According to the “Food Safety Law of the People’s Republic of China” and the “Catalogue of Coenzyme Q10 and Other Five Health Food Raw Materials”, the State Administration for Market Regulation has formulated the “Coenzyme Q10 and Other Five Health Food Raw Materials Catalog” “Product Formulation and Technical Requirements for Registration of Health Food Ingredients” is now announced and will come into effect on June 1, 2021.
Coenzyme Q10 and other five health food raw materials registered product dosage forms and technical requirements:
1. Coenzyme Q10 and other five health food raw materials registered product dosage forms and main production processes:
Coenzyme Q10, In the catalog of five health food raw materials including fish oil, broken Ganoderma spore powder, spirulina and melatonin, the available dosage forms and main production processes are as follows during product registration:
(1) Tablets: crushing and sieving , mixing, granulating, drying, tableting, coating, packaging, etc.
(2) Hard capsules: crushing, sieving, mixing, granulating, drying, encapsulating, packaging, etc.
(3) Soft capsules: mixing, homogenizing, filtering, pill pressing, drying, packaging, etc.
(4) Granules: crushing, sieving, mixing, granulating, drying, packaging, etc.
(5) Powder: crushing, sieving, mixing, packaging, packaging, etc.
2. Technical requirements for registered products in the “Coenzyme Q10 Catalog of Health Food Raw Materials”:
(1) Available excipients
Vitamin E, sodium ascorbate, povidone K30, neotame, talc, magnesium stearate, sucrose, stevioside, dextrin, lactose, microcrystalline cellulose, β-cyclic Dextrin, 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, sodium carboxymethylcellulose, vitamin C, edible corn starch, potato starch, cassava Starch, edible wheat starch, edible sweet potato starch, sodium carboxymethyl starch, hollow capsules (including hydroxypropyl starch hollow capsules, gelatin hollow capsules), gelatin, glycerin, purified water, drinking water, ethyl parahydroxybenzoate and its Sodium salt, sorbic acid and its potassium salt (calculated as sorbic acid), soybean oil, corn oil, sunflower oil, olive oil, powdered soybean lecithin, concentrated soybean lecithin, soybean lecithin, polyoxyethylene sorbitan monooleate ,beeswax.
Food flavors and pigments.
(2) Available dosage forms
When registering health foods using Coenzyme Q10 as a single raw material, the available product dosage forms include tablets (oral tablets, buccal tablets, chewable tablets), Granules, hard capsules, soft capsules.
(3) Product technical requirements
In addition to technical indicators that meet the requirements of different dosage forms, the technical requirements for each dosage form of products should also contain microbiological indicators that comply with the “National Food Safety Standard Health Food” (GB16740) ) regulations, the following requirements should also be met:
[The iconic ingredient] is “Coenzyme Q10”, which is marked with a range value. According to the daily dosage requirements of the health food raw material catalog, the maximum value of the iconic ingredient range per 100g shall not exceed the maximum daily dosage after conversion, and the minimum value shall not be lower than the minimum daily dosage.
3. Technical requirements for registered products in the “Health Food Raw Materials Catalog Broken Ganoderma Spore Powder”:
(1) Available excipients
Edible corn starch, potato starch, tapioca starch, edible wheat starch, edible sweet potato starch, hydroxypropyl methylcellulose, xanthan gum (also known as xanthan gum), hard Magnesium fatty acid, silicon dioxide, sodium carboxymethyl cellulose, vitamin C, dextrin, microcrystalline cellulose, povidone K30, sorbitol and sorbitol liquid, vitamin E, calcium hydrogen phosphate, carboxymethyl starch Sodium, hollow capsules (including hydroxypropyl starch hollow capsules, gelatin hollow capsules), triethylglycerol.
(2) Available dosage forms
When registering health foods using broken Ganoderma spore powder as a single raw material, the available product dosage forms include tablets (oral tablets), granules, Hard capsules and powders.
(3) Product technical requirements
In addition to technical indicators that meet the requirements of different dosage forms, the technical requirements for each dosage form of products should also contain microbiological indicators that comply with the “National Food Safety Standard Health Food” (GB16740) ) regulations, the following requirements should also be met:
1. [Physical and chemical indicators] should be added to “666” and “DDT”; powders should be added to “peroxide value”.
2. [Iconic ingredients] include at least two indicators: “polysaccharides” and “total triterpenes”. When setting the index value, it should comply with the daily dosage, raw material technical requirements, etc. in the health food raw material catalog.
