Brazil Updates Authorized Ingredients, Claims and Labeling Rules for Food Supplements

On May 15, 2025, the Brazilian National Health Surveillance Agency (ANVISA) released Normative Instruction IN No. 361/2025, amending Normative Instruction IN No. 28/2018, which outlines the lists of components, limits of use, claims and complementary labeling of food supplements.

The amendments, which took immediate effect, primarily revise the annexes of IN No. 28/2018. However, a 24-month grace period has been granted to businesses for compliance and necessary adjustments.

Amendments to Annex 1

Annex I lists constituents authorized for use in food supplements, excluding those intended for infants (0–12 months) and young children (1–3 years). The updates include the addition of a new source of vitamin D and two new bioactive substances.

Nutrients
Vitamin D	CAS
Calcidiol obtained from Saccharomyces cerevisiae ^xii	63283-36-3
Bioactive Substances
Phenolic compounds of Opuntia ficus-indica	CAS
Opuntia ficus-indica extract	/
Xylooligosaccharides	CAS
Xylooligosaccharides	/

^xii Constituent allowed only for food supplements indicated for individuals over 11 years of age, including pregnant and breastfeeding women.

Amendments to Annex 3

Annex 3 establishes minimum limits for constituents in food supplements, based on daily consumption recommendations and target population groups. The amendments introduce the minimum intake limits for two bioactive substances and revise footnote iii.

Bioactive substances	Units	Population groups
Bioactive substances	Units	0-6 months	7-11 months	1-3 years	4-8 years	9-18 yeas	≥ 19 years	Pregnant	Lactating
Phenolic compounds of Opuntia ficus-indica	mg	NA	NA	NA	NA	NA	NE (as niacin equivalent)	NA	NA
Xylooligosaccharides	mg	NA	NA	NA	NA	NA	NE (as niacin equivalent)	NA	NA

ⁱⁱⁱ As Cholecalciferol. 1 μg cholecalciferol = 40 IU Vitamin D = 0.3333 μg calcidiol.

Amendments to Annex 4

Annex 4 defines maximum limits for constituents in food supplements by daily recommended intake and population group. The amendments add upper limits for the same two bioactive substances and update footnote iii.

Bioactive substances	Units	Population groups
Bioactive substances	Units	0-6 months	7-11 months	1-3 years	4-8 years	9-18 yeas	≥ 19 years	Pregnant	Lactating
Phenolic compounds of Opuntia ficus-indica	mg	NA	NA	NA	NA	NA	54.6	NA	NA
Xylooligosaccharides	mg	NA	NA	NA	NA	NA	2	NA	NA

ⁱⁱⁱ As Cholecalciferol. 1 μg cholecalciferol = 40 IU Vitamin D = 0.3333 μg calcidiol.

Amendments to Annex 5

Annex 5 lists authorized claims for food supplements, along with required conditions for use. The amendments add three authorized health claims for astaxanthin.

Constituents	Authorized claims	Specific composition and labelling requirements
Astaxanthin	Astaxanthin is an antioxidant that can help protect against free radical damage.	The claim is restricted to food supplements whose minimum amount of astaxanthin provided in the daily consumption recommendation of the product is 2 mg.
	Astaxanthin may aid in visual accommodation.	The claim is restricted to food supplements whose minimum amount of astaxanthin provided in the daily consumption recommendation of the product is 4 mg.
	Astaxanthin can help reduce eye strain.	The claim is restricted to food supplements whose minimum amount of astaxanthin provided in the daily consumption recommendation of the product is 5 mg.

Amendments to Annex 6

Annex 6 outlines additional labeling requirements. The amendments introduce warnings for the following constituents:

Constituents	Additional labeling requirements
Calcidiol obtained from Saccharomyces cerevisiae	The warning "This product should not be consumed by children under 11 years of age." should appear on the product labeling.
Phenolic compounds of Opuntia ficus-indica	The warning "This product should not be consumed by pregnant women, breastfeeding women and children." must appear on the product labeling.
Xylooligosaccharides