Frequently Asked Questions on FDA Generally Recognized As Safe (GRAS) Certification, Vol. 2

From April 28 to May 5, 2024, the National Health Commission (NHC) Government Services Platform issued notifications regarding the acceptance of “three new foods” (new food raw materials, new food additives, and new food-related products). The applications for Lemon Myrtle and fructo-oligosaccharide have been accepted.

In accordance with the Healthy China 2030 Plan released by the State Council, China’s booming health industry is projected to reach a market size of 16 trillion yuan by 2030, showing immense potential. In the era of “big health”, new food ingredients are continually emerging, industry regulations and standards undergo constant updates, and emerging fields that integrate traditional and modern technologies such as foods with medical properties, and food ingredients used in cosmetics, are evolving rapidly. As consumer demand steadily rises, the functional food sector stands poised for rapid development.

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.

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 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.

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.