METHYLPARABEN

METHYLPARABEN

SCIENTIFIC COMMITTEE ON CONSUMER SAFETY (SCCS) Request for a scientific opinion on Methylparaben (CAS No. 99-76-3, EC No. 202-785-7) Commission Department requesting the Opinion: Directorate-General for Internal Market, Industry, Entrepreneurship and (small and medium-sized enterprises) SMEs.

On 7 November 2018, the Commission adopted a review of Regulation (EC) No 1223/2009 on cosmetic products (‘Cosmetics Regulation’) regarding substances with endocrine disrupting properties.

The Cosmetics Regulation does not have explicit provisions on substances with endocrine disrupting properties.

A priority list of 28 potential EDs in cosmetics was consolidated in early 2019 based on input provided through a stakeholder consultation.

Methylparaben is one of the above-mentioned 10 substances for which the call for data took place.

Methylparaben (CAS No. 99-76-3, EC No. 202-785-7) with the chemical name ‘Methyl 4- hydroxybenzoate’ is currently regulated as a preservative (Annex V, 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 is produced naturally in a variety of plants, but it is also synthesised for use in a range of products including, but not limited to cosmetics, food products and pharmaceuticals, since it has a wide spectrum of antimicrobial activity and is also effective against yeasts and moulds.

Terms of reference:

  • 1. In light of the data provided and taking under consideration the concerns related to 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% 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 use of Methylparaben as a preservative in cosmetic products?
  • 3. Does the SCCS have any further scientific concerns with regard to the use of Methylparaben in cosmetic products?

Deadline: 9 months.

The SCCS approved this mandate by written procedure on 3 February 2022.

Link: https://ec.europa.eu/health/system/files/2022-02/sccs2022_q_001.pdf