Cosmetic legislation is not slowing down. We have further changes in cosmetic law. This time it is about the long-discussed and long-awaited new rules of use of retinoids and many other substances, including: genistein, daidzein, kojic acid, alpha-arbutin, arbutin, 3-(4′-methylbenzylidene)-camphor, triclocarban and triclosan. This means that as many as 11 ingredients will be subject to new restrictions on the use in cosmetics under Commission Regulation (EU) 2024/996 of 3 April 2024. To learn more details, please read the entry.
Retinoids
Retinoids, specifically: Retinol, Retinyl Acetate and Retinyl Palmitate, have been included in Annex III of the Cosmetics Regulation, i.e. the list of substances subject to restrictions of use in cosmetics. We know that retinoids are extremely effective ingredients with multidirectional effects, including: antioxidant, anti-acne and anti-wrinkle. However, side effects from the use of these substances are known, and the main concerns refer to the documented teratogenic effects due to excessive consumption of vitamin A. Therefore, retinol and other retinoids are classified as Repr. 1B, H360 – may damage fertility or the unborn child.
The Scientific Committee on Consumer Safety (SCCS) in its opinion SCCS/1576/16 concluded that the use of vitamin A in cosmetics is safe, but emphasized that the general population exposure to retinoids may exceed the upper intake level established by the European Food Safety Authority. In 2022, the SCCS Committee adopted revised opinion SCCS/1639/21, which established safe levels for the use of vitamin A in cosmetic products. It was further noted that although the contribution of retinoids from cosmetics to overall exposure is low, this may be of concern for consumers most exposed to vitamin A from food and dietary supplements.
Therefore:
- Retinol,
- Retinyl Acetate,
- Retinyl Palmitate
have been entered in position 376 of Annex III.
The new rules of their application are as follows:
- Maximum permitted concentrations:
- In body lotions = 0.05% retinol equivalent (RE);
- In other leave-on and rinse-off products = 0.3% RE;
- Mandatory labeling: “Contains Vitamin A. Consider your daily intake before use.”
The changes will apply from November 1, 2025 (ban on placing cosmetic products that do not meet the new requirements on the market in the EU). However, starting from May 1, 2027, we will have the prohibition of making such products available on the market.
Alpha-arbutin and arbutin
Alpha-Arbutin and Arbutin are substances used as skin whitening and conditioning agents. The concern with these substances is that they release hydroquinone from their molecules. And hydroquinone is classified as a cat. carcinogen. 2 and it is on the list of prohibited substances (Annex II), except for item 14 in Annex. III, where it is only permitted under certain conditions in artificial nail products. SCCS prepared a total of 3 opinions on alpha-arbutin and arbutin: SCCS/1552/15, SCCS/1550/15 and SCCS/1642/22. Based on these opinions, safe concentrations for the use of Alpha-Arbutin and Arbutin in cosmetics were developed and the need to monitor the level of hydroquinone so that it is not higher than the inevitable trace level was emphasized.
Therefore, Annex III of the Cosmetics Regulation will include:
- Item 377 – Alpha-Arbutin;
- Item 378 – Arbutin.
Their maximum permitted concentrations are:
- For Alpha-Arbutin:
a) Face cream = 2%;
b) Body lotion = 0.5%;
- For Arbutin:
- Face cream = 7%.
Other requirements for both Alpha-Arbutin and Arbutin are: Hydroquinone levels shall remain as low as possible in formulations containing alpha-Arbutin/ Arbutin and shall not be higher than the unavoidable trace level.
We have time to adapt to the new rules for the use of alpha-arbutin and arbutin until: February 1, 2025 – for placing products on the market in the EU under the “old rules” and until November 1, 2025 – for making them available on the market.
Genistein, daidzein and kojic acid
Genistein and Daidzein are used in cosmetic products as skin conditioning ingredients, skin protective and antioxidant, while Kojic Acid is known as a skin brightening, whitening and depigmenting agent. However, the substances mentioned above pose a potential risk to human health due to possible disruption of the endocrine system functioning (so-called ED substances – Endocrine Disruptors).
