ZMUni Compliance Centre

China Cosmetic Regulatory Updates   | New Cosmetics Ingredients   In April 2024, six 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 青稞籽提取物 （HORDEUM VULGARE VAR. COELESTE EXTRACT） 20240024 东方淼森 杜香叶油 (Ledum Palustre Leaf Oil) 20240025 大兴安岭林下 环六肽-9 (Cyclohexapeptide-9) 20240026 上海中翊 甲基苯并噻唑偶氮甲苯胺双-（三乙氧基硅丙基氨基甲酰基PEG-5/PPG-5乙醇） 20240027 莹特丽 双-(苯基偶氮甲苯胺双-(三乙氧基硅丙基氨基甲酰基PEG-5/PPG-5乙醇)砜 20240028 莹特丽 驴乳粉 (Donkey Milk Powder) 20240029 桑阳生物 The technical requirements for the six new cosmetic ingredients mentioned above have not been disclosed, and they have not yet entered the monitoring period.   | Regulations & Policies   On April 3,

On April 30, 2024, the China National Institutes for Food and Drug Control (NIFDC) issued 3 announcements containing a total of 7 technical documents and guiding principles, including: Regulation Official Link 1. Index of International Authoritative Institution Cosmetic Safety Assessment Data 2. Information on Ingredients Usage for Marketed Products https://www.nifdc.org.cn/nifdc/xxgk/ggtzh/tongzhi/202404301550481057159.html  3. Guidelines for Submission of Cosmetic Safety Assessment Data 4. Technical Guidance Principles for Identification and Assessment of Cosmetic Risk Substances https://www.nifdc.org.cn/nifdc/xxgk/ggtzh/tongzhi/202404301559401057174.html  5. Technical Guidelines for Application of Threshold of Toxicological Concern (TTC) Method 6. Technical Guidelines for Application of Read-across 7. Guidelines for Cosmetic Ingredient Data Usage https://www.nifdc.org.cn/nifdc/xxgk/ggtzh/tongzhi/202404301622051057215.html    By issuing these documents, China NIFDC aims to standardize the

On April 22, 2024, the China National Institutes for Food and Drug Control (NIFDC) issued Announcement No. 50 of 2024, extending the use of simplified version safety assessment reports for another year. Companies can submit simplified or full version safety assessment reports during this transition period. The announcement also includes 12 specific measures, mainly strengthening technical guidance, integrating ingredients data resources, innovating evaluation report management mechanisms, and promoting the construction of a safety assessment system.   ZMUni Compliance Centre has compiled the safety assessment regulations issued by the NIFDC in 2024 for your better reading:   Date Regulation (Draft) Remark March 19, 2024 Technical Guidelines

On April 22, 2024, the China National Medical Products Administration released an Announcement on Implementing Several Measures to Optimize Cosmetic Safety Assessment Management (hereinafter referred to as the Announcement). The Announcement takes effect from May l, 2024.   The critical points of the Announcement and its associated attachment, Several Measures to Optimize Cosmetic Safety Assessment Management (referred to as the Measures), which include 12 specific measures, are summarized as follows:   1. Extended Use of Simplified Version of Cosmetic Safety Assessment Reports (or CPSR)  Until May 1, 2025, when applying for registration or filing, cosmetics registrants and filers can still submit simplified safety assessment reports

On April 19, 2024, the China National Center for ADR Monitoring released the Cosmetics Adverse Reactions Collection and Reporting Guidelines for Registrants and Filers (Trial)(hereinafter referred to as Guidelines), giving the cosmetic registrants and filers a further guide and standardization of the collection and reporting of adverse reactions.   The main content of the Guidelines includes:   - Collection of cosmetic adverse reactions   - Recording and transmission of cosmetic adverse reactions - Confirmation of reports on cosmetic adverse reactions - Analysis and evaluation of cosmetic adverse reactions - Submission of reports on cosmetic adverse reactions - Quality control of reports on cosmetic adverse reactions - Management

Since the release and implementation of the Technical Guidelines for Children's Cosmetics (hereinafter as Guidelines) on August 31, 2023, official statistics as of April 7, 2024, show that only 22 children's sunscreen products have successfully passed registration. The distribution of these products by type is as follows:   Type Number Chemical + Physical Sunscreen 2  Chemical Sunscreen 5  Physical Sunscreen 15 ZMUni Compliance Centre makes a summary of key points to note in the registration process of children's sunscreen cosmetics for your reading:   Requirements for Formula   The Guidelines stipulates that the formula of children's sunscreen should not use ingredients whose safety is not yet

On December 1, 2023, the Measures for Toothpaste Supervision and Administration(hereinafter referred to as the Measures) officially came into effect in China, stipulating that toothpaste shall be subject to filing in accordance with provisions regarding general cosmetics in the Cosmetic Supervision and Administration Regulation(CSAR).   ZMUni Compliance Centre has made this Export Compliance Guideline to provide manufacturers and stakeholders a glimpse into the regulatory framework and critical requirements.    Main Content Part I Related Regulations Part II Regulatory Requirements     1. Definition     2. Requirements of Filing     3. Requirements of Namin     4. Requirements of Labeling     5. Requirements of New Ingredient Use

China has issued several regulations and technical guidelines to implement strict management of children's cosmetics, aiming to safeguard the well-being of young consumers.   ZMUni Compliance Centre has made this Export Compliance Guideline to provide manufacturers and stakeholders a glimpse into the regulatory framework and critical requirements.   Main Content 1. Definition 2. Related Regulations 3. Regulatory Requirements Formula Design Executive Standard Labeling and Packaging Safety Assessment 4. Cosmetic Registration/Filing Process in China 1. Definition Children's cosmetics in China refer to cosmetics for children aged 12 and under and have the functions of cleansing, moisturizing, body refreshing, sunscreen, etc. Products labeled "applicable to the whole population,"