What’s new?
On 16 July 2025, the European Commission formally notified the World Trade Organization (WTO) of a draft amendment to Regulation (EC) No 1223/2009 designated as “Omnibus Act 2”.
This regulatory package implements multiple Scientific Committee on Consumer Safety (SCCS) opinions issued over recent years, introducing significant changes across Annexes II through VI of the EU Cosmetics Regulation.
This regulatory update affects multiple ingredient categories including preservatives, colorants, UV filters, and restricted substances, with implementation timelines extending through 2028 to allow adequate industry transition periods.
Key regulatory updates
SILVER ZINC ZEOLITE
Originally banned under Annex II in 2017 due to CMR classification, Silver Zinc Zeolite received industry defense following preservative shortage concerns.
- Remains in Annex II with conditional prohibition while being added to Annex V as permitted preservative under specific conditions
- Permitted product categories: Spray deodorants and powder foundations only
- Maximum concentration of 1% in finished products
- Maximum 2.5% silver content in the zeolite material
TRIPHENYL PHOSPHATE
- Complete ban
- SCCS could not conclude on safety due to unresolved genotoxicity concerns and potential human health risks
ANNEX III UPDATED ENTRIES
- Entry 24 – Water-Soluble Zinc Salts
- Zinc Acetate (CAS No. 557-34-6), Zinc Chloride (CAS No. 7646-85-7), Zinc Gluconate (CAS No. 4468-02-4), Zinc Citrate (CAS No. 546-46-3), Zinc Glutamate (CAS No. 1949-15-1), and Zinc Sulphate, Zinc Sulphate Monohydrate, Zinc Sulphate Heptahydrate (CAS No. 7733-02-0/7446-19-7/7446-20-0) can be considered safe when used in toothpaste in concentrations up to 1 % (as zinc) with the exception of children below 1 year of age where that concentration should not exceed 0,72 % (as zinc).
- Water-soluble zinc salts can be considered safe when used in mouthwash in concentrations up to 0,1 % (as zinc) across all age groups above 6 years.
- Entry 70 – Citral, Geranial, and Neral
- Product category differentiation reflecting aldehyde sensitization concerns
- Entry 75 – Benzyl Salicylate
- Refined usage conditions addressing sensitization potential across different cosmetic applications
ANNEX III NEW ENTRIES
- Aluminium and aluminium-containing ingredients with specific conditions of use
- Maintains existing permissions under Annex III (entries 34, 50, 189, 190, 192), Annex IV (entries 117, 118, 119, 121, 131, 150), and Annex VI (entry 27a)
- Vetiveria Zizanioides Root Extract and Root Oil – fragrance restrictions
- HC Blue No. 18 – specific conditions of use as hair dye
- Hydroxypropyl-p-phenylenediamine and its dihydrochloride salt – specific conditions of use as hair dye
- HC Yellow No. 16 – specific conditions of use as hair dye
- HC Red No. 18 – specific conditions of use as hair dye
ANNEX IV UPDATED ENTRY
- Entry 28 – DHHB (Diethylamino Hydroxybenzoyl Hexyl Benzoate)
- New di-n-hexyl phthalate (DnHexP) impurity limit established to 10 ppm in DHHB UV filter (SCCS originally recommended 1 ppm target, with 260 ppm safety threshold)
- Maintained concentration of 10% maximum DHHB
The detailed concentration limits per product type can be found in the draft annex to the Regulation as notified to the WTO.
What now?
The notification initiated the international consultation period of 60 days required under WTO technical barriers to trade agreements, allowing global stakeholders to comment before final adoption.
Deadlines for compliance:
Starting 1 January 2027, cosmetic products that contain the substances subject to this regulation and that do not comply with the relevant restrictions or conditions may no longer be placed on the EU market.
From 1 August 2028 non-compliant products containing Geranial and Neral may no longer be made available on the EU market (sell-off period).
From 1 July 2028, non-compliant products containing the remaining substances regulated by this amendment cannot be made available on the Union market (sell-off period).