[Updated] China Adds Ginseng, American Ginseng, and Lingzhi to Health Food Raw Material Directory

Updated on January 2, 2024:

As per the official notice issued by SAMR on December 31, 2023, China appends ginseng, American ginseng, and Lingzhi (also known as reishi) into the “Health Food Raw Material Directory”. The notice will come into effect on May 1, 2024.

For further product registration, consultation or translation service, please email [email protected].

Previous Report on Its Consultation Draft in Oct 2022

As disclosed by the notice¹ released on October 25, 2022, China’s State Administration for Market Regulation (SAMR) is soliciting public opinions to append ginseng, American ginseng, and Lingzhi (also known as reishi) into the current “Health Food Raw Material Directory”*. Opinions could be sent to [email protected] prior to November 25, 2022.

*Notes: The current “Health Food Raw Materials Directory” consists of two parts, raw materials for nutrient supplements² and 5 ingredients with functional ingredients³ like coenzyme Q10.

Details of the Three Ingredients

The notice unveils the usage requirements, specific functional claims that products can bear, and the technical specifications for each ingredient.

Usage requirements and permitted functional claims

Name	Usage				Function
	Usage level	Suitable group	Unsuitable group	Notes
Ginseng manually planted for 5 years and below	1-3g	Those easily feel tired	Children, pregnant women, lactating women, and people with damp-heat constitution or yin-deficiency constitution	Not suitable for use with Chinese patent medicines containing Lilu (Veratrum spp.) or Wulingzhi (Trogopterori Faeces). Not recommended for people with colds, thick and greasy tongue coat, or those prone to “excessive internal heat”. For long-term use, it is recommended to reduce the intake amount according to individual constitution.	Relieving fatigue
		Those with weakened immune systems			Enhancing immunity
American ginseng	1.5-3g	Those easily feel tired	Children, pregnant women, lactating women, and people with damp-heat constitution or yang-deficiency constitution	Not suitable for use with Chinese patent medicines containing Lilu (Veratrum spp.). Not recommended for people with colds or thick and greasy tongue coat.	Relieving fatigue
		Those with weakened immune systems			Enhancing immunity
Lingzhi	4-6g	Those with weakened immune systems	Children, pregnant woman and lactating woman	None	Enhancing immunity

Technical requirements

The technical requirements specify the raw material source, sensory requirements, identification method, physicochemical indexes, microorganism indexes, active ingredient indicators, storage, allowed dosage forms, and processing techniques.

Impact for Enterprises

Adding the three ingredients to the raw material directory means it will be easier for enterprises to get the health food certificate through filing, saving time and cost compared with registration. However, it only applies to applications from local enterprises in China as per the Administrative Measures for Registration and Filing of Health Foods. (Read ChemLinked news for more details) In another word, presently, if overseas enterprises want to sell products containing the above functional ingredients after the consultation draft passes in the near future, they shall get the product registered with SAMR.

Regulatory Compliance of the Three Ingredients in China

The above three ingredients are well-accepted by Chinese consumers and normally seen in daily life. This year, a product called “A Whole Root”, with a whole root of ginseng immersed in water, became a hit among young consumers with daily sales of over 50 thousand bottles in its heyday.

“A Whole Root” Beverage

How to use these ingredients legally in products? All the three ingredients can be used in health food. Since ginseng belongs to novel food ingredient, it can also be used in regular food as per specific notice. Detailed requirements are as below.

Regulatory Compliance of Ginseng, American Ginseng, and Lingzhi

Name	Related ingredients	Application scope	Use amount	Notes
Ginseng	Ginseng (limited to ginseng manually planted for 5 years and below)	Foods, including health food	Intake: ≤3g/day	Not suitable for pregnant, lactating women and children under 14 days old. Read more details in this notice.
Ginseng	Ginseng	Health food only	Not specified	Read more at the List of ingredients that can be used in health food.
American ginseng	/	Health food only	Not specified	Read more at the List of ingredients that can be used in health food.
Lingzhi or reishi	Lingzhi or reishi	Healrg food only	Not specified	/
Lingzhi or reishi	Lingzhi or reishi shell-broken spore powder	Health food only	Not specified	For overseas enterprises who need to get such health food registered, the usage amount of Lingzhi shell-broken spore powder is not limited to a specific use amount. Lingzhi shell-broken spore powder was added into the health food raw material directory in 2020. Corresponding notice details the usage amount of lingzhi broken spore powder to help local enterprises in China to get such health foods filed easily. Overseas enterprises may take the requirements detailed in that notice as reference, which could help accelerate the registration pace.

Recommended food ingredient tool:

Combox (developed by REACH24H Consulting Group), where stakeholders can search the regulatory requirements for ingredients in China and make Chinese labels.