Overview:

The labelling of personal care products, cosmetics and perfumes in Brazil follows specific Anvisa regulations, which include the requirement to use the International Nomenclature of Cosmetic Ingredients (INCI).

Introduction:

The Collegiate Board Resolution (RDC) 752/2022 of the National Health Surveillance Agency (Anvisa) establishes guidelines for the labeling of cosmetic products in Brazil. It defines detailed requirements for the presentation of information on labels, including the mandatory use of the International Nomenclature of Cosmetic Ingredients (INCI), guaranteeing transparency and safety for consumers. In addition, RDC 752/2022 aims to standardize and harmonize the information on labels, contributing to the quality and reliability of cosmetic products available on the Brazilian market.

Anvisa’s revision of the labeling guidelines for cosmetic products brought significant changes.

The Main Changes Introduced Include:

  • INCI Mandatory: The INCI remains mandatory on the labeling of these products, in accordance with RDC No. 752/2022.
  • Portuguese translation available: Anvisa has made translations available through the INCI Translation Panel.
  • How to Report the Translation on the Labeling: The Portuguese-language translation can be presented right after the INCI description or in digital format, according to the guidelines.
  • Contributions for additions or updates: Companies can contribute by requesting additions or updates using a specific form.
  • Forecast for Stock Out: There is no specific forecast; products manufactured after November 1, 2023, must comply with the new regulations.
  • Products without Translation Can Remain on the Market: Only products manufactured until October 31, 2023, can be marketed without translation.
  • Type of Label to Include Composition in Portuguese: The company must guarantee the integrity of the label during the product’s shelf life. Various technologies are acceptable, as long as the print remains legible during the shelf life.
  • Ingredients not found on the Panel: Companies must request the inclusion of ingredients not found on the INCI Translation Panel.

Following these guidelines is key to ensuring regulatory compliance and transparency in the labeling of cosmetic products.

Conclusion

The changes introduced by RDC 752/2022 represent a significant milestone in the regulation of the labeling of cosmetic products by Anvisa Brazil.

By updating the rules on the labeling of cosmetic products by Anvisa, the resolution seeks to ensure greater safety, efficacy and quality of these products.

Time GRP Brazil

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GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).

About Global Regulatory Partners

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.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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