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Lastest Update
Technical Guidelines for Determination and Research of New Cosmetic Ingredients (Draft for Comments)
Dec 13, 2023
EN
BackgroundSince the implementation of the Cosmetic Supervision and Administration Regulation (CSAR) in 2021, the China National Medical Product Administration (NMPA) has introduced a risk-based classification system for cosmetic products and NCIs. High-risk NCIs must undergo registration with the NMPA, while low-risk NCIs only need to be notified and can subsequently be manufactured and imported once enterprises complete the online dossier submission. This streamlined process reduces the market entry threshold for NCIs in China. However, challenges have arisen during the registration and notification process for NCIs. Some registrants and notifiers have encountered difficulties due to their incomplete understanding of the identification and categorization of NCIs as well as inadequate data preparation. Common mistakes include the unclear definitions of NCIs, NCIs’ functions exceeding the scope of cosmetic definitions, and the inaccurate determination of applicable situations for NCIs.To standardize and provide guidance for the determination and research of NCIs, the China National Institutes for Food and Drug Control (NIFDC) released the first draft of the Technical Guidelines for Determination of New Cosmetic Ingredients on January 19, 2023, to seek feedback from the public.Taking industry input into account, NIFDC released the second draft, which was renamed to Technical Guidelines for Determination and Research of New Cosmetic Ingredients (Guidelines) on December 1, 2023.The Guidelines is divided into four parts: overview, categorization, general requirements, and explanation of terms. Notifiers and registrants should utilize the Guidelines to assess whether an ingredient belongs to NCI, determine the appropriate NCI category, and conduct research in alignment with the provided requirements.
Chinese Mainland
Pre-market Approval
Ingredients
CSAR
New Ingredient Management
Enterprise Obligations
Regulations on Supervision and Administration of Enterprises in Implementing Entity Responsibility for Cosmetic Quality and Safety
Dec 08, 2022
EN
On November 29, 2022, China National Medical Products Administration (NMPA) launched a public consultation on the draft of Regulations on Supervision and Administration of Enterprises in Implementing Entity Responsibility for Cosmetic Quality and Safety (the Regulations). Consisting of 5 chapters and 33 articles, the draft Regulations specifies the responsibility entities of cosmetic's quality and safety, emphasizes the responsibilities of key positions related to cosmetic quality and safety, as well as clarifies the scope of personnel subject to penalties when certain misconduct happens, and the situations where penalties can be mitigated or exempted.
Chinese Mainland
CSAR
Enterprise Obligations
Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices
Nov 05, 2022
EN
In March 2022, China National Medical Products Administration (NMPA) released the draft Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (Points). Seven months after its release, on October 25, 2022, NMPA released the finalized version, which will take effect on December 1, 2022. Compared to the previous draft, the finalized Points adopts minor amendments. Following the framework set in the draft, it consists of 105 inspection points, and sets separate inspection items for manufacturing and entrusting enterprises. Besides, it introduces the judgment principles of cosmetics regulatory departments, offering enterprises guidance on complying with the Good Manufacturing Practices for Cosmetics.
Chinese Mainland
GMP
Enterprise Obligations
Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (Draft for Comments)
Apr 11, 2022
EN
On January 7, 2022, China NMPA issued the finalized Good Manufacturing Practices for Cosmetics and will implement it on July 1, 2022. Cosmetics registrants, notifiers, and entrusted production enterprises shall organize the cosmetic production in accordance with the Practices. Following that, on March 30, 2022, NMPA released the draft of Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (hereinafter referred to as “Points”) for public consultation. Regulatory authorities across China will use the Points as a basis to determine whether the enterprise complies with GMP. Any suggestions about the Points can be mailed to NMPA (hzpjgc@nmpa.gov.cn) before April 20, 2022.The Points is an upgraded version of Practice for Cosmetics Production Licensing implemented in 2016, with more stringent inspection requirements. The expected effective date of the Points is July 1, 2022, which is the same as that of Good Manufacturing Practices for Cosmetics.Main ContentsThere are a total of 106 articles in the Points, and separate inspection points are set for the manufacturing and entrusting enterprises.1. Applicable Scope2. Inspection Classification and Judgment Principles3. Other MattersAnnex I Inspection Points for Cosmetic Good Manufacturing Practices (For Manufacturing Enterprises)Annex II Inspection Points for Cosmetic Good Manufacturing Practices (For Entrusting Enterprises)
Chinese Mainland
Post-market Surveillance
GMP
CSAR
Enterprise Obligations
Good Manufacturing Practices for Cosmetics
Jan 14, 2022
EN