Therefore, SCCS has developed opinions (SCCS/1641/22 and SCCS/1637/2) on the safety of these compounds, where, taking into account the potential health risk, it has determined safe levels of use of Genistein, Daidzein and Kojic Acid in cosmetics. The new amendment to the Cosmetics Regulation therefore introduces further substances into Annex III:
- Genistein – pos. 373: maximum allowed concentration = 0.007%,
- Daidzein – pos. 374: maximum allowed concentration = 0.02%,
- Kojic Acid – pos. 375: maximum allowed concentration = 1%, can ONLY be used in face and hand products.
The transitional periods are analogous to those for alpha-arbutin and arbutin, i.e.: February 1, 2025 – for placing products on the market and November 1, 2025 – for making them available on the market.
4-Methylbenzylidene Camphor
4-Methylbenzylidene Camphor is a substance that has previously been used as a UV filter and it was included in item 18 of Annex VI, i.e. in the list of permitted sunscreen substances. However, it turned out that it was one of ED ingredients. In opinion SCCS/1640/21, the SCCS Committee noted that there is evidence of an effect of 4-Methylbenzylidene Camphor on the thyroid and estrogen systems and that it is not possible to define a maximum concentration for the safe use of this substance. The use of 4-Methylbenzylidene Camphor in cosmetic products will therefore be banned. It will be included in point 1730 of Annex II of the Cosmetics Regulation. The ban will apply from May 1, 2025 to placing cosmetic products containing this substance on the market in the EU, and from May 1, 2026 – to making such cosmetics available on the market.
Triclosan and Triclocarban
And finally, Triclosan and Triclocarban, which were also suspected of having an adverse effect on the endocrine system. So far, these ingredients have been used as preservatives (Annex V of the Cosmetics Regulation, item 25 for triclosan and item 23 for triclocarban). In the light of scientific opinion SCCS/1643/22, it was concluded that the use of Triclosan and Triclocarban in cosmetic products under the current authorized conditions poses a potential risk to human health.
Therefore, changes have been made to the conditions of use of triclosan. The possibility of using it in mouthwashes has been deleted, and a ban on its use in toothpastes for children under 3 years of age has been added. Currently, Triclosan will be subject to the following restrictions (item 25, Annex V):
- Products in which it will be allowed:
- Toothpastes;
- Hand soaps;
- Bath soaps/shower gels;
- Deodorants (non-sprays);
- Facial powders and blemish concealers;
- Nail products for cleaning the fingernails and toenails before the application of artificial nail systems;
- Maximum allowed concentration = 0.3%;
- In addition, triclosan will not be allowed to be used in toothpastes intended for children under 3 years of age;
- The following labeling is mandatory for toothpastes containing Triclosan: “Not to be used for children under 3 years of age”.
On the other hand, Triclocarban (item 23, Annex V) can be used in all cosmetic products, except for mouthwash in a maximum concentration 0.2%. The existing regulations did not specify the type of permitted products in which Triclocarban could be used as a preservative.
The purity criteria for triclocarban have remained unchanged, i.e.:
- 3,3′,4,4′-tetrachloroazobenzene ≤ 1 ppm;
- 3,3′,4,4′-tetrachloroazoxybenzene ≤ 1 ppm.
Additionally, the following restrictions have been added:
- “Not to be used in toothpaste intended for children under 6 years of age.”;
- The following labeling is mandatory for toothpaste containing Triclocarban: “Not to be used for children under 6 years of age.”
It is worth recalling that Triclocarban is also included in entry 100 of Annex III to the Cosmetics Regulation, where it is permitted for purposes other than inhibiting the growth of microorganisms in rinse-off products at a maximum concentration of 1.5%. And this record will not change.
For triclosan and triclocarban, the change dates will be as follows: 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.
Summary
I hope you’ve reached the end of the post. Ah, a lot of changes. A lot of changes, because they will concern as many as 11 ingredients: Retinol, Retinyl Acetate, Retinyl Palmitate, Alpha-Arbutin, Arbutin, Genistein, Daidzein, Kojic Acid, 4-Methylbenzylidene Camphor, Triclosan and Triclocarban. If you would like to read the new regulation, you can find it here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202400996
New rules for the use of retinoids and… more Read More »
