In June 2023, the EU Commission notified the WTO of a draft of the regulation, to amend the ingredient restrictions on EU skincare products, such as the use of Vitamin A compounds, including future restrictions on Retinol, Kojic Acid, Daidzein, Genistein, Arbutin and Alpha-Arbutin, 4-Methylbenzylidene Camphor, Triclosan, and Triclocarban.
Vitamin A derivatives, Retinol, Retinyl Acetate and Retinyl Palmitate
The draft outlines prohibitions and future restrictions on retinol on EU skincare products commonly used, including those known as Vitamin A derivatives: Retinol, Retinyl Acetate, and Retinyl Palmitate. These ingredients have skin-conditioning properties and are widely utilized in cosmetic products. Despite rumors of an outright ban, we would like to clarify that, at this time, only usage restrictions have been proposed.
For Retinol, Retinyl Acetate and Retinyl Palmitate the restrictions will vary if the ingredients are used in a body lotion or other products. Body lotions will be allowed to have 0,05 % Retinol Equivalent (RE), and the other leave-on and rinse-off products will be allowed to have 0,3 % RE.
For future restrictions on Retinol, Retinyl Acetate, or Retinyl Palmitate the following wording will be mandatory: ‘Contains Vitamin A-related compounds, which contribute to your daily intake of Vitamin A’.
This proposal stems from the fact that these ingredients have not been previously regulated, to mention a few of them. According to the assessment of the Scientific Committee for Consumer Safety (SCCS), it can be inferred that there is a potential risk to human health associated with the use of Vitamin A in cosmetic products when its concentration exceeds certain levels. Furthermore, a warning must be included to inform consumers who are already exposed to Vitamin A of the possibility of overexposure through dietary sources and dietary supplements through the use of these products containing Vitamin A derivatives.
Currently unregulated ingredients: Alpha-Arbutin and Arbutin
Other ingredients that are included in the new draft are Alpha-Arbutin and Arbutin. These ingredients are commonly recognized for their use in cosmetic products as skin-lightening and conditioning agents. The SCCS concluded that these ingredients were safe individually, but their assessment in combination with other substances in cosmetic products had not been considered, raising concerns.
In this case, there is a difference for products of face use and body use level, allowing Arbutin on face creams up to 7%, Alpha-Arbutin up to 2% on face creams, and 0.5% on body lotions. Hydroquinone levels shall remain as low as possible in formulations containing alpha-arbutin and shall not be higher than the unavoidable trace level.
Paying attention to endocrine disruptors: Genistein and Daidzein, also Kojic Acid
Additionally, the use of potential endocrine disruptors like Genistein and Daidzein, which are used as skin conditioners and antioxidants, and Kojic Acid used as a skin-lightening, whitening, and depigmenting agent, is restricted.
Genistein and Daidzein will not be prohibited, but their use will be limited. When the draft regulation is published, Genistein will be allowed in cosmetic products up to 0.007% and Daidzein will be used up to 0.02%. Regarding Kojic Acid, the substance will be allowed for face and hand products up to 1%, and no other products will contain it.
Changes at Annex V: Preservatives with new restrictions Triclocarban and Triclosan
The SCCS concluded that there is a potential risk to human health associated with the use of the ingredients Triclocarban and Triclosan as preservatives (Annex V) when their concentration exceeds certain levels and when they are used in specific age groups. Triclocarban is also listed in Annex III for uses other than preservatives, but no comments added in this draft.
Triclocarban will be allowed in all cosmetic products up to 0.2%, with the exception of mouthwash. The ingredient must not be used in toothpaste intended for children under 6 years of age, and certain purity criteria should be followed. For toothpaste containing Triclocarban the following labeling is obligatory: ‘Not to be used for children under 6 years of age’.
Triclosan’s situation is a bit different. The substance will be allowed up to 0.3% in certain products such as toothpaste, hand soaps, body soaps /shower gels, deodorants (non-sprayed), face powders and blemish concealers, and nail products for cleaning the fingernails and toenails before the application of artificial nail systems. Any other uses of Triclosan will not be allowed. The ingredient should not be used in toothpaste intended for children under 3 years of age and for toothpaste containing Triclosan the following labelling is obligatory: ‘Not to be used for children under 3 years of age’.
Which ingredient will be forbidden? 4-Methylbenzylidene Camphor
In light of the SCCS assessment, it can be concluded that there is a potential risk to human health associated with the use of the ingredient 4-methylbenzylidene Camphor as a UV filter in cosmetic products. Therefore, this substance should no longer be authorized for use as a UV filter in cosmetic products. To ensure that it is not used for purposes other than a UV filter, which would also pose a potential risk to human health, its use in cosmetic products must be entirely prohibited and added to Annex II of the Regulation, and its entry in Annex VI will be deleted.
How these ingredients will be introduced in the Cosmetic Regulation? Timeline
The European Commission aims to publish the regulation officially in the fourth quarter of 2023. After its publication, the industry will be allowed a reasonable period of time to adjust formulations and comply with the new restrictions.
The proposed dates for compliance with the restrictions and prohibitions vary depending on the ingredients. The products with ingredients to be added to Annex II and thus, prohibited, such as 4-Methylbenzylidene Camphor will have 12 months after the entry into force of the regulation to be placed on the market, and 24 months to be available to the consumers, as this requires the search for new ingredients for the formulations.
Products containing ingredients added to Annex III will have a shorter period, as a reformulation will be required in some cases. Genistein, Daidzein, Kojic Acid, Alpha-Arbutin and Arbutin will have 9 months after the entry into force of the regulation to be placed on the market, and 18 months to be available to the consumers, and Retinol, Retinyl Acetate and Retinyl Palmitate will have a longer period, will have 18 months after the entry into force of the regulation to be placed on the market, and 36 months to be available on the market.
For Triclocarban and Triclosan, already regulated but suffering modifications of the conditions of use, a period of 8 months will be allowed to reformulate after the entry into force of the regulation for the products entering the market, and 17 months to be available on the market.
How can Cosmeservice help you?
Acting promptly demonstrates a commitment to safety and ensures readiness within the specified deadlines. Let us help you navigate the upcoming ingredient restrictions on EU skincare products and share our expertise with you. For further details and information, please do not hesitate to contact us. Our cosmetic regulatory experts’ team is at your disposal. Write to us at firstname.lastname@example.org.
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