Kyowa Hakko Bio, a subsidiary firm of Kirin, says its postbiotics is now approved for use in general foods and health supplements in India.
The Food Safety and Standards Authority of India (FSSAI) approved IMMUSE in August, a proprietary Lactococcus lactis strain Plasma (LC-Plasma) postbiotic, for use in general foods and health supplements.
Outside of India, the ingredient is already used in a variety of functional foods, beverages, and supplement items. Kirin’s Foods with Function Claims (FFC) series, branded as iMUSE in Japan, is one example. In fact, the substance is the first to be recognized for its immunological health advantages by Japan’s Consumer Affairs Agency (CAA).
The company has received approval to sell its postbiotic ingredient in Vietnam. The registration in countries around the region, such as Indonesia, Malaysia, and Thailand, however, is still underway.
Dr Ryo Ohashi, managing director, Kyowa Hakko Bio Singapore, believes that the strong history of dairy, natural products, and probiotics use, could help promote postbiotic consumption in India. “India has a big population, which is why we are interested in this market. Also, India has a strong history in dairy and probiotics use. People know the benefits of probiotics.
“Although our ingredient is a postbiotic and it functions a bit differently from probiotics, the concept itself is close to that of probiotics. As such, we believe that customers in India will be receptive to the idea of using a postbiotic,” said Dr Ohashi.
The company had filed a registration with the FSSAI in January this year and the green light was given earlier than its registrations submitted elsewhere. This included Indonesia and Thailand, where a registration was filed about two years ago, while a registration was also filed in Malaysia about a year ago.
Unlike probiotics, there is no clear regulatory framework for postbiotics in many countries, which could pose as a challenge to the industry. “India’s regulators see our ingredient as a parabiotic instead of postbiotics. We need to explain to them what a postbiotics is,” he said.
A 2020 paper published in Microbial Cell Factories describes postbiotics as “the complex mixture of metabolic products secreted by probiotics in cell-free supernatants such as enzymes, secreted proteins, short chain fatty acids, vitamins, secreted biosurfactants, amino acids, peptides, organic acids.”
Paraprobiotics, on the other hand, are described as “the inactivated microbial cells of probiotics (intact or ruptured containing cell components such as peptidoglycans, teichoic acids, surface proteins, etc.) or crude cell extracts (i.e. with complex chemical composition)”.
So far, the FSSAI has published a list of permitted pre- and probiotics.
Asked the registration process for postbiotics, he said that the Indian authorities had asked about their human clinical trial findings, as well as whether the postbiotic has already received approval in other countries. IMMUSE currently enjoys the self-affirmed GRAS status in the US, which he said was “good supporting data.”
There are also concerns coming from the Indian authorities on whether postbiotics will produce antibiotic resistant effects. “This is a dead cell, but regulators still see it as probiotics, live cells. They will ask if it is antibiotic resistant,” he said.
In 2021, the International Scientific Association for Probiotics and Prebiotics (ISAPP) published a consensus statement in Nature Reviews Gastroenterology & Hepatology defining postbiotic as “a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host”.
“As the authorities only have the framework for probiotics, they will tend to adapt the framework that they use for probiotics to define postbiotics. “There are physical differences between pro- and postbiotics, but there’s still confusion, even with the regulators,” added Amy Lau, business development and marketing lead.
