EU
EU Proposes New Classifications for Key Ingredients
The European Chemicals Agency (ECHA) has proposed harmonized classifications and labeling for three ingredients used in cosmetics:
- Formyl Morpholine: The proposed classification includes Skin Sensitizer 1B (H317), indicating potential allergen risks.
- Dimethylaminopropylamine: Proposed changes could classify this as a reproductive toxin (Repr. 1B) and endocrine disruptor.
- Hydroxycitronellal: Already restricted as a fragrance ingredient, it is now proposed as a reproductive toxin (Repr. 2).
If adopted, these changes could restrict or ban the use of some ingredients. Stay prepared to adjust your formulations!
Homosalate: New UV Filter Concentration Limits in the EU
Starting 1 January 2025, stricter limits on Homosalate in face products will apply. Key points:
- Maximum concentration: 7.34%.
- Affects all new products entering the EU market and those available from 1 July 2025.
Manufacturers and Responsible Persons must act now to reformulate or withdraw non-compliant products.
Reminder 4-MBC (Methylbenzylidene Camphor)
As included in previous newsletter, this sunscreen is prohibited with agreed placing on the market date being 1st May 2025 and off shelf date 1st May 2026 .
Butylparaben and Salicylic Acid: Are They Safe for Children?
The SCCS has revisited safety assessments for two widely used preservatives:
- Butylparaben: Safety concerns for children under 10. The SCCS recommends reducing concentrations to 0.028%for safe use.
- Salicylic Acid: Safety risks identified for children, particularly in higher concentrations. New proposed safe limits:
- 0.1% for dermal products.
- Reduced concentrations in rinse-off and leave-on products.
Manufacturers targeting children’s cosmetics should pay close attention to these developments.
Reminder Labelling of Extended Fragrance Allergens
Placing on the market date 31st July 2026 for new products and for existing products still on the market, if no extended allergens included on the label, the off shelf date is 31st July 2028.
UK
UK Tightens Restrictions on Methyl Salicylate
From 31 March 2025, new restrictions will apply to Methyl Salicylate, commonly used in fragrances and oral care products. Key highlights:
- Strict limits on concentrations across various product types, including mouthwash, toothpaste, and skin products.
- Compliance deadlines: New products must comply by 30 September 2025, and older products must be withdrawn by 31 March 2026.
BHT Restriction Reminder
The amendment to Annex III in the UK Cosmetic Regulation in 2024, restricts the use of butylated hydroxytoluene (BHT) in cosmetic products under the following conditions:
- in toothpaste at a maximum of 0.1%;
- in mouthwash and leave on oral care products at a maximum of 0.001%; and
- in other leave-on and rinse-off products a maximum of 0.8%.
The placing on the market deadline is 24th February 2025, and the off-shelf deadline is 24th June 2025 in the UK.
USA
California’s Proposition 65 Adds Vinyl Acetate
As of 3 January 2025, products sold in California containing Vinyl Acetate must display a warning label, as this ingredient is classified as a carcinogen.
- Complete ban in California: Effective 1 January 2027.
- Reminder: Vinyl Acetate has already been banned in Europe since 2019.
Compliance is critical to avoid penalties and protect brand reputation in California markets.
