Foodmate News: Since the implementation of the "Administrative Measures on the Registration of Formula Food for Special Medical Purposes" on July 1, 2016, according to the "Food Safety Law" and the Administrative Measures, Formula Food for Special Medical Purposes (FSMP) that need to be registered include two categories: those that comply with GB25596 Infant formula food for special medical purposes and those that comply with GB29922 FSMP. At present, the products approved by registration do not cover all categories that need to be registered, and the registered FSMPs are mostly concentrated in well-known brands and imported brands. To show the registration and approval of FSMP more clearly, Foodmate conducted specific statistics and analysis from the following aspects.

01. Overview of FSMP registration approval

Since the implementation of the "Administrative Measures on the Registration of Formula Food for Special Medical Purposes" on July 1, 2016, there have been 51 FSMPs approved for registration until June 30, 2020. Among them, there are 31 infant formulas foods for special medical purposes suitable for infants aged 0 to 12 months and 20 FSMP suitable for people over 1 year old, including 16 full nutritional formulas and 4 non-full nutritional formulas. Among them, the product is mainly in powder form, and there are only 5 liquid products. The specific number of registrations for each product category is shown in the table below:

02. Registration and approval of FSMPs over the years

The products that have passed the registration in the past years are as follows: 3 in 2017, 18 in 2018, 22 in 2019, and 8 in the first half of 2020.Among them, all registered products in 2017 are imported products. The registered products are mainly domestic products (only one is imported) in the first half of 2020. The number of domestic/import products that have been registered in the past years is shown in the figure below.


03. Distribution of registered products

The number of approval formula products produced by domestic and foreign companies: 11 Nestlé, 8 Abbott, 5 Synutra, 4 Nutricia, 4 Beingmate, 3 Mead Johnson, 3 Hengrui Health, 2 Daily Dairy and 2 Meilu (AusNuotore). Yili, Aptamil, Wyeth, Richen Bio, M.F. Nutrition, Junyue, Balanceway, Aumix Dairy and Yabao Pharmaceutical have 1 approved product separately.


04. Country distribution of registered products

Generally, the number of imported brands that pass the registration is greater than the number of domestic brands. The country distributions of the registered products are as follows (in descending order): 22 in China, 8 in the Netherlands, 4 in the United Kingdom, 3 in Spain, 3 in Switzerland, 3 in the US, 3 in Germany (2 of Nestlé, 1 of Aptamil), 2 in Korea, 2 in Singapore and 1 in Ireland.


In addition, through statistics, it is found that 4 of the 7 products in the Netherlands belong to Nestlé, 2 of the 3 products in Germany belong to Nestlé, and 3 products in Switzerland belong to Nestlé; products from 3 countries (Spain, the United States and Singapore) all belong to Abbott, it can be seen that the country distributions of registered products mainly depends on the country distributions of production plants of well-known brands. A total of 9 overseas countries have registered products, while Nestlé and Abbott have spanned 6 countries.

05. Approval of product registration for different applicable ages

There is a total of 31 products for infants aged 0 months to 12 months (8 domestic products and 21 imported products) and 20 products for people over 1 year old (12 domestic products, 7 imported products). imported products are mainly consumed by babies aged 0-12 months; among the products suitable for people over 1-year old, domestic products are more registered.


06. Organizational status of registered products

There are 51 registered FSMPs, 90% of which are powder products. only 5 of them are liquid products, including Abbott’s 2 preterm/low birth weight infant formulas, Hengrui Health’s 2 electrolyte formulas and Nestlé’s 1 full nutritional formula food.


07. Summary

For the FSMPs that have been approved by registration, there are more products suitable for babies 0-12 months of age, and the six categories of special medical infant formulas covered by the national standard have been fully covered. The FSMPs that suitable for over 1-year old people are mainly full nutritional formula foods and non-full nutritional formula foods, and no products have been registered for specific full nutritional formula food.

The registered FSMPs have a higher concentration of brands. Nestlé, Abbott, Synutra, and Nutricia accounted for more than half of the total number of registered products. In addition, powder products account for most of the registered products. Companies can develop more liquid FSMPs and enter the market through registration approval to meet clinical needs.

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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.