2023 outlook: The must know nutraceutical regulations on the horizon in APAC this year

Taiwan regulations on aloe vera and anti-fatigue claims ​

From January 1 this year, aloe vera raw materials used in food must be derived from the leaves of the species of Aloe Ferox ​and Aloe Vera.​

Moreover, the aloe vera rind – the outer skin of the plant – must be removed before it could be processed for commercial use, according to the announcement​ from the Taiwan Food and Drug Administration.

Aloin – a laxative substance found in aloe vera, should not be present in more than 10 part per million (ppm) in a food product.

Aloe vera-containing products should also warn certain consumer groups, such as pregnant women, to refrain from consumption, unless it has been tested to contain less than one ppm of aloin.

Products manufactured or imported before Jan 1, 2023 could still be sold in the market until the date of expiry.

On the other hand, the transition period for companies to end animal tests for validating anti-fatigue claims in health foods and beverages​ will end on April 15 this year.

This means that companies would need to present evidence from human clinical studies once the transition period ends.

At the moment, there are 13 health claims for health food certification in Taiwan, including alleviating osteoporosis, regulating blood lipids, and regulating immunity.

Local health food firm Grape King Bio, which produces ComeBest – an energy beverage which makes anti-fatigue claim, said the policy change would incur high costs for the industry, since human clinical trials would cost more than animal studies.

Firms would also need to spend a longer period on safety assessment and consider more variables such as diet and lifestyle habits when designing human clinical trials, so as to reduce the impact of the variables, Dr Hsu Sheng-Chieh, executive director of the R&D division at Grape King Bio told us earlier.​

Further down the road in January 1 next year, manufacturers of fish oil and red yeast rice sold in Taiwan would need to adopt new labelling rules​, such as warning specific individuals, including pregnant women, diabetic patients to consume the products under doctor’s supervision. 

Hong Kong introduces maximum permitted concentration of harmful substances in infant formula and edible oils​

From June 1 this year, Hong Kong’s Amendment Regulation regarding harmful substances in food will come into operation.

The amended policy​ is known as The Harmful Substances in Food (Amendment) Regulation 2021 and would affect nutrition products such as infant formula and the omega-3 industry.

Specifically, the Amendment Regulation has updated the maximum permitted concentration of three harmful substances, namely aflatoxins, erucic acid, and melamine in food.

For instance, the maximum permitted concentration of aflatoxin B1 in infant formula and follow-up formula is 0.1 μg/kg.

In addition, it has introduced maximum permitted concentration of five harmful substances, namely benzo[a]pyrene (B[a]P), deoxynivalenol, glycidyl fatty acid esters, patulin, and 3-monochloropropane-1,2-diol (3-MCPD), in food.

For example, the maximum permitted concentrations for glycidyl fatty acid esters in “Powdered infant formula and powdered follow-up formula intended to be consumed principally by persons under the age of 12 months” and “Liquid infant formula and liquid follow-up formula intended to be consumed principally by persons under the age of 12 months” are 50 μg/kg and five μg/kg respectively.

On the other hand, the maximum permitted concentration for (B[a]P) applies to “fresh” or “unused” edible oil or fat at five μg/kg, which is of relevance to the omega-3 industry.

As for infant formula and follow-up formula for babies under 12 months, the maximum permitted concentration of (B[a]P) is one μg/kg.

The guidelines​ to the Amendment Regulation was published by Hong Kong’s Centre for Food Safety and the Food and Environmental Hygiene Department.

Also, from December 1 this year, the Amendment Regulation will officially prohibit the import of any edible oil or fat containing partially hydrogenated oil (PHO) and the sale of any food, including edible oil or fat, containing PHO.

Malaysia implementing Guidance on Quantitative by Input (QBI)​

From January 1 this year, companies could refer to a new set of guidance when making quantitative claims of active ingredients for traditional medicine and health supplement products.

