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As revealed by an official notice [1] released on Dec. 1st, 2020, the five heavily watched new functional ingredients (namely, coenzyme Q10, reishi shell-broken spore powder, spirulina, fish oil and melatonin) were finally added into the health food raw material positive list. It took China over a year and a half to approve this after the release of consultation draft (CL news [2]) in March 2019.
In addition, the interpretation SAMR released on Dec 3 emphasized that ingredients and their usage amount as well as corresponding functions, specified in the raw material catalogue can only apply to the production of health food instead of ordinary food.
Major Content
The notice unveils the usage requirements, specific functional claims that products can bear and also the technical specifications for each ingredient.
Usage requirement and specific permitted functional claims
Name | Daily usage | Function | |||
Usage level | Suitable group | Unsuitable group | Notes | ||
Coenzyme Q10 | 30-50mg | Adults | Children, pregnant woman, lactating woman, those with allergies | People taking pharmaceutical drugs should consult the doctor before consuming the product | Enhance immunity; |
Melatonin | 1-3mg | Adults | Children, pregnant woman, lactating woman | People who work on driving, mechanical operation and dangerous operation cannot consume this product before or during the operation, and the patients having autoimmune disease (like rheumatoid) or hyperthyroidism should take the product with caution. | Sleep improvement |
Fish oil | No more than 4.0g (among them, the usage amount of EPA+DHA should be no less than 1.0g) | People with high blood lipids | Children, pregnant woman, lactating woman; those with bleeding tendency and patients with bleeding diseases; those with hepatic insufficiency | This product is not suitable to those who are allergic to marine products | Assist to reduce blood lipids |
Reishi shell-broken spore powder | 1-4g | Those with weakened immune systems | Children, pregnant woman, lactating woman | / | Enhance immunity |
Spirulina | 3-4g | Those with weakened immune systems | Children, pregnant woman, lactating woman and those with allergic constitution | / | Enhance immunity |
Technical requirements
The technical requirements for raw material mainly specify the raw material source, sensory requirements, identification method, physicochemical indexes, microorganism indexes, active ingredient indicators, storage, allowed dosage forms, etc.
Significance
In China, based on the regulations stipulated in Administrative Measures for Registration and Filing of Health Foods [3], health foods subject to filing mechanism can only use the ingredients that are listed in the health food raw material positive list as raw material. The first batch of Health Food Raw Materials Directory (The Directory was updated [4] on Dec 1st, 2020. View more at CL news [5] here.) was released by the former CFDA (now SAMR) in 2016. After four years, these five ingredients now are considered as the second batch of allowed raw materials. (For requirements of permitted auxiliary material, check List of Auxiliary Materials for Health Food Filing and Terms of Use, 2019 edition [6])
Why does it matter? Before this notice, these five ingredients are allowed to be used in the production of health foods as well. But health foods use these ingredients as the raw material can only choose to get products registered because these five ingredients are not listed in the raw material positive list. However, things are different now. It will be much easier for enterprises to obtain the “blue hat” certificate for their products via filing. Compared to the registration mechanism, it takes less time and cost for enterprises to get health food filed. Recommended webinar: Practical Instruction on Health Food Filing in China [7].
For the further translation service of raw material technical requirement released in this notice or if there’s any question related to health food filing and registration, please email [email protected] to find out more.
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