Introduction
Retinoids, derivatives of vitamin A, are widely used in the cosmetic industry due to their proven benefits in improving skin texture, reducing wrinkles, and stimulating cellular renewal. Among the most common are Retinol, Retinyl Palmitate, and Retinyl Acetate. However, their use is strictly regulated in the European Union (EU) to ensure consumer safety. The Commission Regulation (EU) 2024/996, published on 3 April 2024, introduces significant amendments to Regulation (EC) No 1223/2009, establishing new restrictions on the use of these compounds in cosmetic products.
Amendments Introduced by Regulation (EU) 2024/996
Regulation (EU) 2024/996 sets specific limits on the concentration of vitamin A and its derivatives in cosmetic products, based on the recommendations of the Scientific Committee on Consumer Safety (SCCS). The key amendments are as follows:
- Maximum Permitted Concentrations:
- Body lotions: Vitamin A (including Retinol, Retinyl Acetate, and Retinyl Palmitate) must not exceed 0.05% Retinol Equivalent (RE).
- Other leave-on and rinse-off products: A maximum concentration of 0.3% RE is permitted.
- Labelling Requirements:
- Products containing vitamin A must carry a warning informing consumer about the risk of excessive exposure to vitamin A, especially for those already consuming it through diet and supplements. This measure aims to prevent total intake exceeding safe levels.
Rationale Behind the New Restrictions on Cosmetic Retinoids
The Scientific Committee on Consumer Safety (SCCS), in its opinion, concluded that vitamin A is safe at the specified concentrations. However, while the contribution of cosmetic products to total vitamin A exposure is relatively low, there is concern regarding the top 5% of the population with the highest dietary intake of vitamin A. As a result, stricter limits were deemed necessary to protect consumers from the potential effects of hypervitaminosis A, which can have adverse health impacts.
Moreover, the SCCS recommended a specific warning on the labelling of products containing retinoids to inform consumers about the risks associated with prolonged use and concurrent exposure to other vitamin A derivatives (such as dietary supplements).
Other updates include:
- Risk assessment in vulnerable populations: Special attention has been given to the exposure of pregnant and breastfeeding women due to the potential teratogenic risk of retinoids.
• Post-market surveillance and reporting requirements: Manufacturers must implement stricter monitoring to identify and report any adverse reactions related to the use of retinoids in their formulations.
Implications for the Cosmetic Industry
Cosmetic companies must adapt to these new regulations to ensure compliance and product safety. Key actions include:
- Product Reformulation: Ensuring that the concentrations of Retinol, Retinyl Acetate, and Retinyl Palmitate in formulations comply with the new limits.
- Labelling Updates: Including the required warnings regarding vitamin A exposure, providing clear information to consumers.
- Total Exposure Evaluation: Considering the contribution of cosmetic products to the consumer’s total vitamin A intake, particularly in those with high dietary exposure.
- Monitoring and Surveillance: Implementing systems to track and report adverse effects associated with the use of retinoids in cosmetic products.
Conclusion
The implementation of Regulation (EU) 2024/996 reflects the European Union’s commitment to consumer safety regarding the use of retinoids in cosmetic products. The new restrictions and labelling requirements aim to minimise the risks associated with excessive vitamin A exposure. For industry professionals, staying informed and ensuring compliance with these regulations is crucial to maintaining consumer trust and ensuring product safety in the evolving regulatory landscape.