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.
Day: 18/06/2026
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.
infoAlimentario 