BACKGROUND
On April 4, 2024, the European Commission published Commission Regulation (EU) 2024/996. This amendment to the EU Cosmetics Regulation addresses the use of Vitamin A, Alpha-Arbutin, and Arbutin, as well as certain substances with potential endocrine-disrupting properties in cosmetic products.
These regulatory updates align with SCCS opinions issued concerning the safety assessments of those substances as cosmetic ingredients.
The amendment impacts Annexes II (substances prohibited in cosmetics), III (substances that may be used provided they comply with specified restrictions) and V (preservatives allowed in cosmetics).
WHAT’S NEW?
Commission Regulation (EU) 2024/996 enters into force on 23 April 2024, providing for transition periods for the industry to adjust to the updated requirements, modify formulations as needed, and remove non-compliant products from the market, as follows:
Amendments to Annex II (added)
- 3-(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 (added)
- Genistein (maximum concentration of 0,007%)
- Daidzein (maximum concentration of 0,002%)
- Kojic Acid (face and hand products, maximum concentration of 1%)
- Alpha-Arbutin (face cream (maximum concentration of 2%) and body lotion (maximum concentration of 0,5%)
- Arbutin (face cream – maximum concentration of 7%)
From 1 February 2025, cosmetic products containing these substances, 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
a) Body lotion (maximum concentration of 0,05% Retinol Equivalents)
b) Other leave-on and rinse-off products (maximum concentration of 0,3% Retinol Equivalents)
For any cosmetic product containing Retinol, Retinyl Acetate or Retinyl Palmitate the following, labelling is obligatory: ‘Contains Vitamin A. Consider your daily intake before use’.
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. There is a sell-off period until 1 May 2027; from this date cosmetic products containing these substances and not complying with the conditions shall not be made available on the Union market (must be off the shelves).
Amendments to Annex V (replaced)
- Triclocarban (all cosmetic products except mouthwash – maximum concentration of 0,2%)
- Triclosan (Toothpastes; Hand soaps; Body soaps/Shower gels; Deodorants (non-spray); Face powders and blemish concealers; Nail products for cleaning the fingernails and toenails before the application of artificial nail systems – maximum concentration of 0,3%)
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 may continue to be made available (sell-off) until 31 October 2025.
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