New Resolution by ANVISA
The Brazilian FDA, ANVISA, has issued a new resolution concerning disinfection products with antimicrobial actions for use on objects, surfaces, and environments in homes, industries, hospitals, healthcare facilities, and both public and private places.
According to the new Resolution RDC Nº 774, only active ingredients in covered products whose antimicrobial substances are already approved by the FDA, the US EPA, or the European Union will be accepted.
For any antimicrobial substance that has not yet received approval from these entities, proponents must first submit all established data and studies.
This resolution addresses various use cases for disinfectant products, each with specific requirements.
It also establishes detailed regulations regarding the registration of products in Brazil and provides numerous details regarding labeling, including mandatory wording requirements.
The new resolution took effect on March 1st, 2023, and it repeals RDC 693/2022. This new RDC adopts Mercosur Resolution 50/2006.