Imported Infant Formula Food: How to get access to China market?

时间(Date) : 2015-12-16 来源(Source) : CIRS 作者(Author) : CIRS

According to the quality and safety report of imported food in China from 2010 to 2014 (click here), the imported volume of infant formula milk powder increased by years, and AQSIQ also attaches great importance to the safety and quality of imported infant formula food, supervises this food category strictly (including the formula check and registration). Meanwhile, the policies for imported infant formula food are changeable, so for related enterprises, they should pay attention to relevant laws and regulations to make sure the products can be imported to China successfully.

1. What is infant formula food in China?
The infant formula food in China in this article includes infant formula (0-6 months), older infants (6-12 months) and young children (12-36 months) formula.

I. Infant formula (0-6 months): the main raw materials are milk, milk protein products/ soy and soy protein products, with appropriate amounts of vitamins, minerals and/ or other ingredients. The product is only processed by physical method and the final form is liquid or powder. It is suitable for normal infant, and the nutrients and energy can meet the nutritional needs of normal infant of 0-6 months. (Infant formula milk powder for 0-6 months belongs to this category)

II.Older infants and young children formula: the main raw materials are milk, milk protein products/ soy and soy protein products, with appropriate amounts of vitamins, minerals and/ or other ingredients. The product is only processed by physical method and the final form is liquid or powder. It is suitable for normal old infant and young children, and the nutrients and energy can meet the nutritional needs of normal old infant and young children. (Infant formula milk powder for 6-36 months belongs to this category)

2. The laws and regulations for imported infant formula food in China
2.1 Laws and regulations

S.N.	Items
1	The Food Safety Law of China (CN version free download)
2	The Administrative Measure of Imported and Exported Food Safety (CN version free download)
3	The Administrative Measure of Inspection, Quarantine, and Supervision of Imported and Exported Dairy Products (CN version free download)
4	The Administrative Measure for Overseas Manufacturer Registration of Imported Food (CN version free download)
5	The AQSIQ Notice of the Implementation Requirements about “The Administrative Measure of Inspection, Quarantine, and Supervision of Imported and Exported Dairy Products”(CN version free download)
6	The AQSIQ Notice about Strengthening the Management of Imported Infant Formula Milk Powder(CN version free download)
7	The Administrative Measures for the Registration of Formula of Infant Formula Milk Powder (exposure draft)(it is only for domestic products) (CN version free download)

2.2 Standards

S.N.	Items
1	GB 10765-2010Food Safety National Standards for Infant Formula (CN version free download)
2	GB 10767-2010Older Infants and Young Children Formula (CN version free download)
3	GB 2760-2014 Food Safety National Standards for the Usage of Food Additives (CN version free download)
4	GB 14880-2012 Food Safety National Standards for the Usage of Nutrition Enrichment (CN version free download)
5	GB13432-2013General Rules for the Labeling of Prepackaged Food for Special Dietary Uses (CN version free download)
6	GB 7718-2011 General Rules for the Labeling of Prepackaged Food(CN version free download)
7	GB 28050-2011 General Rules for Nutrition Labeling of Prepackaged Foods (CN version free download)

3. How to import infant formula food to China?

S.N.	Items	Detailed content
1	Importer and exporter record	The overseas food exporter or his agent should apply for the record to AQSIQ. The importer should apply for the record to the local CIQ.
2	Overseas manufacturer registration (only for imported milk based infant formula food)	The products cannot be imported until the overseas manufacturer is registered. AQSIQ is in charge of the registration, and CNCA organizes and supervises the registration. Overseas manufacturers should guarantee the products meet the requirements of Chinese regulations and National Standards, and provide the required testing report. Public can find the registered overseas manufacturers on the website of CNCA (http://www.cnca.gov.cn/ywzl/gjgnhz/jkzl/ )
3	Formula check	The product formula should be in compliance with the product national standards of GB 10765-2010, GB 10767-2010, and relevant notices; The usage of food additives and nutrition enrichment in infant formula food should be in compliance with GB 2760-2014, GB 14880-2012 and relevant notices
4	Formula registration* (only for imported infant formula milk powder)	For the moment, there is no regulation for imported infant formula milk powder registration, but for the domestic products, CFDA has issued the Administrative Measures for the Registration of Formula of Infant Formula Milk Powder (exposure draft). Overseas enterprise should keep focus on the future progress of this matter. For more interpretations of the draft, please kindly refer to the below link: The guidance on formula registration of infant formula milk powder under CFDA It is learned that CFDA will instead of AQSIQ to supervise the formula registration for importer infant formula milk powder.
5	Nutrition information report	The nutrition information report of imported food should be submitted when importing, which includes the energy, protein, fat, carbohydrate, sodium, nutrition enrichment, and other nutrients with nutrition claims.
6	GB Testing report of imported milk based infant formula food	For the first import, importer or agency should provide the testing report covers all items listed in the national standard of corresponding products, including the required mycotoxins and contaminant for the product listed in GB 2761-2011 and GB 2762-2012. For the re-import, importer or agency should provide the copy of testing report and inspection form in the first import, and additionally provide the testing report stipulated by AQSIQ (CN version free download for the testing item stipulated by AQSIQ). Information in the testing report mentioned above should in compliance with the production date or production batches of imported products. Testing items may be adjusted according to the newest national standards and notices, enterprises should pay attention to the change of regulations. The GB testing report for imported soybean based infant formula food is not mandatory, but as the requirements for the product in China may be different with foreign countries, and Chinese government pays high attention to infant formula food, it is necessary to conduct pre-testing at a qualified laboratory to insure the product quality and to avoid possible rejection by China Customs.
7	Chinese label	The information on the Chinese label should be in compliance with GB 13432-2013 and the requirements in the corresponding product national standard. The Chinese label of imported infant formula milk powder should be printed on the smallest retail package before the entry, and cannot be affixed in China. If there is no Chinese label on the package, or the Chinese label is in-compliant with Chinese laws and regulations, the products will be returned or destroyed.
8	Material preparation	Certificate of origin, certificate of hygiene for dairy products, and other relevant certificates are required when importing.
9	Other important matters about imported infant formula milk powder	If the time interval from the inspection date to expiry date of the product is less than 3 months, the inspection and import is not accepted. The product should be packaged in the smallest retail package to sell to consumers, the large packaging infant formula milk powder is forbidden to import.

In this year of 2015, Chinese government issued a number of laws and regulations, including The Food Safety Law, Administrative Measures for the Registration of Formula of Infant Formula Milk Powder (exposure draft), Supervision and Management on Cross-Border Electronic Commerce of Imported Food through Bonded Online Shopping (exposure draft), to further strengthen the supervision of pre-packaged food, special food and food contact materials in traditional and new trade mode. As a kind of high risk food, infant formula food has been highly concerned by government and society, and the quality control and supervision by Chinese government become more and more strict, related imported enterprises shall keep focusing on the new regulations, strictly comply with the requirements of Chinese laws and regulations, to avoid the unnecessary cost and social credibility loss.

CIRS will continue to pay attention to the regulation change about infant formula food, and enterprises also need to prepare for compliance in advance.

Contact us
Ms. Wing Yu, Food & Health Products, CIRS China
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Tel: +86 571 8720 6538 | Fax: +86 571 8720 6533
Email: Wing.Yu@cirs-group.com

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