The document​ is known as the Guidance on the Acceptance Criteria of Quantification by Input (QBI) of Active Ingredients Claimed on Label of Traditional Medicine and Health Supplement (TMHS) Products, published by the National Pharmaceutical Regulatory Agency (NPRA), under the Ministry of Health Malaysia.

The implementation of this guidance is said to be a piece of good news for companies because it provides companies with another method to quantify the active ingredients, said Wai Mun Poon, principal regulatory consultant and owner of SJ Wong Asia.

Prior to the introduction of the QBI method, companies would need to declare the quantification of all active ingredients claimed on the product label by conducting assay tests.

“Not only the assay result must be declared on the certificate of analysis, it should also be monitored during stability study. This is to ensure the product contains the claimed amount of active ingredient throughout the shelf life. ​

“However, companies often encounter problems such as no available test methods, or that the available test method is not suitable for the complex nature of the health supplement, which normally contains multiple ingredients. These ingredients may cause interference, which make it difficult or not possible to test​

“The Guidance addresses the above issues,”​ Poon explained.  

However, to be able to apply the principles of QBI, the finished product manufacturer must conduct assay on the active ingredient raw material.

The finished product manufacturer may use an in-house method, method from supplier, or outsource to other third party or external laboratories to conduct the testing.

Also, when it is not possible to test the ingredients due to trace or undetectable amount, or interference between ingredients, companies should provide justifications and raw data based on the actual test attempted on the finished product and / or literature reviews.

The Guidance has provided some examples of QBI Value Calculation using lutein and vitamin C.

No assay is required if there are no quantitative claims made on the active ingredients.

The NPRA had sought public feedback​ on the Guidance mid last year.

“The issuance of the Guidance is good news for companies. Nevertheless​, ​I would still encourage companies to conduct the assays as and when new/emerging technology are available, which enable the testing of the active ingredients which wasn’t possible in the past,” ​Poon said.

South Korea adopting “use-by” dates, personalised nutrition pilot project to extend​

From January 1 this year, all food products, including nutraceuticals, will need to change the way they communicate product shelf life to consumers.

Specifically, the prior “sell-by” dates system will be changed to “use-by” dates​, which the country’s food and drug authority believes could help cut down on food wastage.

The “use-by” date is the final date in which a product could be safely consumed, while the “sell-by” date refers to the time in which a retailer must remove its products off the shelves – generally within 60 to 70 per cent of the timeframe in which the food is still considered safe for consumption.

In contrast, the “use-by” dates are within 80 to 90 per cent of the timeframe for safe consumption and adopting this framework could help reduce food waste.

On the other hand, South Korea’s Ministry of Food and Drug Safety (MFDS) has also announced the extension of the personalised nutrition pilot project by two years to boost the industry’s growth.

According to the MFDS, the sector has generated KRW$7.9 billion (US$6.2m) in sales and had amassed 78,000 users as of September last year.

Some of the participating stores are COSMAX Bio, Kolmar BNH, Nutrione.

Last year, minister of MFDS Yu-Kyoung Oh, said that​ the ministry would spare no effort in building up the personalised nutrition industry.

Australia’s transition period for vitamin B6, artemisinin new regulations ends in March​

In March 1 last year, Australia’s Therapeutic Goods Administration (TGA) had required all supplements containing molluscs, vitamin B6, and artemisia to comply with new labelling regulations​.

In the case of mollusc-derived ingredients, companies would need to state the allergen warnings.

For example, they would need to state the allergen warning “contains mollusc” or “contains mollusc products” for products containing eight examples of marine-based ingredients.

The eight samples are concentrated squid omega-3 triglycerides, green-lipped mussel, dried green-lipped mussel, green-lipped mussel oil, oyster, oyster shell, sepia and squid oil.

New vitamin B6 dose restrictions were also stated for adults and children, while pregnancy risk warnings were required for supplements containing certain artemisia species.

Manufacturers were given one year of transition period which ends in March 1 this year.