Food Compliance
Intelligence & Solutions
China Dairy Regulations
Aug 24, 2021
Echo Cao
Tags : ChinaDairy
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CONTENTS

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


NHC (National Health Commission)

  • Draft public health policy, including national food safety standard

  • New food raw materials and new food additives review

  • Develop food safety risk supervision

SAMR (State Administration for Market Regulation)

  • Market supervision, including supervision of food safety

  • Administration on special food, including infant formula registration, health food filing/registration, FSMP registration

  • Qualification accreditation

GAC (General Administration of Customs)

  • Inspection and quarantine of import and export goods

  • Customs clearance

  • Overseas food manufacturers registration

MOFCOM

  • Governing the import report and information release of staple agricultural products (fresh milk, milk powder and whey are included since 10 Jul 2009)

  • Administration of automatic import license of good (fresh milk, milk powder and whey are included since 10 Jul 2009) together with GAC

China Chamber of Commerce of Foodstuffs and Native Produce 

  • Authorized by MOFCOM to deal with the routine work of gathering, summarizing, analyzing and checking of import report information of staple agricultural products

*China has undergone department restructure in 2018. If you are confused about the competent authorities, please click here to read more.

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).


CN Title

EN Title

1

GB 19301-2010 食品安全国家标准   生乳

GB 19301-2010 National Food Safety Standard Raw Milk

2

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

3

GB 25190-2010 食品安全国家标准   灭菌乳

GB 25190-2010 National Food Safety Standard Sterilized Milk

4

GB 25191-2010 食品安全国家标准   调制乳

GB 25191-2010 National Food Safety Standard Modified Milk

5

GB 19302-2010 食品安全国家标准   发酵乳

GB 19302-2010 National Food Safety Standard Fermented Milk

6

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

7

GB 19644-2010 食品安全国家标准   乳粉

GB 19644-2010 National Food Safety Standard Milk Powder

8

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

9

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

10

GB 5420-2010 食品安全国家标准   干酪

GB 5420-2010 National Food Safety Standard Cheese

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

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

20

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

21

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

22

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

23

GB 5413.9-2010 食品安全国家标准   婴幼儿食品和乳品中维生素ADE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

24

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

25

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

26

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,
  Milk and Milk Products

27

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

28

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

29

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

30

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

31

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

32

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

33

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

34

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

35

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

36

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

37

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

38

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

39

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

40

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

41

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

42

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

48

GB 5009.24-2010 食品安全国家标准   食品中黄曲霉毒素M1B1的测定

GB 5009.24-2010 National Food Safety Standard Determination of Aflatoxins M1 and B1 in Foods

50

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

51

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

52

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

53

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

Type

English Name

Chinese name

Effective Date

Remark

MOFCOM Announcement No.50-2009

Adjustment of Catalogue of Staple Agricultural Products Subject to Import Report Administration

关于调整《实行进口报告管理的大宗农产品目录》的公告

2009-08-01

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.

关于对鲜奶、奶粉和乳清实施自动进口许可管理的公告

2009-08-01

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)

2013-5-1

This document will be invalid after the implementation of the new Administrative Measures on Safety of Import and Export Food of the People‘s Republic of China on Jan.1st, 2022.

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)

2013-5-1

Supplementary articles for its upper regulation

GAC order No. 145-2021Administrative Provisions on Registration of Overseas Manufacturers of Imported Foods中华人民共和国进口食品境外生产企业注册管理规定 (original test)2022-1-1

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)

2013-09-23

From 1 Apr 2014, imported baby formula must have the Chinese labels printed on the can or boxes already before entry of the country.

GAC

List of China-Approved Overseas Dairy Manufacturers 

中国批准的国外乳制品生产企业 (Official link)

dynamic update


3. Labeling and claims for dairy products


3.1. Labeling

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

  • Ingredient list

  • Energy and nutrients

  • Net content

  • qualification

  • 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

  • Storage conditions

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.

3.2. Claims

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

Former AQSIQ Order No.152-2013 specified that dairy products intended for the Chinese market should obtain overseas manufacturer registration approval. According to the latest "Provisions on Registration of Overseas Manufacturers of Imported Foods", all of overseas enterprises exporting food to China shall be registered with GAC, and overseas dairy manufacturers are subject to recommendation registration. 

Click the link below to check the registered overseas dairy manufacturers:

4.2. Exporter filing

For exporters firstly exporting their food products to China, they need to finish on-line filing with GAC. Please click here for a step by step guidance to assist you in meeting this obligation. 

4.3. What can be written on the package?

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:

Requirement

Competent authority

Food distribution license

local administration for industry & commerce

Filing of staple agricultural products (for fresh milk, milk powder and whey)

China Chamber of Commerce of Foodstuffs and Native Produce

Automatic import license (for fresh milk, milk powder and whey)

Quota & License Administration Bureau and other local departments under MOFCOM 

Importer filing

Local customs

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.

Some local authorities issued specific guidance for importers who import dairy products, please click here to see Guangzhou customs' guidance.

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 are the most challenging parts for dairy products entering into Chinese markets. 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.     

Tags : ChinaDairy