EU - Amendment on Annex VII to XI to REACH Regulation

Annex VII to XI to Regulation (EC) No 1907/2006 (REACH Regulation) set out standard information requirements for substances manufactured or imported in quantities of 1 tonne or more, 10 tonnes or more, 100 tonnes or more and 1000 tonnes or more, respectively. Annex XI to that Regulation sets out the general rules for adaptation of the standard testing regime set out in Annexes VII to X.

The EU Commission and the European Chemicals Agency (ECHA) amend certain provisions in the Annexes to REACH to provide more clarity on the obligations of registrants and on the role and responsibilities of ECHA under Title II and VI of that Regulation. The reason is that the introductory texts of Annexes VII to X to REACH are insufficient, particularly the information on the physicochemical properties of the substance and the toxicological information.

Other amendments in Annex IX to XI, e.g. the waiving options on the basis of classification, the general rules for adoptation of the standard testing regime, etc are also modified to increase the clarity.