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Monday, August 26, 2024Regulation

o-Phenylphenol, Sodium o-Phenylphenate: preliminary Opinion of the SCCS

o-Phenylphenol, Sodium o-phenylphenate : Opinion préliminaire du CSSC

Following the opinion of the ECHA (European Chemicals Agency) Risk Assessment Committee (RAC) recommending a harmonised classification as Carc. 2 (category 2 carcinogen) for the preservative o-Phenylphenol, the SCCS was asked to assess its safety. The Scientific Committee on Consumer Safety has just published its preliminary Opinion, which is open to comments until 27 September 2024.

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Background

o-Phenylphenol and its salt, Sodium o-Phenylphenate (CAS/CE No.90-43-7/201-993-5 and 132-274/205-055-6) are two cosmetic ingredients.
The use of o-Phenylphenol as a preservative is currently authorised in entry 7 of Annex V to the Cosmetics Regulation (EC) No.1223/2009, with a maximum concentration of 0.15% (as phenol) in leave-on and 0.2% (as phenol) in rinse-off cosmetic products.
The European Risk Assessment Committee (RAC) of ECHA issued in December 2022 an opinion recommending among others a classification for o-Phenylphenol as “Carcinogen of Category 2”.
In December 2023, the Commission services received a dossier to defend the safe use of o-Phenylphenol, as well as its sodium salt as preservatives in cosmetic products.

For an exhaustive background information, see the articles
Regulation 2018/1847: decrease of o-Phenylphenol concentration, prohibition of its salts, CosmeticOBS, 28 November 2018
Benzoyl Peroxide, o-Phenylphenol: ECHA’s RAC opinions, 12 December 2022
Europe notifies the 22nd ATP of the CLP, CosmeticOBS, 29 January 2024
oo-Phenylphenol, Sodium o-Phenylphenate: request for an Opinion to the SCCS, CosmeticOBS, 11 March 2024

The SCCS Opinion

1. In light of the data provided and taking under consideration the classification as “Carcinogen Cat. 2”, does the SCCS consider o-Phenylphenol safe when …

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