Consulta Pública nº 1.338: Anvisa Proposes Updates to Additives and Technological Aids Lists for Food Use

Brazilian Regulatory Authority Seeks Public Contributions

The Brazilian Health Regulatory Agency (ANVISA) has opened a consultation period for a proposal to update its regulations concerning food additives and technological aids. The new guidelines will alter the existing rules under Instrução Normativa - IN nº 211, dated March 1, 2023. The regulatory updates focus on food additives and technological aids' technological functions, maximum usage limits, and conditions of use in food products.

The proposal, published in the Official Federal Gazette (DOU) on July 8, 2025, invites public feedback between July 15 and August 28, 2025, with a potential deadline extension depending on the volume of contributions. The initiative aims to ensure that food safety regulations align with technological advancements and global standards, keeping the regulatory framework in line with evolving industry needs.

ANVISA's decision to propose updates stems from the continuous need for adjustments to the lists of authorized additives and technological aids. These updates help ensure that technological innovations remain consistent with the foundational principles governing the safe use of these substances. Additionally, the changes are driven by issues raised by industry stakeholders, including food manufacturers, public agencies, and regulatory experts, highlighting the importance of aligning with international best practices.

Food additives are substances added intentionally to foods to modify their physical, chemical, biological, or sensory properties during production, processing, or packaging. Technological aids, on the other hand, are materials that aid in food production but are not consumed directly, and their use may result in trace residues in the final product.

The proposed updates include several changes, such as:

1. Revision of Existing Categories: Adjustments to food product categories under the existing regulations will be made. For example, the category for "Other Dairy Products" will be removed, and substances used in these products will be redistributed under the newly proposed categories, aligning with market trends.
2. New Categories and Functions: The consultation aims to introduce specific provisions for the use of additives and technological aids in "plant-based" foods, a growing segment in the global food market. This will address gaps in the current regulation, as the existing list does not cater to this rapidly expanding category.
3.  International Convergence: The updates will harmonize Brazilian regulations with international standards, particularly those established by the Codex Alimentarius, the global food safety standards body. This is part of an ongoing effort to ensure that Brazilian food safety regulations meet global expectations and are consistent with international trade agreements.

Key Dates and Consultation Process

• Public Consultation Period: July 15 to August 28, 2025.
• Status: The proposal is currently open for public comments, and stakeholders are encouraged to submit their contributions.
• Regulatory Impact: The proposal is classified as low-impact, meaning it is unlikely to cause significant disruption in industry operations, but still requires consultation to ensure that stakeholders' concerns are addressed.

The regulatory body has emphasized that updates are essential to maintaining safe food production practices and promoting innovation in the food sector. With new food trends like plant-based diets growing in popularity, regulatory flexibility is crucial to enabling food manufacturers to adapt to market demands while ensuring public safety.

The updates aim to provide clarity for food manufacturers on the substances that can be used in food products, ensuring that they are safe, effective, and aligned with the best available science. The regulatory changes will also aid in reducing trade barriers, as the Brazilian framework will increasingly reflect international norms.

Contributions from stakeholders are crucial for shaping the final regulatory outcome, ensuring that it meets the needs of the food industry while safeguarding public health. ANVISA has committed to transparency throughout the process, with all relevant documents available for public review during the consultation period.

This marks the third regulatory update attempt by ANVISA, following previous initiatives in August 2023 and November 2024. For further details you can consult the regulation (in Portughese) here.