MAPA OR ANVISA? UNDERSTAND WHEN EACH AUTHORITY IS RESPONSIBLE FOR REGULATION

The National Health Surveillance Agency (ANVISA) acts as the guardian of public health in Brazil. Its primary mission is to protect the population by controlling and inspecting products and services that may pose a risk to human health. This covers everything from the research and development phase to the marketing and advertising of items that are essential for the well-being and safety of citizens.

ANVISA focuses its work on sectors that directly impact consumer health and safety. This includes the strict control of medicines and pharmaceutical supplies, from their manufacture to their distribution. In the field of cosmetics, the agency regulates personal care products, perfumes and make-up. Sanitizers, such as cleaning products and disinfectants, also fall under its remit. In addition, ANVISA is responsible for regulating health products, popularly known as correlates, which include medical equipment, materials for use in health and diagnostic devices.

When it comes to food, ANVISA focuses on the sanitary and public health aspects of the end product, complementing MAPA's work. This involves regulating food additives and processing aids, establishing their maximum limits and conditions of use. An analysis of the products regulated by ANVISA reveals that the agency deals with items of direct consumption that are highly sensitive to human health.

The Ministry of Agriculture and Livestock (MAPA) is the body responsible for managing public policies to stimulate agriculture, promoting agribusiness and regulating and standardizing services linked to the sector. Its activities are vast, ranging from primary production in the field to the processing and distribution of agricultural products, with the aim of guaranteeing food security for the Brazilian population and the sector's competitiveness in the national and international markets.  

MAPA's scope of action is focused on the agricultural production chain. One of its most crucial areas is Agricultural Defense, which encompasses animal and plant health defense, the inspection of products of animal origin (such as meat, dairy products, eggs and honey) and products of plant origin (such as grains, fruit and vegetables). This area is also responsible for registering establishments and products in the sector. MAPA also regulates agricultural inputs, including fertilizers, pesticides, seeds, feed and biological products. The production and certification of organic products is also under the Ministry's supervision.

The breakdown of MAPA's duties shows an intense focus on agricultural defense, inspection of products of animal and plant origin, and registration of establishments and products. This means that MAPA acts at the base of the production chain, ensuring health and quality from the farm to the initial processing industry. Its work is vital for the country's food safety, guaranteeing that raw materials and agricultural products reach the market with quality and health standards that prevent diseases and ensure the integrity of the food.

It is in the food and beverage category that the distinction between the competencies of ANVISA and MAPA can become more challenging for companies. Both bodies play crucial roles, but with different focuses, which creates doubts as to which is the primary regulator. Although Brazilian legislation seeks to avoid duplication of inspection, interpretation and application can be complex.

The practical distinction lies in the criteria of origin, processing and purpose of the product. MAPA, on the one hand, tends to regulate products of animal and plant origin in their primary form or with more basic processing, focusing on the quality, identity and health of the raw material and the agro-industrial product. ANVISA, on the other hand, focuses more on the public health aspects of the end product, such as additives, contaminants, nutritional labeling and microbiological standards, with an emphasis on safety for human consumption, regardless of origin.

The information available makes it clear that regulation is not an “either/or” choice in all cases, but rather a shared responsibility with complementary focuses. For companies, this means that the analysis of the product must be thorough, taking into account its composition, processing, purpose and distribution channel. It's not just about knowing “who” regulates, but “what” each regulates within the chain. Lack of clarity can result in misguided regulatory efforts, wasted resources and risks of non-compliance.

Regulatory compliance is not just a legal requirement; it is a fundamental strategic investment for the longevity and success of any business. Non-compliance can lead to serious consequences, such as high fines, establishment bans, product seizures, lawsuits and, perhaps most damagingly, irreparable damage to a company's reputation and credibility. Being up to date with regulations, on the other hand, guarantees legal certainty, opens doors to new markets and strengthens the brand's image in the competitive landscape.

Navigating the complex regulatory maze of ANVISA and MAPA requires in-depth knowledge and experience. This is where Stone Okamont stands out as an indispensable strategic partner.

By offering a comprehensive and specialized service, Stone Okamont not only helps to avoid these risks, but also speeds up the process of entering the market and ensures continuity of operations. Hiring a consultancy like Stone Okamont transforms regulatory compliance from a bureaucratic burden into a manageable and strategic process, freeing the company to focus on its core business, while working to ensure that all legal requirements are met efficiently and safely.