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China Health Foods: Controversial Points Raised by New Drafts of Health Food Regulations

On Sep. 17-18, 2015, REACH24H Food Summit was held to offer attendees access to the latest regulatory updates in China’s food & food contact materials industry. Health food was an important part of this year’s summit. Mr. Lin Fei from China’s National Institute for Food and Drug Control was invited to deliver a speech on the main changes in the three newly released drafts of China’s new health food registration and filing system, namely “Administrative Measures of Registration and Filing of Health Food”, “Administrative Measures on Health Food Labeling”, and “Administrative Measures on Health Food Raw Material Directory and Health Function Directory” (see Chemlinked news report).

Mr. Lin indicated during the summit that although the draft regulations have already been released, there is considerable public debate, particularly amongst health food enterprises regarding the controversial points in the draft regulations, which may still result in considerable changes before final promulgation.

According to the new FSL and also the “Administrative Measures on Health Food Raw Material Directory and Health Function Directory”, there will be an approved health food raw material directory subject to specialized health food regulations. Mr. Lin questioned the practicality of this new step given the fact that many health food raw materials are commonly used in conventional foods. Heightened regulatory requirements for these ingredients would pose major problems for conventional food manufacturers using any raw materials listed in this directory.

In Article 27 of “Administrative Measures of Registration and Filing of Health Food”, it stipulates that “the conclusion on whether health food registration will be approved or not should be given within 60 working days”.  Mr. Lin explained that it will probably be revised in the final version as it is unpractical to conduct a thorough technical review and give a conclusion within such a short period of time.

For the registration of imported health foods, there is a newly added dossier requirement, i.e. an analytic report of overseas sale and human consumption should also be submitted during the application. Many health food enterprises commented that it is quite difficult to provide detailed reports with sales and human consumption data on products being sold in multiple overseas markets. 

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