Zinc Pyrithione in Cosmetics: Regulatory Updates and Restrictions
The cosmetic ingredient Zinc Pyrithione, INCI Zinc Pyrithione (ZPT), is currently allowed as a preservative in rinse-off products (excluding oral hygiene products) up to 0.5% in generic products and up to 1.0% in hair products (Annex V / 8). In addition, ZPT is allowed up to 0.1% in leave-on hair products (Annex III / 101).
Zinc Pyrithione has been the subject of several safety assessments by the Scientific Committee on Consumer Safety (SCCS). In particular, SCCS opinions issued in 2014 and 2018 concluded that Zinc Pyrithione was safe as an anti-dandruff agent in rinse-off hair products at a maximum concentration of 2.0%.
ZPT as a suspected carcinogen
In October 2016, the Swedish Chemicals Agency submitted a dossier to ECHA in support of classifying and labelling ZPT as CMR 1B. On 14 September 2018, ECHA’s Risk Assessment Committee adopted an opinion proposing harmonised EU classification and labelling of ZPT as a CMR 1B substance under Regulation (EC) No 1272/2008. Under Article 15(2) of the Cosmetics Regulation, substances classified as CMR category 1A or 1B are prohibited in cosmetic products.
In April 2019, Cosmetics Europe submitted a safety dossier on ZPT with the aim of demonstrating the safety of the ingredient as an anti-dandruff agent in rinse-off hair products.
SCCS opinion
On the basis of the toxicological data available in the literature, the SCCS issued a partial opinion. Pending further information, it considered Zinc Pyrithione safe when used as an anti-dandruff agent in rinse-off hair products at a maximum concentration of 1%. The Committee did not express a final opinion on the overall safety profile of the ingredient, clearly indicating that further updates may be provided in the future.