National Health Commission, State Administration for Market Regulation

August 12, 2024

Interpretation of the “Announcement on Rehmannia and Three Other Substances That Have Traditionally Been Used Both as Food and as Chinese Medicinal Materials” (No. 4, 2024)

In China’s traditional food culture, certain Chinese medicinal materials are widely consumed as food ingredients in folk practice—substances that, according to tradition, serve both as food and as medicinal herbs (hereinafter referred to as “food‑medicine substances”). The Food Safety Law stipulates that pharmaceuticals may not be added to foods intended for production or sale, but food‑medicine substances may be used; the list of such substances is formulated and promulgated jointly by the State Council’s health administrative department and the State Council’s food safety supervision authority. To standardize the management of the food‑medicine substance list, the National Health Commission has issued the Regulations on the Administration of the Food‑Medicine Substance List, specifying that provincial health administrative departments, based on local conditions, may submit proposals to add to or revise the list, while also preparing and submitting relevant safety documentation in accordance with applicable requirements. Upon receipt of such applications, the National Health Commission conducts a review and, for those meeting food safety standards, issues a public announcement in conjunction with the State Administration for Market Regulation to include them in the list.

The four newly approved food‑medicine substances—Rehmannia glutinosa, Ophiopogon japonicus, Asparagus cochinchinensis, and Citrus reticulata Blanco peel—are evaluated for safety primarily in accordance with the principles and methods of food safety risk assessment. Their safety is further determined through comprehensive deliberation, taking into account their traditional use as food in China and the needs of local industries for high‑quality development. The specific details are as follows:

Rehmannia root. Listed in the Pharmacopoeia of the People’s Republic of China (2020 edition), it refers to the fresh or dried tuberous roots of Rehmannia glutinosa Libosch., a plant belonging to the Scrophulariaceae family. In regions such as Henan, Gansu, and Shandong, rehmannia has a long history of consumption as a food ingredient, typically prepared by pickling into salted vegetables, steeping in tea, infusing in liquor, incorporating into dishes, simmering in soups, or braising with meat. When consumed according to traditional practices, no adverse reactions have been reported. Prepared rehmannia, a processed form of raw rehmannia, is included under the rehmannia entry; it is produced through conventional processing methods and may be used as a food‑medicine substance.

Ophiopogon japonicus. Listed in the Pharmacopoeia of the People’s Republic of China (2020 edition), it is the dried tuberous roots of Ophiopogon japonicus (L.f.) Ker‑Gawl., a plant belonging to the Liliaceae family. In China, Ophiopogon japonicus has a long history of being used as a food ingredient in regions such as Sichuan and Guangdong, typically prepared by steeping in tea, cooking into porridge, or simmering in soups. When consumed according to traditional practices, no adverse reactions have been reported.

Tian Dong. Listed in the Pharmacopoeia of the People’s Republic of China (2020 edition), it is the dried tuberous roots of Asparagus cochinchinensis (Lour.) Merr., a plant belonging to the Liliaceae family. In Sichuan and other regions, Tian Dong has a long history of being used as a food ingredient, typically prepared by steaming fresh specimens, simmering in soups, brewing liquor, making tea, cooking congee, or producing candied fruits. When consumed according to traditional practices, no adverse reactions have been reported.

Citrus grandis peel. Listed in the Pharmacopoeia of the People’s Republic of China (2020 edition), it is the dried outer pericarp of the unripe or nearly ripe fruit of either the Citrus grandis ‘Tomentosa’ or Citrus grandis (L.) Osbeck, both belonging to the Rutaceae family. In Guangdong, Guangxi, and other regions, citrus grandis peel has a long history of use as a food ingredient, typically prepared by steeping in tea, simmering in soups, braising with meat, incorporating into dishes, or processing into traditional beverages, candies, candied fruits, preserved fruits, and pastries. When consumed according to customary practices, no adverse reactions have been reported.

As food‑medicine substances, the aforementioned materials are recommended to be consumed in appropriate amounts according to traditional practices; they are not recommended for special populations such as pregnant women, lactating women, and infants and young children. When used as ingredients in health foods, these substances shall be managed in accordance with relevant regulations governing health foods; when used as Chinese medicinal materials, they shall be managed in accordance with applicable regulations for Chinese medicinal materials.

