Q&As

REACH

Registration

A. Registration, general

What are the options for an importer of a mixture when he is unable to obtain the relevant information from his supplier on the components of the mixture?
To fulfil his duties as a registrant an EEA-based importer of mixtures has to have information on the composition of the mixtures he imports into the EEA. This obligation already existed under the previous legislation as regards substances to be classified as dangerous. Under REACH, an importer needs to know at least the identity and percentage content of all substances in the mixtures he imports that could exceed the amount of one tonne/year.
 
If the non-EEA supplier is not willing or not able to provide the required information, the importer has the following options:
- identify the formulator of the mixture (if different from the supplier) and ask him directly for the required information,
- propose to the non-EEA formulator that he appoints an only representative in accordance with Article 8 of the REACH Regulation,
- establish the composition of the mixture by analytical means,
- find an alternative supplier who is prepared to provide all required information for the mixture.
I would like to cooperate with a company in another Member State by ‘chemical leasing'. Does this business model influence my registration obligations under REACH?
Business models such as ‘chemical leasing', where the purchase is based on the fulfilled functions performed by the chemical and where the value-based units, such as the number of painted articles, are the main basis for payment, or any other business models do not influence your registration obligations. 
 
It is still the manufacturer or the importer to the EU who is responsible for registering the relevant substances under REACH.
When do I have to register my substance?

A substance must be registered before the manufacture or import can start at an annual quantity of one tonne or more. Before the registration of such substances, the manufacturer or importer has to make an inquiry to ECHA regarding any previous registration for the same substance.
 
Upon registration, the registrant may have to wait for three weeks after the registration dossier is submitted before starting or continuing the manufacture or import of the substance (Article 21 of the REACH Regulation).

How do I communicate that I ceased manufacture/import?

You can cease manufacture due to the following scenarios:

  • You ceased manufacture/import due to commercial reasons according to Article 50(2) of the REACH Regulation. The registered volume in your registration is updated to zero and the status of your registration is changed to "inactive". If you restart manufacture/import of the substance, you should inform ECHA via the 'Restart manufacture or import' button available on the reference number page in REACH-IT.
  • You ceased manufacture following a draft decision according to Article 50(3) of the REACH Regulation. The status of your registration will be changed to "Invalid". A new registration must be submitted if you wish to restart manufacturing/importing your substance.

Below are the steps on how to cease/restart manufacture in REACH-IT.

 

You should use the functionality ‘restart manufacture or import’ to reactivate the reference number, when a substance is manufactured/imported again.

I now have my registration number. What happens next?

Your registration remains your responsibility, so keep it always up-to-date.

Safety Data Sheet
If you need to give your customers safety data sheets, you will need to include your registration number in the safety data sheets the next time you update them. In addition, if you have conducted a chemical safety assessment and needed to develop exposure scenarios, you have to attach them to the safety data sheet, outlining the use-specific conditions of safe use of the substance. This needs to be done as soon as possible.

SME verification
If you have claimed you are an SME and have benefited from the reduced registration fees, ECHA may verify the size of your company. Make sure that your REACH-IT account includes all the necessary documentation to justify the size of your company.

Joint Submission management and Data sharing
We strongly recommended that you put in place a mechanism discuss within your joint submission and for dossier update, when necessary. For example, you must also share data and give access to the joint submission to newcomers. You can charge for access to the data by sharing the costs in a fair, transparent and non-discriminatory way.

Dossier evaluation
ECHA will check the compliance of at least 20% of the received registration dossiers to verify that the information submitted is compliant with the legal requirements. The outcome of this dossier evaluation may be a request for additional information. Additionally, ECHA will examine the testing proposals included in the dossiers. This will happen by 1 June 2022 for registrations submitted for the deadline of 31 May 2018, and within 180 days for other registrations.

ECHA will communicate with you via REACH-IT, if the information of your registration dossier is being assessed, so we invite you to check your account regularly.

B. Registration, registrant

Should the importer always be considered as the same legal entity as the consignee stated on the simplified administrative document (SAD) used by the customs authorities? Does this imply that the consignee is considered to be responsible for registration?

No. The importer is the natural or legal person established within the European Union (EU, for REACH and CLP also covering the European Economic Area, EEA) who is responsible for import, i.e. the physical introduction (of goods) into the customs territory of the EU (Article 3(10) of REACH).

