Brazilian regulators open the door to supplement and probiotic innovation

1 Feb 2021

Health claim approvals for dietary supplements and probiotics in Brazil are opening the door to market innovation, says one expert – but more work is needed to ensure full consumer transparency.

In the final months of 2020, Brazil’s National Health Surveillance Agency (ANVISA) updated rules around formulations, dosage and usage limits, authorised health claims and labelling for food supplements. The norm was approved by the agency’s collegiate board and published in the Federal Official Gazette.

Brazilian regulators open the door to supplement and probiotic innovation

The new rules are advantageous for brands using certain ingredients. Food manufacturers that use resistant corn starch in their products, for instance, are now able to make a health claim, informing consumers that the nutrient helps absorb calcium from food and retain it in bones, provided the food or supplement provides at least 10 g of resistant corn starch fibre as part of the daily recommended intake.

Dietary supplement brands can also claim that type II undenatured collagen assists in maintaining joint function, when a minimum amount of 10 mg total collagen is used.

The regulation also clarifies the warning labels that some ingredients must bear on their packaging. Supplements containing glucosamine L-methylfolate, for instance, must warn consumers: "In pregnant women, it should be assessed whether the maternal condition justifies the potential risk to the foetus, considering that the evidence is very limited to determine the risk of glucosamine in pregnancy."

Manufacturers have two years to ensure their products are compliant with the new rules.

Probiotic innovation

Dafné Didier, head of regulatory and quality affairs at Tacta Food School, a consultancy headquartered in Fortaleza, said the regulations were created to guarantee that products meet legal requirements regarding constituents, dosage, health claims, and limits, and to accommodate industry innovations.

One company looking to benefit from a recent ANVISA approval is Kerry, which manufacturers the probiotic Bacillus coagulans GBI-30 6086 and commercialises it under the brand name Ganeden BC30. In November last year, ANVISA backed the claim that the probiotic contributes to gastrointestinal health in adults and children over the age of three.

John Quilter, vice president of Kerry’s ProActive Health global portfolio said the approval had sparked a “refreshed interest” in Ganeden BC30.

“All across Latin America consumers are interested in food products with additional benefits for their health and wellbeing,” he said. “Brazil is a very dynamic market regarding innovation and consumers are very aware of the connection between what they eat and drink and their general wellbeing. GanedenBC30 has a very solid scientific background that demonstrates its digestive health benefits and our customers are very interested in it, therefore we knew we had to request the approval from the local authorities for our customers to communicate more effectively to their consumers.”

Kerry conducted its own market research in Brazil and found that 49% of the 800 individuals surveyed had either used products with beneficial bacteria, such as probiotics, over the past six months or would consider doing so.

According to Kerry, Ganeden BC30 is a hardy, spore-forming probiotic which means it is more resistant to processing conditions than other strains and can survive in the food matrices consumers expect to find probiotics, such as yoghurts, breakfast bars, juices and snacks.

In order to be marketed and sold in Brazil, all finished products containing GanedenBC30 must carry the new claim, register their product separately with ANVISA, and include all required disclaimer statements on packaging.

More action needed

Although the recent regulation gives consumers more clarity, Didier believes that more action is needed to ensure full transparency.

“[…] I still believe that a good part of consumers has difficulties understanding the information that is on the labelling of products,” he told The Ingredients Network.

“Even among those who consume [them] with a certain frequency, there is a lot of information on food supplements that needs a greater reading by the consumer for understanding. I believe that we are better than before, but we still need to work more in order that the principle of information and transparency is fully attended.”

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