Policy priorities: The need-to-know nutraceutical regulations set to shape the APAC sector in 2024

South Korea​

South Korea is fully implementing the "use-by" date labelling system​ instead of the "sell-by" date or expiry date system for food products from January 1 this year, the Ministry of Food and Drug Administration (MFDS) announced in late December last year.  

The country piloted the "use-by" date system in January last year for the top 100 companies with the highest domestic sales and is fully implementing the the system this year. 

Meanwhile, products that were manufactured prior to 2024 and labelled with the "sell-by" date could still be sold in the market until they expire. 

"In order to reduce food waste and achieve carbon neutrality, the Ministry of Food and Drug Safety is focused on informing consumers the safe consumption period of food products, instead of the business-centred 'expiration date' (or sell-by date) labelling that informs them the period allowed for product distribution and sale. ​

"The consumption date (or use-by date) labelling system was introduced in January this year, and will be implemented in earnest on January 1 next year after a one-year guidance period to ensure stable operation of the system," ​the MFDS said on December 28 last year. 

Secondly, from January 1 this year, South Korea has officially removed restrictions on protein manufacturing methods.​

Prior to this, when manufacturing protein products, the method is limited to separating and purifying protein from raw materials such as beans and oil, or to manufacture the products only with the use of proteolytic or autolytic enzymes.

The MFDS has decided to remove these restrictions on the back of booming demand for protein products.

“The raw materials used to manufacture proteins have expanded, but the manufacturing methods are limited, which limits the manufacture of a variety of products,”​ said the MFDS.

Prior to that, the MFDS had expanded the list of permitted raw materials for manufacturing protein products from nine sources, such as oils, eggs, legumes, and nuts, to all permitted food ingredients last year.

The MFDS has also introduced new rules in the testing of fatty acid amounts in palmetto fruit extract health foods products. This is to detect and guard against the mixing of cheap vegetable oils into the products.

Under the new standards, palmetto fruit extract health foods must contain fatty acids which are 80 per cent or more of the total fatty acids amounts, while phytosterols must be 0.2 per cent or more of the total sterols amount, and beta-sitosterol at 0.1 per cent or more.

Thirdly, companies could expect vitamin K2 to be approved as a health functional food ingredient by March​, following the announcement of MFDS’ minister Oh Yu-Kyoung.

At present, only vitamins, minerals, dietary fibre, protein in the notified health functional food ingredient list, and those listed in the Food or Food Additives code could be used in health functional foods.

China​

From January 1, companies producing novel Foods with Special Medical Purposes (FSMP) that are not yet approved but have an urgent demand in clinical settings could fast track the approval process using a new priority system.

The priority system is also applicable to FSMPs that are designed for rare diseases and other situations that the State Administration of Market Regulation (SAMR) has approved.

Under the priority system, it will take at most 30 working days for the assessment process.

This arrangement was part of the 10 major regulatory changes introduced to the FSMP framework as announced by the SAMR on December 1, 2023.​

A newly added regulation is that the FSMPs are “not allowed to make functional claims on the nutrients and other components of the product, [so as] not to mislead the consumers.”​

When necessary, the regulator could inspect the companies that are manufacturing the raw materials and food additives used in the FSMPs, instead of just inspecting the company manufacturing the final product.

The product’s name, registration number, and the intended consumers should be labelled at the main display of the product. Currently, the requirement is to display this set of information at a “visible”​ area.

In addition, the person making the product registration would need to bear greater accountability.

For instance, they are supposed to bear the legal responsibility for the registration documents submitted, such as ensuring that the documents are true, complete, legal, and traceable.

The penalty for violating the rules have also increased from between 10k to 30k yuan (US$1.4k to US$4.2k) to between 30k and 200k yuan (US$4.2k to US$27.8k).

“From Jan 1, 2024, the new version of the regulation will officially come into force. We believe that the SAMR would revise the relevant registration-related documents to ensure that the new regulations are smoothly implemented. ​

“For companies that are going to register their FSMPs, we advise that them to keep a lookout for changes to the registration-related documents and make early preparations,” ​said the Hangzhou-based consultancy CIRS.

Secondly, eighty-five new national standards or Guobiao / GB standards​ will also be implemented this year. For example, six GB standards related to six different compounds for nutrient fortification will be implemented from March 6.

The six compounds include GB standards on copper carbonate, iron, L-carnitine tartrate, and chromium chloride. The GB standards cover the sensory requirements, physical and chemical properties of these compounds when used for nutrient fortification.

Thirdly, the SAMR had earlier implemented a pilot program in August 2023​ that allows health foods to make new functional claims.

The program allows companies to make function claims outside of the existing list of the 24 approved claims, so long as their applications to do so are approved by the SAMR.

Nonetheless, the new claims should meet either of the following three requirements, which is to either 1) supplement dietary nutrient, 2) to maintain or improve the body’s health status, or 3) to reduce the risk factors of disease onset.

Taiwan ​

From January 1 this year, various health foods, including fish oil and red yeast rice products will need to comply with new labelling rules,​ in order for them to be sold in Taiwan.

Fish oil products, for example, will need to have the statement ““infants, pregnant women, patients with diabetes mellitus or people with abnormal blood coagulation taking anticoagulant are suggested to seek doctor’s recommendations before consumption​,” printed on the product packaging.

