Nano MBBT in Annex VI to Cosmetics Regulation
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Regulation 2018/885 of 20 June 2018, published in Official Journal of the European Union on 21 June, amends Annex VI (UV-filter) of Cosmetics Regulation 1223/2009, to insert Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (MBBT) in its nano form. This provision will apply 20 after its publication in the OJ.
The whereas of Regulation 2018/885
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.
In its opinion of 25 March 2015, the Scientific Committee on Consumer Safety (SCCS) concluded that the use of MBBT (nano) as a UV-filter, with the characteristics as indicated in the opinion and at a concentration up to 10% w/w in dermally applied cosmetic products does not pose a risk to human health after application on healthy, intact skin and also damaged skin. The characteristics indicated by the SCCS in that opinion relate to the physico-chemical properties of the material (such as purity, median particle size, number size distribution).
The SCCS also considered that the conclusions of its opinion of 25 March 2015 do not apply to applications that might lead to the exposure of the end-user’s lungs to MBBT (nano) by inhalation.
In light of the SCCS opinion and in order to take into account technical and scientific progress, the use of MBBT (nano) as a UV-filter in cosmetic products, according to the SCCS’s specifications, should ...