ECHA introduces changes to the compliance check process as of 1 January 2019

Date: 19 December 2018


In the course of the 27th Meeting of Competent Authorities for REACH and CLP (CARACAL) ECHA published a document (CA/63/2018) concerning the changed dossier evaluation and compliance check on 12 June 2018. The introduced changes will be effective from 1 January 2019.

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ECHA has critically reviewed the current process and based on the experience of the past ten years decided to introduce some changes. As a major change ECHA will extend the scope of the compliance check to all relevant dossiers within a joint submission. In particular, this will affect the following most important points:

  • In the future, ECHA will firstly check the lead dossier, and, if present, the boundary composition. Subsequently, ECHA will screen the members’ dossiers to identify whether the composition is consistent across the joint submission (and consistent with the substance identity profile, SIP) and whether deviations may impact the hazard assessment.
  • Partial or full opt-out dossiers will be assessed at the same time as the data submitted jointly. This will result in a separate decision addressed only to the relevant opt-out registrants.
  • CSR related issues will no longer be included in the draft decision unless the CSR is jointly submitted and the request refers to completeness in the sense of e.g. missing exposure assessment or missing exposure scenarios.
  • Once a draft decision is issued, registrants will need to comply with the requests in the decision according to the tonnage declared when receiving the draft decision. It will no longer be possible to change the tonnage band or the type of registration (full vs. intermediate) as soon as a draft decision is issued by ECHA. ECHA will no longer consider second attempts made for waiving an endpoint (e.g. a new read-across) via dossier update during an on-going compliance check procedure.
  • As a general rule, ECHA will no longer offer an informal communication to the registrants after the draft decision is issued.
  • ECHA will stop publishing a list of substances which are potentially candidates for compliance check.

ECHA strongly highlighted that “as the phase-in registration period is now over, registrants should shift their attention to the quality of their dossiers and update them without undue delay, as stipulated in Article 22.” Subsequently, ECHA expect that registrants comply with their obligation and ECHA will consistently apply its expectation in the dossier evaluation process.

Thus, ECHA is expecting dossiers to be up-to-date and will not inform registrants or grant a chance for dossier updates prior to regulatory measures.
In light of the planned changes, ECHA strongly encouraged registrants to take a pro-active role, to review the dossiers and update them, if necessary, without waiting for an alert or a draft decision.

SCC has a lot of experience in preparing and updating REACH dossiers according to the current REACH requirements.

In case you are planning to update your REACH dossiers we can provide you with support. Please get into contact with This email address is being protected from spambots. You need JavaScript enabled to view it..