Regarding the nine newly added items, including Codonopsis pilosula, in accordance with… Notice on Substances That Are Both Foods and Traditional Chinese Medicinal Materials

No. 9, 2023

(No. 8 of 2019)

National Health Commission, State Administration for Market Regulation

November 25, 2019

Catalogue of Six Newly Added Substances That Are Traditionally Both Food and Chinese Medicinal Materials, Including Danggui

Note: Substances listed in the Catalogue of Substances That Are Both Food and Traditional Chinese Medicinal Materials shall, when used in food production and operation, comply with the provisions of the Food Safety Law.

Interpretation

In China’s traditional food culture, certain Chinese medicinal materials are widely consumed as food ingredients in the general population—substances that, according to tradition, serve both as food and as medicinal herbs (hereinafter referred to as “food‑medicine substances”). The six newly approved food‑medicine substances, including Danggui, were determined through systematic research and comprehensive evaluation, guided by the principles and methods of food safety risk assessment. This determination was made in accordance with the Food Safety Law, taking into account China’s traditional dietary practices and revisions to the Chinese Pharmacopoeia, while also considering local needs and drawing on relevant international regulatory experience. Based on the feedback received, there is strong support for regulating these substances as food‑medicine substances. Specific details are provided below:

Danggui is listed in the Chinese Pharmacopoeia (2015 edition). Traditionally, it has been used in China as a spice and seasoning, and it is also employed as a spice in the United States, the European Union, and Japan. The source plants and edible parts specified in the Catalogue of Food‑Medicinal Substances are consistent with those documented in the Chinese Pharmacopoeia.

Nardostachys, saffron, amomum, turmeric, and long pepper are listed in the Chinese Pharmacopoeia (2015 edition). Traditionally in China, these five spices—nardostachys, saffron, amomum, turmeric, and long pepper—are used as flavoring agents and seasonings, and they are also included in the “Names of Spices and Seasonings” standard (GB/T 12729.1-2008). The source plants and edible parts specified in the Catalogue of Food‑Medicine Substances are consistent with those documented in the Chinese Pharmacopoeia.

When the aforementioned substances are used as food‑medicine materials, it is recommended that they be processed in accordance with traditional methods, involving only procedures such as grinding, slicing, pressing, stir-frying, boiling, or soaking in alcohol. When these food‑medicine materials are added to foods, their labels, instruction manuals, advertisements, and promotional materials must not contain false information and must not make any claims regarding disease prevention or treatment. When these substances are used as ingredients in health foods, they shall be managed in compliance with relevant regulations for health foods; when used as Chinese medicinal materials, they shall be managed in accordance with applicable regulations governing Chinese medicinal materials.

In accordance with the provisions of the Food Safety Law, following a safety assessment and extensive public consultation, a pilot program will be launched for the production and operation of nine substances—namely, Codonopsis pilosula, Cistanche deserticola, Dendrobium officinale, American ginseng, Astragalus membranaceus, Ganoderma lucidum, Cornus officinalis, Gastrodia elata, and Eucommia ulmoides leaves—that are traditionally used both as food and as Chinese medicinal materials (hereinafter referred to as “food‑medicine substances”). Each provincial health commission, in coordination with the market supervision administration (department or commission), shall, based on local conditions, formulate a specific pilot plan. Such plans must specify the types of food‑medicine substances to be piloted, the risk‑monitoring schedule, and the corresponding regulatory measures, and, after obtaining approval from the provincial people’s government, submit them to the National Health Commission and the State Administration for Market Regulation for review and confirmation.

Based on the implementation experiences of pilot programs in various regions, the National Health Commission, in collaboration with the State Administration for Market Regulation, will conduct a feasibility study to determine whether to include the aforementioned substances in the Catalogue of Food‑Drug Substances.