In September 2020 and 2021, China National Medical Products Administration (NMPA) released the first and the second draft of Good Manufacturing Practices for Cosmetics (hereinafter referred to as “Practices”). After two rounds of public consultation, on January 7, 2022, NMPA released the finalized Practices and will implement it on July 1, 2022.Starting from July 1, 2022, cosmetics registrants, notifiers, and entrusted production enterprises (including cosmetic enterprises that only engage in the preparation of semi-finished products, and toothpaste enterprises) shall organize the cosmetic production in accordance with the Practices. For enterprises that have obtained production licenses before July 1, 2022, if their facilities, equipment, etc., shall be upgraded according to the regulation, the upgrading and reconstruction shall be completed before July 1, 2023.Main ContentsThe Practices are divided into nine chapters with two annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall. The promulgation of the Practices indicates that cosmetics production in China will enter a more standardized era.Chapter I General RulesChapter II Institutions and PersonnelChapter III Quality Assurance and ControlChapter IV Plant Facilities and Equipment ManagementChapter V Materials and Products ManagementChapter VI Production ManagementChapter VII Entrusted Production ManagementChapter VIII Product Sales ManagementChapter IX Supplementary RulesAnnex I Electronic Record Requirements for Cosmetics ProductionAnnex II Environmental Requirements for Cosmetics Production Plant
Chinese Mainland
GMP
CSAR
Enterprise Obligations
Supervision and Administration Provisions on Children Cosmetics
Oct 19, 2021
EN
On Jun. 18, 2021, China NMPA issued the draft Supervision and Administration Provisions on Children Cosmetics. On Oct. 8, 2021, China NMPA promulgated the finalized version of Supervision and Administration Provisions on Children Cosmetics. Except for labeling requirements, other requirements in the finalized Provisions will come into force on Jan. 1, 2022.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related Resoucres[Featured Page] Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking[News]China to Implement the First Children Cosmetics Regulation in 2022China Consults on Supervision and Administration Provisions on Children Cosmetics: the Strictest Supervision EverInfant and Children Cosmetics Face Stricter Supervision in China[Cosmepedia]China Children Cosmetics RegulationChina Cosmetics Regulation
Chinese Mainland
Children Cosmetics
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
CSAR
Enterprise Obligations
Measures for the Management of Cosmetic Adverse Reaction Monitoring (Second Draft for Comments)
Oct 08, 2021
EN
On September 28, 2020, China NMPA issued the first draft of Measures for the Management of Cosmetic Adverse Reaction Monitoring. On September 29, 2021, China NMPA promulgated the second draft of Measures for the Management of Cosmetic Adverse Reaction Monitoring (the new Measures) for public comments until October 19. The new Measures includes a total of 7 chapters and 54 articles. Compared to the first draft released in 2020, the second draft is further modified and refined to add clarity and increase the logicality.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related Resoucres[Featured Page] Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking[News] China Starts a New Round of Consultation on Regulations for Cosmetic Adverse Reaction MonitoringChina NMPA Consults on the Second Draft of Good Manufacturing Practices for CosmeticsChina to Implement Supervision and Administration Measures on Cosmetics Manufacture and OperationChina Formally Implements A Brand-new Cosmetic and New Cosmetic Ingredients Pre-market Approval System on May 1China Implements Amended Cosmetic Prohibited Ingredient Inventories: 24 Newly Prohibited Ingredients Including Cannabidiol (CBD)China Releases the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021)Detailing China’s Requirements for Cosmetic Quality and Safety DirectorsChina Finalizes Requirements for Cosmetic LabelingChina Consults on Supervision and Administration Provisions on Children Cosmetics: the Strictest Supervision Ever[English Translation]Good Manufacturing Practices for CosmeticsSupervision and Administration Measures on Cosmetics Manufacture and OperationAdministrative Measures on Cosmetics LabelingTechnical Guidelines for Cosmetic Safety Assessment 2021Cosmetic Classification Rules and Catalogs
Chinese Mainland
Post-market Surveillance
CSAR
Enterprise Obligations
Good Manufacturing Practices for Cosmetics (Second Draft for Comments)
Sep 13, 2021
EN
On Sep. 28, 2020, China NMPA released the first draft of Good Manufacturing Practices (GMP) for Cosmetics. On Sep. 8, 2021, China NMPA consults on the second draft of Good Manufacturing Practices for Cosmetics (the Practices). The number of articles in the second draft is reduced from 77 to 64, and some standards are relaxed.Domestic cosmetic registrants, notifiers, and entrusted production enterprises should organize the cosmetics production in accordance with the requirements of the Good Manufacturing Practices for Cosmetics. The Practices are divided into 9 chapters and 2 annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall. As the second draft mentions that the regulation’s effective date is Jan. 1, 2022, it is expected that its finalized version will be issued before 2022.