ASEAN is a culturally diverse region with 10 member states and a combined population of about 650 million. Its nutraceutical market is growing at a CAGR of 8.4%, with about 40% of the population consuming nutraceuticals daily.
However, ASEAN does not have a harmonised regulation for the registration of nutraceuticals, and companies looking to explore the market must register the product following current laws in these countries.
One author of a recent review article on this issue, Dr. Lal Hingorani told NutraIngredients-Asia: “Nutraceuticals are selling under different heads mainly, vitamins and minerals, herbal or botanical products, and probiotics. Around the world, countries are trying to have similar laws for registration and marketing products, but as yet, no consensus has reached between different countries.”
Wai Mun Poon, a regulatory affairs consultant at Wong SJ Asia Pte Ltd added it was challenging for companies to market their product across ASEAN due to different regulatory requirements in each country such as definition terms.
Dr. Hingorani pointed out: “ASEAN countries have started working on universal norms for registration of products, but a lot of work is to be put in to finalise.”
While there were no harmonised regulations for registration of supplements, the ASEAN Consultative Committee for Standards and Quality, Traditional Medicine and Health Supplements Product Working Group (TMHS PWG) helps manufacturers understand the regulatory procedures of these countries.
According to Poon, the unit had agreed on the common definition of a health supplement and developed 10 technical requirements for Health Supplements in 2015, such as contamination limits, labelling requirements, maximum level of vitamins and minerals, claims substantiation requirements, negative list of ingredients, safety, stability studies, and GMP requirements.
These were developed based on existing international standards.
Problems faced by exporters
In the review article, researchers wrote that about the existing challenges within the industry.
For example, in Indonesia: “The most challenging parts of the Indonesian market include its complex registration process, strong presence of a local manufacturer, increased distribution cost, and price sensitivity,” they wrote.
According to them, ASEAN consumers were price sensitive and demanding, so they recommended exporters to work with local partners.
However, exporters also faced their own set of challenges.
“For example, most of the ASEAN countries demand that the product should contain ≥80% of the declared nutrients that are mentioned on the label; however, the situation is quite different in Singapore, where the product must contain 100% of the claimed label nutrient,” they wrote.
In other cases, some countries ask for safety and efficacy data, while some require post-market surveillance. Post-marketing control are required in Singapore, Malaysia, Thailand, and Indonesia but not in Cambodia, Laos, or Myanmar.
Researchers said: “These documents should be compiled in such a manner that they should meet the requirements of most of the countries with a single dossier only and the exporter should not have to go for repeated generation of data.”
Dr. Hingorani added that if registration was harmonised across countries, consumers would have quicker access to nutraceuticals, especially at times of future pandemics.
“With the number of viral infections spreading across some continents, people are looking at various nutraceuticals for enhancing their immunity. Markets for such products have increased by 25-35%.”
“If there is harmony in registration, people in all these countries will be able to access these products quickly, and companies will be able to enter the markets quickly.”
Poon told us although a region-wide agreement had not been signed yet, some ASEAN countries, including Malaysia and Singapore, had begun to regulate health supplement products using the ASEAN harmonised technical requirements.
“This shows that the ASEAN regulators are committed to make the harmonisation happens,” she said.
The target date for signing of the agreement was set at July 2021, however Poon foresees it being delayed due to the Covid-19 disruption.
Once the agreement has been signed, Poon pointed out there will be another set of challenges.
“Some of the technical requirements such as claims substantiation requirements and safety substantiation requirements are very subjective. It is possible to have a situation where the data is accepted by one country but not the other, due to different interpretation.”
“However, the working group actively conducting trainings to educate regulators on these harmonised requirements. Hopefully these trainings will help to narrow the gaps in terms of understandings and interpretation of the technical requirements.
“Some of these technical requirements may be hard for many SMEs that have limited capacity to meet. However, they could use these standards as a ‘goal’ to upgrade themselves and improve the quality of their products so that they can compete internationally.”
Source: Nutrition, Elsevier
“Nutraceutical regulations: An opportunity in ASEAN countries”
Authors: Chandani Tripathi, et al.