The responsibility for import depends on many factors such as who orders, who pays, and who deals with the customs formalities or the "INCOTERMS" chosen, but these might not be conclusive on their own. In many instances, the end receiver of the goods (the consignee) will also be the legal entity responsible for the import. However, this is not always the case.

If, for example, you order goods from a company (Company B) established in the EU, which acts as a distributor, you probably do not know where the goods originate from. Company B may choose to order the goods from either an EU-based manufacturer or from a non-EU-based manufacturer.

If the Company B chooses to order from a non-EU-based manufacturer, the goods may be delivered directly from them to you to save on transportation costs. If this happens, your company will be stated as the consignee on the simplified administrative document form and customs handling will take place in your country. Payment for the goods will, however, be settled between you and Company B.

Company B should be considered the legal entity responsible for the physical introduction of the goods into the customs territory of the EEA (importer). You would then be a downstream user. The obligation to register would consequently lie with Company B.

You, on the other hand, will have to be able to prove through documentation to the enforcement authorities that you are a downstream user, for example, by showing that the order was placed to the distributor.

In addition, when interpreting the term "importer" according to the REACH Regulation, it is not possible to fall back upon the Community Customs Code (Regulation (EEC) No. 2913/92), recast in Regulation (EU) 952/2013.

Who has to register substances?

Only a natural or legal person established within the European Economic Area (EEA)/EU can be a registrant. Registration must take place when this person:
1. manufactures a substance within the EU in quantities of 1 tonne or more per year;
2. imports a substance into the EU of quantities of 1 tonne or more per year; or
3. has been appointed as an only representative according to Article 8 of REACH (see FAQs on Only Representative of non-EU manufacturer).

The national law of each country provides the specific provisions concerning natural or legal personality and when such a natural or legal person is established in its territory.

A company not established within the EU does not have direct obligations under REACH. For obligations of a non-EU company, please see to Q&A 12.

You can use the Navigator tool to determine your obligations under REACH and find the appropriate guidance.

Who is the registrant in case of toll manufacturing of substances?

A toll manufacturer is normally understood to be a company that manufactures a substance (on its own, in a mixture or in an article) in its own technical facilities following the instructions of a third party in exchange for an economic compensation. The substance is generally put on the market by the third party. This construction is, for example, used for an intermediate step in the production process for which sophisticated equipment is needed (distillation, centrifugation etc.). According to the REACH Regulation, manufacturers of substances are required to register the substances they manufacture above one tonne per year. From this point of view the toll manufacturer is a manufacturer and has to register the substance.

This scenario is further discussed in the factsheet Toll manufacturer under the REACH Regulation.
 

Who is the registrant in case of an international company?

International companies sometimes have several daughter companies in the EEA/EU, often spread over several countries. If these subsidiaries of the parent company are separate legal entities from it, (a natural or legal person as defined under applicable national law), then each of those must determine if they qualify as registrant under REACH.

Please see Q&A 27 on who has to register a substance.

Can a Non-EEA manufacturer of a substance register under REACH?

No. The obligation to register a substance applies only to actors established within the EEA. Thus, the registration of substances imported into the EEA on their own, in mixtures or, in certain cases, in articles will have to be done by the importer established in the EEA. This implies that each individual importer needs to register the substance. However, according to Article 8(1) of the REACH Regulation manufacturers of substances, formulators of mixtures or producers of articles established outside the EEA, can nominate an only representative established within the EEA to carry out the required registration. This will relieve the individual EEA importers within the supply chain of that non-EEA manufacturer from their registration obligations for these substances. They will be regarded as downstream users of this only representative. However, the registration obligation may still apply if the EEA-importers import the same substance from other non-EEA manufacturers.
 
More information on the only representative role can be found in Only Representative of non-EU manufacturer and in section 2.1.2.5-'Only representative of a "non-EU manufacturer"' of the Guidance on registration.

For more information, see: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries.

C. Registration, tonnage

Can I register for a tonnage band higher than the actual tonnage of the substance?

Yes. Companies are free to register a substance for a tonnage band which is above the actual tonnage of the substance. This is also reflected in Section 2.2.6.3- 'Calculation of the total volume' of the Guidance on registration.