In China’s traditional food culture, certain Chinese medicinal materials are widely consumed as food ingredients in the general population—substances that, according to tradition, serve both as food and as medicinal herbs (hereinafter referred to as “food‑medicine substances”). This pilot program for the management of nine such substances, including Codonopsis pilosula, is primarily guided by the Food Safety Law. It takes into account China’s traditional dietary practices and the revisions to the Chinese Pharmacopoeia, while also considering local needs and drawing on relevant international regulatory experience. The selection was determined through systematic research and comprehensive evaluation, employing the principles and methods of food safety risk assessment. Details are provided below:
Codonopsis. It is listed in the Chinese Pharmacopoeia (2015 edition) and refers to the dried roots of plants belonging to the Campanulaceae family, namely Codonopsis pilosula, Codonopsis lanceolata, and Codonopsis tangshen. In Shanxi Province, Gansu Province, and other regions, Codonopsis has a long history of being used as a food ingredient, typically prepared by simmering in soups, cooking congee, steaming rice, adding to dishes, incorporating into hot pots, infusing in traditional liquor, or making candied Codonopsis slices. Codonopsis should not be used concurrently with Veratrum.
Cistanche deserticola. According to the Chinese Pharmacopoeia (2015 edition), Cistanche is the fleshy, scale‑bearing stem of the plant Cistanche deserticola, which belongs to the Orobanchaceae family. In the Inner Mongolia Autonomous Region, Cistanche has a long history of being used as a food ingredient, typically prepared by stewing with meat, incorporating into dishes, making staple foods, brewing tea, or, in traditional practice, steeping in liquor.
Dendrobium officinale. Listed in the Chinese Pharmacopoeia (2015 edition), it is the stem of the orchid Dendrobium officinale. In Yunnan Province, Zhejiang Province, and other regions, Dendrobium officinale has a long history of being consumed as a food ingredient, typically prepared by eating it directly, simmering it in soups, incorporating it into dishes, juicing it, brewing it into tea, or steeping it in liquor using traditional methods.
American ginseng. It is listed in the Chinese Pharmacopoeia (2015 edition) as the dried root of Panax quinquefolius, a plant belonging to the Araliaceae family. In Shandong Province and other regions, Panax quinquefolius has a long history of being used as a food ingredient, typically prepared by steeping in water, cooking into porridge, simmering in soups, or incorporating into dishes. Panax quinquefolius should not be used concurrently with Veratrum.
Astragalus. It is listed in the Chinese Pharmacopoeia (2015 edition) and refers to the dried roots of Astragalus membranaceus and Astragalus mongholicus, both leguminous plants. In Shanxi Province, Gansu Province, and other regions, astragalus has a long history of being used as a food ingredient, typically prepared by simmering in soups, braising with meat, cooking congee, steaming rice, adding to dishes, incorporating into hot pot, or traditionally steeping in alcohol.
Lingzhi. It is listed in the Chinese Pharmacopoeia (2015 edition) and refers to the dried fruiting bodies of the fungi Ganoderma lucidum and Ganoderma sinense, both belonging to the family Polyporaceae. In Anhui Province, Shandong Province, and other regions, Lingzhi has a long history of being consumed as a food ingredient, typically prepared by simmering in soups, steeping in tea, or traditionally infusing in liquor.
Cornus officinalis. It is listed in the Chinese Pharmacopoeia (2015 edition) and refers to the mature pulp of the fruit of Cornus officinalis, a plant belonging to the Cornaceae family. In Shaanxi Province, Henan Province, and other regions, Cornus officinalis has a long history of being used as a food ingredient, typically prepared by simmering in soups, incorporated into dishes, or processed using traditional methods into fruit wines, fruit juices, candied fruits, and dried fruit preserves.
Tianma. It is listed in the Chinese Pharmacopoeia (2015 edition) and refers to the tuber of the orchid plant Gastrodia elata. In Guizhou Province, Yunnan Province, and other regions, Gastrodia has a long history of being used as a food ingredient, typically prepared by stewing with meat, adding to dishes, or incorporating into hot pot. Individuals with allergic constitutions should avoid consuming it.
Eucommia leaf. It is listed in the Chinese Pharmacopoeia (2015 edition) and refers to the leaves of Eucommia ulmoides, a plant belonging to the Eucommiaceae family. In provinces such as Hunan and Henan, Du Zhong leaves have a long history of being used as a food ingredient, with common preparations including incorporating young Du Zhong leaves into dishes, cooking them into porridge, brewing them into tea, and using them to make staple foods.
When the aforementioned substances are used as food‑medicine materials, it is recommended to consume them in appropriate amounts according to traditional practices; they are not recommended for special populations such as pregnant women, breastfeeding women, and infants and young children. Traditional methods typically include processes such as grinding, slicing, pressing, stir‑frying, boiling, or soaking in alcohol. When used as food‑medicine materials, their labels, package inserts, advertisements, and promotional materials must not contain false information and must not make claims related to disease prevention or treatment. When these substances are used as ingredients in health foods, they shall be managed in accordance with relevant regulations governing health foods; when used as Chinese medicinal materials, they shall be managed in accordance with applicable regulations for Chinese medicinal materials.
To standardize the pilot program, local authorities are required to submit a pilot plan that specifies the types of food‑drug substances to be tested, the risk‑monitoring schedule, and the accompanying regulatory measures. After obtaining approval from the provincial people’s government, the plan shall be submitted to the National Health Commission and the State Administration for Market Regulation for review and confirmation. Pilot production and operations must be conducted strictly in accordance with the approved plan, with strengthened ongoing and post‑event supervision. The National Health Commission, in collaboration with the State Administration for Market Regulation, will, based on the outcomes of the pilot program, consider timely inclusion of relevant substances in the catalog of food‑drug substances.

