China
Navigating the GACC registrations
From January 1 this year, all food and supplements manufacturers exporting products into China have to be registered with the Chinese customs.
Otherwise, the exports will not be accepted into the country, China’s General Administration of Customs PRC (GACC) announced in April last year.
Some of these products, including dietary supplements and special dietary foods, will need to obtain recommendation or endorsement from their country’s competent authority before they could register their products.
The competent authorities overseeing the recommendations include Australia’s Therapeutic Goods Administration (TGA), Canadian Food Inspection Agency (CFIA), and Japan’s Ministry of Agriculture, Forestry, and Fisheries (MAFF).
“Decree No. 248 [Regulations of the PRC on the Registration and Administration of Overseas Manufacturers of Imported Food] has been on top of mind for most businesses.
“The companies would need to complete the registration on their own, but the competent authorities of the respective countries will for one, help the companies apply for a registration account and password.
“After the companies have finished the registration, the competent authorities will evaluate the companies’ factories to see if they fulfil the requirements of GACC before making the recommendations to the GACC,” Cathy Yu, GM of the food business division at Hangzhou-based consultancy firm CIRS told us.
For overseas firms, some of the common challenges are difficulties in accessing and navigating the registration systems.
“For overseas companies, they may not have quick access to new announcements or do not know how to fill in the form or could not locate the registration system and so, they will require the help of third-party organisations like us.
“Also, although they may already have the relevant documents required, they may not fully understand the requirements of the GACC,” she said.
South Korea
More dosage formats for OTC vitamins and minerals
Vitamins and minerals that are sold as over the counter (OTC) products in South Korea can be made into more formats, including jelly, film, and disintegrating tablets.
Regulatory expert Dr. Sun-Ho Frank Kim, founder of Seah Bio Solutions, said that this would provide more room for the OTC vitamins and minerals industry to innovate.
“This should be good information for the pharmaceutical and medicinal product industry, but it does not have any relation and impact to the Health Functional Food (HFF) industry in Korea. This is only applicable to the OTC vitamin and mineral products,” he said.
Vitamins and minerals which are available OTC are regulated under the Pharmaceutical Affairs Act and guidelines by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Aside from OTC, vitamins and minerals can also be regulated and sold as Health Functional Foods (HFF) in South Korea and this is a less stringent regulatory regime.
“Pharmaceutical products still have a lot of limitations when it comes to product promotion, marketing, and quality control etc, because they are considered medicinal products.
“They cannot be promoted on the social networking service (SNS) or Instagram or Facebook.
“The OTC products could only be distributed in the pharmacy or drugstore or even in hospital supplies stores and we can’t buy them in the supermarket or the retailer shop.
“In contrast, HFFs are fairly freely sold, even in the online marketing space.”
Personalised nutrition
Dr. Kim also expects new regulations on the personalised nutrition industry to come up next year.
The Ministry of Food and Drug Safety (MFDS) announced a two-year personalised nutrition sandbox project which will end in July next year.
Seven companies were involved in the initial stage of this project.
They were Pulmuone Health & Living, Amorepacific, Amway Korea, COSMAX NBT, Herbalife Korea, Bigsome, and Mono Labs.
With the sandbox project coming to an end next year, Dr. Kim expects the government to open up the industry.
“I will say that many businesses are expecting the expansion of the personalised nutrition industry. This will impact many in the industry, up from the suppliers to the manufacturers and sellers.
“We understand from non-official sources that this project will be implemented in full scale. That means that any online marketer and even an individual could run a personalised nutrition business. So eventually, the market expansion will be very drastic.
“Every businessman is now the eagerly waiting for the official announcement of the regulatory change. This should be the big issue that we should take note of for next year,” he said.
He explained that the government is opening up the industry as a way to provide more employment.
“This is really one of the reasons, because the government has a responsibility to rise the employment rate in the country.”
Australia
Therapeutic advertising code made more liberal
Australia’s new Therapeutic Goods Advertising Code has kicked in on Jan 1 this year, which is intended to be a simplified and more liberal version of the previous code.
The number and types of mandatory warnings needed to be shown in the advertisements of complementary medicines have been reduced.
Under the new code, all complementary medicines advertisements will need to include the statement “Always read the label and follow the directions for use”.
If the product cannot be viewed before purchase, the advertisement will also need to list down the health warnings or provide a weblink to the health warnings.
Health warnings refer to contraindications, precautions, or restrictions related to the product, or an ingredient used in the product.
The new code is significantly simplified from the previous code, where a few types of warning statements were permitted for use.
