Wednesday, April 13, 2022International

Brazil notifies its regulation on sunscreen products and multifunctional cosmetics with SPF

Le Brésil notifie sa réglementation sur les produits solaires et les cosmétiques multifonctionnels avec FPS

On 5 April 2022, Brazil notified the WTO of its Resolution No. 629, adopted on 10 March to internalise Mercosur Resolution No. 08/2011, and aimed at defining the applicable provisions for the measurement of protection indices and the labelling of sunscreen products and other cosmetics containing UV filters. With an implementation date given for 1 April 2022.

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This Resolution applies to two categories of products:
• sunscreen products: “any cosmetic preparation intended to come into contact with the skin and lips for the exclusive or principal purpose of protecting them against UVB and UVA radiation by absorbing, scattering or reflecting the radiation”
• Multifunctional products: “any cosmetic preparation intended to come into contact with the skin and lips, where protection against UV radiation is not the main objective but an additional benefit of the product”

It has two stated objectives:
• establish definitions, technical requirements, labelling rules and methods for assessing effectiveness (determination of protection indices)
• ensure the effectiveness of sunscreen products, and guarantee a high level of public health protection, by setting simple and understandable labelling criteria to guide the consumer in the choice of the appropriate product

Methods of assessing the protection index

The determination of the Sun Protection Factor (SPF) should be carried out using only in vivo methods, strictly applying one of the following references or their updates:
• FDA, Department of Health and Human Services, Sunscreen drug products for over-the-counter human use. Final Monograph: Proposed Rule, 21 CFR Part 352 et al, 1999
• COLIPA/JCIA/CTFA-SA. International Sun Protection Factor (SPF) …

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