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mendments Made To (Ec) No 1223/2009 Cosmetic Regulation Annex-II, Annex-III, Annex-V, Annex VI

Commission Regulation (EU) 2024/996 was published by the Official Journal of the European Union on 4 April 2024. This draft regulation was notified to WTO on June 8, 2023; It is intended for the use of Vitamin A, Alpha-Arbutin and Arbutin and some substances with endocrine disrupting properties in cosmetic products.

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

The changes made to the EU Cosmetics Regulation are as follows:

  • Cosmetics Regulation 1223/2009 Annex II:

The use of 3-(4′-methylbenzylidene)-camphor is prohibited and added to Annex II.

CHEMICAL NAME/INCI CAS No EC No
3-(4′-methylbenzylidene)-camphor; [INCI: 4-Methylbenzylidene Camphor] 36861-47-9/38102-62-4 253-242-6/-

*As of May 1, 2025, products containing this substance will not be offered to the Union market.

*As of May 1, 2026, cosmetic products containing this substance will not be available for sale in the Union market..

  • Cosmetics Regulation 1223/2009 Annex III:

The following ingredients can be used within the limits specified in the ready-to-use formulation.

INCI Adı CAS no Product type, body parts Maximum allowed concentration Other Directions for use and Warnings
Genistein (*) 446-72-0 0,007 %
Daidzein (*) 486-66-8 0,02 %
Kojic Acid (*) 501-30-4 Yüz ve el
ürünleri
%1
Alpha -Arbutin (*) 84380-01-8 (a) Face cream
(b) Body lotion
(a) %2
(b) %0,5
Hydroquinone levels in formulations containing Alpha-Arbutin should be kept as low as possible and not higher than the unavoidable trace level.
Arbutin (*) 497-76-7 Face cream %7 Hydroquinone levels in formulations containing arbutin should be kept as low as possible and not higher than the unavoidable trace level.

*As of February 1, 2025, cosmetic products containing the above substances and not complying with the conditions specified in Annex III will not be offered to the Union market.

*As of November 1, 2025, cosmetic products containing the above substances and not complying with the conditions specified in Annex III will not be available for sale in the Union market.

INCI Adı CAS no Product type, body parts Maximum allowed concentration Other Directions for use and Warnings
Retinol (*)

Retinyl Acetate (*)

Retinyl Palmitate (*)

11103-57-4/
68-26-8

127-47-9

79-81-2

(a) Body lotion

(b) diğer durulanan
ve durulanmayan ürünler

(a) %0,05
Retinol Equivalent (RE)
(b) %0,3 RE
The following labeling is mandatory for any cosmetic product containing Retinol, Retinyl Acetate or Retinyl Palmitate: "Contains vitamin A. Consider your daily intake of vitamin A before use"

*As of 1 November 2025, cosmetic products containing Retinol, Retinyl Acetate and/or Retinyl Palmitate and not complying with the conditions specified in Annex III will not be offered to the Union market.

*As of May 1, 2027, cosmetic products containing Retinol, Retinyl Acetate and/or Retinyl Palmitate and that do not comply with the conditions specified in Annex III will not be available for sale in the Union market.

  • Cosmetics Regulation 1223/2009 Annex-V:

Annex V – Entries 23 and 25 in the List of permitted preservatives in cosmetic products have been replaced as follows:

INCI Adı CAS no Product type, body parts Maximum allowed concentration Other Directions for use and Warnings
Triclocarban (*),(**) 101-20-2 All cosmetic products except mouthwash. 0,2 % Saflık kriterleri:
3,3′,4,4′-
Tetrachloroazobenz
ene ≤ 1 ppm

3,3′,4,4′
Tetrachloroazoxybenzene ≤ 1 ppm

It should not be used in toothpastes intended for children under 6 years of age.

The following labeling is mandatory for toothpaste containing triclocarban: 'Not for use by children under 6 years'.
Triclosan (*) 3380-34-5 Toothpastes; Hand soaps; Body soaps/Shower gels; Deodorants (non-spray); Face powders and spot concealers; Nail products for cleaning fingernails and toenails before applying artificial nail systems; 0,3 % It should not be used in toothpastes intended for children under 3 years of age. The following labeling is mandatory for toothpaste containing triclocarban: 'Not to be used for children under 3 years of age'

** The use of this ingredient in cosmetic products for other purposes should be limited to a maximum concentration of 1.5% in rinsed products.

*As of 31 December 2024, cosmetic products containing Triclosan and/or Triclocarban and not complying with the conditions specified in Annex V will not be offered to the Union market.

*As of 31 October 2025, cosmetic products containing Triclosan and/or Triclocarban and not complying with the conditions specified in Annex V will not be available for sale in the Union market.

  • Cosmetics Regulation 1223/2009 Annex VI:

Annex VI/18 (4-Methylbenzylidene Camphor) has been deleted from the list of UV filters permitted in cosmetic products.

Reference:  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202400996