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.

In the first quarter of 2024, according to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, EFSA published assessment results for 6 Novel Foods, including applications for 4 new Novel Foods, notification on 1 new traditional food from a third country and the modification of 1 novel food already authorized. Additionally, EFSA requested scientific and technical assistance as regards the evaluation of 1 Novel Food, and there were no new authorizations (approvals) for Novel Food in the EU in the first quarter of 2024.

In the first quarter of 2024, the official website of the FDA updated the GRAS status of 27 products. Among these, approval was granted for 2 substances, 2 substances ceased to be evaluated at the notifier’s request, and 23 substances are still pending after submission. This article provides a summary of the US FDA GRAS acceptance and approval status in the first quarter of 2024, for the information and reference of businesses.

From April 7 to April 14, 2024, the National Health Commission (NHC) Government Services Platform issued notifications for the approval and review of “three new foods” (new food raw materials, new food additives, and new food-related products). This includes delivering an extension notice for 1 new food raw material and issuing a non-approval decision on 1 new food-related product.