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

According to the US Federal Food, Drug, and Cosmetic Act (FD&C Act), all businesses involved in the production, processing, packaging, or storage of food (including food additives and dietary supplements) – collectively referred to as food facilities – must complete registration with the US Food and Drug Administration (FDA). These businesses are also required to update their registration every even-numbered year between October 1 and December 31 and ensure that the FDA is permitted to conduct facility inspections within the scope allowed by the FD&C Act.

As of now, China has officially approved four thickening component formulas for special medical purposes designed for individuals over 10 years old with swallowing difficulties and/or aspiration risks, all of which were approved in the past two years. All four products are domestically produced and are in powdered form. Each of the following companies – Jilin Maifu, Hebei Aisheng, Shandong Ruoyao, and Jiangsu Daisy FSMP – has had one formula approved.

On September 2, 2024, the China National Center for Food Safety Risk Assessment (CFSA) issued a call for public comment on six new food-related products: four food contact additives with expanded scope, one new food contact resin, and one food contact resin with expanded scope. Comments are welcome until October 2, 2024. The details are as follows:

Recently, China’s National Center for Food Safety Risk Assessment (CFSA) issued a set of FAQs on “three new foods” and substances traditionally used as both food and traditional Chinese medicine (TCM), covering a total of 25 questions. In this article, CIRS Group compiles common regulatory issues concerning “three new foods” and substances traditionally used as both food and TCM.

On August 26, 2024, China’s National Center for Food Safety Risk Assessment (CFSA) issued a set of FAQs on “three new foods” and substances traditionally used as both food and traditional Chinese medicine (TCM), covering a total of 25 questions. In this article, CIRS Group summarizes the key issues regarding the use of various food ingredients, including food extracts, red ginseng, Ganoderma spore powder, and protein hydrolysates, that are of concern to businesses.

On August 26, 2024, China’s National Health Commission (NHC) and the State Administration for Market Regulation (SAMR) jointly issued Announcement No. 4 of 2024, adding four substances—Rehmannia glutinosa Libosch., Ophiopogon japonicus (L.f) Ker-Gawl., Asparagus cochinchinensis (Lour.) Merr., and Citri grandis exocarpium—to the list of substances traditionally used as both food and traditional Chinese medicine (TCM).

Hydroxytyrosol is a naturally occurring polyphenol primarily found in olives and their products, such as olive oil and olive leaves. It is widely studied for its outstanding antioxidant properties and has numerous applications in the food and cosmetic industries. As a powerful antioxidant, hydroxytyrosol helps reduce oxidation in foods, extending shelf life and preserving flavor. Due to its health benefits, hydroxytyrosol is often added to health foods to support cardiovascular health, boost immunity, and reduce inflammation.

On August 5, 2024, China’s National Health Commission (NHC) issued Announcement No. 3 of 2024, officially approving eight “three new foods.” Among them is hydroxytyrosol, a new food additive for which CIRS Group assisted a client in the synthetic biology field in securing approval.

According to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, in the second quarter of 2024, the EFSA published assessment results for three Novel Foods (NF), including one new NF application, modification of one already authorized NF, and notification on one new traditional food from a third country. In addition, the EU approved nine NF in the second quarter of 2024, including amendments to the specifications and conditions of use of three already authorized NF.