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REACH

Evaluation

Compliance checks

What is the aim of the strategy for compliance checks (CCH)?

The strategy aims to systematically target dossier elements that are immediately relevant for the safe use of the substance. The chances of non-compliant dossiers being picked up for compliance check are higher. This approach encourages registrants to comply with REACH and to improve their chemical safety assessments. Compliance check approach has been developed in consultation with the Member State competent authorities (MSCAs) and results in an improved quality control of the dossiers.

How does it work in practice?

ECHA and the Member States identify substances/dossiers of concern based on the IT screening and following manual screening. These dossiers are potentially relevant for further regulatory risk management measures and therefore become prioritised for compliance check. Under the CCH, the eight higher tier endpoints are evaluated.  

What happens if my dossier is selected for compliance check?

If the selected endpoints in your dossier are found to be compliant with the standard information requirements, there will be no further administrative action. If the selected endpoints of your dossier are found to be non-compliant, you 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?

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

No. Issuing a compliance check draft decision does not necessarily mean that ECHA has checked the entire dossier. REACH does not limit the number of compliance checks, thus it cannot be excluded that you may receive multiple draft decisions on the same dossier.

Registrants will be able to provide their views on the intended information request. The decision becomes effective only after completion of the decision making procedure involving the Member States.

By when is it possible to submit new data to ECHA so that it will still be taken into consideration for the compliance check evaluation?

The preparation of a draft decision after a compliance check of a dossier follows the timelines set in Articles 50 and 51 of the REACH Regulation.

When the draft decision is sent to the registrant, the registrant has 30 days to comment. The commenting period for the registrant starts from the day of the receipt of the draft decision via REACH-IT. ECHA will take the comments into account and may amend the draft decision accordingly.

Dossier updates submitted after issuing the draft decision are normally no longer taken into account.

ECHA will notify the Member State competent authorities (MSCAs) of the draft decision after consideration of any comments received.
 
The reason for this is that Article 51 of the REACH Regulation sets deadlines for the decision-making which cannot be put on hold once ECHA's draft decision has been referred to the MSCAs. The REACH Regulation provides strict timelines for the MSCA proposals for amendment, the referral to the Member State Committee (MSC), the comments from the registrant on the proposals for amendment and for the agreement-seeking on the draft decision by the MSC. It is therefore of key importance that the factual basis for the decision-making, i.e. the registration dossier subject to the regulatory action does not change during this stage of the decision-making process.

Any updates of the registration that contain information relevant for the endpoints addressed will be taken into account in the phase of following up to the dossier evaluation decisions (Article 42 of the REACH Regulation).
 

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

The ultimate goal is to focus on those endpoints that matter for human health and the environment with special emphasis for those which are related to the Persistent, Bioaccumulative and Toxic (PBT) or Carcinogenic, Mutagenic or Toxic to reproduction (CMR) status of a substance.  

Follow up to dossier evaluation decisions

I cannot provide the information requested in the ECHA decision by the deadline. Is it possible to extend the deadline?

We are not able to alter the deadline of the decision, as it was unanimously agreed by all Member States. We will check whether a dossier update was provided and evaluate the updated registration dossier only when the deadline in the decision has passed. Then we will establish whether the requests in the decision are fulfilled. We advise you to update your registration dossiers by the deadline and, if necessary, include any relevant explanations and proof concerning the status of any pending information requirements, including the expected submission date. You should then update your dossier again as soon as the missing information is available. Member State authorities may take these justifications into account when deciding on possible enforcement actions. Please see Q&A No 1065.

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

We do not have a standard practice for organising teleconferences/meetings with registrants after a decision has been issued. We can, however, clarify how, in practical terms, the decision is executed regarding technical or contextual matters. If you have such enquiries, we ask you to provide them in written form so that we can prepare the best possible answer for you.

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

We are not in a position to discuss the content of the decision as it was unanimously agreed by all Member States. We can, however, clarify how, in practical terms, the decision is executed regarding technical or contextual matters. If you have such enquiries, we ask you to provide them in written form so that we can prepare the best possible answer for you.

Is it possible to adapt the standard information requirements requested in a decision by providing read-across/waiver/weight-of-evidence/alternate tests? Can ECHA let me know whether my proposed adaptation is acceptable (before the deadline expires)?

We cannot elaborate further on alternative approaches, amended testing strategies, or any other scientific aspects of the decision, as we do not have the legal competence to alter a decision unanimously agreed by all Member States. You may adapt the testing requested in a decision according to the specific rules outlined in Annexes VI to X or according to the general rules contained in Annex XI of the REACH Regulation. For any such adaptation to comply with the respective information requirement, it needs to be scientifically justified, referring and conforming to the appropriate rules in the respective annex, and adequate and reliable documentation. We will check whether a dossier update was provided and evaluate the updated registration dossier only when the deadline in the decision has passed, i.e. we do not perform intermediate follow-up evaluations. Once the deadline has passed, we will establish whether the requests in the decision are fulfilled.

What if I do not update my registration dossier by the deadline? What if the information I submitted is not sufficient?
If a dossier update is not received by the deadline, or if we find that the updated information submitted does not fulfil the request in the decision and thereby does not meet the standard information requirements, we inform the Member State competent authorities (MSCAs) and the national enforcement authorities (NEAs) of the respective Member State about the non-compliance with the decision. You will receive a copy of the document containing such information. 
 
The MSCAs and NEAs have to consider and decide on enforcement actions, where appropriate. 
 
Starting from sending such information package to the NEA, the responsibility for handling this case of non-compliance with the REACH Regulation is transferred to the national authorities. 
 
We will support the national authorities in technical or scientific matters, if requested to do so by them. All direct questions that we receive in this situation will be channelled to the national authorities to make sure that they take your communication into account. 
 
Consequently, we will not evaluate any dossier updates unless the respective NEA asks us to do so. Therefore, if you receive such information, you should first contact the national authorities and any communication should be directed to them. 
 
What if I face technical difficulties during testing?
Facing technical difficulties in testing a substance usually leads to the inability to provide the requested information by the deadline set in the decision. In this case, we advise you to update your registration dossiers by the deadline and, if necessary, include any relevant explanations and proof concerning the status of any pending information requirements, including 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. For these cases, please see Q&A No 1064

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