CosmeticOBS - L'Observatoire des cosmétiques
Nov. 14, 2017SCCS

Zinc pyrithione: Request for an addendum to SCCS' Opinion pro Add to my portfolio
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CosmeticOBS - Observatoire des Cosmétiques

The safety of the cosmetic ingredient, preservative and anti-dandruff agent, Zinc Pyrithione, will be re-assessed by the SCCS. The request was published from the European Commission following the availability of new scientific studies. The Scientific Committee has until February 2018 to give its Opinion.

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Background

The cosmetic ingredient Zinc Pyrithione (ZPT) (CAS 13463-41-7; EU 236-671-3) with the chemical name: Bis[(2-pyridyl-1-oxo)-thio]zinc was introduced into the Cosmetics Directive as a preservative by Directive 82/368/EEC. It was authorised as a preservative at the maximum concentration of 0.5% with the limitation "Authorized in products rinsed off after use, forbidden in products for oral hygiene".

ZPT has been subject to different safety evaluations by the SCC in 1984 (XI/389/84), SCCNFP in 2002 (SCCNFP/0671/03) and the SCCS in 2014 (SCCS/1512/13) .
In particular, in the Opinion of 2002, experts assessed ZPT safe for the consumer as antidandruff agent in rinse-off hair care products at a maximum concentration of 1.0% and later in 2014 safe at 2.0%.

ZPT is currently regulated as a preservative in rinse-off products (excluding oral hygiene products) in a concentration up to 0.5% in general and up to 1.0% in hair products (Annex V/8).
Furthermore, ZPT is also allowed in a concentration up to 0.1% in leave-on hair products (Annex III/101).

A CLH dossier was submitted in October 2016 by the Swedish Chemicals Agency ("KEMI") to ECHA to support the harmonised classification and labelling of ZPT as a CMR 1B.

As new studies are available and used in the CLH report for ZPT, the Swedish Medical Products Agency ...