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SCCS Opinion on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - Children's exposure
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Orientador(es)
Resumo(s)
The SCCS concludes the following:
1. In light of the data provided and taking under consideration the conclusions of the SCCS/1651/23 Opinion on children exposure, does the SCCS consider Butylparaben safe for children, when used as a preservative up to a maximum concentration of 0.14 %?
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.Alternatively, what is, according to the SCCS, the maximum concentration of Butylparaben that is considered safe for the age groups of children considered in this opinion”?
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. Does the SCCS have any further scientific concerns regarding the use of Butylparaben in cosmetic products and children’s exposure?
This Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of 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.
Descrição
SCCS External Experts: E. Benfentati, N. Cabaton, E. Corsini, Ch. Delmaar, A. Koutsodimou, H. Louro , W. Uter, N. von Goetz.
Adopted on: 30 April 2025
Adopted on: 30 April 2025
Palavras-chave
Butylparaben Environmental Genotoxicity Children C No. 202-318-7 Safety Assessment Regulation 1223/2009 CAS No. 94-26-8 Preservative SCCS Genotoxicidade Ambiental