This news update discussing how ECHA tightens its practice on dossier updates is brought to you by EHCA.
ECHA tightens its practice on dossier updates.
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.
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.
For more information regarding how ECHA tightens its practice on dossier updates, please visit the EHCA link above. Please contact Nexreg for Regulatory Services.