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Monday, December 23, 2019Regulation

Zinc Pyrithione: Opinion of the SCCS

Zinc pyrithione : Opinion du CSSC

The SCCS has just published its Opinion on the safety of the preservative and anti-dandruff agent Zinc Pyrithione in cosmetic products, on behalf of the European Commission following the classification of the substance as CMR 1B. It was adopted on 13 December 2019 by written procedure, and is open for comments until 24 February 2020.

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Background

Zinc Pyrithione (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). It is also allowed in a concentration up to 0.1% in leave-on hair products (Annex Ш/101).
On 14 September 2018, ECHA’s Risk Assessment Committee (RAC) adopted an opinion proposing harmonised classification and labelling at EU level of ZPT as a CMR 1B substance under Regulation (EC) No.1272/20081.
According to Article 15(2) of the Cosmetics Regulation, the use in cosmetic products of substances classified as CMR substances, of category 1A or 1B shall be prohibited unless exempted by way of exception.
In April 2019, a safety dossier on ZPT was submitted by Cosmetics Europe to demonstrate the safety of the ingredient as an anti-dandruff in rinse-off hair products.

For an exhaustive background information, see the article
Zinc Pyrithione : request for the Opinion of SCCS, CosmeticOBS, 20 May 2019

Opinion

1. In view of the conditions laid out in Article 15(d) of the Regulation (EC) No.1223/2009 and taking into account the scientific data provided, does the SCCS consider Zinc Pyrithione safe when used as an …

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