The European Commission has revised certain information requirements for registering chemicals under REACH, which will start to apply from January 2022.
The regulation on amending Annexes VII to XI under REACH was released on 17 June 2021. It clarifies the information companies need to submit in their registrations and makes ECHA’s evaluation practices more transparent and predictable
The main changes concern:
- Requirements for surface tension and water solubility of metals and sparingly soluble metal compounds;
- Requirements for in vitro testing for eye irritation and in vivo testing for skin or eye irritation;
- Requirements and adaptations for 28-day and 90-day repeated dose toxicity studies;
- Specific rules for adapting reproductive toxicity studies;
- General rules for adaptation based on:
- Use of existing data;
- Weight of evidence;
- Substance-tailored exposure-driven testing; and
- Grouping of substances – in particular, those of unknown or variable composition, complex reaction products and biological materials (UVCBs);
- 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; and
- Additional requirements for human health and environmental testing to be performed at appropriately high dose levels.
ECHA will publish more advice to registrants in late 2021. It is suggested related companies need to start preparing in respond to the changes.
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