On April 28, 2024, the China National Center for Food Safety Evaluation (CFSA) issued 2 new food raw materials, Nannochloropsis oil and egg yolk phospholipid and protein for public comments. In addition, rye pollen was approved as a new food raw material in the National Health Commission (NHC) Announcement No. 3 of 2023. Based on the industry data and through the review by the Expert Review Committee, it is now proposed to revise its content requirement of dietary fiber in the announcement to ≥30%. Comments are welcomed before May 28, 2024.

It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper inspection capabilities for producing its products, and conduct batch-by-batch inspections of manufactured products according to relevant laws, regulations, and national food safety standards for infant formula milk powder.

On March 13, 2024, the National Health Commission (NHC) of China issued Announcement No. 2 of 2024, officially approving 23 “three new foods”, including a new food-related product, Polybutylene succinate adipate (PBSA)”, submitted by CIRS Group on behalf of PTTMCC Biochem Co., Ltd. (PTTMCC).

On April 10, 2024, the European Commission issued Implementing Regulation (EU) 2024/1037, (EU) 2024/1047, (EU) 2024/1046, and (EU) 2024/1048, having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, authorizing the placing on the market of monosodium salt of L-5-methyltetrahydrofolic acid, 3'-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637), beta-glucan from Euglena gracilis microalgae, and protein concentrate from Lemna gibba and Lemna minor as a novel food. These Regulations enter into force from April 30, 2024. On April 11, 2024, the European Commission issued Implementing Regulation (EU) 2024/1052, authorizing the placing on the market of calcidiol monohydrate as a novel food. This Regulation enters into force from May 1, 2024. Moreover, the the European Commission amended the specifications and conditions of use of 3 already authorised novel foods, namely astaxanthin-rich oleoresin from Haematococcus pluvialis algae, lactitol, and galacto-oligosaccharide.

From April 15 to April 21, 2024, the National Health Commission (NHC) Government Services Platform issued notifications regarding the approval and review of “three new foods” (new food raw materials, new food additives, and new food-related products). This includes extension notice for 10 new food additives and 7 new food-related products; notification of review opinions for 2 new food additives and 2 new food-related products; and non-approval decision on 8 new food additives.

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on health food to help you gain a clearer understanding of the current requirements in China.

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on new food raw material and new food additive to help you gain a clearer understanding of the current requirements in China.

From April 15 to April 21, 2024, the National Health Commission (NHC) Government Services Platform issued notifications for the acceptance of “three new foods” (new food raw materials, new food additives, and new food-related products). The application for the new food additive recombinant human lactoferrin has been accepted.

It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper production capabilities compatible with the production of its products, comply with good manufacturing practices for powdered infant formula foods, and implement a Hazard Analysis and Critical Control Point (HACCP) system. When applying for infant formula milk powder registration, the applicant shall submit 9 required documents to the State Administration for Market Regulation (SAMR), including “8) Materials on R&D, production, and inspection capabilities”. Additionally, the review agency may organize on-site inspections as necessary for verification to ensure the consistency between the application materials and the actual circumstances.

It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper R&D capabilities aligned with its products. When applying for registration of infant formula milk powder products, the applicant shall submit 9 required documents to the State Administration for Market Regulation (SAMR), including 8) Materials on R&D, production, and inspection capabilities. Additionally, the review agency may organize on-site inspections as necessary for verification to ensure the consistency between the application materials and the actual circumstances.