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related Resoucres[Featured Page] Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking[News] China NMPA Consults on the Second Draft of Good Manufacturing Practices for CosmeticsChina to Implement Supervision and Administration Measures on Cosmetics Manufacture and OperationChina Formally Implements A Brand-new Cosmetic and New Cosmetic Ingredients Pre-market Approval System on May 1China Implements Amended Cosmetic Prohibited Ingredient Inventories: 24 Newly Prohibited Ingredients Including Cannabidiol (CBD)China Releases the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021)Detailing China’s Requirements for Cosmetic Quality and Safety DirectorsChina Finalizes Requirements for Cosmetic LabelingChina Consults on Supervision and Administration Provisions on Children Cosmetics: the Strictest Supervision EverChina Publicizes the First Notification of a New Cosmetic Ingredient[English Translation]Supervision and Administration Measures on Cosmetics Manufacture and OperationAdministrative Measures on Cosmetics LabelingTechnical Guidelines for Cosmetic Safety Assessment 2021Cosmetic Classification Rules and Catalogs
Chinese Mainland
Pre-market Approval
GMP
CSAR
Enterprise Obligations
Supervision and Administration Measures on Cosmetics Manufacture and Operation
Aug 10, 2021
EN
On Aug. 2, 2021, China State Administration for Market Regulation released the finalized Supervision and Administration Measures on Cosmetics Manufacture and Operation, which will come into force on Jan. 1, 2022.The Measures consists of 7 chapters with 66 provisions, detailing cosmetic manufacture and operation management. Highlights include:Optimizing production license management system;Refining and clarifying the production management requirements;Refining and clarifying the operation management requirements;Strengthening the supervisory responsibilities of the administration department.In addition, detailed requirements have been made for issues of concern, such as the responsibilities and qualification requirements for the person in charge of quality and safety, the requirements for operators in e-commerce platforms, etc.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related Resources[Featured Page] Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking[News]China to Implement Supervision and Administration Measures on Cosmetics Manufacture and OperationChina Formally Implements A Brand-new Cosmetic and New Cosmetic Ingredients Pre-market Approval System on May 1China Implements Amended Cosmetic Prohibited Ingredient Inventories: 24 Newly Prohibited Ingredients Including Cannabidiol (CBD)Detailing China’s Requirements for Cosmetic Quality and Safety DirectorsChina Finalizes Requirements for Cosmetic LabelingChina Consults on Supervision and Administration Provisions on Children Cosmetics: the Strictest Supervision EverChina Publicizes the First Notification of a New Cosmetic Ingredient
Chinese Mainland
Children Cosmetics
Pre-market Approval
Post-market Surveillance
CSAR
Enterprise Obligations
Technical Guidelines for Cosmetic Safety Assessment
Apr 21, 2021
EN
On Jul. 29, 2020, China opened a public consultation on Technical Guidelines for Cosmetic Safety Assessment. On Apr. 9, 2021, the finalized Technical Guidelines for Cosmetic Safety Assessment was officially published and will take effect on May 1, 2021. The Technical Guidelines clarify the detailed requirements for conducting safety assessment, requirements for safety assessors, content necessary in the assessment report, attach corresponding samples, and set transitional measures.*Subscribe to Cosmetic Regulatory Database ($800) to access all the CSAR-related translations and other 1000+ key regulations in over 12 APAC countries for FREE.Related ResourcesIn order to stay fully up-to-date with the changes and the ongoing announcements around CSAR and its sub-regulations, remember to bookmark and tune in to ChemLinkeds' comprehensive and detailed CSAR homepage.[Featured Page]Catch the Significant Moments: China Cosmetic Regulatory Reform Tracking[News]China Details Cosmetic Safety Assessment RequirementsChina Unveils the Cosmetic Classification Rules and CatalogsChina Finalizes Standards for Cosmetic Efficacy Claim EvaluationChina NMPA Answers FAQs about Cosmetics Registration and NotificationChina Introduces Transitional Measures to Implement the New Provisions on Cosmetic Registration and Notification DossiersChina Finalizes Dossier Requirements for Registration and Notification of Cosmetics and New Cosmetic IngredientsChina Instructions for Toothpaste Notification Dossiers Require Mandatory Efficacy Evaluation and Safety AssessmentChina Publishes the Finalized Administrative Measures on Cosmetics Registration and NotificationChina’s Long-Anticipated Cosmetic Supervision and Administration Regulation (CSAR) Officially Takes Effect[Free Webinar Series]Prepare for Cosmetic Registration and Notification under China's New RegulationsGet Ready for China’s New Cosmetic Ingredient Registration and NotificationExpert Interview: Detailing Ingredient Submission Code Required for Cosmetic Registration and Notification[English Translations]Provisions for Management of Cosmetic Registration and Notification DossiersProvisions for Management of New Cosmetic Ingredient Registration and Notification DossiersAdministrative Measures on Cosmetic Registration
Chinese Mainland
Pre-market Approval
Safety Assessment
Testing
CSAR
Enterprise Obligations
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