazard class, Annex IV, section 5.5- 'Classification of mixtures of metal compounds' of the Guidance on the Application of the CLP Criteria notes that metal alloys, or alloy manufacturing products, are not simple mixtures of metals or metal components, since the alloy clearly has distinctive properties compared to a classical mixture of its component metals. 
 
Regarding labelling, point 1.3.4 of Annex I to CLP provides that metals in the massive form, as well as alloys, do not require a label if they do not present a hazard to human health by inhalation, ingestion or contact with skin or to the aquatic environment in the form in which they are placed on the market, although classified as hazardous in accordance with the classification criteria of CLP. However, the supplier shall provide the information on the classification of an alloy to downstream users or distributors by means of the Safety Data Sheet. 
 
According to point 2.7 of Annex II to CLP, special labelling rules apply to alloys containing cadmium and which are intended to be used for brazing or soldering.  They shall bear the following statement: "Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions." (EUH207).
Do active substances contained in plant protection or biocidal products have to be classified in accordance with CLP?
Yes, they do. Active substances contained in plant protection or biocidal products have to be classified according to the CLP criteria as of 1 December 2010. In contrast to other substances supplied and used in the industrial supply chain, all hazard classifications of these substances will normally be harmonised at the EU level. The harmonised classifications appear in Tables 3.1 and 3.2 of Annex VI to CLP. However, where new information is available which may lead to a change of the harmonised classification, the procedure for harmonisation of classification and labelling of substances shall apply in accordance with Articles 36 (2) and 37 (1), (4), (5) and (6). It is also noted that the requirement for self-classification for hazard-classes and differentiations not covered by the harmonised classification as provided for in Article 4 (3) equally applies to plant protection or biocidal products.
Do active substances contained in plant protection products and biocidal products have to be notified to the Classification and Labelling Inventory?

Yes, they do. An active substance contained in a plant protection or a biocidal product counts as being registered under REACH under the conditions explained in REACH Article 15. However, where the respective dossiers do not contain the information required for notification in accordance with CLP Article 40, a separate notification to the C&L Inventory has to be made. This is because the update obligation for registration dossiers under REACH Article 22 does not apply to dossiers of active substances used in plant protection or biocidal products.

However, if the same substance has any non-biocidal or non-pesticidal use(s), a registration dossier in accordance with the provisions of REACH has to be submitted where the manufacture or import volume is equal to or above 1 tonne per year per manufacturer/importer for the total of these other uses. If the information required for a notification to the C&L Inventory has already been included in the registration dossier, a separate notification is not needed. If the registration dossier does not contain that information, it needs to be updated with the CLP information without undue delay.

Do the monomers and any other substance used for the manufacturing of a polymer have to be notified to the Classification and labelling Inventory by the importer of the polymer?

No, they do not. In accordance with Article 3(5) of the REACH Regulation, a polymer is a substance. Importing a polymer does not correspond to the placing on the market of the monomers and any other substance from which the polymer substance originates. The C&L notification provisions for the import of a polymer can therefore only apply to the polymer substance itself.

It should be noted that any residual/unreacted monomers present in the composition of the polymer are considered as constituents of the polymer. Thus, as any other constituent, they should be taken into account for classification of the polymer.

Are substances occurring in nature exempted from CLP?
A number of substances and mixtures are exempt from the requirements of CLP in accordance with CLP Article 1. Substances occurring in nature, as defined in Article 3(39) of REACH, are not explicitly included in these exemptions. If substances occurring in nature are placed on the market in a form not listed in Article 1(5) of CLP, which are in the finished state and intended for the final user, they should be classified, labelled and packaged in accordance with CLP.
What are the classification, labelling and packaging requirements for a biocidal product?

A biocidal product has to comply with the classification, labelling and packaging requirements under the CLP Regulation and until 1 June 2015, Directive 1999/45/EC. This obligation is confirmed by Article 2(3)(e) and (m), and Article 69(1) of the Biocidal Products Regulation (EU) 528/2012 (BPR).

According to the BPR (Article 20(1)), the applicant for an authorisation of a biocidal product will have to provide a draft summary of biocidal product characteristics (SPC), taking into account the properties of the active substance(s) as well as any relevant co-formulant(s). As mandatory information, the SPC includes the hazard and precautionary statements (Article 22(2)(i) of BPR). Once authorisation is granted, the holder of the authorisation must ensure that the authorised product is classified, labelled and packaged in accordance with the approved SPC, as well as with the CLP Regulation and, until 1 June 2015, Directive 1999/45/EC (Article 69(1) of the BPR). In addition, authorised biocidal products are subject to specific label elements to ensure the effective communication of information on risks resulting from their use and risk management measures (Article 69(2)of the BPR).

When an authorisation holder wishes to change the label elements related to classification that are part of the authorisation of a product, i.e. hazard and precautionary statements, or is compelled by the CLP Regulation to do so, the change has to be notified to all the Member States in which the product is authorised or, where relevant, to ECHA (see Article 50(2) of the BPR and Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products. If the change leads to new hazard or precautionary statements, the authorisation needs to be updated to reflect this new condition.

Does food have to be classified, labelled and packaged in accordance with CLP, and the substances in food notified to the Classification and Labelling Inventory?

According to Article 1(5)(e) of CLP, the CLP Regulation does not apply to food, as defined in Regulation (EC) No 178/2002 (Food Safety Regulation), which is in the finished state intended for the final user. 

The CLP Regulation does not define the term 'intended for final user', but Regulation (EC) No 178/2002 defines 'final consumer' as 'the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity'. The same concept can be applied in the context of CLP, i.e. intended for the final user should be read as intended for the 'ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity'. This also applies to the use of a substance or a mixture 

  • as a food additive in foodstuffs within the scope of Directive  89/107/EEC,
  • as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC.

Since Article 1(5)(e) of CLP only refers to food in the finished state, intended for the final user, substances or mixtures used in food at any stage of production are not exempt from CLP and therefore must be classified, packaged, labelled and notified. For instance, the CLP Regulation applies to the manufacturer/supplier of a food additive (e.g. preservative) who supplies the substance to another company that uses it in the production of food. In such a case, the chemical substance in the form in which it is supplied should not be regarded as a product being in the finished state intended for the final user, and the exemption stated in Art. 1(5)(e) CLP is not applicable (see also FAQ ID 179).

Do feedingstuffs have to be classified, labelled and packaged in accordance with the CLP Regulation, and their substances notified to the Classification and Labelling Inventory?

According to Article 1(5)(e) of CLP, the CLP Regulation does not apply to feedingstuffs within the scope of Regulation (EC) No 178/2002 (Food Safety Regulation), which are in the finished state, intended for the final user, including when they are used: 

  • as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;
  • in animal nutrition within the scope of Directive 82/471/EEC.

It is important to note that the conditions 'in the finished state' and 'intended for the final user' must both be fulfilled at the same time, otherwise CLP applies. 

The terms 'finished state' and 'intended for final user' are not defined in CLP. The CLP definition of 'use' includes 'consumption', which would mean that a consumer qualifies as a user. Drawing a parallel between the term 'final user' in CLP and the definition 'final consumer of foodstuff'* in Regulation (EC) No 178/2002, feedingstuff  can only be considered to be 'intended for the final user', if it is ready for direct oral feeding to animals. 

In accordance with Article 2(a) and Article 2(e) of Regulation (EC) No 1831/2003 (Regulation on additives for use in animal nutrition), neither feed additives nor premixtures can be used directly to feed animals. They do not fulfil the condition of 'intended for the final user', since they require the additional activity of mixing/processing before being used by the ultimate consumer (animals). Therefore, CLP applies to all additives and premixtures, including those authorised, labelled and packaged in accordance with Regulation 1831/2003. 

Feeding stuffs 'intended to be used by the final users' (animals), i.e. to be fed directly to animals, such as feed material or compound feedingstuffs are exempted from the scope of CLP, provided they are in the finished state. This includes both complete and complementary feedingstuffs - where the latter (although not sufficient for a daily ration) could be directly fed to animals and would thus also be exempted from CLP. 

*Intended for the final user should be read as intended for the 'ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity'.

Do pure essential oils need to be labelled in accordance with the CLP Regulation?

The obligations under CLP apply to any hazardous substance or mixture that is not regulated by product-specific EU legislation with more specific rules on classification and labelling.

Pure essential oils are placed on the market for several different uses. They may, for example, be intended for use as a cosmetic product. The intended use will determine whether a particular product is subject to product-specific legislation.

For instance, if a pure essential oil falls under the definition of a cosmetic product*, the product also has to fulfil all the requirements of the Cosmetic Products Regulation (CPR, Regulation No 1223/2009).

A cosmetic product is excluded from the scope of CLP if all of the following three conditions are cumulatively met:

  1. The product falls within the definition of a cosmetic product according to the CPR. If the CPR applies, all requirements set out in that regulation have to be fulfilled, otherwise the cosmetic product will be considered as incompliant. This means that, among other things, the cosmetic product must have been assessed and notified as defined in Article 10 and Article 13 of the CPR, respectively, as well as be fully labelled in accordance with the regulation with the appropriate label information and instructions for use.
  2. At the moment of placing on the market, the product is intended for the end user, i.e. either a consumer or professional ultimately using the cosmetic product. 
  3. The product is in the finished state, i.e., its final formulation, as placed on the market and made available to the end user.

In fulfilling all of the above, the cosmetic product would be meeting the conditions for exemption provided in Article 1(5) of CLP, i.e., being in the finished state and intended for the final user.

The obligation to label an essential oil in accordance with CLP applies unless the product is outside the scope of CLP. To be outside the scope of CLP, the product must be covered by any of the product-specific pieces of legislation specified in Article 1(5) of CLP, must have undergone the processes defined in the relevant regulation or directive, and at the moment of the placing on the market must be in its finished state and intended for the final user.


*Definition of ‘cosmetic product’, Article 2(1)(a) of the CPR: "Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours."

Technical questions and answers on C and L notifications

A. Submitting a C&L notification

Which IT-tool should I use to submit a C&L notification
  1. You can use the online C&L notification tool directly in REACH-IT to submit a C&L notification of your substance. Here are a few examples, where this is the best option:
    • If you agree with the harmonised classification and labelling.
    • If you agree with a classification and labelling already notified or registered.
    • If you want to provide your own classification and labelling details.
  1. You can use IUCLID 6 to create a C&L notification dossier and submit it to ECHA via REACH-IT. Here are two examples, where a IUCLID 6 dossier is your only option:
    • If your substance has multiple compositions (e.g. same main constituent(s) but different impurities and/or additives)
    • If you want to notify one composition with different classification and labelling.
    • In the examples above you should identify in section 1.2 of your substance dataset in IUCLID 6 the composition(s) of your substance, as well as any impurities and additives present in the substance. You will also have to indicate the different sets of classification and labelling and link them to the different compositions.

Further information can be found in the manual - How to prepare a classification and labelling notification at:https://echa.europa.eu/manuals

How can I edit the ‘Hazard category’ and ‘Hazard statement’ in the online C&L notification?

You can edit the C&L notification of harmonised substances by clicking the option below. The wizard will open an additional page, where it is possible to edit the ‘Hazard category’ and ‘Hazard statement’.

How do I notify my substance using: a) the harmonised classification and labelling? b) the same classification and labelling used by a previous notifier? c) a different (my own) classification and labelling?

At the sixth step of the online C&L notification tool wizard (i.e. C&L inventory) you will be prompted to agree with the:

  • Harmonised C&L

    This option is pre-selected if the classification and labelling of the substance has been harmonised. You may also notify additional information to the selected harmonised classification and labelling.

  • Notified C&L

    This option is pre-selected if the classification and labelling of the substance has not been harmonised. Here you can notify the substance using one of the already notified sets of classification and labelling or notify a different C&L.

The purpose of the pre-notified entries is to reduce the administrative work done by the notifier. It is the responsibility of the notifier to provide a valid classification and labelling for their substance. 

Who has to submit a C&L notification?

Manufacturers or importers who place a substance on the market will have to notify certain information to ECHA that will be included in the C&L inventory if the substance is:

  • Subject to registration under Regulation (EC) No 1907/2006 (REACH);
  • Classified as hazardous under CLP;
  • Classified as hazardous under CLP and present in a mixture, which is placed on the market, above the concentration limits specified in Annex I of CLP which results in the classification of the mixture as hazardous.

However, if the classification and labelling information required by the CLP Regulation has already been submitted in a REACH registration dossier, a separate notification to the C&L inventory is not necessary.

Alternatively, a third party who is not a manufacturer or importer (e.g. an OR who has already been appointed for the purposes of registration under REACH) may submit a group notification on behalf of the EU importers. Further information on this topic can be found in our C&L notification pages at http://echa.europa.eu/regulations/clp/cl-inventory/notification-to-the-cl-inventory/who

How to prepare and what to submit in a C&L notification?

Notifications can only be submitted electronically via the REACH-IT portal on the ECHA website. You must first sign-up in REACH-IT and create an account to be able to submit your notification.

Further information and step by step instructions on this topic, can be found on the ECHA website at:
http://echa.europa.eu/support/dossier-submission-tools/reach-it/notification-to-the-cl-inventory
http://echa.europa.eu/regulations/clp/cl-inventory/notification-to-the-cl-inventory/what

 

B. C&L notification updates

How can I update a C&L notification?

a) If the C&L notification was submitted as a IUCLID 6 file via REACH-IT (either as part of a registration dossier or independently as a C&L notification dossier)

  1. Information to be included in your IUCLID 6 substance data-set
    1. Indicate the reference number of your substance in section 1.3
  2. Information to be included in your IUCLID 6 dossier header (dossier creation wizard)
    1. Tick the box that the dossier is an update
    2. Indicate the submission number of the last successful submission
    3. Specify the reason for the dossier update

For Further information please consult the manual ‘How to prepare a classification and labelling notification’ at: https://echa.europa.eu/manuals

b) If the C&L notification was submitted in REACH-IT using the online C&L notification tool

  1. Search for your C&L notification using the reference number
  2. Use the button ‘Create and submit online an update’.

How can I update the classification and labelling of a NONS registration?

a) For substances previously notified above 1tpa under Directive 67/548/EEC

If the registration number for the substance has already been successfully claimed, the classification and labelling can be updated as a spontaneous update of the registration dossier.

Further information on how to proceed can be found in the Questions and Answers for the registrants of previously notified substances at: https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/scope/REACH/NONS-Registrants+of+Previously+Notified+Substances 

Please  also refer to the section: Other updates of Annex 4 of the manual "How to prepare registration and PPORD dossiers

b) For substances previously notified below 1tpa under Directive 67/548/EEC

If the substance fulfils the classification criteria as specified in Annex I of the CLP Regulation and

  • the annual tonnage band has remained below 1tpa, the registration number cannot be claimed and the submission of a C&L notification for the NONS is required.
  • the annual tonnage band has increased above 1tpa, the registration number must be claimed without any delay and an update of the classification and labelling as part of the registration dossier is required.
What information can be updated in a C&L notification?

a) Information that can be updated: Most information can be updated, such as the composition of the substance, the classification and labelling, the contact details, the members of a group of manufacturers/importers etc.

b) Information that cannot be updated: submitting legal entity, EC number, CAS number.

Can I update the classification and labelling of my registration dossier by submitting a C&L notification?

No, if you have already submitted a registration dossier for your substance, you should submit a spontaneous update of your registration dossier in order to update the classification and labelling of this substance.

If you are a member of a Joint Submission, and you submitted the C&L information of your substance jointly in both the lead registration dossier and your member registration dossier before the 30th November 2010, you need to ask the Lead Registrant to submit a lead registration dossier update including the classification and labelling according to the CLP criteria.

A C&L notification can only be submitted for substances previously notified under the Directive 67/548/EEC, where the annual tonnage band has never exceeded 1tpa and the NONS could not be claimed under REACH.

What should I do, if a previously notified substance is no longer manufactured/imported?

You can inform ECHA that you no longer manufacture/import a substance by using the ‘Cease manufacture or import’ functionality in REACH-IT:

  • Search for your C&L notification using the reference number.
  • Use the ‘Cease manufacture or import’ and confirm your decision. The status of your notification will changed to ‘Inactive’.
  • You can at any point reactivate the notification again by using the "Restart manufacture or import" functionality. The status of your notification will become ‘Active’ again.
  • Note that this functionality is shared with the ‘cease/restart manufacture or import’ for registration dossiers (deactivation based on REACH article 50(2)).

C. Reference numbers for C&L notification

What is the reference number of my C&L notification?

After the submission of a C&L notification (created via the online C&L notification tool or by submitting a IUCLID 6 dossier via REACH-IT) a submission number is assigned.

If the submission is successful (i.e., the submission passed the virus check, the format check, and the Business Rules checks), then each notified substance receives a reference number is assigned. Both the submission and reference numbers are available in your submission report.

  • If the C&L notification was submitted via the online C&L notification tool or by submitting a IUCLID 6 C&L notification dossier via REACH-IT the reference number (here called the notification number) will have the following format: 02-XXXXXXXXXX-CC-0000.
  • If the C&L notification was submitted as part of a registration by submitting a IUCLID 6 registration dossier via REACH-IT the reference number (here called the registration number) will have the following format: 01-XXXXXXXXXX-CC-0000.

After the submission of a C&L notification update, a new submission number will be linked to notification, but the reference number previously assigned will remain the same.

I have successfully submitted a C&L notification and received a reference number, but I cannot find the C&L notification using the REACH-IT Advanced search functionality.

Some of the possible reasons are described below:

  • There is a time delay between the moment a reference number has been assigned to a C&L notification, and the moment this C&L notification is stored in the internal C&L inventory. Please, try again later;
  • The C&L notification was submitted for a group of manufacturers/importers. Only the group creator who submitted the C&L notification will be able to see it. A member of the group cannot.
  • The C&L notification was submitted by the lead registrant for all members of a joint submission. Only the lead registrant who submitted the C&L notification will be able to see it. A member of the joint submission cannot.
  • If more than one composition, and more than one set of classification and labelling are specified in the IUCLID 6 dossier without being properly linked, the C&L information cannot be automatically transferred to the C&L inventory. If a reference number was issued, your C&L notification is considered valid, but the transfer to the C&L inventory will happen at a later stage.
D. Group of manufacturers-importers in REACH-IT

How can I edit the members of my Group of manufacturers/importers?

The original notifier (i.e. group creator) can add or delete members of the group by using the ‘Add member’ or ‘Delete member’ button.

The original notifier can also delete all members of the group by using the ‘Delete group’ button. In this way the whole group will be deleted. The C&L notifications are not affected by the deletion of the group and remain in possession of the original notifier.

Once a group of manufacturers/importers has been updated, all notifications and submission reports associated to this group will be refreshed. Editing a group of manufacturers/importers is not considered a spontaneous update of the notification and there is no need to inform ECHA of such change.

Note that all the changes in the group definition will be kept and tracked in the REACH-IT database, which means that ECHA and the enforcement authorities will know when a company has joined a group.

I am a member of a group of manufacturers/importers. How do I know, that I have a valid C&L notification?

The members of a group of manufacturers and importers do not receive a submission report and need to contact the original notifier to receive the reference number (or a copy of the submission report). The original notifier (group creator) is responsible for informing the group members on the status of the notification and for sharing the submission report with the group members.

Can a member of a group of manufacturers/importers update a C&L notification?

Only the original notifier (group creator) will be able to update the C&L notification. Members of the group are considered ‘co-notifiers’ of the C&L notification, but cannot update it.

How do I submit the classification and labelling for a single substance, if members of the group of manufacturers/importers disagree on a common classification and labelling?

The situation can be illustrated by the following example:

  • The initial notifier (group creator, M1) submitted a C&L notification (CL) for a substance (S) on behalf of a group of manufacturers/importers composed of three members (M1, M2 and M3).
  • At a later stage one member (M3) realises, that their substance (S3) contains some impurity/additive that is absent from the originally notified substance (S). This impurity/additive calls for a different classification and labelling and the member (M3) askes the group to update the C&L notification.
  • The other two members (M1, M2) want to keep the original C&L notification (CL).
  • Depending on the agreement between the group members, two scenarios can play out.

Technical solution 1

  • In case all members (M1, M2, M3) agree with both sets of classification and labelling for the substance (S), the original C&L notification (CL) should be updated with the new composition and classification
  • This technical solution has to be done in IUCLID 6, because only this tool allows multiple compositions and classification. In order to include another composition to your substance, please refer to the manual: How to prepare a classification and labelling notification available at https://echa.europa.eu/manuals.
  • When submitting the updated C&L notification dossier for substance (S), you should indicate in REACH-IT that the notification is on behalf of the same group M1+M2+M3.
  • The following information will be stored in REACH-IT:
    • Substance (S) has two compositions (S, S3)
    • Each composition has its own set of classification and labelling (CL, CL3)
    • There is a single C&L notification (covering both compositions and both sets of classification and labelling) valid for all group members (M1, M2, M3)

Technical solution 2

  • If there is no agreement on a single C&L notification for the substance (S) it is advisable to split the group in two.
  • The initial notifier (group creator, M1) can delete the third member (M3), so that the original notification is still valid only for the remaining group members (M1, M2). No other update is needed.
  • The third member (M3) has to notify their substance composition (S3) with their own classification and labelling (CL3) independently using either IUCLID 6 or creating the notification online using REACH-IT.
  • The following information will be stored in REACH-IT:
    • Substance (S) has two compositions (S, S3)
    • Each composition has its own set of classification and labelling (CL, CL3)
    • There are two independent C&L notifications (each covering one composition and one set of classification and labelling)
    • The group (M1, M2) has notified the substance S with the classification and labelling CL
    • The single notifier (M3) has notified the substance S3 with the classification and labelling CL3.
E. C&L Inventory

How can I download the whole C&L inventory?

At the moment, it is only possible to download the whole C&L inventory in batches using the advanced search (accessible from the home page). Use the starting digits of the EC numbers to limit the number of entries in a batch. We suggest to use the following: 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 3, 4, 5.

advanced chemical search

Understanding CLP

Does CLP apply to me?
CLP applies to you if you manufacture, import, use or distribute chemical substances or mixtures. You must classify, label and package any substance or mixture, regardless of its annual tonnage, in accordance with the CLP Regulation before you place it on the EU market. Placing on the market of a substance or mixture means making it physically available to third parties, whether in return for payment or free of charge.
 
If you are a manufacturer or importer, you are required under CLP to classify substances that are subject to registration or to notification in line with Article 7 or 9 of REACH, even if you do not place them on the market. This includes e.g. the classification of substances that are used for product and process-orientated research and development (PPORD).
 
If you are a manufacturer or importer, you must notify hazardous substances that you place on the market on their own or contained in hazardous mixtures above certain applicable concentration limits, regardless of the annual tonnage manufactured or imported, as well as substances subject to registration under REACH and that you place on the market, to the Classification & Labelling Inventory established at the Agency. However, the duty to notify does not apply in case you have already submitted the information which is relevant for a notification under CLP as part of a registration.
What is GHS?
GHS stands for the Globally Harmonised System of classification and labelling of chemicals. It provides a basis for uniform physical, environmental, health and safety information on hazardous chemicals at global level through the harmonisation of the classification criteria, labelling rules and guidance on the preparation of Safety Data Sheets. 
 
The GHS is developed and maintained at United Nations level with the aim of avoiding different hazard information requirements on physical, health and environmental hazards for the same chemicals around the world. In addition, it also aims to facilitate trade: by applying GHS across different countries, it will no longer be necessary for an exported chemical to be reclassified and relabelled in order to comply with different classification criteria, labelling rules and Safety Data Sheet requirements of the importing country.
 
For further information on the development of the UN GHS, please see: http://www.unece.org/trans/danger/publi/ghs/histback_e.html 
What are the differences between GHS and CLP?
The GHS was implemented through Community legislation in the form of Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP Regulation) which is legally binding and directly applicable in the Member States of the EU, whereas GHS is not legally binding.
 
GHS and CLP are not identical because CLP is also based on the old EU legislation on classification and labelling, i.e. the Dangerous Substances Directive 67/548/EEC (DSD) and the Dangerous Preparations Directive 1999/45/EC (DPD).
 
In addition, and based on the so-called UN GHS "building block approach", CLP does not include all the hazard categories included for a hazard class because they were not part of DSD, e.g. category 4 of the hazard class flammable liquids, or category 3 (mild irritant) of the hazard class skin corrosion/irritation. CLP includes special labelling and packaging rules that are not part of the UN GHS, but which were brought over from the DSD and DPD, e.g. the rules on small packaging (CLP Article 29), on supplemental information for certain mixtures (Part 2 of Annex II to CLP) and for the provision of child-resistant fastenings or tactile warnings. Also, it includes rules for the situation when a substance is both covered by CLP and by transport legislation (CLP Article 33).
 
It should be noted that in contrast to the UN GHS, CLP does not include specific rules on Safety Data Sheets as they are already regulated by REACH, through its Article 31 and Annex II.
Where can I find the consolidated version of the CLP Regulation?

You can find the latest consolidated version of CLP via the ECHA website at: http://echa.europa.eu/regulations/clp/legislation. Note that the text has no legal value. For legal purposes please refer to the texts published in the Official Journal of the European Union.

ECHA Accounts

Account management

What is an ECHA Account?

An ECHA Account is a means by which ECHA can provide services and downloads within a specific legal framework. When creating an account, the account holder has to agree to specific terms and conditions. In general, ECHA Accounts provide access to the following:

  1. ECHA IT tools (REACH-IT, R4BP 3, ePIC, Poison Centres Notifications, ECHA Cloud Services, etc);
  2. The right to download and install locally ECHA IT tools, for example IUCLID and Chesar;
  3. Additional services on the ECHA website, such as the possibility to receive notification on a substance of interest;
  4. User account details
There are two types of ECHA accounts:
  • Personal account: This provides access to options (2), (3) and (4) stated above. Notably, a personal account is not associated with a Legal Entity.
  • Business account: This type of account provides access to all the options (1) – (4) stated above. A business account is created by adding the legal entity information to a personal account (e.g. Company name, VAT, address, etc).

