Compliance checks

ECHA may examine according to Article 41 of REACH any registration dossier at any time to verify if the information submitted by registrants is compliant with the legal requirements. The legal requirements (standard information requirements) are cumulative and depend on the tonnage band.

 

Tonnage per year
(manufactured/imported)
Standard information required under REACH
1 to < 10 Annex VII
10 to <100 Annexes VII-VIII
100 to < 1000 Annexes VII-IX
1000 or more Annexes VII-X
 

After the substance identity is verified, compliance checks evaluate the 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 or the environment.

Dossier selection for compliance check is either random or concern based (targeted).

The concern based selection allows ECHA to target endpoints, which are relevant for the safe use of substances.

Compliance check focuses on eight key endpoints: genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation. These are the key endpoints for identification of substances of concern.

To ensure that ECHA undertakes a compliance check on the most up to date information in the registration dossier, ECHA requests Registrants to pro-actively review their related registration dossiers and update them with any new and/or relevant information such as new hazard information, changes in uses and exposure, updates to the chemical safety report (CSR), changes of classification or changes in quantities manufactured or imported, including the cease of manufacture or import.

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.

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