EU Notifies WTO of Draft Regulation Aligning REACH Annex XVII with Updates to CLP's Harmonized List

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May 4, 2021Scott StephensBlog

The European Union (EU) filed draft legislation with the World Trade Organization (WTO) on 23 April 2021 under the Technical Barriers to Trade (TBT) Agreement. This legislation aligns the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation's Annex XVII restrictions with substances recently classified as carcinogens, mutagens, and reproductive toxins (CMRs) in table 3 of Annex VI of the Regulation on the Classification, Labeling, and Packaging of Substances and Mixtures (CLP Regulation).

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The proposed legislation adds 26 category 1B CMRs to appendices 2, 4 and 6 of REACH Annex XVII (i.e., the list of substances subject to marketing and use restrictions). This action is based on the addition of these substances to the CLP's harmonized list, in accordance with the CLP's 15th and 17th adaptations to technical and scientific progress (ATP).

The 15th ATP, Delegated Regulation (EU) 2020/1182, was published in the EU Official Journal on 11 August 2020 and will apply from 1 March 2022.

The 17th ATP, which the EU Commission adopted on 11 March 2021, has not yet been published in the EU Official Journal and, thus, its application date is not yet determined. 

In the EU, all substances classified as 1A and 1B CMRs are subject to the restrictions laid out in REACH Annex XVII, including bans on placing on the market and use for supply to the general public.

When substances are newly classified as 1A/1B CMRs and added to the CLP's harmonized list, they are subsequently added to REACH's appendices 1–6 of Annex XVII. These appendices list individual CMR classified substances according to their category and hazard class: 

  • Appendix 1 - 1A carcinogens
  • Appendix 2 - 1B carcinogens
  • Appendix 3 - 1A mutagens
  • Appendix 4 - 1B mutagens
  • Appendix 5 - 1A reproductive toxins
  • Appendix 6 - 1B reproductive toxins

The appendices correspond to Annex XVII's CMR restriction entries, i.e., 28 (carcinogens), 29 (mutagens) and 30 (reproductive toxins).

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The WTO notification lists the fourth quarter of 2021 as the timeframe for the adoption of the proposed legislation.

REACH Annex XVII restrictions will apply from 1 March 2022 for those substances added per the 15th ATP. For restrictions added per the 17th ATP, they will apply from the date that will be determined once the 17th ATP has been published in the EU Official Journal. 

Interested parties have until 22 June 2021 to submit comments on the draft regulation to the European Commission at grow-eu-tbt@ec.europa.eu.

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