Resolution of the Directive Board (RDC) 432, November 4th, 2020 – ANVISA
ANVISA has published the Resolution of the Directive Board – RDC nº432 to establish the obligation of describing the composition of personal hygiene products, cosmetics, and perfumes in the Portuguese language on the labeling.
The Resolution will be in force from November 5th, 2021.
– It will be mandatory to describe in the labeling of personal hygiene products, cosmetics, and perfumes their respective composition in Portuguese, without any prejudice of the other requirements predicted in the legislation in force.
– The International Nomenclature of Cosmetic Ingredient (INCI) remains mandatory in the labels of personal hygiene products, cosmetics, and perfumes.
– The chemical composition in the Portuguese language must be presented on the original label of the product, on a complementary label, as long it’s assured the integrity of the colors and the material on which the label is manufactured, in a way to prevent the partial or total removal of the label ( it’s mandatory to use the updated Brazilian Common Denomination – DCB – or any other reference pointed out by ANVISA).
When there’s not a description of the substance in the Brazilian Common Denomination (DCB) – or other reference pointed out by ANVISA, the manufacturer is obligated to translate the name of the substance to the International Nomenclature of Cosmetic Ingredient (INCI) and to recognize the lack of translation to the Portuguese language.
– The products manufactured before the enforcement of this Resolution can be commercialized until their respective dates of expiration.
– It’s not necessary to submit a petition of Alteration of Labels of the registered products when they are intended exclusively for the fulfillment of this Resolution.
– The failure of complying with the requirements of this Resolution is a sanitary infraction submitted to the penalties predicted in Law nº 6.437, of August 20th, 1977, without losses of civil or penal sanctions applicable.
Access the full content of the Resolution in the link below:
RDC Nº 432
For more information and explanations about it, send us an e-mail: [email protected]
Passarini Regulatory Affairs