Thursday, October 3, 2013SCCS

SCCS: Opinion on Methylene bis-benzotriazolyl tetramethylbutylphenol

© CosmeticOBS-L'Observatoire des Cosmétiques

It has been adopted by written procedure on 18 March 2013, and is open for comments until April 26, 2013. The SCCS has just released its Opinion on Methylene bis-benzotriazolyl tetramethylbutylphenol (MBBT), an anti-UV filter, which fulfill the definition of a nanomaterial.

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Background
Methylene bis-benzotriazolyl tetramethylbutylphenol (CAS: 103597-45-1), is listed as a UV filter in sunscreen and used in sunscreens, day care products and skin lightening products.

As a result of the recast of the European Cosmetic Directive (76/768/EEC) into the Cosmetic Regulation (EC No. 1223/2009) a new description was necessary for this chemical. According to the description stated in the Cosmetic Regulation under article 2 this material could fulfill the definition of a nanomaterial. Based on this new definition supplementary data on the material on its nano form, was submitted by the applicant.
According to the applicant, they take into account the available information on the nano-form of this ingredient.

The SCCS was asked to answer the following questions:
 1. Does the SCCS consider Methylene bis-benzotriazolyl tetramethylbutylphenol in its nano form safe for use as a UV-filter with a concentration up to 10 % in cosmetic products taking into account the scientific data provided?
 2. Does the SCCS have any further scientific concern with regard to the use of Methylene bis-benzotriazolyl tetramethylbutylphenol in its nano form in cosmetic products?

Opinion
Since no data on genotoxicity are available, no conclusion on the safety of this substance can be drawn. However regarding systemic …

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