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The 2025 edition of Paris Packaging Week!
Monday, June 7, 2021European Commission

Publication of the 3rd Regulation on CMRs

Publication du 3e Règlement CMR

The European Union has just published Regulation 2021/850, the 3rd annual text aiming to ban or regulate substances recently classified as CMR. It confirms the entry of 12 new substances in Annex II (prohibited substances) to the Cosmetics Regulation 1223/2009, and two modifications of Annex III (restricted substances), to add Titanium dioxide and modify the restrictions of Salicylic acid. It will apply from 1 October 2021.

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Article updated on 17 June 2021, to take account of the Corrigendum published in the Official Journal of the European Union L 214/68, specifying the entry number of Titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm.

This Regulation deals with substances classified as CMR by Regulation 2020/217 (14th ATP to CLP), which will apply from 1 October 2021.

Key points of Regulation 2021/850

• An entry is added to Annex III (restricted substances) to the Cosmetics Regulation to specify new conditions of use for Titanium Dioxide.
• 12 substances are added to Annex II (prohibited substances).
• The wording of the conditions of use of Salicylic Acid, established by the previous CMR Regulation, is modified for more clarity.
• The text enters into force on the same date as the ATP it transposes, i.e. 1 October 2021.

The “Whereas” of Regulation 2021/850

  1. Regulation (EC) No.1272/2008 of the European Parliament and of the Council provides for a harmonised classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on an opinion prepared by the Committee for Risk Assessment of the European Chemicals Agency. The substances are classified as CMR substances …

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