From an investment standpoint the Chinese dairy market has been one of the most desirable markets across the globe. The huge population and poor reputation of domestic dairy products has led to an enormous demand for overseas dairy, particularly baby formula. However constant changes in regulations and standards have made the Chinese market an extremely difficult nut for foreign enterprises to crack. Every year a significant volume of imported dairy products fail to pass customs inspection and quarantine and are held at port or destroyed. In the majority of cases lack of regulatory knowledge and failure to comply with regulations are primary causative factors in customs inspection failure at port.
To facilitate market access it is advisable to arm yourself with a rudimentary understanding of Chinese dairy regulations and dairy product standards
1. Main competent authorities and organizations
*China has undergone department restructure in 2018. If you are confused about the competent authorities, please click here to read more.
Since the 2008 Chinese melamine adulterated milk powder scandal, the safety of infant formula has become a topic of utmost national importance. This food safety incident has shaped the nation’s food safety legislative framework and also the purchasing habits of Chinese consumer who now eschew domestic products in favor of comparatively higher quality and safer imported dairy. The Chinese government has responded to this incident by issuing numerous new dairy-related regulations in an attempt to overhaul its domestic dairy industry as well as ensuring the safety of imported dairy products.
2. Main regulatory updates for dairy products since 2008
2.1. National food safety standards (dairy)
In response to the melamine contamination issue in Sep 2008, former MOH (now NHC), former MOA (now MPARA), former AQSIQ, MIIT and former SAIC (now SAMR) jointly released the limit of melamine in milk and milk products on 17 Oct 2008. The maximum limit of melamine in infant formula is 1mg/kg and in liquid milk (including raw material milk), milk powder and other formula powder is 2.5mg/kg (see MOH news press). In addition, on 7 Oct of the same year, AQSIQ and SAC published the testing standard GB/T 22388-2008 Determination of Melamine in Raw Milk and Dairy Products.
After 2 years’ of further legislative development, former MOH issued the following national food safety standards for milk and milk products on 22 Apr 2010, covering product standards, production standards and testing standards (see MOH Notice).
GB 19301-2010 食品安全国家标准 生乳
GB 19301-2010 National Food Safety Standard Raw Milk
GB 19645-2010 食品安全国家标准 巴氏杀菌乳
GB 19645-2010 National Food Safety Standard Pasteurized Milk
GB 25190-2010 食品安全国家标准 灭菌乳
GB 25190-2010 National Food Safety Standard Sterilized Milk
GB 25191-2010 食品安全国家标准 调制乳
GB 25191-2010 National Food Safety Standard Modified Milk
GB 19302-2010 食品安全国家标准 发酵乳
GB 19302-2010 National Food Safety Standard Fermented Milk
GB 13102-2010 食品安全国家标准 炼乳
GB 13102-2010 National Food Safety Standard Evaporated Milk, Sweetened Condensed Milk and Formulated Condensed Milk
GB 19644-2010 食品安全国家标准 乳粉
GB 19644-2010 National Food Safety Standard Milk Powder
GB 11674-2010 食品安全国家标准 乳清粉和乳清蛋白粉
GB 11674-2010 National Food Safety Standard Whey Powder and Whey Protein Powder
GB 19646—2010 食品安全国家标准 稀奶油、奶油和无水奶油
GB 19646-2010 National Food Safety Standard Cream, Butter and Anhydrous Milkfat
GB 5420-2010 食品安全国家标准 干酪
GB 5420-2010 National Food Safety Standard Cheese
GB 25192-2010 食品安全国家标准 再制干酪
GB 25192-2010 National Food Safety Standard Process(ed) Cheese
GB 10769-2010 食品安全国家标准 婴幼儿谷类辅助食品
GB 10769-2010 National Food Safety Standard Cereal-based Complementary Foods for Infants and Young Children
GB 10770-2010 食品安全国家标准 婴幼儿灌装辅助食品
GB 10770-2010 National Food Safety Standard Canned Complementary Foods for Infants and Young Children
