ZMUni Compliance Centre

On April 30, 2024, the China State Administration for Market Regulation (SAMR) issued a regulation specifying the filing requirements for health food containing three ingredients: Ginseng, American Ginseng, and Lingzhi. The regulation stipulates five key aspects, including auxiliary materials usage, product dosage forms, product processing, product technical requirements, and others. It came into effect on May 1, 2024.   Prior to this, in December 2023, SAMR issued a relevant announcement, including Ginseng, American Ginseng, and Lingzhi in the Health Food Raw Materials Directory.   So far China has published several directories of health food ingredients eligible for the filing process:   Health Food Raw

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

On April 10, 2024, the National Institutes for Food and Drug Control (NIFDC) released a series of drafts, including:   Technical Guidelines for Cosmetic Stability Assessment； Technical Guidelines for Preservative Effectiveness Testing of Cosmetics； Technical Guidelines for Compatibility Assessment of Cosmetic Packaging Materials； Technical Guidelines for Application of Skin Sensitization Integrated Testing and Assessment Strategies ； Index of Authoritative Institution Cosmetic Safety Assessment Data ； Information on Cosmetic Ingredient Usage.   By issuing these drafts, China NIFDC aims to standardize the cosmetic safety assessment process and promote the orderly implementation of the cosmetic safety assessment system. The draft is now seeking

On April 3, 2024, the National Institutes for Food and Drug Control (NIFDC) issued a draft of Guidelines for the Use of Cosmetic Ingredient Date, aiming to standardize the process of cosmetic safety assessments and promote the orderly implementation of the cosmetic safety assessment system. The draft is now seeking public comments until April 10, 2024. The Guidelines specifies the main types of ingredient information that can be used in cosmetics safety assessments and defines the information usage requirements by cosmetic registrants and filers in conducting safety assessments, as well as the supporting documentation that should be provided: No. Category 1

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