Brazil – ANVISA publishes the Regulatory Agenda 2026/2027

The Collegiate Board of Directors of the National Health Surveillance Agency (ANVISA in Portuguese) has published the Regulatory Agenda 2026-2027, which includes 161 topics, of which 97 were migrated from the 2024-2025 Agenda, 26 topics for periodic updates, and 38 new topics.

The Regulatory Agenda includes 35 subtopics related to the food category.

  1. Regulation on the quantitative declaration of ingredients in the labelling of packaged foods.
  2. Nutritional Surveillance Requirements.
  3. Review of regulations on food additives and processing aids authorized for use in dairy products
  4. Review of regulations on food additives and processing aids in food.
  5. Review of regulations on the authorization of use and labeling of sweetener additives in food
  6. Review of regulations on contaminants in food.
  7. Review of regulations on food-grade PET-PCR containers intended to come into contact with food
  8. Review of regulations on food enrichment and restoration.
  9. Review of regulations on foreign matter in food.
  10. Review of regulations on health requirements for flavored ice for beverages.
  11. Review of regulations on the human health risk assessment of veterinary medicinal products, maximum residue limits (MRLs) in food of animal origin, and analytical methods.
  12. Regulations on gluten-free labeling in food.
  13. Review of regulations on food irradiation.
  14. Review of regulations on cellulosic materials, containers, and equipment intended to come into contact with food
  15. Review of Regulations on monomers, other substances, primers, and polymers authorized for the production of plastic containers and equipment in contact with food.
  16. Review of regulations on the registration of foods exempt from registration.
  17. Review of regulations on the labeling of allergenic foods.
  18. Review of regulations on the general labeling of packaged foods.
  19. Review of regulations on the nutritional labeling of packaged foods.
  20. Review of Good Practices for Food Services (Revision of RDC No. 216/2004).
  21. Review of hygiene and sanitation requirements and good manufacturing practices for food-producing. establishments or manufacturers (Revision of RDC No. 275/2002).
  22. Periodic update of the list of plant parts authorized for the preparation of teas and their use as spices.
  23. Regulation of the lists of novel foods and authorized ingredients and their specifications.
  24. Periodic update of the list of components, limits of use, declarations, and supplementary labeling of food supplements.
  25. Periodic update of the list of plant species Authorized names, composition, and fatty acid values.
  26. Maximum acidity limits and peroxide value for vegetable oils and fats.
  27. Periodic updates to the list of maximum permissible limits (MPLs) for contaminants in food.
  28. Periodic updates to the list of MRLs, ADIs, and DRfAs for veterinary medicinal product additives in food of animal origin.
  29. Periodic updates to the lists of food additives and processing aids authorized for use in food.
  30. Periodic updates to the lists of components, limits of use, and claims for infant formulas, transitional foods, and cereal-based foods for infants and young children, enteral nutrition formulas, and dietary formulas for inborn errors of metabolism.
  31. Regulation of the use of information transmission technology in food labeling.
  32. Regulation of formulated colorants and the labeling of colorants and flavorings in packaged foods.
  33. Regulation of foods for medical purposes.
  34. Regulation of foods of plant origin.
  35. Regulation of sanitary requirements for silicone materials in contact with food.

Brazil – Anvisa approves update of the Regulatory Agenda 2024-2025

The Collegiate Council of the National Health Surveillance Agency (ANVISA in Portuguese) approved, during the 23rd Ordinary Public Assembly of the Agency, the update of the Regulatory Agenda 2024-2025. Based on the consolidated updates, the new list of regulatory topics of the Agenda for the 2024-2025 period now consists of 171 topics, distributed in 16 macro-themes of the Agency’s activities.
Of the 117 topics, 34 are food-related issues.

As foreseen in ANVISA’s Regulatory Agenda Manual, the set of prioritized topics can be reviewed annually, with the possibility of changes, exclusions and inclusions of topics.The objective of the annual update is to keep the document aligned with the regulatory priorities of the period, to ensure predictability and timeliness of the Agency’s regulatory planning.

Brazil – Anvisa approves Regulatory Agenda 2024-2025

The Collegiate Board of Directors (DICOL in Portuguese) of the National Health Surveillance Agency (ANVISA in Portuguese) approved through the Deliberative Circuit (CD 1.312, of December 15, 2023), the Regulatory Agenda (RA) for the 2024-2025 cycle.

The document, published in Ordinance 1.409/2023, is composed of 172 regulatory topics distributed in 16 macro-themes. According to the Normative Agenda Manual, the themes are aligned with the strategic objectives of the 2024-2027 Strategic Plan and are feasible to advance during the Agenda’s term.

The construction of the RA 2024-2025 was initiated through a consultation directed to society and entities of the National Health Surveillance System (SNVS) on the regulatory topics that should be addressed by Anvisa in the next biennium. On July 21, 2023, Public Notice 9 was published to receive comments from any interested party regarding the preliminary list of 102 regulatory proposals for the Agency’s AR 2024-2025, as well as suggestions for the inclusion of other regulatory topics.

Brasil – ANVISA/Regulatory Agenda 2024-2025: preliminary list of topics is open for input

From July 31 to September 14, the society and the entities of the National Health Surveillance System (SNVS) will be able to give their opinion in the guided consultation on the preliminary list of topics proposed by Anvisa for prioritization in the RA 2024-2025. It is also possible to suggest the inclusion of other topics, in case any regulatory demand of interest is not present in the list.

Contributions can be sent through an electronic form, open to the participation of any interested party.

Food topics:

  • Review of legislation on the use of functional and/or health claims on foods.
  • General labeling of packaged foods.
  • Updated labeling requirements for major allergenic foods.
  • Labeling of foods intended for industrial purposes only.
  • Updated macroscopic and microscopic foreign matter requirements for cassava starch and flour and rice flour.
  • Sanitary requirements for silicone food contact materials.
  • Update of the regulatory framework for metallic food contact materials.
  • Update of sanitary requirements for dietary supplements (Revision of DRC No. 243/2018).
  • Edition of regulatory act on food for medical use.
  • Revision and consolidation of regulations on infant formula and enteral nutrition formulas
  • Revision of the regulation on food additives and food technology adjuvants.
  • Revision of the regulation of food additives and food technology adjuvants authorized for use in dairy products.
  • Re-evaluation of the authorization for the use of the food additive titanium dioxide in foods.
  • Nutrivigilance requirements applicable to the regulated sector, including those related to the establishment of a nutrivigilance system and the submission of mandatory periodic notifications and reports.
  • Revision of the standard for hygienic-sanitary requirements and good manufacturing practices for food producing or processing establishments.
  • Updating the regulatory framework for food irradiation.
  • Regulation of sanitary requirements for foods of plant origin.
  • Good practices for food services

Brazil – ANVISA updates Regulatory Agenda for the year 2023

Anvisa’s Collegiate Council approved the second update of the Normative Agenda 2021-2023, which will be published in the Official Gazette of the Federation. The measure was deliberated this Wednesday (12/7), during the 23rd Ordinary Public Meeting of the Agency, and defined the new current list of prioritized regulatory projects for 2023.

Based on the consolidated updates, the new updated list of regulatory projects of the Anvisa Agenda for the period 2021-2023 now comprises 159 regulatory projects, distributed in 16 macro-themes of the Agency’s activities. Consult the list in spreadsheet, with the detail of the projects and the respective justifications of the changes and exclusions made. See also the specific page of the Regulatory Agenda 2021-2023 on the portal.