ZMUni Compliance Centre

Today (Tuesday, March 19, 2024), China's National Institutes for Food and Drug Control (NIFDC) unveils two draft technical guidelines for cosmetic safety assessment. The first set of guidelines focuses on the application of the Threshold of Toxicological Concern (TTC) method in cosmetic safety assessment.   It covers various aspects, including an overview, scope, terminology, substance classification, assessment procedures, and mixtures. Additionally, it includes three appendices: Appendix 1 presents a flowchart illustrating the application of TTC in cosmetic safety assessment Appendix 2 and Appendix 3 provide examples of applying the TTC method in safety assessments of cosmetic ingredients, specifically chemical substances

As the May 1st deadline approaches, there seems to be a turning point for the complete version of the Cosmetic Product Safety Report (CPSR) in China.   Recently, the Chinese regulatory authorities released a draft of "Several Measures for Optimizing the Safety Assessment of Cosmetics" for public consultation. Here are the key points ZMUni Compliance Centre compiled:   1. Transition Period Clarification Cosmetics that have undergone safety assessments before May 1, 2024, can submit simplified CPSR when applying for registration or filing before November 1, 2024. Starting from November 1, 2024, the maximum historical usage volume will no longer be

On March 13, 2024, the National Health Commission of China announced the approval of 6 new food ingredients and 7 new varieties of food additives.   The 6 newly approved food ingredients are: 石斛原球茎（Dendrobium protocorm） (3R,3'S)-二羟基-β-胡萝卜素（Meso-zeaxanthin） 克鲁维毕赤酵母（Pichia kluyveri） 枯草芽孢杆菌 DE111（Bacillus subtilis DE111） α-甘磷酸胆碱 （L-alpha-Glycerylphosphorylcholine） 假肠膜明串珠菌（Leuconostoc pseudomesenteroides）   The 7 newly approved varieties of food additives are: Type Name Source Antioxidants 混合三烯生育酚浓缩物Mixed tocotrienol tocopherol concentrate / Sweeteners 甜菊糖苷（酶转化法）Enzymatically produced steviol glycosides / Enzyme preparations D-阿洛酮糖-3-差向异构酶 D-psicose 3-epimerase Bacillus subtilis   环糊精葡萄糖苷转移酶Cyclomaltodextin glucanotransferase AnoxybacillusCaldiproteolyticus 纤维素酶 Cellulase Penicillium oxalicum Nutrient fortifiers 2’-岩藻糖基乳糖 2’-fucosyllactose Escherichia coli BL21(DE3) d-核糖d-ribose /   Additionally, information on 5 food additives

On March 12, 2024, the National Health Commission of China released 47 new national food safety standards, including the GB 2760-2024 National Food Safety Standard for Uses of Food Additives. The 2024 version of GB 2760 will be officially implemented on February 8, 2025.   Key Changes Summarized by ZMUni Compliance Centre:   GB 2760-2024 incorporates the food additive varieties and usage regulations that have been approved by the National Health Commission through public announcements since the implementation of GB 2760-2014, up to the 5th announcement of the National Health Commission in 2023.   GB 2760-2024 adds the inclusion of

China Food Regulatory Updates On February 8th, the State Administration for Market Regulation (SAMR) drafted the "Technical Requirements for Filing Health Food Ingredients Ginseng, American Ginseng, and Reishi (Draft for Comments)" and is now soliciting public opinions.   On February 26th, 2024, the National Technical Committee on Special Dietary Foods of the Standardization Administration of China (SAC/TC466) released 12 draft national standards for testing methods of health food for public comments. See previous report.   On February 26th, the General Administration of Customs of China revoked the registration of the United States-based beverage production company JERRY&SONS PHARMACEUTICAL INC (registration number in

China Cosmetic Regulatory Updates New Cosmetics Ingredients In February 2024, a total of 4 new cosmetic ingredients were filed with the China National Medical Products Administration (NMPA). They include:   Ingredient Name in CN & EN Filing No. Filer in CN β-烟酰胺单核苷酸（β-Nicotinamide adenine dinucleotide） 20240013 华熙生物 双-1,4（三乙氧基硅丙基氨基甲酰基聚（己二酸乙二醇酯）丙胺基）蒽醌 （Bis-1,4-(triethoxy silylpropyl)aminoformylpoly(hexanedioic acid ethylene glycol ester)anthraquinone） 20240014 莹特丽 两色金鸡菊（Coreopsis tinctoria） 20240015 护家科技 三（聚甘油-3/月桂基）氢化三聚亚油酸酯 （Triglyceride of trihydroxystearin and lauric acid, polyglycerin-3） 20240016 禾大化学品   Additionally, the previously filed new ingredient "Asciquorp" by Amorepacific Corporation has been canceled as of February 1st, making it the first ingredient to be canceled. The reason for the cancellation has not

On February 26, 2024, the National Technical Committee on Special Dietary Foods of the Standardization Administration of China (SAC/TC466) released 12 draft national standards for testing methods of health food for public comments. These 12 standards include: Determination of puerarin in health foods Determination of coenzyme Q10 in health foods Determination of pantothenic acid in health foods Determination of Melatonin in health foods Determination of thiamine, riboflavin, pyridoxine, niacin, niacinamide and caffeine in health foods Determination of dehydroepiandrosterone in health foods Determination of lycopene in health foods Determination of icariin in health foods Determination of chlorogenic acid in health foods

China Food Regulatory Updates   On January 9, 2024, the State Administration for Market Regulation (SAMR) drafted the "Administrative Measures for Supervision and Administration of Delegated Production of Food (Draft for Comments)" and is now soliciting public opinions.   On January 9, 2024, the Ministry of Industry and Information Technology of the People's Republic of China publicly solicited opinions on the proposed amendment to the Mandatory National Standard No. 2, "Restrictive Packaging Requirements for Food and Cosmetics."   On January 12, 2024, the Ministry of Agriculture and Rural Affairs of the People's Republic of China issued Announcement No. 744, approving methylococcus