China CFSA is Collecting Public Comments on 8 New Food Additives including Rebaudioside M and 2’-FL
On October 26, 2023, China National Center for Food Safety Risk Assessment (CFSA) issued 8 new food additives for public comments, including 1 new food additive, 2 new food enzymes, 1 new food nutrition enhancer and 4 food additives with expanded scope. The deadline for public comments is November 21, 2023.
EU Newly Approved Two HMOs, 3-FL and 6’-SL, as Novel Food
European Union (EU) has maintained a relatively stable trend of food substance approvals in Q2 over recent years, while the approval of food substances in Q1 and Q4 experience notable fluctuations. In contrast, Q3 has seen only one approval in 2021 and 2022, and none this year.
While Q4 just started, it has seen two newly approved HMO substances, 3-FL and 6'-SL, both of which are of microbial origin.
Capsule-Type Common Food Imports Permitted in China
For a long time, there has been ambiguity regarding whether capsule forms are allowed for common food. The industry generally holds the view that capsules are commonly seen in health and pharmaceutical products, yet not suitable for common food. Consequently, few capsule-type common food products have been imported into China through general trade. It is anticipated that more of these products will enter the Chinese market following this notice.
Latest Compliance Advances of Human Milk Oligosaccharides (HMOs) in China
Human Milk Oligosaccharides (HMOs) stand as a vital category of naturally occurring nutrients found in breast milk. Currently, there are over 200 known structures of HMOs, with 6 types being extensively researched, of which the nutritional necessity and safety have gained broad international recognition.
Notably, in China, there’s widespread attention on four compliant HMOs: 2’-fucosyllactose (2’-FL), lacto-N-neotetraose (LNnT), 6’-sialyllactose sodium salt (6’-SL), and 3’-sialyllactose sodium salt (3’-SL).
China Health Food Registration and Filing
In China health food is usually defined as food product that have specific health function or supply vitamins and (or) minerals. With the goal of regulating body's function, health food is suitable for specific groups of people. However, it is not used for the purpose of curing disease and causes no acute, sub-acute or chronic health effect to human body. The Definitions/Names of these Food Products in Different Countries are Different: China: Health Food EU: Food Supplement
China Approves New Food Raw Materials, Additives, and Food-Related Products
On October 7, the National Health Commission of the People’s Republic of China (NHC) issued an announcement (No. 8 of 2023) on the approval of 15 “Three New Foods”, including four new food raw materials, six new food additives, and five food-related products.
China's NHC Released New Standard for Food Contact Ink and 16 Other FCM National Standards
On September 25, 2023, the National Health Commission (NHC) released announcement No. 6, 2023 regarding 85 national food safety standards, including National Food Safety Standard - Tea (GB 31608-2023), along with three modification documents.
Among these standards, 17 are related to food contact materials, including five for food contact materials products standards, two general principles, and ten inspection methods. Of particular importance is the introduction of a new food contact ink standard. Additionally, revisions have been made to existing standards pertaining to food-contact plastics, metals, rubber, and composite materials. These updates further clarify the management principles and requirements and the approved use of fundamental materials, aiming to bolster food safety, ensure consumers’ well-being, and address practical industry concerns.
The Number of FSMP Product Registrations in 2023 is Growing Rapidly – Bringing the Total to 140 Approved Products
According to the information recently released by the State Administration for Market Regulation (SAMR), the number of foods for special medical purposes (FSMP) products approved in China has reached 140.
Companies must register FSMP products with the SAMR, and it is applicable to both foreign and domestic products sold in China. As of September 20, 46 new FSMP Products have been approved for use in 2023, covering 23 nutritionally complete foods, 18 nutritionally incomplete foods, and five infant formulas for special medical purposes.
China Directory of Health Food Functions is Expected to be Expanded
On August 28, 2023, the State Administration for Market Regulation (SAMR) issued the Detailed Rules for Technical Evaluation of New Functions and Products of Health Food (Trial) (hereinafter referred to as the Detailed Rules), which takes effect on the day of publication.
The Detailed Rules serve as the supplementary document of the Administrative Measures on Health Food Raw Materials Directory and Function Directory, providing more comprehensive requirements for the application of health food new functions and products. Enterprises can now refer to the Detailed Rules for a clear understanding of the application processes, dossier, and testing requirements. This marks a significant shift where health functions will no longer be confined to the current 24 functions outlined in the Directory of Health Functions Available to Be Claimed for Health Food – Non-nutrition Supplements (2023 Version), and a broader range of new health functions are expected to be included in the Directory of Health Food Functions.
DEHCH Added to Authorized Substances List for Food Contact Plastic Materials
On August 11, 2023, the European Commission released the Commission Regulation (EU) 2023/1627, amending Annex I to Regulation (EU) No 10/2011 by adding bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (FCM No 1079) into the authorized substance list for food contact plastic materials.
SAMR Health Food (Dietary Supplement) Registration/Filing in China
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NHC New Food Raw Material Registration in China
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NHC New Food Additive Registration in China
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SAMR Infant Formula Milk Powder Registration
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Label Translation and Review of Pre-packaged General Food
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New Food Contact Substance Registration in China
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SAMR Health Food (Dietary Supplement) Registration/Filing in China
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NHC New Food Raw Material Registration in China
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NHC New Food Additive Registration in China
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SAMR Infant Formula Milk Powder Registration
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Label Translation and Review of Pre-packaged General Food
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New Food Contact Substance Registration in China
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