On 3 April 2024, Regulation (EU) 2024/996 was published in the Official Journal of the European Union amending Regulation (EC) No 1223/2009 regarding the use of Vitamin A compounds, Arbutin, Alpha-Arbutin, Triclosan, Triclocarban, Kojic Acid, Daidzein, Genistein, and 4-Methylbenzylidene Camphor.
Specifically, based on the latest scientific opinions by the Scientific Committee on Consumer Safety (SCCS), European Commission published the regulation amending Annexes II, III, V, and VI to Regulation (EC) No 1223/2009.
Amending Annex II
In Annex II-List of substances prohibited in cosmetic products, the following entry is added:
| Reference number | Chemical name/ INCI | CAS no | EC no |
| ‘1730 | 3-(4'-methylbenzylidene)- camphor; [INCI: 4-Methylbenzylidene Camphor] | 36861-47-9/38102-62-4 | 253-242-6/- |
Timeline
- From 1 May 2025 products containing that substance shall not be placed on the Union market.
- From 1 May 2026 cosmetic products containing that substance shall not be made available on the Union market.
Amending Annex III
In Annex III-List of substances which cosmetic products must not contain except subject to the restrictions laid down, the following entries are added:
| Reference number | INCI name | CAS no | Product type, body parts | Maximum concentration in ready use preparation | Other | Wordings of conditions of use and warnings |
| ‘373 | Genistein (*) | 446-72-0 | - | 0,007 % | - | - |
| 374 | Daidzein (*) | 486-66-8 | - | 0,02 % | - | - |
| 375 | Kojic Acid (*) | 501-30-4 | Face and hand products | 1 % | - | - |
| 376 | Retinol (**) Retinyl Acetate (**) Retinyl Palmitate (**) | 11103-57-4/ 68-26-8 127-47-9 79-81-2 | (a) Body lotion (b) other leave-on and rinse-off products | (a) 0,05 % Retinol Equivalent (RE) (b) 0,3 % RE | - | 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’. |
| 377 | Alpha -Arbutin (*) | 84380-01-8 | (a) Face cream (b) Body lotion | (a) 2 % (b) 0,5 % | Hydroquinone levels shall remain as low as possible in formulations containing alpha-Arbutin and shall not be higher than the unavoidable trace level. | - |
| 378 | Arbutin (*) | 497-76-7 | Face cream | 7 % | Hydroquinone levels shall remain as low as possible in formulations containing Arbutin and shall not be higher than the unavoidable trace level. | - |
Timeline
(*)
- From 1 February 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market.
- From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.
(**)
- From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market.
- From 1 May 2027 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.
Amending Annex V
In Annex V-List of preservatives allowed in cosmetic products, entries 23 and 25 are replaced by the following:
| Reference number | INCI name | CAS no | Product type, body parts | Maximum concentration in ready use preparation | Other | Wordings of conditions of use and warnings |
| '23 | Triclocarban (*), (**) | 101-20-2 | All cosmetic products, with the exception of mouthwash. | 0,2 % | Purity criteria: 3,3',4,4'- Tetrachloroazobenz ene ≤ 1 ppm 3,3',4,4' Tetrachloroazoxybenzene ≤ 1 ppm Not to be used in toothpaste intended for children under 6 years of age. | For toothpaste containing Triclocarban the following labelling is obligatory: ‘Not to be used for children under 6 years of age’. |
| '25 | Triclosan (*) | 3380-34-5 | Toothpastes; Hand soaps; Body soaps/Shower gels; Deodorants (nonspray); Face powders and blemish concealers; Nail products for cleaning the fingernails and toenails before the application of artificial nail systems; | 0,3 % | Not to be used in toothpaste intended for children under 3 years of age. | For toothpaste containing Triclosan the following labelling is obligatory: ‘Not to be used for children under 3 years of age’. |
Timeline
(*)
- Cosmetic products containing that substance 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, continue to be made available on the Union market until 31 October 2025.
(**)
For uses other than preservative, see Annex III, No 100
Amending Annex VI
In Annex VI-List of UV filters allowed in cosmetic products, entry 18 is deleted.