ZMUni Compliance Centre

Q1: What technical requirements should be considered when using New Cosmetic Ingredients(NCI) to produce cosmetics? When using NCI for cosmetics production circulated in China, attention should be paid to the technical requirements outlined in the publicly disclosed registration and filing information regarding "Technical Requirements for New Cosmetic Ingredients". These requirements include the safe usage amount of the ingredient (maximum allowable concentration when used in cosmetics), the purpose of usage, suitability and scope of the ingredient, as well as other limitations, requirements, and cautionary statements. Additionally, if an NCI is ordered to be temporarily suspended from use during the safety monitoring period, the registrant or filer of

China's cosmetic authority NMPA issued two notifications on March 21, 2024, regarding safety technical specifications for cosmetics. 1. Notification No. 12 of 2024 includes the incorporation of 19 cosmetic testing items into the "Safety Technical Specification for Cosmetics (2015 Edition)."  11 newly added testing methods include: General principles for sample pre-treatment in cosmetic toxicology tests. Acute inhalation toxicity test methods. Acute inhalation toxicity test acute toxicity classification. Test method for measuring reactive oxygen species (ROS) in photo-reactivity. Test method for U937 cell activation in vitro skin sensitization. Test method for in vitro skin absorption. Test method for 28-day repeated oral dose

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

On March 5, Premier Li Keqiang presented the government work report at the 14th National People's Congress. China's GDP in 2023 exceeded 126 trillion yuan, with a 5.2% growth rate, placing it among the world's top economies. Consumer prices rose by 0.2%. The anticipated targets for China's development in 2024 include a GDP growth rate of around 5%, consumer price inflation rate of around 3%, and synchronized growth in household income and the economy.   The government report also emphasized the development of new productive forces, the silver economy, healthy consumption, and technological innovation.   During the Two Sessions, topics