A full explanation of ECHA accounts is provided in the manual here.

Can I administer my ECHA user account by myself?
Yes. Any user can perform the following actions:
 
  • Request for a new password: you need to know the answer to your security question.
  • Recover a forgotten password: you need to know the answer to your security question once you click on the verification link sent to your email address.
  • Recover your username: if you know your email address associated to the account, a message will be delivered to that email address with all the usernames related to that email address.
If your account is locked after several incorrect attempts, you will be able to use the account recovery functionality. Once you provide the answer to the security question, a password will be sent to your email address. You may alternatively contact another user of the same account with "legal entity manager" role, so this user will provide you immediately with a new password.
 
Remember that you can contact your user administrator to provide you with access or to modify data related to a particular account. If you are the administrator and you cannot perform any of the actions previously mentioned, you can contact the ECHA Helpdesk. When communicating with ECHA Helpdesk, please always include all the possible relative information (e.g. “legal entity manager” account name, UUID). This will help us to resolve your request faster.
 
Further information can be found in the ECHA Accounts Manual.
 
What are the different user roles in ECHA Accounts?

Users need to have at least one role, i.e. “manager” or “reader”, to access ECHA IT tools. The assigned roles determine the level of access to ECHA Accounts.

For account management
Legal Entity Manager: you can modify the legal entity data (e.g. company name, company address, VAT), contact details and user data (e.g. user email, phone number, etc).

 

Access to ECHA applications
  • Manager: full access to the application selected (REACH-IT, R4BP 3, ePIC)
  • Reader: read-only access to the application selected (REACH-IT, R4BP 3, ePIC)
  • IUCLID SME Full Access: full access to the ECHA Cloud services
  • IUCLID SME Read Only: read–only access to the ECHA Cloud services
What is a "foreign user"?

A foreign user is an external user from company B who has been appointed by the LE manager from company A to work for company A. A foreign user can perform actions on behalf of the company that grants him permission to use an account from their own ECHA account.

Company B, functioning as foreign user, must create a business account before company A can include the foreign user LE UUID to their account. The foreign user will be able to work on your behalf in REACH-IT, R4BP 3, ePIC and ECHA Cloud Services as if they were users of your company. 

If needed, you can disassociate the foreign user from the "Users" tab.

For further information see the ECHA Accounts manual.

How can I sign up?
You can select the option "Register a company" either in the REACH-IT portal, R4BP 3 portal, ePIC portal or the ECHA Cloud Services portal. You will need to:
  • Introduce your user details
  • Verify the e-mail address (access the e-mail address linked to your user account and click on the verification link)
  • Create your legal entity (or company details). If you already have a LEOX (previously created in the IUCLID 5 website or in IUCLID 5), you can import your company details
 
How can I manage my ECHA account?

You can:

  • Access REACH-IT, R4BP 3, ePIC or ECHA Cloud Services and select either the legal entity or username available on the top banner.
  • Access directly the ECHA Accounts portal.
How can I remove access of a particular user in REACH-IT, R4BP 3, ePIC and ECHA Cloud Services?

A user with a "Legal entity Manager" role can edit or remove the manager or reader role of another user. This will prevent the user from accessing to the relevant application. More information can be found in ECHA Accounts manual.

What are the password complexity requirements and password policy?

As mentioned in the ECHA Accounts Manual, the following rules must be applied, when changing/updating a password:

The password must have at least 8 characters and contain three of the following character types: uppercase letter [A to Z], lowercase letter [a to z], number [0-9] and non-alphabetical.

Please also note the following restrictions:

  • The password must not contain parts of the username, first name or last name.
  • The password cannot be the same as the previously used passwords.
  • The password cannot be changed more than once a day. 
I received a One-time-Password (OTP) but I can still not log in to my account.

In order to solve this issue, please:

  1. try to verify your email before using the OTP provided to you by ECHA. If the account is not verified, then you cannot proceed and change the password.
  2. contact the ECHA Helpdesk to re-check and reset your account, in case the e-mail verification fails.
How can I update my company name in ECHA Accounts?

A company name change needs to be communicated to ECHA using available ECHA applications such as REACH-IT, R4BP 3 or ePIC. The company name can be easily changed by logging in to ECHA Accounts through any of the ECHA applications. See steps below:

  1. Log into ECHA Accounts
  2. Click on “Accounts, Users & parties”
  3. Click on the button “Edit” and “Change name”
  4. Modify the company name, agree to the disclaimer and upload a supporting document from a national registry to prove the official name change.

Important note: Under the Biocidal Products Regulation (BPR), a company name change is considered legally valid only once an administrative change on request is authorised by your national authorities. Useful instructions on how to submit an administrative change on request (NA-ADC) via R4BP 3 can be found in the chapter “National authorisation – changes on request” of the Biocides Submission Manual: national authorisations.

Which type of account can access REACH-IT, R4BP, ECHA Cloud Services, etc.?

Only the business account associated with a LE/Company/Organisation can access an ECHA IT tool (REACH-IT, R4BP, ePIC, ECHA Cloud Services, etc.). If you do not have access to the ECHA on-line IT tools, after the creation of a new user account you need to continue and promote a personal account to a business account.

If you would like to see a detailed description of this process along with a full explanation of all aspects of ECHA accounts, see the ECHA Accounts manual.

I had an account on the website of IUCLID, Chesar, or Poison-Centres before 15th November 2018. What should I do?

On 15th November 2018, ECHA changed the method of logging in to the IUCLID, Chesar, and Poison-Centres websites to allow only ECHA Accounts to access them. It is no longer possible to log in to the IUCLID and Chesar websites using the accounts previously created on those websites.

If you have an ECHA account used to access any of the on-line tools provided by ECHA, the account credentials can now be used to log in to the IUCLID and Chesar websites. The on-line tools include: REACH-IT, R4BP 3, ePIC, Poison Centres Notifications Portal, and the ECHA Cloud Services.

If you do not have an ECHA account, and you want to access either the Chesar or the IUCLID website to download software, you will have to create an ECHA account first. This can be done from the ECHA website by following the steps:

  • Click on “sign in” (top right hand corner)
  • Select “personal or other account”
  • Click on “sign-up”

Once the account has been created, you will receive a verification email. You will be able to sign in to your account once the email has been verified.

If you want to continue receiving news alerts via email for either IUCLID or Chesar, you must log in with an ECHA Account, and activate the relevant options under My Account from within the appropriate website(s).

For more information consult ECHA account Q&A's

EUSES

Release module

Is it still possible to fill in the Elocal values?
Yes, it is still possible. However, in certain scenarios you may need to select the value for some parameters (to better define the scenario) before the Elocal field in the output tab becomes editable. For example, after selecting the scenario (1) Human hygiene, you still need to select a value for ‘use tonnage or consumption-based approach’ in order for the fields “local emission to wastewater” and “local emission to air” to become editable. Note also that in EUSES 2.2.0, default emission scenarios are provided which may be used to cover new uses.
Are direct releases calculated for the tonnage based scenarios?
The calculation of direct releases is only implemented for the consumption based approach. You can find more details on the 'Practical guide: How to use EUSES 2.2.0' (available on the EUSES webpage https://echa.europa.eu/support/dossier-submission-tools/euses ).
Where can I find the equations implemented in the release module in EUSES 2.2.0?
The calculations are implemented according to the respective ESD and agreements published in the TAB. However, for most of the product types you can find the equations in the Excel files published on the ECHA ESD webpage https://echa.europa.eu/en/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents . For PT 11 you can find the equations in the EUSES 2.1 model calculations III available through the EUSES webpage https://echa.europa.eu/support/dossier-submission-tools/euses.
SimpleTreat

Is SimpleTreat 4.0 implemented with the adaptations as discussed in the TAB?
The standalone version of SimpleTreat 4 is implemented in EUSES 2.2.0. For instance, the option between Municipal STP and Industrial STP was introduced because it is a functionality of the standalone version of SimpleTreat 4. However, the default operation mode of the STP was set to "Municipal", which is the default value for the environmental risk assessment of biocides. All the default values agreed for biocides and included in the TAB were implemented as default values in SimpleTreat 4 in EUSES. You find these default values described in the TAB v2.0, ENV 9 (Technical Agreements for Biocides - link on the webpage https://echa.europa.eu/en/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents).
Can I use SimpleTreat 3.1 for the environmental risk assessment of biocides?

There are two scenarios where using SimpleTreat 3.1 is no longer adequate:

1)  You must use SimpleTreat 4.0 for active substance CARs submitted to ECHA (and consecutive product authorisation after approval of the active substance) after July 2017 (more precisely after 25 July 2017, i.e. six months after the decision at WG-I-2017).

2) For product authorisation you must use SimpleTreat 4.0 for applications submitted after January 2019 (more precisely after 25 January 2019, i.e. two years after the WG decision) (see also the TAB v2.0, ENV 9 - link on the webpage https://echa.europa.eu/en/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents).

I come to different results for the STP output when using SimpleTreat 4.0 standalone compared to the version implemented in EUSES.
Small differences in the results may be due to the temperature conversion from Kelvin to Celsius. In EUSES 2.2.0 the temperature conversion makes use of the more precise value of 273.15 K instead of the value 273 K used in SimpleTreat 4.0 standalone.
Specific product types

In PT 8 scenarios, which equations are implemented for the calculation of the concentrations in soil after degradation?
The Excel file (see link in answer above) includes both the time weighted concentrations and the concentrations over each assessment period. In EUSES 2.2.0 the concentrations after removal are calculated at the end of the assessment periods (not time weighted concentrations).
Should I use the previous version of EUSES to calculate the releases from the use of insecticides and disinfectants used in stables?
The previous versions of EUSES should not be used for the calculation of PT3 and PT 18. Excel files to calculate the emissions from PT 18 and PT 3 scenarios not included in EUSES will be published on ECHA ESD page by the end of 2019. Until then, please use the equations provided in the ESD to estimate the emissions. The implementation of PT 18 stables and manure scenarios in previous EUSES is no longer up to date.
In the case of PT 18 products, often the product is sold in a concentrated formulation which needs to be diluted before its use. Which value do I need to enter in EUSES: the amount of concentrated product or the amount of product after its dilution?
You need to enter the quantity of commercial product, that is, before dilution.
Are the city scenario and the storm water scenario (direct emissions to surface water in urban areas) implemented in EUSES?
Yes, they are.  You can find more details on the direct releases to surface water via the rainwater sewer in PT 6, 7, 8, 9, 10 and 14 in the Section 5.2.2 of the 'Practical guide: How to use EUSES 2.2.0' (available on the EUSES webpage https://echa.europa.eu/support/dossier-submission-tools/euses).
In case of the PT 10 scenario, house in the countryside, how can I assess the emissions if I do not have leaching data?
When no leaching data is available it should be assumed 100 % leaching (of the applied amount) for TIME 3; 75 % for TIME 2; and 50 % for TIME 1. We assume the conclusions for PT 8, from the document “Summary: Conclusions of the 2nd EU Leaching Workshop on Wood Preservatives ENV 104,” can be applied to PT 10.
Substance properties

Do I still need to set the value of the Henry's Law constant?
You can provide experimental values together with the temperature at which it was measured. Otherwise EUSES will use the Henry's law constant at 25 °C which is automatically calculated. In this respect nothing has changed compared to the previous version of EUSES.
Why can't I use the vapour pressure and the water solubility values which I determined at a temperature different from 20/25 °C?
Those fields were removed since the equations implemented in EUSES to calculate VP / water solubility at 25 °C from a measured VP (at a given temperature) were only applicable within a narrow temperature range. On the other hand, the water solubility is usually determined at 20 °C and the VP is usually determined at 20 °C for volatile substances as well.
Can I use the measured DT50 values to overwrite the degradation rate constant or the total rate constant?
Output or default values can always be overwritten in EUSES; this also applies to degradation rates. Measured DT 50 values can be used to overwrite the degradation rate constant.
Under what circumstances would a DT50 affect the PEC water?
It affects the PEC in water only in cases of direct release (e.g. in PT 8 bridge over pond scenario).
Technical questions on EUSES

Will EUSES 2.2.0 be updated in case of changes to ESDs and TAB?
EUSES 2.2.0 reflects the agreements on exposure assessment in effect at the beginning of 2019. Any change to exposure scenarios will be included in a new ECHA tool which will merge CHESAR and EUSES and which will be developed over the coming years. Until the new tool is available, if different default values are agreed on, you need to overwrite them in EUSES. We will also update the Excel files on the ECHA ESD webpage in case of major changes in the scenarios (ECHA ESD webpage https://echa.europa.eu/en/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents).
Can I import a file from the previous version of EUSES?
Only a very limited part of the information will be imported into EUSES 2.2.0. You can find more details in Section 3.2 of the 'Practical guide: How to use EUSES 2.2.0' (available on the EUSES webpage https://echa.europa.eu/support/dossier-submission-tools/euses)
PIC

PIC Regulation

A. Obligations and processes

Can ECHA or DNAs change the information provided in my export notification or delete my notification?

As an exporter, you are responsible for the content of your export notification, therefore only you can edit the data in a notification. If information is found to be either missing or incorrect, the DNA or ECHA will send the notification back to the exporter for revision.

A fully processed export notification (checked and accepted by both the DNA and ECHA) can no longer be edited or deleted.

Why is my RIN still not active although I notified well in advance of the export?

Export notifications for chemicals listed in part 2 or 3 of Annex I to the PIC Regulation can be activated only if an applicable explicit consent response from the importing country or an accepted waiver proposal is recorded in ePIC.

In the absence of an applicable consent, it is your Designated National Authority's responsibility to make a new request to the importing country.

If 60 days have elapsed since the explicit consent request was registered and there is no response from the importing country, you can propose a standard waiver to activate your RIN. For further information on how to propose waivers though ePIC, see Waiver Information Sheet and ePIC User Manual for Industry.

Why is my RIN not active until the end of the year? Do I need to submit a new notification?

For exports of chemicals listed in part 1 of Annex I of the PIC Regulation, the notification is automatically activated from the expected date of first export until the end of the year, provided that the data requirements are met.

Chemicals listed in parts 2 and 3 of Annex I are additionally subject to the explicit consent procedure. In these cases, the active period of the RIN depends on the availability and on the validity period of the explicit consent response received from the importing country or on the validity period of the accepted waiver proposal.

Further details on RIN statuses can be found in Q&A 1047.

The active period of the existing notification can be extended in case a new consent/waiver with a longer validity period is recorded in the system. There is no need to submit a subsequent notification.

Please contact your Designated National Authority (DNA) if you believe that a new consent from the importing country should be sought.


 

I had submitted a notification with a certain expected amount and I now realise that I will be exporting more than I had originally foreseen. Should I submit a new notification?

There is no need to submit a new export notification. The actual quantities exported are to be provided by the exporter in the annual Article 10 industry report. Similarly, the Article 10 industry report should include a list of names and addresses of each importer to which the shipments took place. Further information on Article 10 can be found in the Article 10 Reporting factsheet.

When should I submit a special RIN request?

A special RIN is a simplified procedure for notifying an export of a PIC chemical. The special RIN request can be applied to the following exports:

  • An Annex I or Annex V chemical for research and analysis purposes, in quantities of 10 kg or less, per year and per importing country, or
  • A chemical listed in Annex I part 3 for which a positive import decision is available in the latest PIC Circular, or
  • The importing country has waived its right to receive an export notification for this/all chemical(s).

Special RIN requests are managed by the National Designated Authorities (DNAs) and ECHA is not involved in this process.

Further information on special RIN requests can be found in “Special RIN Requests” factsheet.

B. Article 10 reporting

Shall I use ePIC to fulfil my reporting obligations under Article 10?

Yes, ePIC provides the industry with a user interface to report exports and imports of chemicals subject to the PIC Regulation that took place during the previous calendar year, and by that fulfil their obligations under the Article 10 of that regulation. The report for exports is pre-filled from the export notifications – to the extent possible - by ePIC when the data is available in the system.


When and how should I report the exact quantities of PIC chemicals exported and imported during the previous calendar year?

You should submit the information concerning exports and imports of PIC chemicals that took place during the previous calendar year to your designated national authority (DNA) during the first quarter of each year. The information should be provided by using ePIC’s ‘Article 10 reports’ functionality.

Export of PIC chemicals

On 1 January of each year, ePIC automatically pre-generates a draft report for the previous year's exports, as long as there is at least one validated export notification in the system for the reporting period.

You should finalise the report and submit it to your DNA in ePIC, by 31 March at the latest each year.

Import of PIC chemicals

Unlike for exports, the report on imports are not pre-generated. Therefore, you should always create and fill the report manually by using the functionality ‘Create report on imports’ available in ePIC. You should finalise the report and submit it to your DNA in ePIC, by 31 March at the latest each year.

Detailed information on how to submit article 10 reports can be found in the ePIC User Manual for Industry.

I did not submit any export notifications last year but I would still like to report on the quantities of PIC chemicals that I exported. How should I do it?

It is a legal obligation for you to submit an export notification before exporting a chemical that is subject to the PIC Regulation.

If, however, you exported PIC chemicals during the previous calendar year without submitting an export notification, you can still comply with your reporting obligation by manually creating a report using the "Create report on exports" feature.

I have already submitted my report but now realise that some corrections are needed. How shall I proceed?

If there is a need to introduce changes to an already submitted report, you should first contact your designated national authority (DNA) outside the ePIC application. Your DNA can then send the report back to you in ePIC, where you can make the necessary corrections and resubmit.

 

Please find further information in Chapter 12.4.2 “Resubmission of Article 10 reports” of the ePIC Use Manual for Industry.

I cannot create a report, as the system says that ‘a report is already available’. What shall I do?

ePIC automatically pre-generates a draft report for reporting exports, if the exporter had at least one export notification submitted and validated through ePIC during the year to be reported on. Once there is a pre-generated report in the system, you are not be able to create another report manually, and you should use the pre-generated report.

The pre-generated report can be easily accessed from the homepage:

I have never used ePIC since I am not an exporter of PIC chemicals. How should I report on imports of PIC chemicals?

You have two options:

  • The preferred option is that you create an account in ePIC and prepare your report on imports with the dedicated functionality ‘Create report on imports’. To create an account in ePIC, please refer to QA 956.

  • Alternatively, you may contact your designated national authority (DNA) and ask them whether you can provide the relevant information to them outside the system. If they agree, they can create reports based on the information received from the importer.

An export for which I had submitted an export notification did not take place. How can I delete in ePIC the related Article 10 pre-generated report or the related specific row in the pre-generated report?

You are not able to delete either the pre-generated report as a whole or any RIN-specific record in it. If the export did not take place, please report a zero (0) quantity for that export.

C. PIC Information disseminated by ECHA

What information related to PIC is disseminated on the ECHA website?

ECHA is making publicly available the information on chemicals listed in the relevant annexes of the PIC Regulation that are exported from and imported to the European Union: http://echa.europa.eu/information-on-chemicals/pic/chemicals

The following data will be made publicly available from individual exporters submitting export notifications under the PIC Regulation:

1.For export notifications:

  • The year of the export;
  • The exporting EU Member State;
  • The importing country;
  • The non-confidential identity of the chemical or mixture or article exported (as provided by the exporter);
  • Its type (chemical, mixture or article).

2. For explicit consents:

  • The non-confidential identity of the chemical, mixture or article (as provided by the exporter) for which a consent is sought;
  • Its type (chemical, mixture or article);
  • The use category for which consent is sought;
  • The importing country;
  • The exporting EU Member State;
  • Whether a consent is sought;
  • The request date;
  • The validity start date (if applicable);
  • The validity expiry date (if applicable)
  • The status of the consent (Pending, Accepted, Rejected, Closed).
ePIC

A. Log in to ePIC and account management

How do I access ePIC?

All PIC related activities should be carried out using the ePIC portal. If you are new to ePIC, you need to register a company before you can log in.

If you already have a valid account created in REACH-IT or you use a REACH-IT account for REACH or CLP purposes, refer to the ECHA Accounts Q&As and ECHA Accounts Manual.

I try to log in to ePIC and I receive a message indicating that “no role or company details have been provided”. What shall I do?

You need an ePIC role in ‘ECHA Accounts’ before you gain access to the ePIC application.

If you have signed up in ‘ECHA Accounts’ from 2 September 2014, you may also receive this message, if no legal entity details have been provided. If this applies to you, log in to ECHA Accounts, encode your legal entity and include a contact person before you log in to ePIC.

I can access ePIC but I am not able to create any notifications. What should I do?

You may have a “read-only” access to ePIC. You should contact your Legal Entity Manager within your company to verify your ePIC role.

The following roles are available in the system:

For account management: Legal Entity Manager - can modify the legal entity data, contact data and user data.

  • Access to ECHA application (ePIC in this case):

  • Manager: full access

  • Reader: read-only access

Please find further information on the ECHA Accounts Q&As and ECHA Accounts Manual.

My company has changed name and we have valid notifications under the old name of the company. Do we need to send new notifications with the new company name?
A company can change its legal entity name in “ECHA accounts”. The name change will have the following consequences:
  • The PDF templates for the already submitted export notifications will not be impacted by the change: they will still have the ‘old’ name in the exporter details section.
  • The name change will take immediate effect in the customs application, e.g. when customs checks the current RINs, the new legal entity name will be displayed.
Therefore, in case of name change of the exporting company, there is no need to submit new notifications for exports that have already been notified.
Can a legal entity be created after a successful merger of two companies use the export notifications submitted by one of the companies before the merger?
The PIC Regulation does not describe a so-called “legal entity change” and therefore no such functionality is available within the ePIC submission tool. It is not possible to transfer assets (export notifications, special RIN request etc.) from one account to another in ePIC. To continue exporting, the legal successor will need to submit new notifications.
B. Functionalities of ePIC

Which functionalities are available to exporters in ePIC?

The ePIC industry interface enables exporters and importers of PIC chemicals to submit data to and exchange information with authorities in a secure way. More specifically, through this interface industry users can submit:

  • export notifications,

  • special RIN requests,

  • waiver proposals,

  • exports and/or imports reports.

Industry users can also follow in ePIC the progress of the processing and status of their submissions.

How can I submit a waiver proposal?

A waiver proposal can be submitted in ePIC from the notification form using the ‘Propose waiver’ functionality.

 

More information can be found in ‘Waiver information sheet.

I created an export notification for a mixture but I did not manage to attach a Safety Data Sheet (SDS). How can I do this?

In case the export notification concerns a mixture, the “Attachments” section of the notification form displays automatically all SDS files that are associated to the selected mixture.

 

If no SDS is displayed in the “Attachments” section, you need to go back to your mixture master data (using “Manage mixtures” functionality in ePIC) and upload the SDS file(s) before (re)submitting your notification. Once the SDS file(s) are attached to your mixture and you have saved the record, the uploaded document(s) will be automatically displayed in the export notification form. If you have attached several language versions of the SDS, you may choose the relevant one(s) by selecting the checkboxes in the “Action” column.

 

Note that you should not use the options "Other" or "Emergency" for uploading SDS files.

I have received an e-mail stating that "Information requirements are not met", but with no further information. How can I find out which information requirements are not met?

The reason why your notification has been sent back to you can be consulted in ePIC, in the “Message history” section.

You can access the message history of a notification by clicking on the link you received in the automated e-mail. Alternatively, you can view messages by doing the following:

1.Log in to ePIC if necessary

2.Search for the RIN

3.Go to View menu (see image)

4.Select "Message history"

5.Click in the arrow Arrow next to the message to open it. You can consult the details there.

If you need additional clarification you can contact your DNA directly.
The contact details for the designated national authorities

What are the statuses of an export notification in ePIC?

The ePIC application shows the status of a RIN at the present moment in time. The possible statuses are: "Inactive", "Active", "Disabled" or "Expired".

"Inactive" means that the export cannot take place yet.

Inactive

"Inactive" without the validity period in brackets: The RIN has not been activated yet. The export cannot take place unless an appropriate explicit consent/waiver has been registered in the system.

"Inactive" with the validity period in brackets means that the notification has been activated, but the export will happen in the future. For example, a RIN status such as the following "Inactive (19/07/2017 – 25/10/2017)” tells you that:

  • The RIN is inactive today

  • The RIN shall be active from 19 July 2017 until 25 October 2017; and

  • The RIN activation is linked to a consent/waiver whose validity ends on 25 October 2017

The status "Active" with the validity period in brackets means that the export can take place at present. The validity period of the RIN is indicated in brackets.

 

 Disabled

"Disabled" means that the export notification has been either rejected or disabled due to a negative explicit consent response. 

 

The status "Expired" means that the export notification refers to previous years' exports.

I am trying to prepare an export notification for a group entry, but the system displays an error message. What shall I do?

It is not possible to create an export notification for a chemical by selecting the generic group entry only. You must specify either the CAS number or the EC number (when available) of the specific substance you intend to export.

How do I attach more than one language version of the SDS in my notification?

In case the export notification concerns a chemical, you can upload several language versions of the SDS in the “Attachments” section of the export notification form. You should not use document types “Other” or “Emergency”.

 

In case the export concerns a mixture, the different language versions can be added using the “Manage mixture” functionality. Once the safety data sheet is attached to your mixture and you have saved the record, the uploaded document(s) will be automatically displayed in the “Attachments” section of the export notification form. If several language versions are attached to your notification, you should choose the relevant one(s) by selecting the checkboxes in the “Action” column.

