REACH: EU Plans Changes on Information Requirements for Registration Dossiers
The EU plans to modify Annexes VII–XI that define the standard information requirements for substances manufactured or imported in quantities of 1 ton or more (Annex VII), 10 tons or more (Annex VIII), 100 tons or more (Annex IX), 1,000 tons or more (Annex X). Annex XI contains general rules for adaption of the standard testing regime set out in annexes VII to X.
With these changes, the EU seeks to make individual requirements more precise and thereby create legal security. The changes involve some 23 more or less comprehensive modifications. They cover information on physicochemical and toxicological chemical properties. The topics include data on:
- Surface tension
- Solubility of metals and metal compounds
- Studies that determine eye irritations caused by chemicals
- Clarification of the cases in which a study must be undertaken
The EU expressly notes that the modifications may force companies to update their registration dossiers. Companies must be granted enough time to do so.
The modifications take effect six months after they go into force. Comments on the draft can be made until November 16.
Together with the Action Plan (Actions 5 and 6) formulated by the ECHA, the EU agreed to modify the
information requirements and adjust the Annexes accordingly. The modifications were agreed upon at a meeting of the REACH-CLP working group (CARACAL) in July 2019.
We can submit a registration according to Article 10 and Article 18 (REACH) and handle the duties of a sole representative according to Article 8. Please contact us at reach@kft.de.
