Published last week, the Guide for Procedural Instruction for Probiotic Assessment Request for Food Use [Guia para Instrução Processual de Petição de Avaliação de Probióticos para Uso em Alimentos] outlines necessary procedures for making an application to ANVISA for use of probiotics in a food product and any related health claims, particularly around the design of supporting technical-scientific dossiers.
In Brazil, use of probiotics in food requires prior evaluation from the health agency under RDC No.241/2018; a resolution issued last year by the Collegiate Board of Directors of the National Sanitary Surveillance Agency. ANVISA evaluates applications around three main elements: unequivocal proof of the identify of the probiotic microorganism's lineage; its safety; and its beneficial effect.
ANVISA said whilst the guide was already in effect, contributions were welcome until March 26, 2020 - all of which would be evaluated as potential additions.
A 'reference for compliance'
The health agency said the guide had been developed in line with national regulations around use of probiotics in food, as well as broader international guidelines. Specifically, it outlined best practice on procedures, routines and methods deemed adequate to comply with technical or administrative requirements in Brazil when making such an application.
The guide detailed ANVISA's methodology to assess the strength of evidence provided by a company around each area of evaluation – lineage identify, safety and beneficial effect. The agency said its methodology was supported by the Brazilian scientific institution Oswaldo Cruz Foundation (Fiocruz).
ANVISA said the guide should be considered a “reference for compliance with legislation” and did not confer or create new obligations, nor was it exhaustive on the topic. Probiotics in food, it said, was an extremely broad and diverse topic, so certain applications might need additional evidence or documentation.
The agency acknowledged that while applicants could use different approaches, providing they adhered to regulatory requirements, in these cases alternative methodologies had to be “duly substantiated”.
Working closely with industry
George Paraskevakos, executive director or the International Probiotics Association (IPA), said the IPA's regulatory affairs committee, led by Lallemand's Solange Henoud, had carried out extensive work alongside ANVISA on the matter.
“IPA is happy to have been present throughout the entire journey with ANVISA for these guidelines,” he said. “From the first workshop we conducted at ANVISA headquarters back in 2015 to the culmination of a guideline which we feel is plausible and we can work with. ...We are looking forward to submitting our comments in writing from the last public stakeholder meeting and will continue to work closely with ANVISA to keep these guidelines current."
Probiotics in Brazil
Latin America represented a significant opportunity for probiotic fortified food and beverages worldwide, according to ingredients major Kerry. A recent white paper from the firm showed Brazil to be the largest and fastest-growing probiotic market in LATAM, representing 52% of the market and set to grow at a CAGR of around 11% through 2022; Mexico was second-largest at 28% of the market.
However, speaking to sister site FoodNavigator-LATAM last year, Kerry's executive director Mike Bush said while Brazil represented Latin America's biggest opportunity, consumer education remained a significant challenge. “The challenges with introducing new probiotic products and brands into untapped economies such as Latin America and China must be met with science-backed probiotics that are well-positioned and can be efficiently formulated into better-for-you versions of everyday foods and beverages,” Bush said.
“The ingredients that win out are well-studied, branded probiotics that easily convey a benefit-driven story that consumers can understand and trust.”
In May last year, DuPont won a health claim for gastrointestinal health through ANVISA for its probiotic strain Bifiodobacterium lactis HN019, opening up plentiful opportunities for brands looking to use the strain in foods and dietary supplements.
Megan DeStefano, global marketing manager for probiotics at DuPont Nutrition & Health, said at the time the company was working to get other new probiotic strains approved in Brazil.