,"Brazilian Health Regulatory Agency (ANVISA) published Directive IN No. 418 in the Official Gazette, formally amending Directive No. 28 of 2018, which governs the management of food supplements in Brazil. The new directive introduces comprehensive updates covering approved ingredients, compositional limits, permitted claims, intake thresholds, and labelling obligations, with the objective of aligning regulatory oversight with scientific developments and consumer safety considerations. The directive entered into force on the date of publication and provides a transition period of 24 months for compliance. One of the key amendments is the expansion of the list of ingredients authorized for use in food supplements. Newly approved substances for the general population include high-fiber cassava flour, refined tuna oil, magnesium citrate malate, β-nicotinamide mononucleotide, vitamin B12 obtained from Chlorella sorokiniana, olive leaf extract standardized for oleuropein, collagen oligopeptides, and quercetin, among others. In addition, the regulation introduces new ingredients specifically permitted for infant food supplements, namely bovine lactoferrin and a combined probiotic preparation containing Lactobacillus rhamnosus and Lactobacillus reuteri, which is restricted to products intended for children aged 0 to 3 years. The directive also establishes specific compositional limits for electrolyte liquid supplements. Potassium content is capped at a maximum of 700 mg per liter, while sodium content must fall within the range of 460 to 1,150 mg per liter. Furthermore, products classified as “pure electrolyte liquid supplements” are permitted only for children aged 9 years and above and adults aged 19 years and above, and their use is explicitly prohibited for pregnant and lactating women. Daily maximum intake levels have been defined for lactoferrin when used in food supplements, differentiated by age group. The maximum allowable daily intake is set at 48 mg for children aged 0 to 3 years, 100 mg for individuals aged 4 to 18 years, and 150 mg for adults aged 19 years and above. These limits aim to ensure safe consumption across population groups while supporting the use of lactoferrin in both infant and general dietary supplements. ANVISA has also revised the list of permitted claims applicable to food supplements. Notably, astaxanthin is now allowed to carry the claim “helps maintain skin health,” provided that the recommended daily serving of the supplement delivers at least 3 mg of astaxanthin. This revision reflects updated scientific substantiation requirements and clarifies conditions under which specific functional claims may be used. In addition, the directive introduces new labelling requirements for certain ingredients. Food supplements containing β-nicotinamide mononucleotide, collagen oligopeptides, quercetin, and other specified substances must include a mandatory warning statement indicating that the product should not be consumed by pregnant or breastfeeding women or by children. This labelling obligation is intended to enhance consumer awareness and mitigate potential risks associated with vulnerable population groups."
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