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Regulation (EU) 2024/996 of the European Commission, of 04/03/2024, amends Regulation (EC) No. 1223/2009 of the European Parliament and of the Council with regard to the use of vitamin A as it has potential disruptive properties of the endocrine system in cosmetic products.
The new menu of Regulation (EC) No. 1223/2009 adds the substances Retinol (CAS# 11103-57-4/ 68-26-8), Retinyl Acetate (CAS# 127-47-9) and Retinyl Palmitate (CAS# 79-81-2 ) in Annex III/376 of the regulation, allowing use in body lotions up to a maximum concentration of 0.05% and 0.3% for other leave-on and rinse-off products.
Furthermore, for any cosmetic product that contains Retinol, Retinol Acetate or Retinol Palmitate, it is mandatory to add the following phrase to the label: “Contains Vitamin A. Consider your daily intake before use”.
This Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union 04/04/2024.
ELI: http://data.europa.eu/eli/reg/2024/996/oj
Substances with CAS numbers 11103-57-4/68-26-8, CAS 127-47-9 and CAS 79-81-2,
which were given the names “Retinol”, “Retinol Acetate” and “Retinol Palmitate” respectively under the International Nomenclature of Cosmetic Ingredients (INCI) and which are collectively known as Vitamin A, were not regulated by the Regulation (EC ) no. 1223/2009. These substances are used in cosmetic products as skin conditioning agents.
The Scientific Committee for Consumer Safety (SCCS) concluded, in its opinion of 24 and 25 October 2022, that vitamin A is safe in cosmetic products up to concentrations of 0.05% retinol equivalent (RE) in body lotions, and 0.3% of RE in other leave-on and rinse-off products. The SCCS added that the total daily amount of vitamin A from cosmetic products used daily by the individual, although low, is cumulative and may be of concern to consumers with greater exposure to vitamin A (5 % of the total population) from foods and dietary supplements.
In light of the SCCS opinion, there is a potential risk to human health from the use of vitamin A in cosmetic products when its daily exposure exceeds certain levels. Furthermore, a warning should be included to inform consumers already exposed to vitamin A from foods and dietary supplements about the possibility of overexposure due to the use of such compounds.
The industry must be given reasonable periods of time to adapt to the new requirements, in particular by making the necessary adjustments to product formulations, in order to ensure that only cosmetic products that comply with the new requirements are placed on the market. The industry must also be given a reasonable period of time to recall cosmetic products that do not meet these requirements.
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