I am trying to enter a CAS number in ePIC but the system does not recognise it. Does this mean that the substance is not subject to the PIC Regulation?

No. It should be understood that the lists of substances under group entries in ePIC are not fully comprehensive and new entries can be added on a case-by-case basis.

From a legal perspective, when a group entry is subject to the provisions of the PIC Regulation, all the substances under that entry are covered irrespective whether the  specific substance identifiers (e.g. CAS or EC numbers) is already included under the group entry in ePIC or not.

If you are exporting a substance that you believe belongs to this group but cannot find it in ePIC, you should contact the ECHA Helpdesk.

ECHA then verifies the entry and adds the substance under the relevant group in ePIC if needed.

R4BP 3

Company information

How do I update my company details?

You can update your company details using ECHA Accounts. Once you log into R4BP 3, select the legal entity under the ECHA banner and click on "Edit" to modify your company details. Here you can modify company billing or contact information.

If more than one contact person has been specified in ECHA Accounts, you can modify this person from the company detailscontacts tab within your case in R4BP 3.

In addition, remember that certain administrative changes, such as the authorisation holder transfer, name or address of the authorisation holder of national authorisations, require the approval of the relevant Member States.

Additional information can be found in Q&A 1474.

Functionality

What is the difference between case number and submission number?

A case number identifies a particular application or notification submitted to ECHA. A submission number relates to a particular application or notification, and identifies the number of a submission.

If you need to prepare two submissions for the same case (application or notification), e.g. the evaluating authority requests additional information, the following format applies:

Initial submission number: BC-YY 000000-11/1

Submission number for the additional information for the same case: BC-YY 000000-11/2

Note: the case number remains unchanged, while the submission number changes.

What is the difference between Tasks and Messages?

A task item relates to a case, requiring an action from you within a specific deadline, e.g. a request for additional information. Messages will provide you with information about the status of your case. Member state competent authorities and ECHA will send communications to your R4BP 3 message inbox. Requests for action will however be sent to your R4BP 3 task inbox. It is your responsibility to regularly monitor your message inbox and task items in your R4BP 3 account to make sure that you react promptly to any request from ECHA or national authorities.

What is the meaning of "tasks due to expire" and "my messages" in the homepage of R4BP 3?

"Tasks due to expire" includes up to 10 tasks where you are required to respond within 10 days.

The "My messages" box shows the latest 10 messages.

New messages are displayed in red while those you have read are displayed in black.

What is the meaning of related cases and related assets in R4BP 3?

The "Related cases" sub-tab on the case details page will show you both open and closed cases that relate to the particular case/asset you are viewing. A case does not have a final decision yet. For example, a ‘Mutual recognition in parallel' case that is being evaluated in one MSCA can be viewed through the other related ‘Mutual recognition in parallel' cases being assessed in other MSCAs. The "Related assets" tab allows you to access assets related to a particular asset/case.

What document formats are allowed in R4BP 3?

The following file types are supported: .i6z, .doc, .docx, .pdf, .xls, .xlsx, .ppt, .pptx, .txt and .xml.

File names must NOT exceed 150 characters or contain ASCII special characters.

It is recommended that your file does not exceed 3 GB. If your file is larger than 3 GB, contact ECHA for further support.

What are the opening hours for R4BP 3?

R4BP 3 can be accessed 24 hours, 7 days a week. The access will be disrupted during maintenance activities. Further information can be found in the ECHA opening hours section

What is the meaning of “D”, “T” and “N” next to my asset?

“D” stands for delegation, “T” stands for transfer and “N” stands for nomination.

For more information on delegations, nominations and transfers of cases and/or assets in R4BP 3, please refer to the Biocides Submission Manual – BSM Technical Guide: How to use R4BP 3 .

How can I manage the email notification alerts I receive in my email?

You receive email notification alerts to the email addresses specified in the contact details of your account.

These emails inform the case owner about the completion of steps in an application or notification submitted through R4BP 3.

If you need to modify or delete a particular user, log in to R4BP 3 and select your user under the ECHA banner; then go to the ‘Contacts’ tab and remove or modify the entry.

Why does R4BP 3 not accept my IUCLID file or SPC when I want to reply to a task created by my competent authority?

Your authorities may request more information from you by using a communication functionality. You can find this message in your message tab.

If the message contains a deadline for your attention, you will find it in the tasks tab with the subject "reply to communication."

Since the communication functionality for authorities is built only to request additional information to support their assessment, you will not be able to upload the technical dossier or the SPC in an XML format. If you have to do so, please contact your authorities and ask them to complete their pending task (to request for additional information).

I receive the error message “the system is expecting a complete SPC, not just an empty auto-generated SPC”. Why?

If you receive this message, it means that you are working with an SPC template migrated from R4BP 2, available in R4BP 3 and not all minimum information needed in the SPC has been provided. 

If you include more than one SPC, e.g. in different languages, make sure that all the SPCs are complete.

Information on chemicals

What information is available for biocides since November 2018?

The following information is available in the “Information on chemicals” section for Biocides:

  • The list of biocidal active substances for which an application for approval has been submitted, approval has been granted or refused. The published information includes also documents such as the assessment report, study summaries (Document IIIA), opinion and a link to the related legal text approving or not approving substance to be used as a biocidal active substance.
  • The list of union, simplified and national biocidal product authorisations. The published information includes also documents such as the assessment report, summary of product characteristics, decision or authorisation document, and in case of union authorisations also the Opinion and link to the related legal text.
  • The list of active substances and suppliers (“Article 95 list”).
What information is available in the biocidal product factsheet?

The biocidal product factsheet contains detailed information on the biocidal product’s authorisation as available in R4BP 3. The factsheet also includes a map with the authorisation status of a product, authorisation details of all mutually recognised applications and historical data on previous assessments.

A biocidal product factsheet also contains the:

  • Summary of product characteristics (finalised or updated after 1 January 2016 in R4BP 3).
  • Product assessment report.
  • Product authorisation/decision documents.
  • Biocidal product committee opinion (for Union authorisations).
How does ECHA guarantee the reliability of Biocides data publicly available?

The biocides data available in the “Information on chemicals” section on the ECHA’s website originates from the information provided by applicants and verified by the evaluating competent authority. ECHA does not verify the adequacy or the correctness of information provided that falls under the responsibility of the national authorities. For confidential data assessed by your evaluating competent authority, you will need to ensure the adequacy of the information published with your national authorities.

For further information on this topic, see Q&A 1554 and Q&A 1555.

When will the information from my application be published on ECHA’s website?

Information on biocidal product authorisations will be published in the “Information on chemicals” section on ECHA’s website when a product asset is created in R4BP 3. Information on active substances will be published when the evaluation is started by the evaluating Member State authority.

How can I ensure that confidential information will not be published?

During the approval/authorisation process for active substance or biocidal product, the applicant has to provide comments within 30 days to ensure that documents subject to dissemination according to Article 67 of the BPR (the SPC, assessment report, Document III-A, Decisions/authorisation document and Opinion) do not contain confidential information. Once an authorisation, a renewal or a change on request is approved in R4BP 3, you can verify the correctness of the following R4BP 3 information disseminated on the ECHA website as available in your asset:

  • The summary of product characteristics (SPC) in XML format. Note: information on the function of other substances or of substances of concern will not be made publicly available.
  • Documents under the “Documents” tab with access level ‘Public’:
    • Active substance/product assessment report.
    • Product authorisation/decision documents.
    • Active substance Document IIIA.
    • Active substance/Union authorisation Opinion.
Certain information from my published approval/authorisation is incorrect/missing. What shall I do?

When you notice that certain published information from your active substance/authorisation is incorrect or is missing please contact the Member State responsible for evaluating your application. ECHA will publish the updated information as soon as the changes are applied in R4BP 3.

When data is inaccurate or incorrect as provided by your national authorities, you will need to contact your national authorities so they will be able to apply the necessary actions.

For other reasons, contact ECHA.

I cannot find information from an application on ECHA’s website. Why?

The most common reasons are:

  • Data from active substance or biocidal product applications must be available in R4BP 3, i.e., new applications or updates must be authorised by your authorities in R4BP 3.
  • For biocidal products, the information is derived from assets available in R4BP 3. Information from pending cases is not published.
  • Due to technical limitations only a limited number of cancelled and expired authorisations are currently disseminated. They will be progressively published.
Known Issue

I try to upload my SPC file and R4BP 3 seems not to react. Why?

Only files that contain ASCII characters in its filename are accepted in R4BP 3. If the name of your SPC contains non-ASCII characters, just change the name and upload it again to R4BP 3.

Messages

How do I find a message in R4BP 3?

Messages in R4BP 3 include communications/decisions from authority users to the case owner. Most of the communications are related to the different steps in the submission process i.e. the format check, business rule failure, submission acceptance by ECHA, invoicing.

The final decision on your application/notification will also be communicated through the R4BP 3 message inbox.

Relevant search options are:

  • Status: sent/received
  • Message status: read or unread.
  • Communication number: every communication/decision is identified in R4BP 3 with a unique communication number.
Migration to R4BP 3

Where can I find my remaining data from R4BP2?

Since 3 December 2014, all data for on-going applications and authorisations from R4BP2 have been migrated to R4BP 3. You need to access R4BP 3 to search for this information: search for assets if you are looking for authorisations, search for cases if you are looking for on-going applications.

If you cannot find a case or an asset corresponding to one of your ongoing applications or authorisations in R4BP that have been recorded in R4BP2, you need to send a request for each of the cases or assets to the competent authority responsible for this case or asset; When doing so, please include the following files:

  • Ongoing application (case): use the template file "case correction". Include the applicant LE UUID, authorisation holder LE UUID and application number in R4BP2.
  • Existing authorisation (asset): use the template file "asset correction". Include the authorisation number in R4BP2 and the LE UUID of the authorisation holder.

The LE UUID can be found in the legal entity details of an ECHA account. Further information can be found in the ECHA Accounts manual.

The responsible competent authority will assess your request. If they confirm your ownership of the case or asset, they will request ECHA to transfer your data to the R4BP 3 account corresponding to the LE UUID you have provided.

Payments

Who sets ECHA fees and charges payable for the Biocidal Products Regulation?

The European Commission sets the ECHA fees and charges payable under the Biocidal Products Regulation (EU) No 528/2012 (‘the BPR'). The charges are revised annually and agreed with the EU Member States and reflected in the Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013.

The fees for the chemical similarity check service are defined in the ECHA Management Board Decision 31/2013.

Where can I find an overview of the fees?
All fees are specified in the Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 ("the BPR Fee Regulation").
When will I receive ECHA's invoice and where can I find it?
After ECHA receives and processes your BPR application/notification – through the Register for Biocidal Products (R4BP 3) – you will receive an electronic invoice in PDF format in your R4BP 3 account (look in messages). You can open the invoice directly from this message or find it in the financial management tab of the specific case.
What is the deadline for paying ECHA's invoice?

Unless specified otherwise, you must pay the fees within 30 days from the date of invoice; the payment due date is specified on the invoice PDF. If the payment is not made by the due date, your application might be rejected due to non-payment. The date of your payment is the date on which the full amount stated in your invoice is deposited in the bank account held by ECHA. (See Q&A 771).

Where the payment is delayed due to reasons outside of your control, ECHA needs sufficient evidence in which you prove that you have made the payment before the due date stated in your invoice.

How do I know I paid on time?
The date of your payment is the date on which the full amount stated in your invoice is deposited in the bank account held by ECHA. (See Q&A 771). You will know that your payment was made on time and it is accepted and processed by ECHA when you see the step “Submission accepted by ECHA” in the Events History tab of your specific case.
Where the payment is delayed due to reasons outside of your control, ECHA needs sufficient evidence in which you prove that you have made the payment before the due date stated in your invoice.
How do I pay ECHA's invoice?

You must pay your invoice by bank transfer. ECHA's full bank details are stated in the invoice.

ECHA recommends that you pay the invoice as a SEPA payment with shared cost. Within the Single Euro Payments Area (SEPA), the use of IBAN (International Bank Account Number) and BIC (Bank Identifier Code)/SWIFT code is mandatory. This payment method will ensure that ECHA receives the full invoiced amount without any deduction of bank charges. For further information regarding SEPA, please consult: http://www.ecb.int/paym/sepa/html/index.en.html.

If you choose another kind of bank transfer, please make sure that your company bears the full cost of the bank transfer. The invoice will not be considered paid until the full amount has been received by ECHA.

What is ECHA's bank account number for the payment of invoices related to the BPR?

Payments of BPR invoices must be made in euros by means of a bank transfer.

The following bank details are indicated on all invoices issued under the BPR as from 01 July 

Bank:			ING Belgium, Avenue Marnix 24, 1000 Brussels, Belgium.

IBAN:			BE62 3631 8785 2361

BIC/SWIFT:		BBRUBEBB
What reference should I indicate in my payment?
You must indicate the invoice number in the free text message/communications field of your payment. The invoice number consists of eight digits you will find next to ECHA's bank details in your invoice. Please instruct your accounts payable/payments department and your bank accordingly. Separate instructions apply for appeal fees..

What are the consequences of not paying an invoice within the payment due date?
The date on which the full invoice amount is deposited into ECHA's bank account is the only accepted date of your payment. If your payment is not in ECHA's account by the due date, your application/notification will be rejected unless you provide a confirmation from a financial institution that shows that you have ordered the transfer before the due date.
If my application is rejected/withdrawn before or during validation or during the assessment, do I receive a refund?

Where an application for active substance approval or biocidal product authorisation or an application for a minor or major change of a product is rejected/withdrawn before or during the validation phase, ECHA will reimburse 90 % of the fee.

Where an application for active substance approval or biocidal product authorisation or an application for a major change of a product is rejected/withdrawn before the evaluating competent authority has transmitted its assessment report to ECHA, 75 % of the fee will be reimbursed.

Where an application is rejected/withdrawn after the evaluating competent authority has transmitted its assessment report to ECHA, the Agency will not reimburse the fee.

Why is ECHA's invoice without value added tax (VAT)?
ECHA's invoices are exempt from VAT because the Agency is not carrying out an economic activity within the meaning of Directive 2006/112/EC on the common system of value added tax. This means that no VAT has to be paid on the fees defined in the BPR Fee Regulation. For the reason above, ECHA has no VAT number and ECHA's invoices are exempt from VAT
 
ECHA's Finnish Business ID number is 2139942-8 and it is always mentioned on ECHA's invoices. However, this number is not a VAT number.
Why are the activities of ECHA not taxable?

ECHA is not a private company or a service provider but a European public authority. The exclusion of ECHA's activities and transactions from taxation also results from Article 13(1) of Directive 2006/112/EC (1) on a common system of value added tax, which stipulates:

"States, regional and local government authorities and other bodies governed by public law shall not be regarded as taxable persons in respect of the activities or transactions in which they engage as public authorities, even where they collect dues, fees, contributions or payments in connection with those activities or transactions".

As it is not a taxable person, ECHA does not have a tax residence in any Member State and thus has no taxation number in Finland.

The invoices that ECHA sends through R4BP 3 to companies are issued according to the BPR and the BPR Fee Regulation. Thus, they do not concern private transactions but are fees under public law applicable in all Member States. Based on Directive 2006/112/EC and particularly Article 13(1), these fees are not subject to taxation in any Member State. In the absence of taxation of the fees in any Member State or elsewhere, ECHA shall not be bound to complete any formalities imposed on taxable persons for the avoidance of double taxation.

1) OJ L 347, 11.12.2006, p. 1

How long does it take until ECHA receives my payment?
The bank statement of any given day is available to ECHA only on the next banking business day. A SEPA payment must be transmitted within three banking business days (since 1 November 2009). It, therefore, normally takes up to four banking business days before ECHA can handle your payment. For this reason, ECHA recommends that you make your payments before the due date stated in your invoice.
 
The handling time may be longer if your payment cannot be dealt with automatically. By following ECHA's instructions regarding payments, you can significantly reduce ECHA's handling time of your payments.
How does ECHA handle my payment?

On the basis of the daily electronic bank statement, ECHA’s system automatically matches your payment with your open invoice - provided you have indicated the correct payment reference (invoice) number in the free-text message/communications field and you have paid the correct amount. 

An additional condition is that you pay each invoice separately as a single payment. One bank transaction per invoice therefore ensures the fast registration of your payment.

ECHA strongly advises you not to pay two or more invoices in the same transaction ("multiple invoice payment"). If you, however, include more than one invoice in the payment, make sure that the invoice references are mentioned in full. Otherwise, the payment has to be manually handled by ECHA's accounting department. This may delay the processing of your payment.

If you can only make multiple invoice payments and you are unable to indicate the full reference numbers in the payment, make sure you follow the instructions in Q&A 775.

How can I ensure a successful submission of the application/notification allowing it to pass to the next step?

Your payment can be swiftly dealt with by ECHA if you follow the guidelines below when making your bank transfer:

  1. Pay one invoice per transaction (single payment);
  2. Indicate the correct reference number (eight digit invoice number in your invoice);
  3. Pay the full amount of the invoice;
  4. Instruct your bank to use a charger bearer code SHAR (shared costs) if the payment is as a SEPA payment, and a charger bearer code OUR for SWIFT/ international payments.
  5. If you discover a mistake after your payment has been made, please immediately contact ECHA using the ECHA Helpdesk webform available at http://echa.europa.eu/contact.
How can I see that ECHA has received and validated my payment?

ECHA does not send confirmations of receipt of payment.
A message will be sent to your R4BP 3 Messages-Inbox informing you that your application/notification has been accepted by ECHA only after the payment has been received and accepted. You can follow up the status of your case under the events history tab in R4BP 3.

When should I provide ECHA with a payment advice?

A payment advice can either be an extract from your accounts payable department attached to your email message in PDF format. Alternatively, it can be a list of the invoice numbers paid, their total amounts and the payment date in the email message itself.

A payment advice must be sent in the following cases:

  • your payment reference (invoice) number was incorrect;
  • in the case of a multiple invoice payment where each invoice number is not mentioned in the bank payment message;
  • by request of ECHA's accounting department.

If you have indicated the reference (invoice) number in your payment message and it is correct, ECHA does not need any separate payment advice.

You must send a payment advice to ECHA's accounting department: payments (at) echa.europa.eu.

Please indicate 'Payment advice and the payment date' in the subject field. Example: "Payment advice 1 September 2013". No payment advice by conventional mail is required unless ECHA exceptionally requests it.

What is a proof of payment and when does it need to be sent to ECHA?

A proof of payment can either be a copy of your bank statement or a separate confirmation stamped by your bank.

The bank statement can serve as proof that you paid ECHA's invoice by the due date. The bank statement copy or the document stamped by your bank must clearly show the date when you ordered the bank transfer.

If ECHA has received your proof of payment but has not received the payment within a time period judged normal for bank transfers, ECHA's accounting department will contact you.

A payment advice printed from your accounting programme is not a valid proof of payment.

Proofs of payment should be sent as scanned PDF attachments to ECHA's accounting department: payments (at) echa.europa.eu.

No proofs of payment by conventional mail are required unless ECHA exceptionally requests them.

Does ECHA send credit notes?
If an invoice is cancelled e.g. incorrect invoice, incorrect billing information etc., you will receive a credit note for the whole amount of the invoice and, if needed, a replacement invoice. These electronic documents can be downloaded in PDF format from the financial management tab of the specific case in your R4BP 3 account.
If I have received two invoices and one credit note, which invoice reference number do I indicate in the payment?

In this case, you must indicate the reference number of the latest invoice. The narrative in your invoice will explain the reasons why a new invoice was issued.

If I have already paid the invoice for which ECHA later issues a credit note, how will the paid amount be credited back to my company?
ECHA will either reallocate the received amount to another unpaid invoice belonging to the same legal entity or refund the amount to you.
What are the rules of a refund?

In certain cases of double payment or unclear overpayment, ECHA will refund the received amount paid in excess. Moreover, fees or charges paid after the payment deadline are “returned to sender” through the bank as undue payments.

Please also refer to Q&A 768.

For the payment of certain refunds, ECHA will request the bank account information of your company. In addition, ECHA requires your company to complete and sign the following two forms to process the refund: "Legal entities" that can be found at: http://ec.europa.eu/budget/contracts_grants/info_contracts/legal_entities/legal_entities_en.cfm 
and "Financial identification" that can be found at: http://ec.europa.eu/budget/contracts_grants/info_contracts/financial_id/financial_id_en.cfm.

Please send the original signed and stamped forms to ECHA by regular post to the following address:

European Chemicals Agency
R1 Accounting
P.O. Box 400
00121 Helsinki 
Finland

We advice that you submit the documents to ECHA's accounting department at payments (at) echa.europa.eu before posting them. 

Do ECHA invoices have to be electronically signed?
After your application/notification has been received by ECHA, you will receive your invoice electronically through R4BP 3 – no paper invoice is sent. Invoices can be downloaded in PDF format from the financial management tab of the specific case in your R4BP 3 account.
 
The requirements mentioned in Directive 1999/93/EC on electronic signatures do not apply to invoices issued by ECHA. The rule on electronic signature of invoices is based on Article 233 of Directive 2006/112/EC ('the VAT Directive'), which according to Article 220, only applies to taxable persons. However, ECHA is not a taxable person, but an EU public body that does not carry out any economic activity.
 
In any case, the purpose of the provisions of the VAT Directive relating to electronic invoices is to guarantee the authenticity of the origin and the integrity of the content. For invoices notified by ECHA, this objective is met in a more efficient way. Invoices issued by ECHA are notified to their recipient through R4BP 3, which is a secured online platform.
How can I prepare my accounts payable department or my accounting company in view of ECHA's invoices?

All the information you need for proceeding with the payment is visible in the invoice itself. However, depending on your internal administrative procedures, it is advisable that your accounting/accounts payable department is prepared for the payment of ECHA's invoices.

We therefore recommend that you set up ECHA's bank account information in the accounting system well in advance of the first invoice's due date.

PLEASE NOTE OUR NEW BANK DETAILS SHOWN ON INVOICES AS FROM 01 JULY 2019.

As from 01 July 2019 ECHA will change the bank account details shown on its fees and charges invoices. The Agency’s new house bank is ING Belgium NV.  ECHA’s new financial identification form covers all the details needed for this new bank account.

If you use an external accounting company, please ensure that all required information about ECHA and the Biocidal Products Regulation is passed on. It is also advisable to clearly relate to ECHA's status as an EU body which is exempt from any national tax or any value added tax. Please refer to Q&A 769 and Q&A 770.

Please make sure that the persons handling the payments of ECHA's invoices are aware that the payment should be made at the full amount so that any possible bank charges are not deducted from the payment.

Please inform your accounting department that if the invoice is paid after the due date, the application/notification will be rejected.

Please ensure that ECHA’s invoice number is stated in the payment instruction (see Q&A 766).

What information about my company appears on ECHA's invoice and credit note?

The following information about your company is visible on the invoices and credit notes:

  • Company name and billing address indicated by the applicant – the information appearing on the invoice is the one filled in the ‘Billing address’ tab in ECHA Accounts.
  • Customer ID number – which is the same as the Legal entity UUID.
  • DUNS number and VAT number – if provided by the registrant during the sign-up; can be modified later on in the Legal entity details section of ECHA Accounts.
  • Purchase order number – if provided by the registrant when submitting the application/notification in R4BP 3.

If you are submitting an application/notification on behalf of the asset owner you can select either your billing address (case owner) or the billing address of the asset owner.

Additional information on how to update your company's general information in ECHA Accounts can be found in the section “How to update legal entity details” of the ECHA Accounts Manual.

Does ECHA need a purchase order for my application?

When submitting an application/notification, you can indicate your own internal purchase order number. It is not possible to add any forgotten purchase order number or modify it afterwards.

As you register online in R4BP 3 you should not send any purchase orders by ordinary mail or email to ECHA. Please make sure that your system does not send any purchase orders automatically to ECHA. Your purchase order is only for your internal purposes.

What is the contact address of ECHA's accounting department (accounts receivable)?
For any enquiry, please contact ECHA by using the ECHA Helpdesk web form that is available at http://echa.europa.eu/contact
My company information has changed and the invoice is not correct; does ECHA issue updated invoices?

If your invoice has not yet been paid, ECHA can cancel it and create a new one with your new company information. If the invoice has been accepted and paid, ECHA cannot modify the invoice.

ECHA is unable to update any company information on your behalf. It is the responsibility of the account owner within the company to make sure that the information is up-to-date.

Firstly, please update your company information in ECHA Accounts as soon as possible. You can easily update your information by signing into ECHA Accounts, selecting the legal entity under the ECHA banner and checking the "Billing address" section. Here you can modify and update your information by clicking on "Edit". Please save your changes at all times.

Immediately after updating your company details, you need to contact the ECHA Helpdesk by using the webform available on the ECHA website at: http://echa.europa.eu/contact.

The company size in your ECHA Accounts cannot be considered for invoicing purposes of applications/notifications submitted through R4BP 3 (further information can be found in FAQ 787). Additional information on how to update your company's general information in ECHA Accounts can be found in section 6.1 – "Updating legal entity details" of the ECHA Accounts Manual available at: http://echa.europa.eu/documents/10162/21721613/echa_accounts_en.pdf

How do I indicate my company size?

You may indicate your company size in ECHA Accounts; however, this information will not be considered relevant for invoicing purposes of ECHA's fees for applications/notifications submitted through R4BP 3.

By default the company size will be considered as non-SME for all applications/notifications submitted through R4BP 3 where an ECHA fee is applicable, except for those applications/notifications where companies already have an SME status recognised by ECHA.

An SME reduction may be applied for applications for approval, renewal or inclusion in Annex I to Regulation (EU) No 528/2012 of an active substance or for Union authorisation of a biocidal product or biocidal product family only if your application contains a claim for SME reduction and if ECHA has already recognised the SME status. You must indicate the claim for SME reduction when you make the submission of the above-mentioned applications.

