European Commission adopts ‘clarifications’ to REACH information requirements

REACH (EC 1907/2006) is a regulation aimed at improving the protection of human health and the environment through a better and earlier identification of the intrinsic properties of chemical substances. (Source: EC)

The EC clarification and amendment apply to Annexes VI to X of the REACH regulation. It helps clear the unclear and inconsistent words in these annexes. The draft amendment says:

• Regulation (EC) No 1907/2006 lays down specific registration duties and obligations on manufacturers, importers, and downstream users to generate data on substances they manufacture, import, or use, assess the risks related to those substances, develop and recommend appropriate risk management measures.
• Annex VI to Regulation (EC) No 1907/2006 sets out information requirements referred to in Article 10, point (a)(i) to (v) and (x) of that Regulation. Annexes VII to X of that Regulation set out standard information requirements for manufactured or imported substances in various tonnes.
• In June 2019, EC and ECHA agreed that specific information requirements in the Annexes to Regulation (EC) No 1907/2006 should be amended to provide more clarity on the obligations of registrants regarding the submission of information.
• The requirements laid down in Annex VI, sections 1 & 2 to Regulation (EC) No 1907/2006 will be amended. This is about the requirements for general registrant information and substance identification information.
• The specific rules for adaptation from the standard information requirements set out in Annexes VII to X to Regulation (EC) No 1907/2006 will be amended.
• Specific rules for adaptation from the standard information laid down in Annex VII to Regulation (EC) No 1907/2006 on mutagenicity and aquatic toxicity will be amended to ensure clarity and valuable information.
• The information requirements in Annex VIII Regulation (EC) No 1907/2006 on testing for mutagenicity, reproductive toxicity, and ecotoxicological information will be amended to clarify the obligations of registrants.
• Information requirements on testing for mutagenicity in Annex IX to Regulation (EC) No 1907/2006 should be amended.
• Annex X to Regulation (EC) No 1907/2006 should be amended to clarify specific information requirements on mutagenicity, developmental and reproductive toxicity, and ecotoxicological information.

Click on this to get a copy of the complete draft regulation and amended annexes. These amendments imply that some registration dossiers will have to be updated; therefore, a specified time (to be decided later) to apply them might be deferred.

The feedback period for this draft regulation is opened until the 19th of July 2021 (Midnight, CET). For the feedback to be taken into account for finalising the draft act, it must adhere to feedback rules, and you can find them here.