On July 1, 2024, the Brazilian National Health Surveillance Agency (ANVISA) issued through the Official Gazette Directive INNo304, amending the regulation on the management of food supplements (Directive 28 of 2018). Major revisions include:

(1) Add lentil powder, acerola cherry powder, hydroxytyrosol and its derivatives to the list of nutrients permitted for dietary supplements (except supplements for infants and children aged 0-3 years) (Annex 1);

(2) Add Lactobacillus Swiss R0052, Bifidobacterium longum R0033 and Bifidobacterium bifidum R0071 to the list of nutrients permitted for dietary supplements for infants and young children aged 0-3 years (Annex 2);

(3) In the list of nutrients that must be made available to consumers in the form of food supplements (Annex 3), the addition range of hydroxytyrosol and its derivatives in supplements intended for single consumption by persons over 19 years of age is specified as 5-35mg;

(4) Revise the list of allowable claims for food supplements (Annex 5), adding that Lactobacillus Swiss R0052, Bifidobacterium longum R0033 and Bifidobacterium bifidobacterium R0071 can use the "contribute to gastrointestinal health" claim, provided that the added amount meets the added amount requirements in Annex 3;

(5) To amend the labeling regulations for food supplements (Annex 6), adding the requirement that food supplement labels containing lentil powder should be marked with the warning "Pregnant women, nursing mothers and children should not consume this product".

The directive enters into force on the date of publication of the Communique.