EU Cosmetics Regulation Annexes Amended Based on SCCS Opinions

By Percefoni Doufou-Shafiq, Ph.D., Regulatory Affairs Lead, Software, UL Solutions

On April 28, 2026, the European  Commission adopted Regulation (EU) 2026/909, updating Annexes II, III, V, and VI to the Cosmetics Regulation (EC) No 1223/2009. The amendments introduce new restrictions and prohibitions of certain ingredients based on opinions published by the Scientific Committee on Consumer Safety (SCCS). The changes address concerns related to potential endocrine-disrupting properties, fragrance allergens, and other safety risks.

Silver zinc zeolite, a preservative, is listed in Annex II due to its classification as “Toxic for Reproduction Category 2.” Given the reduction of authorized preservatives available for use in cosmetic products, the industry submitted a dossier defending its safe use. In its December 21, 2023 opinion, the SCCS concluded that if the Silver content in Silver zinc zeolite is less than 2.5%, then the substance can be safely used in concentrations of 1% in spray deodorants and powder foundations. The Commission has therefore allowed the use of this ingredient when the above-mentioned conditions are met, as reflected in its addition to Annex V (Authorized preservatives).

Triphenyl phosphate, previously unregulated under the EU Cosmetics Regulation and used as a plasticizer in cosmetic products, was also assessed by the SCCS (July 25, 2024). The SCCS could not support the safe use of Triphenyl phosphate because insufficient information could not exclude its potential for genotoxicity. Therefore, given the potential risk to human health, the decision was to prohibit the use of this substance and list it in Annex II of the Cosmetics Regulation (Prohibited substances).

The SCCS evaluated the fragrance allergen Benzyl salicylate, which is already listed in Annex III with specific labeling requirements, and identified as a potential risk to human health due to possible endocrine-disrupting properties. Consequently, the substance remains in Annex III and is now subject to stricter restrictions, with maximum concentration limits for specific product categories (e.g. body lotions and face make-up).

Similarly, the  Commission adopted the SCCS opinion on Citral, which is also already listed in Annex III with specific labeling requirements. Due to its sensitizing potential, there are now specific limits established for various product types.

After assessment from SCCS for soluble Zinc salts in oral products, the Commission has set new concentration limits in Annex III for oral products intended for use by children below 1 year of age.

Aluminum-containing ingredients have raised safety concerns related to contribution to the total systemic exposure, but according to the SCCS, these can be considered safe under specific conditions of use and are now included as an entry in Annex III with defined concentration limits and are prohibited in products that can lead to inhalation exposure.

Several dyes used in oxidative and non-oxidative hair products have been newly added to Annex III with concentration restrictions and additional labeling requirements after SCCS assessment on their safety.

Diethylamino hydroxybenzoyl hexyl benzoate (DHHB) is authorized as a UV filter in cosmetic products (listed in Annex VI). However, use of this substance has raised concerns due to potential presence of the contaminant Di-n-hexyl phthalate (DnHexP) (a phthalate classified as ‘Toxic to Reproduction’) in the production of DHHB. Although the SCCS recommended a 1 ppm contaminant level of DnHexP in DHHB, the Commission and Member States agree that such low contaminant levels raise DHHB production costs significantly, which has an economic impact especially to smaller companies. Therefore, they set a limit of 10 ppm for DnHexP as an acceptable unavoidable impurity.

Although the relevant amendments to the Annexes apply without delay (from April 28, 2026), there are provisions for a reasonable timetable in order for the industry to adapt to the requirements, phase out older products and reformulate following the newer restrictions.

UL’s ChemADVISOR™ Regulatory Database is being updated to reflect the changes.

References

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products

Regulation (EU) 2026/909