At present, four batches of the list of food‑medicine substances have been published, encompassing a total of 106 substances. These include the “Notice of the Ministry of Health on Further Standardizing the Management of Raw Materials for Health Foods” (Wei Fa Jian Fa [2002] No. 51), the “Announcement on Six Newly Added Substances, Including Danggui, That Are Traditionally Both Food and Chinese Medicinal Materials” (No. 8, 2019), and the “Announcement on Nine Newly Added Substances, Including Dangshen, That Are Traditionally Both Food and Chinese Medicinal Materials” (No. 9, 2023).

A list of foods with health-promoting properties as recorded in historical materia medica texts.

Foods that support hearing (enhance or improve auditory function): lotus seeds, Chinese yam, water chestnuts, water celery, mustard greens, and honey.

Foods that promote eye health (enhance or improve vision): Chinese yam, goji berries, water celery, pork liver, lamb liver, wild duck meat, herring, abalone, snails, and clams.

Foods that promote hair growth: white sesame seeds, chives seeds, and walnut kernels.

Hair-nourishing (moisturizing and adding shine to hair) foods: abalone.

Foods that darken the hair and beard: black sesame, walnut kernels, and barley.

Foods that promote long beards (beneficial for men who don’t grow beards): turtle meat.

Foods that promote beauty and enhance complexion (helping the skin appear rosy and radiant): goji berries, cherries, lychees, black sesame seeds, Chinese yam, pine nuts, milk, and lotus pistils.

Foods that strengthen and whiten teeth: Sichuan peppercorns, water celery, and lettuce.

Foods that promote lightness and help reduce obesity: water caltrops, jujubes, Chinese torreya nuts, longan, lotus leaves, oats, and green millet.

Foods for obese individuals (to improve the constitution of thin people and strengthen the body): wheat, japonica rice, sour jujube, grapes, lotus root, Chinese yam, black sesame, and beef.

Foods that enhance intelligence (such as improving cognitive function and supporting brain health): Japonica rice, buckwheat, walnuts, grapes, pineapple, lychee, longan, jujubes, lily bulbs, Chinese yam, tea, black sesame seeds, black fungus, and cuttlefish.

Foods that strengthen resolve (boost morale): lily bulbs, Chinese yam.

Foods that calm the mind (promote mental tranquility and improve sleep, among other benefits): lotus seeds, sour jujubes, lily bulbs, plums, lychees, longan, Chinese yam, quail, oyster meat, and yellow croaker.

Foods that tonify the spirit (enhance mental vitality and reduce fatigue): tea, buckwheat, and walnuts.

Foods that enhance strength (such as physical stamina and endurance) include buckwheat, barley, mulberries, and hazelnuts.

Foods that strengthen the bones and muscles (fortifying the body, including the tendons, bones, muscles, and physical stamina): chestnuts, sour jujubes, loaches, and table salt.

Foods that promote hunger resistance (help the body tolerate hunger and delay the next meal): buckwheat, pine nuts, water caltrops, shiitake mushrooms, and grapes.

Foods that stimulate appetite and enhance digestion: scallions, ginger, garlic, Chinese chives, cilantro, black pepper, chili peppers, carrots, and white radish.

Foods that tonify kidney yang (help regulate sexual function and treat conditions such as erectile dysfunction and premature ejaculation) include: walnuts, chestnuts, hyacinth beans, pineapple, cherries, Chinese chives, Sichuan peppercorns, dog meat, dog penis, lamb, lamb fat, sparrow meat, venison, deer penis, bird’s nest, sea shrimp, sea cucumber, eel, and silkworm pupae.

Foods that nourish the kidneys (enhancing fertility, also known as “replenishing the lineage,” and including a fetal‑protective effect): lemon, grapes, black hen, sparrow meat, sparrow brains, chicken eggs, deer bones, common carp, sea bass, and sea cucumber.

List of Foods with Therapeutic Effects as Recorded in Historical Herbal Texts