On August 12, 2020, the State Administration for Market Regulation issued the technical requirements for the filing of five kinds of health food raw materials such as coenzyme Q10 (draft for comment), the draft for comments made specific requirements for the filing of 5 kinds of health food raw materials, so what are these five raw materials, in what aspects are applied, what are the regulatory requirements, what is the regulatory situation abroad, the food partner network registration department takes everyone to understand one by one, today we want to understand the coenzyme Q10.
Introduction to Coenzyme Q10
Coenzyme Q10, also known as ubiquinone 10, is a fat-soluble quinone, its structure is similar to vitamin K, because of its side chain on the six positions of the parent nucleus - polyisoamyl group polymerization degree of 10 and named, is a quinone ring compound, at room temperature is yellow or orange yellow powder crystal, odorless and odorless. It is easily decomposed by light and is widely distributed in nature, mainly in yeast, plant leaves, seeds and animal hearts, livers and kidneys, and is also high in foods such as beef and sardines [1].
The preparation methods of CoQ10 mainly include: biological extraction method, microbial fermentation method and chemical synthesis method[1].
Coenzyme Q10 application
<h1 class="pgc-h-arrow-right">01</h1>
<h1 class="pgc-h-arrow-right" > pharmaceutical industry</h1>
Coenzyme Q10 is included in the Pharmacopoeia of the People's Republic of China (Part II), which is mainly used in the clinical treatment of cardiovascular disease, periodontitis, migraine, Parkinson's disease, diabetes, anti-tumor, kidney failure, etc., and also has auxiliary efficacy for many other diseases, mainly including tablets, capsules, softgels, injections and other dosage forms. A distinguishing feature of CoQ10 is that it is non-toxic, teratogenic, and has no significant side effects, and is very safe for clinical use [2].
<h1 class="pgc-h-arrow-right">02</h1>
<h1 class="pgc-h-arrow-right" > food industry</h1>
In the mid-1990s, health supplements and functional foods containing coenzyme Q10 ingredients appeared in foreign markets. Coenzyme Q10 can greatly improve the oxygen function, nutritional function and immune enhancement function of human cells. Coenzyme Q10 product categories include powders, capsules, or oral liquids, such as combinations with other natural antioxidant ingredients to form complex anti-aging functional foods, or hypoxia-resistant functional foods and beverages for highland or mountaineering consumers[2]. According to china's relevant regulations, coenzyme Q10 is currently limited to health food in the food field. China in 2003 approved the first coenzyme Q10 as the main raw material of health food, its health care function is to delay aging, anti-fatigue, this product opened the application of coenzyme Q10 in China's food field precedent.
<h1 class="pgc-h-arrow-right">03</h1>
<h1 class="pgc-h-arrow-right" > cosmetics industry</h1>
As a natural antioxidant, Coenzyme Q10 is more widely used in cosmetics in health and beauty. Because CoQ10 can be used to scavenge oxygen free radicals, delay skin aging, and has anti-aging functions, it is valued by many cosmetic manufacturers, and according to the needs of different functions of cosmetics, it is mixed into various lotions and creams. Coenzyme Q10 can also be used in oral hygiene products, and is patented for toothpaste in compatibility with hinoki powder, glycyrrhizic acid, vitamin B6, or lysozyme to prevent dental disease and gingivitis[2].
Coenzyme Q10 health food related regulatory requirements
On September 2, 2009, in order to standardize the declaration and review of coenzyme-containing Q10 health food products, the former State Food and Drug Administration issued a notice on the relevant provisions of the registration declaration and review of coenzyme Q10 health food products (hereinafter referred to as the notice of the relevant provisions of the declaration and review).
On April 1, 2019, the State Administration for Market Regulation issued the catalogue of raw materials for five kinds of health food, including Coenzyme Q10, technical requirements (draft for comment) and drafting instructions (hereinafter referred to as the first draft for comments) to solicit opinions and suggestions from the public.
On August 12, 2020, the State Administration for Market Regulation issued the technical requirements for the filing of five health food raw material catalogs such as Coenzyme Q10 (Draft for Solicitation of Comments) (hereinafter referred to as the Second Consultation Draft), once again soliciting opinions and suggestions from the public.
Based on the State Administration for Market Regulation's two solicitations of opinions on CoQ10 and the Notice on the Relevant Provisions on the Registration Declaration and Review of Coenzyme Q10 Health Food Products (State Food and Drug Administration License [2009] No. 566), the Registration Department of The Food Partner Network introduced the differences in the relevant regulatory requirements of Coenzyme Q10, as follows.
