China Food for Special Medical Purpose (FSMP) Regulation

1. Competent authority

Competent authority	Responsibility
State Administration for Market Regulation (SAMR)	Market supervision Administration on special food, including the registration of food for special medical purposes (FSMP)
National Health Commission (NHC)	National standard drafting New food ingredient registration
General Administration of Customs of China (GACC)	Customs inspection, quarantine, and declaration Overseas food manufacturers registration

2. Market access approval

2.1 Import permit at state level

Only FSMP products that meet corresponding national standards and have obtained the registration certificate are allowed to be imported to China.

2.2 Overseas manufacturer registration

According to the Administrative Provisions on Registration of Overseas Manufacturers of Imported Foods, overseas manufacturer registration is mandatory for all imported food products and the registration of FSMP manufacturers should be recommended by the local competent authorities.

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2.3 Inspection and quarantine

Imported FSMP products are subject to food sanitation inspection. Inspection items include Chinese label, foreign matter, the existence of prohibited food additives and other items related to sanitation.

2.4 Exporter and importer filing

Regardless of food categories, the overseas exporters or agents and importers in China shall log into this system and get themselves filed with GACC.

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2.5 Product registration

Different from common prepackaged foods, FSMP manufacturers shall get their products registered with SAMR according to Administrative Measures for Registration of Foods for Special Medical Purpose.

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3. Product compliance

3.1 Product requirements

The national food safety standards specify the definition and technical requirements (ingredients, sensory requirements, nutrient composition, contaminant & mycotoxin & microorganism level, package, etc.) of FSMP products. Please refer to the corresponding GB standards for more details:

Category	Referenced GB standard
Infant Formula Foods for Special Medical Use (0 to 12-month-old infants)	GB 25596-2010 General Rules of Infant Formula Foods for Special Medical Use
Foods for Special Medical Purposes (over one-year-old people)	GB 29922-2013 General Rules for Foods for Special Medical Purposes

Recommended resources:

Online course: China Dairy Industry: Regulation Dynamics and Business Opportunities

3.2 Label

The labeling of FSMP products should follow the general rules such as GB 7718-2011 General Standard for the Labeling of Prepackaged Foods and GB 13432-2013 Labeling of Prepackaged Foods for Special Dietary Uses. Besides, Label and Instruction of Foods for Special Medical Purpose (For Trial) offers the detailed explanation to the labeling items of FSMP products. Moreover, the additional requirement for imported dairy products is the mandatory labeling of registration No. of overseas manufacturers and the direct printing of Chinese label on the minimum sales package.

Related document:

It is noteworthy that FSMP products are subject to some additional labeling requirements specified in their GB standards. A summary of special requirements can be found below.

Category

Additional labeling requirements

Infant Formula Foods for Special Medical Use (0 to 12-month-old infants)

Nutrients and optional components should be labelled in per 100 kilojoules (100 kJ).
The categories of the infant formula for special medical use (such as lactose-free formula) and applicable special medical conditions should be clearly written on the label. For the infant formula for premature delivered or low birth weight babies, the osmotic pressure of the formula should also be labeled. For products consumed by infants over 6 months old, the statement “When over 6-month-old babies at special medical condition consume this product, auxiliary food should be added” needs to be claimed.
The statement “Under the guidance of doctor or clinical nutritionist” should be clearly marked on the label.
Any image of baby or women shall not be presented on the package, neither "humanized", “maternized” or other similar terms.

Foods for Special Medical Purposes (over one-year-old people)

The contents of nutrients and optional ingredients shall be indicated with “per 100 kilojoule (/100kJ”.
The product’s formula features or nutritional characteristics shall be indicated on the label. The product category and suitable group should be marked.
The following statements shall be indicated on the label:

a) “Unsuitable for non-target population”

b) “Under the guidance of doctor or clinical nutritionist”

c) “This product is prohibited from being used as parenteral nutrition or through intravenous injection”

Apart from the requirements mentioned above, the labeling of FSMP products shall not involve any claim of diseases prevention or therapy function.

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