On June 8, 2023 the Scientific Committee on Consumer Safety (SCCS) issued Preliminary Opinions on Methylparaben (CAS 99-76-3, EC 202-785-7) and Butylparaben (CAS 94-26-8, EC 202-318-7). The deadline for the public consultations is August 21, 2023.
BACKGROUND
Butylparaben (CAS 94-26-8, EC 202-318-7) with the chemical name ‘Butyl 4-hydroxybenzoate’ is currently regulated as a preservative under Annex V to the European Cosmetics Regulation No. 1223/2009 (entry 12a) in a concentration up to 0.14 % (as acid) when used on its own or for the sum of its combined use with propylparaben and its salts (Annex V, entry 12a, column g).
Butylparaben has been subject to several safety evaluations by the Scientific Committee on Consumer Products (SCCP) in 2005 (SCCP/0874/05), 2006 (SCCP/1017/06), and 2008 (SCCP/1183/08); and by the SCCS in 2010 (SCCS/1348/10), 2011 (SCCS/1446/11) and 2013 (SCCS/1514/13). In particular, the last SCCS assessment in 2013 stated that the additional submitted data did not address the concern expressed in the previous opinions on the relevance of the rat model for the risk assessment of parabens. Although much toxicological data on parabens in rodents exist, adequate evidence has not been provided for the safe use of propyl- or butylparaben in cosmetics.
Methylparaben (CAS 99-76-3, EC 202-785-7) with the chemical name ‘Methyl 4-hydroxybenzoate’ is currently regulated as a preservative under Annex V to the European Cosmetics Regulation No. 1223/2009 (entry 12) in a concentration up to 0.4 % (as acid) when used on its own or up to 0.8% for mixtures of esters (Annex V, entry 12, column g).
Methylparaben has been subject to several safety evaluations by the SCCP in 2005 (SCCP/0874/05) and (SCCP/0874/05), 2006 (SCCP/1017/06), 2008 (SCCP/1183/08) and by the SCCS in 2010 (SCCS/1348/10) and 2011 (SCCS/1446/11).
Upon the European Commission’s call for data, stakeholders submitted scientific evidence to demonstrate the safety of Methylparaben and Butylparaben as preservatives in cosmetic products. The European Commission requested the SCCS to carry out a safety assessment on Methylparaben and Butylparaben in view of the information provided.
WHAT’S NEW?
In light of the data provided and taking under consideration the concerns related to the potential endocrine-disrupting properties of Methylparaben and Butylparaben, the SCCS is of the opinion that:
1. The use of Butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid) is safe. The SCCS noted potential safety concerns due to the absence of solid children’s exposure data to Butylparaben in cosmetic products.
2. The use of Methylparaben as a preservative in cosmetic products up to a maximum concentration of 0.4% (as acid) when used on its own and up to 0.8% (as acid) for mixtures of esters as indicated in entry 12 of Annex V to the Cosmetics Regulation, is safe.
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