ZMUni Compliance Centre

On April 3rd, 2024, the China National Institutes for Food and Drug Control (NIFDC) issued two announcements, further clarifying matters related to changes in special cosmetics. Q1: How do we apply for changes when there are alterations in the suppliers of ingredients used in special cosmetics?   According to the requirements of the "Regulations on the Management of Registration and Filing Materials for Cosmetics"(hereinafter refer as Regulations), applicants of registered or filed products should update and maintain the commodity name, manufacturer information, submission code, and safety information attachments of the ingredients through the registration and filing information platform if there are

China Food Regulatory Updates   On March 1, 2024, China National Center for Food Safety Risk Assessment (CFSA) solicited public comments on the following three new food ingredients: Maritime pinebark extract; Bifidobacteriumlongumsubsp. infantis M-63; N-acetylglucosamine (edible glutamate rod Bacillus RDG-2110 (Corynebacterium glutamicum RDG-2110). The deadline for public comments was set for April 1, 2024.   On March 4, 2024, China’s Two Sessions officially commenced. During the sessions, significant attention was drawn to various food-related topics, including functional labeling of food, medicinal food with the same source, encouragement of research on new varieties of green food additives, strengthening the development of the natural sweetener

China Cosmetic Regulatory Updates   | New Cosmetics Ingredients   In March 2024, a total of 7 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 明胶交联聚合物 (Gelatin Crosslinked Polymer) 20240017 华诺生物 南方红豆杉籽油（TAXUSWALLICHIANAMAIREI Seed Oil） 20240018 贝泰妮生物 南方红豆杉嫩枝提取物（TAXUSWALLICHIANAMAIREI Twig Extract） 20240019 贝泰妮生物 补骨脂酚 （Bakuchiol) 20240020 粤微生物 刺云实胶（Caesalpinia Apinosa Gum）/AMPS铵交联聚合(Ammonium Crosslinked Polymer) 20240021 科莱恩 聚丙烯酸酯交联聚合物-11（Polyacrylate crosslinked polymer -11） 20240022 科莱恩 山梨醇聚醚-230 五硬脂酸酯(Polysorbate-230 Pentastearate) 20240023 苹果化学 The technical requirements for the 7 new cosmetic ingredients mentioned above have not been disclosed, and they have not yet entered

On March 26, 2024, China’s State Administration for Market Regulation (SAMR) issued an Announcement on “Encouraging Food Enterprises to Optimize the Labeling of Production Dates and Shelf Life for Pre-packaged Food Products”, aiming to help consumers to clearly identify the label of pre-packaged food (including food additives). The announcement is outlined as follows:   1. The main display area of the primary packaging of pre-packaged food products shall prominently label the production date and shelf life of the pre-packaged food. For multi-layered packaging, the production date and shelf life of the pre-packaged food shall be labeled on the outermost layer 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