July 21, 2021
by Tatjana Benko, senior regulatory specialist, UL
The European Commission has published Regulation (EU) 2021/979 amending Annexes VII to XI to Regulation (EC) No. 1907/2006 (REACH Regulation), which will come into force in January 2022.
Annexes VII–X to REACH Regulation clarify information requirements that companies need to submit in their registration dossiers, depending on the quantity of the substance that is manufactured or imported into the European Union (EU)/European Economic Area (EEA).
Annex VII defines information requirements for substances manufactured or imported in quantities of one tonne or more. The main changes are related to the information requirements for surface tension and water solubility of metals and sparingly soluble metal compounds and in vitro studies for eye irritation.
If your company registers substances manufactured or imported in quantities of 10 tonnes or more, then additional information requirements should be provided in alignment with Annex VIII. The main changes of Annex VIII relate to requirements for in vivo testing of skin and eye irritation and requirements and adaptations for 28 and 90 days repeated dose toxicity studies.
Annex IX defines information requirements for substances manufactured or imported in quantities of 100 tonnes and more. Main changes relate to new specific rules for adaptation of dissociation constant and viscosity. Annex IX will be amended to exclude the waiving of conducting relevant studies on fate and behavior in the environment on the sole basis of a low octanol-water partition coefficient.
If your company registers substances manufactured or imported in quantities of 1000 tonnes or more, then additional information is required in accordance with Annex X. Specific rules for adopting reproductive toxicity studies to better specify cases, where testing is not required, are set out in Annexes IX and X.
Annex XI contains general rules for adapting the standard testing regime set out in Annexes VII to X and explains the standard conditions for testing under REACH. The main changes concern:
- The provisions on the use of existing data
- Weight of evidence
- Grouping of substances — what documentation is required for read-across, including specifically for UVCB substances
ECHA guidance will be updated in allignment with Regulation (EU) 2021/979 and published until the end of 2021.
Recommended action items
- Follow the ECHA website since ECHA will publish more advice in late 2021.
- Align your registration dossier with new REACH registration information requirements, if necessary.
- Regulation (EU) 2021/979
- Regulation (EC) No. 1907/2006 (REACH)
- ECHA Information requirements