Faster route to market: China seeks feedback on co-enzyme Q10, fish oil, melatonin production standards

The other four raw materials are melatonin, fish oil, spirulina, and the fungus Ganoderma lucidum.

China’s State Administration for Market Regulation (SAMR) is considering the addition of these raw materials into the Health Food Raw Materials Directory which is mainly made up of “low-risk” materials such as minerals and vitamins.

Using raw materials from the directory allows a health foods product to be registered with the China authorities via the health foods filing track. 

This is a faster go-to-market strategy, where the product approval process usually takes months. In comparison, the health foods registration track could take years to complete before they are approved for sale in the country’s retail stores.

Recently, the SAMR also listed out the production standards of health foods containing these raw materials for public consultation.​

The production standards surround topics such as the method of production, the approved recommended dietary allowance (RDA), and the permitted dosage formats.

All of the health foods should also be manufactured according to the national food safety standards for health foods known as GB-16740.

“In contrast to vitamins and minerals, the five raw materials including co-enzyme Q10 will build up the unique technical requirements of health foods raw materials, this is a first for the health foods industry (in China),”​ the SAMR said in a statement.

The following list out the main production standards for each of the five raw materials. The public consultation ends on Sep 12.

Co-enzyme Q10​

The regulator has proposed to allow health foods containing only co-enzyme Q10 to be made in the form of tablets (including chewables), granules, hard capsules, and soft capsules.

The RDA is proposed at 30 to 50mg.

Ganoderma lucidum ​

Health foods containing only ganoderma lucidum can be made into tablets, granules, hard capsules, and powder.

The ganoderma lucidum health foods should also contain the bioactives polysaccharides and total triterpene.

Spirulina​

Health foods containing only spirulina can be made into tablets, granules, and hard capsules.

The product should also at least contain the bioactives beta-carotene and phycocyanin.

Fish oil ​

Health foods containing only fish oil can be made into soft capsules.

The product should contain at least DHA, EPA, and both DHA and EPA.

Melatonin​

Health foods containing melatonin can be made into tablets (including lozenges), granules, hard and soft capsules.

An RDA of 1mg to 3mg is proposed.

The health foods can also add in vitamin B6.

More to come  ​

With the five raw materials added into the directory, it can be expected that more health foods containing these materials would be launched in China, said Cathy Yu, GM of the food business division at Hangzhou-based regulatory consulting firm CIRS.

“It is almost certain that more health foods containing the five raw materials would be launched in China, since the health foods filing track was more simplified than the registration track. ​

“Moreover, products containing these five raw materials are relatively popular in China, and thus, it is believed that more of such products will undergo the filing track when entering the China market,”​ she said told NutraIngredients-Asia. ​

The Global Organisation for EPA and DHA Omega-3s (GOED) also said that the addition of fish oil into the raw materials directory was a “positive step”.​

While the EPA and EHA omega-3 awareness amongst China consumers is lower than neighbouring countries, Chris Gearheart, director – member communications at GOED, said the US$440m omega-3 supplement market in China still accounted for 10% of the global market.

Moreover, with the market growing in high single digits, GOED expects the growth in 2020 to 2021 to reach 6%.

Designed for low-risk products ​

The dual health foods registration and filing track was implemented four years ago to facilitate the market entry of different health foods. The filing track is designed to allow low-risk health foods enter the market with less haste.

“Vitamins and minerals were the first batches of raw materials approved for the filing track. Now, there are five more commonly used raw materials considered. ​

“It can be seen that there will be more raw materials, more formulations that will be incorporated into the filing track,”​ Yu added.