GB 23790-2010 食品安全国家标准 粉状婴幼儿配方食品良好生产规范
GB 23790-2010 National Food Safety Standard Good Manufacturing Practice for Powdered Formulae for Infants and Young Children
GB 5413.33-2010 食品安全国家标准 生乳相对密度的测定
GB 5413.33-2010 National Food Safety Standard Determination of Specific Gravity in Raw Milk
GB 5413.30-2010 食品安全国家标准 乳和乳制品杂质度的测定
GB 5413.30-2010 National Food Safety Standard Determination of Impurities in Milk and Milk Products
GB 5413.34-2010 食品安全国家标准 乳和乳制品酸度的测定
GB 5413.34-2010 National Food Safety Standard Determination of Acidity in Milk and Milk Products
GB 5413.3-2010 食品安全国家标准 婴幼儿食品和乳品中脂肪的测定
GB 5413.3-2010 National Food Safety Standard Determination of Fat in Foods for Infants and Young Children, Milk and Milk products
GB 5413.29-2010 食品安全国家标准 婴幼儿食品和乳品中溶解性的测定
GB 5413.29-2010 National Food Safety Standard Determination of Solubility in Foods for Infants and Young Children, Milk and Milk products
GB 5413.27-2010 食品安全国家标准 婴幼儿食品和乳品中脂肪酸的测定
GB 5413.27-2010 National Food Safety Standard Determination of Fatty Acids in Foods for Infants and Young Children, Milk and Milk Products
GB 5413.5-2010 食品安全国家标准 婴幼儿食品和乳品中乳糖、蔗糖的测定
GB 5413.5-2010 National Food Safety Standard Determination of Lactose and Sucrose in Foods for Infants and Young Children, Milk and Milk Products
GB 5413.6-2010 食品安全国家标准 婴幼儿食品和乳品中不溶性膳食纤维的测定
GB 5413.6-2010 National Food Safety Standard Determination of Insoluble Dietary Fiber in Foods for Infants and Young Children, Milk and Milk Products
GB 5413.9-2010 食品安全国家标准 婴幼儿食品和乳品中维生素A、D、E的测定
GB 5413.9-2010 National Food Safety Standard Determination of Vitamin A, D, E in Foods for Infants and Young Children, Milk and Milk Products
GB 5413.10-2010 食品安全国家标准 婴幼儿食品和乳品中维生素K1的测定
GB 5413.10-2010 National Food Safety Standard Determination of Vitamin K1 in Foods for Infants and Young Children, Milk and Milk Products
GB 5413.11-2010 食品安全国家标准 婴幼儿食品和乳品中维生素B1的测定
GB 5413.11-2010 National Food Safety Standard Determination of Vitamin B1 in Foods for Infants and Young Children, Milk and Milk Products
GB 5413.12-2010 食品安全国家标准 婴幼儿食品和乳品中维生素B2的测定
GB 5413.12-2010 National Food Safety Standard Determination of Vitamin B2 in Foods for Infants and Young Children,
GB 5413.13-2010 食品安全国家标准 婴幼儿食品和乳品中维生素B6的测定
GB 5413.13-2010 National Food Safety Standard Determination of Vitamin B6 in Foods for Infants and Young Children, Milk and Milk Products
GB 5413.14-2010 食品安全国家标准 婴幼儿食品和乳品中维生素B12的测定
GB 5413.14-2010 National Food Safety Standard Determination of Vitamin B12 in Foods for Infants and Young Children, Milk and Milk Products
GB 5413.15-2010 食品安全国家标准 婴幼儿食品和乳品中烟酸和烟酰胺的测定
GB 5413.15-2010 National Food Safety Standard Determination of Vitamin Niacin and Niacinamide in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.16-2010 食品安全国家标准 婴幼儿食品和乳品中叶酸(叶酸盐活性)的测定
GB 5413.16-2010 National Food Safety Standard Determination of Folic Acid (Folate Activity) in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.17-2010 食品安全国家标准 婴幼儿食品和乳品中泛酸的测定
GB 5413.17-2010 National Food Safety Standard Determination of Pantothenic Acid in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.18-2010 食品安全国家标准 婴幼儿食品和乳品中维生素C的测定
GB 5413.18-2010 National Food Safety Standard Determination of Vitamin C in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.19-2010 食品安全国家标准 婴幼儿食品和乳品中游离生物素的测定
GB 5413.19-2010 National Food Safety Standard Determination of Free Biotin in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.21-2010 食品安全国家标准 婴幼儿食品和乳品中钙、铁、锌、钠、钾、镁、铜和锰的测定
GB 5413.21-2010 National Food Safety Standard Determination of Calcium, Iron, Zinc, Sodium, Potassium, Magnesium, Copper and Manganese in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.22-2010 食品安全国家标准 婴幼儿食品和乳品中磷的测定
GB 5413.22-2010 National Food Safety Standard Determination of Phosphorus in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.23-2010 食品安全国家标准 婴幼儿食品和乳品中碘的测定
