Q&As

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REACH

Evaluation

Compliance checks

What is the impact of the Integrated Regulatory Strategy on ECHA’s compliance checks?

The Integrated Regulatory Strategy, developed in consultation with the Member State competent authorities, aims to encourage registrants to comply with REACH and to improve their chemical safety assessments.

The Integrated Regulatory Strategy has three main pillars: 1) efficient selection of substances which may raise potential concern; 2) generation of the necessary information through compliance check for assessing their safety; and 3) assurance that any remaining concerns are subsequently addressed through the most suitable regulatory risk management instrument.

It can therefore be assumed that the selected substances that raise potential concern will be more likely addressed with further regulatory risk management measures, and that the substances that demand most urgent action will be part of the prioritisation.

More information is available at the Integrated Regulatory Strategy -page.

How are dossiers selected for compliance check?

ECHA and the Member States first identify substances and their dossiers using an IT-based screening, and then carry out further checks by a manual screening. The main criteria for selecting a dossier for compliance check are:

  • high tonnages;
  • suspected data gaps in the higher-tier human health or environment information requirements;
  • high potential for exposure of humans or environment (e.g. widespread uses or uncertain information on uses).

A detailed description of what is considered as high potential for exposure is available in the screening definition document.

What happens if my dossier is selected for compliance check?

If your dossier meets the criteria for selection (see Q&A ID 0647), ECHA will start a compliance check assessment, focusing on selected information requirements (or properties) (see Q&A ID 0654).

At that stage, the information on the dossier evaluation status page will be updated.

From then on, you can follow the progress of the evaluation through the entire process (see Q&A ID 1572 ).

If the information requirements (or properties) assessed are found to be non-compliant, the relevant members of the joint submission will receive a draft decision from ECHA.

If I get a draft decision from ECHA, does that mean that ECHA has checked the entire dossier and found it non-compliant?

No, by default ECHA assesses specific information requirements (or properties) (see Q&A ID 0654) in dossiers related to substances manufactured or imported at more than 100 tonnes per year. If the check has been targeted to different information requirements, the decision indicates the scope of the assessment undertaken.

REACH does not limit the number of compliance checks per dossier. Therefore you may receive multiple draft decisions on the same dossier.

When can we provide the (new) data ECHA has requested?

The updated dossier containing the information requested needs to be submitted by the deadline set in the (adopted) decision (Article 22(2) of REACH). This is independent from your legal obligation to update your dossier with any (new) relevant information “without undue delay” (Article 22(1)).

The updated registration dossier will be assessed after the deadline set in the decision has passed (Article 42 of REACH), on whether it contains the information requested in the decision.

What are the target endpoints ECHA is screening in the dossiers?

Under ECHA’s Integrated Regulatory Strategy (see Q&A ID 0646), the compliance check of dossiers related to substances manufactured or imported at more than 100 tonnes per year mainly focuses on eight key information requirements (or properties): genotoxicity, repeated dose toxicity, pre-natal developmental toxicity, reproductive toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation.

The goal is to focus on the information requirements (or properties)that matter most for human health and the environment, with special emphasis on those which are related to the persistent, bioaccumulative and toxic (PBT) or carcinogenic, mutagenic or toxic to reproduction (CMR) properties of a substance.

More information on the strategy on compliance checks is available at compliance checks page.

How do I know whether ECHA has started to assess my substance or my dossier?

ECHA does not inform you of the start of a compliance check on your dossier. However, you can find out whether ECHA has started to evaluate dossiers for a particular substance by regularly monitoring ECHA’s ‘Dossier evaluation status’ page (see Q&A ID 0650), and subsequently follow the progress through the evaluation process. You will also be able to see when ECHA has started the evaluation of your testing proposal.

See here the dossier evaluation status page or Infocard page.

By using the filtering options, you can find out whether ECHA has started its assessment of a given dossier:

  • these are marked as ‘Under assessment’ in the ‘Status’ column,
  • the start date is displayed in the ‘Latest update’ column.

Once the dossier moves forward to another stage of the evaluation process, the date in the ‘Latest update’ column changes with each change in the data, or if additional data was included in the table. You can therefore also follow the progress from the draft decision stage to the adopted decision up to when the evaluation is eventually closed. You should check the dossier evaluation status page regularly if you want to be up to date with the evaluation process.

ECHA takes into account any dossier update submitted before a draft decision is issued. Therefore you can still consider updating your dossier, especially with regard to tonnage and uses, before that time.

Note that if a ‘Dossier evaluation status’ entry is published under the ‘REACH’ activity on the Infocard page, this means that a dossier evaluation process has been initiated. By clicking on this entry, you can see the stage of the evaluation process for your substance.

To learn more about other regulatory activities under REACH and CLP, you can also consult the Public activities coordination tool (PACT).

