SCCS publishes Scientific Opinion on children’s exposure to Butylparaben (SCCS/1674/25)
Ingredient: Butylparaben

Date of publication: 30/04/2025

The SCCS concluded that Butylparaben at 0.14% is not safe for children when used in combination, establishing new limits: 0.14% in rinse-off products, 0.002% in leave-on products, and 0.092% in oral care products.

What’s new?

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.

Main conclusions

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

What now?

Expected timeline for regulatory implementation:

  • Final opinion published
  • Amendment to Annex V of Cosmetics Regulation expected
  • Transition periods typically 18-24 months

References

SCCS (Scientific Committee on Consumer Safety), Opinion on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) – children exposure, preliminary version of 10 January 2025, final version of 30 April 2025, SCCS/1674/25

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