Regulatory Agenda

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

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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.

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Brazil – Anvisa approves Regulatory Agenda 2024-2025

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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.

For further information, you can access the original source in Portuguese

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

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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

For further information, you can access the original source in Portuguese

Brazil – ANVISA updates Regulatory Agenda for the year 2023

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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.

For further information, you can access the original source in Portuguese

The Americas – Brazil: ANVISA updates the Regulatory Agenda for the year 2022 including those related to food

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Anvisa’s Collegiate Council has just approved the annual update of the 2021-2023 Regulatory Agenda, originally published in May 2021. As foreseen in the Guiding Document of the Regulatory Agenda – IA 2021-2023, the set of regulatory projects of the Agenda may be reviewed annually, with the possibility of alterations, exclusions and inclusions of projects. The purpose of the annual update is to keep the document aligned with the regulatory priorities of the period, to ensure the predictability and timeliness of the Agency’s regulatory planning.

In Food:

  • Foods for Infants, Toddlers, Teats, Pacifiers and Bottles.
  • Functional and Health Claims on Foods
  • Labeling of packaged foods
  • Food contact materials.
  • Food identity and quality standards.
  • Flows and procedures for authorizing the use of food additives and processing aids.
  • Flows and procedures for new ingredients
  • Food irradiation
For further information, you can access the original source in Portuguese