On December 2, 2022, the National Institute for Nutrition and Health of the Chinese Center for Disease Control and Prevention issued the National Food Safety Standard General Principles for Food for Special Medical Purpose (Draft for Comments) (hereinafter referred to as the Draft). The product classification and technical requirements in the standard were further revised, focusing on the connection with infant food for special medical purpose, the classification and standards of special full nutrition and the refinement of technical indicators of non-full nutrition formula food. Antion analyzed and interpreted its main changes as follows:
Modified the description of sensory requirements and raw material requirements
"The products suitable for people aged 1-10 shall not use hydrogenated fat" are added in the raw material requirements. The texts of the original sensory requirements are sorted into a form that is easier for enterprises to read.
Modified the technical requirements of nutritional components of full nutrition formula food
The energy value of dietary fiber in food for special medical purpose was calculated according to 8 kJ/g. If other substances contribute 5% or more of the total energy, they shall be included in the total energy. After modification, it is more clear.
Some optional ingredients and content requirements were added. The full nutrition formula food for people aged 1 to 10 was added vitamin K2, 1, 3-dioleic acid-2-palmitate triglyceride, lutein, lactoferrin and casein phosphopeptide. The full nutrition formula food for people over 10 years old was added vitamin K2, eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA), β-hydroxy-β-methylbutyrate calcium (CaHMB).
Newly added partial nutrition-adjusted full nutrition formula food
"Partial nutrition-adjusted full nutrition formula food" is a kind of full nutrition formula that only partially adjusts the nutritional components without targeting people with specific disease or medical condition, such as ketogenic formula, high-protein formula and high-energy density formula. This kind of food can be used in clinic for a variety of diseases, such as glucose carrier deficiency of intractable epilepsy patients and simple obesity.
Clarified the management requirements for special full nutrition formula food
For special full nutrition formula without specific food standard, it shall be based on medical and/or nutritional research results, whose safety and clinical application (effect) of people with specific disease or medical condition need to be clinically verified.
Modified the the technical requirements of nutritional components of non-full nutrition formula food
Added 1) Protein content requirements in "protein components"; 2) Four amino acid components, namely essential amino acid, branched chain amino acid, arginine and glutamine; 3) the technical requirements of the source of fat raw materials, solubility, fatty acid composition and the use of other raw materials in "fat (fatty acid) components"; 4) the limit on "insoluble dietary fiber" in "carbohydrate components"; 5) "Dietary fiber components" and corresponding "technical requirements" in common non full nutrition components; 6) the requirements for added carbohydrates in "thickening components": "shall not be used for the purpose of providing energy and nutritional components"; in addition, the new requirement of "no additional nutrients shall be added"; 7) Revised the technical requirements for electrolyte formula: from "based on carbohydrate" to "based on carbohydrate and/or peptide"; 8) the requirements of "fat shall not be added for the purpose of energy supply", the source of protein and its energy supply ratio in the technical requirements of "liquid formula"; 9) the technical requirements of perioperative carbohydrate formula; 10) the requirements for amino acid metabolism disorder formula: revised from "amino acids as main raw materials" to "amino acids and/or peptides as main raw materials"; "in addition to amino acids that shall be restricted, the composition of other amino acids, especially essential amino acids, shall meet the requirements of high-quality protein". The refinement of the technical indicators of the full nutrition formula food is conducive to the product innovation to effectively solve the problem of the closure of the standard and promoting the high-quality development of the industry of food for special medical purpose in China.
Revised requirements for food additives and labeling
Further clarified the use of food additives in food for special medical purpose. According to the draft, the products with suitable people between 1 and 3 years old must comply with the provisions of GB 2760 on the use of flavoring substances in older infant formula and young children formula. If the suitable people do not include 1 to 3 years old, the category and amount of additives allowed in the same or similar products in GB 2760 can be used.
The labeling requirements of dietary fiber were increased, and the category of dietary fiber (soluble/insoluble) shall be marked according to the dietary fiber added in the formula. The thickening component products, liquid formula food, electrolyte formula and other products shall be marked with relevant information, including the thickening component products shall be marked with the corresponding swallowing disorder food classification, flushing temperature, storage time and other parameters after the product is prepared with water. The addition of relevant information is more consistent with the edible characteristics of formula food for special medical use, convenient for consumers to operate and further improve the labeling requirements.
Conclusion
The draft is currently in the stage of soliciting opinions, and the deadline for feedback is December 15, 2022. Relevant enterprises can give their opinions if they have any. Antion hopes to help the related enterprises of food for special medical purpose and industry personnel better understand the changing trend of regulations and standards and the regulatory trend, and provide a reference for the next step of work.
Source: Antion
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