Regulatory review: ASEAN harmonisation, Japan’s FFC, China infant formula in the spotlight

ASEAN health supplements harmonisation delayed once again, but firms eyeing SEA advised to adopt standards​​

The harmonisation of traditional medicines and health supplements technical standards in South East Asia is yet again delayed, but a regulatory expert has advised companies to start following the standards if they want to market their products to the region.

The signing of the harmonisation agreement will not take place as expected in this month’s ASEAN Economic Ministers (AEM) and the target is for it to take place early next year.

Despite the delay, Wai Mun Poon, principal regulatory consultant at Wong SJ Asia, has advised companies planning to market their products in SEA to start following the standards.

Credibility doubts arise: Japan set to revise Foods with Function Claims scientific evaluation​​

Japan’s Consumer Affairs Agency (CAA), which regulates the Foods with Function Claims (FFC) market, is reviewing the methods that companies use to support the science behind their goods, following the recent removal of two products from the market.

Systematic review, which is the most common method that companies use to support the functional claims and science of FFC products, will be required to comply with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA 2020​), said the CAA.

The CAA is in the midst of collecting public feedback on how the guidelines stated in PRISMA 2020 could be implemented.

Positive participation: Singapore’s HSA to expand types of supplements applicable for voluntary notification​​

Singapore’s Health Sciences Authority (HSA) has expanded the types of health supplements applicable for voluntary notification from August 1, 2023.

The expansion would allow products such as probiotics, omega fatty acids, glucosamine, echinacea supplements to go through voluntary notification.

This followed “positive participation” from the industry since implementing the initiative a year ago, said the regulator.

Taiwan approves use of GM-yeast fermented trans-resveratrol in supplements​​

Taiwan Food and Drug Administration has approved the use of trans-resveratrol produced by genetically modified yeast in dietary supplements.

Trans-resveratrol fermented by the genetically modified brewer’s yeast Saccharomyces cerevisiae​ EFSC4687 can be used in dietary supplements with a daily dosage limit of 150mg.

The raw material containing trans-resveratrol should have a purity level of 98 per cent and should not contain genetically modified microorganisms and its transgene since it needs to go through a series of purification processes.

“Imported raw ingredients” and similar terms banned in China’s infant formula product labelling from Oct 1​  

Chinese authorities are imposing stricter rules on the infant formula industry, with terms such as “imported raw ingredients” and “imported milk source” banned on all product labelling from October 1, 2023.

In the new regulations, the SAMR has decided that terms such as “imported milk source”, “originating from overseas farms”, “imported raw ingredients”, “non-polluted milk source” and other “unclear” messaging will be banned on infant formula labelling.

Functional health claims such as strengthening the immune system, modulating the gut microbiome, and cognitive health benefits, as well as disease prevention claims are not allowed either.