Your company is only eligible for an SME reduction, if your SME status has been recognised by ECHA before the submission of your applications. You will need to provide documentary evidence before ECHA can accept your eligibility for an SME reduction.

Recognition of the SME status is valid for a period of two years. Further information on this process can be found at: http://echa.europa.eu/support/small-and-medium-sized-enterprises-smes/sme-fees-under-bpr

For applications for approval, renewal or inclusion of an active substance in Annex I, the SME status is determined by reference to the active substances manufacturer in the Union that is represented by the prospective applicant.

For applications for product authorisation or a renewal of product authorisation, the question is determined by references to the prospective authorisation holder established in the Union.

What documents are needed in R4BP 3 for SME status recognition under Biocidal Products Regulation?

Under the Biocidal Products Regulation (BPR), applicants can benefit from reduced fees established for SMEs. ECHA is responsible for checking the size of companies who claim to be eligible for reduced fees.

Before requesting recognition of SME status in R4BP 3, companies should familiarise themselves with the rules set by Commission Recommendation 2003/361/EC on the SME definition.

To support the request for SME recognition, companies should upload documentary proof of their SME status as part of the “SM-APP – SME Verification” application in R4BP 3. The documentary evidence should include:

  1. Information about the ownership structure (upstream, downstream) at the time of the application.
  2. The financial statements (consolidated, if available) together with accompanying notes for the two latest accounting periods before the time of the application.
  3. Official certificate/information confirming the average number of employees for each of the two latest accounting periods before the time of application.

The above listed documents should be provided for all partner and linked enterprises, as defined by Article 3 of the Commission Recommendation 2003/361/EC.

In accordance with Article 6(4) of the Biocidal Products Fee Regulation (EU) No 564/2013, the Agency has to decide on the SME status within 45 days from the day of submission of the complete documentary evidence.

In the case of an application for approval, renewal or inclusion of an active substance in Annex I to the BPR, the SME assessment should be done by referring to the headcount, turnover and balance sheet information of the active substance manufacturer established in the Union and its linked and partner enterprises.

If an application for product authorisation or renewal of product authorisation, the SME assessment should be done by reference to the headcount, turnover and balance sheet information of the prospective authorisation holder established in the Union and its linked and partner enterprises.

The list of documentary evidence accepted by ECHA and more information on company’s size assessment and links to relevant legislation can be found in "SME fees under Biocidal Products Regulation.

You can find instructions on how to upload documents and other useful information about R4BP 3 in the Biocides Submission Manuals.

Roles

What is the difference between an asset owner and a case owner?

In the R4BP 3 context, an asset is a positive regulatory decision on an application (with a unique asset number). This decision is related to either an active substance (e.g. a decision on technical equivalence or the approval of an active substance) or a biocidal product (e.g. a national authorisation or a Union authorisation).

The asset owner is the legal entity in whose name an application or notification is made under the Biocidal Products Regulation i.e. in the case of an application for a product authorisation, the asset owner will be the product authorisation holder. If the asset owner does not appoint a representative, the asset owner and the case owner can be the same.

The case owner is the legal entity that submits an application through R4BP 3 and follows it through its processing. This could be either the future asset owner or a third party, such as a consultant.

How do I indicate that the asset owner will be different to the case owner?

If the asset owner is different to the case owner i.e. a representative or consultant is appointed, you need to specify the identity of the asset owner when you submit a new application. You can do this in Step 1 of the application wizard, under "Asset owner details". If the case owner is different from the asset owner, the former will need to enter the asset owner UUID during the submission of an application/notification through R4BP 3.

SPC editor tool

How can I ensure that minimum information is provided in a family SPC?

The family SPC ensures that minimum information is provided in the different levels of a family SPCs. The meta SPC level is complete if minimum required data is provided in the products within a meta SPC and the meta SPC; the family SPC is complete if all the meta SPCs, administrative information and product information are considered as complete.
To provide the active substance name in the “Administrative information” section, first fill in the product information section.

QA 1232

Also, consider that the active substance concentration of a meta SPC cannot be specified until the concentration of the active substance is provided in the product information section. Likewise, the active substance concentration of the product cannot be provided until the active substance concentration range is specified within the related meta SPC the products belong to.

Which web browser do I need to use for the SPC online tool editor?

The SPC editor tool is supported by Internet Explorer 10, Firefox 29 and above or Google Chrome 35 and above. Compatibility issues may appear if you use Internet Explorer 11: just select the compatibility view icon to display the page correctly. If the compatibility view icon is not available, go to tools >> compatibility view settings and add "europa.eu" (or display all websites in compatibility view).

 

Where can I find my download SPC XML file?
By default, the file is saved in the "Download" folder. If you need to change the default download location, you will need to:
 
  • For Internet Explorer:
    • Click on the gear icon in the upper right corner, then click/tap on <View downloads>.
    • Click on the <Browser> and define the location
  • For Firefox and Google Chrome:
    • From the Menu bar, select <Option>, then <General> and click on <Browse> to define the location.
Understanding how to use the SPC editor tool

If you submit an initial application where the SPC is required, go to the SPC editor, select “New” and provide all the minimum required information. Save the file and upload it in R4BP 3 when required by the wizard.

If you need to prepare an SPC when a case or asset is already in R4BP 3, you must edit the existing SPC in R4BP 3. This is the case when: you apply for a change on request; an authority asks you for further information, or the case has been migrated from R4BP2.

If the above applies, please follow these steps:

  • Download the SPC from R4BP 3. Go to the case or asset, select the “SPC documents” sub-tab and click on “Download SPC”. Save it on your desktop.
  • Go to the SPC editor, select “Open” and provide the minimum required information. Save the changes on your desktop.
  • Upload your SPC XML file when required by the R4BP 3 wizard.

To technically pass the R4BP 3 upload step, you have to populate all mandatory fields. The SPC editor tool has a built-in feature that allows you to determine whether you have provided the minimum required information. If the error icon is displayed in the relevant tab () you are not providing the minimum information required.

In the example below, the error icon is displayed in the “H & P statements” tab because at least one hazard and precautionary statement must be provided (see the text in red in the example below).

QA56

When you enter <+Add hazard statement> and <+Add precautionary statement>, if applicable, the SPC will consider this minimum information as correctly entered.

QA56

To prepare an SPC that R4BP 3 will accept as a valid format, you need to use:

  • a single numerical value or a single letter in the free-text fields; or
  • a value from the respective dropdown lists.

Note: Ensure that the format of your file is correct following the instructions included in Q&A 1054.

How can I create an SPC in a different language?

You need to complete the following steps:

  1. Open the SPC file saved on your computer with the SPC online editor.
  2. Select New >> Draft from final SPC (only if you are working with a final SPC downloaded from R4BP 3).
  3. Click on New >> Market area version and press when the editor asks you to discard your current changes.
  4. Enter the target language and press <OK>.


spc editor

Once you complete these steps, the free-text fields in the ‘Authorised uses’ and ‘Directions for use’ tabs will still contain the same text as the original SPC: you will need to manually complete the translation of these sections.

I cannot edit my SPC file. Why?

Final SPCs are read-only documents that cannot be edited. A lock icon under the language labelling section below the ECHA logo indicates that you are working with a final SPC. To edit a final SPC, you need to select:

  • New >> Draft for changes, renewals – if you apply for changes on request or renewals;
  • New >> Draft for simplified authorisations – if you modify a simplified authorisation; or
  • New >> Draft from final SPC – for any other case that requires the modification of a final SPC.
How do I add an additional product type or type of formulation in a family SPC?

Once you have added the first product type or type of formulation, click on the blank space next to the selected item to enter more options.

QA1233

How can I transfer content from one SPC file to another?

The <Import XML> button allows you to transfer content from another SPC to the SPC you are working with. In an SPC for a single biocidal product, this functionality replaces the content of the file you are working on with the content of the (other/selected) file. In an SPC for a biocidal product family, the functionality will add the imported content to the existing content of the SPC file you are working on. If you need to modify the content of an existing biocidal product family SPC, you will need to do so manually.

The SPC online editor opens a blank page. Why?

The SPC online editor may open a blank page depending on the cookies available in your web browser. You will need to remove the cookies following these instructions:

You may alternatively open your browser in private mode to bypass the blank page to be opened, using the following keyboard shortcuts (pressing the keys at the same time):

  • In Internet Explorer and Firefox: Ctrl + Shift + P.
  • In Chrome: Ctrl + Shift + N.
Searching in R4BP 3

How can I retrieve information relevant to a particular case?

If you are looking for a particular case, you need to use the "Cases" tab. Clicking on the case number link will direct you to the ‘Case details' page containing company details, product/substance details, dossier and supporting documents, events history, invoices related to your case and related cases.

How do I find information on my applications/notifications in R4BP 3?

You can verify the status of your application in your R4BP 3 message inbox. You can find your approved applications/notification under the “Assets” tab.

You can also find the status of your application when using the “Case” tab with the status “Closed – Approved”. In addition, you can search for on-going applications (“In progress”) as well as rejected applications/notifications (“Closed – Rejected”) in the “Cases” tab.

screenshot of a dropdown

For more information on how to find messages in R4BP 3, please refer to: Biocides Submission Manual – BSM Technical guide: How to use R4BP 3.

I do not find a task, message, case or asset in R4BP 3. Why?

By default, R4BP 3 displays information based on certain criteria. In particular:

  • Tasks: filtered by "open tasks";
  • Messages: received within the last two months;
  • Cases: status "in progress"; and
  • Assets: status "active".

To find further information, you may change the search criteria in R4BP 3.

For the migration of assets from R4BP2 to R4BP 3 special rules apply. Further details can be found in the Q&A migration to R4BP 3.

Where can I find my application related to the review programme in R4BP 3?

Only notification procedure (RP-NOT) can be found as assets in R4BP 3. All other related case types related to the review programme, i.e., declarations of interest to notify (DI-SUB), changes of participants (PA-CHG) or active substance evaluation under Regulation (EU) No 1602/2014 can be found as cases. Select "Closed – Approved" as search criteria to find more on your case.

Information on the review programme is also publicly available in the existing active substance website.

I can see in the events history the message "Active substance in dossier not recognised". Why?

For active substance applications, i.e., application for approval of active substance (AS-APP) or active substance evaluation under the Review programme (AS-EVA), the messages "active substance in dossier not recgonised" will be displayed in the ‘Format checks' step if the active substance to be included is not recognised yet in R4BP 3. Once ECHA completes the assessment on the substance identity your application will be processed as usual.

How can I add, replace or join new participants to my active substance evaluation under the review programme?

You will need to:

  • Select the AS-EVA case (Active substance evaluation under the review programme).
  • Click on <Create new case> and select "PA – CHG Change of participants." If you need to add a participant, enter the company UUID. New participants will need to create an account in R4BP 3 and provide you with the primary legal entity associated to their account.

ECHA will make an assessment of your request. Once completed, the participant will be added or removed from the AS-EVA case.Only one change can be applied until ECHA takes a decision.
Note: Changes of participants reported to ECHA prior July 2015 via ECHA webforms will not be updated in R4BP 3. In order to include properly this information in R4BP 3 the case owner of the related AS-EVA case will need to include the list of participants submitting a PA-GHG case.

Submissions

How do I submit my application to ECHA?
To submit your application, follow these two steps:
 
  1. Check for your relevant application type in the R4BP 3 support page.
  2. Check the Biocides submission manuals for further information on minimum information requirements and submission through R4BP 3.
Do not forget to include the relevant supporting documentation whenever  needed.
How does ECHA process my case?

As part of the formal process of an application acceptance, ECHA takes a number of steps before it submitts an application to competent authorities – i.e. national authorisation application, or to ECHA for further assessment.

At a glance, the steps include:

  • Virus scan
  • File format check:
    • Virus scan
    • Business rules confirmation
  • Application acceptance
  • Invoice assessment (where applicable)
  • Confidentiality claim screening

At the end of this process, you will receive a message saying “Submission accepted by ECHA” if the application has been successful, or “Case rejected by ECHA” if the application has been rejected.

For more information, please refer to chapter 6 of the Biocides Submission Manual – BSM Technical Guide: BSM Technical guide: How to use R4BP 3 .

Accepted applications will be forwarded to the MSCA nominated by the applicant during the submission process or to ECHA, e.g. for an assessment of technical equivalence.

It is the case owner’s responsibility to regularly check the ‘Message list’ in R4BP 3, to monitor the status of the application (messages are sent after each processing step) and the ‘Tasks’ tab to complete certain actions (e.g. requests for additional information).

What are the steps I can expect when a competent authority is dealing with my case?

The following steps will normally be performed by your competent authority when your case is processed:

  • Acceptance: your case is accepted or rejected for further processing;
  • Validation: validation on whether you have provided the correct information for the assessment of your case;
  • Evaluation: formal assessment on the quality and adequacy of the data and the related conclusions related to your case.

You can monitor the progress of your case through the ‘Events history' sub-tab in R4BP 3.

The ‘Events history' sub-tab provides you with a list of all the actions that your case has gone through in chronological order (e.g. BRC confirmation started, Invoice sent (when applicable), Submission format verified, etc.). This is a very useful sub-tab, helping you to follow the application processing steps.

If you wish to view submitted documents or financial related documents, go under other sub-tabs, e.g. ‘Documents' or ‘Financial management'.
In addition, depending on the application type, you may receive the following messages:

  • New task: an action is required from your side, i.e. provide additional information;
  • New information from authority, i.e. invoice delivered if required in your case.

For every step your authority complets you will receive a message. You can check the history of all messages sent to you when clicking on the ‘Events history' tab.

Note: Some applications related to changes on request or simplified authorisation do not include the validation step.

Notifications and some simplified authorisation cases will only include the evaluation step for your authorities.
 

What is the meaning of "step started, due by <date>" in the events history tab?

An informative deadline based on the legal text is included to inform you when a step is expected to be completed by an authority. It is a reminder for information purposes. No action is required from your side.

How can I know the status of my case?

You can search for your case details in R4BP 3 and select the "Events history" sub-tab. You will find a chronological description of the events related to your case, including the topic, the subject of the message and the sender.

The case owner will also receive a message (in their R4BP 3 account) for every relevant step of the process. You need to check the tasks in order to identify any requests for action you have received from your authority.

How can I follow communications submitted by authorities?

You will receive notifications to your email address based on the details provided in your R4BP 3 account.

If your email is not linked to the contact person in your R4BP 3 user account, you need to regularly monitor messages and tasks in R4BP 3.

By default, the “Messages” inbox displays the messages received in the last two months; the “Tasks” inbox displays all open tasks. Q&A 796 indicates the main differences between “Messages” and “Task” inboxes.

How can I withdraw a case made in R4BP 3?

As a case owner, you can withdraw an ongoing case in R4BP 3 at any time.

To withdraw your case in R4BP 3, the action ‘Withdraw case’ should be initiated in the corresponding case details screen. The status of the case will change to ‘Closed – Withdrawn’.

According to Article 13 of the BPR Fee Regulation, only applications for active substance approval, Union authorisation, and minor and major changes can be partially refunded after a withdrawal. Useful information can also be found in Q&A 768. Fees already paid to ECHA for any application types other than the ones mentioned above will not be refunded.

Applications initiated within a case that has been withdrawn, i.e. when a delegation allows a different company to submit a related application, will also need to be withdrawn. If no action is taken, your authorities will be forced to reject these delegated applications.

I receive the error message “invalid XML format or missing information” when I upload the SPC. Why?

The common reason why you receive this error message is because you have used an incompatible format. This happens when you copy/paste data from an external source into the SPC free-text fields. 
While this action does not always trigger a format error, it is safest if you copy the data into “Notepad” to clear any format/style; then copy the data from Notepad into the SPC online editor.

Another reason may be that you are working with an SPC file created using the old SPC online tool version available before October 2016. If this is your case, you can:

  • Download the SPC available in R4BP 3 and start working from this file using the current SPC online editor; or
  • Use the <SPC version convertor> available in the SPC online editor.

IMPORTANT: When working with an SPC that contains an incorrect format, make sure that you completely remove ALL content in the free-text fields before you paste the content without a format or style.

How does grouping of applications work in R4BP 3?

R4BP 3 allows certain application types, such as mutual recognitions, to be grouped. In practice, you can include:

  • a technical dossier (if required), 
  • supporting documentation, and
  • as many SPCs as Member States you intend to submit your application to. 

Remember that the market area of the SPCs needs to match the market area selected in the grouping during R4BP 3 submission.
As a result, R4BP 3 will automatically generate as many cases as SPCs as you have included in your submission. 

The information related to the technical dossier and supporting documentation can be found in the reference asset; the SPCs can be found in every case.

Once these applications are processed by R4BP 3, they will be handled independently by your authorities.

Why do I receive the error message “the system is expecting SPCs for one single biocidal product (i.e. SPCs with same product UUID)”?

This R4BP 3 message ensures that the SPCs uploaded in an application submitted through R4BP 3 belongs to the same product according to the submission criteria you define in the wizard. In particular, this error message appears in R4BP 3:

  • If you apply for a mutual recognition in a different market area, please select a new market area version in the SPC editor from the original SPC to create an SPC in a different market area correctly. 

Exceptions apply to special case types NA-MRG (conversion of a frame into a biocidal product family) and NA-NPF (addition of a family member to a biocidal product family). Further information on these case types can be found in the video tutorial: Processes in R4BP 3: merging assets via NA-MRG and the BSM application instructions: national authorisations.

  • If you group submissions, include as many SPCs as market areas as you have selected in the application wizard for single product applications. You can easily create a new market area version of the original SPC in the SPC editor.

Further useful information on how to create an SPC can be found in the BSM technical guide: using SPC.

 

I receive the error message “The system is expecting an SPC(s) that has been created from the reference SPC (i.e. same product UUID)”. Why?

R4BP 3 ensures that you consider the terms and conditions of an already existing authorisation.

If you apply for a change on request or renewal of national authorisation, you need to modify the existing SPC in the reference asset (national authorisation).

If you create a new SPC or start from an invalid SPC, R4BP 3 will not accept your SPC. You need to search for your asset, download this SPC within the asset and edit it with the SPC editor.

Where can I find information on how to create a BPR dossier with IUCLID?

To create your dossier, you will need to read the instructions provided in the BSM Technical guide: How to prepare a biocides dossier. This manual will help you to build basic minimum information in IUCLID, as well as how to include Annex II and Annex III information requirements or a letter of access when applicable. This is the minimum information that ECHA will check to ensure that key data is provided in IUCLID format.

The authority responsible for validating your application will provide support to you on what minimum information requirements are needed for your application.

My assets are not linked as mutual recognition in R4BP 3. What can I do?

The following two scenarios are likely:

  • If the authorisations were migrated from R4BP2, ECHA has agreed on a process to make sure that the links between different assets can be created. Contact your authorities to know more on how to proceed.
  • To re-unite former authorisaitions that were part of frame formulations in R4BP2, single product authorisation assets can be merged with the process NA-MRG (Conversion from frame formulation into a family). However, the merging does not take into account any linked mutual recognitions. These relations are lost. Make sure that you select the relevant market areas that should be linked as mutual recognitions where you intend to apply for a family application. If you need to To recover the links in R4BP 3, please contact ECHA for further analysis.

The following two scenarios may apply:

  • If the authorisations were migrated from R4BP2, ECHA has agreed on a process to make sure that the links between different assets can be created. Contact your authorities to know more on how to proceed.
  • To re-unite former authorisations that were part of frame formulations in R4BP2, single product authorisation assets can be merged with the process NA-MRG. However, the merging does not take into account any kind of linked mutual recognitions. These relations are lost unfortunately. To recover the links in R4BP 3, please contact ECHA.
What is a master SPC?
A master SPC identifies the SPC used as a source of information to be displayed in your R4BP 3 application. When you upload one or more translated SPCs, you need to define which SPC will be considered as the master SPC. If only one SPC is provided, you need to select the available SPC by default.
I receive the message “Warning: some previously uploaded files have been removed from the SPC package, since they no longer meet the required constraints (probably the SPC package of the reference item has been updated in the meantime)”. Why?

R4BP 3 ensures that the information provided in your application is consistent. If you submit updated information related to a particular asset (i.e. changes on request, same biocidal product or renewal) the SPC available in this asset will be updated with the new information of the SPC available in the latest case approved by your authorities.

If you submitted several cases in parallel from the same asset, you need to take into consideration what information has been included in the SPC available in the asset. If you receive the warning message, you should download the SPC available in the asset and edit it.

Use the <Compare with> button available in the SPC editor to compare what information has changed in the SPC available in the asset and the case you are working with.

How can I handle family applications submitted following the workaround solution with the new family SPC structure?

If you have submitted a family application based on the new family concept, ECHA has migrated all information on your behalf to the new family SPC. These migrated SPCs are available in R4BP 3. 

The migration to the new structure provides data in the SPC to the best extent possible. However, you may still need to work on the SPC to report your family SPC correctly, i.e add more than one meta SPC, match products to the relevant meta or define the concentration limits of the active substance that applies to every meta SPC.

How can I group SPCs and assets in a grouped submission of administrative changes?

When you use the submitted grouped application for administrative changes as a new application in R4BP 3, you need to follow these steps in the upload SPC step:

1 – Browse and upload the SPCs related to your administrative change.

2 – Select the relevant asset under the “Selected assets” list.

3 – Click on the icon “Match SPC with the selected asset”.

4 – Upload the SPC associated to the asset displayed in selected assets area. If more than one SPC file is matched to an asset, then the master language SPC file must be indicated.

5 – Click on <Check selected SPC(s) & Asset>.

Steps 2 to 5 need to be completed for every asset/SPC combination until all asset/SPC combinations are matched and successfully checked (marked by a green “thumb up” icon). In the example below, an asset/SPC combination is still missing (marked by a red “thumb down” icon)

What do I need to consider for case transfers?

The case owner and the prospective asset owner in an ‘In progress’ case can be changed in R4BP 3 in certain scenarios. Please consider the following information when you complete the changes in R4BP 3:

  • Case transfer is a two-step process – the case owner or prospective asset owner initiates a transfer using the delegation tab in the relevant case; an additional action then needs to be performed to accept the transfer.
  • The current case/asset owner initiates the change; the new case/asset owner can then accept the transfer.

     

  • Changing the case owner and the prospective asset owner are two different actions: when the case owner and prospective asset owner are the same company, you need to complete the <Add transfer> actions twice to transfer the case owner and the prospective asset owner.

     

There are certain scenarios where the prospective asset owner cannot be changed, i.e. in the case of certain notifications, changes on request, renewals or mutual recognitions.

IMPORTANT NOTE: Case owners/asset owners need to agree outside R4BP 3 on the terms and conditions to share the IUCLID technical dossier. A IUCLID technical dossier is not part of the transfer of a case to a different entity. Sharing the technical dossier needs to be considered as part of the agreement reached between parties outside R4BP 3.

The new case/asset owner will have access to all the information available in the different tabs related to a case. Pending tasks will be reallocated to the new case owner and new messages will only be delivered to the new case owner.

Additional information can be found in the chapter “Exchanging data with other entities” available in BSM Technical guide: using R4BP 3.

I received a virus check failure. Why?

The following are the most common reasons for a virus check failure:

  • A virus is part of any of the documents submitted in your application. Make sure that you check all the information to be submitted to ECHA with an antivirus software product.
  • One or more files included in a IUCLID technical dossier is password protected.

When you submit data to ECHA through R4BP 3, only authorities will have access to your data. You can submit your data again making sure that it is not password protected.

For any other reasons, please contact ECHA.

Can I submit renewals linked to mutually recognised applications when the (prospective) authorisation holders are different?

Yes. This option applies to the submission renewals subject to mutual recognition. If the nomination of a case owner is not present, the authorisation holder can establish a nomination from the asset.

Screenshot

The case owner will be able to submit a renewal subject to mutual recognition with different authorisation holders provided that:

  • a mutual recognition link is available between assets; and
  • an active nomination to the same case owner is available in mutually recognised assets.

The case owner will be able to see when a nomination has been established if in step 1 of the R4BP 3 wizard for renewal there is an option to select the asset(s) under a different asset owner.

Case owners are responsible for following up any communications or requests for additional information from authorities.

When can I submit a mutual recognition in parallel?
It is expected that a mutual recognition in parallel (NA-MRP) is submitted at the same time to the different Member States where the mutual recognition applies. Technically, it is still possible to submit an NA-MRP as long as the validation step of the reference application has not been completed by your authorities: once the evaluation step is created in R4BP 3 in the reference application, it is no longer possible to include other NA-MRP applications to other Member States.
I receive the error message “The system is expecting an SPC with the same UUIDs of meta SPC(s) and same number of product(s) as in the reference SPC”. Why?
R4BP 3 verifies that the scope of a mutual recognition for a biocidal product family application is consistent across different Member States. The basic principle to be considered for mutual recognition applications is that the same application is also submitted to other Member States. R4BP 3 does not allow a reduced or increased number of members to be provided in a family application to a concerned Member State. Similarly, a mutual recognition for biocidal product family submitted to a concerned Member State cannot have more or less meta-SPCs or biocidal products than the reference application. If this issue is triggered by the sameness criteria used to group the family members, you need to contact your national authorities.
Is it possible to include additional Member States in a grouped application?

Technically, additional Member States can be included in an existing renewal application subject to mutual recognition. It is important that you clarify the application submission with your concerned competent authority. If a draft application is continued, R4BP 3 will perform again the checks on existing data to ensure that the information is up to date. If the information is not valid, the wizard will suggest that you update certain information or simply delete the draft application to make a new submission, depending on the circumstances.

