The European Commission has revised certain information requirements for registering chemicals under REACH. The changes will start to apply in early 2022 and companies are advised to start preparing. The European Chemicals Agency (ECHA) is to publish more advice in late 2021.
The update of the REACH annexes clarifies the information companies need to submit in their registrations and makes the ECHA’s evaluation practices more transparent and predictable.
The law comes into effect on 8 July 2021 and will apply from 8 January 2022. The main changes concern the following:
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
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.
Additional requirements for human health and environmental testing to be performed at appropriately high dose levels.
ECHA is updating its guidance materials and will publish more advice to registrants towards the end of 2021.
The Commission Regulation of 17 June 2021 amending REACH annexes is available here.
European Chemicals Agency June 2021