A registration at a higher tonnage band will trigger a higher registration fee in accordance with Regulation (EC) No 340/2008. In addition, the technical dossier will need to comprise all the information required for the registered tonnage band. Practical advice on how to complete a IUCLID dossier is provided in the Manual How to prepare registration and PPORD dossier at: http://echa.europa.eu/manuals.

Does a registration of an isolated intermediate pursuant to Article 17(2) or Article 18(2) of REACH have to be updated due to a change of tonnage band?
A manufacturer or importer who has registered an isolated intermediate pursuant to Article 17(2) or Article 18(2) of REACH does in general not have to update this registration in case of a change of tonnage band. However, such a registration would have to be updated due to a change of tonnage band in two cases.
 
Case 1: Where the registration is for a transported isolated intermediate and the 1000 t/a threshold is reached, the registrant must update his registration dossier by submitting the information specified in Annex VII of the REACH Regulation, if not already included in the dossier.
 
Case 2: Where the registrant ceases manufacture and import of the isolated intermediate, he has the duties described in Q&A 54, which include an update of the registration.
How do I calculate the tonnage?

Each registrant has to calculate the yearly tonnage for the registration dossier. The yearly tonnage is calculated as the volume per manufacturer/importer per calendar year.

 

What do I need to do if I find that my volume has exceeded the tonnage band I have registered the substance?

A registrant needs to update their registration without undue delay as soon as the ‘annual or total quantities’ they manufacture or import reach the next tonnage band threshold, as required by Article 22(1)(c). As soon as the annual volume of a substance that has already been registered reaches the next tonnage threshold, the manufacturer or importer has the duty to inform ECHA of the additional data required, following Article 12(2).

D. Registration, dossier creation

ECHA has assigned a list number to my substance. Should I report this in my registration dossier?

The list numbers published by ECHA are not official EC entries. However, we recommend you to assign such an entry to the substance you intend to register provided this list number is linked to a CAS number (list numbers starting with 6 or 8) or a chemical name (list numbers starting with 9) corresponding to a correct and specific identifier for your substance. If this entry is too generic for your substance and there is no appropriate EC entry available, you should not assign any list/EC number to your substance.

E. Registration, completeness check

What are the consequences if my registration fails at the completeness check?

If your registration dossier fails the technical completeness check (TCC) for the first time, you are given a deadline of 4 months during which you have one chance to amend the incompleteness. If you fail to submit the complete dossier by this given deadline, your submission will be rejected.

Rejection of a new registration means that the registration number is not assigned to your substance and any fees paid for this registration will not be refunded or otherwise credited. Consequently, you may only start to manufacture/import the substance or to produce or import an article once you have a complete registration and ECHA has issued you a registration number. If you wish to proceed with your registration you need to make a new initial submission. It will be subject to a new completeness check and registration fee.

Rejection of a registration update means that you maintain your existing registration number but any new information included in that update will not be included in the ECHA’s database. Any fees paid for this registration update will not be refunded or otherwise credited. If the update covered a change of tonnage band, you may not manufacture/import the substance or produce or import an article containing it at the increased tonnage band until ECHA has confirmed that your registration update is complete.

If the update of the registration dossier was submitted to include nanoforms of the substance then the rejection means that, even though you maintain your existing registration number for the non-nanoforms of the substance, the registration does not cover the manufacture or import of the nanoforms of the substance. Registrants that manufacture/import nanoforms of the substance after 1 January 2020 without a registration that covers these nanoforms are in breach of the REACH regulation which may trigger enforcement measures. Therefore, if your registration update to include nanoforms was rejected, you need to, at earliest possible, submit a new registration update in order to fulfil your obligations for nanoforms.

How can I check my dossier for business rules and technical completeness check failures before I submit it to ECHA?

As a first step, prepare your registration/PPORD dataset and dossier according to the advice given in the manual ‘How to prepare registration and PPORD dossiers’ available at: http://echa.europa.eu/manuals. Annexes 1-3 of the manual also give an overview of the business rules and technical completeness check rules that apply to registration and PPORD dossiers. 

Next, use the IUCLID Validation assistant plug-in to help you detect business rules and technical completeness check failures present in your dataset and dossier. To run the Validation assistant, right click on your dataset in the Navigation panel Validate follow the steps in the wizard. The same validation should be performed on the dossier to make sure that no failures have been introduced during dossier creation.