I have received a draft decision. What should I do?

If you have received a draft decision, it means that there are non-compliant information requirements (or properties) in your dossier or in the jointly submitted registration dossier.

Check in the decision which members of your joint submission have received the draft decision, and get promptly in touch with them.

You have 30 days to provide your comments on the content of the decision. ECHA strongly recommends that you provide your comments collectively, in one consolidated set. ECHA only accepts comments submitted using the webform. A link to the webform is provided in the notification letter accompanying the draft decision.

For more information, see also the ‘Decision under dossier evaluation’ under recommendations to registrants and the practical guide ‘How to act in dossier evaluation’

I have a dossier containing information requirements which I have opted out from and I have received a (draft) decision. What are my obligations to bring my dossier into compliance?

As of January 2019, ECHA sends its (draft) decision to all non-compliant registrants of the joint submission. If you have opted out for one or more information requirements (Article 11(3) of REACH) and your information is found to be non-compliant, you also receive a separate (draft) decision.

 

You and the other recipients of ECHA’s decision will need to coordinate at least the following:

  • If the requested information already exists, you will need to agree on the costs and sharing of the existing data.
  • If the requested information needs to be generated, you will need to:
    i  agree on the test to be performed, including on the testing material to be used as representative for all registrants;
    ii  inform ECHA of who will perform the test; and
    iii  share the costs and new data.
Where can I find support material on the evaluation processes under REACH?

For increased transparency on evaluation and other processes, ECHA has published supporting information on the following pages:

For more information, see also ‘Decision under dossier evaluation’ under recommendations to registrants and check the practical guide ‘How to act in dossier evaluation’.

I am a member of the joint submission. Why have I received a draft decision?

As of January 2019, ECHA addresses its (draft) decisions to all registrants relying on non-compliant information requirements. Similarly, ECHA addresses its (draft) decisions on testing proposals to all those registrants intending to rely on the proposed tests to fulfil their information requirement.

Substance information exchange forums (SIEFs) ceased to exist as of 1 June 2018. Nevertheless, the registrants of the same substance continue to be bound by the obligation to submit jointly the information on their substance.

By setting out clearly how the information requirements apply at each tonnage band, ECHA’s decision gives the registrants greater certainty and clarity on their individual legal obligations, which helps ensure that all registrants within the joint submission become compliant.

Addressing evaluation decisions to all non-compliant registrants also aims to supports data and cost sharing as well as collaboration and communication between co-registrants regarding their joint submissions.

All recipients must comply with the same information requirements, and will need to share existing/new data while respecting their legal obligation to avoid unnecessary (vertebrate animal) testing.

Until when can I update my dossier so that the update is taken into account in the compliance check?

Your legal obligation is to keep your dossier up to date – in other words, to update your dossier without undue delay if you become aware of new information. Do not wait until ECHA starts dossier evaluation, but ensure that your data is always up to date.

Dossier updates submitted to ECHA will be taken into account only until ECHA issues the draft decision. We advise that you make sure that information on your tonnage, uses and registration type are regularly updated to match the actual use of the substance, so that ECHA can assess its safe use in the EU/EEA.

Information on dossier evaluation status can be found at Dossier evaluation status page.

Remember that after the draft decision is issued, the factual basis (namely the version of your registration dossier) of the evaluation cannot change during the decision-making process. Nevertheless, exceptions may be applicable in the following cases:

  1. You inform ECHA that a new key study on the registered substance, in the form of a robust study summary, can fulfil the information request in the draft decision and hence avoid further animal testing. ECHA may ask you to update and assess the study prior to proceeding.
  2. You cease manufacture or import of your substance after receiving the draft decision (see Q&A ID 1580).

For more information, see also the practical guide ‘How to act in dossier evaluation’ and ECHA’s recommendations to registrants.

We cannot provide comments by the deadline set in the notification letter accompanying the draft decision. Can we have more time?

In principle no. The REACH Regulation sets the deadlines which apply during the decision-making procedure. The deadlines cannot be extended.

Similarly strict timelines are in place for the proposals for amendment by Member State competent authorities, the referral to the Member State Committee (MSC), your comments on the proposals for amendment, and the agreement-seeking on the draft decision by the MSC.

For more details, see the practical guide ‘How to act in dossier evaluation'.

What happens if I decide to cease manufacture or import after I have received a draft decision?

If you decide to cease manufacturing or importing your registered substance upon receipt of the draft decision, you should inform ECHA of your intention using REACH-IT. When you confirm that you have ceased/are ceasing manufacture or import, ECHA proceeds by invalidating your registration number in line with Article 50(3), after which you are not allowed to manufacture or import the substance into the EU/EEA market.

Consequently, you will not receive the adopted decision (if you have already received an adopted decision, see Q&A ID 1580).

