Cosmetic Regulatory Changes You Should Be Aware of

The following EU cosmetic regulation changes are likely to impact clinics and they should consider these changes when purchasing future skincare products.

There is no need for immediate action but the following should be considered and included in clinic strategy decision-making.

The regulations do not impact prescription-only medication or medical devices and apply only to cosmetic preparations.

It is worth noting there is no regulatory category for the following terms often used in marketing:

• Cosmeceutical
• Medical Grade Skincare
• Clinic Dispensed Skincare
• Dr Led Skincare etc

The regulations affect a core ingredient Vitamin A or Retinol and include Retinyl Palmitate and Retinyl Acetate.

The scope does not include other forms of Vitamin A such as Retinyl Retinoate and Retinoic Acid therefore these ingredients will NOT be allowed to be used once the regulation comes into law, in the EU at least.

Whilst the regulation is likely to take effect in the EU, there will be a transition period and the UK is likely to follow suit in line with the EU or shortly after.

The SCCS (A European body) for the Scientific Committee on Consumer Safety mirrored in the UK by OPSS, Office for Product Safety and Standards, has recently published a revision to the scientific opinion on the above Vitamin A derivatives.

The SCCS concludes the following:

1. In light of the data provided, does the SCCS consider that the contribution of cosmetic products among the overall/total exposure to vitamin A is of concern? The SCCS is of the opinion that vitamin A in cosmetics at the concentrations of 0.05% Retinol Equivalent (RE) in body lotion, and 0.3% RE for other leave-on and rinse-off products is safe. Regarding the contribution from cosmetics to overall/total exposure, no conclusion can be drawn due to inconsistencies in the presented model calculations. However, the probabilistic assessment regarding the contribution of food and food supplements shows that the exposure to vitamin A of the most exposed consumers (5% of the total population) may already exceed the upper limit. Compared to food, the contribution of vitamin A from cosmetics is lower. However, it will add to the overall consumer exposure, and this may be of concern for consumers with the highest exposure (5% of the total population) to vitamin A from food and food supplements.

2. SCCS is invited to update accordingly opinion SCCS/1576/16 on vitamin A notably as regards, as needed, the maximum concentration limits for the different categories of cosmetic products indicated in that Opinion. Since cosmetics alone do not exceed the upper limit, the allocation of contributions of different exposure sources is a risk management issue and cannot be addressed at the level of risk assessment. Therefore, it is beyond the scope of the SCCS to suggest maximum concentration limits that take into account contributions from other sources e.g. food, and food supplements.

The SCCS considers that the teratogenic potential, effects on the liver and local effects on the skin of vitamin A are the most critical toxicological endpoints.

Actions for clinics

Whilst clinics do not need to take any immediate action, they may want to consider the SCCS opinion in the immediate effect with regard to the teratogenic consideration.

The EU will vote in November 2023 on whether the SCCS opinion should transition to law, in the EU, following no new products will be allowed onto the EU market after an 18-month transition period and no products should be made available for sale to the public after 24 months, containing greater than 0.05% Vitamin A or its permitted derivatives in body products or 0.3% in face leave on or wash off products.

Clinic owners may also want to consider continuing to supply products not in this scope and whether introducing new products out with this scope may leave them vulnerable after the transition period.

Other changes:

Below is a summary of other changes being decided in November 2023.

Annex II changes

4-Methylbenzylidene camphor (4-MBC) will be added to Annex II of the EU Cosmetic Products Regulation (CPR) and therefore be banned for use in cosmetic products.

The transition period is 12 months for placing on the market and 24 months for making it available (off-shelf).

Annex III Changes

Genistein and daidzein will be added to Annex III of the CPR and therefore be restricted for use at 0.007% and 0.02% respectively.

Kojic acid will be added to Annex III of the CPR and therefore be restricted for use at 1% in face and hand products.

Alpha-arbutin will be added to Annex III of the CPR and therefore be restricted for use at 2% in face creams, and 0.5% in body lotions. Hydroquinone levels should remain as low as possible in formulations containing alpha-arbutin and should not exceed 3 ppm.

Arbutin will be added to Annex III of the CPR and therefore be restricted for use at 7% in face creams. Hydroquinone levels should remain as low as possible in formulations containing beta-arbutin and should not exceed 3 ppm.

Triclocarban entry is updated and therefore ingredient will be restricted for use at 1.5% in rinse-off products. Purity criteria: 3,3',4,4'-Tetrachloroazobenzene ≤ 1 ppm, 3,3',4,4'-Tetrachloroazoxybenzene ≤ 1 ppm. This entry for triclocarban applies when the ingredient is not used for the purposes of product preservation.

The transition period is 9 months for placing on the market and 18 months for making available (off-shelf).

Annex V Changes

Triclocarban entry is updated and therefore ingredient will be restricted for use as a preservative at 0.2% in all cosmetic products (except mouthwash and baby wipes). Purity criteria: 3,3',4,4'-Tetrachloroazobenzene ≤ 1 ppm, 3,3',4,4'-Tetrachloroazoxybenzene ≤ 1 ppm. This use is prohibited in cosmetic products intended for children under 0,5 years of age.

Triclosan entry is updated and therefore ingredient will be restricted for use as a preservative at 0.3% in toothpaste, hand soaps, body soaps/shower gels, deodorants (non-spray), face powders and blemish concealers, nail products for cleaning the fingernails and toenails before the application of artificial nail systems. This use is prohibited in toothpaste intended for children under 3 years of age. This use is prohibited in cosmetic products intended for children under 0,5 years of age.

The transition period is 9 months for placing on the market and 18 months for making available (off-shelf).