Following June 14, the General Administration of Market Regulation, together with the National Health and Health Commission and the State Bureau of Traditional Chinese Medicine adjusted the catalogue of health food raw materials: four new nutrients and two new raw materials for the record, after 20 days, on July 5, the official website of the General Administration of Market Regulation issued a notice for comments.

Photo: Website of the State Administration for Market Regulation

Why this consultation

In the development of health food and functional food, protein and DHA are used as important nutrients. The three newly approved raw materials for the record: soy protein isolate, whey protein, algal oil DHA, are widely used and have a certain volume. The official document released in early June still lacks many regulations on the landing of products. The solicitation of comments, the two raw materials for the record - soy protein isolate and whey protein to do the formulation, excipients, dosage description and regulations, and clarify the management requirements of similar products registration transfer to the record. Secondly, DHA algal oil as a new nutrient, the description specifies the requirements for formula compatibility, the agreement for the record of DHA algal oil raw material additives, and the normative requirements for the record name and function claim. For the development of large doses of food, it is impossible to use ingredients, which ingredients are available, which is the content that enterprises are more concerned about when developing products, and the improvement of regulations also allows enterprises to have evidence on actual production.

Health food raw material soy protein isolate whey protein record product dosage form and technical requirements (draft for comment) summary of key content

1) Dosage form: powder

2) Relevant accessories:

Such as soy protein isolate + other archived raw materials, 26 auxiliary materials can be selected:

Acacia gum, Aspartame (containing phenylalanine), white granulated sugar, soy phospholipid, fructooligosaccharide, isomaltose oligosaccharide, silica, fructose, Xanthan gum, pectin, phospholipid, maltodextrin, xylitol, glucose, hydroxypropyl cellulose, milk powder, lactose, edible corn starch, stevia glycoside, vitamins C, Magnesium stearate, corn oil, sucrose, fruit and vegetable powder, tricalcium phosphate, food flavor

Such as whey protein + other archived raw materials, there are 15 optional auxiliary materials:

Soy phospholipids, Phospholipids, fructooligosaccharides, silica, D-mannitol, maltodextrin, Xylitol, Citric acid, isomaltose oligosaccharides, milk powder, Stevia glycoside, Vitamin C, Glucose, Vitamin E, food flavor

Such as soy protein isolate + whey protein + other archived raw materials, there are 22 optional excipients:

Phospholipids, soy phospholipids, aspartame, silicon dioxide, glucose, fructose, Xanthan gum, Stevia glycoside, aspartame (containing phenylalanine), Xylitol, isomaltose oligosaccharide, fructose oligosaccharide, milk powder, Vitamin C, Vitamin E, maltodextrin, lactose, hydroxypropyl cellulose, magnesium stearate, fruit and vegetable powder, tricalcium phosphate, flavor

Plant bridge view: Aspartame as an auxiliary material, is it a big question mark? In addition, it is recommended that the sweetener in the ingredients can be set several more, for the development of product selection, the convention of additives each functional direction can only choose one ingredient, may be better.

3) Product specifications

The signature ingredient contains at least a "protein" index, with a maximum daily serving size of 35g and a limit of 800g per package. The health function is to "enhance immunity".

Summary of the key contents of the interpretation document (draft for comment) of the Nutrient Supplements in the Catalogue of Health Food Raw Materials (2023 version)

1. Add 2 new compounds of hematin chloride and vitamin K to the raw material catalog (2 synthesis method).

2. Update 5 national standards, and update 5 raw material standards such as calcium dihydrogen phosphate.

3. National food safety standards have been added to 7 raw materials. 7 raw materials such as ferrous fumarate were added to the food standards on the basis of the original Chinese Pharmacopoeia and drug standards.

4, 1 raw material, zinc citrate (Sanshui) increase food standards on the basis of the original Ministry of Health announcement.

5, "casein phosphopeptide + calcium", included in the catalogue of health food raw materials, the product is allowed to claim health function "supplement calcium".

6, DHA algal oil filing description, it is recommended that DHA algal oil as a unilateral raw material for product filing, allowing the claimed health function is to "supplement n-3 polyunsaturated fatty acids"; The excipients vitamin C and vitamin E that are necessary for the process must not claim health care function.

Summary of key contents of the interpretation document (draft for comment) of the "Health Food Raw Material Catalogue Soy protein Isolate" and "Health Food Raw material Catalogue Whey Protein"

1. Formula compatibility

Soy protein isolate and whey protein can be used as raw materials alone, or they can be used in combination.

2. The daily amount of protein for product filing is 6-25g.

3, product note: pregnant women, nursing mothers are advised to consult clinicians, nutrition professionals, etc.

4, product name: For soy protein isolate, whey protein with nutrients as raw materials, the product name no longer reflects the name of the nutrient.