Updating of registration dossiers: a compliance check campaign conducted by ECHA
Last December, the European Commission voted on an update to the REACH regulation concerning the changes to be made to registration dossiers. Until then, companies had to update their dossiers "without undue delay". This lack of clarity on the deadlines involved gave companies the flexibility to wait as long as they wished, without obligation, before updating their dossiers.
Therefore, this regulation update provides for the following deadlines:
- 3 months for administrative updates
- 6, 9 or 12 months for more complex updates (e.g. change of classification or labelling of a substance without harmonized classification, etc.)
ECHA's checks focus on Annex XIV substances (substances subject to authorization) for which the sunset date (date from which the substance is banned in Europe) has passed but for which no authorization dossier has been submitted.
148 registration dossiers are concerned by these substances. The companies that ECHA will contact via REACH-IT will have to declare if:
- The manufacture of the substance has stopped and the information has not yet been updated on REACH-IT,
- Or if the registrations were for uses exempt from authorization (e.g. intermediaries).
Towards further changes to the REACH regulation for registrations
The European Commission has recently revised the information requirements for REACH registration dossiers through the different annexes of the regulation.
The information to be submitted has therefore been clarified, in order to make ECHA's dossier evaluation process more transparent and predictable. ECHA will publish an updated version of its guidance for companies by the end of 2021. The regulation updating the REACH annexes is effective since July 8, 2021 and will enter into force from January 8, 2022.
The main changes concern:
- rrequirements for surface tension and water solubility of metals and sparingly soluble metal compounds,
- requirements for in vitro testing for eye irritation and in vivo for eye or skin irritation,
- requirements and adaptations for 28- and 90-day repeated dose toxicity studies
- rules for adapting reproductive toxicity studies
- general rules for adaptation based on:
- existing data
- weight of evidence
- substance-tailored exposure-driven testing
- grouping of substances
- new rules for adapting studies on fate and behaviour in the environment based on a low octanol-water partition coefficient
- new specific rules for adapting for dissociation constant and viscosity
- additional requirements for human health and environmental testing to be performed at appropriately high dose levels.
Wish to know more about your REACH registration compliance?
For more information, do not hesitate to contact one of our experts!