,Brazils National Health Surveillance Agency (Anvisa) has opened a regulatory process proposing a new normative act linked to a Draft Resolution of Anvisas Collegiate Board that establishes updated requirements for Good Practices, the Hazard Analysis and Critical Control Points (HACCP) system, and Standard Operating Procedures (SOPs) to be implemented throughout the food production chain.
The proposal is driven by public health concerns and Brazils constitutional obligation to ensure the right to health and safe food, as set out in Article 6 of the Federal Constitution. Anvisa highlights the global burden of foodborne diseases, referencing the World Health Organizations 2015 report on the Global Burden of Foodborne Diseases, which estimated that around 600 million people worldwide fall ill each year due to contaminated food. The report identified 31 major biological and chemical hazards responsible for foodborne and waterborne diseases.
According to Anvisa, foodborne illnesses are largely associated with failures in hygienic and sanitary controls, particularly the non-compliance with Good Manufacturing Practices (GMP) and insufficient implementation of HACCP-based preventive systems by food manufacturers and processors. Such gaps increase the risk of unsafe food reaching consumers or food products failing to meet quality standards.
The proposed normative act aims to strengthen regulatory requirements by reinforcing:
Mandatory adoption of Good Practices in food manufacturing establishments;
Systematic application of HACCP principles for identifying, evaluating, and controlling food safety hazards;
Implementation and documentation of Standard Operating Procedures (SOPs) to ensure consistency, traceability, and effective process control.
The regulatory initiative is part of Anvisas 20242025 Regulatory Agenda (Item 3.26), which focuses on revising GMP standards for food manufacturing establishments. The process has undergone a Regulatory Impact Analysis (RIA), which has been approved, and a Public Consultation, which has been completed.
Food business operators and stakeholders were invited to submit contributions through an official online form, with Anvisa emphasizing transparency and stakeholder engagement. The proposal is being handled by the General Management of Sanitary Inspection and Inspection (GGFIS), with rapporteurship by Daniel Meirelles Fernandes Pereira.
If adopted, the new regulation is expected to enhance food safety governance in Brazil, reduce foodborne disease risks, and align national food hygiene controls with internationally recognized preventive approaches.