China and European Union (EU) have different supervision laws and regulations on formula foods for special medical purposes (FSMP). Foodmate compares and analyzes FSMP supervisions in China and that in EU from product category, product standard, industry access, advertising, marketing and other aspects to enhance your understanding of regulatory differences. The comparison will be published in two parts, this is part-I (including definition, product category and product standard).

In China, FSMPs refer to formula foods specially prepared to meet the special needs of nutrients or diets for people with limited eating, digestive and absorption disorders, metabolic disorders or specific disease states, including those suitable for infants from 0 month to 12 months and those for people over 1 year old.

In EU, FSMPs are called food for special medical purposes, a little different from that of China, which refers to food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone. Therefore, EU has also included infant formula for special medical purposes in the regulation of FSMPs. Moreover, the nutritional composition of FSMP developed to satisfy the nutritional requirements of unhealthy infants should be based on that of infant formula and follow-on formula. However, the nutrient content can be adjusted appropriately according to the needs of patients.

Classification of FSMPs

The classification of FSMP in China is also a little different from that in EU. EU does not distinguish infant FSMPs and FSMPs as clearly as China does. The classification of infant formula FSMPs in China is based on infant symptoms and has explicit name, and the FSMPs for people over 1 year old can be divided into three main kinds of products: nutritionally complete food, nutritionally complete food with a nutrient-adapted formulation specific for a medical condition, and nutritionally incomplete food. EU classifies all FSMPs into the above three categories, regardless of the age of the people who eat them.

Because there are certain differences in classification, we use Chinese FSMP classification system as a benchmark to compare with EU classification. The details showed in the table below. It can be seen that the classification of FSMPs in Chinese regulations is more specific.

Product standards

In China, there are two standards for FSMPs, one is GB 25596-2010 “National food safety standard General rules for infant formula for special medical purposes”, another is GB 29922-2013 “National food safety standard General rules for food for special medical purposes”. Both these two standards specify product definition, technology requirements, some labeling requirements, instruction for use and packing requirements in detail. Meanwhile, FSMP belongs to food for special dietary food, and its label should not only comply with GB 7718-2011 “National food safety standard General principle for prepackaged food label”, but also with GB 13432-2013 “National food safety standard Label of prepackaged food for special dietary”.

In EU, (EU) 609/2013 “on food intended for infants and young children, food for special medical purposes” is a principle regulation which specifies product definition and regulatory principles for all infant formula food, FSMP and other special dietary foods. And (EU) 2016/128 “supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes” is a regulation specifically aimed at FSMP and specifies technology requirements, selling requirements, labeling requirements and advertising requirements in detail. In addition, 2006/141/EC “on infant formulae and follow-on formulae and amending Directive 1999/21/EC” specified that requirements for infant formula manufactured from protein hydrolysates are effective before Feb 21, 2021. As all above regulations has included corresponding requirements for product label, EU did not established label requirements for relevant product alone. But all product should meet the requirements of (EU) 1169/2011 “on the provision of food information to consumers”

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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. 

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