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Le symposium sur les tests cliniques et précliniques
Wednesday, July 10, 2013SCCS

SCCS: Opinions open for comments

© CosmeticOBS-L'Observatoire des Cosmétiques

They have been adopted during the SCCS plenary meeting, on 18 June, 2013, and are open for comments until August 16, 2013. The SCCS has just released three new opinions on Zinc pyrithione (preservative), 3-Benzylidene camphor (UV filter) and hydroxyanthraquinone-aminopropyl methyl morpholinium methosulfate (hair dye). Opinions that should not completely satisfy the industry.

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~ 4 minutes

Zinc pyrithione

Background
Zinc pyrithione 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 VI/1, 8).
Furthermore zinc pyrithione is also allowed in a concentration up to 0.1% in leave-on hair products (Annex III/1, 101).
In the present submission by COLIPA (submission II), which is a supplemental dossier to submission I, the applicant applies for an extension of the authorized concentration from 1.0% to 2.0% in rinse-off antidandruff hair care products.

Opinion
SCCS confirms the previous opinion (SCCNFP/0671/03) on the safe use of zinc pyrithione for preservative purposes in cosmetic rinse-off hair care products at a maximum concentration of 1.0%.

SCCS considers that zinc pyrithione, when used in a concentration up to 2.0% as anti-dandruff agent in rinse-off hair care products, is not safe for the consumer. This conclusion is based on the fact that a MoS below 100 was obtained based on the information available

Data provided by the applicant is incomplete in order to enable risk assessment based on PBPK modelling.

Aggregate exposure to Zinc Pyrithione from non-cosmetic sources has not been considered.

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