The legislation for cosmetic products in the European Union established measures to assess substances with potential as endocrine disruptors, as indicated in Article 15.4 of Regulation 1223/2009: “4. Where there are Community or international criteria for identifying substances as endocrine disruptors, or no later than 11 January 2015, the Commission shall review the Regulation with regard to substances with endocrine-disrupting properties.”
The planned measures have taken some time to materialize, although we now have Commission Regulation (EU) 2024/996 of 3 April 2024 amending Regulation (EC) No 1223/2009 concerning the use of vitamin A, Alpha-Arbutin and Arbutin, and certain substances with possible endocrine-disrupting properties in cosmetic products. From 1 May 2025, the measure to delete entry 18 of Annex VI will be applicable.
Endocrine disruptors – What do we mean? A brief mention of what is considered as substances with endocrine activity (SAE) by EFSA, those substances that can interact with or interfere with normal hormonal action. When this causes adverse effects, they are called endocrine disruptors.
How did we get here? From the provisions of Regulation (EC) No 1223/2009 and with the work of the SCCS (Scientific Committee on Consumer Safety), steps have been taken to address substances with potential as endocrine disruptors.
In the analysis of the newly approved regulation, it is noted that the use of vitamin A in cosmetic products may lead to overexposure by the population, as indicated by the Scientific Committee on Consumer Safety (SCCS) (2016), as it could exceed the upper limit of consumption established by EFSA (European Food Safety Authority). In this regard, the opinion of the SCCS (2022) on vitamin A is considered, maintaining the safety of vitamin A in cosmetic products, while noting that the overall exposure of consumers may be concerning for those consumers with the highest exposure to vitamin A (the top 5% of the total population) from foods and food supplements.
Furthermore, in recent years, the SCCS has studied some substances with possible endocrine-disrupting properties (“4-Methylbenzylidene Camphor”, “Genistein”, “Daidzein”, “Kojic Acid”, “Triclosan”, and “Triclocarban”), which along with data collected by the European Commission in 2019, have allowed for some conclusions to be drawn and incorporated into Regulation (EU) 2024/996.
The combination of “Alpha-Arbutin” and “Arbutin” with “Hydroquinone” should be kept as low as possible in formulations containing these substances, as stipulated in the new legislation.
The SCCS (2022) observed that there is sufficient evidence that the substance “4-Methylbenzylidene Camphor” can act as an endocrine disruptor, and therefore, there is a potential risk to human health associated with its use. “4-Methylbenzylidene Camphor” is now listed in Annex II as “List of substances prohibited in cosmetic products,” and the entry in Annex VI as “List of permitted UV filters in cosmetic products” will be deleted with effect from 1 May 2025.
The SCCS (2022) concluded that both the substance “Genistein” and the substance “Daidzein” are safe for use in cosmetic products up to a maximum concentration of 0.007% and 0.02%, respectively. Therefore, if these limits are exceeded, there is a potential risk to human health, and they should be limited to a maximum concentration of 0.007% and 0.02%, respectively, to ensure safe use.
Regarding “Kojic Acid,” the SCCS (2022) considers it safe at a maximum concentration of 1%; therefore, this is the limit established to prevent potential risks to human health associated with its use.
For “Triclosan,” the SCCS sets a maximum concentration of 0.3%, in addition to not allowing its use in mouth rinses or toothpaste intended for children under three years of age, and incorporating labeling requirements to enhance consumer protection.
In the case of “Triclocarban,” a similar scenario is proposed, considering a maximum concentration and labeling requirements to increase consumer protection.
Finally, it is important to stay informed about the opinions and rulings of the SCCS that impact legislation on cosmetic products. AINIA will continue to provide updates on the evolution of legislation applicable to cosmetic products.
