From early 2022, Company which planning to register the chemical under REACH should be aware of the recent update by European Commission. The update of the REACH annexes clarifies the information that companies need to submit in their registrations and makes ECHA’s evaluation practices more transparent and predictable.
Effective Law from 8 July 2021; Apply from 8 January 2022
ECHA will update its guidance materials and publish more advice to registrants towards the end of 2021.
The main changes are:
- 1. requirements for surface tension and water solubility of metals and sparingly soluble metal compounds
- 2. requirements for in vitro testing for eye irritation and in vivo testing for skin or eye irritation
- 3. requirements and adaptations for 28-day and 90-day repeated dose toxicity studies
- 4. 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);
- 5. new rules for adapting studies on fate and behavior in the environment based on a low octanol-water partition coefficient
- 6. new specific rules for adapting for dissociation constant and viscosity
- 7. additional requirements for human health and environmental testing to be performed at appropriately high dose levels
Reference: https://echa.europa.eu/-/upcoming-changes-to-reach-information-requirements