A new strategy
ECHA set up a compliance strategy in order to improve efficiency and transparency regarding dossiers evaluations. Furthermore, this approach allows authorities to focus on the most worrying substances for human health and environment. These new methods have to be taken into account from January 2015.
Improve transparency of controls
ECHA focuses on 8 endpoints that are likely to be checked for compliance: genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation. This list is not exhaustive.
The agency reserves the right to add new endpoints on any dossiers at anytime and without notifying registrants. However, this initiative allows registrants to update their dossier before the evaluation of the latter starts.
Shorten processing times
For the sake of clarity and efficiency, ECHA won’t take into account any dossier updates once the draft decision has been sent to registrants.
Nevertheless, assessed companies can add comments on the draft decision – they should be taken into account during the final decision. Once this decision is received, dossiers have to be updated before the given deadline.
Throughout the whole process, ECHA keeps helping registrants to clarify processes and content of draft decisions.
60 days for dossiers updates
As soon as registrants receive a draft decision on a testing proposal, they have 30 days to comment on it. Then, once the final decision is issued, they get another 30-day period to update dossier, if needed.
To avoid any non-necessary tests on vertebrate animals, ECHA set up a more flexible approach. In case testing proposals implied read-across and includes at least two categories of registered substances, ECHA imposes deadline on a case-by-case basis. And don’t forget: registrants concerned by this case can comment on the deadline and ask for extra time.
See ECHA fact sheet : « Follow-up to dossier evaluation decision »