The application will be considered as submitted once a case number is created in R4BP 3.

 

Is an application saved as a draft considered as submitted?

No. A draft application allows you to save your work in progress and return to your application at a later date to edit and submit it, but it cannot be considered as a submission.

When you resume work on a draft application, R4BP 3 will perform the checks on existing data again to ensure that the information is up to date. If the information is not valid, the wizard will suggest that you update certain information or simply delete the draft application to make a new submission, depending on the circumstances.

The application will be considered as submitted once a case number is created in R4BP 3.

REACH

Authorisation

a) General / Procedure

Are any substances already subject to authorisation?

Yes. The List of Substances Subject to Authorisation (Annex XIV of the REACH Regulation) includes several substances.

Substances are regularly added to Annex XIV by the European Commission, on the basis of recommendations issued by ECHA. The link to the updated Annex XIV can be found on ECHA's website at: https://echa.europa.eu/authorisation-list.

Further details on the procedure for the inclusion of substances to Annex XIV of the REACH Regulation are available in FAQ ID=127, as well as on ECHA's website at: http://echa.europa.eu/regulations/reach/authorisation.

Where do I find the candidate list?

The Candidate List of Substances of Very High Concern (SVHC) for authorisation (Candidate List) is available on ECHA's website at: http://echa.europa.eu/candidate-list-table.

Additional substances are regularly included in the Candidate List, once these have been identified as SVHC.

How is a substance included in the Candidate List?
When the European Commission or a Member State considers that a substance may meet the criteria for identification as SVHC pursuant to Article 57 of REACH, ECHA (on request of the European Commission) or the Member State prepares an Annex XV SVHC dossier. With this Annex XV dossier ECHA or the Member State proposes the inclusion of the substance in the Candidate List by outlining the scientific evidence for identifying the substance as a SVHC.
 
ECHA's website includes a public registry of intentions in order to allow interested parties to be aware of the substances for which the authorities intend to submit Annex XV dossiers and thus facilitates timely preparation of the interested parties for commenting later in the process.
 
Once an Annex XV SVHC dossier has been prepared, a consultation of the Member States and interested parties is required, as specified in Article 59 of REACH. Further details on this consultation process are available on the ECHA website at http://echa.europa.eu/proposals-to-identify-substances-of-very-high-concern.
 
Following this consultation, the substance may be included in the Candidate List. The Candidate List is made available on ECHA's website in its last updated version at http://echa.europa.eu/candidate-list-table.
How is a substance from the Candidate List included in the "Authorisation List"?

Substances included in the Candidate List may be prioritised for inclusion in Annex XIV of the REACH Regulation (the so called "Authorisation List"). The Authorisation List contains all substances which, after a certain deadline, may only be used and/or placed on the market after a specific authorisation has been granted.

ECHA has to make at least every second year a recommendation of priority substances for inclusion in Annex XIV to the European Commission. Interested parties are invited to submit comments during this process. In addition, the Member State Committee issues an opinion on the recommendation before it is submitted to the European Commission. The European Commission then decides using the comitology procedure which of the recommended substances are to be included in Annex XIV and specifies, based on ECHA's recommendation, the transitional arrangements and, where relevant, exemptions and review periods. Further details on the procedure for inclusion of substances in Annex XIV of the REACH Regulation are available on ECHA's website at http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list .

How are authorisations granted for substances on the "Authorisation List"?

Applications for authorisation need to be made within the deadline (the so called "latest application date") that is specified in the "Authorisation List" for the corresponding substance if the applicant wishes to use the substance without interruption after the sunset date. Authorisation applications need to be submitted to ECHA. Third parties can provide information on alternative substances and technologies during public consultations on the uses that authorisation has been applied for. These are made available on ECHA's web-site. The ECHA Committees for Risk Assessment (RAC) and Socioeconomic Analysis (SEAC) give draft opinions on the application. Applicants will have the opportunity to comment on these draft opinions. RAC and SEAC will adopt final opinions and ECHA sends them to the European Commission. The European Commission decides, using the comitology procedure, whether an authorisation is granted or refused. ECHA will establish a publicly available database that will contain summaries of the Commission decisions. Further details on the application for authorisation procedure are available on ECHA's website under the following links:http://echa.europa.eu/regulations/reach/authorisation http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation

In which language do Applications for authorisation have to be submitted to ECHA?

Applications for authorisation may be submitted in any one of the official EU languages selected by the applicant. This means that the whole application, including the attachments and the Chemical Safety Report, must be submitted in the same language. This is a legal requirement based on Article 104(1) of REACH and Article 2 of Regulation No 1 of 15 April 1958.

Who can apply for an authorisation?

Only manufacturers, importers or downstream users of an Annex XIV substance as well as duly mandated Only Representatives can apply for an authorisation and be holders of a granted authorisation.

Can an Only Representative apply for an authorisation?

Yes. A duly mandated Only Representative ("OR") of a non-EU manufacturer can apply for an authorisation regardless of whether the OR assisted the non-EU entity with the registration of the Annex XIV substance to date. Once the OR has been appointed, it will have to comply with all other applicable obligations under REACH on behalf of the non-EU manufacturer who has appointed them. In cases where a non-EU manufacturer has not yet been appointed an OR, for example due to no obligation to register a substance, an OR may nevertheless be appointed. The OR will then represent the non-EU manufacturer with regard to all applicable REACH obligations.

Will only the person who submitted the authorisation application to ECHA benefit from the granted authorisation?

The holder of an authorisation is the person who submitted the authorisation application to ECHA. However, a downstream user may continue his use of an Annex XIV substance provided that this use is in accordance with the conditions of an authorisation granted to an actor up his supply chain for that use. Moreover, a manufacturer, importer or downstream user can continue placing an Annex XIV substance on the market for a use for which his immediate downstream user was granted an authorisation.

See supply chain coverage diagram

Who will decide on the granting and conditions of an authorisation?

The European Commission is responsible for taking decisions on Applications for authorisations. ECHA's Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will adopt opinions on the application for authorisation which will be taken into account by the Commission in its final decision.

Will my application be processed if I submit it outside the submission windows?

Yes. Be aware, however, that ECHA recommends applicants to submit their applications within submission windows that are published on its website. This concept ensures a batch wise process and a good synchronisation with the operational schedule of RAC and SEAC committees.

Why should I submit the application before the Latest Application Date?

You should apply before the Latest Application Date to be sure that you will be able to continue to use the substance while your application is being treated by ECHA and the Commission. In other words, you should apply early to take advantage of the transitional arrangements and continue your use after the sunset date even if no decision has been taken by the Commission.

The date of submission of the application will be considered as the date on which your application has been received for the purpose of benefitting from the transitional arrangements described in Article 58(1)(c)(ii), provided that you pass the business rules checks. This date is relevant if you intend to take advantage of these transitional arrangements and continue your use after the sunset date if no decision has been taken by the Commission. The following two situations may occur:

1. You have submitted your application early enough and it passes business rules checks before the latest application date: in this case you will benefit from the transitional arrangements described in Article 58(1)(c)(ii) provided that you pay your invoice in due time.

2. You have submitted your application just before the latest application date but it passes the business rules after the latest application date: in this case you can benefit from the transitional arrangements described in Article 58(1)(c)(ii) provided that you pay your invoice in due time. If your application does not pass the business rules checks you will have to resubmit your application. If you resubmit your application after the latest application date you will not be able to benefit from the transitional arrangements.

Therefore ECHA recommends that you submit your application during the submission window three months earlier than the latest application date. If you choose to submit in the latest submission window, ECHA recommends that you do so at the very beginning of the window.

The date from which the 10 months' time limit for the Committees to prepare their draft opinions starts is the date on which ECHA has received the application fee.

Will my application be processed if I submit it after the Latest Application Date?

Yes, the application will still be accepted for processing and evaluated by RAC and SEAC. However, the transitional arrangements under Article 58 (1)(c)(ii) of the REACH Regulation will not apply. These transitional arrangements would allow the applicant to use the substance even after the Sunset Date if no decision has been taken by the Commission.

Are end points related to the intrinsic properties of Annex XIV more critical than other end points?

If the substance has a threshold you need to demonstrate that the risks associated for the hazard endpoint mentioned in Annex XIV are adequately controlled. If the substance does not have a threshold, you need to demonstrate minimisation of emissions and exposure as far as possible. The Chemical Safety Report (CSR) should therefore focus on the Annex XIV endpoint but information on other endpoints might be necessary for comparing the risks with the alternatives. The alternatives should result in reduced overall risks to human health and the environment. Therefore, it is important not only to consider the risks arising from the Annex XIV endpoint but also on all other possible risks from the Annex XIV substance and the alternatives.

Can the decision taken by the Commission be different for the several uses included in my application?

A decision on authorising a use can be different from one use to another. Thus, if certain uses are authorised and others are not, then the non-authorised uses are no longer permitted.

How RAC and SEAC work together? Can they disagree with each other?

The primary objective of RAC and SEAC is to provide consistent opinions of high scientific quality to support the desicion making of the European Commission. The remits of both Committees are clear and cooperation between them is ensured by agreed procedures.
See also: http://echa.europa.eu/documents/10162/13555/common_approach_rac_seac_en.pdf

Can a distributor be considered as the immediate Downstream User (DU) in the context of article 56(1) (e) and apply for an authorisation?

No. A distributor who only stores the Annex XIV substance before placing it on the market cannot be considered as Downstream Users in the context of Article 56(1)(e) (see Article 3(14) of the REACH Regulation). However, actors can no longer be considered as distributors if they use the substances themselves (e.g. repackaging). Then they are considered as downstream users and, as such, shall apply for authorisation (and may cover uses of their downstream users), unless already covered by an authorisation.

Distributors (i.e. entities who only store the substance) are "transparent" in the supply chain if they do not "use" the substance. Therefore an application granted to a downstream user should be understood as covering the manufacturer/importer of that substance and all the distributors in between. However, this only applies in cases where there are no actors using the substance (e.g. formulators, repackaging companies, etc.) between the downstream user applicant and the manufacturer/importer. Also, distributors have to communicate the relevant information (e.g. safety data sheets, authorisation numbers) to their downstream users.

Can a Downstream User apply for uses upstream in the supply chain?

No. A downstream user (Company B) holding an authorisation for his use(s) (for instance, an end-use) can be supplied by an actor (Company A) up his supply chain (for instance, a formulator) in accordance with Article 56(1)(e). However, the use of Company A (that is the formulation of the Annex XIV substance) cannot be covered by an authorisation granted down the supply chain to Company B. Company A needs to have his use (the formulation) covered by a separate authorisation granted directly to him or to an actor up his supply chain (for instance the manufacturer of the Annex XIV substance). Note that distributors who only store the Annex XIV substance before placing it on the market cannot be considered as Downstream Users in the context of Article 56(1)(e), see Q&A 577 for more details.

See supply chain coverage diagram

I use an Annex XIV substance in a mixture. Should the information in the application be presented for the mixture or for the substance?

Information presented should be for the substance as the authorisation is (or is not) granted for a given substance.
See also FAQ ID=130 in Frequently Asked Questions about REACH.

May an authorisation be reviewed before the expiry of the period for which it has been granted for?

Yes. An authorisation can be reviewed before the expiry of the review period. REACH Art 61(2) specifies that: "Authorisations may be reviewed at any time if: (a) the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio- economic impact; or (b) new information on possible substitutes becomes available"". In this case, the Commission shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for the review and indicate by when it (i.e. the Commission) will take a final decision.

What rights does the applicant have to challenge the decision of the Commission?

An applicant has the right to contest the decision of the Commission before the General Court.

Who will enforce the authorisation decisions and how?

The enforcement of REACH is a responsibility of each EU Member State, as well as the members of the EEA (Norway, Iceland and Liechtenstein). They must ensure that there is an official system of controls and lay down legislation specifying penalties for non-compliance with the provisions of REACH. See also FAQ ID=3 in Frequently Asked Questions about REACH.

What other key sources of information might ECHA use when evaluating Applications for authorisation?

All information available to ECHA could be used; for instance, CLP notifications, dossier evaluation results or any relevant information arising from the public consultation on alternatives.

When will I receive the decision of the Commission after I have submitted my application?

It will take about 2 years. Article 64 of the REACH Regulation gives many details. Below we give an overall description of the timelines. Once you have submitted the application it takes about 2-3 months for its processing and for the application fee to be received by ECHA. The Committees will prepare their draft opinions within 10 months from that date of receipt of the fee. The applicant can comment on the draft opinions within 2 months before the Committees adopt their final opinions. This will take 2 months. Some weeks are also reserved for sending and receiving the draft opinion. Thus, it takes about 17-18 months for the applicant to receive the final opinions from the date it had submitted the application. ECHA will publish the opinions on its website and send them to the Commission, the Member States and the applicant. A final decision granting or refusing the authorisation shall be taken via a 'comitology' procedure (see the "examination procedure" referred to in Article 5 of Regulation (EU) No 182/2011). All in all, it would normally take about 6 months to have the final decision from the publication of the opinions of the Scientific Committees on ECHA's website.

Are there clear criteria on which the opinions will be based and which could provide more certainty about the outcome of the application?

The criteria for granting an authorisation are clearly defined in Art. 60 of REACH: under the "adequate control route" (Art. 60(2)) an application shall be granted if the risk to human health and the environment from the use of the substance arising from the intrinsic properties specified in Annex XIV is adequately controlled.

 Under the "socio-economic route" (Art. 60(4)), an authorisation may be granted if it is shown that (i) the socio-economic benefits outweigh the risk to human health and the environment from the use of the substance and (ii) there is no suitable alternative substances or technologies.

The factors to be taken into account for assessing the availability of suitable alternatives are described in Art. 60(5) and in the Guidance on Applications for Authorisation.

Also, two important documents describe how RAC and SEAC intend to evaluate the applications:

As a downstream user relying on an authorisation granted to a manufacturer/importer up in my supply chain, will I receive a unique authorisation number for all the authorised uses?

No. An authorisation number is unique to each combination of [applicant-substance-use applied for]. If the downstream user is himself an applicant (in either single or joint application), he will get its own authorisation number(s) related to the authorised use(s). If the downstream user is not an applicant but that he relies on an authorisation granted to a manufacturer/importer up his supply chain for his uses, the downstream user will not receive his own authorisation number(s) but he will be informed by his supplier about the authorisation number (which should be mentioned at least on the label of the product). 

Can restrictions be applied on the use of Annex XIV substances in articles?

Yes. After the sunset date, according to Article 69(2), ECHA has the obligation to consider the risks related to the corresponding Annex XIV substance in articles and possibly apply the restriction procedure if the risk to human health or the environment is not adequately controlled. In this case, the Agency shall prepare a dossier which conforms to the requirements of Annex XV. This assessment will have to be done for each Annex XIV substance after its corresponding sunset date.

In addition, Member States or ECHA (on request from the Commission) may propose a restriction at any time on the use of any substance (including SVHCs) in articles if the risks arising from the use of these articles are not properly controlled.
 

Can an Only Representative apply for an authorisation on behalf of several companies located outside the EU?

Yes. The non-EU companies can also be located in different jurisdictions. The application fee will be assessed for each non-EU legal entity the Only Representative represents in the application.

Only Representatives have to sign-up in REACH-IT for each non-EU company they represent and submit the relevant IUCLID dossier using the appropriate accounts. It is not possible to use the same Legal Entity Object (having the same company UUID) for multiple accounts, but it is possible to use the same company identification information (name, VAT, etc.). Similarly as for Registration, Only Representatives must indicate in the "company size" field of REACH-IT the size of the non-EU company they are representing. In the determination of their size, linked and partner enterprises to the company the Only Representative represents should also be taken into account.

In addition, Only Representatives are advised to attach clear documentation of their appointment in their application (for instance, a copy of the appointment) in the field "Assignment from non EU manufacturer" of the IUCLID file (IUCLID section 1.7). Only Representatives are also advised to indicate the list of the importers' names covered by the application in the field "Other importers".

For more details:

 
Will ECHA inform the applicant if it has accepted the justifications for claiming certain information confidential?

No. ECHA will not inform the applicant of its decision on all the confidentiality claims in the application for authorisation.

On the other hand, there may be situations where ECHA finds it necessary to make publicly available information that the applicant claimed confidential. In such cases ECHA will inform the applicant of this decision and allow him to respond appropriately.

An example of such a situation is if insufficient information falling under the broad information of uses is given in the public parts of the application for authorisation ("public versions" of the assessment reports, i.e. the Chemical Safety Report, Analysis of alternatives, Socio-economic analysis, Substitution plan or their annexes). In such a case ECHA has reserved the right under Article 64(2) of REACH to supplement the broad information package for the public consultation on alternatives with the necessary information from the "complete versions" of these assessment reports with the aim to make the public consultation meaningful. ECHA gives the applicant the opportunity to comment its proposal for broad information of uses before the final version is issued and published.

See also Q&A 590, 592 and 594.
How is the time-limited review period set in authorisation decisions?

ECHA has consulted the services of the European Commission on this. As a general principle, if you apply for authorisation before the latest application date, the review period would be counted from the sunset date. In practice, this means that applying early would not shorten your time for placing on the market and/or using the substance after the sunset date as compared to applying closer to the latest application date.

If you apply for authorisation after the latest application date, the placing on the market and use of the substance will no longer be allowed as from the sunset date, unless a decision granting an authorisation has been adopted by then. If the decision is adopted before the sunset date, the review period would in principle be counted from the sunset date. If a decision is adopted after the sunset date, the review period would be counted from the date of entry into force of the decision

I am a downstream user of an Annex XIV substance and the European Commission has not yet decided on the application for authorisation submitted by a company up my supply chain covering my use. The sunset date of the substance has passed.
a) Do I have to stop using the substance?
b) Do I have to notify my use to ECHA?

a) It depends.
You do not have to stop if the application made up your supply chain has been submitted before the substance’s latest application date. In this case, you can continue using the substance after its sunset date, awaiting for the European Commission’s decision.
You have to stop if the authorisation application has been submitted after the substance’s latest application date. You can restart using the substance only if the European Commission decides to grant an authorisation for your use. 

b) Not yet. As long as the European Commission’s decision on the authorisation application covering your use is pending, you cannot notify your use to ECHA. The notification of authorised uses is possible only after an authorisation has been granted. Once the decision to grant an authorisation has been adopted, you then need to submit a downstream user notification of your authorised use (Article 66 of REACH) to ECHA within three months from the first delivery of the substance (see also Q&A 1441).

 

I am a downstream user of an Annex XIV substance and the European Commission has decided to grant an authorisation for my use to a company up my supply chain. Do I have to notify my use to ECHA?

Yes. If you rely on an authorisation granted to an actor up your supply chain, you must notify your authorised use to ECHA. You must submit your notification within three months from the first delivery of the substance following issuing of the authorisation decision. Your notification needs to refer to the relevant authorisation number(s). Authorisation numbers are indicated on the label of the product and the safety data sheet you receive from your supplier. As they are use-specific, you need to select the specific authorisation number(s) which correspond to your use. Authorisation numbers have the format 'REACH/x/x/x' (see also Q&A 750).

Naturally, you need to comply with the conditions of the authorisation, which should be communicated to you by your supplier in the safety data sheet.

For further information on the downstream user notification for authorised uses (Article 66 of REACH), see: 

https://echa.europa.eu/support/dossier-submission-tools/reach-it/downstream-user-authorised-use 

https://newsletter.echa.europa.eu/home/-/newsletter/entry/4_15_downstream-users-notify-echa-if-you-use-an-authorised-substance

 

What environmental release information will ECHA publish as part of the opinions on applications for authorisation?

ECHA will publish the emissions of non-threshold substances such as environmental endocrine disruptors, PBTs, and vPvBs. It will also publish the release factors related to these emissions to the environment in cases where the applicant has not claimed the volumes used to be confidential. In such cases, ECHA will disclose the emissions as such and redacted information on the release factor (see example).

ECHA encourages applicants to be transparent about the release factors. Indeed, in two thirds of applications received to date (March 2020), applicants have provided this information without claiming the information on the release factor and thus the volume used confidential.

Note that the actual release factors and volumes used are always made available to ECHA’s Committees for Risk Assessment and Socio-economic Analysis when they evaluate the applications and give opinions to the European Commission.

Justification:

Article 64(6) of the REACH Regulation says that the Agency shall determine in accordance with Article 118 and 119 which parts of its opinions should be made publicly available on its website. Article 118(2)(c) provides that disclosure of precise tonnage is normally deemed to undermine the protection of commercial interests of the concerned party.

Under the Aarhus Regulation (Article 6(1)), an overriding public interest in disclosure is deemed to exist where a request is made for information relating to emissions to the environment. ECHA thus considers that emission values are non-confidential from a viewpoint of public interest and right to know.  

This policy is consistent with the ECHA’s core values of transparency and efficiency, recognising the overriding public interest in the disclosure of emissions set out in the Aarhus Regulation.

Example:

The volume used of substance is 2 000 kg per year, the release factor is 0.2% and thus the emissions to the environment are 4 kg per year. Unless the applicant has claimed the volume confidential, ECHA will publish this information as part of its opinion.

If the applicant claimed that the volume used should not be disclosed to the public, ECHA would instead publish the volume within a range (e.g. 1 000-5 000 kg), the corresponding release factor also within a range (e.g. 0.1%-0.4 %) and the emission to the environment (4 kg).

The authorisation decision states as a condition that a monitoring programme needs to be established so that the first measurements shall be performed at the latest by a particular date in spring 2020. Due to Covid-19 emergency, it will not be possible to finalise these monitoring programmes within the deadlines of the decision. What should we do?
This question relates to the implementation of the Commission’s authorisation decision and, as such, is a matter for the national enforcement authorities of the Member States. Please contact your national enforcement authority without delay and ask them how to address the issue.
b) Scope

Does the use of a substance listed on Annex XIV require an authorisation when contained in a mixture at a concentration below that specified in Article 56(6) (a) and (b) of REACH?

Authorisation is required for the use of a substance included in Annex XIV of REACH, either on its own or in a mixture. If a substance is used as such, this is a use of the substance on its own, and the exemptions in Article 56(6) (a) and (b) of REACH cannot be applied. If the substance is used in a mixture, then the aforementioned exemptions may be applied. These exemptions apply to SVHCs meeting the criteria of points (d), (e) and (f) of Article 57 of REACH below a concentration limit of 0.1 % w/w, and for all other substances below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.

Does the exemption from the authorisation requirement for substances in mixtures (Article 56(6)b of REACH) depend on their classification in any hazard class or only the hazard classes for which the substance was included in the authorisation list?

The authorisation requirement does not apply to the use of CMR substances when they are present in mixtures below the concentration limits specified in Article 11(3) of the CLP Regulation, which result in the classification of the mixture as hazardous (Article 56(6)b of REACH).

Only the hazard class (or hazard classes) which specifically led to inclusion of the substance in the authorisation list should be taken into account.

The basis for this is to target the intrinsic properties of highest concern, which is the objective of the authorisation process.

This is reflected in the legal provisions of REACH:

  • Article 62(4), which requires an application for authorisation only for the hazard class given in the authorisation list, and
  • Article 60(2), which limits the assessment of a request for authorisation to the hazard class given in the authorisation list under the adequate control route.

 

Is there any tonnage threshold below which Annex XIV substances are exempted from the authorisation requirement?

No. There is no tonnage threshold below which (the placing on the market for) a use of an Annex XIV substance is exempted from the authorisation requirement.

Does the authorisation requirement apply to the use of substances in articles?
No. The placing on the market or the use of an article which contains an Annex XIV substance is not subject to the authorisation requirement. However, if not specifically exempted otherwise, the incorporation of an Annex XIV substance into an article is a use which is subject to the authorisation requirement. Moreover, the Chemical Safety Report of an application for authorisation for a given substance should cover the whole substance service-life for the "use(s) applied for", including the service life of articles and the waste stage (see Article 62(4)(d) and Annex I (5.1.2) and (5.2.2) of REACH).
 
Other legal requirements also apply to substances of the Candidate List present in articles, such as communication obligations along the supply chain and notification to ECHA:
 
Article 33(1) of REACH requires that a supplier of articles containing a SVHC included in the Candidate List for authorisation in a concentration above 0.1% (w/w) has to provide relevant safety information to the recipients of these articles. Upon request of a consumer, the same supplier has to provide relevant safety information about the SVHC available to him also to this consumer (Article 33(2) of REACH). This obligation applies irrespective of the tonnage of the substance used and also applies to imported articles. Importers and producers of articles have to, under certain conditions, notify to ECHA if their articles contain Candidate List substances (as per Article 7 of REACH).
For more information, see: 
 
Does the authorisation requirement apply to a substance in Annex XIV that is present as an impurity in another substance or mixture?

The authorisation requirement applies to the placing on the market and use of a substance on its own as listed in Annex XIV. Therefore, it usually does not apply if the Annex XIV substance is only an impurity or additive or constituent of another substance, unless this is specified in the Annex XIV entry (e.g. substance W and substances X, Y and Z containing substance W in a concentration ≥ x %) or the other substance is also listed in Annex XIV.If a substance listed in Annex XIV is included as a component in a mixture, the authorisation requirement applies for this use (i.e. the formulation of the mixture). Further, the placing on the market and use of such mixtures require authorisation, unless the Annex XIV substance is present in the mixture below the concentration limits set out in REACH Article 56(6).
See also: Guidance for identification and naming of substances under REACH (link to http://echa.europa.eu/documents/10162/13643/substance_id_en.pdf)

Are uses of recovered substances exempted from the authorisation requirement?

