The General Directorate of Medicines, Supplies, and Drugs (DIGEMID in Spanish) approves thru Directoral Resolution No. 063-2026-DIGEMID-DG-MINSAA the “List of Documents Considered Equivalent to the Good Manufacturing Practices Certificate,” whose Annex is an integral part of this Resolution. The documents not included in the list approved in Article 1 of this resolution may be consulted with the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) for the purpose of being considered equivalent to Good Manufacturing Practice certificates and incorporated into said list if applicable.
The Americas
Regulatory news in the Americas
Brazil – ANVISA modifies regulations on technological functions, maximum limits, and usage conditions of authorized food additives and technological aids
The National Health Surveillance Agency of Brazil (ANVISA in Portuguese) has published Normative Instruction IN No. 452, which amends Normative Instruction No. 211, dated March 1, 2023. This IN reviews the technological functions, maximum limits, and usage conditions of authorized food additives and technological aids.
Among the main changes, the use of ethanol as a carrier agent is now allowed in ready-to-eat breads, semi-finished breads, pizza dough, and confectionery products, with a maximum limit of 20,000 mg/kg. When the residual ethanol content exceeds 0.5% in the final product, it must be indicated on the label that the food contains alcohol. For food supplements, the phosphate limits (INS 338, 339(ii), 339(iii), 340(i), 340(ii), 341(i), 341(ii), 341(iii), and 452(i)) are set at 2200 mg/kg, expressed as phosphorus.
The IN also includes recently authorized additives: ferrous gluconate (INS 579) as a color stabilizer for olives, with a limit of 150 mg/kg (expressed as iron); neohesperidin dihydrochalcone (INS 959) as a sweetener, with limits of 400 mg/kg for liquid syrup supplements, 50 mg/kg for other liquids, and 100 mg/kg for solid supplements; and silicon dioxide (INS 551) as an anti-caking agent, authorized in sufficient quantity for powdered products.
Brazil – Congressman is confident in a quick approval of health regulations for dietary supplements
Deputy Felipe Carreras (PSB-PE) stated that he believes in the swift approval of the proposals that expand health control and sanctions for fraud and misleading advertising regarding dietary supplements. The three bills (PL 5229/25, 5319/25, and 6000/25), recommended by the working group he coordinated in the Chamber of Deputies, already have urgent approval and are therefore ready for a vote in the Plenary. In addition to criminalization and increased fines for irregularities, the proposals focus on food security.
The congressman argued that the regulation of this sector cannot be limited solely to the resolutions of Anvisa (Brazilian Health Regulatory Agency), as is currently the case.
“There is no national law on this matter.” There is an RDC, which is a resolution from the board of directors of Anvisa (National Health Surveillance Agency of Brazil). Recently, we had a serious problem with a brand of milk, with a batch that caused gastrointestinal symptoms in children. That batch was withdrawn from the market. Do you know what penalty that big company received? None. Today, the problem with the mineral water has been reported, where a batch is being withdrawn because it contains bacteria. “Maybe it will only receive an administrative sanction,” he complained.
Felipe Carreras is expected to be the rapporteur for the proposals related to the health control of dietary supplements in the full House. The deputy recalled that in the working group’s hearings, all involved sectors were heard, from companies to doctors and nutritionists.
Brazil – A bill prohibiting the supply of ultra-processed foods in the public transportation system is presented in the Chamber of Deputies
Bill 1094/26, presented by Deputy Sidney Leite (PSD-AM), prohibits air, rail, land, and river transport companies operating in Brazil from offering ultra-processed foods to passengers. The text is currently under review in the Chamber of Deputies.
According to the Dietary Guidelines for the Brazilian Population from the Ministry of Health, ultra-processed foods are those produced industrially and that have a high content of additives (such as preservatives, sweeteners, and colorants), sugars, fats, and sodium.
“The proposal aims to promote healthier food environments.” In addition to promoting the substitution of fresh or minimally processed foods, the measure helps to raise public awareness about food safety and reduce the negative impacts of excessive consumption of ultra-processed foods,” states the project author.
Brazil – Supreme Court of Justice compiles resolutions on the right to information in product packaging and labeling
The Superior Court of Justice (TSJ) published a compilation of resolutions related to the right to information about the packaging and labeling of products sold in the country, in order to ensure that consumers have access to essential data about the composition and health risks, without imposing unfeasible or disproportionate burdens on suppliers.
Among the notable precedents, the Superior Court of Justice (STJ), in the ruling of Special Appeal No. 1,185,323, established that beers with an alcohol content of up to 0.5% cannot bear the designation “non-alcoholic” on their labels. Under the direction of Minister Laurita Vaz, the court ruled that, although the administrative regulation classifies such beverages as non-alcoholic, the protection guidelines of the Consumer Protection Code (CPC) prevail to prevent the public—especially people with medical or religious restrictions—from being misled.
On the contrary, in the ruling REsp No. 1,605,489, the Third Panel exempted wine producers from indicating sodium and calorie values, understanding that the sector has its own regulations from the Ministry of Agriculture and that the principle of specialty should guide the labeling of such beverages.
Another relevant precedent analyzed by the Court, REsp 1.788.075, refers to the presence of genetically modified organisms (GMOs), popularly known as transgenic organisms. The Court validated a federal decree that limits the mandatory labeling of GMOs only to foods with a concentration higher than 1%, justifying that minimal accidental contamination during the storage and transportation of grains would make production unfeasible if the absolute absence of traces were required.
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