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Wednesday, January 25, 2017Regulation

MBBT [nano] in Anne VI to the Cosmetics Regulation in 2017

© CosmeticOBS-L'Observatoire des Cosmétiques

The European Union has just transmitted to WTO a draft Regulation aimed at allowing the use of MBBT (Methylene bis-benzotriazolyl tetramethylbutylphenol) in its nano-form as a UV filter in Europe. The substance should be added in Annex VI to Cosmetics Regulation 1223/2009 during 3rd quarter 2017.

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Notification date

20 January 2017

Content

The substance Methylene bis-benzotriazolyl tetramethylbutylphenol (MBBT) is currently regulated in entry 23 of Annex VI of the Cosmetics Regulation (EC) 1223/2009 as an authorised U.V. filter with the maximum concentration of 10% in cosmetic products. The safety of mentioned use conditions was confirmed by the Scientific Committee on Cosmetic Products and Non Food (SCCNPF) in 1998 but this Opinion did not cover the nano form. The Scientific Committee on Consumer Safety (SCCS) adopted on 25 March 2015 a scientific Opinion which established the safety of the nano form at a concentration up to 10% in dermally applied cosmetics products. This draft Commission Regulation aims at authorising the use of MBBT nano as a UV-filter in cosmetic products.

The text of the future regulation

Whereas

  1. 2,2’-Methylene-bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethyl-butyl)phenol)/Bisoctrizole with the International Nomenclature of Cosmetic Ingredients name Methylene bis-benzotriazolyl tetramethylbutylphenol (MBBT) is authorised for use as a UV-filter in cosmetic products under entry 23 of Annex VI to Regulation (EC) No 1223/2009. The use of MBBT (nano) as a UV-filter in cosmetic products is currently not regulated.

2. In its Opinion of 25 March 2015, the Scientific Committee on Consumer Safety (SCCS) concluded that the use of …

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