<h1 class="pgc-h-arrow-right" > raw material requirements</h1>
The notice of the relevant provisions of the declaration and review requires that when CoQ10 is compatible with food and articles that are both food and medicine according to tradition, sufficient compatibility basis, literature basis, research data, test data and relevant information that CoQ10 will not have a chemical reaction with other raw materials should be provided. Coenzyme Q10 must not be compatible with other raw materials except for food and items that have traditionally been both food and medicine.
In the second draft for comments, coenzyme Q10 is used as a single raw material, and the excipients available are: vitamin E, sodium ascorbate, povidone K30, citric acid, neo sweet, talc, magnesium stearate, sucrose, steviol glycosides, dextrin, lactose, microcrystalline cellulose, β-cyclic dextrin, cross-linked povidone, citric acid, methyl aspartic acid (aka aspartame), edible glucose, silicon dioxide, fructooligosaccharides, pregelatinized starch, low-substituted hydroxypropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, Polyethylene glycol, D-mannitol, sorbitol and sorbitol liquid, sodium carboxymethylcellulose, 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, ethylparaben and its sodium salts, sorbic acid and its potassium salt (in sorbate), soybean oil, corn oil, sunflower seed oil, olive oil, powdered soybean phospholipids, soybean phospholipid concentrate, soybean phospholipids, soybean phospholipids, Polyoxyethylene sorbitan monooleate, beeswax, flavors, colors.
< h1 class="pgc-h-arrow-right" > production process</h1>
In the first draft for comments, the production process of coenzyme Q10 includes three kinds, namely chemical synthesis method, animal and plant tissue extraction method and microbial fermentation method. According to the research results of the contracting unit of the health food raw material catalog, it is believed that the microbial fermentation method has a low cost, and has replaced the other two methods at present, becoming the main production method of coenzyme Q10 raw materials in the world, and at present, the enterprises producing coenzyme Q10 raw materials in China are also mainly based on fermentation method.
The strains used in the fermentation method are all yeasts or erythroid bacteria, and the coenzyme Q10 raw materials are mainly prepared through the process of fermentation, extraction and refining.
In the second draft for comments, the coenzyme Q10 health food raw material catalog mainly uses the following production processes when filing products:
1. Tablets: crushing, sieving, mixing, granulation, drying, tablet pressing, coating, packaging, etc.
Second, hard capsules: crushing, sieving, mixing, granulation, drying, sacing, packaging, etc.
Third, soft capsules: drying, mixing, homogenization, filtration, pressing pills, packaging, etc.
Fourth, granules: crushing, sieving, mixing, granulation, drying, packaging, etc.
Fifth, powder: crushing, sieving, mixing, packing, packaging, etc.
Sixth, the raw materials that have been premixed, buried, microencapsulated and other pretreatments shall be marked with the names of the raw materials that have been premixed, buried (**, **, **), microencapsulated (**, **, **) and other forms in the form of premixing, embedding, microencapsulation and other pretreatments.
< h1 class="pgc-h-arrow-right" > dosage form</h1>
<h1 class="pgc-h-arrow-right">04</h1>
<h1 class="pgc-h-arrow-right" > health care function</h1>
<h1 class="pgc-h-arrow-right">05</h1>
<h1 class="pgc-h-arrow-right" > daily usage</h1>
<h1 class="pgc-h-arrow-right">06</h1>
<h1 class="pgc-h-arrow-right" > suitable and unsuitable people</h1>
Overview of foreign regulations
In 2003, the U.S. FDA issued an approval document to formally apply CoQ10 as a food additive to food production, and approved liquid CoQ10 as a food additive in September 2004 [3].
In 2004, Japan's Ministry of Health and Welfare approved Coenzyme Q10 as a food additive for use in beverages, confectionery, pastries, cheese, and yogurt.[3]
The above content is for the reference of small partners, if there is a small partner who wants to do the registration and filing of coenzyme Q10 related health food, you can contact us.
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bibliography:
Fu Junhe. Study on dosage form of coenzyme Q10 health food[D].Nanchang University, 2010.
Tao Zhijie,Wang Gailing,Li Yan. New progress in the preparation and application of coenzyme Q10[J].Animal Husbandry and Feed Sciences,2010,31(09):9-11.
Ma Ju,Shi Ning. Research Progress on the Application of Coenzyme Q10 in Food[J].Food Science and Technology,2009,34(02):18-21.
Source: Food Partner Network Special Foods and Additives
Editor: Wang Liting