On 16 May 2025, the European Commission notified the WTO of a draft amendment to the Cosmetic Regulation. The publication is amending Regulation (EC) No 1223/2009 of the European Parliament and the Council as regards the use of Benzyl Salicylate, Triphenyl Phosphate, Ammonium Silver Zinc Aluminium Silicate, Aluminium, water-soluble zinc salts, Acetylated Vetiver Oil, Citral, HC Blue No. 18, HC Red No. 18, HC Yellow No. 16, Hydroxypropyl p-phenylenediamine and its dihydrochloride salt, and DHHB in cosmetic products.
Specifically, based on the latest scientific opinions by the Scientific Committee on Consumer Safety (SCCS), European Commission prepared the draft regulation amending Annexes II, III, V, and VI to Regulation (EC) No 1223/2009.
Amendments to Annexes II and III: new bans and restrictions
The substance Triphenyl Phosphate has been banned under Annex II due to the fact the SCCS could not conclude on its safety, and potential genotoxicity and risk to human health could not be excluded.
Additionally, the Annex III entries concerning zinc acetate, zinc chloride, zinc gluconate, and zinc glutamate (entry 24) citral, geranial, and neral (entry 70), and benzyl salicylate (entry 75) have been amended to include conditions of use specific to the product type.
Finally, new Annex III entries have been added concerning aluminium and aluminium-containing ingredients, with the exception of entries 34, 50, 189, 190, and 192 of Annex III, entries 117, 118, 119, 121, 131, and 150 of Annex IV, and entry 27a of Annex VI.
Additional updates include:
- Vetiveria Zizanioides Root Extract and Vetiveria Zizanioides Root Oil
- HC Blue No. 18
- Hydroxypropyl-p-phenylenediamine and its hydrochloride salt (Hydroxypropyl-p-phenylenediamine 2HCl)
- HC Yellow No. 16
- HC Red No. 18
The full concentration limits per product type can be found in the draft annex to the regulation as notified to the WTO.
Amendment to Annex VI: DHHB
Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) is an approved UV filter in cosmetics and can be used at a maximum concentration of 10% under entry 28 of Annex VI. Note that Di-n-hexyl phthalate
(DnHexP) as an unavoidable trace impurity in DHHB must not exceed 10 ppm.
Silver Zinc Zeolite-New conditions
The substance ‘silver zinc zeolite’ (CAS No. 130328-20-0), which has been assigned the INCI name Ammonium Silver Zinc Aluminium Silicate’, has been classified as ‘Toxic for Reproduction of Category 2’ by Commission Regulation (EU) 2017/7764. Pursuant to Article 15(1) of Regulation (EC) No 1223/2009, silver zinc zeolite is listed as a prohibited substance in cosmetic products (entry 1597 in Annex II to that Regulation). In view of the diminishing number of available preservatives in cosmetic products, the industry submitted a dossier to defend the safe use of silver zinc zeolite as a preservative in cosmetic products. In its opinion of 21 December 2023, the SCCS concluded 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 %.
Considering the SCCS opinion, silver zinc zeolite should be deleted from the list of prohibited substances in cosmetic products in Annex II to Regulation (EC) No 1223/2009 and should, therefore, be added to the list of preservatives allowed in cosmetic products in Annex V to that Regulation.
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