ZMUni Compliance Centre

Highlight: amino acids in foods for special dietary uses, food safety standard for food flavors, registration of food for special medical purposes, infant formula liquid milk 1. On November 1, 2023, the State Administration for Market (SAMR) of China issued the "Guidelines for the Examination of Production Licenses for Infant Formula Liquid Milk (Consultation Draft)". The draft guidelines focus on the characteristics of liquid infant formula products and provide provisions in several key areas. Firstly, there are strict requirements for raw materials and ingredients. Secondly, it specifies the production processes and dynamic control requirements for clean operation areas. Thirdly, there are

New Cosmetics Ingredients In November 2023, a total of 13 new cosmetic ingredients were filed with the China National Medical Products Administration (NMPA). They include: β-Nicotinamide Mononucleotide (20230044) 3,3,5-Trimethylcyclohexyl 2-hydroxypropanoate Dimethylamide (20230045) N-Acetylaminopropionic Acid HCl (20230046) Sorbitol Polyether-230 Tetraoleate (20230047) Phosphatidylserine (20230049) Oligo Isomaltose (20230050) Bis-Polypogostemonol Succinate (20230051) Bis-Polypogostemonol Sebacate (20230052) Polydimethylsiloxane Quaternary Ammonium Salt-16/Epoxpropoxy Polydimethylsiloxane Crosslinked Polymer (20230053) Phosphatidylcholine Polymer-MBH (20230054) Bakuchiol (20230048, 20230055) Sodium Lactate (20230056) Regulations & Policies On November 2, 2023, China NMPA released the "Determination of Chlorphenesin Acetate in Cosmetics," which is a supplementary test method for the qualitative and quantitative determination of chlorphenesin acetate

On November 28, 2023, the State Administration for Market Regulation of China issued the "Administrative Measures for the Registration of Food for Special Medical Purposes" (hereinafter referred to as the "Measures"), which will be implemented from January 1, 2024. The previous version was published on March 7, 2016, and has been simultaneously abolished. ​ The revised "Measures" consist of 7 chapters and 64 articles, covering application requirements, registration procedures, clinical trials, labeling and instructions, supervision and management, legal responsibilities, and other aspects. The main contents include: 1. Strict product registration and detailed management requirements. The Measures further emphasize the conditions, capabilities, legal responsibilities,

Regulation Focus 1. Last week, the China National Medical Products Administration (NMPA) assigned filing numbers to three new cosmetic ingredients. The specific details are as follows: Isomaltooligosaccharide Filing No.: 20230051 Provided by: P2 Science Intended Use: Moisturizer Notes: Applicable for various skincare cosmetics (excluding spray products); recommended maximum usage amount is 60%. Bis-Polycitronellyl Azelate Filing No.: 20230052 Provided by: P2 Science Intended Use: Hair conditioner, moisturizer Notes: Applicable for various haircare and skincare cosmetics (excluding spray products); recommended maximum usage amount is 50%. Silicone Quaternium-16/Glycidoxy Dimethicone Crosspolymer Filing No.: 20230053 Provided by: Dow Intended Use: Hair styling, hair conditioner Notes:

In April 2021, the China National Medical Products Administration (NMPA) issued the "Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)" (referred to as the "Guidelines" below), which officially came into effect on May 1, 2021. The requirements are as follows: Starting from January 1, 2022, when registering or filing cosmetics, the registrant or filer needs to submit safety assessment data for the products. Before May 1, 2024, for the registration of special cosmetics or the filing of general cosmetics, the registrant or filer needs to submit a simplified version of the Cosmetic Product Safety Report (CPSR) in accordance with the requirements

On November 22nd, the China National Medical Products Administration（NMPA) released the "Provisions on the Management of Toothpaste Filing Information." These provisions specify the requirements for the preparation of materials, user information, and inspection items for toothpaste filing. In addition, there are three attachments, including the formulation instructions for toothpaste product standards, toothpaste product standards (examples), and requirements for microbiological and physicochemical testing for toothpaste filing. These provisions will be implemented starting from December 1st, 2023. Similar to cosmetics, toothpaste filing also requires full ingredient labeling and toothpaste products need to undergo safety assessments (although the specific implementation time has not

The deadline for supplementing the safety information of cosmetic ingredients in China is approaching! 1. For cosmetics registered or filed before May 1, 2021, if the product formula contains ingredients that require quality specifications according to the "Cosmetic Safety Technical Specification," it is necessary to supplement the relevant documentation or safety information for those ingredients. The safety information for other ingredients in the product formula should be kept on file by the registrant or filer. Deadline for relevant supplementation: December 31, 2023. 2. For cosmetics registered or filed between May 1, 2021, and December 31, 2023, if the product formula

Regulation Focus 1.  On November 17th, 2023, China NHC (National Health Commission) approved the inclusion of nine substances, including Codonopsis pilosula, Cistanche deserticola, Dendrobium officinale, Panax quinquefolius, Astragalus membranaceus, Ganoderma lucidum, Fructus Corni, Gastrodia elata, and Eucommia ulmoides leaves, into the list of substances that are both foods and traditional Chinese medicine. Previously, these ingredients could only be used in health food products, but now they can also be used in ordinary foods, such as being added to hot pot dishes or beverages. http://www.nhc.gov.cn/sps/s7892/202311/f0d6ef3033b54333a882e3d009ff49bf.shtml    2. On November 13th,  the Food Evaluation Center of China SAMR released the Announcement Regarding the