Organised by NutraIngredients-Asia, the theme of the day was “Opportunity Asia and Middle East: Regulations and Market Access Decoded” – featuring insights in the probiotic regulatory development space across Southeast Asia, South Korea, China, and the Middle East.
With the rapid growth of the probiotic industry, regional regulators are now stepping up to regulate the category.
For example, Indonesia had introduced the 2021 Guidelines for the Assessment of Health Supplements Products Containing Probiotics in June.
The purpose was to provide guidance for conducting independent assessment of probiotic supplements before a company submits its registration to the authority.
Probiotics that have no record of use or approval in the country would also need to go through safety assessment first, said Wai Mun Poon, founder of Wong SJ Asia, an expert in Southeast Asia regulations.
“You will notice that the regulators are paying a lot of attention on the probiotic products. For example, Indonesia has introduced a new regulation for the use of probiotic ingredient in health supplements, as well as for Thailand and the Philippines.”
At the moment, there is no harmonised approach to regulate probiotics in Southeast Asia, and Poon stressed that it would be crucial for companies interested in the region to know the difference in regulations.
“In Thailand and Philippines, the permitted probiotic claims applicable to food can also be applied to supplements.
“However, in Malaysia, if an ingredient is approved for use in the health supplement, it doesn’t mean that it can be used in food and vice versa.
“It is very important to understand how the products are classified and look at the right regulations,” she said.
She added that the other challenge would be the restrictions in the permitted bacteria genus and health claims.
The key challenge will be that most of the regulatory agencies only recognise lactobacillus and the bifidobacterial as the permitted source of probiotic ingredient.
As for the health claims, the commonly recognised function is for digestive health. And so, if you are thinking of bringing some innovative products with new claims or new strains, it might be difficult.
- Wai Mun Poon, founder of Wong SJ Asia, expert in Southeast Asia nutraceutical regulations
Elsewhere in South Korea, regulators are keeping a close eye on non-compliant probiotic products.
As such, companies that are importing to South Korea should pay close attention to the customs clearance process.
“Early this year, the Ministry of Food and Drug Safety (MFDS) has conducted a crackdown on a couple of probiotics that have repeatedly failed in terms of product conformity,” said Dr. Sun-Ho Frank Kim, founder of Seah Bio Solutions.
Some of these products had bacteria count that was lower than the labelled amount and coliform was also detected in some of them.
“As such, before shipping the products in commercial scale to Korea, the suppliers and the importer should conduct a pre-test,” said Dr Kim.
On the other hand, he noticed that the Korean authorities have been keeping tabs on products sold via cross-border e-commerce, with the purpose of sieving products with exaggerated claims and those containing non-compliant ingredients.
The authority has just started to regulate cross-border sales as well under the Health Functional Food act.
For the cross-border sales, the shippers should be very careful because the authority is starting to conduct random pickup and inspection at the product quarantine stage.
- Dr. Sun-Ho Frank Kim, founder of Seah Bio Solutions, expert in South Korea's nutraceutical regulations
In the case of China, the registration process of probiotics is said to be much more difficult than the other types of health foods.
In fact, this is especially so when registering probiotic health foods for infants.
You can use the probiotic strains from the positive list for food and infant food.
[However], I suggest that you only develop probiotic health food for people over the age of three. It is almost impossible to get the blue hat registration for probiotic health foods made for infants.
In fact, the probiotic health food registration is more difficult than other health food registration because very specific materials are required.
- Cathy Yu, GM of the food division and senior food regulatory consultant at CIRS
She added that it usually would take about three years to obtain registration approval from the SAMR – which the bulk of the process spent on product testing.
In the Middle East, consumer bodies are demanding authorities to set regulatory standards to prevent probiotic products from making misleading claims.
At the moment, there is no specific regulatory standards and classification for probiotics in most countries in the Middle East, said Dr Majed M Abukhader, associate professor at the College of Pharmacy at the National University of Science and Technology, Muscat in Oman.
Unlike the US, Canada, Australia, and India, he said that there has been insufficient information on how probiotic supplements were being categorised.
This issue is important because in recent years, in the Egyptian societies, as well as consumer care bodies, there are concerns regarding health claims [made by probiotics].
Some of these probiotic products, including the dairy and non-dairy ones, have made some claims on the outer product package, claiming that the product is healthy for the gut or can boost the immunity.
The consumer bodies are actually concerned about the misleading claims, so they are demanding better or much stricter regulatory requirements.
- Dr Majed M Abukhader, associate professor at the College of Pharmacy at the National University of Science and Technology, Muscat
In the region, Iran is perhaps the most advanced in terms of its probiotic regulations.
This is because the country, alongside Egypt, is starting to push for innovation in probiotic products, and this has led to the growth of the entire ecosystem.
Dr Abukhader also said that Iran has developed a set of national standards for probiotics.
In the other parts of the Middle East, most of the probiotics consumed are in the form of fermented dairy products, instead of probiotic supplements.
This is because dairy products are cheaper than probiotic supplements. Also, most of the countries lacked the investment, R&D infrastructure, a competitive probiotic industry in building their own probiotic supplements, according to Dr Abukhader.
This means that virtually all probiotic supplements sold in the Middle East are imported products, although Egypt has started on producing its own supplement, while an Iranian pharmaceutical company is producing probiotic supplements under license from Probi.
On the other hand, there is a lack of awareness among healthcare professionals about the benefits of probiotics, and so, they tend not to prescribe probiotics to consumers.
Across APAC, South Korean probiotic brands have managed to build strong connections with their domestic audience – a similar trend seen in China, while domestic engagement is weak in India.
“In South Korea, we can see that 64 per cent of the products that are available [online] are domestic brands.
“But more importantly, they have generated 81 per cent of the online engagement.
“These domestic companies clearly know how to resonate with the local consumers, how to engage them, [have consumers] appreciate their product and review the products online,” said Ewa Hudson, director of insights at Lumina Intelligence.
Dr Kim added that the consumers have good knowledge of probiotics and that the authorities have been willing to assess and permit new health claims on probiotics.
In China, local brands have also managed to build strong connections with their domestic audience, but the connection was not as strong when compared to South Korea.
“In China, we have 52 per cent of the local players and local products on the market delivering 67 per cent of the reviews.
“Again, there is strong position of local players in digital marketing, but maybe not as strong as their counterparts in Korea.”
As compared to South Korea and China, local Indian probiotic brands have received low interest and engagement from their domestic audience.
“Forty-three per cent of the products sold were local products, but they only delivered 14 per cent of the engagement.
“So obviously the engagement will be coming from international brands, and not from the local players,” said Hudson, who added that this meant tremendous opportunities for overseas brands to grow in India.