Fórmulas infantis para lactentes no Brasil: um estudo da legislação e da literatura

Introduction: Nutrition in the first months of life is crucial for child development, and breastfeeding is widely recommended by institutions such as the World Health Organization (WHO) and the Brazilian Ministry of Health. However, in situations where breastfeeding is not possible, infant formulas have emerged as an essential alternative. In this context, understanding the Brazilian regulatory framework for these formulas is fundamental to ensuring food safety and product quality. Objective: To describe how Brazilian legislation regulates the formulation, commercialization, microbiological quality, and use of infant formulas (IF) for infants, as well as to analyze the implications of this regulation for public health and the infant food market. Method: This is a narrative review study of the literature and national legislation regarding IF. Resolutions from the National Health Surveillance Agency (Anvisa), federal laws, and technical standards were consulted, in addition to scientific articles published between 2014 and 2024 in databases such as SciELO, LILACS, PubMed, and Google Scholar. The descriptors used were “infant formulas,” “nutritional composition,” and “Brazilian legislation.” Results: The analysis showed that Brazil has a robust set of regulatory instruments, including Law No. 11,265/2006 (NBCAL) and Resolutions RDC No. 43, 44, and 45/2011, which regulate the composition, labeling, and commercialization of IF, as well as RDC No. 429/2020, which defines rules for nutritional labeling. RDC No. 724/2022 is also noteworthy, as it establishes strict microbiological standards. Reviewed studies indicated that, although most IF partially comply with current legislation, nonconformities were mainly related to labeling and nutritional composition. Conclusion: The analyzed studies revealed at least one nonconformity with current legislation, highlighting the need for infant formula manufacturers to adapt their products to the relevant regulations and for health authorities to intensify inspections to ensure greater effectiveness in law enforcement, thus guaranteeing product quality and protecting infant health.