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Monday, September 4, 2023International

Brazil notifies a change in its regulations on Zinc Pyrithione

Le Brésil notifie un changement de sa réglementation de la Zinc pyrithione

On 10 August 2023, Brazil notified its Resolution No.806, amending the 2021 list of substances that personal care products, cosmetics and perfumes must not contain, except under the conditions and with the restrictions it establishes. It transcribes Mercosur Resolution no. 35/22, which modified the conditions of use of Zinc Pyrithione.

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As a result of this amendment, the two entries relating to Zinc Pyrithione (CAS: 13463-41-7, EC: 236-671-3), an antiseborrhoeic, anti-dandruff agent and preservative, have been grouped together in the single entry No.49.
The substance, previously authorised in rinse-off anti-dandruff products up to 2% and 0.25% in the same type of leave-on products, is now only authorised as an anti-dandruff agent in rinse-off hair products up to 1%.

The adaptation period has been set at one year, and products will have to comply with this new provision by 11 August 2024, failing which the notification or registration will be cancelled.

As a reminder, Brazil has already banned the use of Zinc Pyrithione as a preservative.
In Europe, it was added to Annex II to[] Cosmetics Regulation 1223/2009 by Regulation 2020/1182 and has been totally banned in all cosmetic products since 1 March 2022.

Committee on Technical Barriers to Trade, Notification, G/TBT/N/BRA/1238/Add.1, World Trade Organization, 10 August 2023
Resolução de Diretoria Colegiada Nº806, Ministério da Saúde - MS Agência Nacional de Vigilância Sanitária – ANVISA, 7 August 2023

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