New amendment to EU Cosmetics Regulation: Retinol and other substances banned or restricted in cosmetics

April 4, 2024. On April 4, 2024, the Official Journal of the European Union published Commission Regulation (EU) 2024/996. The amendment to the EU Cosmetics Regulation addresses the use of Vitamin A, Alpha-Arbutin, and Arbutin and certain substances with potential endocrine-disrupting properties in cosmetic products. In June 2023, the EU notified the World Trade Organisation (WTO) of this draft regulation.

New restricted and banned substances

The new addition to Annex II (list of substances prohibited in cosmetics) is 3-(4′-methylbenzylidene)-camphor [INCI: 4-Methylbenzylidene Camphor]. From 1 May 2025, products containing this substance shall not be placed on the Union market. From 1 May 2026, cosmetic products containing this substance shall not be made available on the Union market.

Amendments to Annex III: restricted substances

Annex III (list of substances which cosmetic products must not contain except subject to the restrictions laid down) is amended to include:

  • Genistein
  • Daidzein
  • Kojic Acid
  • Alpha-Arbutin
  • Arbutin

From 1 February 2025, cosmetic products containing these substances above, and not complying with the conditions specified in Annex III shall not be placed on the Union market. From 1 November 2025, cosmetic products containing these substances and not complying with the conditions shall not be made available on the Union market.

  • Retinol
  • Retinyl Acetate
  • Retinyl Palmitate

From 1 November 2025, cosmetic products containing Retinol, Retinyl Acetate, and Retinyl Palmitate, and not complying with the conditions specified in Annex III shall not be placed on the Union market. From 1 May 2027, cosmetic products containing these substances and not complying with the conditions shall not be made available on the Union market.

Amendments to Annex V and Annex VI: preservatives and UV filters

Annex V (list of preservatives allowed in cosmetic products) is updated in regards to:

  • Triclocarban
  • Triclosan

Cosmetic products containing these substances that do not comply with the conditions may, provided that they comply with the conditions applicable on 23 April 2024, be placed on the Union market until 31 December 2024 and, if they have already been placed on the market before that date, they continue to be made available on the Union market until 31 October 2025.

Lastly, Annex VI (list of UV filters allowed in cosmetic products) is amended to exclude entry 18 (4-Methylbenzylidene Camphor).

The Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union (23 April 2024).

Contact us if you need help you ensuring the compliance of your cosmetic products in the EU, UK, and US markets.

 

References:

European Commission. (2024). Commission Regulation (EU) 2024/996 of 3 April 2024 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Vitamin A, Alpha-Arbutin and Arbutin and certain substances with potential endocrine disrupting properties in cosmetic products. Retrieved on 04/04/2024.

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