While the Validation assistant cannot replicate all the checks performed by ECHA, it simulates the majority of the verifications done and helps you minimise the chance of failure during submission. It is important to keep in mind, that any failure in the Validation assistant Submission checks tab, that is left uncorrected before submitting your dossier in REACH-IT, will lead to your submission not being accepted by ECHA. 

You can find a video tutorials on the use of the IUCLID Validation assistant in the link below:

https://www.youtube.com/watch?v=zQEncCL8cCE&index=4&list=PLOPGDACSd6qyDkdXwPua1Fjb5bJksY75k

Please note that if the Validation assistant does not indicate any failures, this is not an automatic confirmation of that your dossier is complete. As of 21 June 2016, the technical completeness check includes additional manual verifications of the registration dossier by ECHA staff. These checks cannot be replicated using the Validation assistant plug-in; the related completeness issues cannot be displayed by the tool.

Information on the areas of the additional verifications can be found in the following location; https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf.

We also recommend you to have a look at our webinars on the completeness check process: 

https://echa.europa.eu/-/completeness-check-preparing-a-registration-dossier-that-can-be-successfully-submitted-to-echa

https://echa.europa.eu/-/revised-completeness-check-what-changes-and-how-you-can-prepa-1

 

I submitted a dossier in response to an ECHA decision under compliance check and my dossier failed the technical completeness check (TCC). How should I proceed?

If your dossier is submitted before the compliance check deadline has passed, you may follow the deadline given in the TCC letter. ECHA will not continue with the Evaluation process before you have submitted the requested update for the technical completeness check failure(s).

If you fail TCC for the second time while submitting the requested update, your submission will be rejected.

If at this point the compliance check deadline has already passed, it means that ECHA has not received a response to the compliance check decision and may proceed with further regulatory actions. It is therefore advisable not to leave the submission of updates to regulatory requests to the last moment.

You can inform ECHA about not meeting the compliance check deadline via the contact form: https://echa.europa.eu/contact
 

Do I need to modify the all the data waiving justifications and use in IUCLID 6 ‘Justification for data waiving’ pick list values if I had prepared my data in IUCLID 5 and provided the justifications in free text?

There is no need to change the data waiving justification from free text to an available picklist phrase. A free text justification will be considered equally complete to a picklist value, if it is in line with column 2 of REACH Annexes VII-X, or sections 2-3 of Annex XI.

However, when preparing a dossier in IUCLID 6 from IUCLID 5 data, please review the selection in the field ‘Endpoint’ in particular for IUCLID sections where different information requirements can be addressed (e.g. 4.13, 7.8.1) to ensure that you have clearly indicated that the appropriate requirement is being waived.

What should I do if the Validation assistant reports QLT warnings in the Quality checks tab?

The quality rules warn the user of common inconsistencies and shortcomings in the dossier. These warnings will not prevent you from successfully submitting your dossier in REACH-IT. However, leaving quality warnings uncorrected may lead to future clarification requests by ECHA.

Does the manual verification apply to all submitted registration dossiers?

The manual verification applies to all registration dossiers submitted to ECHA. The manual checks focus on ensuring that registrants who waive or deviate from the standard information requirements provide justifications foreseen by the legislation. Therefore, the extent of the verification depends on whether the dossier contains waiving of standard information or deviations from substance identification conventions, as well as on the specific requirements that apply to the registration type (i.e. lead, member, individual registration) and the registration scope (tonnage band, isolated intermediate).

For further information, please refer to the document ‘Information on manual verification at completeness check’ available at: https://echa.europa.eu/manuals.

I received a task in REACH-IT indicating that my submission failed the technical completeness check. Where can I find further information on the reasons and implications of the failure?

In the task you have a link to the “Submission page” of the submission. Follow this link and go to the “Key documents” section at the bottom of the page. Here you can download the technical completeness check communication which contains all the relevant information regarding the failure, as well as the steps required by you. 

I am unfamiliar with the registration process. What does the completeness check consist of?

The completeness check is based on REACH Article 20(2). It applies to all registration dossiers submitted to ECHA, (i.e. initial submissions and updates). The completeness check consists of two parallel verifications: (i) the technical completeness check, in which ECHA verifies that all the required elements have been provided in the registration dossier; and (ii) the financial completeness check, in which ECHA verifies that the registration fee has been paid, if applicable to that submission.

