On August 12, 2020, The State Administration for Market Regulation of China issued coenzyme Q10 and other 4 health food raw materials catalog filing product technical requirements (draft for comments). Today, Foodmate Registration Department will share some knowledges of Coenzyme Q10 with you.

Introduction to Coenzyme Q10

Coenzyme Q10, also known as ubiquinone 10, is a fat-soluble quinone. Its structure is similar to vitamin K. Yellow or orange powder crystals at room temperature, odorless and tasteless. It is easily decomposed by light and is widely distributed in nature. It is mainly found in yeast, plant leaves, seeds and animal hearts, livers and kidneys. Beef, sardines and other foods are also high in content[1].

The preparation methods of coenzyme Q10 mainly include: biological extraction method, microbial fermentation method and chemical synthesis method[1].

Coenzyme Q10 application

01 Pharmaceutical Industry

Coenzyme Q10 is included in the Pharmacopoeia of the People’s Republic of China (Part 2). It is mainly used in the treatment of cardiovascular disease, periodontitis, migraine, Parkinson’s disease, diabetes, anti-tumor, renal failure, etc. , It also has auxiliary effects on many other diseases, mainly including tablets, capsules, soft capsules, injections and other dosage forms. A notable feature of Coenzyme Q10 is that it is non-toxic, non-teratogenic and has no obvious side effects, and is very safe for clinical use [2].

02 Food industry

In the mid-1990s, health products and functional foods containing coenzyme Q10 ingredients appeared in foreign markets. Coenzyme Q10 can greatly improve the oxygen function, nutrition function and immune enhancement function of human cells. The product categories of Coenzyme Q10 include powders, capsules or oral liquids, etc., such as composite anti-aging functional foods that are combined with other natural antioxidant materials, or hypoxia-resistant functional foods and beverages for consumers in plateau or mountain sports[2]. According to relevant regulations in China, Coenzyme Q10 is currently only used in health food in the food field. China approved the first health food with Coenzyme Q10 as the main raw material in 2003. Its health function is to delay aging and anti-fatigue. This product opened the first application of Coenzyme Q10 in the food industry in China.

03 Cosmetics Industry

As a natural antioxidant, Coenzyme Q10 is widely used in cosmetics in health and beauty. Because Coenzyme Q10 can be used to scavenge oxygen free radicals, delay skin aging, and has anti-aging functions, it has been valued by many cosmetic manufacturers. According to the needs of different functions of cosmetics, various lotions and creams are formulated. Coenzyme Q10 can also be used in oral hygiene products. In the toothpaste patent, it is compatible with cypress powder, glycyrrhizic acid, vitamin B6 or lysozyme, which can prevent dental disease and gingivitis[2].

Coenzyme Q10 health food related regulatory requirements

On September 2, 2009, the former State Food and Drug Administration issued a notice on the registration, application and review of health food products containing Coenzyme Q10 in order to regulate the application and review of health food products containing Coenzyme Q10.

On April 1, 2019, SAMR issued the catalogue, technical requirements and drafting instructions of five health food ingredients including Coenzyme Q10 (draft for comments) (abbreviation: the first draft) to solicit opinions and suggestions from the society.

On August 12, 2020, SAMR issued the technical requirements for the catalogue of five health food raw materials including Coenzyme Q10 (draft for comments) (abbreviation: the second draft) to solicit opinions and suggestions from the society again.

based on the two solicitation of opinions on Coenzyme Q10 by SAMR and the notice on the registration, application and review of health food products containing Coenzyme Q10 (State Food and Drug Administration [2009] No. 566), the Registration Department of Foodmate introduced the differences in the relevant regulatory requirements of Coenzyme Q10. The details are as follows.

01 Raw materials requirements

The notification of the relevant provisions of the application and review requires that when coenzyme Q10 is compatible with food and traditionally both food and medicine, sufficient compatibility basis, literature basis, research data, test data, and relevant information that Coenzyme Q10 will not react with other raw materials should be provided. Except for food and articles that are traditionally both food and medicine, Coenzyme Q10 must not be compatible with other raw materials.

