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.
Compliance checks are generally conducted on registration dossiers for substances which are on the Community Rolling Action Plan (see CoRAP list for further details).
Compliance check focusses on eight key endpoints which are outlined in the regulatory 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.
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.
To ensure the safe use of your substance and compliance of the related registration dossier under the REACH Regulation, and to ensure ECHA undertakes a compliance check on the most up to date information in the registration dossier, ECHA requests Registrants to review their related registration dossiers and update them with any new and/or relevant information including, where applicable, an update of the CSR and change of the tonnage band.
What are the possible outcomes of the compliance check?
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.
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.
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.
5% Compliance Checks