DuPont Nutrition & Health today announced it has received approval from the Brazilian Health Regulatory Agency (ANVISA) recognizing a health claim for the Bifidobacterium lactis HN019™ probiotic strain. Customers in Brazil can now bring new probiotic foods and dietary supplements faster to market using the first DuPont probiotic to qualify for an approved health claim in the local market.
The approved health claim is an important win for DuPont – and a powerful recognition of the science behind the Bifidobacterium lactis HN019™ probiotic strain.
Eligible for on-pack claim
The approval means foods and supplements containing the strain can now include the claim ‘Bifidobacterium lactis HN019™ may contribute to gastrointestinal health’ on product packaging.
"During its careful evaluation process, the health authority has recognized the potential health effect of HN019™ and our expertise as a reliable probiotic supplier. For our customers, it means the approval process for their products is more likely to be swift and successful," said Carolina Zago, regulatory affairs South America, DuPont Nutrition & Health.
Documented by science
Since 2015, when ANVISA stepped up its requirements for approving probiotic-enriched products, many applications have failed due to insufficient documentation of safety or efficacy. This makes the approval of HN019™ a particular triumph.
Numerous in vitro and clinical studies have documented the positive effect of HN019™ on gastrointestinal health and immune function. In two dietary intervention studies, consumption of HN019™ was seen to modulate the composition of gut microbiota favorably – even at a low dose.
A meta-analysis of four clinical trials also has shown that daily consumption of HN019™ enhances cellular immune activity in healthy elderly adults.
A gut ecosystem in balance
"Our gastrointestinal system is an extremely complex ecosystem – and represents our greatest area of contact with the environment. We rely on our gut microbiota to digest and absorb nutrients, excrete waste products and stimulate the body’s immune response, so we are better protected from potential pathogens," explained Daniel Borges, dietary supplements sales manager, DuPont Nutrition & Health.
"By approving this health claim, ANVISA has recognized the ability of HN019™ to help keep that ecosystem in balance."
Among scientists, a higher concentration of Lactobacillus and Bifidobacterium in the intestine is broadly associated with a healthier gastrointestinal tract.
Collaboration is key in approval process
DuPont has an extensive portfolio of scientifically proven DuPont™ Danisco® probiotic cultures for foods and dietary supplements and can deliver probiotic supplements ready for sale in a range of formats. Much of the probiotic research is conducted at the dedicated DuPont Health & Nutrition Center working in collaboration with in-house regulatory experts and external bodies.
"We are continuing our work to get new probiotic strains included on the positive list in Brazil. This hard works follows success in Switzerland where DuPont™ Danisco® Bifidobacterium lactis HN019™ probiotic also was recognised as supporting digestion by reducing transit time as well as in Japan where HN019™ was recorded to improve defecation for those suffering from constipation allowing food manufacturers to state a health claim on the product. These positive outcomes further validate the strong scientific evidence DuPont has on the link between digestive health and probiotics, and we look to build on these approvals in the future," said Megan DeStefano, global marketing manager, Probiotics, DuPont Nutrition & Health.
Find out more about our probiotic strains at www.danisco.com/product-range/probiotics/.