If you start to manufacture or import the substance again, you will have to register the substance once more and you may have to share the costs accrued for the maintenance and update of the registration dossier due to an evaluation process or for other reasons.

For more information, see also the practical guide ‘How to act in dossier evaluation’ and ECHA’s recommendations to registrants.

Follow up to dossier evaluation decisions

Can the deadline of the dossier evaluation decision be extended if we cannot provide the requested information on time?

No, ECHA cannot alter the deadline of the decision, because it is unanimously agreed by the representatives of the Member States.

ECHA acknowledges that technical difficulties in testing a substance may lead to delays or to the inability to provide the requested information by the deadline set in the decision. In any case, we advise you to submit an update of your dossier by the deadline set in the decision, including any relevant explanations and evidence concerning the possible delay and the expected submission date. You should then update your dossier again as soon as the missing information is available.

However, if you believe that the technical difficulties prevent you from testing altogether, you can, on your own responsibility, adapt the standard information requirements (see Q&A ID 1064).

After the deadline, ECHA will check whether a dossier update was submitted and whether the information provided fulfils the information requirements. If during the follow-up evaluation ECHA finds that some or all of the requested information is missing, the national enforcement authorities will be informed

Is it possible to have a teleconference/meeting with ECHA to discuss the request in the (draft) decision?

No, not as a regular practice. ECHA considers that after 10 years of REACH implementation, there is broad knowledge in all industry sectors, which can then support you.

However, if you have questions regarding a (draft) decision, you may submit your enquiry to ECHA using a contact form and we will assess your specific question.

Is it possible to discuss (in writing) with ECHA the scientific arguments an adopted decision was based on?

No, ECHA cannot discuss the content of the adopted decision after it has been unanimously agreed by the Member States representatives.

If you have general questions on ECHA’s decisions or processes, you may submit a request to the ECHA Helpdesk and we will assess your concerns.

Is it possible to adapt the standard information requirements requested in a decision by using read-across, weight-of-evidence or alternative tests instead of the study requested?

Yes. If you believe that you have scientific grounds to fulfil the requested information by adapting the requests in the decision, you may do so on your own responsibility.

Any adaptation must fulfil the specific rules outlined in Annexes VII to X or the general rules of adaptations in Annex XI to the REACH Regulation.

See also ECHA’s recommendations to registrants.

What if the information submitted is not sufficient?

Once the deadline set in the decision has passed and after ECHA has assessed whether the information you submitted is sufficient, ECHA will address the non-compliance through a new decision-making process according to Articles 50 and 51 of REACH.

This means that you will receive a new draft decision informing you that the information you submitted is not sufficient and that you still need to address the request in the original decision in order to fulfil the information requirements for the endpoint(s).

The decision has no deadline. Once the decision is adopted by the Member States, ECHA will inform the national enforcement authorities of the countries where the registrants are located.  

What happens if I decide to cease manufacture, or import, or downgrade tonnage band after I have received an adopted decision?

If upon receipt of the adopted decision you cease the manufacture or import of your substance, or if you downgrade the tonnage band of your registration, you will have to comply with the decision, regardless see Q&A ID 1597.

For more information, see also the practical guide ‘How to act in dossier evaluation’and ECHA’s recommendations to registrants.

I am a member and I have received an adopted decision. What should I do?

See also Q&A ID 1574.

Check the end of the decision for the list of addressees of the decision and contact them. You will need to collectively agree on who will perform the test(s) (see Q&A ID 1583) and inform ECHA about this within 90 days of the adoption of the decision. If no agreement is reached, ECHA will designate one of the registrants to perform the studies on behalf of all other addressees of the decision. For more information, see the practical guide ‘How to act in dossier evaluation’.

How do we inform ECHA of the name of the registrant(s) who will perform the test(s) listed in the adopted decision?

After you have collectively agreed on who will perform the test(s), you have to inform ECHA accordingly within 90 days from the receipt of the adopted decision (Article 53(1) of REACH).

Please use the link to the webform provided in the notification letter accompanying the adopted decision.

Who is responsible for generating the requested data and submitting the information to ECHA?

All recipients of the same decision are collectively responsible for fulfilling the requests in the decision that are relevant to their registered tonnage band.

After you receive the adopted decision, you need to agree collectively on who of the recipients is going to perform the requested studies. This is independent from the fact that the lead registrant is the one who submits the information “acting with the agreement of the other assenting registrants” (Article 11(1) of REACH).

The recipients of the decision are expected to agree on the testing to be performed as per their data (and cost) sharing obligations. You also need to agree on the material to be tested for each study requested, ensuring that it produces appropriate information and is representative of the registered substance as manufactured by all members of the joint submission.

You are also collectively responsible for the submission of the requested information by the (lead) registrant appointed to do so on behalf of the other registrants of the joint submission.

