Compliance checks

ECHA may examine any registration dossier to verify if the information submitted by registrants is compliant with the legal requirements. Compliance checks evaluate the substance identity description and the safety information in the dossier including the chemical safety report or specific parts of the dossier, for example the information related to the protection of human health.

According to REACH, ECHA must check at least 5% of the registration dossiers of each tonnage band. Dossier selection for compliance check is either random or concern based (targeted).

In the targeted compliance checks, ECHA evaluates only a specific part of the registration dossier (e.g. either specific endpoints in IUCLID or in the chemical safety report (CSR)) based on a specified concern. This allows ECHA to target endpoints which are identified as relevant for the safe use of substances.

Substances potentially subject to compliance checks

To increase the efficiency and transparency of compliance checks, ECHA publishes a list of substances which will be potentially subject to compliance check. This list is developed in accordance with ECHA's new Compliance Check Strategy and it is based on i.a. the results of the common screening approach that has been developed by ECHA together with the Member States.

In addition to the substances identified here, compliance checks are normally conducted on registration dossiers for substances which are on the Community Rolling Action Plan (CoRAP list).

Compliance check focusses on eight key endpoints which are outlined in the new compliance check strategy. These are genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation. They are key endpoints for identification of substances of concern and will allow concluding whether the criteria for substances of very high concern are likely to be fulfilled.

The list of substances potentially subject to compliance checks will be updated a few times per year.  Registrants are advised to check this list regularly.

This list is only indicative and not exhaustive:  ECHA may at any time open a compliance check on any dossier to verify if the information submitted by registrants is compliant with the legal requirements.

Registrants may wish to review their related registration dossiers and update them with any new and/or relevant information including, where applicable, an update of the CSR.

What are the possible outcomes of the compliance check?

 

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No action towards the registrant

There is no administrative action if the dossier is considered compliant with the information requirements provided in REACH. However, this does not necessarily mean that there are no shortcomings in the dossier. A new additional compliance check can still start at any time.

 
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Quality observation letter

ECHA may identify shortcomings that are not necessarily related to a lack of information. For example, the risk management measures proposed by the registrant may be inadequate or the proposed classification and labelling may not reflect the reported study results.

In these cases, ECHA will send a quality observation letter and invite the registrant to update the dossier. A quality observation letter may also be sent to clarify certain aspects of the dossier.

ECHA informs Member States about these letters and on the response of the registrants. If the registrant does not clarify the issue, the Member States may initiate some processes, for example, a proposal for harmonised classification and labelling.

 
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Decisions to request additional information

Following the compliance check, ECHA may conclude that additional testing or other information is required. In these cases, it prepares a draft decision to be sent to the registrant for comments. Based on the comments, the draft decision may be modified accordingly. The draft decision is sent to the Member States which can propose amendments to it. If any amendments are proposed, the issue is referred to the Member State Committee. All draft decisions made by the Agency must be unanimously supported by the Member States and will only then become legally binding decisions.

ECHA may combine issuing a draft decision with the sending of a quality observation letter.

As a result of the targeted compliance check, registrants may receive multiple compliance check decisions to request additional information on the same dossier if it is non-compliant for more than one information requirement.