The Collegiate Directive Resolution-RDC 752/2022 deals with the definition, classification, technical requirements for labeling and packaging, parameters for microbiological control, as well as the technical requirements and procedures for the regularization of personal hygiene products, cosmetics, and perfumes.
The proposal internalizes the technical regulation provided for in GMC MERCOSUR Resolution No. 48/2021 and, in compliance with the provisions of Decree No. 10,139/2019, promotes the consolidation of RDC No. 07/ 2015, which provides on the technical requirements for the regularization of personal hygiene products, cosmetics and perfumes.
The updating of technical requirements in compliance with the harmonization of Mercosur standards is a regulatory convergence measure and, by ensuring mandatory minimum criteria for the labeling of personal hygiene products, cosmetics, and perfumes to be applied by the regulatory authorities of the countries in the region, it contributes to the reduction of information asymmetry and risks associated with the inappropriate use of these products.
In this sense, the objective of the norm approved by the Agency is to ensure that the consumer has access to clear and updated information about the characteristics of products, their safety, method of use and effectiveness, through labeling.
For products already regulated at Anvisa until the effective date of this Resolution, the RDC establishes a deadline of October 2025, for labeling adequacy.
In turn, petitions for registration or labeling changes filed before the effective date of this Resolution, or which are already under analysis at Anvisa, will be analyzed according to the Resolutions in effect at the time of the filing.
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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
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