This update is the latest revision of a regulatory framework ANVISA established nearly a decade ago, which was designed to be updated periodically to bring Brazil’s ever-expanding dietary-supplement category under a more specific set of regulations.
“This Normative Instruction amends Normative Instruction No. 28 of July 26, 2018 [...] to update the list of constituents authorized for use in dietary supplements, the list of minimum limits, the list of maximum limits, the list of authorized claims and the list of additional labeling requirements,” the Sept. 16 update reads.
Among the newly authorized ingredients are choline, krill oil (Euphausia superba), L-cysteine and L-cystine, 6-methoxy-2-benzoxazolinone (6-MBOA), collagen, eggshell membrane hydrolysate, squalene, glycosaminoglycans, bioactive collagen peptides from hydrolyzed collagen with an average molecular weight of 3 kDa.
The regulation also establishes several new intake parameters.
For adults aged 19 and older, the minimum daily amount is 0.5 mg for 6-MBOA, 200 mg for squalene and 5 g for the specified bioactive collagen peptides. Maximum levels are set at 1.5 mg for 6-MBOA, 637 mg for squalene and 22.5 mg for glycosaminoglycans for adults, while no maximum level is specified in the new table for the 3 kDa collagen peptides. Krill oil’s permitted use is subject simultaneously to the minimum and maximum limits established for EPA/DHA and choline.
The update also expands the list of health claims that may appear on supplement labeling. For creatine, ANVISA authorizes a claim stating that daily consumption, when combined with regular resistance training, may increase the effect of resistance training on muscle strength in adults over 55. It also added authorized claims connecting 6-MBOA with improved sleep quality and 3 kDa bioactive collagen peptides with maintaining joint health. The claims are tied to specified composition and labeling conditions in the regulation.
ANVISA has also introduced additional warning requirements. Products containing 6-MBOA must carry a warning against use by pregnant or breastfeeding women or children. The label must also advise people with severe sleep disorders, diagnosed anxiety or depression, other psychological conditions or those taking medication to consult a physician.
Products containing squalene, the specified collagen peptides or eggshell membrane hydrolysate must state that they should not be consumed by pregnant or breastfeeding women or children, and krill oil products must carry a warning against consumption by children under the age of four.
The update went into effect following its publication in the Official Gazette on Sept. 18.