IV. Technical requirements for registered products in the “Health Food Raw Material Catalog Spirulina”:
(1) Available excipients
Maltodextrin, microcrystalline cellulose, pregelatinized starch, magnesium stearate, sodium carboxymethylcellulose, silicon dioxide, sodium carboxymethyl starch, glycerin, hydroxypropyl Methyl cellulose, titanium dioxide, polyethylene glycol, edible corn starch.��Potato starch, tapioca starch, edible wheat starch, edible sweet potato starch, dextrin, white sugar, lactose, vitamin E, povidone K30, isomaltooligosaccharide, sodium bicarbonate, citric acid, sucrose, polyvinyl alcohol, Polyoxyethylene sorbitan monooleate, sorbitol and sorbitol liquid, milk powder, calcium carbonate, crospovidone, hydroxypropyl cellulose, stearic acid, honey, sugar, hollow capsules (including hydroxypropyl cellulose Propyl starch hollow capsules, gelatin hollow capsules), concentrated soybean lecithin, powdered soybean lecithin, fractionated soybean lecithin, transparent soybean lecithin, and soybean lecithin.
Food flavors and pigments.
(2) Available dosage forms
When registering health foods using spirulina as a single raw material, the available product dosage forms include tablets (oral tablets, chewable tablets), granules, Hard capsule.
(3) Product technical requirements
In addition to technical indicators that meet the requirements of different dosage forms, the technical requirements for each dosage form of products should also contain microbiological indicators that comply with the “National Food Safety Standard Health Food” (GB16740) ), the following requirements should also be met:
1. [Physical and chemical indicators] Add “protein”.
2. [Iconic ingredients] include at least two indicators: “β-carotene” and “phycocyanin”. When setting the index value, it should comply with the daily dosage, raw material technical requirements, etc. in the health food raw material catalog.
3. “Vibrio parahaemolyticus” was added to [Microbiological Indicators].
5. Technical requirements for registered products in the “Health Food Raw Materials Catalog Fish Oil”:
(1) Available Excipients
Vitamin E, gelatin, glycerin, purified water, drinking water, ethyl parahydroxybenzoate and its sodium salt, soy lecithin, caramel color.
(2) Available dosage forms
For health food registration using fish oil as a single raw material, the optional product dosage form is soft capsule.
(3) Product technical requirements
In addition to the technical indicators that meet the requirements for soft capsules, the product technical requirements should also contain microbial indicators that comply with the provisions of the “National Food Safety Standard Health Food” (GB16740) In addition, the following requirements should also be met:
1. “Moisture and volatile matter”, “iodine value”, and “benzo[a]pyrene” are added to [Physical and Chemical Indicators].
2. [Iconic ingredients] include at least three indicators: “DHA”, “EPA” and “DHA+EPA”. When setting the index value, it should comply with the daily dosage, raw material technical requirements, etc. in the health food raw material catalog.
6. Technical requirements for registered products in the “Health Food Raw Materials Catalog Melatonin”:
(1 ) Available excipients
Edible corn starch, potato starch, tapioca starch, edible wheat starch, edible sweet potato starch, calcium carbonate, citric acid, microcrystalline cellulose, magnesium stearate, pregelatinized starch, Silicon dioxide, lactose, hydroxypropylcellulose, dextrin, beeswax, soybean oil, gelatin, glycerin, titanium dioxide, polyethylene glycol, purified water, drinking water, sorbitol and sorbitol liquid, powdered soybean lecithin, corn oil , maltodextrin, D-mannitol, stearic acid, croscarmellose sodium, talc, carboxymethylcellulose sodium, white sugar, polyoxyethylene sorbitan monooleate, polyvitamin Ketone K30, triethyl glyceride, sodium carboxymethyl starch, calcium hydrogen phosphate, fructooligosaccharides, hydroxypropyl methylcellulose, ethyl parahydroxybenzoate, calcium sulfate, walnut oil, edible glucose, hollow capsules (including Hydroxypropyl starch hollow capsules, gelatin hollow capsules).
Food flavors and pigments.
(2) Available dosage forms
When melatonin is used as a health food raw material, a single melatonin raw material can be used to register the health food, or vitamin B6 can be added at the same time (in line with nutrient supplementation) According to the vitamin B6 standard in the raw material catalog of the drug, which shall not exceed the daily dosage of the corresponding group of people in the raw material catalog) as a raw material combination for product registration, the optional product dosage forms include tablets (oral tablets, lozenges), granules, and hard capsules , soft capsules.
(3) Product technical requirements
In addition to technical indicators that meet the requirements of different dosage forms, the technical requirements for each dosage form of products should also contain microbiological indicators that comply with the “National Food Safety Standard Health Food” (GB16740) ) regulations, the following requirements should also be met:
[Iconic ingredients] At least include “melatonin”, marked with a range value, and should meet the daily dosage requirements of the health food raw material catalog, per 100g The maximum value in the range of iconic ingredients shall not exceed the maximum daily dosage after conversion, and the minimum value shall not be lower than the minimum daily dosage.
When “vitamin B6” is used in raw materials, “vitamin B6” should be added and marked with a range value. The maximum value in the range value of the iconic ingredient per 100g shall not exceed the nutrient supplement raw material after conversion. The maximum and minimum daily dosage of vitamin B6 in the catalog should not be lower than the minimum daily dosage of vitamin B6 in the nutrient supplement raw material catalog.
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