China Specifies Filing Requirements for Health Food Using Coenzyme Q10 and the Other Four Functional Ingredients

Recently, China SAMR published a series of notifications regarding requirements for filing of health food product using the five functional ingredients (i.e., coenzyme Q10, reishi shell-broken spore powder, spirulina, fish oil and melatonin, hereafter referred to as "the Five Ingredients"), which have been added into the health food raw material positive list earlier in 2020. These notifications specified dosage forms and technical requirements for filing, and provided explanations on some filing issues.

Dosage forms and technical requirements

The Notification Regarding Dosage Forms and Technical Requirements of Health Food Filing Using the Five Ingredients (hereafter referred to as "Technical Requirements") released on Feb.1 of 2021 specified the dosage forms, auxiliary materials and technical requirements (physicochemical indicators, active ingredients, microorganism indicators, etc.) allowed for filing of health food using the Five Ingredients. This notification will come into effect on Jun. 1, 2021.

Ingredient	Allowed dosage forms	Allowed auxiliary materials
Coenzyme Q10	Tablet (oral tablet, lozenge, chewing tablet), granule, hard capsule, soft capsule	49 auxiliary materials such as vitamin E, soybean oil, etc; food flavors and colorants.
Reishi shell-broken spore powder	Tablet (oral tablet), granule, hard capsule, powder	20 auxiliary materials such as edible corn starch, silicon dioxide, etc.
Spirulina	Tablet (oral tablet, chewing tablet), granule, hard capsule	41 auxiliary materials such as maltodextrin, citric acid, etc; food flavors and colorants.
Fish oil	Soft capsule	8 auxiliary materials such as vitamin E, gelatin, etc.
Melatonin	Tablet (oral tablet, lozenge), granule, hard capsule, soft capsule	44 auxiliary materials such as edible corn starcapch, lactose, etc; food flavors and colorants.

Notes on filing issues

As revealed by Interpretation on Health Food Raw Material Directory of the Five Ingredients unveiled earlier on Jan. 27 and the Interpretation on Dosages Forms and Technical Requirements of Filing Products Using the Five Ingredients released on Feb. 1, 2021, filing issues such as application scope, the use of auxiliary material, function indicating, principles of transferring health food registration to filing, etc., have been further explained.

1. Application scope

Only when these 5 functional ingredients are used as the single active ingredients in the final product, can enterprises apply for filing (except for the combination of melatonin & vitamin B₆). In addition, such filing only applies to domestic products.

For imported products using the Five Ingredients:

If the product is imported for the first time, it still has to complete registration;
If the product is re-imported with approved registration certificate, it can transfer to filing before the registration certificate expires.
If the product registration application was accepted before the directory for the Five Ingredients was released, and the materials used are listed in the directory, the product could be subject to filing supervision.

2. The use of auxiliary materials

Auxiliary materials used should be included in the permitted list specified in the Technical Requirements. If it is outside the scope of permitted list while included in the List of Auxiliary Materials for Health Food Filing and Terms of Use (2021)*, supporting documents on its safety and function should be provided. Types of food flavors and colorants used for coenzyme Q10, spirulina and melatonin products are not restricted.

* The List of Auxiliary Materials for Health Food Filing and Terms of Use (2021) is not published yet. You can find the 2020 exposure draft edition on ChemLinked.

3. Function indicating

According to the interpretations, health function of the filing products should be consistent with that listed in the raw material directory. For example, the functions of coenzyme Q10 include enhancing immunity and anti-oxidant, applicants could select either of them or indicate both functions.

4 . Principles of transferring health food registration to filing

If the dosage form of the registered product (single active ingredient) is listed in the Technical Requirements for the corresponding ingredient, then the registration certificate could be transferred to filing certificate.
If the product's dosage form is not permitted in the current regulation, the enterprises need to change the product formula following the allowable filing dosages and then the products could be subject to filing supervision.

If the amount of raw material used in the registered product falls outside of the daily amount range listed in the raw material directory, the amount should be adjusted before transferring to filing product.
If the health function registered or to be registered is not listed in the raw material directory of the corresponding material:

for new applications, scientific proof on the health function will be strictly reviewed. Products with sufficient proof will be approved for registration;
for registration renewal, human trial report should be provided. Products with sufficient proof will be allowed for registration extension;
* Note: health function of the approved registration or registration renewal will be considered to be added into the corresponding raw material directory.
if the applicant agrees to alter the health function, the product will be transferred to filing product after the applicant qualification is confirmed.