On October 11, 2024, the State Administration of Market Regulation (SAMR) issued the ‘Dosage Forms and Technical Requirements for Health Food Products for Record (2024 Edition) (Draft for Opinion)’ and the ‘Regulations on Usable Excipients and Their Usage for Health Food Products for Record (2024 Edition) (Draft for Opinion)’ for public consultation, and the deadline for feedback is November 10, 2024, for the society.
In order to help enterprises quickly understand the key information, CIRS Group has compared the above two drafts with the current regulations to help you understand the important changes.
Major changes in dosage forms (or food forms) of health food products on record
- New dosage forms for composites, teas (bagged teas), and pastes
The three new dosage forms added in the exposure draft, namely, Composites, Tea (bagged teas) and Paste, are the dosage forms that can be used in the filing of ginseng, American ginseng, and ganoderma lucidum products, and the main production processes are shown below:
Dosage forms |
Main production processes |
Composites |
Mixing, filtration, dissolution, preparation, volume setting, filling, sterilization, and packaging |
Teas (bagged teas) |
Mixing, drying, pulverizing, sterilizing, and packaging. |
Paste |
Mixing, filtration, preparation (or honey preparation), filling, sterilizing, and packaging. |
- New food forms for confectionery products (candies, chocolates, jellies) and beverages
Compared with the current filed dosage forms, the food forms of confectionery products (candies, chocolates, jellies) and beverages have been added in the exposure draft, and the main production processes, requirements for the use of excipients, requirements for the contents of product specifications, and technical requirements have been described in detail. Among them, the main production process and available excipients are shown in the following table:
Food forms |
Main producing processes |
Available excipients |
|
---|---|---|---|
Confectionery products |
Candies |
Gelatinizing, sugaring, boiling, mixing, blending, filtering, aerating, molding, drying, sand mixing, coating, polishing, coating, caramelizing, sand texturizing, granulating, cooling, tableting, de-filming, fine grinding, refining, temperature regulating, shearing, packaging, etc. |
Excipients catalog* + other excipients other excipients: tomato red, cochineal orange (a.k.a. annatto, descending annatto), calcium ascorbate, potassium bicarbonate, sodium D-isoascorbate, modified soy phospholipids, rosmarinus officinalis sweet glycoside, monosodium citrate, cochineal red and its aluminum chromophore |
Chocolates |
Mixing, fine grinding, refining, tempering, mold casting, cooling, coating, polishing, and packaging. |
||
Jellies |
Dissolving, blending, sterilizing, sweetening, mixing, filtering, cooling, and packaging. |
Excipients catalog* + other excipients other excipients: tomato red, cochineal orange (a.k.a. annatto, descending annatto), calcium ascorbate, potassium bicarbonate, sodium D-isoascorbate, modified soy phospholipids, rosmarinic acid sweet glycoside, monosodium citrate, cochineal red and its aluminum color precipitate, orange juice concentrate, marmalade (should be identified with specific varieties), canned mandarin oranges, canned peaches, canned pineapple, raw cow's milk, thin cream/cream/anhydrous cream, dried cheese, reconstituted Cheese, nuts and seeds (should identify specific varieties), brewed cereal products (should identify specific varieties), alginate, konjac flour, konjac extract powder |
|
Beverages |
Mixing, dissolving, blending, filtering, carbonating (aerating), sterilizing, filling, packaging, etc. |
Excipients catalog* + other excipients other excipients: Carbon dioxide, Streptococcus lactis, Sodium D-isoascorbate, Modified soy lecithin, Monosodium citrate, Potassium bicarbonate, Luo han guo sweet glycoside, Isomaltose, Lycopene, Cochineal red and its aluminum precipitates, Mono-diglycerol diacetyltartaric acid, Sodium stearoyl lactylate, Ethyl malt phenol, Di-calcium phosphate, Raw cow's milk, Thin cream/cream/anhydrous cream, Cheddar cheese, Remanufactured cheese, Soybeans, Soymilk, Nuts and seeds (specify species), Concentrates (juices, syrups) (specify species), Jams (specify species), Black tea, Green tea, Jasmine tea, Black tea, Yellow tea, Brewed cereal products (specify species) |
* Excipients catalog means Regulations on Available Excipients and Their Use in Health Food Recorded Products.
- Adjustment of technical requirements for powder products
The 2024 Draft for Opinion also makes some adjustments to the technical requirements for powder products released in 2021, including the formulation of serving methods and granularity, as shown below:
Dimensions |
The 2021 version of the current legislation |
2024 Draft for Opinion |
Maximum level and consumption method |
The maximum daily consumption is 20g; add a reminder that ‘powder is usually dissolved or dispersed in water or other liquids, and can also be taken directly with water’. For the method of consumption for ‘direct oral’, the unsuitable population should include ‘people under six years’. |
The maximum daily consumption is 20g, unless otherwise specified. Powder is usually dissolved or dispersed in water or other liquids, or can be taken directly with water, should be filled in according to the product. For the method of consumption for ‘direct oral’, the unsuitable population should include ‘people under six years’. |
Specifications |
For large-dose packages, the volume of each package should not exceed 500g in principle, and it is not recommended to exceed one month's intake. Large-dose packages should be accompanied by utensils for dividing the dose. |
For large-dose packages, the volume of each package should not exceed 500g in principle, and it is not recommended to exceed one month's intake. Large-dose packages should be accompanied by utensils for dividing the dose. |
Granularity |
Conforms to any one of the coarse, medium, fine, and finest powders in the Chinese Pharmacopoeia. |
Reference to the Chinese Pharmacopoeia in the coarse powder, medium powder, fine powder, and the finest powder, to develop their own range values for granularity. |
Major Changes in the Catalog of Health Food Recorded Excipients
Compared with the current 2021 version of the excipient catalog, the 2024 Draft for Opinion does not change the catalog of excipients, but updates, supplements, and improves the standards related to excipients, as shown below:
Adjustment |
Related excipients |
Standard substitution |
17: β-Cyclodextrin, Indigo Aluminum Precipitate, Titanium Dioxide, Sodium Pyrophosphate, Potassium Dihydrogen Phosphate, Dipotassium Hydrogen Phosphate, Disodium Hydrogen Phosphate, Tricalcium Phosphate, Sodium Tripolyphosphate, Stevioside, Sodium Starch Sodium Octenyl Succinate, Fructose Syrup, Fructose, Maltodextrin, Glucose Syrup, Oligofructose, Phospholipids |
New national standards |
8: ethanol/alcohol, α-cyclodextrin, γ-cyclodextrin, erythrose, monocrystalline rock sugar/polycrystalline rock sugar, brown sugar, oligogalactose, oligofructose |
Improvement of the standard basis |
19: dibutylhydroxytoluene (BHT), beeswax, potassium alginate, carrageenan, maltitol/maltitol liquid, methyl aspartylphenylalaninate (aka aspartame), microcrystalline cellulose, ethanol/food alcohol, magnesium stearate, soybean oil, olive oil, peanut oil, cocoa powder, cocoa butter, sunflower oil, condensed milk/concentrated milk for food industry, potato starch, corn oil, fruit and vegetable powder ( the name of the specific fruit and vegetable powder used must be specified) |
CIRS Analysis
Compared with the current filed dosage forms, the consultation draft aims to enrich the filed dosage forms of health food, and add candies, chocolates, jellies, and beverages as food forms, which are more likely to be preferred by young people, so as to further satisfy the needs of all kinds of consumer groups and all age classes for health food. In addition, compared with the current excipient catalog, the 2024 Draft for Opinion updates / replaces, adds / improves a number of excipient standards, providing more room for enterprises to choose suppliers.
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