In the second draft, coenzyme Q10 was used as the single raw material, and the available excipients were: vitamin E, sodium ascorbate, povidone K30, citric acid, neotame, talc, magnesium stearate, sucrose, stevioside, paste Essence, lactose, microcrystalline cellulose, β-cyclodextrin, crospovidone, citric acid, aspartame (also known as aspartame), edible glucose, silicon dioxide, Fructooligosaccharides, pregelatinized starch, low-substituted hydroxypropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, D-mannitol, sorbitol and sorbitol liquid, carboxymethyl cellulose Sodium, vitamin C, edible corn starch, potato starch, tapioca starch, edible wheat starch, edible sweet potato starch, sodium carboxymethyl starch, hollow capsules, gelatin, glycerin, purified water, drinking water, ethyl paraben and its Sodium salt, sorbic acid and its potassium salt (calculated as sorbic acid), soybean oil, corn oil, sunflower oil, olive oil, powdered soybean phospholipids, concentrated soybean phospholipids, soybean phospholipids, polyoxyethylene sorbitan monooleate , Beeswax, food flavors, pigments.

02 Production process

In the first draft, the production process of Coenzyme Q10 includes three methods, namely chemical synthesis, animal and plant tissue extraction, and microbial fermentation. According to the research results of the contractor of the health food raw material catalog, it is believed that the microbial fermentation method is low in cost. It has replaced the other two methods and has become the main production method of coenzyme Q10 raw materials in the world, and the current production of coenzyme Q10 raw materials in China is also based on fermentation.

The strains used in the fermentation method are all yeasts or Rhodobacter sphaeroides, and the raw materials of Coenzyme Q10 are prepared mainly through the processes of fermentation, extraction and purification.

In the second draft, the main production processes used for the Coenzyme Q10 health food raw material catalogue are as follows:

1. Tablets: crushing, sieving, mixing, granulating, drying, tableting, coating, packaging, etc.

2. Hard capsules: crushing, sieving, mixing, granulating, drying, encapsulating, packaging, etc.

3. Soft capsules: drying, mixing, homogenizing, filtering, pelletizing, packaging, etc.

4. Granules: crushing, sieving, mixing, granulating, drying, packaging, etc.

5. Powder: crushing, sieving, mixing, sub-packing, packaging, etc.

6. The pre-processed raw materials that have been pre-mixed, embedded, and microencapsulated should be pre-mixed (**, **, **), embedded (**, **, **), and microencapsulated ( **, **, **) and other forms, mark the name of the raw materials that have been pre-processed by pre-mixing, embedding, and microencapsulation

03 Dosage form

04 Health function

05 Daily dosage

06 Suitable and unsuitable people

Overview of foreign supervision

In 2003, the US FDA issued an approval document to formally apply Coenzyme Q10 as a food additive to food production, and in September 2004 approved the use of liquid Coenzyme Q10 as a food additive[3].

In 2004, the Ministry of Health and Welfare of Japan approved Coenzyme Q10 as a food additive to be used in beverages, candies, pastries, cheese, and yogurt[3].

The above content is for your reference. If you want to know more about the registration of coenzyme Q10 related health food, please contact us.

References:

[1] Fu Junhe. Study on the dosage form of coenzyme Q10 health food[D]. Nanchang University, 2010.

[2] Tao Zhijie, Wang Gailing, Li Yan. New progress in the preparation and application of coenzyme Q10[J]. Animal Husbandry and Feed Science, 2010, 31 (09): 9-11.

[3] Ma Ju, Shi Ning. Research progress on the application of coenzyme Q10 in food [J]. Food Science and Technology, 2009, 34 (02): 18-21.

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Business Division of Food Safety and Regulatory Compliance of Global Foodmate provides food standards & regulations research, labelling compliance consulting/Chinese label design, industry public opinion monitoring and analysis, registration services (of Infant formula, FSMP, Health food, Novel Food Ingredients, Novel Food Additives, New Varieties of Food-Related Products and Overseas manufacturers of imported food) and other comprehensive food safety solutions for domestic and overseas enterprises and institutions in food industry. 

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