Status Quo of China’s FSMP Registration in 2022 H1

According to the data sourced from the State Administration for Market Regulation (SAMR), only two food for special medical purposes (FSMP) products were granted registration approval during the first half of 2022, and both are from China.

In addition, the Center for Food Evaluation subordinated to SAMR has delivered the Decision Paper of three FSMP products in the first half of 2022, which means the products will be included in SAMR database if they obtain the approval result.

The overall status quo of FSMP registration

By June 30, 2022, 43 enterprises have 83 FSMP products registered in China. Most of them are Chinese products, accounting for 65.1%. The sources of registered FSMP are shown below:

FSMP includes infant formula food for special medical purposes and FSMP targeting at population over one year old. At present, the latter accounts for around 57%. Moreover, FSMP targeting at population over one year old can be further classified into nutritionally complete formula food, nutritionally incomplete formula food, and specific full nutritional formula food. The table below showcases the registration number for products of each type.

FSMP registration trend

1. The registered products are more diversified

After FSMP registration policy was announced in 2016,  the first registration approval was obtained in 2017. Before the end of 2018, most of approved products were infant formula food for special medical purposes, while there was a sharp increase of FSMP targeting at population over one years old starting from 2019. Moreover, the product type is being more and more diversified. Apart from nutritionally complete formula food, there are nutritionally incomplete formula food such as electrolyte formula, carbohydrate components, protein (amino acid) components, etc. In the first half of 2022, the first fat (fatty acid) component product was granted approval. It is believed that more types of FSMP products like thickening component products and liquid formula products will enter into Chinese market in the near future.

2. The number of domestic FSMP products overtakes the imported ones

Before 2019, most registered FSMP products are imported because such product has been well developed in overseas market. Seeing the market potential of FSMP, more and more Chinese enterprises started to increase the investment on this sector. The market has witnessed the rapid growth of registration approval for domestic FSMP products from 2019. All of the 24 products registered in 2021 are Chinese domestic products.

Suggestion for FSMP enterprises

Administrative Measures on the Registration of Food for Special Medical Purposes (hereinafter the Administrative Measure) is one of the major references for FSMP registration. According to the legislation scheme of 2022 issued by SAMR in this Aprilr, the revision draft of the Administrative Measure should be submitted to relevant authority for review by June 30, 2022. Therefore, FSMP enterprises should closely monitor the regulatory changes for product compliance.

Additionally, FSMP manufacturers should pay more attention to the food safety management. In this February, due to the detection of Cronobacter and Salmonella, Abbott Nutrition recalled infant formula products from three of its brands, involving Similac (including Similac HMFortif, FSMP for infants), Alimentum, and EleCare, and even closed its manufacturing facility in Sturgis, Michigan. This event also became one of the leading factors for the milk powder shortage in America. Manufacturers should learn from this lesson and strengthen the food safety management

Feel free to contact ChemLinked if you need the FSMP registration data in details.