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Tuesday, March 6, 2018Regulation

Phenylene Bis-Diphenyltriazine, Zinc Pyrithione, o-Phenylphenol salts: 1 Opinion, 2 Addendum of the SCCS

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The SCCS has just published its new Opinion on the safety of the UV-filter Phenylene Bis-Diphenyltriazine, as well as addendum to its Opinions on Zinc pyrithione and the o-Phenylphenol salts. These texts were adopted during the plenary meeting of 21-22 February 2018, and are opened to comments until 30 April 2018.

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Phenylene Bis-Diphenyltriazine

Background

Following submission I on Phenylene Bis-Diphenyltriazine to assess its safety for use in cosmetic products, the SCCS concluded in its Opinion in July 2015 (SCCS/1556/15) that:
‘The SCCS considers Phenylene bis-diphenyltriazine, S86, not safe for use as a UV-filter in sunscreen products in a concentration up to 10.0% taking into account the scientific data provided.’

In March 2017, in light of the opinion SCCS/1556/15, the cosmetics company Pierre Fabre transmitted a new safety dossier (submission II) on Phenylene Bis-Diphenyltriazine that addresses the major issues raised by the SCCS notably i) additional physico‐chemical characterization studies, ii) additional toxicity studies in line with the required guidelines (studies were performed according GLP) and iii) finally the file was rewritten focusing on the active ingredient to be more in line with normal practice.

For full background information, see the articles
Three requests for SCCS opinions of 1st July 2013
Deoxyarbutin, UV filter S86: 2 Opinions of the SCCS of 8 September 2015
Phenylene Bis-Diphenyltriazine (S86): 2nd Request for Opinion to SCCS of 12 September 2017

Opinion

1. In light of the new data provided, does the SCCS consider Phenylene Bis-Diphenyltriazine, S86 safe for use as a UV-filter in …

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