SCCS Issued Preliminary Opinions on Methylparaben and Butylparaben

On June 8, the Scientific Committee on Consumer Safety (SCCS) issued preliminary opinions on Methylparaben (CAS No. 99-76-3, EC No. 202-785-7) and Butylparaben (CAS No. 94-26-8, EC No. 202-318-7). The deadline for the public consultation is August 21, 2023.

Methylparaben

1. In light of the data provided and taking into consideration the concerns related to the potential endocrine disrupting properties of Methylparaben, does the SCCS consider Methylparaben safe when used 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?

On the basis of the safety assessment of Methylparaben, and considering the concerns related to potential endocrine activity, the SCCS has concluded that Methylparaben is safe when used 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.

2. Alternatively, what is according to the SCCS the maximum concentration considered safe for the use of Methylparaben as a preservative in cosmetic products?

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3. Does the SCCS have any further scientific concerns with regard to the use of Methylparaben in cosmetic products?

The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Methylparaben for the environment.

Butylparaben

1. In light of the data provided and taking into consideration the concerns related to the potential endocrine disrupting properties of Butylparaben, does the SCCS consider Butylparaben safe when used as a preservative in cosmetic products up to a maximum concentration of 0.14 %?

On the basis of safety assessment considering all available data and the concerns related to endocrine activity, the SCCS is of the opinion that the use of Butylparaben as a preservative in cosmetic products at concentrations of up to 0.14% (expressed as acid) is safe.

2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Butylparaben as a preservative in cosmetic products?

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3. Does the SCCS have any further scientific concerns with regard to the use of Butylparaben in cosmetic products?

In the absence of solid exposure data for children to Butylparaben in cosmetic products, potential safety concerns have been noted by the SCCS.

The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Butylparaben for the environment.

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Further Information

SCCS/1652/23：https://health.ec.europa.eu/system/files/2023-06/sccs_o_276.pdf

SCCS/1651/23：https://health.ec.europa.eu/system/files/2023-06/sccs_o_275.pdf