On December 3, 2023, State Administration for Market Regulation (SAMR) unveiled the updated Administrative Measures for Registration of Foods for Special Medical Purpose, replacing the 2016 version. Major revisions include priority review and approval procedures, situations not approved for registration, labels, penalties, and measures to optimize the registration procedure. The new version will come into force on January 1, 2024.

On August 28, 2023, the State Administration for Market Regulation (SAMR) published Detailed Rules on Implementation for Technical Evaluation of New Functions and Products of Health Food (Trial), with immediate effect.

According to the data from Special Food Information Query Platform, 24 food for special medical purposes (FSMP) products were granted registration approval in 2023 H1. Among them, one imported product was approved.

On July 10 2023, State Administration for Market Regulation (SAMR) unveiled the updated Administrative Measures for Registration of Infant and Young Children Milk Powder Formula Recipes, replacing the 2016 version. Major revisions include the definition of situations not approved for registration, labels, on-site inspection requirements, and measures to optimize business environment. The new version will come into force on October 1, 2023.

Before the release of the new GB standards, China’s infant formula industry once has around 1,300 valid recipes on the market. Since the new GB standards came into effect yesterday, lots of recipes registered as per the old standards became invalid.

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.

164 imported health food has been granted filing approvals by the end of H1 2022, while registration approval has been halted since 2018. 23 imported health food has been granted filing approvals over the past 12 months, and more can be expected.

15 foods for special medical purposes products (FSMP) obtained registration approval in 2021H1. All of them are produced by domestic enterprises. By the end of June 2021, 72 FSMP products were registered in China. FSMP for infants accounted for 50% of all. Among them, premature/low birth weight infant formula, lactose free formula and partially-hydrolyzed lactoprotein infant formula occupy the majority.

In the first half of 2021 (by June 30), only two imported health food products obtained the filing certificates issued by SAMR, while no imported health food was granted registration approval. Compared to the filing performance of 2020 H1, the number of imported health food products obtained filling certificates drops sharply.

On Mar. 18, 2021, China NHC released the new national food safety standards for infant formula(GB 10765-2021), older infant formula(GB 19766-2021), and young children formula(GB 10767-2021). These 3 standards replace GB 10765-2010 and GB 10767-2010, and will be effective starting from Feb. 22, 2023.

In the first half of 2020 (by June 30), 32 imported health food products obtained the filing certificates issued by SAMR, while no imported health food was granted registration approval.