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What is Compliance Check?

What is Compliance Check?

ECHA may examine any registration dossier to verify that 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.

There are two types of compliance checks (CCHs), overall and targeted CCHs:

  • The scope of an overall CCH covers those elements necessary for the safe use of the chemical that are part of the REACH registration dossier. The overall CCH usually occurs in one single assessment.
  • In a targeted CCH, the focus is only on specific parts of the selected dossier. The targeted CCHs vary from standardised checks on only one or a few endpoints using IT screening of the whole database to more comprehensive checks where most of the endpoints are covered. Depending on the case, ECHA may escalate targeted CCH into an overall CCH when major non-compliances that deserve a wider assessment are detected in the dossier.

A compliance check is only considered to contribute to the 5% target, where ECHA has taken one of the following actions:

  1. CCH decision (draft or final) is sent to the registrant to request data;
  2. Concluded without regulatory action (Quality observation letter (QOBL) is sent to the registrant or CCH is closed without action).

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