No. Uses of recovered substances are not exempted from the authorisation requirement. As in case of use(s) of any other Annex XIV substance, use(s) of a recovered substance whose identifiers correspond to those of an entry in the Annex XIV of REACH is subject to the authorisation requirement, unless the use of the substance is specifically exempted otherwise.
See also: Guidance on waste and recovered substances http://echa.europa.eu/documents/10162/13632/waste_recovered_en.pdf

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) of REACH also apply to analytical activities such as monitoring and quality control?

Yes. Under Article 3(23) of REACH, scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year. Thus, the use of an Annex XIV substance in analysis is exempted from authorisation under Article 56(3) if the substance is used, on its own or in a mixture, in analytical activities such as monitoring and quality control where these activities are carried out under controlled conditions and in a volume not exceeding one tonne per year and per legal entity. 

The exemption applies to the use of an Annex XIV substance when it is required as part of an analytical method for the measurement of another substance or property (e.g. used as an extraction solvent or reagent, or to validate the technical specification or performance of a product) and the analysis of the Annex XIV substance itself (e.g. for quality or process control). Where these conditions are met, there is no need to apply for an authorisation for this use or to include this task as a working contributing scenario (i.e. PROC 15) in an application for authorisation. 

This exemption applies irrespective of where the analysis is performed i.e. on-site or off-site facilities. However, this exemption does not cover sampling activities (see Q&A 1153).

Does the authorisation requirement apply to a substance listed in Annex XIV of REACH which is used exclusively as an analytical reagent or in routine analysis?
If the substance is used for monitoring or quality control purposes under controlled conditions in quantities below 1 tonne per year, it falls under Article 56(3) of REACH, which exempts substances used in scientific research and development from the authorisation requirement.
Article 2(5), subparagraphs (a) and (b), and Article 56 subparagraphs (4)((a), (b), and (c)) and (5)((a) and (b)) of REACH exempt from the authorisation requirement a number of uses in products (medicinal products, food or feedingstuffs, plant protection products, biocidal products, motor fuels, cosmetic products and food contact materials, respectively) within the scope of, or covered by, the sector-specific Union legislation specified in those provisions. 1. Do these exemptions cover the incorporation of the Annex XIV substance into the product during the manufacturing process? 2. Do these exemptions also cover the life-cycle steps (such as formulation) preceding the incorporation of the substance into the product in question?
  1. Yes, these exemptions cover the incorporation of a substance into the product during the manufacturing process.
  2. Yes, the uses of a substance upstream preceding an exempted end-use are also exempted but only in the volumes ending up in the exempted end-use.  It should be noted that, with regard to uses in cosmetic products and in food contact materials, the exemption only applies when the intrinsic properties specified in Annex XIV for the substance in question concern hazards to human health.
 
Article 56 (4)(d) of REACH contains an exemption from the authorisation requirement for the use as fuels in closed systems. Does this exemption also cover the life-cycle steps (such as formulation) preceding this end-use?

Yes, the uses of a substance upstream, preceding "use as fuels in closed systems", are also exempted under the condition that the control of the risks – i.e., use in closed systems – is also pursued in the upstream life-cycle steps preceding the end-use as a fuel.

Does an application for authorisation for the use of a substance in a medical device regulated by the sector-specific legislation referred to in Article 60(2) 2nd subparagraph of REACH have to be submitted for a substance for which Annex XIV specifies human health hazards only? Does this exemption cover the incorporation of the Annex XIV substance into the product during the manufacturing process? If so, are the life-cycle steps preceding the incorporation of the substance in the medical device subject to authorisation?

Pursuant to Articles 60(2) and 62(6) of REACH, an application for authorisation is not required for a substance used in a medical device regulated under Directives 90/385/EEC, 93/42/EEC or 98/79/EC if that substance has been identified in Annex XIV for human health concerns only.   Nor is an application required in such cases for the incorporation of the substance into the medical device during the manufacturing process or for the uses and corresponding volumes of that substance upstream preceding the end-use.

Article 56 (3) of REACH exempts from the authorisation requirement the use of a substance in scientific research and development (SRD). Does this exemption also cover the life-cycle steps (such as formulation) preceding the end-use in SRD?
Yes, the uses of a substance upstream preceding an exempted end-use in SRD are also exempted in quantities of the substance ending up in SRD (i.e. under 1 t/y per user) subject to what is set out below.
 
Article 3(23) defines SRD as any scientific experimentation, analysis or chemical research to be carried out "under controlled conditions" and "in a volume less than one tonne per year". Therefore, the exemption in Article 56 (3) covers an activity which is delimited by a certain level of control of risks– i.e., use under controlled conditions and in a volume less than 1 tonne per year. It also applies to the upstream life-cycle stages of the substance preceding its end-use in SRD, for the volumes ending up in that end-use and which, during the upstream life-cycle, are handled and/or used under controlled conditions, even if the volume handled and/or used during the upstream life-cycle stages exceeds 1 tonne per year.

In case of any contradictions between the position expressed in this Q&A and the positions expressed previously by ECHA in the RCOM of 20 December 2011, the position expressed in this Q&A should be considered as the current understanding of the law. It takes precedence over any other views communicated previously by ECHA on this issue.
 
Is the manufacture of a substance, whether for export or placing on the EU market, subject to the authorisation requirement?

The manufacture of a substance is not subject to the authorisation requirement. After a substance has been manufactured it may have to be handled before it is exported or placed on the EU market. Operations which are necessary for the handling of a substance on its own in the manufacturing for export or placing on the EU market are considered to be part of the manufacturing stage (e.g. filling into appropriate containers, storage, addition of stabiliser, dilution to a safer concentration -if necessary for transport safety-), but not other uses such as the formulation of a mixture or incorporation of the substance into articles. The formulation of a mixture or incorporation of the substance into articles are considered "uses" within the meaning of Title VII of REACH and are subject to the authorisation requirement whether or not the mixture or articles will be exported or placed on the EU market. 

Does the exemption for the use of Annex XIV substances in scientific research and development under Article 56(3) of REACH also apply to sampling activities for further quality control analysis?

No. When a sample containing an Annex XIV substance is taken from a production line for further analysis the sampling activity shall be described and assessed e.g. in a worker contributing scenario that is part of the application for authorisation. However, activities considered to form part of the use of the sample in performing analytical activities can benefit from the exemption under Article 56(3) of REACH. See also Q&A 585.

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) of REACH also apply to analytical activities using in vitro diagnostic (IVD) medical devices (as defined in Directive 98/79/EC) at a laboratory scale?

Yes. The use of an Annex XIV substance when it is required, on its own or in a mixture, as part of an in vitro diagnostic (IVD) method (e.g. in a reagent, calibrator, control material or kit) is considered as scientific research and development and is therefore exempted from authorisation requirements if this activity is carried out under controlled conditions and in a volume not exceeding one tonne per year per legal entity (see Q&A 585). 

Annex XIV substances may be required to provide a range of functions during IVD analysis, including: to remove impurities, to prevent undesired reactions that would lead to false positive results, to stabilise or solubilise proteins during analysis, to inactivate viruses prior to analysis.

The exemption covers also IVD medical devices for veterinary and animal health purposes.

 

 

 

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) of REACH also apply to the use of an Annex XIV substance in upstream life-cycle stages to produce in vitro diagnostic (IVD) medical devices?

It depends. See the more general Q&As 1498 and 1030, as well as Q&A 1442.

For instance, the incorporation of an Annex XIV substance into an IVD medical device which is an article is not exempted under Article 56(3) REACH. Similarly, the use of an Annex XIV substance in upstream life-cycle stages to produce IVD medical devices which are not articles (e.g. reagents, calibrator, control material or kits) and where the Annex XIV substance is not incorporated into the IVD device is not exempted under Article 56(3) REACH. An example of the latter is the use of an Annex XIV substance to lyse cell membranes during the purification of antibodies that are subsequently used in an IVD medical device which is not an article: that use would require an authorisation. 

 

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) REACH also apply to Annex XIV substances used together with or incorporated in SRD articles?
It depends. The exemption applies, for example, to an Annex XIV substance used together with (but not becoming an integral part of) an article both produced for SRD purposes (e.g. reagent used together with an analytical apparatus). However, the exemption does not apply to an Annex XIV substance which is integrated in (i.e. becoming an integral part of) an article produced for SRD or non-SRD purposes (e.g. mercury in thermometers). Similarly, the exemption does not apply to an Annex XIV substance used to produce an SRD article if the substance is not intentionally incorporated into the SRD article (e.g. used as processing aid or solvent during the manufacturing of the SRD article).
Are uses in Product and Process Orientated Research and Development (PPORD) exempted from the authorisation requirement?

Uses in PPORD are not generically exempted from the authorisation requirement.

However:

  1. Specific entries in the Authorisation List may include an exemption for uses in PPORD below a specified maximum quantity;
  2. Activities to develop products and processes may fall under the definition of Scientific Research & Development (SRD) if they are carried out under controlled conditions in a volume less than one tonne per year. In this case, they are exempted from authorisation.
For more information, see also ECHA’s “Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD)”, available at: https://echa.europa.eu/guidance-documents/guidance-on-reach.
c) Format and content of authorisation

What is the format for authorisation applications?

Application for authorisation dossiers shall consist in an IUCLID file, to which a series of specific documents are attached. For the purpose of an application for authorisation, the latest version of IUCLID should be used. Formats for these attachments are provided by ECHA on its website

How can an applicant submit an application to ECHA?

Authorisation application dossiers shall be submitted electronically via REACH-IT. See (http://echa.europa.eu/applying-for-authorisation)

In which language shall I submit my application for authorisation to ECHA?

The whole application can be submitted in any single official EU language. For example, you can submit the whole application in English. However, you cannot submit an application where most of the documents are in English and rest in another language, For details, see question 129.

What will ECHA do if it receives applications that contain documents in more than one official EU language?

ECHA would consider those parts of the Application that are not in the main language as "not received". These documents could be essential for conformity of the application under Article 62 of REACH. If so, the Committees would request the applicant to submit an update of these documents in the main language. If the applicant fails to submit the translations, the Committees would not consider the application to be in conformity with the requirements of Article 62.

What is meant by the "Broad Information on Uses" package and what does it contain?

The Broad Information on Uses (BIU) of the Annex XIV substance refers to a "brief wording" containing:

- information based on the name of the use applied for,
- the use descriptors and function, and
- key information on the conditions of use.

In addition, the BIU contains the following documents:

- the public version of the Analysis of alternatives,
- the public version of the Substitution Plan, if provided in the application,
- the public version of the Socio Economic Analysis, if provided in the application, and
- the public version of sections 9 ("Exposure assessment") and 10 ("Risk characterisation") of the Chemical Safety Report (CSR) covering the use applied for.

For further details and example, see: http://echa.europa.eu/documents/10162/13555/public_information_afa_en.pdf

Will the applicant's name be made public?

Yes. The applicant's name will normally be made public as part of the Broad information Use during the public consultation on alternatives.

How can I provide in my application a "complete" and a "public" version of sections 9 ("Exposure assessment") and 10 ("Risk characterisation") of the Chemical Safety Report (CSR) covering the uses applied for?

Include the complete versions of sections 9 and 10 in your Chemical Safety Report (CSR) and attach the CSR to section 13 of IUCLID (naming it for instance "CSR.pdf").

Attach a public version of sections 9 and 10 naming it clearly (e.g. "Public_version_of_CSR sec9-10.pdf") and attach it as a separate document in section 13 of IUCLID.

If all the information contained in sections 9 and 10 can be made public, then these two sections will be published as they are provided in the CSR.

Do I need to update my Chemical Safety Report (CSR)?

If you (as the applicant) have already registered the Annex XIV substance, the CSR prepared for registration purposes should be the basis for the preparation of the CSR needed in an application for authorisation. However, it is likely that it needs to be updated and adapted to the authorisation context (e.g. regarding the refinement of uses, emissions and exposures, the overall quality of the CSR, etc). When submitting your application you can attach a version of your CSR specifically developed for authorisation. You can use this opportunity in cases, where you may wish to provide – for the authorisation purposes –  only an extract of the latest updated CSR submitted in the registration process. This updated CSR would contain only those parts that are relevant for the authorisation application, but developed in more detail.

Or you can simply refer to the CSR provided in your registration dossier. In the latter case you should – if necessary – update your CSR before you submit your application to ECHA. If you develop a specific CSR for authorisation, you should be aware that as a rule the information contained in the CSR submitted in an authorisation application should be in the CSR provided in the registration dossier.

After the sunset date the applicant will need to update the CSR submitted in the registration in order to remove all uses for which he has not applied for authorisation.

Following the authorisation decision taken by the Commission, the Applicant may also need to further update the CSR submitted in his registration.

How can an applicant provide information in its application which should not be made publicly available?

Applicants can provide information which should not be made public in the "complete versions" of the assessment reports (Chemical Safety Report, Analysis of Alternatives, Substitution Plan, Socio-Economic Analysis). Formats and instructions are available under the "Preparing Applications for authorisation" page (http://echa.europa.eu/applying-for-authorisation/preparing-applications-for-authorisation).

Applicants need to make "public versions" of these "complete versions". In "public versions"  the applicants need to blank out confidential business information. The "public versions" will be published on ECHA's website during public consultation on alternatives. Applicants need to provide solid justifications as to why the information which has been blanked out should not be made public.

What is a joint application?

A joint application for authorisation in REACH is made and submitted simultaneously by a group of applicants (i.e. the submitting applicant and the co-applicants). The submitting applicant starts by uploading the IUCLID dossier in REACH-IT. When the dossier has been successfully uploaded, the submitting applicant receives the joint application name and security token, which he will communicate to the co-applicants.

The submitting applicant and co-applicants indicate the substance-use combinations they are applying for, scope of their use(s) and provide the information on their role in the supply chain by completing the information in REACH-IT. The submitting applicant finalises the joint application after all co-applicants have completed their parts of the information and confirmed their participation. 

 

Is a joint application easier to submit and manage than separate applications?

Due to the possible complexity and technical issues of joint applications, ECHA recommends to prepare and submit a joint application when (i) all co-applicants of the group apply for all uses in the joint application, and (ii) the co-applicants have agreed on a way to share all the information provided in the application.

In complex cases, it may be preferable for each applicant to submit their own application separately. The applicants can cooperate during the preparation of their applications. For details, see the manual ‘How to prepare an application for authorisation manual’.https://echa.europa.eu/manuals, Application for Authorisation Guidance (Appendix 2) and the presentations "Description of uses for authorisation / Broad Information on Uses" and "Joint versus Individual applications" for additional information.

Can an additional legal entity join a group of applicants after the submission of a joint application?

No. In contrast with Joint Registrations, an additional legal entity cannot join the group of applicants which have already submitted a joint application for authorisation.

What is a subsequent application?

An applicant may submit a subsequent application in which he can refer to appropriate parts of an application previously submitted for a use of a substance, provided that the subsequent applicant has permission from the previous applicant(s) to refer to these parts. Furthermore, the subsequent applicant shall update the information taken over from the original application as necessary. This subsequent application will be processed and evaluated on its own merits.

How will ECHA communicate with the applicant once an application has been submitted?

Via REACH-IT and the secured webforms. However, for organisational and practical issues, emails can be used.

I consider that the substance that I will apply for has a threshold. What if RAC disagrees with my assessment?
RAC intends to develop "reference DNELs" and "reference dose response relationships" for substances that have been listed in Annex XIV. The intention is to make these available before the latest application date has expired (see Q&A 752).
 
If you disagree with RAC's view you can justify this in your application. RAC will evaluate this during the opinion making process.
 
If RAC has not made the "reference DNELs" or ""reference dose response relationships" available before the latest application date it will do so during the opinion making. In any case, you and RAC will need to clarify the possible scientific issues relating to the thresholdness of the substance during the opinion making process.
 
If a threshold cannot be demonstrated, it is not possible to apply based on Article 60(2) in relation to adequate control. However, the application can be evaluated based on Article 60(4). In this case ECHA strongly recommends that the application contains a socio-economic analysis(see Q&A 617).
In a joint application, can confidential information from a joint applicant made secret to the other applicants?
No. The submitting applicant (i.e. the applicant submitting the joint application on behalf of the group of joint applicants) has access to all the information contained in the application. Furthermore, during opinion making confidential information is likely to be referred to within the group of joint applicants; for instance, in ECHA's messages in REACH-IT all co-applicants receive a copy of the message. 
 
ECHA will treat a joint application as a whole and has no possibility to make any special arrangements to accommodate confidentiality issues between joint applicants. 
 
See also Q&A 596.
Can I submit a single application covering several substances?

Yes, if they form a group. The possibility to cover more than one substance in the same application is limited to substances that meet the definition of a group of substances as stated in Section 1(5) of Annex XI of the REACH Regulation. In all other cases, you have to submit a separate application for each substance. See Appendix I of the Guidance on the preparation of an application for authorisation on substance grouping.

When commenting the draft opinions of RAC and SEAC, can I submit additional or new data that I had not provided when the committees were preparing them?

When reading the Committees' draft opinions you may have noticed misinterpretations, misunderstandings or even errors that need to be addressed in the draft opinions. ECHA encourages you to provide all the necessary clarifications with the relevant supporting evidence during the commenting period. However, the Committees will only take into account new data or information (e.g. new measurements, figures) that are related to such misinterpretations, misunderstandings or errors noted by the applicant. It is the obligation of the applicant to provide the necessary relevant data at the time of the initial submission of the application or in response to earlier requests from the Committees.

d) Authorisation fees and invoicing

How is the fee for an application for an authorisation calculated?

Several scenarios can be envisaged: A base fee is payable, which covers one substance and one use. An additional fee applies for each additional use and substance. No additional fee for additional applicant(s) is levied, though. However, the levels of the base fee and of the additional fees per use and substance depend on the size of the largest company that is party to the application - .i.e. if in joint applications companies are of a different size, the highest applicable fee will be levied.  

For example, in the case of an application submitted by four parties with ten three uses and two substances in total, the relevant fee will be the base fee applicable to the largest applicant + three additional applicant fees + nine two additional use fees applicable to the largest applicant + one additional substance fee applicable to the largest applicant.

The table below shows four examples of calculated fee for applications for a single substance where the (largest) applicant is a large company.

Table: Fees depend on the number of uses, not applicants

Examples A B C D
Applicants 1 2 1 2
Uses 1 1 2 2
Fee €54 100 €54 100 €102 790 €102 790

The possibility to cover more than one substance in the same application is limited to substances that meet the definition of a group of substances as defined in Section 1(5) of Annex XI of the REACH Regulation. In all other cases, a separate application must be submitted for each substance.

Further information: ECHA Fee Calculator: a tool provided by ECHA to estimate the possible amount of a fee related to a given application for authorisation.

On the REACH Fee regulation: see more information on REACH Legislation -page and Commission Implementing Regulation (EU) 2018/895 of 22 June 2018

 

Application for one applicant and one substance only

If you submit an application for an authorisation on your own, you will have to pay a base fee. That fee covers one use and one substance. If you need to apply for authorisation for more uses, you will need to add an additional fee for each additional use you want to cover. Thus, if your application covers three uses, the fee that you will have to pay is the sum of the basic fee + two additional use fees. The level of the base fee and the additional fees depend on the size of your company; reduced fees apply if you are a micro, small, or medium-sized enterprise.

How will ECHA calculate the fee and send the invoice in the case of joint applications?

ECHA will calculate the fee based on the Fee Regulation. It has made available a Fee Calculator to help the applicants to know in advance the amount that they would expect to pay.

ECHA will send the invoice always to the legal person that submitted the application. Thus, in a joint application ECHA will send the invoice to that applicant that submitted the application. It is then up to this applicant to split the invoice according to the agreement that the applicants have made between themselves. For clarity, ECHA is not in a position to send separate invoices to each of the parties covered by the application. 

How will the applications be invoiced and paid?

ECHA sends the applicant an invoice in about 8 weeks after the submission.  

The applicant has 14 calendar days to pay the invoice with a possibility to extend it by another 7 calendar days. Thus, all in all the applicant is given 21 days to pay the invoice from the date it received the invoice.

If the payment is not made by the extended payment due date, the application for authorisation will be considered as not received by ECHA. In this case the application is not processed further. The only way to proceed is to re-submit the application.

The Fee Regulation (EC No 340/2008) related to the fees for Applications for authorisation has been amended by Commission Implementing Regulation (EU) No 254/2013 of 20 March 2013. Updated articles 8(2) and 9(2) state that "the Agency shall issue one invoice covering the base fee and any applicable additional fees". How will these additional fees be levied?

The necessity to impose an additional fee will reflect ECHA's workload associated with processing and evaluating the application. The calculation of the base fee and any applicable additional fees is described in Q&A 600. An application would lead to additional workload if the number of ‘uses applied for' and/or exposure scenarios is greater than one. One "use applied for" shall be covered by at least one exposure scenario. However, the number of uses vs the number of exposure scenarios might not be identical. Thus, in order to reflect the additional workload, ECHA calculates the fee based on the highest number of uses vs. exposure scenarios.

Example 1: Iif you apply for two uses that are covered together in your Chemical Safety Report by one generic exposure scenario, ECHA will calculate the invoice based on two uses.

Example 2: If you apply for two uses which are covered by three different exposure scenarios, ECHA will estimate whether the evaluation of the additional exposure scenario increases ECHA's workload and whether the fee can be based on three uses.

Is there a fee for confidentiality claims in Applications for authorisation?

No.

Will ECHA consider one exposure scenario for article service life as equivalent to one use for determining the fee?

No. Currently ECHA will not impose a fee for an exposure scenario covering an article service life. ECHA needs to gain experience with the first applications for authorisations. ECHA reserves its right to re-evaluate this approach if, based on the experience gained with handling this type of exposure scenarios in the context of an Applications for Authorisation, ECHA concludes that the associated workload warrants a fee. It is also possible that a fee may be imposed for instance, in conjunction with a review of the Fee Regulation in the future.

e) Preparing for authorisation application

What is the purpose of the teleconference based information sessions?

Teleconference based information sessions (TIS) give an opportunity for future applicants to clarify regulatory and procedural aspects of the authorisation application process, and for ECHA to have a better understanding of the practical issues related to Applications for authorisation. ECHA organised earlier “Pre-submission information sessions” (PSIS). TIS are a more focussed, teleconference based way of fulfilling the same purpose as with PSIS.

For further details see ECHA's Support webpage on teleconference based information sessions (link to: https://echa.europa.eu/applying-for-authorisation/pre-submission-information-sessions).

When and how can I request a teleconference based information sessions?

You can make a request for a teleconference based information session (TIS) either when notifying ECHA of your intention to submit an application for authorisation, or later. You should nevertheless send your request for a TIS at least eight months before the planned date for the submission of your application for authorisation. Although you can still notify less than eight months in advance of the submission of your application, this may have an impact on ECHA's availability to organise a TIS for your company. Please bear in mind the TIS should take place within one month after the meeting request and that you probably would like to have sufficient time after the TIS to potentially further work on your application before submitting it to ECHA.

Requests for TIS are made via a secure web form, available on ECHA's website. For further details see ECHA's Support webpage on TIS (link to: https://echa.europa.eu/applying-for-authorisation/pre-submission-information-sessions).

How can I have access to the Lead Registrant's Chemical Safety Report (CSR) data if he is not taking part in the application for authorisation? What can I do if the data owner refuses to give me access to its data? Can I use the information available on ECHA's dissemination website?

A CSR has to be submitted as part of the application. This CSR can be (i) the applicant's own CSR for authorisation, or (ii) a reference to CSR submitted by the same applicant for registration, or (iii) a reference to CSR of a previous applicant (case of subsequent applications for authorisation). If the applicant for authorisation is a Downstream User (i.e. not a registrant) and he generates his own CSR for the authorisation, this CSR can be based on updated information from the registrant's CSR as long as he has the right to use the information from the respective data owners.

However, data sharing obligations as specified under Art 30 of REACH do not apply for authorisation. The reproduction or further distribution of information from Registration Dossiers and Notifications to the C&L Inventory which are published on ECHA's dissemination website may be subject to copyright protection. Furthermore, the use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner. The Agency does not take responsibility for any copyright or other infringements that may be caused by using the information.

Potential applicants are reminded that they shall ensure that they have adequate rights to submit this information to the Agency and acknowledge that this information can be used for the purpose of the application for authorisation.

See also question 916

Will a pre-submission information session (PSIS) be available for the whole group of applicants participating in a joint application or will there be a separate PSIS for each co-applicant?

In joint applications, only one PSIS will be available, and this session is for the group of applicants as a whole. Due to the limited availability of places for the PSIS, it is for the group of applicants to decide who would be the most appropriate to represent them in the session.

How should I develop the ‘uses applied for' and exposure scenarios in my application?

The description of the ‘uses applied for' and of the related exposure scenarios is key step in the preparation of an application for authorisation. The concept of "use applied for" in the context of applications for authorisation might significantly differ from what industrial actors usually understand by a "use" in their day-to-day practice. The ‘use applied for' description, scope and level of details are not only related to the risks linked to the exposure/release of the Annex XIV substance but also to the analysis of alternatives and, where relevant, to the socio-economic analysis and substitution plan. The following documents describe this issue in more details:

 
Which DNEL should I use?

The demonstration of adequate control or minimisation of the risks should be made in the Chemical Safety Report (CSR) of the application for authorisation. REACH Annex I defines the Derived No-Effect Level (DNEL), i.e. the level of exposure above which humans should not be exposed and the way the risk characterisation for the human population should be performed, based on the DNEL (if a DNEL can be determined). DNELs derived according to the ECHA guidance are therefore the reference data for the demonstration of adequate control. 

It should be noted that the Committee for Risk Assessment (RAC) has derived reference DNELs for  some substances on Annex XIV and intends to continue doing so for other Annex XIV substances. 

For more details, see:

How many pages should an application contain?