If during the technical completeness check the registration dossier you submitted is found incomplete, ECHA will issue a deadline by which you have only one attempt to submit the complete information. If you do not provide the requested information by the set deadline in the form of an update dossier, the submission will be rejected. In such a case, any registration fee you had paid in relation with this submission will not be refunded or otherwise credited.

You can find more information about the registration process on "From sbmission to decision" .

We also recommend you to have a look at our webinar on the technical completeness check process.

F. Registration, information on chemicals

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.

G. Registration, scope

Which substances have to be registered?
Registration is required for all substances:
- as defined in Article 3(1) of REACH;
- manufactured in or imported into the EU in quantities of 1 tonne or more per registrant per year;
- unless they are exempted from registration or regarded as being already registered, according to provisions in Articles 2, 9, 15 or 24 of the REACH Regulation;
- irrespective of whether they are classified as dangerous or not.
 
If you want to know whether you have to register a substance you should first consult the Guidance on registration, section 2.2- 'What to register?. There you will also find information on substances exempted from registration. In addition, the Navigator tool can help to clarify the registration obligations for your specific substance.
What falls under the definition of PPORD (Product and Process Oriented Research and Development)?
According to Article 3 (22) of the REACH Regulation PPORD is defined as "any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance".Any scientific development of a substance consisting of, for example, campaign(s) for the scaling-up, improvement of a production process in a pilot plant or in the full-scale production, or the investigation of the fields of applications for that substance, falls under the definition of PPORD irrespective of the tonnage involved.
In order to promote innovation, Article 9 of the REACH Regulation specifies that substances manufactured or imported on their own or in mixtures, as well as substances incorporated in articles or imported in articles for the purpose of PPORD can be exempted from the duty to register for a period of 5 years. To be exempted a company needs to submit a PPORD notification to the ECHA. Upon request, ECHA may further extend this exemption for up to another 5 years, or 10 years for the development of medicinal products (for human or veterinary use) as well as for substances that are not placed on the market. Further information is provided by the specific Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD): http://echa.europa.eu/guidance-documents/guidance-on-reach.
Will a registration under the REACH Regulation be required for substances that are manufactured within the EEA but exported 100% outside of the EEA?
Yes. Article 6 of the REACH Regulation requires a manufacturer of a substance in quantities of more than 1 tonne per year to submit a registration, irrespective of whether this substance will subsequently be exported outside of the EEA. Therefore, substances manufactured in the EEA above this limit that do not meet any of the criteria for exemption from registration in accordance with Article 2 of the REACH Regulation and which are subsequently exported to non-EEA countries must be registered. The rationale for this duty is that the exposure resulting from manufacture and any other activity before export could be relevant for workers and the environment in the EEA.
How do I document the re-import of a registered substance?

Substances which have been registered, exported and then re-imported are exempted from registration under certain conditions.

To benefit from this exemption, you need to document that the following conditions are fulfilled:

  1. The substance must have been registered before it was exported from the EU.
  2. The substance already registered and exported must be the same, as the substance being re-imported.
  3. The substance must not only be the same but it must actually proceed from the same supply chain in which the substance was registered.
  4. The re-importer must have been provided with information on the exported substance as required by REACH (e.g. safety data sheet).

For further information, see the Guidance on registration, chapter 2.2.3.6 "Re-imported substance".

Which substances used in food or feedingstuffs are exempted from registration?

When a substance is used in food for humans or feedingstuffs for animals in accordance with the Food Safety Regulation ((EC) No 178/2002), the substance does not have to be registered.

This includes the use of the substance:

  • as a food additive in foodstuffs (Council Directive 89/107/ECC);
  • as a flavouring in foodstuffs (Council Directive 88/388/ECC and Commission Decision 1999/217/EC);
  • as an additive in feedingstuffs (Regulation (EC) No 1831/2003);
  • in animal nutrition (Council Directive 82/471/EEC).

Amounts of the same substance used for other uses than food and feedingstuffs are not exempted from registration. Only the amounts of the substance used in food and feedingstuffs are exempted from the registration obligation under REACH.

For further information, see the Guidance on registration, chapter 2.2.3.1.

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How do I register if I am located outside the EEA?