Red yeast rice products, on the other hand, will need to include the statement “consuming this product together with statin and fibrate-derived hypolipidemic agents or grapefruit may result in liver and kidney damage or rhabdomyolysis” ​on the packaging.  ​

The rule was first announced in November 2022 following a public consultation conducted by the Taiwan FDA in June.

The reason for adding the precaution statements is because fish oil and red yeast oil could potentially interact with certain medications.

In addition, products that claim to provide certain health benefits based on the results of animal experiments should state so on the product labelling.

For example, the product should state that “based on the testing results from animal model, the product can help to …”​ or other similar statements with the same meaning.

For products containing ingredients where there is not yet a suitable method to assess its health benefits, they would need to state that “the health care effects of the product is known from academic theory but not approved by product experiments”​ under the “health care claims” segment of the product packaging.

At the same time, health foods that are in capsules and tablets should come with the statements “this product is not a drug, for health care only. Patients still need medical treatment” ​and “please consume according to the recommended intake, excessive intake does not benefit health.”​

Health foods in other formats should be labelled with “this product is for health care only, without therapeutic efficacy.”​

Also put in place from January 1 this year, the use of Eucalyptus globulus leaf and extract will only be limited to food flavourings.​

Previously, they could be used as food raw materials in herbal medicines.

Having assessed its medicinal properties and international regulatory status, Taiwan’s Ministry of Health and Welfare has decided that they could no longer be used as a food raw material.

Nonetheless, throat lozenges and chewing gum containing Eucalyptus globulus leaves, its leaf extract, or its leaf essential oil as food flavouring, can still be sold in the market and are not affected by the regulatory change.

Australia ​

From March this year, the Therapeutic Goods Administration (TGA) will implement new warning statements to complementary medicine ingredients that are deemed as having “low-negligible risk changes”​ as part of the Permissible Ingredients Determination.

Five ingredients will be affected, namely curcuma species and curcumin, green tea extract, benzophenone, soy phosphatidylserine-enriched ingredients, and Terminalia ferdinandiana. ​

The TGA had earlier conducted a public consultation on its proposal which ended on September 14 last year.

It said that a total of 27 submissions were received in response to the consultation which varied in stance and recommendations.

“However, the majority of respondents from the complementary medicines industry did not support or only partially supported the proposals, with many suggesting rewording or clarification of the proposed warning statements and requirements,”​ said the TGA.

The final decisions were published in December 2023.​

For example, the TGA has decided that the curcuma longa products will come with the warning statement: “In very rare cases, curcuma species may harm the liver. Stop use and see a doctor if you have yellowing skin / eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.”​

Also, the maximum daily dose of (1E,6E)-1,7- bis(4-hydroxy-3-methoxyphenyl)-1,6- heptadiene-3,5-dione in the medicine must not provide more than 36mg for children from two to three years old, 48mg for children from four to 11 years old, and 123mg for children from 12 to 17 years old.

Instead of the word “curcumin”, the TGA has decided to use the chemical name “(1E,6E)-1,7- bis(4-hydroxy-3-methoxyphenyl)-1,6- heptadiene-3,5-dione” on the maximum daily dose requirements, after considering the industry’s feedback.

The chemical will also not be permitted for use in children aged below two years old.

A similar warning statement is also applied to products containing Camellia sinensis ​or green tea extract in relation to the rare cases of it causing liver injury.

The statement would be applicable to Camellia sinensis ​products for oral use, except when the preparation of Camellia sinensis​ is derived from an aqueous extract and contains 300 mg or less epigallocatechin-3-gallate per maximum recommended daily dose.

The statement is also not applicable when Camellia sinensis​ is used in combination with other permitted ingredients as a flavour proprietary excipient formulation. Also, the total concentration of flavour proprietary excipient formulations containing Camellia sinensis must not be more than 5 per cent of the total medicine.

The rules will commence on March 1, 2024, and will include a 12-month transition period until March 1, 2025.

Japan ​

In Japan, the Consumer Affairs Agency (CAA) had announced on September 2023 that manufacturers of Foods with Function Claims (FFC) will need to comply with the requirements of PRISMA 2020.​

Also known as the Preferred Reporting Items for Systematic reviews and Meta-Analyses 2020, PRISMA 2020 is an international guideline that sets out the types of information that should be present in systematic reviews.

At the moment, about 90 per cent of the FFCs make functional claims based on systematic reviews, which makes the adoption of PRISMA 2020 even more important.

The CAA has conducted a public consultation on adopting PRIMSA 2020 in July 2023 and FFCs submissions are required to comply with PRISMA 2020 from April 1, 2025.

There is, however, no transitional period and companies can start to submit the research review supporting the functions of their FFCs in accordance with PRIMSA 2020 as needed.

The move will replace the out-of-date PRISMA 2009.

According to Noriaki Kikuchi, director, Food with Function Claims Department at Japan Health and Nutrition Food Association (JHNFA), CAA’s focus for year 2024 when it comes to FFCs, would surround PRISMA 2020.  

The association is preparing the industry in adopting PRISMA 2020 through guidebooks and seminars, he said.

Another association, Japan Alliance of Health Food Association (JAOHFA), also said earlier that it was working with CAA to help the industry understand PRIMSA 2020 and the preparation required.

Secondly, Japan is also expected to implement self-inspection and Good Manufacturing Practices (GMP) standards​ for companies operating health foods business in the second half of January. 

Companies that manufacture, process, and sell natural extracts as raw materials for use in health foods in the form of tablets, capsules, and liquids will need to follow the GMP standards.