[Updated] China Unveils Filing Requirements for Health Food Added with Ginseng, American Ginseng, and Lingzhi

On February 8, 2024, China State Administration for Market Regulation (SAMR) announced to solicit public comments on the draft of Technical Requirements for Health Food Filing Using Health Food Ingredients Including Ginseng, American Ginseng, and Lingzhi. Stakeholders may submit comments via email to [email protected] no later than March 8.

Background

As previously reported in ChemLinked News, three ingredients including Ginseng, American Ginseng, and Lingzhi (Ganoderma), will officially be added to the “Health Food Raw Material Directory” from May 1, 2024. After that, locally-produced health food products added with the three ingredients are allowed to obtain the market authorization by product filing instead of product registration. For imported products added with the three ingredients, product registration will still be required.

Proposed filing requirements 

The draft specifies the filing requirements for health food products added with the three ingredients, mainly covering five aspects, namely, auxiliary materials, product dosage forms, product processing, product technical requirements, and other requirements.

1. Auxiliary materials 

For products added with the three ingredients, only the 58 types of permitted auxiliary materials listed in this draft can be used. If enterprises intend to use auxiliary materials outside the permitted scope, necessary supporting documents must be provided. Besides, the types and amounts of the used auxiliary materials shall be minimized as much as possible while meeting product requirements. The selected auxiliary materials should not interact with the raw materials to avoid affecting the detection of product technical indicators.

2. Product dosage forms 

Products added with the three ingredients can be in most common dosage forms, such as tablets, capsules, powders, oral liquids, granules, ointments, and tea preparations once meeting the corresponding requirements stated in the Chinese Pharmacopoeia. It should be noted that oral liquid products are no longer subject to daily intake limits. Besides, the draft clarifies that ginseng honey tablets are currently not available for these kinds of products.

For products added with other dosage forms, the draft also specifies the corresponding obligations. More importantly, they must comply with the attribute requirements for health food. For products produced as alcoholic beverages, production and technical requirements are in line with the technical requirements under the Chinese Pharmacopoeia for alcoholic beverages.

3. Product processing 

As per the draft, the raw materials that can enjoy filing should have a fixed source and place of origin. During the manufacture of the final product, only physical crushing or extraction and heating processes in which water as a solvent are allowed. No other production processes that alter the substance's fundamental nature, such as steaming, should be employed.

In addition, the production research data submitted by the applicant should be based on commercial-scale production rather than pilot-scale production, for the purpose of minimizing changes to the main processes and key process parameters after obtaining the filing certificate.

4. Product technical requirements 

For products added with ginseng, they should be named as per "brand + ginseng + attribute name". It is not allowed to name such products as per "brand + ginseng (years) + attribute name". The term "ginseng grown under forest cover" should not be indicated in the filing certificate, product instructions, or product technical requirements. Products added with ginseng grown under forest cover as an ingredient should apply for registration as health food.

For different varieties of Lingzhi products, it is allowed to name the products according to different varieties, such as "brand + Lingzhi + attribute name", "brand + Lingzhi (Ganoderma Lucidum) + attribute name", and "brand + Lingzhi (Ganoderma Sinense) + attribute name".

For products added with American ginseng, they should be named as per "brand + American ginseng + attribute name".

Products should also meet the identification requirements and physicochemical parameters stated in this draft.

5. Others  

The draft specifies the basic requirements for the use of raw materials, which are consistent with the existing requirements for functional products in the filing management. As traditional Chinese medicine materials are to be included in the filing management for the first time, if the production processes involves extraction of the ingredients, it is necessary to strictly comply with the provisions of Article 35 of the Regulations for the Implementation of the Food Safety Law. At the same time, the applicants should fulfill their responsibilities and each province should strengthen the traceability and supervision of the filed products.

For the full English version of this draft, please feel free to contact us via [email protected].