,China has issued a draft national food safety standard for Total Nutritional Formula Foods for Sarcopenia for public consultation, introducing a specialized regulatory framework for foods for special medical purposes (FSMPs) targeting adult patients with muscle loss conditions.
The draft applies to total nutritional formula foods intended for individuals aged 18 years and above diagnosed with sarcopenia, a progressive skeletal muscle disorder associated with aging and/or disease. The condition is characterized by reduced muscle mass, diminished strength, and impaired physical function, which may increase the risk of falls, fractures, disability, and mortality. The products covered under this standard are designed to serve as a sole source of nutrition and must meet the complete dietary requirements of this patient population under medical supervision. The standard establishes strict requirements for product formulation and safety. Manufacturers must base formulations on established medical and nutritional evidence, and both safety and clinical efficacy must be scientifically validated. Raw materials must comply with relevant safety standards, and the use of any substances harmful to health is strictly prohibited. Production processes must also meet national regulatory requirements for FSMP manufacturing.
Detailed nutritional specifications form the core of the proposed standard.
1.The energy content must not be less than 418 kJ (100 kcal) per 100 mL or 100 g of product, ensuring adequate caloric density.
2. Protein content is emphasized as a critical component, with a minimum requirement of 1.08 g per 100 kJ (4.5 g per 100 kcal), and all protein sources must be of high quality, including intact proteins, hydrolyzed proteins, or peptides. In addition, leucinea key amino acid for muscle protein synthesismust be present within a defined range, reflecting its functional importance in managing sarcopenia.
3.Fat and carbohydrate contributions are also carefully regulated. Fat must provide 20%30% of total energy, with limits placed on saturated and trans fatty acids, while essential fatty acids such as linoleic acid and alpha-linolenic acid must meet minimum thresholds. Carbohydrates are required to contribute 45%60% of total energy intake, ensuring balanced macronutrient distribution.
4.The draft further specifies comprehensive requirements for vitamins and minerals, with defined minimum and maximum levels for a wide range of micronutrients, including vitamins A, D, E, B-complex vitamins, and key minerals such as calcium, iron, zinc, selenium, and iodine. These levels are calculated based on a daily energy intake of 1800 kcal, ensuring that the product can meet the full nutritional needs of the target population.
5.In addition to mandatory nutrients, the standard allows for the inclusion of optional functional components such as taurine, L-carnitine, nucleotides, dietary fiber, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), ?-hydroxy-?-methylbutyrate (HMB), and creatine. Where these components are added or claimed on the label, their content must comply with specified limits.
Labeling requirements are detailed and stringent. Products must clearly identify themselves as Total Nutritional Formula Food for Sarcopenia and specify the target population as adult patients with sarcopenia. Labels must include warnings such as use under the guidance of a doctor or clinical nutritionist and not suitable for non-target populations.
Additionally, products must clearly state that they are not intended for parenteral nutrition or intravenous use.
Instructions for use, preparation, and storage must be clearly provided, along with warnings regarding improper use. Packaging may include the use of food-grade gases such as carbon dioxide or nitrogen, in accordance with food safety standards.
The standard also addresses safety parameters, including limits for contaminants and mycotoxins in line with existing national standards. Microbiological requirements are defined based on product form. Solid products must meet specified limits for total plate count and coliforms, while liquid and semi-solid products must meet commercial sterility requirements. Provisions are also included for products containing live microorganisms.
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