The National Directorate of Pharmacy and Drugs, under the Ministry of Health, has published Resolution No. 226, which orders the inclusion of safety information in the monographs and package inserts of registered products, those undergoing sanitary registration or renewal, and all new registration applications containing probiotics in their formulation.
Month: January 2026
Brazil – Deadline for submitting the modification protocol provided for in RDC 839/2023 has passed
The National Health Surveillance Agency (ANVISA) informs that the deadline for food companies to submit the modification provided for in Collegiate Board Resolution (RDC) 839/2023 (which establishes the verification of safety and authorization for the use of new foods and new ingredients) ended on December 18, 2025.
Companies that had requested safety assessments for new foods and ingredients and had pending processes at the start of the regulation’s implementation could choose from three options:
- Submit additional documentation via an addendum to comply with the new regulations;
- Maintain the analysis in accordance with the previous standard; or
- Withdraw the request.
For those who opted for the modification, the 24-month period defined in Article 68, § 3, of RDC 839/2023 ends on December 18, 2025.
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