Infant (and young children) formula food is one of the main sources of infant (and young children) nutrition, which directly affects the early growth and development of infants and their life quality. All the countries/areas in the world supervise such kind of products strictly to ensure babies get best feeding. Foodmate compares and analyzes regulatory authorities, supervision model, supervision regulations and standards of infant (and young children) formula in China and European Union (EU) to help you understand the supervision differences between China and EU. Now, let's look at the first part — regulatory authorities and regulatory models.

1. Regulatory authorities of infant (and young children) formula
In China, infant (and young children) formula is jointly supervised by the National Health Commission, Ministry of Agriculture and Rural Affairs, the State Administration for Market Regulation, the General Administration of Customs and provincial and local administrative agencies. All departments cooperate with each other to ensure the safety of infant (and young children) formula food sold in China.

The Animal Husbandry and Veterinary Bureau under the Ministry of Agriculture and Rural Affairs is responsible for the quality and safety of raw milk production and purchase; The National Health Commission is responsible for drafting national standards for infant (and young children) formula food, conducting food safety risk monitoring, assessment and communication, as well as undertaking the safety review of the application of novel food ingredients, novel food additives, and novel food-related products used in infant (and young children) formula foods; The Special Food Safety Supervision and Administration Department under the State Administration of Market Supervision and Administration and the National Certification and Accreditation Supervision and Administration Committee are responsible for the supervision of market access, production, circulation and consumption of infant (and young children) formula; The General Administration of Customs is responsible for the supervision of the import and export of infant (and young children) formula. The unqualified products found in different supervision links shall be notified and dealt with by the corresponding supervision departments.

As EU is a multi-member union, it is only responsible for establishing and issuing regulations at union level .The specific links of product market circulation and import supervision are the responsibility of the member states. 

European Council is the highest authority in EU, which is responsible for determining major polices and laws; meanwhile, European Council, European parliament and European Commission are jointly responsible for setting policy and issuing infant formula standards and regulations based on scientific advice from the European Food Safety Authority (EFSA); EFSA conducts food safety risk assessment, collects and analyzes food safety-related information to make scientific recommendations on events directly or indirectly related to food safety, and provides recommendations on food regulations, therefore, EFSA could provide scientific basis for EU policy and legislation on food safety for infants (and young children), but unlike National Health Commission in China, this institution does not have the power to establish and issue regulations; In addition, European Commission and EFSA are responsible for the collection and analysis of food safety related information in the Rapid alert System of Food and Feed  (RASFF), issuing alerts and undertaking food safety risk assessment. RASFF will notify all the infant (and young children formula) that does not comply to EU regulations.

2. Supervision mode of infant (and young children) formula food
In China, obtaining the registration certificate and food production license for infant (and young children formula) is a necessary condition for domestic enterprises. According to Food Safety Act of People’s Republic of China, both domestic and overseas infant (and young children) formula milk powder production enterprises are required to register product formula according to relevant regulations before production. After obtaining formula food registration certificates, a food production license for the corresponding product is also needed before domestic production enterprises producing such products.

After the product are placed on the market, the main responsibility of the enterprise and the strict sampling inspection and punishment system shall be implemented for infant (and young children) formula. Of which, the main responsibility of the enterprise means the manufacturer should produce formula according to submitted application materials during formula registration, and take the main responsibility for each link of production and operation.

Regulation at the EU level aims to ensure the free movement of goods, food safety and consumer safety within the single market. Therefore, at EU level, the Directorate General for Health and Food Safety of European Commission is responsible for the formulation and coordination of major policies, which are implemented by the Member States. When the Member States have any problems, they can ask EFSA to explain. The EU does not establish specific regulations for manufacturers of infant (and young children) formula, but all food production enterprises are required to obtain at least one on-the-spot audit from the competent authorities in order to obtain a company registration or a production license. Food may not be produced until a production license has been obtained.

about the product supervision, EU requires that when infant formula is placed on the market, the food business operator shall notify the competent authority of each Member State where the product concerned is being marketed of the information appearing on the label, by sending to it a model of the label used for the product, and of any other information the competent authority may reasonably request to establish compliance with (EU) 2016/127. EU member states could also set up their own effective regulatory system under  (EU) 2016/127.

3. Summary：
All in all，both China and the EU have strict supervision on infant (and young children) formula food. In China, all the agencies coordinate the supervision of the whole process from the raw material to the finished product. The production of infant (and young children) formula food in both China and the EU is subject to production license management, factories are required to meet on-site audit requirements before getting production permits. At the same time, infant (and young children) formula in China must be registered before it can be produced but it is not necessary in EU.

In this article, we introduce the regulatory authorities and supervision model in China and EU, we will introduce differences of regulations and standards between China and EU in next article.

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Business Division of Food Safety and Regulatory Compliance of Global Foodmate provides food standards & regulations research, labelling compliance consulting/Chinese label design, industry public opinion monitoring and analysis, registration services (of Infant formula, FSMP, Health food, Novel Food Ingredients, Novel Food Additives, New Varieties of Food-Related Products and Overseas manufacturers of imported food) and other comprehensive food safety solutions for domestic and overseas enterprises and institutions in food industry. 

Please feel free to contact us: +86 10 68869850, E-mail: global_info@foodmate.net