SCCS Declares Revised Safe Limits for Butylparaben in Children’s Cosmetic Products

New Safety Threshold for Butylparaben in Children’s Products

The SCCS’s latest assessment, released in January 2025, revealed that Butylparaben poses potential endocrine-related risks for children when applied in combination with multiple cosmetic products. This reassessment follows earlier evaluations that identified data gaps on children’s specific exposure to the preservative.

Key findings from the report include:

Unsafe Combined Use: Products containing Butylparaben at 0.14% are unsafe for children aged 0.5–10 years when multiple products are used simultaneously.Revised Safe Concentration: To mitigate risks, the SCCS recommends a maximum concentration of 0.028% for products used across combined categories.Individual Product Safety: At 0.14%, the preservative remains safe for single-use categories, such as body lotion, provided no aggregated exposure occurs.

Insights into Endocrine Risks

Butylparaben’s endocrine-disrupting potential has been a primary concern. The SCCS highlighted that the preservative exhibited hormonal activity in laboratory tests. While human toxicokinetics and toxicodynamics data suggest similar metabolic pathways between children and adults, children’s smaller body sizes and developing physiology amplify potential risks.

Impact on Common Cosmetic Products

The SCCS guidance outlines product-specific recommendations based on age groups. For instance:

Products such as shower gels, body lotions, and face creams are identified as common exposure sources for children aged 0.5 to 10 years.Toothpaste ingestion was highlighted as a key oral exposure route for children up to 6 years old.

Need for Updated Exposure Studies

The SCCS stressed the importance of conducting comprehensive dermal absorption studies tailored to European children. Current evaluations assume a conservative absorption rate of 50% in the absence of robust data. Improved methodologies, such as 3D scanning for body surface area measurement, were also recommended to refine safety assessments.