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Pharmacosmetech show 2022
Wednesday, May 11, 2022International

The latest adjustments to Brazilian cosmetic regulations (2/3)

Les derniers ajustements de la réglementation cosmétique brésilienne (2/3)

Brazil has just notified several updates of its regulations applicable to cosmetic products. Overview of the main measures of the “Modifications to the conditions of use of ingredients”, “Products related to skin tanning”, and “Restrictions on Lead acetate, Formaldehyde and Pyrogallol” sections.

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Modifications to the conditions of use of ingredients

Resolution “RDC No.642” of 24 March 2022 internalises Mercosur Resolution No.133/96. It defines the criteria for inclusion, exclusion and modification of the concentration of substances used in personal care products, cosmetics and perfumes.
These criteria are applicable to prohibited and restricted ingredients, as well as to colorants, preservatives and UV filters (i.e. the lists equivalent to Annexes II, III, IV, V and VI of the European Cosmetics Regulation 1223/2009).

The application for inclusion of a substance on these lists must be accompanied by the following information:
I - generic name of the substance;
II - chemical name (IUPAC);
III - synonym / trade name / manufacturer;
IV - empirical formula;
V - chemical description;
VI - CAS registration (No.);
VII - INCI name;
VIII - PCPC name; IX - EC registration (No.);
X - specification:
a) physico-chemical description,
b) purity tests,
c) identification and content of impurities,
d) other relevant tests.
XI - area of application and respective dosage recommended for use;
XII - safety data on the substance, such as, for example, acute toxicity, mucosal irritation, skin irritation, sensitisation, toxicity, phototoxicity, photosensitisation, photomutagenicity, dermal absorption (in vitro/in vivo), teratogenicity …

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