China Issues Guidance for the Registration of Nutritionally Complete Food for Special Medical Purposes (FSMP)

On January 14, 2025, China’s State Administration for Market Regulation (SAMR) issued new guidance regarding the registration of nutritionally complete food for special medical purposes (FSMP). This guidance clarifies the requirements for formula design and labeling, and simplifies the application materials for product registration as well as the onsite inspection requirements for nutritionally complete FSMP.

Background

In China, all FSMP products, including nutritionally complete FSMP, must complete registration following the Administrative Measures for Registration of Foods for Special Medical Purpose before entering the market.

Nutritionally complete FSMP, also known as full nutrition formula, is classified under FSMP for individuals over one year old (Check Table 1). According to GB 29922 General Rules for Foods for Special Medical Purposes, these products serve as a sole nutrition source to meet the nutritional requirements of the target group. Specifically, nutritionally complete FSMP can be further divided into formulas for individuals aged 1-10 years and those over 10 years old.

Table 1: Classification of China’s FSMP products

Please note that a draft of GB 29922 was unveiled in January 2024, which can influence FSMP types and technical requirements in the future.

Key Content of the Guidance

The guidance clarifies requirements for formula design and labeling, particularly in the following areas:

• The content of energy, vitamins, minerals, and optional ingredients need to follow GB 29922.

• Energy ratios of three macronutrients can reference the recommended ranges in the “Dietary Reference Intakes for Nutrients in China.” The energy density of products should not exceed 1.2 kcal/mL in its ready-to-eat state. Specific sources for carbohydrates, proteins, and fats are suggested.

• The use of nutritional fortifiers must adhere to GB 14880-2012 National Food Safety Standard — Standard for the Use of Nutritional Fortification Substances in Foods, while food additives should comply with GB 2760 National Food Safety Standard — Standard for Uses of Food Additives by following the use method provided in the guidance.

• If a product's energy ratios of the three major macronutrients, energy density in its ready-to-eat state, applicable population and age range do not fully comply with the guidance, supporting design basis and literature must be provided. The guidance also listed the situation where additional materials are required. For example, additional materials are needed for products using hydrolyzed protein as a protein source.

• Others: The target applicable consumption groups are detailed. The labeling requirements for product name, formula feature/ nutritional characteristics, consumption method, consumption amount, etc., are given.

The guidance also simplifies the application materials needed for product registration, particularly regarding the materials for production process design, stability research, as well as R&D and production capacity. For example, when submitting production process design materials, applicants registering a nutritionally complete formula on the same production line as previously approved products need only provide a consistency statement, provided that the production processes, parameter designs, form selections, and processing conditions are fundamentally consistent with those of the previously registered products.

Lastly, onsite inspection requirements have been optimized with clarified exemptions. Generally, production site inspections and sampling tests will not be conducted for nutritionally complete formulas that meet requirements, except in the following cases:

• First-time registration of a nutritionally complete formula by the applicant.

• First-time use of a production line for this registration of nutritionally complete formula.

• The situation does not fall under the above two conditions, but there are significant changes in the production process compared to already registered products.

• Other circumstances necessitating inspections, such as previous applications that concealed information or provided false materials, etc.

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