ZMUni Compliance Centre

     On October 11, 2024, the State Administration for Market Regulation (SAMR) of China issued a public notice seeking comments on two draft documents: the 2024 Edition of the Dosage Forms and Technical Requirements for Health Food Filing (Draft) and the 2024 Edition of the List of Auxiliary Materials for Health Food Filing and Terms of Use (Draft). Comments can be submitted via the official website (http://www.samr.gov.cn), email (bjspba@cfe-samr.org.cn), or mail, with a deadline of November 11, 2024.   The 2024 Edition Drafts supplements new dosage forms for nutrient supplement health food filings, expanding options to include candy, beverages, chocolate, jelly, and powders—formats that are

      On October 8, 2024, the National Health Commission (NHC) launched a public consultation for 19 national food safety standards. The draft standards cover six related to food additives, one for contaminants, one product standard, and eleven testing standards. Comments can be submitted through the online system until October 18, 2024.   The 19 standards are as follows:   No. Standard Revision/Formulation 6 Standards for Food Additives 1.  General Rules for Flavorings Revision 2.  Food Additive Erythritol Revision 3.  Food Additive Sodium Alga Acid (Also known as Sodium Alginate) Revision 4.  Amendment Sheet Standards for Six Colorants, including Brilliant

This article focuses on summarizing the regulatory developments related to food within China and internationally in September 2024, with an emphasis on updates in regulations concerning new food ingredients, food additives, feed additives, and special foods.   China Food Regulatory Updates   1. New Food Ingredients & Food Additives   On September 13, 2024, China's National Center for Food Safety Risk Assessment  (CFSA), under the National Health Commission, issued a notice regarding the improvement of safety evaluation data requirements for "three new foods (new food additive, food ingredients, and food contact materials)." The release of this new regulation signifies a comprehensive opening for

  China Cosmetic Regulatory Updates    | New Cosmetics Ingredients (NCI) Notification in China   In September 2024, 6 new cosmetic ingredients were filed with the China National Medical Products Administration (NMPA). They include: Notification No. Ingredient Name in CN & EN Notifier in CN 20240065 吡咯并喹啉醌二钠盐 (Pyrroloquinoline Quinone Disodium Salt) 润辉生物技术 20240066 3,4-二羟基苯乙醇 (Hydroxytyrosol) 上海华茂药业 20240067 金露梅（DASIPHORA FRUTICOSA）提取物 (Dasiphora Fruticosa Extract) 贝泰妮 20240068 β-烟酰胺单核苷酸 (Nicotinamide Mononucleotide) 邦泰生物 20240069 L-高丝氨酸 (L-Homoserine) 盛德百泰生物 20240070 麦芽糖酸 (Maltobionic Acid) 上海克琴    The technical requirements for the 6 NCI mentioned above have not been disclosed, and they have not yet entered the monitoring period.   In

  On August 26, 2024, the National Center for Food Safety Risk Assessment of China released a collections of FAQs, addressing common questions about "Three New Foods" and food-drug substances. The collection highlighted key issues related to 25 new food ingredients, new varieties of food additives, and food-drug substances.   ZMUni Compliance Centre has selected a few typical issues from the collection to share here, aiming to assist international stakeholders looking to enter the Chinese market.   Q1: What are "Three New Foods" and How Does China Manage Them?   A: As defined in Article 37 of the Food Safety Law, "Three New Foods" includes:   Category

  On September 13, 2024, China's National Center for Food Safety Risk Assessment, under the National Health Commission, issued a notice regarding the improvement of safety evaluation data requirements for "three new foods (new food additive, food ingredients, and food contact materials)." The release of this new regulation signifies a comprehensive opening for the application of synthetic biology new materials in the food sector! Table 1. Compliance Pathways for Genetically Modified Microorganisms(GMM) in the Food Sector Type Approval Year Approval Authority  Genetically Modified Microbial Enzymes 2017 Ministry of Agriculture and Rural Affairs is responsible for safety assessment; The National Health Commission oversees product

  This article focuses on summarizing the regulatory developments related to food within China and internationally in August 2024, with an emphasis on updates in regulations concerning new food ingredients, food additives, feed additives and special foods.    China Food Regulatory Updates    | New Food Ingredients & Food Additives   On August 5, 2024, China's National Health Commission (NHC) announced the approval of three new food ingredients (Arabinoxylan, Bifidobacterium longum subsp. infantis M-63, N-acetylglucosamine) and four new varieties of food additives (Hydroxytyrosol, Methylene chloride, 2'-fucosyllactose, Polyglycerol polyricinoleate (PGPR).   On August 26, 2024, the National Center for Food Safety Risk Assessment (CFSA) released an

  China Cosmetic Regulatory Updates   | New Cosmetics Ingredients (NCI) Notification   In August 2024, 9 new cosmetic ingredients were filed with the China National Medical Products Administration (NMPA). They include: Ingredient Name in CN & EN Notification No. Filer in CN 吡咯并喹啉醌二钠盐 （Pyrroloquinoline Quinone Disodium Salt，PQQ） 20240056 湖北美琪 紫檀芪 (Pterocarpus Marsupium Bark Extract) 20240057 广州青囊 β-烟酰胺单核苷酸 (Nicotinamide Mononucleotide) 20240058 植恩生物 乙酰姜黄酮 (Acetyl Zingerone) 20240059 敷尔佳 裂褶菌（SCHIZOPHYLLUM COMMUNE）发酵产物滤液 (Schizophyllum Commune(Mushroom) Ferment Filtrate) 20240060 丸美生物 sr-贻贝寡肽-1 (sr-Mussel Oligopeptide-1) 20240061 深圳柏垠 氧化白藜芦醇 (Oxyresveratrol) 20240062 溪木源 岷江蓝雪花（CERATOSTIGMA WILLMOTTIANUM）提取物 (Ceratostigma Willmottianum Flower Extract) 20240063 贝泰妮 黄蜀葵（ABELMOSCHUS MANIHOT）花提取物 (Abelmoschus Manihot Flower Extract) 20240064 康恩贝   The technical requirements