Can ECHA let me know whether my proposed adaptation is acceptable before the deadline in the decision expires?

No. ECHA will only check whether a dossier update was submitted once the deadline set in the decision has passed. ECHA will then evaluate whether the submitted information (test or adaptation) fulfils the requests in the decision (see Q&A ID 1582). This is part of the follow-up evaluation process.

In other words, ECHA does not perform any evaluations before the deadline in the decision has expired.

What happens if we do not update the registration dossier by the deadline in the decision?

Once the deadline set in the decision has passed ECHA will assess the dossier. In case the information requested in the decision are not submitted, ECHA will inform the Member State competent authorities and the national enforcement authorities of the respective Member State about the failure to respond to the request(s) in the decision.

When ECHA sends information to national enforcement authorities, the responsibility for handling the non-compliance with REACH is transferred to the national authorities, which then consider and decide on enforcement actions, where appropriate. Consequently, ECHA will not evaluate any subsequent dossier updates unless the respective national authority asks ECHA to do so.

You should direct all questions to your national authorities.

Who enforces ECHA’s adopted decision if I cease manufacture or import after receiving it?

If you do not update your registration by the deadline set in the decision, because you ceased manufacture or import after you received the adopted decision, ECHA will inform the Member State competent authorities and the national enforcement authorities of the country you are located in (see Q&A ID 1065).

Your authorities are responsible for any enforcement actions related to evaluation decisions according to your national legislation.

Who is responsible for submitting the requested information if there is a change of lead registrant after the decision has been received?

Any registrant receiving the adopted decision remains legally responsible for providing the information requested in the decision (see Q&A ID 1583), and will be the addressee of any enforcement actions related to evaluation decisions according to their national legislation, where appropriate.

Until 2019, the recipient of a decision was generally the lead registrant. If the recipient of the decision does not submit the requested information because they changed their role, their national enforcement authority will direct any enforcement actions towards them, where appropriate. This is independent from whether a newly appointed lead registrant would have submitted the information.

As of 2019, ECHA issues decisions to all members of a joint submission for which a non-compliance was found. All addressees of the decision are thus responsible for the submission of the requested information. Consequently, a change of lead after the adopted decision has been issued will not change the legal responsibility of the other recipients. In addition, if at the follow-up stage ECHA identifies that the registrants have failed to comply with the information requirements, it will notify the enforcement authorities of all the countries where the incompliant registrants are located.

Can ECHA let me know whether my proposed adaptation is acceptable before the deadline in the decision expires?

No. ECHA will only check whether a dossier update was submitted once the deadline set in the decision has passed. ECHA will then evaluate whether the submitted information (test or adaptation) fulfils the requests in the decision (see Q&A ID 1064). This is part of the follow-up evaluation process.

In other words, ECHA does not perform any evaluations before the deadline in the decision has expired.

What happens if we do not update the registration dossier by the deadline in the decision?

Once the deadline set in the decision has passed ECHA will assess the dossier. In case the information requested in the decision are not submitted, ECHA will inform the Member State competent authorities and the national enforcement authorities of the respective Member State about the failure to respond to the request(s) in the decision.

When ECHA sends information to national enforcement authorities, the responsibility for handling the non-compliance with REACH is transferred to the national authorities, which then consider and decide on enforcement actions, where appropriate. Consequently, ECHA will not evaluate any subsequent dossier updates unless the respective national authority asks ECHA to do so.

You should direct all questions to your national authorities.

Who enforces ECHA’s adopted decision if I cease manufacture or import after receiving it?

If you do not update your registration by the deadline set in the decision, because you ceased manufacture or import after you received the adopted decision, ECHA will inform the Member State competent authorities and the national enforcement authorities of the country you are located in (see Q&A ID 1065).

Your authorities are responsible for any enforcement actions related to evaluation decisions according to your national legislation.

Who is responsible for submitting the requested information if there is a change of lead registrant after the decision has been received?

Any registrant receiving the adopted decision remains legally responsible for providing the information requested in the decision (see Q&A ID 1583), and will be the addressee of any enforcement actions related to evaluation decisions according to their national legislation, where appropriate.

Until 2019, the recipient of a decision was generally the lead registrant. If the recipient of the decision does not submit the requested information because they changed their role, their national enforcement authority will direct any enforcement actions towards them, where appropriate. This is independent from whether a newly appointed lead registrant would have submitted the information.

As of 2019, ECHA issues decisions to all members of a joint submission for which a non-compliance was found. All addressees of the decision are thus responsible for the submission of the requested information. Consequently, a change of lead after the adopted decision has been issued will not change the legal responsibility of the other recipients. In addition, if at the follow-up stage ECHA identifies that the registrants have failed to comply with the information requirements, it will notify the enforcement authorities of all the countries where the incompliant registrants are located.

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