Major Changes: Candies, Chocolates, Jellies, and Beverages are Proposed to be Included in Health Food Filings!

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.

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)

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.

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)