Zinc pyrithione: Request for an addendum to SCCS' Opinion
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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.
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 ...