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Monday, May 2, 2022International

The latest adjustments to Brazilian cosmetic regulations (1/3)

Les derniers ajustements de la réglementation cosmétique brésilienne (1/3)

Brazil has just notified several updates of its regulations applicable to cosmetic products. List of authorised colourants, products for children, conditions of modification of the conditions of use of ingredients, labelling, microbiological controls… Overview of the main measures of the “Colorants” and “Children’s products” sections.

Reading time
~ 16 minutes

List of authorised colorants

The “RDC” Resolution n°628 of 10 March 2022 internalises the Mercosur Resolution n°16/2012. It establishes the list of authorised colouring substances for personal care products, cosmetics and perfumes.
It is constructed in the same way as Annex IV to Cosmetics Regulation 1223/2009, authorising 159 substances depending on the area of application of the products:
• Substances allowed in all types of products
• Substances allowed in all types of products, except those applied to the eye area
• Substances allowed only in products that do not come into contact with mucous membranes
• Substances allowed only in products with a short skin contact time (equivalent to rinse-off products in Europe)

The few points of divergence with the European regulation

Impurities
Maximum impurity limits for artificial organic colorants are defined for:
• Barium soluble in 0.001N hydrochloric acid (expressed as barium chloride): 500 ppm
• Arsenic: 3 ppm
• Lead: 20 ppm
• Other heavy metals: 100 ppm

The differences in the list of authorised substances
Two colorants are listed in Brazil but banned in Europe:
• CI 45425
• CI 77013
The Brazilian list does not mention the nano form for CI 77266 (Carbon Black) contrary …

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