On July 1 , 2024 , the Brazilian National Health Surveillance Agency ( ANVISA ) issued Directive INNo304 through the Government Gazette to revise the food supplement management regulations (i.e. Directive No. 28 of 2018 ). The main contents of the revision include:

( 1 ) New substances such as lentil powder, acerola cherry powder, hydroxytyrosol and its derivatives have been added to the list of nutrients permitted for use in dietary supplements ( except for dietary supplements for infants and young children aged 0-3 years) (Annex 1 );

( 2 ) The list of nutrients permitted for dietary supplements for infants and young children aged 0-3 years (Appendix 2 ) includes new substances such as Lactobacillus helveticus R0052 , Bifidobacterium longum R0033 and Bifidobacterium bifidum R0071 ;

( 3 ) The list of nutrients that must be provided to consumers in the form of food supplements (Annex 3 ) stipulates that the amount of hydroxytyrosol and its derivatives in a single serving of supplements for people over 19 years of age should be within the range of 5-35 mg ;

( 4 ) Revised the list of claims permitted for food supplements (Annex 5 ), adding Lactobacillus helveticus R0052 , Bifidobacterium longum R0033 and Bifidobacterium bifidum R0071 as being allowed to use the claim of “contributing to gastrointestinal health”, provided that the added amount meets the requirements of the added amount in Annex 3 ;

( 5 ) The food supplement labeling regulations (Annex 6 ) were revised to include a new requirement that food supplements containing lentil flour should include a warning that “Pregnant women, breastfeeding mothers and children should not consume this product”.

This directive shall take effect from the date of publication in the Gazette.

For more information, see: