July 24, 2023 – A popular cosmetic ingredient commonly known as ‘Vitamin A’ comprises a group of chemically related compounds, including Retinol and its derivatives. Those substances are widely used in cosmetic products because they help boost collagen production, improving skin texture.
Currently, there are no restrictions on the use of Retinol in the EU Cosmetics Regulation. However, in June 2023, the European Commission notified the World Trade Organisation (WTO) of a draft regulation restricting the use of Retinol, Retinyl Acetate, and Retinyl Palmitate in cosmetic products.
Consumers’ exposure to Vitamin A
Vitamin A is in the spotlight of EU authorities because consumers’ overall exposure from several sources (cosmetics, food, food supplements) may exceed safe levels, i.e., tolerable Upper intake Levels (UL).
In light of this, the European Commission mandated the Scientific Committee on Consumer Safety (SCCS) to evaluate the safety of Vitamin A in cosmetic products. Hence, the SCCS identified the safe limits for the use of Retinol, Retinyl Acetate, and Retinyl Palmitate in cosmetic products. Following the opinion, the European Commission decided to restrict those substances by amending the EU Cosmetics Regulation.
The upcoming restrictions on Retinol
Retinol, Retinyl Acetate, and Retinyl Palmitate will be added to Annex III to the EU Cosmetics Regulation, namely the list of restricted substances. According to the draft regulation, these ingredients must meet the below concentration limits.
In the final regulation, there might be some changes. In particular, the mandatory warning is under discussion. As it is, it might give consumers a wrong message as Vitamin A is generally seen as a substance with no safety risks.
What should beauty brands do?
Are you selling or developing cosmetic products containing Retinol, Retinyl Acetate, or Retinyl Palmitate? It is time to act now.
The European Commission will likely publish the official regulation by the end of 2023. Although the regulation foresees long transition periods for manufacturers to comply with the new restrictions (18 months for new products and 36 months for products already available on the EU market), we invite beauty brands to act now.
As a matter of fact, many safety assessors are already applying the new restrictions in their safety assessments. The SCCS opinion is the latest scientific findings in the matter, and, therefore, safety assessors must consider it in their product evaluation.
Additionally, an early reformulation shows the commitment of your company towards safety.
Contact us if you need help you ensuring the compliance of your cosmetic products in the EU, UK, and US markets.
References:
- European Food Safety Authority. (2022). Guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals. Retrieved on 05/07/2023
- European Commission. (2023). Commission Regulation (EU) …/… of XXX amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Vitamin A, Alpha-Arbutin and Arbutin and certain substances with potential endocrine disrupting properties in cosmetic products. Retrieved on 05/07/2023
- European Commission. (2023). Annex to the Commission Regulation …/… Retrieved on 05/07/2023
- World Trade Organization. (2023). Notification G/TBT/N/EU986. Retrieved on 05/07/2023
- Scientific Committee on Consumer Safety. (2022). Revision of the scientific opinion (SCCS/1576/16) on vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate). Retrieved on 05/07/2023
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