An application for authorisation is not a matter of pages but rather how convincing the argumentation is. All the necessary information for the ECHA Committees for making their opinions and for the Commission to make its decision should be included in the application in a clear and convincing way. Overall in a well-argued application, strong or clear messages should not be diluted or obscured by lengthy text. Also you can consider using appendixes to provide additional, complementary information.

Would the application be in conformity according to Article 62(4)(d) of REACH if it took as a premise the ‘Reference DNEL' or ‘dose response relationship' adopted by RAC and published on ECHA's website?

Yes, as long as the application is in conformity with the rest of Article 62 and the applicant decides to use in his assessment the DNELs or dose response relationships derived by RAC for the intrinsic properties of the substance specified in Annex XIV. In this case the applicant does not need to provide the hazard data necessary to derive DNELs or dose response relationships.

See also Q&A 752 and 912

Do I need to include Part A in the Chemical Safety Report (CSR), when I submit it as part of my application for authorisation?

Yes, the Chemical Safety Report shall always include the "Part A" duly completed. Part A contains the Summary of Risk Management Measures and the declarations that these measures are implemented and communicated. See also Q&A 611.

f) Analysis of alternatives

Do I need to consider also Substances of Very High Concern (SVHC) in my Analysis of Alternatives?

Usually not. A suitable alternative should results in an overall reduction of risks to human health and the environment compared to the Annex XIV substance. An alternative substance having a similar (eco)toxicological profile to the Annex XIV substance (for instance a SVHC substance) is unlikely to meet the overall reduction of risks criterion. However, even if the alternative does not lead to an overall reduction of risk, this alternative substance should still be part of your analysis of alternatives but the conclusion regarding the overall reduction of risks should be relatively straightforward. As a consequence, you may consider whether a detailed analysis of its technical and economic feasibility is necessary in such a case.

How will the ECHA Committees (RAC and SEAC) take into account third parties' comments submitted during the public consultation on alternatives?

As a result of the eight-week public consultation both the "complete" and the "public" versions of the comments on the alternatives are made available to the Rapporteurs and the Committee members. The Rapporteurs will use this information as any other information during an evaluation process. The relevance, validity and reliability of the information will be assessed. The applicant will have a possibility to respond to the "public versions" of the comments. The Rapporteurs may pose follow-up questions to the third parties. They may also pose questions or require additional information from the applicant, as a result of the information provided by third parties.

What is the scope of the Analysis of Alternatives and the Socio-economic Analysis? The applicant's perspective or the society as a whole?

Both the applicant's and society's perspectives are relevant in the application. The applicant's perspective is relevant in the Analysis of Alternatives to assess how feasible it would be for the applicant to adopt any alternatives which are available to him. This would include the alternative of ceasing use of the substance altogether. This analysis can be used to identify the non-use scenario(s) which would pertain, if authorisation is not granted. The use and non-use scenarios should be assessed from society's perspective to provide an assessment of whether authorisation is justified from a social perspective or not, based on a comparison of the benefits of authorisation and the risks.

The applicant should undertake an Analysis of Alternatives as if they will be unable to use the substance in question beyond the sunset date, that is, as if their application for authorisation is not granted. Thus, the scope should be whatever the applicant would normally use when choosing alternative substances or technologies in his business. One qualification to this is that alternatives might be suggested through the public consultation of which the applicant was previously unaware or would not normally consider. He might wish, therefore, to extend the normal scope of his analysis in anticipation of this.

It is not possible to generalise about the exact scope of the socio-economic analysis, as this will vary on a case-by-case basis. The principle is that all factors should be incorporated to the extent that they might make a material difference to the conclusions. An iterative approach to developing the analysis, as well as consultation and input from socio-economic analysis experts, can be helpful in establishing the appropriate scope in any given situation.

More details in the presentations of the seminars on application for authorisation:

http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation/afa

I will submit an Analysis of Alternatives for a threshold substance. I have R&D activities to develop and implement safer alternatives that are neither suitable nor available yet. Can I submit a Substitution Plan with my application?

A Substitution Plan should be provided if suitable alternatives are available (cfr. Article 62(4f)). A Substitution Plan is a commitment to take the actions needed to substitute the Annex XIV substance with a suitable alternative substance or technology within a specified timetable. If you conclude that the alternatives you have identified are neither suitable nor available yet, you should not submit a separate Substitution Plan. You should rather include all the relevant information on R&D activities in your Analysis of Alternatives. Refer to the Guidance on Application for Authorisation for more information.

Is it appropriate to provide a socio-economic analysis under the adequate control route?

There is no requirement to submit a socio-economic analysis when submitting an application for authorisation under the adequate control route. However, ECHA recommends that a targeted socio-economic analysis is also prepared under the adequate control route. This would be helpful in particular to the Committees when proposing to the Commission the duration of the review period. Furthermore, if the ECHA Committees do not support the applicant's assessment according to which the risks are adequately controlled, the application can still be evaluated on the provided socio-economic analysis.

How should the "economic feasibility" criteria be interpreted?

Based on Articles 60(4) and 64(4)(b) of the REACH Regulation the Committee for Socio-economic Analysis (SEAC) needs to state in its opinion, if the alternatives to the substance that is applied for are suitable. Economic feasibility is one aspect of this. It is recognised that the evaluation of economic feasibility is intrinsically linked with the evaluation of the other aspect of suitability of the alternatives, i.e. technical feasibility. Usually the more difficult (or easy) it is to substitute a substance the more expensive (or cheap) it is to do this. The note below describes how SEAC intends to evaluate economic feasibility as part of applications for authorisation recognising the link with technical feasibility.

What is the level of details needed for the analysis of alternatives?

The applicant should undertake an Analysis of Alternatives as if they will be unable to use the substance in question beyond the sunset date, that is, as if their application for authorisation is not granted. Thus, the level of detail should be whatever the applicant would normally use when choosing alternative substances or technologies in his business. However, as stated in the guidance on applications for authorisation: "It is strongly recommended that the applicant demonstrates that a comprehensive and adequate assessment of alternatives has been done. This is because the Agency in its opinions and the Commission in its assessment of whether suitable alternatives are available will take "all relevant aspects" into account {Art. 60(5)}, including information submitted by interested third parties." However, regarding the assessment of the risks arising from the use of the alternative and the comparison of these risks with the ones arising from the use of the Annex XIV substance "the applicant is not required to generate new hazard data or provide a chemical safety assessment for each of the alternatives. Nor is it required that the risks associated with alternative substances or technologies are assessed in the same detail as the risks associated with the Annex XIV substance."

In conclusion, the level of effort that needs to be put into the analysis of alternatives will be a matter of judgment for the applicant and should reach a point where the applicant is comfortable in defending its analysis in front of the ECHA Committees.
 

Should I consider in my socio-economic analysis the aspects outside the EU?

Yes, if they are relevant. However, the focus of the socio-economic analysis should be the EU but information on effects outside the EU may be relevant as well. See chapter 2.4.3 in the "Guidance on the preparation of socio-economic analysis as part of an application for authorisation"[PDF] for more information. 

g) Technical instructions for specific Annex XIV entries

The entry for Hexabromocyclododecane (HBCDD) indicates 2 EC entries and 5 CAS entries. How should the substance identification sections (1.1 and 1.2) in an IUCLID application for authorisation dossier be filled in?

The Annex XIV entry for HBCDD is a relatively broad entry, which might be considered to describe UVCB substances (with undefined Br positions), as well as multi-constituent substances (containing more than one defined diastereoisomers at concentrations between ≥10% and <80%), and mono-constituent substances (one diastereoisomer ≥80%).

If the application concerns one particular HBCDD substance (either UVCB, or multi- or mono-constituent), then sections 1.1 and 1.2 should describe this specific substance, following the general instructions provided in the Manual: How to prepare an application for authorisation (link to: https://echa.europa.eu/manuals).

Should the application concern more than one substances covered by the HBCDD entry (for instance due to different manufacture processes by one manufacturer, or in case of a joint application with applicants manufacturing/importing significantly different HBCDD substances), the application can still be considered as an application for "one Annex XIV substance". Therefore ECHA will charge a fee for "one substance", and the IUCLID dossier shall accordingly contain one substance dataset.

In this latter case, for technical reasons in section 1.1 of the IUCLID application dossier the following information should be filled in: IUPAC name: Hexabromocyclododecane; Type of substance – Composition: other: multiple substances under Annex XIV entry. The actual compositions of the substances applying for can be listed individually as different compositions in section 1.2 by using the repeatable block-function. In the "Brief description" field of each listed composition, please indicate also a remark, e.g. "substance manufactured from manufacturing site A" or "substance manufactured/imported by applicant B".

It is reminded that the REACH Annex XIV substance entry number (for HBCDD this number is "3") shall always be given in section 1.3 of the IUCLID dossier.

General instructions on how to prepare an IUCLID application for authorisation dossier are provided in the Manual: How to prepare an application for authorisation (link to: https://echa.europa.eu/manuals)

Can an application for authorisation for chromium trioxide cover the use of the chromic acids and their oligomers generated from adding chromium trioxide to water?

Yes. The reasoning and some example are provided below.

When brought in contact with water, chromium trioxide (EC number 215-607-8) forms two acids and several oligomers: Chromic acid (EC number 231-801-5), Dichromic acid (EC number 236-881-5), Oligomers of chromic acid and dichromic acid (further referred as "Chromic acids and their oligomers"). These chemical species are all identified as substances of very high concern (SVHC) and included in Annex XIV1 as two separate entries. Latest Application Date (21 March 2016) and Sunset Date (21 September 2017) are identical for both entries.

Chromic acids and their oligomers generated in water from chromium trioxide are commonly referred to as an aqueous solution of chromium trioxide. With regard to the authorisation requirements, it may be justifiable in some situations to consider for practical reasons chromic acids and their oligomers as an aqueous solution of chromium trioxide.

The generation of chromic acids and their oligomers by adding chromium trioxide to water is a use of a substance under REACH. This may be a discreet use of chromium oxide by a formulator or part of an integrated process in the use of chromium oxide. Considering this in the context of applications for authorisation, this operation should be considered as a "use applied for" and be addressed in the chemical safety report (CSR), the analysis of alternatives and, if appropriate, in the socio-economic analysis. Hence, applications for authorisation that are meant to cover further uses down the supply chain after the initial step in which chromium trioxide is brought in contact with water, have to refer to the chromic acids and their oligomers.

This answer is strictly limited to chromium trioxide and chromic acids and their oligomers generated from chromium trioxide in water. The system in aqueous solution is a complex equilibrium between multiple chemical species which depends on several physico-chemical parameters and the different chemical species cannot be isolated from the aqueous solution. The answer should thus not be applied by analogy to any other substance.

The table below describes possible scenarios in the case of an application for authorisation is made by the manufacturer/importer/user of chromium trioxide and/or chromic acids and their oligomers. Technical instructions are provided in the last column of the table.

As a general rule, sections 1.1, 1.2 and 1.3 of IUCLID should always refer to the substance applied for (i.e. the substance indicated in the third column - "Application for authorisation" of Table 1). In addition, if there is more than one substance which is imported/used (scenario #2 below) or if the substance actually imported/used is different from the substance applied for (scenario #3b below) this information should be described in section 1.2.

For each use, the assessment performed in the assessment reports (CSR, analysis of alternatives (AoA) and socio-economic analysis (SEA)) should relate to the substance relevant for that use. The substance at the use level (e.g. chromic acids and their oligomers - used in electroplating) might indeed differ from the substance applied for (e.g. chromium trioxide) in terms of hazard, physical form / potential for exposure to Cr(VI), alternatives, etc.

Table 1 - Possible scenarios in the case of an application made by the manufacturer/importer of chromium trioxide and/or chromic acids and their oligomers2

 

Scenario # Actor / Scenario Application for authorisation Explanation / Technical instructions
1 Manufacturer / importer/User of chromium trioxide who generates chromic acids and their oligomers in water applies for an authorisation for this use and the further uses of chromic acids and their oligomers (by itself and/or its downstream users) One application for authorisation for chromium trioxide covering the further uses of the chromic acids and their oligomers Substance ID in IUCLID
  • Section 1.1:indicate chromium trioxide as reference substance
  • Section 1.2: describe the actual composition of chromium trioxide
  • Section 1.3: indicate the A.XIV entry 16 (entry number for chromium trioxide)
Assessment reports in IUCLID (CSR, AoA, SEA):
  • Assessment to be based on the relevant substance per use (chromium trioxide or chromic acids and their oligomers). The two substances may differ e.g. in terms of hazard, form / potential for exposure to Cr(VI), alternatives etc.
2

Importer/User of both
- chromium trioxide
and
- chromic acids and their oligomers generated in water from chromium trioxide

applies for an authorisation for the generation in water  of chromic acids and their oligomers and their further uses (by itself  and/or its downstream users)
 

One application for authorisation for chromium trioxide covering the further uses of the chromic acids and their oligomers

The application should be made for chromium trioxide making clear that chromic acids and their oligomers are also imported/used.

Substance ID in IUCLID:

  • Section 1.1: indicate chromium trioxide as reference substance
  • Section 1.2: describe as first composition the actual composition of chromium trioxide and as second composition the actual composition of chromic acids and their oligomers. In addition, indicate in the "brief description" field that both chromium trioxide and chromic acids and their oligomers are imported/used.
  • Section 1.3: indicate the A.XIV entry 16 (entry number for chromium trioxide)

Assessment reports in IUCLID (CSR, AoA, SEA):

  • Assessment to be based on the relevant substance per use (chromium trioxide or chromic acids and their oligomers). The two substances may differ e.g. in terms of hazard, form / potential for exposure to Cr(VI), alternatives etc.
3 Importer/User of chromic acids and their oligomers generated in water from chromium trioxide applies for an authorisation for the further uses of chromic acids and their oligomers (by itself and/or its downstream users) One application for authorisation either for
  1. chromic acids and their oligomers generated from chromium trioxide covering the further uses
  2. or for
  3. chromium trioxide covering the further uses of chromic acids and their oligomers

In case the importer/user decides to apply for an authorisation for chromic acids and their oligomers in an application for chromium trioxide (case b), it has to become clear from the application that what is actually imported/used are chromic acids and their oligomers:

Substance ID in IUCLID:

  • Section 1.1: indicate as reference substance the substance applied for: either chromic acids and their oligomers (case a) or chromium trioxide (case b)
  • Section 1.2:
    • in case a): describe the actual composition of chromic acids and their oligomers
    • in case b): for technical reasons describe as first composition the composition of chromium trioxide (100% purity) and as second composition the actual composition of chromic acids and their oligomers. In addition, indicate in the "brief description" field that what is actually imported/used are chromic acids and their oligomers.
  • Section 1.3 indicate the A.XIV entry of the substance applied for: 17 if applying for the chromic acids and their oligomers (case a) or 16 if applying for chromium trioxide (case b)

Assessment reports in IUCLID (CSR, AoA, SEA):

  • Assessment to be based on chromic acids in terms of e.g. in terms of hazard, form / potential for exposure to Cr(VI), alternatives etc.

 

4 Manufacturer/Importer/User of chromic acids and their oligomers generated by alternative methods other than from adding chromium trioxide to water3
or
Importer/User who is unaware of the manufacturing methods of the chromic acids and their oligomers applies for an authorisation for the further uses of chromic acids and their oligomers (by itself and/or its downstream users)
One application for authorisation for chromic acids and their oligomers covering the further uses

The approaches described above cannot be applied as the starting material for manufacturing chromic acids and their oligomers is not chromium trioxide or is not known.

Substance ID in IUCLID:

  • Sections 1.1: indicate as reference substance: chromic acids and their oligomers
  • Section 1.2: describe the actual composition of chromic acids and their oligomers
  • Section 1.3: indicate the A.XIV entry 17 (entry number for chromic acids and their oligomers)

Assessment reports in IUCLID (CSR, AoA, SEA):

  • Assessment to be based on chromic acids and their oligomers, in terms of e.g. hazard, form / potential for exposure to Cr(VI), alternatives etc.

 

Please see also Q&A=804 (Do chromic acids and their oligomers, generated in water from chromium trioxide, require their own registration under REACH?)

1  Entry#17: 'Acids generated from chromium trioxide and their oligomers. Group containing: chromic acid, dichromic acid, and oligomers of chromic acid and dichromic acid' And Entry#16: 'chromium trioxide'

2  Chromic acids and their oligomers generated from chromium trioxide could be described in IUCLID sections 1.1 and 1.2 e.g. as a UVCB substance with IUPAC name "Acids generated from chromium trioxide and their oligomers" and Brief description "complex composition typically including oligomers of chromic and dichromic acids in equilibrium with each other". As constituents there could be listed i) chromic acid, ii) dichromic acid, and iii) oligomers of chromic and dichromic acids.

3  Further clarification may be needed as to whether alternative methods would lead to similar equilibrium as for aqueous solutions

The entries for 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (entry 42) and 4-Nonylphenol, branched and linear, ethoxylated (entry 43) cover several substances each. How should the substance identification sections (1.1 and 1.2) in an IUCLID application for authorisation dossier be filled in?

These Annex XIV entries are relatively broad entries, covering well-defined substances and UVCB substances, polymers and homologues.

If the application concerns one particular substance within the scope of one of these entries, then sections 1.1 and 1.2 should describe this specific substance, following the general instructions provided in the Manual: How to prepare an application for authorisation.

If the application concerns more than one substance covered by the applicable entry (i.e., either entry 42 or entry 43 in the authorisation list), the application will still be considered as an application for "one Annex XIV substance" for that specific entry. Therefore ECHA will charge a fee for "one substance", and the IUCLID dossier shall accordingly contain one substance dataset.

In this latter case, for technical reasons section 1.1 of the IUCLID application dossier should contain the following information:

  • IUPAC name: the name of the entry as it appears in the Authorisation List (“4-Nonylphenol, branched and linear” or “4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated” accordingly);
  • Type of substance – Composition: “other:” “multiple substances under Annex XIV entry”.

In this case, in section 1.2 the available information about the actual compositions of the substances applying for can be provided, listed as different compositions by using the repeatable block-function.

It is reminded that in all cases the REACH Annex XIV substance entry number (for these entries the number is "42" and “43” accordingly) shall be given in section 1.3 of the IUCLID dossier.

General instructions on how to prepare an IUCLID application for authorisation dossier are provided in the Manual: How to prepare an application for authorisation.

It is noted that in the case the application concerns both entries (42 and 43) a single multi-substance dossier will need to be submitted. In this case, ECHA will charge a fee for two substances and the IUCLID dossier shall accordingly contain two substance datasets, according to the instructions provided in the manual.

The substance I use has been identified as ‘nonylphenol ethoxylated’ (CAS# 9016-45-9). Should I consider that this substance is listed under entry 43 of the Authorisation list?

Yes, given the method of manufacture of this type of substance. The commercially manufactured nonylphenol ethoxylates predominantly consist of C9 alkyl substituents in position 4 (para-) of the phenol ring. Therefore a substance defined as nonylphenol ethoxylated is covered by the entry 43 for ‘4-Nonylphenol, branched and linear, ethoxylated’.

h) Changes of legal entity

What is a change of legal entity that needs to be notified for applications for authorisation or granted authorisations?

A change of legal entity is a change of the legal person who is the applicant of an authorisation or an authorisation holder. This change can take place, for instance, as the result of a merger, a split or an asset sale (sale of a production site or business). See Q&A 1242. Also purely administrative changes such as a change of corporate name or address and a change of Only Representative (OR) of a non-EU company need to be notified. See Q&A 1253.

 

Does a change of corporate name of an applicant or an authorisation holder need to be notified to ECHA and how?

Yes. 
Please submit the notification as follows:

  • Go to REACH-IT and use the “change name” functionality to update the name. Please provide in REACH-IT an extract from commercial register as evidence of the change.
  • Then notify ECHA via this web form. Under "Type of communication” please select "Notification of a change of legal entity", mention the affected submission number (of application) or authorisation number (of granted authorisation), and confirm that you have updated the name in REACH-IT.

In this manner ECHA can quickly process the change. ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.

Can an application for authorisation or a granted authorisation be transferred?

Yes. An application for authorisation or a granted authorisation can be transferred as long as the transfer is the result of the change of legal entity referred to in Q&A 1239 and the person to whom it is transferred qualifies as manufacturer, importer or downstream user with regard to the substance(s) and the use(s) covered by the application for authorisation or the decision. For details, see Q&As 1239 and 1242. On Only Representatives, see Q&A 1250.

Please note that a change of legal entity cannot extend the scope of the original application for authorisation or of the authorisation, e.g. to cover different uses.

How can I notify a change of legal personality regarding an application or an authorisation?


Please follow the next steps:

  • If relevant, create a new REACH-IT account for the successor legal entity. This is relevant when the new legal entity did not have a REACH-IT account before.
  • Log into the REACH-IT account of the original legal entity and from the Menu select Manage company | Legal entity change | Initiate a legal entity change. Then follow the online instructions. For the submission, include two attachments:
  1. Evidence of change, for instance the merger agreement or the agreement of the sale of assets.
  2. Filled announcement using the format indicated below. This describes the change of legal entity and the concerned application(s) or authorisation(s), as well as provides an analysis of the key impacts. It needs to be signed by both the original and the successor legal entity.

See also Q&A 1247.
Remember, that if the original entity has other REACH assets (e.g. registrations), the change of legal entity may need to be notified, too, via the same functionality in REACH-IT. See ECHA’s Practical Guide and technical instructions provided in the REACH-IT tool.

 

Do I have to pay a fee when notifying my change of legal entity?

Currently no fee needs to be paid for this notification for the purposes of authorisation.

 

The application was submitted before the Latest Application Date. If the legal entity changes, do the transitional arrangements set out in Article 56(1)(d) of REACH continue to apply to the legal successor?
Yes, provided that the change does not imply an extension of the scope of the original application (see Q&A 1241).
What will ECHA and the European Commission do and by when, following a notification of a change of legal entity regarding i) a pending application or ii) authorisation decision?

If the change concerns a pending application for authorisation, ECHA will communicate whether the notified change corresponds to the requirements described in Q&A 1241 and is properly documented. Furthermore, it will give its view on whether the change is minor (i.e. purely administrative changes and changes that would not have material implications on the content of the application or the terms of the RAC and SEAC opinions) or major (i.e. all other cases). ECHA endeavours to process notifications in two weeks. If the change is confirmed, ECHA will provide to the original legal entity a token. The original legal entity will need to communicate the token to the successor legal entity, who will need to accept the legal entity change in REACH-IT. The change is considered valid as of the date of the notification.

In this case ECHA will amend its database concerning the change of the legal entity. If the change is major, the RAC and the SEAC might need additional time to assess the implications of the change during the opinion-making process. If ECHA has already adopted an opinion, it will send its assessment to the European Commission so that it can take this into account when deciding on the authorisation.

In cases concerning granted authorisations, ECHA will send its assessment on the nature of the change to the European Commission, including its assessment on whether a review of the authorisation should be triggered on the basis of Article 61(2) of REACH.

The timelines for the assessment about any implications for the RAC and SEAC opinions or for the authorisation decision (potential trigger of a review of the authorisation) depend on the stage in the process at which the notification was made.

ECHA or the Commission may request for clarifications or additional information concerning your notification.

 

How should an applicant or an authorisation holder inform ECHA about a legal entity change?

An applicant for authorisation or an authorisation holder should inform ECHA about any legal entity change as soon as it has taken place (i.e. when they have the documentary evidence) using the ‘Legal entity change’ functionality in REACH IT. To reduce uncertainty you can also consult ECHA on the specific case in advance, provided you have sufficient information about the foreseen change. For any questions, please contact ECHA at legal-entity-changes-authorisation@echa.europa.eu.

I am preparing an application for authorisation while knowing that a change of legal entity will take place in the near future. How should I address this in the application?
As you foresee a change of legal entity, to the extent feasible we recommend to also describe this in the application and analyse the potential consequences of this change in your assessment. This would facilitate the assessment of the application by ECHA / the Commission once such change has occurred. You are advised to use the same format as in Q&A 1242 for reporting your analysis of the key impacts on the information in the application.
Does a change of an Only Representative (OR) concerning an application for authorisation or a granted authorisation need to be notified to ECHA and how?

Yes.

Please proceed as follows:

  • Create a new REACH-IT account for the new Only Representative. 
  • Log into the REACH-IT account of the original Only Representative and from the Menu select Manage company | Legal entity change | Initiate a legal entity change. Then follow the online instructions.

ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.

Does a change of corporate name of an applicant or an authorisation holder need to be notified to ECHA and how?

Yes.

Please submit the notification as follows:

  • Log into REACH-IT and use the “change name” functionality to update the name. Please provide in REACH-IT an extract from commercial register as evidence of the change.

ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.

i) Review reports

What is difference between a Review Report and the Application for Authorisation?

The Review Report updates the Application for Authorisation (AfA), and it must be sent to ECHA. The fee is the same as the one for an AfA. The Review Report will follow the same process as for an AfA. The greater the relevant technical and other progress during the review period, the greater the need to update the information. The information elements are the same. In other words, a Review Report should include an updated version of the assessment reports submitted in the original application (Chemical Safety Report, Analysis of Alternatives and – when relevant – an updated Socio-economic Analysis and an updated Substitution Plan). The use description may also need to be updated e.g. to reflect a more narrow scope. 

See Section 6 of the Practical Guide “How to apply for an authorisation” at https://echa.europa.eu/documents/10162/13637/apply_for_authorisation_en.pdf/bd1c2842-4c90-7a1a-3e48-f5eaf3954676
All the Q&As related to Applications for Authorisation are also valid for Review Reports mutatis mutandis.

