Q&As

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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.

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