CFSA FAQ: Can Food Extracts and Red Ginseng Be Used as Food Ingredients?

On August 26, 2024, China’s National Center for Food Safety Risk Assessment (CFSA) issued a set of FAQs on “three new foods” and substances traditionally used as both food and traditional Chinese medicine (TCM), covering a total of 25 questions.

In this article, CIRS Group summarizes the key issues regarding the use of various food ingredients, including food extracts, red ginseng, Ganoderma spore powder, and protein hydrolysates, that are of concern to businesses.

Q1: Can food extracts be used as food ingredients?

A1: Using food extracts as ingredients can be complex due to the varied nature of food components and extraction methods. Substances listed in the directory of substances traditionally used as both food and TCM can be subjected to simple aqueous extraction without altering the substance. Concentrates, extracts, or powders obtained from this aqueous solution using methods such as freeze-drying, spray-drying, vacuum-drying, or hot-air drying can be used in ordinary food production. The finished product should contain an amount equivalent to the traditional use of the original substance. For new food ingredients, follow official guidelines. For more details, refer to the Guidance on New Food Ingredients, Ordinary Foods, and Health Foods issued by the former National Health and Family Planning Commission (NHFPC).

Q2: Is it necessary to strictly follow the “properties” of the approved new food raw material described in the announcement?

A2: The production and use of new food raw materials should be consistent with the specifications in the official announcements. Currently, applications for new food raw materials with varying properties undergo a more inclusive safety review process. This ensures safety while striving to provide a comprehensive description in the announcement.

For example, regarding characteristics specified in previous announcements, such as for maca powder, products that have undergone simple physical processing (like slicing, drying, or grinding) without altering their fundamental properties are considered within the scope of the announcement, provided that their safety is ensured.

Q3: Can protein hydrolysates be used as food ingredients?

A3: It is stipulated in Announcement No. 3 of 2013 by the former NHFPC that, substances made from edible animal or plant proteins using food-grade enzymes permitted by the Standard for the Use of Food Additives (GB2760) are classified as ordinary food. “Edible” refers to animals or plants that are regulated as ordinary food. If a protein source is from a new food ingredient and processed using approved food-grade enzymes, the same guidelines for unsuitable groups and recommended consumption should apply as for the new food ingredient. The recommended consumption should be based on the protein content, and both information should be clearly labeled according to the original announcement.

For instance, hydrolyzed egg yolk powder (Announcement No. 20 of 2008), corn oligopeptides powder (Announcement No. 15 of 2010), and wheat oligopeptides (Announcement No. 16 of 2012), are all made from edible animal or plant proteins and processed with enzymes approved under GB2760. These products meet the requirements outlined in Announcement No. 3 of 2013, and can be regulated as ordinary food.

Q4: Can red ginseng be used as a food ingredient?

A4: According to Announcement No. 17 of 2012 issued by the former Ministry of Health (MOH), ginseng (artificially cultivated for five years or less) was approved as a new resource food, now referred to as a new food ingredient. This announcement specifies its Latin name, basic information, consumption limits, and restrictions for certain groups.

According to the Pharmacopoeia of the People’s Republic of China - 2020 Edition (Pharmacopoeia 2020), red ginseng is a processed form of ginseng made by steaming and drying. Red ginseng made from ginseng that meets the specified requirements can be used as a food ingredient. Its consumption limits and restrictions should also follow those set for ginseng. All food production and sales must strictly comply with relevant laws, regulations, standards, and official announcements.

Q5: Can lotus rhizome node and Chinese waxgourd peel be used as ordinary food ingredients?

A5: Lotus rhizome node and Chinese waxgourd peel are widely consumed food ingredients in China and are regulated under food safety standards. Due to various eating habits and preferences, they are also used as parts of lotus and wax gourd. Currently, there are no known food safety issues associated with these ingredients.

Q6: Can ganoderma lucidum spore, ganoderma lucidum spore powder, and broken ganoderma lucidum spore powder be used as food ingredients?

A6: On November 17, 2023, the National Health Commission (NHC) and the State Administration for Market Regulation (SAMR) jointly issued Announcement No. 9 of 2023, which includes nine substances into the directory of substances traditionally used as both food and TCM. Ganoderma is defined as the dried fruiting bodies of Ganoderma lucidum (Leyss.ex Fr.) Karst. or Ganoderma sinense Zhao, Xu et Zhang. However, Ganoderma spores, being the seeds of Ganoderma, do not fall under this classification. Therefore, the announcement does not apply to Ganoderma spores.

Moreover, the NHFPC’s “Reply regarding Ganoderma Lucidum Spore Powder (Document No. 390 [2014])” clarifies that Ganoderma spore powder lacks a long history of consumption as food and is primarily used as a medicine. Therefore, there is currently insufficient scientific evidence to support its use as an ordinary food ingredient.

Q7: How is Imperatae Rhizoma defined in the directory of substances traditionally used as both food and TCM? Can it be labeled as Cogongrass Rhizomeon product labels?

A7: The former MOH’s “Notice on Further Standardizing the Management of Health Food Ingredients (Document No. 51 [2002]) categorizes Imperatae Rhizoma as a substance traditionally used as both food and TCM. Simple processing methods like air-drying or baking, commonly used for various food ingredients, do not affect their status as food ingredients. According to the National Food Safety Standard - General Rules for the Labeling of Prepackaged Food (GB7781-2011), prepackaged food labels must include an ingredient list where each ingredient’s name clearly reflects the true nature of the food. This ensures that consumers are not misled or confused about the food’s attributes, physical state, or production method.

Q8: Can dried Rhizoma Phragmitis be considered a substance traditionally used as both food and TCM?

A8: The Pharmacopoeia 2020 defines Rhizoma Phragmitis as the fresh or dried rhizomes of Phragmites communis Trin.The former MOH’s Document No. 51 of 2002 lists it as a substance that can be used both as food and medicine. Dried Rhizoma Phragmitis, which is simply a preserved form of fresh ones through physical dehydration, is considered equivalent in use. According to the Regulations for Managing Substances Traditionally Used as Both Food and Traditional Chinese Medicine, both fresh and dried Rhizoma Phragmitis are classified as food and drug materials.

Q9: Can black jujube and Citri Exocarpium Rubrum be considered as substances traditionally used as both food and TCM?

A9: The Pharmacopoeia 2020 includes Citri Exocarpium Rubrum (dried outer peel of Citrus reticulata Blanco and its cultivated varieties), citri reticulatae pericaprium (dried mature peel of Citrus reticulata Blanco and its cultivated varieties), jujube (dried mature fruit of Ziziphus jujuba Mill.), and Fructus choerospondiatis (dried mature fruit of Choerospondias axillaris (Roxb.) Burtt et Hill). These are consistent with Citri Exocarpium Rubrum, citri reticulatae pericaprium, and jujube listed in Document No. 51 of 2002 by the former MOH.

Q10: Are oyster shells considered food and drug substances?

A10: The Pharmacopoeia 2020 includes oyster shells from Ostrea gigas Thunberg, Ostrea talienwhanensis Crosse, and Ostrea rivularis Gould. According to Document No. 51 of 2002 by the former MOH, oysters are listed as substances used both as food and medicine. This includes the shells of these oyster species. Therefore, the shells of the three types of oysters included in the Pharmacopoeia are considered food and drug substances.

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Further Information

CFSA FAQs

How Are “Three New Foods” Defined and Regulated? FAQs from China’s CFSA, Vol. 2