GB 5413.23-2010 National Food Safety Standard Determination of Iodine in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.24-2010 食品安全国家标准 婴幼儿食品和乳品中氯的测定
GB 5413.24-2010 National Food Safety Standard Determination of Chlorine in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.25-2010 食品安全国家标准 婴幼儿食品和乳品中肌醇的测定
GB 5413.25-2010 National Food Safety Standard Determination of Inositol in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.26-2010 食品安全国家标准 婴幼儿食品和乳品中牛磺酸的测定
GB 5413.26-2010 National Food Safety Standard Determination of Taurine in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.35-2010 食品安全国家标准 婴幼儿食品和乳品中β-胡萝卜素的测定
GB 5413.35-2010 National Food Safety Standard Determination of β-Carotene in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.36-2010 食品安全国家标准 婴幼儿食品和乳品中反式脂肪酸的测定
GB 5413.36-2010 National Food Safety Standard Determination of Trans Fatty Acids in Foods for Infants and Young Children,Milk and Milk Products
GB 5413.37-2010 食品安全国家标准 乳和乳制品中黄曲霉毒素M1的测定
GB 5413.37-2010 National Food Safety Standard Determination of Aflatoxin M1 in Milk and Milk Products
GB 5009.24-2010 食品安全国家标准 食品中黄曲霉毒素M1和B1的测定
GB 5009.24-2010 National Food Safety Standard Determination of Aflatoxins M1 and B1 in Foods
GB 21703-2010 食品安全国家标准 乳和乳制品中苯甲酸和山梨酸的测定
GB 21703-2010 National Food Safety Standard Determination of Benzoic Acid and Sorbic Acid in Milk and Milk Products
GB 22031-2010 食品安全国家标准 干酪及加工干酪制品中添加的柠檬酸盐的测定
GB 22031-2010 National Food Safety Standard Determination of Added Citrate Content in Cheese and Processed Cheese Products
GB 5413.38-2010 食品安全国家标准 生乳冰点的测定
GB 5413.38-2010 National Food Safety Standard Determination of Freezing Point in Raw Milk
GB 5413.39-2010 食品安全国家标准 乳和乳制品中非脂乳固体的测定
GB 5413.39-2010 National Food Safety Standard Determination of Nonfat Total Milk Solids in Milk and Milk Products
2.2. Regulations for imported dairy products since 2009
MOFCOM Announcement No.50-2009
Adjustment of Catalogue of Staple Agricultural Products Subject to Import Report Administration
Fresh milk, milk powder and whey are newly added to this catalogue. The importers should report required information to the department.
MOFCOM and GAC Jointly Announcement No.45-2009
Announcement on Implementing automatic import licensing administration on fresh milk, milk powder and whey.
The importer of the three products should apply for an automatic import licenses from department designated by MOFCOM.
former AQSIQ Order No.152-2013
Administrative Measures on Inspection, Quarantine and Supervision of Import and Export Dairy Products (ChemLinked news)
进出口乳品检验检疫监督管理办法 (Original text)
New requirements for registration of overseas dairy manufacturers according to Administrative Provisions on Registration of Overseas Manufacturers of Imported Foods
former AQSIQ Announcement No.53-2013
Announcement on Implementation of AQSIQ Order No.152 (ChemLinked news)
关于实施《进出口检验检疫监督管理办法》有关要求的公告 (Original text)
Supplementary articles for its upper regulation
former AQSIQ Announcement No.133-2013
Announcement on Enhancing the Imported Baby Formula Management (Chemlinked news)
关于加强进口婴幼儿配方乳粉管理的公告 (Original text)
From 1 Apr 2014, imported baby formula must have the Chinese labels printed on the can or boxes already before entry of the country.
List of China CNCA-Approved Overseas Infant Formula Manufacturers (ChemLinked Analysis)
中国认监委认可的国外婴幼儿配方乳粉生产企业 (Official link)
Firstly published on 2014-4-30 and the Latest update is 2014-12-22
64 foreign manufacturers in 18 countries have been approved.
List of Importers, Brands and Overseas Manufacturers of Imported Infant Formula in China (ChemLinked analysis)
国家质检总局进口婴幼儿配方乳粉进口商及品牌名单 (Official link)
Firstly published on 2014-7-7 and the Latest update is 2015-4-28
201 importers import around 270 brands to China.
