On 30 April 2025, the SCCS adopted a final opinion on children’s exposure to Butylparaben, following public consultation initiated in January 2025. The assessment built upon conclusions from previous opinion SCCS/1651/23 on children’s exposure to parabens.
Butylparaben is currently permitted as a preservative up to 0.14% (as acid) under Entry 12 of Annex V to the EU Cosmetics Regulation.
The assessment considered potential endocrine effects and aggregate exposure scenarios in children aged 0.5 to 10 years.
Safety conclusion at 0.14%:
- Not safe for children (0.5-10 years) when used in product combinations
- Safe in individual product categories (except body lotion)
- Aggregate exposure should not exceed 245 μg/kg bw/day
Proposed safe concentrations:
- 0.14% (as acid) in rinse-off products
- 0.002% (as acid) in leave-on products
- 0.092% (as acid) in oral care products
Expected timeline for regulatory implementation:
- Final opinion published
- Amendment to Annex V of Cosmetics Regulation expected
- Transition periods typically 18-24 months