“This new code is really a simplification…It was redrafted to improve readability and structure.
“There is not a whole lot of additional requirements. In particular, mandatory requirements are being simplified,” said adjunct professor John Skerritt, deputy secretary at Australian Department of Health at the Complementary Medicines Australia (CMA) Annual Conference Program.
The Advertising Code guidance has been updated on Dec 24 last year to assist companies in transiting to the new code.
“But we also realised so much of these could be misinterpreted, that’s why having a longer period of getting feedback on the guidance [document] will be important.”
Companies will have until June 30, 2022 to transit to the new code, which professor Skerritt believes is a reasonable time frame, given that the rules are now more liberal.
“I realised it’s a comparatively short transition, but it reflects the fact that if anything, the new code is actually liberalising requirements.
“For example, if you still have all the advertising collaterals for a product and [the advertisements] are still showing the old mandatory statements after July 1, 2022, no one is going to come after you, because you are actually putting this [higher] level of mandatory warnings, whereas the new code requires this [at a lower] level.
“That’s why there is a fairly short transition period, because this [the new rules] is actually simplification and clarification.
“If we have raised the bar, then we would have a longer period of transition that would be fair and reasonable,” he explained.
India
Recommended Dietary Allowance of vitamins and minerals
The Food Safety and Standards Authority of India (FSSAI) has introduced a new set of Recommended Dietary Allowance (RDA) rules which will come into force from July 1, 2023.
The new set of RDAs, known as RDA 2020, has increased the RDAs of nutrients such as magnesium and biotin, while reducing that of vitamin B12, iron, iodine, and copper.
Sandeep Gupta, founder and CEO at the Expert Nutraceutical Advocacy Council (ENAC) said that RDA 2020 has yet to be gazetted and there could be minor changes made.
“For instance, the implementation [of the changes] can be imposed by the FSSAI when the RDA is gazetted.
“Nonetheless, the larger sector is already reformulating their products to RDA 2020,” he said.
ASEAN
Harmonisation is still work in progress
The signing of the harmonisation of supplement rules across the Association of Southeast Asian Nations (ASEAN) has been extended to February 2022, from the initial date of November 2021.
The finalisation of the ASEAN Agreement on Regulatory Framework for Health Supplements has been in discussion for 16 years.
There are currently no harmonised regulations for the registration of dietary supplements in ASEAN and each country has varying standards.
The Traditional Medicines & Health Supplements Product Working Group (TMHS PWG) and its Scientific Committee (ATSC) has developed 10 technical requirements and guidelines to form the regulations.
These covered contaminant limits, stability and shelf life, claims substantiation, good manufacturing practice, labelling requirements and maximum level of vitamins and minerals.
One reason for extending the date of signing was the amendment made to one of the 10 standards.
In early 2021, Thailand permitted the use of Hemp (Cannabis spp) and Kratom (Mitragyna speciose), which are in the ASEAN negative list of substances for health supplement and traditional medicine.
“The Product Working Group has agreed to add an additional footnote to the standard to address the situation in Thailand, the footnote states that the two substances are only permitted for domestic manufacture and trade within Thailand,” said Wai Mun Poon, regulatory affairs consultant at Wong SJ Asia Pte Ltd.
“Each Member States will need to go through some internal process for final approval and endorsement of the changes before they can move on to the finalisation and signing. The administrative procedure took some time and resulted in the delay.”
The harmonisation of technical requirements and guidelines for health supplements will make it easier for supplement manufacturers to sell the same product formulation in all 10 ASEAN countries, and also manufacture in this region instead of producing them elsewhere and importing them in.
Once harmonisation is signed, ASEAN countries have five years to implement the standards, and some countries are already beginning to comply to these requirements.
Poon gave us a rundown on the countries making gradual process.
Singapore, Malaysia and Indonesia have met standards for the maximum level of vitamins and mineral substances, and heavy metal limits.
Malaysia and Indonesia have met the standards for microbial contamination limits, stability, and claims requirements, while Vietnam has met the standard for good manufacturing practices.
One of the biggest challenges with this harmonisation is that small supplement companies and start-ups may lack the resources to implement the standards.
According to Poon, local authorities are likely to give companies a grace period to comply with the requirements.
“As for how long the ‘grace period’ will be, I think each authority will determine based on the readiness of their local industry.
“The key objective for these technical requirements is to promote trade. We may come to a situation that those companies that cannot meet the harmonised requirement will not be able to market outside their own country.
“Therefore, to plan for expansion and growth, companies especially those within ASEAN should aim to upgrade themselves to meet the ASEAN requirements.”
