Probiotics players must negotiate patchwork of regulations in Latin America, expert says

Pineda, who is a principal in the Brussels-based firm DPE International Consulting, said Argentina presents an especially interesting case. Argentina has for a number of years been driving the process of getting a probiotics standard agreed upon through the Codex process, he said. 

“Argentina has a specific process and protocol that any product has to go through to be registered,”​ he said. “You have to substantiate the efficacy.”​

Latin America’s biggest market, Brazil, is presenting a special opportunity for probiotics, Pineda said. All common supplement ingredients, including probiotics, stand to benefit from a major regulatory overhaul that will finally recognize dietary supplements as a product category.

“In Brazil there are many things happening right now,” ​Pineda said. “In December of last year there was a public consultation process launched, affecting probiotics to be included in a list of ingredients for use in supplements.”​

Pineda told Nutraingredients-USA that the regulation overhaul has been a long time coming. ANVISA (Agência Nacional de Vigilância Sanitária, or the National Health Surveillance Agency) the country’s regulatory body for foods and food ingredients, had first started to consider the overhaul in 2008. With such a long development time already come and gone, Pineda said he was loathe to speculate as to when the overhaul will finally go into effect, but said there is reason to believe it will be before the end of this year.

Lack of one category complicated matters

As matters have stood for many years, there has been no overarching definition of what constitutes a dietary supplement. Products that would be considered dietary supplements in North America or Europe and dealt with under a unified regulatory structure were seen as add-ons to food in Brazil. And the regulations that applied to them depended on the specifics of how the formulations went beyond what nutrients could be found in unfortified foods and what a company planned to say about these isolated and concentrated ingredients on product labels and in marketing materials.

Pineda said another aspect of this regulatory overhaul in Brazil will be coming up with a standardized way to prove the efficacy and safety of the products. Once this regulatory overhaul is complete, market entry for Brazil should be more streamlined than it has been in the past. In the past, the regulations a product had to comply with were determined by the end usage, which was confusing and cumbersome. By way of comparison, Pineda said Argentina’s regulatory hoops take some time to jump through, but the process is clear and straightforward.

In the accompanying video, Pineda also offered insights into what the probiotics regulations look like in Chile, Peru and Colombia.