China Infant Formula Regulation

1. Competent authority

Competent authority	Responsibility
State Administration for Market Regulation (SAMR)	Market supervision Administration on special food, including infant formula recipe registration
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 manufacturer registration

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:

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:

Category	Referenced GB standard
Formula for infants (0-6 months)	GB 10765-2021 National Food Safety Standard — Infant Formula
Formula for older infants (6-12 months)	GB 10766-2021 National Food Safety Standard — Older Infant Formula
Formula for young children (12-36 months)	GB 10767-2021 National Food Safety Standard — Young Children Formula
Infant Formula Foods for Special Medical Use	GB 25596-2010 National Food Safety Stardard — General Rules of Infant Formula Foods for Special Medical Use (Recommended reading: pedia related to Foods for Special Medical Purpose for more info)

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.

Category	Additional requirements
Formula for infants (0-6 months)	Category, properties (for example, milk-based or soy-based and states of products) and age range of the product shall be labeled. Label of the infant formula shall include “The best feeding for infants of 0-6 months old is breast milk. This product may be used to fulfill infants' needs when breast milk is insufficient or absent.” Images of infants and women are not allowed on labels. Expressions such as humanized milk and maternized milk shall not be used. Directions for use shall be labeled as per GB 10765-2021.
Formula for older infants (6-12 months)	Category, property (for example, milk-based or bean-based and states of products) and age range of the product shall be labeled. “Complementary foods shall be consumed as an addition” shall be labeled. Images of infants and women are not allowed on labels. Expressions such as “humanized milk” and “maternized milk” shall not be used. Directions for use shall be labeled as per GB 10766-2021.
Formula for young children (12-36 months)	Category of the product, properties (e.g. product state) and suitable age groups should be labeled. Directions for use shall be labeled as per GB 10767-2021.
Infant Formula Foods for Special Medical Use	The categories of infant formula for special medical use (such as lactose-free formula) and applicable special medical conditions should be clearly written on the label. For infant formula for premature-delivered or low birth weight babies, the osmotic pressure of the formula should also be labeled. For products taken by infants more than 6 months old, the formula should label that when it is used for special medical condition babies more than 6 months old, auxiliary food should be added. “Under the guidance of a doctor or a clinical nutritionist” should be clearly marked on the label. There should not be any image of baby or women, and cannot use "humanized", “maternized” or other similar terms. Instructions shall be labeled as per GB 25596-2010.

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.