Brazil publishes new regulations on microbiological control of cosmetics and perfumes

On 3 October 2022 the Brazilian National Health Surveillance Agency (ANVISA) published a new Technical Note 31/2022/SEI/GHCOS/DIRE3/ANVISA on the regularization of personal hygiene products, cosmetics, and perfumes which came into force directly.

On 19 September 2022, the Brazilian National Health Surveillance Agency adopted Resolution 752/2022. It entered into force on 3 October 2022. Resolution 752/2022 requires labelling adaptations which demand the addition of customer service information, particular definitions for tanning products, hypoallergenic goods, personal hygiene products, and specific wrapping features.

Resolution 752/2022 is the result of adapting several directives of the Common Market of the South (MERCOSUR). Therefore, it is an effort of the Brazilian government to standardize regulations in the region and simplify the trade of those goods within the MERCOSUR region and towards it. 

In addition to technical requirements and regularization as well as labelling and packaging procedures, the new standard defines the parameters for the microbiological control of these products. In this regard the Technical Note 31/2022/SEI/GHCOS/DIRE3/ANVISA for contains guidance to meeting the mandatory requirements for microbiological specifications of the finished product, provided for in item III of Article 8 of Resolution 752/2022.This Note points out the technical requirements and procedures concerning microbiological control. In this regard, two possible options could occur:

• if a product is keen to pollute in a microbiological dimension, the product shall comply with several parameters set in Chapter V of Resolution 752/2022.
•  if a product is potentially not a harm in a microbiological dimension such condition should be demonstrated technically under ISO29621:2017.

Existing product registration  must be adapted before 3 October 2025 and new products have to comply with the novel regulation. For more information in Portuguese visit: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2022/anvisa-divulga-orientacoes-sobre-controle-microbiologico-de-cosmeticos