The Measures of the People's Republic of China for the Administration of Import and Export Food Safety (Order No. 249 of the General Administration of Customs of the People's Republic of China) and the Regulations of the People's Republic of China on the Registration and Administration of Overseas Manufacturers of Imported Food (Order No. 248 of the General Administration of Customs of the People's Republic of China) came into effect on January 1, 2022, which stipulated new provisions for foods for special dietary uses.

Definition and main categories of foods for special dietary uses

In the National Food Safety Standard Prepackaged Foods for Special Dietary Uses (GB 13432-2013), food for special dietary uses defined as "food specially processed or formulated to supply particular dietary needs which exist by reason of a physical or physiological condition and (or) condition of disease or disorder."

In Appendix A of GB 13432-2013, the categories of foods for special dietary uses mainly include:

➤ Formula for infants and young children: Infant formula; Formula for older infants and young children; Infant formula for special medical purpose.

➤ Complementary foods for infant and young children: Cereal-based complementary foods for infants and young children; Canned complementary foods for infants and young children.

➤ Foods for special medical purpose (except infant formula for special medical purpose).

➤ Other foods for special dietary uses in addition to the above (including complementary food supplement, sports nutrition food and other foods for special dietary uses with corresponding national standards).

Requirements for registration of overseas manufacturers of imported foods for special dietary uses

Article 18 of Order No. 249

The General Administration of Customs (GACC) shall exercise registration administration on overseas manufacturers that export food to China, and promulgate a name list of enterprises that have been registered.

Overseas manufacturers of imported foods for special dietary uses shall be recommended by the competent authorities of their countries/regions to the GACC for registration.

Article 7 of Order No. 248

Overseas manufacturers of foods for special dietary uses shall be recommended by the competent authorities of their countries/regions to the GACC for registration.

Article 8 of Order No. 248

The competent authority of the country/region shall examine and inspect the manufacturer to be recommended for registration; after confirming that the manufacturer conforms with the registration requirements, the competent authority of the country/region recommends it to the GACC for registration, and submits the following application materials:

1. Letter of recommendation by the competent authority of the country/region;

2. List of recommended manufacturers and the manufacturers' applications for registration;

3. Documents certifying identification of the manufacturer, such as the business license issued by the competent authority of the country/region;

4. Statement that the manufacturer recommended by the competent authority of the country/region conform with requirements of these Regulations;

5. Reports of examinations/inspections/review conducted by the competent authority of the country/region to relevant manufacturers.

If necessary, the GACC may request documents related to the manufacturer's food safety, sanitation, and protection system, such as floor plans of the factory/workshops/cold storages, and the processing flow chart and others.

Requirements of the Customs for importers of foods for special dietary uses

Article 21 of Order No. 249

A food importer shall establish a food import and sales record system, truthfully record the name, net content/specification, quantity, production date, production or import lot number, shelf life, the name, address, and contact information of the overseas exporter or purchaser, delivery date, and other information on food, and keep relevant documents. The records and documents shall be kept for not less than six months after the expiration of shelf life of food, or for not less than two years after sale in the absence of such shelf life.

Article 22 of Order No. 249

A food importer shall establish an overseas exporter and overseas manufacture audit system with a focus on examining the following:

(I) Formulation and implementations of food safety risk control measures;

(II) Ensurance that the food complies with the laws, regulations, and national food safety standards of China.

New regulations on Chinese labels of imported foods for special dietary uses

Article 30 of Order No. 249

The packages, labels, and marks of imported foods shall comply with the laws, regulations, national food safety standards of China, and shall be accompanied by an instruction manual in Chinese if the law so requires.

The labels of imported dietary supplements or foods for special dietary uses in Chinese must be printed on the smallest sales package, and shall not be affixed thereto.

In addition, the Chinese labels of imported foods for special dietary uses shall meet the requirements of GB 13432-2013. A registered manufacturer shall mark the Chinese registration number or the registration number approved by the competent authority of the country/region on the inner and outer packaging of the foods exported to China.

Special provisions for import of infant and young children formula milk powder

According to the relevant provisions of the Food Safety Law and its implementing regulations, the product formula of infant and young children formula milk powder shall be registered with the food and drug administration under the State Council (SAMR). Foods for special medical purpose shall be registered with the food and drug administration under the State Council. When importing infant and young children formula milk powder and foods for special medical purpose, relevant registration certificates of the food and drug administration under the State Council shall be submitted. Meanwhile, the contents of the Chinese labels and instructions of imported infant and young children formula milk powder and foods for special medical purpose shall be consistent with the registered labels and instructions.

Import declaration for infant and young children formula milk powder shall not be accepted if the date for inspection submission is within 3 months from the expiration date of shelf life. Imported infant and young children formula milk powder must be canned in the smallest sales package sold to consumers. Import declaration for bulk packaged infant and young children formula milk powder shall not be accepted.

Source: GACC

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