News

ECHA tightens its practice on dossier updates

ECHA/NA/15/02 

ECHA starts publishing a list of likely cases for compliance checks. At the same time, the Agency tightens and clarifies deadlines for dossier updates to reduce processing times once dossier evaluation has been started.  

Helsinki, 28 January 2015 - ECHA has started to implement its new compliance check strategy. The goal is to increase efficiency and transparency in dossier evaluation and focus on those substances that matter the most for human health and the environment. Some practices will also change as of January 2015.

Increased transparency of compliance check plans

ECHA starts publishing a list of substances for which a compliance check would in all probability be conducted. This gives the registrants the possibility for early dossier updates before the compliance check starts. However, the list is indicative and non-exhaustive: ECHA reserves the right to open further compliance checks on any dossier at any time and without prior notice to the registrants.

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.

Compliance checks: no dossier updates considered during the decision-making

To shorten processing times, ECHA will no longer take into account dossier updates after the draft decision on a compliance check has been sent to the registrant for comments.

The change does not affect the 30-day period given to registrants to submit comments on the draft decision. Comments will be taken into account in the decision making.

ECHA continues to offer informal interaction with registrants to clarify the process and content of the draft decision. 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: 60 days to update

When the 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.