2.3. Regulations for domestic dairy products
Action Plan of Improving the Quality of Formula Powder and Enhancing Consumer Confidence
提高乳粉质量水平 提振社会消费信心行动方案 (Original text)
Introducing stricter industry entry of infant formula companies and speeding up the industry restructuring
State Council Circular No.57-2013
Opinions on Further Strengthening the Quality and Safety of Baby Formula (ChemLinked news)
进一步加强婴幼儿配方乳粉质量安全工作意见 (Original text)
The navigating policy that triggers the reform of baby formula industry; introduces stricter requirements for both domestic and imported milk powder
former CFDA Announcement No. 20-2013
The List of 128 Baby Formula Manufacturers in China (before reform) (Chemlinked news)
全国128家婴幼儿配方乳粉生产企业相关信息 (Original text)
Directory of 128 baby milk powder makers in China
former AQSIQ Announcement No.133-2013
Enhancing the Management of Imported Infant Formula (ChemLinked news)
婴幼儿配方乳粉管理的公告 (Original text)
Chinese labels of infant formula must be already printed on the cans or boxes when products arrive at ports.
former CFDA Circular No.214-2013
CFDA, NHFPC and SAIC Joint Circular on Further Regulating the Promotion and Sales Activities of Breast Milk Substitutes
关于进一步规范母乳代用品宣传和销售行为的通知 (Original Text)
former CFDA Announcement No.43-2013
Prohibition of Producing Infant Formula Milk Powder by Outsourcing, Rebranding and Sub-packaging, etc. (ChemLinked news)
禁止以委托，贴牌，分装等方式生产婴幼儿配方乳粉 (Original text)
Only for baby formula manufacturers in China
former CFDA Announcement No.44-2013
Provisions on Supervision and Inspection of Baby Formula Manufacturers
婴幼儿奶粉生产企业监督管理规定 (Original text)
Only for baby formula manufacturers in China
former CFDA Announcement No.49-2013
Detailed Rules for Examination on Production Licensing of Baby Formula 2013 (ChemLinked news)
婴幼儿配方乳粉生产企业许可审查细则 (2013年版) (Original text)
It replaces the 2010 version issued by AQSIQ and significantly upgrades production licensing criteria for baby formula manufacturers in China
former CFDA Circular No.251-2013
Further Strengthening the Supervision of the Sale of Infant Formula
关于进一步加强婴幼儿配方乳粉销售监督管理工作的通知 (Original text)
former CFDA Circular No.252-2013
Trial Sale of Infant Formula in Drug Store (ChemLinked news)
关于开展在药店试点销售婴幼儿配方乳粉工作的通知 (Original text)
General Office of the State Council
Work Plan of Promoting Mergers and Acquisitions within Infant Formula Industry
国务院公布婴幼儿配方乳粉企业兼并重组工作方案 (Original text)
10 large infant formula conglomerates each with the annual sales revenue of over 2 billion RMB are encouraged be formed and will occupy a market share of 65% by the end of 2015.
former CFDA Announcement No.24-2014
The Frist Batch of 82 Domestic Infant Formula Manufacturers (ChemLinked news)
关于公布婴幼儿配方乳粉生产企业及产品名录的公告 (Original text)
former CFDA Announcement No.56-2014
The Second Batch of 10 Domestic Infant Formula Manufacturers (ChemLinked News)
关于公布第二批婴幼儿配方乳粉生产企业及产品名录的公告 (Original text)
Food Safety Law (amended) (ChemLinked Analysis)
食品安全法 (修订版) (Original text)
The new law requires registration of the formulations of infant formula products and one formula is only for one product.
3. Labeling and claims for dairy products
All prepackaged foods including dairy products are mainly subject to the labelling requirements in the following three standards:
According to GB 7718-2011 and GB 28050-2011, imported product labels require the following information:
Name of the product
Energy and nutrients
Instruction for use and the target population group
Country of origin
Name, address and contact information of domestic agent, importer or distributor
Date of production and shelf life
Since overseas dairy manufacturers exporting to China are required to be registered with SAMR, every approved manufacturer has a unique registration NO. This number should be indicated on the Chinese labels as well. In some regions, local SAMR requires the name of manufacturer to appear on the label.
The labeling requirements for imported infant formula are very specific and supervision is extremely stringent. According to AQSIQ Announcement No.133-2013 , Chinese labels of imported infant formula must be printed on the cans or boxes before they arrive at port.
