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Updates to registration dossiers not taken into account during substance evaluation decision making
ECHA/NR/20/12
Once ECHA has sent a substance evaluation draft decision to registrants, the Agency and the evaluating Member States will not take dossier updates into account during decision making. If registrants have new relevant information, they need to submit it through their comments to the draft decision.
Helsinki, 31 March 2020 - From 14 April 2020, ECHA starts applying a new policy regarding dossier updates during substance evaluation.
After ECHA has sent registrants a draft decision for commenting, the Agency and evaluating Member States no longer take dossier updates into account in their decision making. This is because registration dossiers must reflect the best knowledge of the registrants at all times and contain the most up-to-date information, in particular on the exposure and use of the substance.
If registrants have new relevant information on their substance after receiving a draft decision, they will need to submit it through their comments to the draft decision. Authorities will consider the comments and amend the draft decision, if needed.
The same approach already applies to dossier evaluation.
- Practical guide: How to act in substance evaluation [PDF] [EN]
- ECHA does not consider dossier updates during evaluation decision making (News release, 26 November 2019)