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Public Consultation on Regulatory Harmonization in Food Receives Approval

The standard will be available for contributions for 90 days.

At the Ordinary Public Meeting held this Wednesday (22/11), Anvisa’s Collegiate Board of Directors approved a draft public consultation that deals with the conditions for carrying out an optimized procedure for analyzing evaluation petitions in the area of food. This procedure includes educational documentation issued by an Equivalent Foreign Regulatory Authority (AREE).

The regulatory proposal will be available for public consultation for a period of 90 days and will be published on the Agency’s portal to receive contributions and suggestions from both the food sector and organized civil society and other specific areas.

The objective of this proposal is to expand the conditions for the optimized analysis procedure for all assessment petitions in the food area, complementing the general criteria established by Anvisa in RDC 741/2022. It involves:

  1. Defining a list of AREEs accepted in the context of food assessment petitions;
  2. Establishing conditions and procedures for admitting new AREEs;
  3. Providing documentary and quality requirements for the limitation of decisions issued by AREE, whether as a sole or complementary reference;
  4. Structuring simplified documentary instruction routes, if AREE decisions are used as a single reference;
  5. Imposing responsibilities on interested parties who adopt the optimized procedure, in the event of review of decisions by AREE.


Collaborative and regulatory convergence practices

The adoption of collaborative and regulatory convergence practices is a fundamental strategy for Anvisa. The application of the “reliance” approach (regulatory sharing) allows the Agency to adopt recognized international practices as a reference, strengthening ties with foreign regulatory agencies and building mutual trust between these authorities.

This regulatory convergence not only establishes sounder administrative processes but also facilitates the introduction of new technologies and expands the population’s access to products regulated by the Agency. By involving organized civil society, the regulated sector, and citizens, participation in public consultation becomes a reality, promoting transparency and inclusiveness.

At Anvisa, collaborative practices have always been intrinsic to food regulation, as evidenced by various regulatory frameworks of the Agency. This includes recognizing decisions of Equivalent Foreign Regulatory Authorities (AREEs), such as Codex Alimentarius, Joint FAO/WHO Expert Committee on Food Additives – JECFA, Food Chemicals Codex – FCC, the United States Pharmacopeia Dietary Supplements Compendium – USP-DSC and references from foreign authorities.

For more details about these collaborative practices, check out the vote of the reporting director, Meiruze Freitas.