BRAZIL – DuPont Nutrition and Health has received approval for its Bifidobacterium lactis HN019™ probiotic strain from the Brazilian Health Regulatory Authority (ANVISA) to market it in Brazil with a claim that the ingredient contributes to gastrointestinal health.
ANVISA granted the approval after assessing four clinical trials to determine whether the strain had a positive effect on gastrointestinal health, reports FoodBev.
According to the trial, daily consumption of HN019 enhanced cellular immune activity in healthy elderly adults, and with this evidence, ANVISA ruled out that DuPont’s health claim on the strain was legit.
Consumption of HN019™ was also found to modulate the composition of gut microbiota favourably – even at a low dose.
According to DuPont, the ruling will enable them include the health claim on product packaging of food and supplements which contain the strain in the Brazilian market.
NVISA stepped up its requirements for approving probiotic-enriched products since 2015 demanding documentation of safety or efficacy.
“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 manager, South America, at DuPont Nutrition & Health.
The new strain is an addition to DuPont’s extensive portfolio of scientifically proven probiotic cultures for foods and dietary supplements which the company claim brings value to the food and beverage industries while improving nutrition and reducing food waste globally.
“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 as well as in Japan, where HN019 was recorded to improve transit 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 of probiotics at DuPont Nutrition & Health.