On May 2, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued a final opinion (SCCS/1674/25) on Butylparaben (CAS No. 94-26-8). The preliminary opinion was issued on January 13, 2025.
Cosmetic Products for Safety Assessment in Children of Different Age Groups
In 2023, the SCCS 12th Notes of Guidance was published and includes a new Appendix 7 offering advice on the types of general cosmetic products that can be used by children of different age groups. The following table shows cosmetic products considered by SCCS for safety assessment in children of different age groups (according to Table A.7.2 in SCCS/1647/22).
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Children between 0.5 and 1 year old |
Children between 1 and 3 years old |
Children between 3 and 6 years old |
Children between 6 and 10 years old |
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Dermal products |
Shower gel |
Shower gel |
Shower gel |
Shower gel |
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Oral products |
Toothpaste (RF 40%) |
Toothpaste (RF 40%) |
Toothpaste (RF 40%) |
Toothpaste (RF 5%) Mouthwash (RF 10%) |
Final Opinion on Butylparaben
1. Based on the safety assessment carried out in consideration of all available information, including the potential endocrine effects, the SCCS is of the opinion that the use of Butylparaben as preservative at a maximum concentration of 0.14% (as acid) in all cosmetic products included in this exposure assessment is not safe for children between 0.5-1 years, 1-3 years, 3-6 years and 6-10 years when used in combination. With the exception of body lotion, it is safe in single dermal and oral product categories when used only in the respective product category.
2. In the SCCS’s opinion, Butylparaben could be considered safe for children of all age groups that were evaluated, provided that the maximum concentration of Butylparaben is reduced in some product types so that the aggregate exposure does not exceed 245 µg/kg bw/day.
During the public consultation, the SCCS received a proposal from the Applicant to maintain the concentration of Butylparaben at 0.14 % (as acid) in rinse-off products and reduce it to 0.002 % (as acid) in leave-on products and 0.092 % (as acid) in oral care products. Based on these reduced concentrations, Butylparaben is considered safe for children of all age groups and product types included in the assessment, whether used individually or in combination.
3. This Opinion is not applicable to any sprayable products (including mouth spray) that may lead to exposure of the end-user’s lungs by inhalation. The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Butylparaben for the environment.
Regulatory Requirements Interpretation of Butylparaben in China
The Global Cosmetic Ingredient Regulatory Database – Global CosIng, an upgraded version of China CosIng independently developed by CIRS Group, is scheduled for official launch soon. The database indicates that Butylparaben (CAS No. 94-26-8) has been included in the “Inventory of Existing Cosmetic Ingredients in China (IECIC) (2021 edition)” and “List of Allowed Preservatives”. When used as a preservative in cosmetics, the maximum allowable concentration is 0.4% (as acid) for single ester; 0.8% (as acid) for mixtures of esters; Less than 0.14% for the propyl ester and its salt or butyl ester and its salt respectively (as acid).
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Further Information
https://health.ec.europa.eu/document/download/453366da-0b79-48f6-963e-648f8c176000_en?filename=sccs_o_296.pdf
