ZMUni Compliance Centre

Regulation Focus 1. Last week, the China National Medical Products Administration (NMPA) approved 2 new cosmetic ingredients for filing. The specific information is as follows: Name NO. by Intend Use Note Bakuchiol 20230048 Sytheon Corporation Hair conditioner, moisturizer, antioxidant, and exfoliant. Usage range has been expanded to include the face, in addition to the eyes, hands, neck, and lips. Additionally, the expiration period has been extended from 4 years to 5 years.   Phosphatidylserine 20230049 Nanjing Ascend Skin protectant, hair conditioning agent, emulsion stabilizer, and emulsifier. Recommended maximum usage amount is 5% So far a total of 97 new cosmetic ingredients have passed

Regulation Focus 1. On November 6th, China GAC issued Announcement No. 160 of 2023 regarding the inspection and quarantine requirements for imported aquaculture products from Chile. http://www.customs.gov.cn/customs/302249/2480148/5472192/index.html  2. On November 7th, China CFSA publicly solicited comments on the draft of the National Food Safety Standard for Food Flavors (GB 29938). https://www.zmuni.com/en/news/china-amends-gb-29938-national-food-safety-standard-food-flavors  3. On November 8th, China SAMR issued a public announcement soliciting opinions on the draft of the General Principles for the Examination of Food Business Licenses. https://www.samr.gov.cn/hd/zjdc/art/2023/art_c022ebbaec1a47b3958a9c7a4da8c841.html    Market focus 1. The 2023 FHC (https://www.fhcchina.com) concluded last week in Shanghai, attracting 2,500 exhibitors from 30 countries and regions, including Italy, Denmark, Japan,

Regulation Focus 1. In October 2023, the China National Medical Products Administration (NMPA) approved 2 new cosmetic ingredients for filing. The specific information is as follows: Name NO. by Intend Use Maximum Allowable Concentration AMINOLEVULINIC ACID HCl 20230046 Huaxi Biotech Hair conditioner, moisturizer, antioxidant, and exfoliant. Residual body cosmetics ≤ 0.008% Residual facial cosmetics ≤ 0.039% Rinse-off body cosmetics ≤ 0.321% Rinse-off hair cosmetics ≤ 0.574% SORBETH-230 TETRAOLEATE 20230047 Applechem Thickening agent, emulsifier ≤10% So far a total of 92 new cosmetic ingredients have passed the filing system in China. Official source: https://www.nmpa.gov.cn/datasearch/home-index.html#category=hzp    ​ 2. On November 13, 2023, China NMPA issued

Today(2023/11/10), China NMPA issued a notice regarding the encouragement of innovation and standardized management of new cosmetic ingredients. The key points include: 1. Encouraging the development of new cosmetic ingredients by combining traditional Chinese advantages and unique plant resources, and supporting the use of modern scientific and technological research and innovation in cosmetic ingredient development. 2. After the filing of new ingredients and their association with cosmetic products on the cosmetic registration and filing information service platform, NMPA shall organize technical verification of the registered ingredients. If necessary, on-site inspections and extended examinations may be conducted. 3. NMPA will further

On November 7th, the National Food Safety Risk Assessment Center issued a public consultation on the draft of the National Food Safety Standard for Food Flavors. Compared to the current standard GB 29938-2020 "General Principles for the Use of Food Flavors," the new version (draft for consultation) has the following main changes: 1. Appendix D, "Requirements for the Content of Synthetic Flavors for Food Use," has been modified to "Technical Requirements for Synthetic Flavors for Food Use." The changes include: a) Addition of three flavor varieties and their quality specifications: L-arabinose, hardwood smoke flavor SEF 7525, hardwood smoke flavor SmokEz

China Food Regulatory Updates Health Food 1. The product formulation and technical requirements for registration of health food ingredients, including isolated soybean protein and whey protein, came into effect from October 1, 2023. Later on October 7, 2023, China SAMR announced the interpretation documents for this regulation. Official source: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2023/art_3cc06f4f2a7f4ef298a3a73f31f5bcff.html  https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2023/art_09e1734bf158458b989cbfca93327ab0.html  2. On October 7, 2023, China SAMR released an interpretation document for the Health Food Ingredient Catalog of Nutrient Supplements (2023 Edition), which provides detailed requirements for the use of materials and product names for casein phosphopeptides + calcium and DHA algal oil. Official source: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2023/art_495b72b3f82c47b3a3c54b7ecb5b2f2d.html  3. On October 17, 2023,

China Cosmetics Regulatory Updates New Cosmetics Ingredients In October 2023, the China National Medical Products Administration (NMPA) approved a total of 8 new cosmetic ingredients for filing. The specific information is as follows: Urolithin A (INCI name: Urolithin A): Submitted by Amazentis SA, a Swiss company. The intended use of this ingredient is as an anti-wrinkle agent for skincare cosmetics, excluding spray products. The maximum allowable concentration when used in cosmetics is: a maximum of 1% in the formulation, with a minimum effective amount of 0.50%. Cestrum Latifolium Leaf Extract (INCI name: Cestrum Latifolium Leaf Extract): Submitted by BASF (China) Co., Ltd. The intended

Heath Food 1. on August 31, 2023, China State Administration for Market Regulation (SAMR) finally published the Directory of Health Functions Allowed for Non-Nutrient Supplements Health Food Claims (2023 Version) and the supporting documents, including: Technical Guidelines for Functional Testing and Evaluation of Health Food (2023 Version); Testing and Evaluation Methods for Health Food Functions (2023 Version); Guiding Principles for the Ethical Review of Health Human Feeding Trials (2023 Version) Official announcement in Chinese: 市场监管总局 国家卫生健康委 国家中医药局关于发布《允许保健食品声称的保健功能目录 非营养素补充剂（2023年版）》及配套文件的公告 2. On August 31, 2023, China SAMR issued a reply to the proposal on the inclusion of red ginseng in the national health food raw material catalog.  Official announcement in Chinese: