EU - Amendment of Annex II to REACH Regulation

​Annex II to Regulation (EC) No 1907/2006 lays down requirements for the compilation of safety data sheets, used to provide information on chemical substances and mixtures in the Union.

As of 1 January 2020, Commission Regulation (EU) 2018/1881 amending Annexes I, III and VI to XII to Regulation (EC) No 1907/2006 shall apply. Regulation (EU) 2018/1881 introduces specific requirements for nanoforms of substances. As information related to those requirements is to be included in the safety data sheets, Annex II to Regulation (EC) No 1907/2006 should be modified accordingly.​

The Commission Communication of 7 November 2018 ‘Towards a comprehensive European Union framework on endocrine disruptors’ indicates that the Commission is assessing how to improve the communication through the supply chain for endocrine disruptors under Regulation (EC) No 1907/2006 in the context of the work on safety data sheets. A number of specific requirements for safety data sheets have been identified as relevant for substances and mixtures with endocrine disrupting properties and Annex II of this Regulation should therefore be modified accordingly.

Specific concentration limits, multiplying factors and acute toxicity estimates set in accordance with Regulation (EC) No 1272/2008, are relevant for the safe use of substances and mixtures, and should therefore be provided in safety data sheets, if available.

Requiring economic operators who have already compiled safety data sheets, to update them immediately in accordance with the provisions of this Regulation would impose a disproportionate burden on them. Operators should rather be allowed to continue providing safety data sheets in accordance with Regulation (EC) No 1907/2006, as amended by Commission Regulation (EU) 2015/830 for a certain period. By way of derogation from Article 3, safety data sheets not complying with the Annex to this Regulation may continue to be provided until 31 December 2022.​