ECHA implements compliance check strategy to tighten practice on dossier updates

This will be done by tightening and clarifying deadlines for dossier updates and focusing on those substances that matter the most for human health and the environment.

Transparency​

As such, the Agency has started publishing a list of substances for which a compliance check would in all probability be conducted, giving registrants the possibility for early dossier updates before the compliance check starts.

However, ECHA warns that the list is indicative and non-exhaustive, meaning that it reserves the right to open further compliance checks on any dossier at any time and without prior notice to the registrants.

The proposal states that the compliance check will mainly focus 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 endpoints.

Time saver​

In order to make processing times shorter, ECHA also says that it will not take into account dossier updates after the draft decision on a compliance check has been sent to the registrant for comments.

This will not affect the 30-day period given to registrants to submit comments, will be taken into account in the decision making, on the draft decision.

“ECHA continues to offer informal interaction with registrants to clarify the process and content of the draft decision,”​ says the Agency’s announcement.

“The registrants are expected to update their dossier after the final decision, before the given deadline. ECHA will evaluate whether the requirements of the decision are met after this deadline.”​

Testing proposals​

The announcement continues, when registrants receive a draft decision on a testing proposal, they will have 30 days to comment and a further 30 days to update their dossier, where relevant.

To avoid unnecessary testing on vertebrate animals, a more flexible approach may on request be taken in case of testing proposals involving read-across and categories for two or more registered substances.

The applicable deadlines will be stated in ECHA's draft decision and the notification letter.