The 10 member states of Association of Southeast Asian Nations (ASEAN) would have been working on harmonising the technical standards for traditional medicines and health supplements for the 20th year in 2024.
Having established, finalised, and endorsed the 10 annexes or technical requirements core to the harmonisation, the plan was for trade ministers to sign the harmonised agreement during this month's ASEAN Economic Ministers (AEM) meeting.
However, in its latest meeting held on July 4 to 6 in Manila, the ASEAN Consultative Committee on Standards and Quality of Traditional Medicines and Health Supplements Product Working Group (ACCSQ TMHS PWG) concluded that the signing will not take place as expected.
It is understood that administrative issues that were beyond the control of the product working group have contributed to the delay, Wai Mun Poon, principal regulatory consultant at Wong SJ Asia told NutraIngredients-Asia in an interview. The target, she said, would be for the signing to take place during next year's AEM.
Despite the delay, Poon has advised companies planning to market their products in the region to start following standards.
“It is a long process. The harmonisation effort started in 2004 and it will be 20 years by next year.
“For those of you who have been following the process, it must have been frustrating, and you may start wondering if ASEAN will ever implement the harmonisation…
“Nevertheless, I will still encourage companies to start to learn and comply to these harmonised standards requirements if you are keen to market your products in ASEAN,” she said, adding that ASEAN took the approach of consultation and consensus, which led to a longer decision-making process.
“As the agreement is being finalised, it will eventually be signed and implemented, although it is taking a long time.
“I will also encourage companies to start participating and monitoring the ongoing discussions and training to understand the interpretation of the requirements and if possible, contribute to the process by participating in the regional trade association,” she added.
She also pointed out that some member states have already started to follow the harmonised technical standards.
For example, Singapore, Malaysia, Indonesia, Brunei, Thailand, and Myanmar are already following the “Guiding principles for inclusion into or exclusion from the negative list of substances for health supplements” as listed in Annex 1, while Myanmar and Brunei are already following the GMP standards as listed in Annex 8.
“Despite the long time for the implementation of the agreement, we are already seeing some member states starting to implement some of the harmonised technical requirements. This shows that ASEAN member states are committed about the harmonisation efforts,” she said.
Harmonisation of the standards is expected to raise the quality of made in ASEAN products and make them more competitive for exports.
Full implementation expected in 2027
The full implementation of the harmonised standards can be expected to take place in year 2027.
After the signing of the agreement, ACCSQ TMHS PWG will be dissolved, and the ASEAN Traditional Medicine and Health Supplement Committee (ATMHSC) will be established.
“Their role is to coordinate, review, monitor, of the implementation of the agreement. They are also responsible for reviewing and updating the annexes or the technical requirements and the agreement.
“A scientific committee may also be established to provide technical advice recommendation,” said Poon.
Asked what could be some of the more challenging technical standards for companies to adhere to, she pointed out that food companies which were new to the health supplement market might find it challenging and costly to adhere to stability studies guidelines as spelled out in annex five.
“Traditional food companies might not have the resources to conduct shelf-life studies which typically takes about two years.” Speaking from her own experience, the cost incurred for conducting assay test for each ingredient could be a five-digit figure in Singapore dollars.
In addition, under annex seven on claims and claims substantiation for health supplements, she said that guidelines have only offered “general principles” and different countries might have different requirements for certain details.
For instance, in the annex, there is a list of criteria for well-documented health supplements claims. However, regulators from different ASEAN member states might have different opinions on what is considered as "well-documented", she said.
The progress so far
In the nearly 20-year period, the ACCSQ TMHS PWG had established 10 annexes or technical requirements core to the harmonisation in 2016.
These annexes largely align with the international CODEX standards and comprises of standards for labelling and claims, product quality and safety.
After the annexes were finalised and endorsed in 2021, each member state is currently in the midst of obtaining the National Instrument of Full Power (IFP), before trade ministers could sign the harmonisation agreement on their country’s behalf.
The IFP is a document in which the minister of foreign affairs authorises the minister of trade to sign a treaty on behalf of the country.
Once signed, member states will be committed to change their laws and regulations to meet the harmonised technical requirements – which will be applicable to both existing and new products.
Some annexes to be revised
On the other hand, Poon pointed out that some technical standards listed in the 10 annexes would need to be revised, since they were established seven years ago in 2016.
However, she said that any updates would most likely take place after the signing of the agreement.
“You may notice that the development of the technical requirements was completed in 2016. By today, some of these technical requirements may be outdated and no longer align with the international standards that they were based on.
“One example is the guideline on minimising risk of the transmissible Spongiform Encephalopathy (TSE) in Health Supplements.
“Further work needs to be done to update these standards and this will probably take place after the signing of the agreement,” she said.