According to the "Food Safety Law" and "Administrative Measures for the Registration of Formula Foods for Special Medical Purposes" (hereinafter referred to as the "Measures"), the registration management of formula foods for special medical purposes is implemented. It has been four and a half years since the "Measures" came into effect from July 2016 to the end of 2020. Foodmate has compiled relevant information on all approved formula foods for special medical purposes (hereinafter referred to as FSMP) from different perspectives and make an analysis for your reference.

1. Approval status of FSMP over the years

Since the approval of the first FSMP in 2017, the number of FSMP approved and registered in the past years is: 3 in 2017; 18 in 2018; 22 in 2019; 12 in 2020.
2. The category of approved FSMP over the years

From 2017 to 2020, China has approved a total of 55 FSMP, including 31 FSMP for infant, 17 full nutritional products, and 7 non-full nutritional products. No specific full nutritional formula foods have been approved yet. Among them, FSMP for infant products have covered all 6 sub-categories and only 1 product is used for disorder of amino acid metabolism.
3. Enterprises of approved FSMP

The 55 approved FSMP involve 19 enterprises. The products approved in the past few years are mainly concentrated in well-known companies of dairy industry, such as Nestlé, Abbott, Nutricia, Synutra, etc.; this year some new companies such as Yabao Pharmaceutical and AusNuotore have registered some FSMP.
4. The country where the approved FSMP belongs

A total of 26 domestic products and 29 imported products have been approved. Most of the approved imported products are produced by well-known companies in various countries. For example, 3 approved products in Spain, 3 in the U.S. and 2 in Singapore all belong to Abbott; 5 approved products in the Netherlands, 2 in Germany and 3 in Switzerland all belong to Nestlé.
5. Summary

At present, the registration approval rate of FSMP in China is less than 20%. This is mainly because of the imperfect standards and regulations, unclear product positioning of the company and unstrict control of raw materials. To change this situation, the government needs to issue more complete and detailed guidance documents as soon as possible, and more responsible companies should take the lead in the research and development of special medical foods in blank areas.

Note: All data in this article comes from the special food information query platform of the State Administration for Market Regulation (as of December 31, 2020). It is understood that in 2020, another two protein component formula foods (国食注字 TY20200012, 国食注字 TY20200013) have been approved, respectively from Guangzhou EnterNutr Biotechnology Co., Ltd. and Jilin M.F. Nutrition Technology Co., Ltd. Changchun Branch, As these two products are not included in the special food information query platform as of the deadline for data statistics in this article, they are not within the scope of this article.

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Please note: Original English article of Business Division of Food Safety and Regulatory Compliance of Global Foodmate, please indicate the source from the Global Foodmate if reprint.

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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