On September 20, 2024, the Brazilian National Health Surveillance Agency (ANVISA) published Directive INNo 318 through the Official Gazette, amending the regulations governing food supplements (i.e., Directive No. 28 of 2018). The main elements of the revision include:

(1) Revision of the standardized name of the ingredient baobab fruit powder (Adansonia digitara) in the list of nutrients permitted for use in dietary supplements (except for supplements consumed by infants and young children aged 0-3 years);

(2) Addition of Bacillus clausii UBBC-07 to the list of nutrients permitted for use in dietary supplements for infants and young children aged 0-3 years;

(3) In the list of minimum daily intake of nutrients in dietary supplements, the minimum daily intake of EPA and DHA through dietary supplements for people aged 4-8 years has been revised from 25mg to 30mg, etc., and in the list of maximum daily intake of nutrients in dietary supplements, the maximum daily intake of EPA and DHA through dietary supplements for people aged 4-8 years has been revised from 180mg to 200mg, etc., etc. ;

(4) Revision of the list of permitted claims for food supplements, such as the addition of a new permitted claim for Vitamin B6, which is “contributes to the synthesis of cysteine”;

(5) Revision of the labeling requirements for food supplements, and addition of the requirement that the label of food supplements containing Bacillus clausii UBBC-07 should bear the warning statement “Pregnant women and lactating mothers should not consume this product, and those who are sick or taking medication should consult a doctor before consuming this product”. The Directive is effective from the date of publication in the Gazette. The Directive is effective from the date of publication in the Gazette, with a transitional period of 24 months.