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 the environment. These new methods have to be taken into account from January 2015.
Improve controls’ transparency
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
- Bioaccumulation
This list is not exhaustive.
The agency reserves the right to add new endpoints on any dossiers at any time 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 will not deem valid any dossier updates once the draft decision has been sent to registrants.
Nevertheless, assessed companies can add comments on the draft decision – these 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 will continue to help registrants in clarifying 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 they have final decision, they get another 30-day period to update dossier, if needed.
To avoid any non-necessary tests on vertebrate animals, the agency set up a more flexible approach in case testing proposals imply read-across and include at least two categories of registered substances; deadlines will then be imposed on a case-by-case basis. Good to know: 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 » .
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 the environment. These new methods have to be taken into account from January 2015.
Improve controls’ transparency
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
- Bioaccumulation
This list is not exhaustive.
The agency reserves the right to add new endpoints on any dossiers at any time 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 will not deem valid any dossier updates once the draft decision has been sent to registrants.
Nevertheless, assessed companies can add comments on the draft decision – these 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 will continue to help registrants in clarifying 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 they have final decision, they get another 30-day period to update dossier, if needed.
To avoid any non-necessary tests on vertebrate animals, the agency set up a more flexible approach in case testing proposals imply read-across and include at least two categories of registered substances; deadlines will then be imposed on a case-by-case basis. Good to know: 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 » .
