Wednesday, November 28, 2018Cosmetic regulations

Regulation 2018/1847: decrease of o-Phenylphenol concentration, prohibition of its salts

Règlement 2018/1847 sur l'o-Phenylphenol et ses sels

Regulation 2018/1847 of 26 November 2018, published in Official Journal of the European Union on November 27, amends Annex V (preservatives) to Cosmetics Regulation 1223/2009, to reduce the allowed concentration of o-Phenylphenol and ban its salts - Sodium o-Phenylphenate, Potassium o-Phenylphenate and MEA o-Phenylphenate. This provision will apply from 17 June 2019.

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The whereas of regulation 2018/1847

(1) The substance Biphenyl-2-ol and its salts, which have been assigned the names o-Phenylphenol, MEA o-Phenylphenate, Potassium o-Phenylphenate and Sodium o-Phenylphenate under the International Nomenclature of Cosmetics Ingredients (INCI), are currently allowed as preservatives in cosmetic products with a maximum concentration of 0.2% (as phenol) in ready for use preparation under entry 7 of Annex V to Regulation (EC) No1223/2009.

(2) The Scientific Committee on Consumer Safety (SCCS) concluded in its Opinion of 25 June 2015, revision of 15 December 2015, as regards the use of o-Phenylphenol as a preservative, that a maximum concentration of 0.2% in leave-on cosmetic products is not safe, while a maximum concentration of 0.15% in such products can be considered safe, and that a maximum concentration of 0.2% in rinse-off cosmetic products is considered safe. The SCCS also concluded that there might be a potential of injury to the vision system attributable to o-Phenylphenol.

(3) Following concerns raised by several Member States regarding the use of MEA o-Phenylphenate, Potassium o-Phenylphenate and Sodium o-Phenylphenate, the SCCS indicated in an addendum to the above-mentioned Opinion, adopted on 21-22 February 2018, that the same conclusions on the safe use levels …

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