Claims are allowed on baby formula in China. The claims include a) content claims and b) function claims (GB 13432-2013 Q&A Revised Version). Content claims are those that describe nutritional features such as the energy level, protein level. Function claims are those stating ingredients can help/maintain the growth/normal physical functions etc. For content claims, when the energy or the ingredients achieve the minimum requirements or the minimum fortification requirements, content claims can be made. Functional claims could be made when the nutritional ingredients meet the requirements of content claims, however there are other requirements. Functional claims can only be made using standardized terminology as articulated in GB28050 and GB13432-2013 Q&A Revised Version.
According to GB 13432-2013, since babies at age of 0-6months need complete and balanced nutrition, no claims can be made on mandatory ingredients of baby formula (0-6 months).
ChemLinked China Compliant New Product Development Tool (CNPD) is designed to help foreign companies design China market ready product formulation. Please click here to design China compliant formulation and claims for infant formula products.
4. Obligation checklist for exporters of dairy products
4.1. Registration of overseas dairy manufacturers
According to former AQSIQ Order No.152-2013, dairy products intended for the Chinese market should be produced by dairy manufacturers already registered with CNCA. There are two lists for you to understand the import situation of dairy products in China:
4.2. Exporter filing
For exporters firstly exporting their food products to China, they need to finish on-line filing with AQSIQ. Please refer to China AQSIQ Requirement: Filing of Overseas Food Exporters, a step by step guidance to assist you in meeting this obligation.
Design China compliant packaging and labels
4.3. What can be written on the can?
According to GB 7718-2011, labels should include name, list of ingredients, net content, size, producers and distributor’s name, address and contact details, date of production and shelf life, storage conditions, food production license number and product standard code. According to GB13432-2013, besides the general requirement, it should also include energy and nutrition labeling, consumption method, suitable consumer and storage conditions.
All imported dairy products must have Chinese labels which are very important during customs inspection and post-market supervision. A substandard label may lead to goods being held at port and costly penalties.
Different interpretations of regulations by different regional authorities make the label issue even trickier and more complicated. Exporters are strongly recommended to find a service provider that can preview the label for you and provide assurance of regulatory compliance in the province you are exporting to.
4.4. Testing report
A testing report is required as part of dossiers for customs inspection and quarantine application. The testing institutes approved to issue the testing report for imported dairy products include overseas laboratories, a third party testing agency or corporate laboratory, or an accredited food testing laboratory in China, as specified by former AQSIQ Announcement No.53-2013.
When imported foods arrive at port, they are subject to spot check by GAC inspectors and samples will be sent to accredited Chinese food labs for testing according to relevant national standards. Based on the regulation, three kinds of test reports are all acceptable by GAC. However, testing reports issued by oversea labs may not be recognized by GAC or there maybe inconsistencies in results generated by overseas labs and GAC recognized labs in China as the test facilities and methods are different. Therefore, in order to ensure the consistency of testing reports, overseas exporters can find a Chinese lab which is recognized by the local customs in the same province as the destination port.
5. Obligation checklist for importers of dairy products
There are so many requirements to meet to be a qualified importer of dairy products in China. Preparation work includes:
Food distribution license
local administration for industry & commerce
Filing of staple agricultural products (for fresh milk, milk powder and whey)
Automatic import license (for fresh milk, milk powder and whey)
The customs inspection and quarantine procedures include:
Apply for the quarantine approval at GAC: raw milk (HS Code: 0401200000), raw milk products (HS Code: 0403100000, 0406100000, 0406200000, 0406300000, 0406400000, 0406900000) and pasteurized milk (HS Code: 0401100000, 0401200000) are three categories that should go through quarantine by GAC.
Apply for customs inspection by submitting required documents according to AQSIQ Order No.152-2013
GAC conducts inspection (select sample and send them to its recognized lab for compliance test)
the importer or its agent applies for the label filing with local customs by submitting required documents;
Compliant goods are allowed to be imported but unqualified goods are rejected or destroyed by the customs.
After dairy products enter the market, the importer should establish the importation and sales record for future reference according to the Administrative Provisions on Recording of Importing and Sales of Foods (former AQSIQ Announcement No.55-2012).
6. Compliance advice
Formulation, Chinese label design and testing of dairy products especially infant formula are from a regulatory compliance perspective one of China’s most challenging areas. ChemLinked new product development tool is useful in designing and checking the compliance of infant formula. After that, a trusted importer or a third party service provider experienced in dealing with Chinese food regulation will be able to fully ensure regulatory compliance. To further substantiate your products compliance with Chinese national standards it is wise to entrust an authoritative Chinese lab to carry out testing. When the goods are to be shipped to a port in China, delivering a small amount to go through all customs procedures can help in avoiding big risks and will pave the way for subsequent shipments.