EU restricts 12 cosmetics ingredients amid health concerns

The European Commission (EC) has restricted 12 cosmetic ingredients due to concerns related to potential endocrine disruption or genotoxicity.

Regulation (EU) 2026/909 was published in the Official Journal of the European Union, with restrictions set to take effect on January 1, 2027. It amends Regulation (EC) No 1223/2009 — the primary regulatory framework for cosmetic products in the EU market.

The commission has made the amendments following updated safety assessments by the Scientific Committee on Consumer Safety (SCCS).

The changes apply to two key regulatory annexes: prohibited substances (Annex II) and restricted substances (Annex III). It also makes smaller amendments or reaffirmations in colorants (Annex IV), preservatives (Annex V), and UV filters (Annex VI).

The new regulation will be binding in its entirety and directly applicable in all EU member states on the day of enforcement.

Compliance with the regulation is mandatory and will necessitate reformulation for cosmetic products containing prohibited substances or substances outside of approved restrictions. Safety assessments and documentation will also need to be updated to reflect compliance by concerned parties.

Prohibitions under Annex II

Of the 12 changes, one ingredient — triphenyl phosphate — has been added to Annex II, while another — silver zinc zeolite — has been moved out of Annex II to lift its existing prohibition.

The SCCS previously assessed triphenyl phosphate in July 2024. At the time, it had not reached a conclusion on the safety of the ingredient due to information provided by the industry being “insufficient to evaluate it and exclude potential genotoxicity fully.” 

Taking the SCCS’s opinion into account, the commission has now concluded that potential endocrine-disrupting and genotoxicity risks of triphenyl phosphate cannot be ruled out. Thus, the commission has categorized it under the list of prohibited cosmetic products in Annex II.

Triphenyl phosphate is primarily used in nail polish and treatments as a plasticizer to increase flexibility, durability, and adhesion.

Silver zinc zeolite is a preservative ingredient that was previously prohibited and categorized as “Toxic for Reproduction Category 2.” However, the substance was filed for defense by the industry due to the diminishing number of available preservatives for use in cosmetic products.

The SCCS decided in 2023 that “silver zinc zeolite is safe up to a maximum concentration of 1% in spray deodorant and powder foundation, provided that the silver content in silver zinc zeolite does not exceed 2.5%.” Citing this decision, the commission has moved the ingredient from Annex II to Annex V (preservatives allowed in cosmetic products) of the regulation.

Updated restrictions

Triphenyl phosphate banned due to potential endocrine-disrupting and genotoxicity risks

Annex III refers to a section of substances banned from use in the cosmetics industry with certain exceptions. The new regulation has updated conditions surrounding ingredients already listed, and moved triphenyl phosphate out of Annex III to Annex II.

Following the updated SCCS opinion, benzyl salicylate, aluminum and aluminum-containing ingredients, and water‑soluble zinc salts remain in their Annex categorization, but are updated within it.

After the SCCS’s investigations on the potentially endocrine-disrupting properties of benzyl salicylate, the commission has categorized it as safe as a fragrance allergen in cosmetic products. Related parties must inform consumers about its presence when its concentration is above 0.001% in leave-on and 0.01% in rinse-off products.

Additionally, the commission has revised the restriction of water‑soluble zinc salts due to health concerns related to their use in oral care products for specific age groups.

Previously, zinc acetate, zinc chloride, zinc gluconate, and zinc glutamate up to a maximum concentration of 1% (as zinc) have been permitted in all cosmetic products. 

The new regulation adds zinc citrate, zinc sulfate, zinc sulfate monohydrate, and zinc sulfate heptahydrate (as zinc) to the list allowed up to a concentration of 1%.

However, the commission makes the exception that the concentration of zinc products should not exceed 0.72% in products for children under one year old.

Aluminum and aluminum-containing ingredients continue to be considered safe under specific conditions of use with substance-specific concentration limits and exposure conditions. Changes to Annexes IV, V, and VI primarily concern updated conditions and reaffirmations of existing regulations.

Under Annex IV, colorants such as HC blue no. 18, HC red no. 18, and HC yellow no. 16 are addressed with specified conditions of use and concentrations dependent on substance-specific use in oxidative and non-oxidative hair dye products.

HC blue no.18 is restricted for on-head concentrations of up to 0.35%. The use of HC red no. 18 in oxidative and non-oxidative hair dye products is restricted to a maximum concentration of 1.5% and 0.5%, respectively. HC yellow no. 16 is concluded to be safe when used for products with on-head concentrations of up to 1% in oxidative and up to 1.5 % in non-oxidative hair dye products.

Additionally, the use of hydroxypropyl-p-phenylenediamine and hydroxypropyl-p-phenylenediamine 2HCl in oxidative hair dye products are restricted to a maximum concentration of 2%.