I have submitted my Review Report on time i.e. at least 18 months before the end of the review period. The Commission has not issued its decision before the end of the review period. Can I continue to use the substance according to the authorisation decision until the Commission issues its decision?
Yes, until a decision on the review (maintaining, amending or withdrawing the authorisation) is adopted - see also Q&A 0571; 0572; 0573 which relate to the submission windows and the (latest) submission dates. The Q&As are also applicable to Review Reports.
I have submitted my Review Report too late i.e. less than 18 months before the end of the review period. The Commission has not issued its decision before the end of the review period. Can I continue to use the substance according to the authorisation until the Commission issues its decision?
No, the substance cannot be used after the end of the review period. You will have to wait the Commission’s decision before you can continue using the substance.
Can I submit a Review Report for a use that has not been authorised?
No. To submit a Review Report, the use has to be the one for which you have an authorisation. But you can submit a new Application for Authorisation.
Can I narrow down the scope of the authorised use in a review report to be more specific?
Yes. As long as your use is within the scope of the authorised use, but more narrowly defined, you can prepare a Review Report for the review of the authorisation. No need to make a new application in this situation. 
In the Review Report, can I split my use which was originally authorised into two or more specific, more narrowly defined different uses?
Yes you can, as long as each of the new redefined uses are within the scope of the previously authorised use. Please explain this clearly in the explanatory note to be submitted with the review report. In this case an updated version of the Chemical Safety Report, Analysis of Alternatives and – when relevant – a Socio-economic Analysis and a Substitution Plan must be submitted for each use. Splitting the use will have an effect on the fee (i.e., an additional charge will be imposed for the second use). At the same time in some cases this may make your Review Report clearer and more focussed, which helps ECHA’s scientific committees’ evaluation and the Commission’s decision making.
Will ECHA’s Scientific Committees use the information gathered from the downstream user notifications (based on REACH Article 66) during the evaluation?
Yes.
Will ECHA’s Scientific Committees use information from enforcement authorities?
Yes. Authorisation holders should use this information too, when preparing the Review Report.
Will I be able to submit another Review Report after this one as a result of a new Commission’s decision?
Yes.
I was unable to demonstrate adequate control of risks for a threshold substance in the original application that I submitted originally. Will I need to do so in the Review Report?
No, you do not have to. However, it would be advisable to do so. Moreover, you shall ensure and demonstrate in the review report that the exposure is reduced to as low level as is technically and practically possible. 
How will I submit the Review Report?
You can submit it to ECHA in the same manner as the original application, using the formats available for that purpose on the ECHA’s website. However, you will naturally need to indicate that it is a Review Report and make a link to the original application. You will also need to write an explanatory note which briefly explains what is different in the review report compared to the original application. For details see the Guide “How to apply for authorisation”: https://echa.europa.eu/documents/10162/13637/apply_for_authorisation_en.pdf/bd1c2842-4c90-7a1a-3e48-f5eaf3954676
CoRAP and Substance Evaluation

When a substance is included in the CoRAP, are there any mechanisms by which a registrant can challenge the inclusion or provide input into the evaluation process?

Registrants cannot challenge the inclusion of a substance into the CoRAP (Community Rolling Action Plan).

However, registrant(s) may provide input into the evaluation process. Registrant(s) of a substance in the CoRAP, particularly those substances on the current year of the CoRAP are encouraged to contact the evaluating Member State Competent Authority (eMSCA) early on in the evaluation process. The contact details for the eMSCA are published in the CoRAP. If the dialogue has not already started, the eMSCA will usually contact the lead registrant when the evaluation starts and offer the opportunity to meet to discuss technical issues related to substance evaluation. The registrants should consider nominating a representative for interacting with the eMSCA. The interaction between registrant(s) and the eMSCA at this phase of the evaluation is informal.

When the outcome of a substance evaluation is that an information request to clarify the suspected concern is deemed necessary (i.e. the evaluating MSCA prepares a draft decision on substance evaluation), the registrant(s) will get the opportunity to formally comment within 30 calendar days on any draft decision as part of the decision making process (Articles 50-52 of the REACH Regulation). The evaluating MSCA shall take the comments of the registrant(s) into account and decide whether the draft decision needs to be amended on the basis of the comments/additional information provided by the registrant(s) (Article 50(1) of REACH).

ECHA communicates to the registrant(s) the draft decision as notified to the other MSCAs and ECHA and the received proposals for amendment. At this stage, the registrant(s) will have the opportunity to comment on the proposals for amendment (Article 51(5) of REACH). Registrants are reminded of their obligation to always keep their registration dossier up to date, cf article 22(1).

What is substance evaluation?

Substance Evaluation is an integral part of the REACH implementation. It aims to clarify whether a substance, which has been identified as being of potential concern, poses an actual risk to human health and/or the environment. To clarify the risks, the registrants may be asked for more information on the substance. Substance evaluation shall be carried out by the Member States, whilst ECHA coordinates the procedure. The substances to be evaluated annually are listed in the CoRAP (Community Rolling Action Plan).

Which Member States will evaluate the listed substances?

Member States may volunteer to evaluate a substance. Two Member States may also decide to make a joint evaluation. However, in all cases only one Member State will be designated as the responsible Member State for the evaluation. Final allocation of the substances to the Member States is decided with the adoption of the CoRAP by ECHA, based on the opinion of the Member State Committee (MSC) on the draft CoRAP. Thus, the CoRAP will include for each substance on the list the Member State responsible for the evaluation. The contact information of the responsible competent authority will also be reported for the substances to be evaluated in the first year, to inform the stakeholders about the body handling each substance.

In case of joint evaluations by two Member States, the co-evaluating Member State is also indicated in the CoRAP.

What happens after the CoRAP is adopted?

From the publication of the CoRAP, the respective Member States have one year to evaluate substances listed for the first year (n) and, where regarded as necessary, to prepare a draft decision for requesting further information to clarify the suspected risks. The evaluation of the substances listed for the second and third year starts only after the publication of the CoRAP update in year n+1 and year n+2 respectively.

What is the difference between dossier evaluation and substance evaluation under REACH?

Dossier evaluation comprises the examination of testing proposals and compliance check of registration dossiers. Testing proposals are triggered by the REACH information requirements and all testing proposals submitted by the registrants must be examined by ECHA. The aim of this examination is to decide on the most appropriate testing in order to fulfil the REACH information requirements. ECHA can perform a compliance check on any registration dossier to verify whether the REACH information requirements are met. Dossiers can be chosen for compliance check based on random selection or prioritised based on a specific concern.

The substance evaluation process is triggered as a result of risk-based concerns and aims to clarify whether a substance poses a risk for human health or the environment. Substance evaluation is targeted at substances (including aggregated tonnages, all uses, etc.). Under substance evaluation any information (beyond the REACH requirements) can be requested provided that it is considered necessary for the purposes of risk assessment of the substance.

Substance evaluation is carried out by the Member States, while ECHA is responsible for dossier evaluation.

The decision making process is essentially the same for both processes.

What is the added value of substance evaluation?

Substance Evaluation may identify risks that could otherwise be missed. This process can further create additional value in respect of:

  • Concerns that go beyond the control of the individual registrant, like regional risks or the potential additional risk caused by aggregated exposures of a (sub)population or releases into the environment.
  • The assessment of groups of similar substances to predict cumulative effects and potentially increased risk levels from exposures to the different substances in the group. 
  • If considered scientifically necessary and proportionate, the request for additional information can go beyond the standard information requirements in REACH.
Why is a substance on the CoRAP list? Which criteria have been used?

The REACH Regulation Article 44(1) provides the general criteria for substances to be selected for substance evaluation. The legal text defines that prioritisation shall be on a risk-based approach. According to Article 44(1): "(...) the criteria shall consider:

hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;

exposure information; tonnage, including aggregated tonnage from the registrations submitted by several registrants".

The criteria have been refined by ECHA in cooperation with the Member States and are published on ECHA's website: Selection criteria to prioritise substances for Substance Evaluation (2011 CoRAP selection criteria) http://echa.europa.eu/documents/10162/13628/background_doc_criteria_ed_32_2011_en.pdf.

These criteria are applied in the initial step of the identification of substances with potential concerns. A further screening and selection process takes into consideration whether the substances are already subject to regulatory measures and the effectiveness of the substance evaluation to clarify the concern by requesting further information on the substance. Thus, meeting the risk-based criteria alone does not automatically mean an inclusion of the substance in the CoRAP.

According to Article 45(5) of the REACH Regulation, a Member State may notify ECHA of a substance, whenever it is in possession of information suggesting that the substance is a priority for evaluation. Thus, the CoRAP may also contain substances that have been included based on notifications from Member States.

Both hazard and exposure information (or a lack of it) is taken into consideration upon prioritising the substances. In the first CoRAP with many substances, the initial concerns are generally related to potential PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive or consumer use(s) and/or high tonnages. In general, the uses of these substances cover various areas and do not focus on any particular industrial, professional or consumer uses.

The final published CoRAP also contains a general indication of the reasons why the substance was prioritised and selected for substance evaluation (grounds for concern). Before inclusion in the CoRAP, the substances have not been evaluated and thus the indicated grounds for concern are just an indication of the possible areas of risk, based on the selection criteria. The initial grounds for concern should not be taken as a statement on a known risk or as a statement on what the evaluation will cover. During the evaluation, other areas of concern may be identified and investigated further. Only after the substance evaluation is completed, risks can be defined and communicated. The Member States have agreed that from the first update of the CoRAP in 2013, more detailed justification documents regarding selection of each substance will be prepared and published.

What does a known or suspected property mean in the grounds for concern in the CoRAP?
For example, the difference between known and suspected CMR-property is the following: "Known" means that the substance has either a harmonised classification and labelling or a self-classification chosen by the registrant(s) for one or more of the CMR-properties. "Suspected" means that e.g. non-conclusive information on intrinsic properties or results of structural prediction models indicate that the substance could have CMR-properties.
 
(CMR = carcinogenic, mutagenic, toxic to reproduction)
When was the first CoRAP adopted?
ECHA submitted a draft CoRAP to the Member State Competent Authorities and the ECHA Member State Committee in October 2011. The draft CoRAP was also published on the ECHA website to inform the stakeholders. The Committee gave its opinion on the draft CoRAP in February 2012. On the basis of the Committee's opinion, ECHA adopted the first CoRAP on 29 February 2012.
Is the CoRAP a new "black list" of chemicals?
The CoRAP list is neither a black list nor a sunset list, i.e. it will not cause a substance to be taken off the market. Instead, substance evaluation is a mechanism to evaluate and get more information on the substances listed therein, when there are concerns that the substances may pose a risk to human health or the environment. The evaluation can result in the conclusion that the concern is resolved and thus no further action is needed. If the initial concern is confirmed in substance evaluation, the Member State may consider further risk management options such as harmonised classification and labelling, restriction or authorisation to control that risk for a respective substance. However, that would be subject to a separate process.
What is the impact of substance evaluation on my business?

The listing of a substance on the CoRAP does not in itself have any legal impact on the registrant and thus does not require any further action by the registrants. When the CoRAP is adopted/updated, the registrants of substances listed for the first year of the CoRAP may expect to receive a draft decision requesting further information after the evaluation period of 12 months. At that point of time, the registrants will be given an opportunity to comment before any final decision to request further information is taken. The final decision will contain a deadline by which the additional information must be submitted.

On the other hand, if the evaluating Member State comes to the conclusion that no further information is necessary to clarify the risk, the substance evaluation process is concluded without a decision to request further information.

Inclusion of a substance in the CoRAP does not automatically mean that the substance poses a risk to human health or the environment, but rather that there is a concern that it may pose a risk, which needs to be clarified (confirmed or dismissed). It also does not automatically trigger, for example, the restriction or authorisation process. However, the Member State responsible for the evaluation of a substance may consider these options once the evaluation is finished, if the risk is confirmed.

Once adopted, is CoRAP fixed?
The CoRAP list will cover a period of three years. The first CoRAP thus includes substances planned for evaluation in the years 2012, 2013 and 2014. The plan should be annually updated. ECHA will make a proposal for the annual update at the latest by 28 February each year. However, currently ECHA plans that the updated CoRAP could already be adopted by the end of February and thus the draft for the CoRAP would be prepared and communicated already in October/November of the previous year. Thus, the first update is expected in February 2013. The rolling nature of the plan means that the list of prioritised substances included for evaluation during the second and third year may change when the plan is updated (e.g. a substance may be dropped or new ones introduced) and that each year a new subsequent year is added.
Is there any interaction between the evaluating Member State and the registrants/stakeholders?

The REACH Regulation does not foresee any formal interaction during the 12 month evaluation process i.e. before the possible draft decision is prepared. Once the draft decision is issued, the registrants will be contacted via REACH-IT. During the decision making procedure registrants will be consulted on any prepared draft decision and proposals made to amend this draft decision. The registrants may submit comments that will be taken into account in the decision making of the evaluating Member State and by the Member State Committee, if the draft decision is referred to the Committee.

The possibility for registrants/stakeholders to interact with the evaluating Member State during the evaluation phase may differ between Member States and substances that are evaluated. However, interaction between the registrants / stakeholders and the evaluating Member State is appreciated in general under substance evaluation. Thus, all relevant information available to the registrants of the substances should be included in the registration dossiers by the start of evaluation (i.e. March each year).

What is the outcome of substance evaluation?

If the evaluating Member State considers that further information is necessary to clarify a potential risk caused by the substance, it may draft a decision specifying the additional data requests. The initially identified concern in the CoRAP does not limit the evaluation made by the Member States and thus the potential request can address any property or exposure scenario of the substance. The registrants of that substance will have an opportunity to provide comments on the draft decision. Such a draft decision will be reviewed and agreed by the other Member States and ECHA, and in the case of proposals for amendment also by the Member State Committee. After this procedure, ECHA will take the final decision in line with the agreement in the Member State Committee. If no unanimous agreement is reached by the Member State Committee, the decision will be taken by the European Commission. The decision will contain a deadline by which the registrants must submit the requested information. It may also be that no request for information is needed because the risks can be clarified with the information already available.  In such cases, the substance evaluation is considered to be completed.

Once the registrants submit the requested information, the responsible Member State has another 12 months to assess this information and decide whether a further request for information is necessary or whether the evaluation can be concluded. In this latter case, the responsible Member State should consider whether and how to use the information obtained for the purposes of Community level risk management measures. The Member States may conclude:

  • EU-wide risk management measures are necessary (e.g. EU wide restriction, EU-wide authorisation, EU-harmonised classification and labelling, occupational exposure limits, measures for the protection of the environment under the Water Framework Directive) or
  • Actions at national level should be taken.

The conclusion can also be that the risks are sufficiently under control with the measures already in place. ECHA informs the European Commission, the registrant and the other Member States about the conclusions.

The decisions on data requests and evaluation reports will be made publicly available once finalised. It should be noted that as the production of the information requested may, in some cases, take several years (e.g. in the case of long term studies and annual environmental monitoring) finishing a final evaluation report may also take several years from the adoption of the CoRAP.

After adoption of the CoRAP, when can a possible first decision requiring further information on a substance be expected? If further information is requested, when would this become available?

From the publication of the CoRAP (March each year), the Member States have 12 months to prepare a draft decision for a substance included for evaluation during the first year, i.e. by end of February of the following year. After that, the decision making process may take approximately four to eight months depending on whether the Member State Committee is involved or not. Thus under favourable conditions, first decisions are likely to be taken between the middle and end of the following year after CoRAP inclusion. The registrants will have the opportunity to comment on the draft decision before the final decision is taken.

The decision will define the deadline by which the registrant(s) must provide the necessary information. Depending on the type of information, the deadline may be between some months and several years.

What is the follow up of substance evaluation?

"Follow up" under substance evaluation means: once the requested information is available and evaluated by the Member State, it will consider whether and how to use the information obtained for the purposes of Community level risk management measures.  The follow up can either be no action or recommendation to take further actions, such as to propose EU wide risk management measures.

A follow up conclusion under substance evaluation is not directly initiating further risk management measures. Any proposed Community-wide actions will be subject to a separate decision making process and Member States need to file a notification for this purpose. For authorisation, restriction and/or harmonised classification under the REACH and the CLP Regulations, stakeholders are consulted at all relevant stages of the process and decisions are taken on the basis of the opinions adopted by the ECHA Committees.

Are substances in the (draft) CoRAP going to be included in the authorisation/restriction processes?
There is no direct link between the CoRAP and the authorisation/restriction processes. While inclusion in the CoRAP means that a substance is going to be evaluated by a Member State to clarify whether there is a potential risk by asking further information, the restriction or authorisation processes aim to control known risks, which cannot be managed by other risk reduction measures. Thus, a follow-up to substance evaluation may be that a Member State wishes to start an authorisation or restriction process.
Where can I get more information on the CoRAP substances?

Information on the substances is available on the ECHA website. This website contains non-confidential information on the properties and uses of the substances that have been retrieved from the registrations for each substance.

Decisions on requests of further information and substance evaluation reports prepared by the Member States will also be published on the ECHA website, when they are available.
Dissemination portal:
http://echa.europa.eu/information-on-chemicals/registered-substances

CoRAP-substances:

https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table

Cosmetics

When can an adaptation of the information requirements under REACH be exercised by a Registrant, in case the substance is used in cosmetic products in the EEA?

In general, testing for human health endpoints can be adapted (‘waived'), if the substance is used in the EEA exclusively in cosmetic products falling within the scope of the Cosmetics Regulation, and if the testing would not be necessary to fulfil the REACH requirements for the assessment of worker exposure.

Two main scenarios are foreseen where cosmetics-based waiving could be applied. 

  • In cases where imported products fall within the scope of the Cosmetics Regulation (EC No 1223/2009) and which, from the time of import, are neither further processed nor repackaged inside the EEA, an adaptation of animal testing requirements for human health endpoints can be sought, based on the absence of relevant worker exposure;  
  • In other cases, you may be able to seek an adaptation of an information requirement by demonstrating that the substance is handled under strictly controlled conditions during all stages of the life-cycle, other than the use as a cosmetic product (i.e. manufacture, formulation and/or packaging stage).  

In all circumstances, you shall provide a reasoned justification for requesting the waiver.

If a chemical is only used in a cosmetic product, and if there is a potential for worker exposure during the manufacturing process, will testing on animals be required under REACH?

Where exposure to workers in the EEA is established, the REACH requirements apply. Note that the REACH provisions under Annexes VII to XI encourage the use of adaptations; animal testing should be performed as a last resort only (Article 25 of REACH).

Consequently, testing on vertebrate animals will be required only if there is no available information which meets the information requirements, and where no adaptation possibility under column 2 of REACH Annexes VII to X, or under Annex XI can be applied.

This will represent the only means to assess the potential human health risks arising from exposure to workers. 

In practice, how can an adaptation of an information requirement be exercised by a Registrant where the substance is solely used in cosmetics?

As for every adaptation of an information requirement in a registration dossier, you need to insert a justification in each of the relevant endpoints of the IUCLID dossier.

Two main types of scenarios have been identified:

  1. Where the substance is imported into the EEA in a cosmetic product that is not further processed in the EEA: in addition to following the instructions provided by ECHA (see below), you shall add, to the respective endpoint(s) in IUCLID, an explanatory note stating that the substance is solely used in cosmetics, imported in the finished state and not further processed nor repackaged inside the EEA;
  2. Where the substance/cosmetic product is further processed in the EEA, but where absence of worker exposure can be demonstrated: you may avail yourself of the regular adaptation possibilities, pursuant to Annex XI, section 3.1 of REACH, to waive the testing requirements addressed by sections 8.6 and 8.7 (repeated dose toxicity and reproductive toxicity respectively) of Annex VIII to REACH and the test in Annex IX and X.

When applying these adaptations, for the purpose of the justification required according to Annex XI, section 3.2, you do not need to consider the life-cycle stages related to the use of the finished cosmetic product, as these are regulated separately under the Cosmetics Regulation.

While testing for acute toxicity cannot normally be waived under Annex XI, section 3.2, for the purpose of registrations dossiers that cover only cosmetic uses, a similar waiver containing the elements of Annex XI, section 3.2 may be used for this endpoint.

See section 5.1 of the Guidance on information requirements and chemical safety assessment, Chapter R.5: Adaptation of information requirements for further details on how to make use of this adaptation possibility.

Furthermore, ECHA provides further specific recommendations to follow below when you create or update your registration dossier.

How can a Registrant indicate the request for adaptation of information requirements for human health endpoints in the IUCLID dossier if the substance is imported and not further processed in the EEA?

In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.

The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier.

Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.

If the substance is only imported in the EEA in a cosmetic product in its final state (neither further processed nor repackaged inside the EEA), the waiving possibility is only relevant for human health endpoints and is only based on the fact that there are no uses in any stage of the life-cycle which may be relevant to REACH (no exposure to workers; exposure to professionals and consumers is covered by the Cosmetics Regulation).

The following specific data waivers can be used only for human health information requirements (Sections 8 of REACH Annexes VII-X).

 

 

IUCLID section

Field

Selection / entry

Substance dataset

Any Endpoint Study Record– Annexes VII to X *

Data waiving

’study waived due to provisions of other regulation’

Justification for data waiving

‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”

Justification for type of information

The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is imported in a cosmetic product in its final state (i.e. the product is from the time of import neither further processed nor repackaged inside the EEA).

Waiving of animal testing requirements for human health endpoints is proposed based on the absence of uses other than in finished cosmetic products.

Section 3.5.5 – Consumer uses **

Product category ***

PC39

Dossier

Dossier header

Dossier submission remark

“This dossier covers a substance that is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is imported in a cosmetic product in its final state. The product is from the time of import neither further processed nor repackaged inside the EEA.” 

Updates only

Dossier header

Spontaneous update, ‘Justification' ****

‘other' +  ”Cosmetics Regulation / 2013

* Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
** The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 9.6.4.3 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.
***All uses outside the cosmetic use have to be documented in Section 3.5

**** A separate justification should be entered for each reason for the update.

How can a Registrant indicate an adaptation of information requirements for human health endpoints in the IUCLID dossier if the substance is imported and further processed in the EEA, without exposure to workers?

In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.

The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier. Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.

If the substance is further processed inside the EEA, i.e. it is imported or manufactured in the EEA, and still further formulated or re-packaged, before or after inclusion in the final cosmetic product, you need to demonstrate the absence of exposure to workers to benefit from the adaptation possibility.

This case also covers situations where you do not need to provide an exposure assessment: either no CSR is required due to the low tonnage of the substance manufactured or imported, or no exposure assessment is required because the substance does not require classification.

Consequently, you should document the absence of exposure as appropriate, using exposure scenarios and/or other approaches. You can apply for the following specific data waivers, specifically for the human health information requirements (Sections 8 of REACH Annexes VII-X).

 

IUCLID section

Field

Selection / entry

Substance dataset

Endpoint Study Record corresponding to: *

-Annex VII

-Annex VIII (except sections 8.6 and 8.7)

Data waiving

‘study waived due to provisions of other regulation’

 

Justification for data waiving

‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”

 

Justification for type of information

The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/ or further processed inside the EEA before/ after inclusion in the final cosmetic product.

Waiving of animal testing requirements for human health endpoints is proposed, since the substance is handled only under strictly controlled conditions, with the exception of the life-cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation). Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)), during all life-cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13:”
<registrant to choose the appropriate option(s)>

  • in the exposure scenario of the CSR.
  • in an assessment report (if no exposure scenario is required).

 

Endpoint Study Record corresponding to: *

-Section 8.6 and 8.7 of

 Annex VIII
-Annex IX
-Annex X

Data waiving

‘exposure considerations'

 

Justification for data waiving

‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”

 

Justification for type of information

“The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/ or further processed inside the EEA before/ after inclusion in the final cosmetic product.

Waiving of animal testing requirements for human health endpoints is proposed since the substance is handled only under strictly controlled conditions, with the exception of the life-cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation). Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)), during all life-cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13:
<registrant to choose the appropriate option(s)>

  • in the exposure scenario of the CSR.
  • in an assessment report (if no exposure scenario is required).

 

Section 3.5.5 – Consumer uses **

Product category ***

PC39

 

       

 

Dossier

Dossier header

Dossier submission remark

“This dossier covers a substance that is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and /or further processed inside the EEA before/ after inclusion in the final cosmetic product. All manipulation of the substance outside the cosmetics use takes place under strictly controlled conditions.”

 

Updates only

Dossier header

Spontaneous update, ‘Justification' ****

‘other:' + “Cosmetics Regulation / 2013”

 

 

*Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
**The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 9.6.4.3 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.
***All uses outside the cosmetic use have to be documented in Section 3.5.

**** A separate justification should be entered for each reason for the update.

See also: https://echa.europa.eu/documents/10162/13628/reach_cosmetics_factsheet_en.pdf

I received a decision under REACH imposing the requirement to provide information performing an animal test. The decision was adopted before March 2013 and I have not yet started the test. Am I still required to comply with the decision?

Yes, the ECHA decision is legally valid and binding, so you have to comply with it.

However, if the substance is used exclusively in a cosmetic product and falls under one of the scenarios described, i.e. animal testing would only serve the purpose to address human health risks resulting from the exposure to the finished cosmetic product, you should be able to comply with the decision you received by requesting use of waiving possibilities, as per the REACH Annexes.

Illustration of cosmetics-based waiving scenarios.

It is only where the required testing relates to potential human health effects for workers that animal tests may be required. In such circumstances, the tests are performed to meet the requirements of REACH.

Does the entry into force of the total marketing ban for animal tested cosmetic products/ingredients affect the compliance of the registration dossiers I already submitted?

No, the entry into force of the total marketing ban under the Cosmetics Regulation (EC) No 1223/2009 does not influence the REACH requirements.

However, if your registered substance is exclusively used in cosmetics, ECHA recommends that you spontaneously update your registration dossier to clearly indicate the uses, should you