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New Regulations on the Import of Foods for Special Dietary Uses

Issue Date:2022-02-08

 

I.    What are foods for special dietary uses?

 

According to the Food Safety Standard for Label of Prepackaged Foods for Special Dietary Uses (GB 13432-2013), foods for special dietary uses refer to food specially processed or formulated to meet special physical or physiological conditions and(or) meet special dietary needs under diseases and disorders. The contents of nutrients and (or) other nutrients in this kind of food are significantly different from those in comparable ordinary foods.

 

II. What do foods for special dietary uses include?

 

According to the categories of foods for special dietary uses in Annex A of GB 13432-2013, foods for special dietary uses include:

 

                                                      

Foods for Special Dietary Uses

 

A    Infant and toddler formula products

-Infant formula

-Larger infant formula

-Toddler formula

-Infant formula for special medical use

B    Supplementary food for infants and toddler

-Cereal supplementary food for infants and toddler

-Canned supplementary food for infants and toddler

C    Formula food for special medical use

C    Other foods for special dietary uses other than the above categories

Including complementary food supplements, sports nutrition food, and foods for special dietary uses of other corresponding food safety standards (such as nutritional supplements for pregnant women and lactating mothers)

 

 

III.        New requirements of customs for food safety supervision of overseas manufacturing enterprises of imported foods for special dietary uses

 

According to Article 18 of Decree No. 249, the General Administration of Customs implements the registration and administration of overseas manufacturing enterprises of exporting food to China and releases the list of registered enterprises. According to Article 7 of 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), the following imported foods are recommended for registration by the competent authorities of the country (region) where they are located to the General Administration of Customs: meat products, casings, aquatic products, dairy products, bird's nest and bird's nest products, bee products, eggs and egg products, edible fats and oils, stuffed and cooked wheaten food, edible grains, grain flour industrial products and malt, fresh and dehydrated vegetables, and dried beans, seasonings, nuts and seeds, dried fruits, unroasted coffee beans and cocoa beans, special dietary food and health food.

 

The competent authorities of the country (region) shall examine and verify the enterprises recommended for registration, and, after confirming that the enterprises meet the registration requirements, recommend their registration to the General Administration of Customs and submit the following application materials:

 

(I)   Letter of recommendation from the competent authority of the country (region);

(II)        List of enterprises and application for enterprise registration;

(III)       Enterprise identity documents, such as the business license issued by the competent authority of the country (region);

(IV)       A statement from the competent authority of the country (region) stating that the recommended enterprise meets the requirements of these provisions;

(V)        A review report of the review inspection of the enterprise by the competent authority of the country (region).

 

When necessary, the General Administration of Customs may request enterprise food safety and hygiene and protection system documents, such as the plan of enterprise factory, workshop and cold storage, process flow diagram, etc.

 

In other words, the overseas manufacturing enterprises of imported foods for special dietary uses should be recommended for registration by the competent authorities of the country (region) where they are located to the General Administration of Customs.

 

IV.        New regulations on Chinese labels for imported foods for special dietary uses

 

According to Article 30 of Order No. 249, the packages, labels, and identifications of imported food shall comply with Chinese laws and regulations and national food safety standards, and be accompanied by an instruction manual in Chinese language, if the law so requires. Chinese labels of imported health food or food for special dietary use must be printed on the minimum sales package, and shall not be affixed.

 

Chinese labels of imported health food and food for special dietary use that meet the requirements of Chinese laws and regulations and national food safety standards must be printed directly on the minimum sales package before they are imported to China, and shall not be affixed in China.

 

Chinese labels of imported food for special dietary use shall comply with relevant requirements of GB 13432-2013. When a registered enterprise exports food for special dietary use to China, it shall mark its Chinese registration number or the registration number approved by the competent authority of the country (region) on the inner and outer packages of the food.

 

 

V. New Requirements of Customs for Importers of Food for Special Dietary Use

 

According to Article 22 of Order No.249, food importers shall establish an audit system for overseas exporters and overseas production enterprises, focusing on the following contents:

 

(I)   Development and implementation of food safety risk control measures;

(II)        Warranty of food with Chinese laws and regulations and national food safety standards.

 

That is, before importing products, importers of food for special dietary use shall review the implementation of food safety risk control measures of overseas enterprises and whether the products meet the requirements of Chinese laws and regulations and national food safety standards to ensure that food for special dietary use imported to China meets the relevant requirements of Chinese laws and regulations.

 

In addition, article 21 of Order No.249 stipulates that food importers 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 until 6 months to the least after the expiration of the shelf life of such products and shall be kept for no less than 2 years for products with no specified shelf life.

 

From January 1, 2022, importers of food for special dietary use shall keep the import and sales records and relevant documents of related products for at least 6 months after the expiration of the shelf life. That is, if the shelf life of the product is two years, the relevant records and documents shall be kept for at least two years and 6 months.

 

VI.        Other Special Import Regulations for Importing Food for Special Dietary Use

 

According to the Announcement on Strengthening the Management of Imported Infant Formula of the former General Administration of Quality Supervision (No.133 of 2013 Announcement of the former General Administration of Quality Supervision), if the inspection date of imported infant formula is less than 3 months from the expiration date of the shelf life, it shall not be declared for import. Imported infant formula must have been filled in the minimum retail package sold to consumers, and imported infant formula milk powder in a large package shall not be declared for import. Chinese labels for imported infant formula must be printed directly on the minimum sales package before they are imported to China, and shall not be affixed in China. If there is no Chinese label on the product package or the Chinese label does not conform to Chinese laws and regulations and national food safety standards, all unqualified products shall be returned or destroyed.

 

According to the Food Safety Law and its implementing regulations, the product formulations of infant formula shall be registered by the Food and Drug Administration of the State Council, and the formula food for special medical use shall be registered by the Food and Drug Administration of the State Council. When imported infant formula and formula food for special medical use are imported, relevant registration certificates of the Food and Drug Administration of the State Council shall be submitted. In addition, the Chinese labels and the contents of instructions for imported infant formula and formula food for special medical use shall be consistent with the registered labels and instructions.


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