China Infant Formula Regulation

1. Competent authority

2. Market access approval

2.1  Import permit at state level

Only infant formula products from the countries that have passed the national assessment can be exported to China. For the permitted exporting countries/regions, please refer to Catalogues of Foods Exported to China from Countries or Regions That Meet the Assessment and Examination Requirements and Conduct Traditional Trade with China

2.2  Overseas manufacturer registration

According to Regulations of the People’s Republic of China on the Registration and Administration of Overseas Manufacturers of Imported Food, overseas manufacturer registration is mandatory for all imported food products. The registration of infant formula manufacturers should be recommended by competent authorities in exporting countries.

Recommended resources:

• Hot topic: All You Should Know About GACC Decree No. 248: Provisions for Overseas Food Manufacturer Registration

• Webinar: Prepare for China’s Overseas Food Manufacturers Registration Under New GACC Requirements

• Webinar: A Tutorial Guide & FAQ for GACC Overseas Food Manufacturer Registration

2.3  Inspection and quarantine

Infant formula products, no matter in powder form or liquid form; soy-based or dairy-based, are subject to imported food sanitation inspection. Inspection items include the check of Chinese label, foreign matter, the existence of prohibited food additives and other items related to sanitation. In Dec 2021, GACC released a notice to clarify the inspection and quarantine requirements for imported dairy-based infant formula products entering China on and after Jan. 1, 2022. Read more here.

2.4  Exporter and importer filing

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

To have a better understanding of China’s food import procedure and supervision mechanism, please check ChemLinked online course: Regulatory Compliance and Import Procedure of Prepackaged Food in China

2.5  Recipe registration

Different from most regular prepackaged foods, infant formula products sold to China shall get their recipe registered with SAMR according to Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes. In July 2023, the authority issued the 2023 version of Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes, which will come into effect on October 1, 2023.

3. Product compliance

3.1  Product requirements

The national food safety standards specify the definition and technical requirements (ingredients, sensory requirements, physicochemical indicators, microorganism level, etc.) of infant formula products. Please refer to the corresponding GB standards for more details:

3.2  Label

The labeling of infant formula products shall follow general rules (GB 13432-2013 National Food Safety Standard Labeling of Prepackaged Foods for Special Dietary Uses, GB 7718-2011 General Standard for the Labeling of Prepackaged Foods and GB 28050-2011 General Rules for Nutrition Labeling of Prepackaged Foods) as well as regulations like Regulations of the People’s Republic of China on the Registration and Administration of Overseas Manufacturers of Imported Food (which specifies that registration number of overseas manufacturers should be indicated on the package of imported infant formula products). Besides, there are other instruments related to product labeling, such as the notice released early in 2013, which requires all product information to be printed on infant formula’s packaging. In Nov. 2021, SAMR issued another notice to further standardize infant formula labeling.

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

3.3 China Infant Formula Registration Service

We have been equipped with a professional technician team to provide a one-stop registration service with expertise and efficiency. Our services include:

• Product preassessment

• Guidance on trial production

• Preparation of dossier review and compilation

• Materials translation

• Test coordination

• Application submission

• Respond to the competent authority’s enquiry and rectify the deficiency

• Guidance on onsite inspection

Please feel free to contact us via food@chemlinked.com if you need any help.