Beyond vitamins and minerals: China’s expanded health food raw material directory comes into effect in March

Aside from fish oil, coenzyme Q10, melatonin, spirulina, and the fungus Ganoderma lucidum are the other raw materials that are added into the directory, the State Administration for Market Regulation (SAMR) said on December 1.​

Prior to that, only vitamins and minerals couldbe found in the directory.

When companies use a raw material listed in the directory to develop new health food products, they can submit the new product applications to the authorities via the vastly quicker filing track.

The filing track typically takes months, while the registration track could take several years before a product is officially approved for sale in general trade channels in the country.

The SAMR had sought public consultation over the expansion of the directory twice, first in March last year​ and in August this year​.

In the latest announcement, the SAMR has specified the recommended daily allowance (RDA), health benefits, and dosage formats for each of the newly approved raw material.

The following lists out the details for each raw material:

Co-enzyme Q10 ​

The RDA of co-enzyme Q10 is set at 30mg to 50mg for adults. 

Health foods containing only co-enzyme Q10 can make the claims 1) strengthen the immunity and 2) anti-oxidation.

Such products can be made into tablets, granules, hard and soft capsules.

Products containing co-enzyme Q10 are not suitable for adolescents, pregnant women, lactating mothers, and individuals allergic to the raw material. 

Melatonin​

The RDA of melatonin is set at 1mg to 3mg for adults. 

Health foods containing only melatonin can claim to “improve sleep”.

Such products can be made into tablets, granules, hard and soft capsules.

Products containing melatonin are not suitable for adolescents, pregnant women, and lactating mothers.

Fish oil ​

The RDA of fish oil should not exceed 4g. Of which, the content of both eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) should not be lower than 1g or 1000mg.  

The product is suitable individuals with high blood lipids level.

Health foods containing only fish oil can make the claim “helps to lower blood lipids”.

Such products can be made into soft capsules.

Products containing fish oil are not suitable for individuals with bleeding tendency, bleeding disorders, compromised liver functions, as well as adolescents, pregnant women, and lactating mothers.

Ganoderma lucidum​

The RDA of Ganoderma lucidum is set at 1mg to 4mg. 

Health foods containing only Ganoderma lucidum can claim to “strengthen the immunity” and are suitable for individuals with low immunity.

Such products can be made into tablets, granules, hard capsules, and powder.

Products containing melatonin are not suitable for adolescents, pregnant women, and lactating mothers.

Spirulina​

The RDA of spirulina is set at 3mg to 4mg. 

Health foods containing only spirulina can claim to “strengthen the immunity” and are suitable for individuals with low immunity.

Such products can be made into tablets, granules, and hard capsules.

Products containing melatonin are not suitable for infants and toddlers, pregnant women, lactating mothers, and individuals allergic to the raw material.

Not yet completed ​

On the other hand, Hangzhou-based regulatory consultancy firm CIRS noted that details on the technical requirements for producing health foods containing the newly raw approved raw materials are not yet released.

As such, companies are advised to make the next move after the technical details on production modes are out.