New cosmetic regulation

New cosmetic regulation on Vitamin A, Alpha-Arbutin, Arbutin and potential endocrine disruptors

BIORIUS Information Letter 127 (follow-up of Information Letter 117):

Commission Regulation (EU) 2024/996, in regard to the use of Vitamin A, Alpha-Arbutin, Arbutin and certain substances with potential endocrine disrupting properties.

Commission Regulation (EU) 2024/996, amending the EU cosmetic Regulation 1223/2009, has been published in the EU Official Journal on April 4th.

This regulation amends annexes of EU Cosmetic Regulation 1223/2009, to align them with Scientific Committee on Consumer Safety (SCCS) opinions, for the following substances:

Compared to our Information Letter 117, implementation deadlines shifted due to delayed publication of the regulation, and the warning on Retinol, Retinol Acetate and Palmitate has been slightly reworded into Contains Vitamin A. Consider you daily intake before use.

The new restrictions of this regulation (EU) 2024/996 are detailed and compared to the former situation, in the following annexes:

Addition to Annex II – Forbidden substances:

INCI nameCAS numberFuture restrictionCurrent situation
4-METHYLBENZYLIDENE CAMPHOR36861-47-9 / 38102-62-4ForbiddenAllowed as UV filter at 4% (Annex VI/18)

Addition to Annex III – Allowed substances under certain conditions:

INCI nameCAS numberFuture restrictionCurrent situation
GENISTEIN446-72-0Max. 0.007%Not regulated
DAIDZEIN486-66-8Max. 0.02%Not regulated
KOJIC ACID501-30-4Max. 1% in face and hand products onlyNot regulated
ALPHA-ARBUTIN *84380-01-8Face cream max. 2%
Body lotion max. 0.5%
Not regulated
ARBUTIN *497-76-7Max. 7% in face cream onlyNot regulated
RETINOL   RETINYL ACETATE RETINYL PALMITATE11103-57-4 / 68-26-8 127-47-9 79-81-2  – Body lotion: max. 0.05% Retinol Equivalent (RE)
– Other leave-on and rinse-off products: max. 0.3% RE
Obligatory labelling for any cosmetic product containing one of these ingredients: ‘Contains Vitamin A. Consider you daily intake before use’.
Not regulated

*Hydroquinone levels shall remain as low as possible in formulations containing this ingredient and shall not be higher than the unavoidable trace level.

Modification of Annex V – Allowed preservatives:

INCI nameCAS numberFuture restrictionCurrent situation
TRICLOCARBAN101-20-2Max. 0.2% in all cosmetic products with the exception of mouthwash. Purity criteria:
3,3′,4,4′-
Tetrachloroazobenzene ≤ 1 ppm 3,3′,4,4′-
Tetrachloroazoxybenzene ≤ 1 ppm
Not to be used in toothpaste intended for children under 6 years of age. Obligatory labelling for toothpaste containing Triclocarban: ‘Not to be used for children under 6 years of age’.
For uses other than preservative, see Annex III/100.
Max. 1.5% in rinse-off products. Purity criteria:
3,3′,4,4′-Tetrachloroazobenzene ≤ 1 ppm
3,3′,4,4′-Tetrachloroazoxybenzene ≤ 1 ppm. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.  For uses other than preservative, see Annex III/100 (Annex V/23)
TRICLOSAN3380-34-5Max. 0.3% in toothpastes; hand soaps ; body soaps/shower gels; deodorants (non-spray); face powders and blemish concealers; nail product for cleaning the fingernails and toenails before the application of artificial nail systems.
Not to be used in toothpaste intended for children under 3 years of age.
Obligatory labelling for toothpaste containing Triclosan: ‘Not to be used for children under 3 years of age’.
Max. 0.3% in toothpastes; hand soaps ; body soaps/shower gels; deodorants (non-spray); face powders and blemish concealers; nail product for cleaning the fingernails and toenails before the application of artificial nail systems.
Max. 0.2% in Mouthwashes (Annex V/23)

Transition periods

Ban of 4-Methylbenzylidene Camphor:

  • Products placed on the EU market must comply with this regulation from May 1st, 2025.
  • Products not compliant with this regulation must have been withdrawn from the EU market at latest on May 1st, 2026.

Restrictions of Genistein, Daidzein, Kojic Acid, Alpha-Arbutin and Arbutin:

  • Products placed on the EU market must comply with this regulation from Feb 1st, 2025.
  • Products not compliant with this regulation must have been withdrawn from the EU market at latest on Nov 1st, 2025.

Restrictions of Retinol, Retinyl Acetate and Retinyl Palmitate:

  • Products placed on the EU market must comply with this regulation from Nov 1st, 2025.
  • Products not compliant with this regulation must have been withdrawn from the EU market at latest on May 1st, 2027.

New restrictions of Triclosan and Triclocarban used as preservatives:

  • Products compliant with the former restriction on Triclosan/Triclocarban can be placed on the EU market until Dec 31st, 2024.
  • Products compliant with the former restriction on Triclosan/Triclocarban can be made available to the consumer until Oct 31st, 2025 providing that they have been placed on the market before Dec 31st, 2024. After Oct 31st, 2025, products not compliant with this new restriction must have been withdrawn from the EU market.

We hope that this will be of help and stay at your disposal for any questions related to this topic. Should you have any question, please, feel free to contact your dedicated Customer Relationship Manager.

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Author

  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.

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