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Search for "Chinese Mainland" related English Translations
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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
Administrative Measures on Toothpaste
Mar 27, 2023
EN
According to Cosmetic Supervision and Administration Regulation (CSAR), toothpaste shall be managed with reference to the provisions on general cosmetics. In order to implement this provision and standardize the supervision of toothpaste, on March 23, 2023, China State Administration for Market Regulation (SAMR) issued the finalized Administrative Measures on Toothpaste (Measures) and will implement it on December 1, 2023.Encompassing 25 articles, the Measures mainlyClarifies the responsibilities of all stakeholders;Clarifies toothpaste’s definition;Clarifies the management requirements for toothpaste products and new ingredients;Clarifies the ongoing use of the existing toothpaste production licensing system;Clarifies the requirements for toothpaste safety assessment, efficacy claims and labeling.In addition, the Measures emphasizes that matters not specified shall be managed with reference to Administrative Measures on Cosmetics Registration and Notification and Supervision and Administration Measures on Cosmetics Produce and Operation.
Chinese Mainland
Ingredients
Labeling/Claim/Advertising
Safety Assessment
CSAR
Toothpaste
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
Several Provisions on Innovative Development of Cosmetics Industry in Shanghai Pudong New Area
Aug 05, 2022
EN
On June 22, 2022, the draft of Several Provisions on the Innovative Development of Cosmetics Industry in Shanghai Pudong New Area (Provisions) was deliberated on the 41st Session of the Standing Committee of the 15th Shanghai Municipal People's Congress. After a two-week commenting period, the finalized Provisions were issued on July 21, and took effect on August 1, 2022.The Provisions proposes to encourage enterprises to accurately develop general cosmetics that meet the individual needs of consumers, allow notifiers in Shanghai to set up business premises to provide consumers with personalized services, optimize the customs clearance for imported cosmetics, and provides ingredient supply and quality management services for enterprises in Pudong New Area, etc.This Provisions has 24 articles, as shown below:Article I Purpose and BasisArticle II Responsibilities of GovernmentArticle III Responsibilities of DepartmentsArticle IV Consultation Mechanism at Municipal and District LevelsArticle V New Models and New FormatsArticle VI Consumption PromotionArticle VII Brand DemonstrationArticle VIII Technology LeadingArticle IX Standards in the Innovation FieldArticle X Protection of Intellectual Property RightArticle XI Digital ApplicationArticle XII Precision CosmeticsArticle XIII Personalized Services and ManagementArticle XIV Ingredient Supply Service PlatformArticle XV Packaging and Labeling of Imported Products by EnterprisesArticle XVI Optimization of Customs Clearance for Imported Cosmetics SamplesArticle XVII Extended Transaction of Large-scale ExhibitionsArticle XVIII Guarantee for Industry TalentArticle XIX Third-party EvaluationArticle XX Exchange of Early Warning InformationArticle XXI Guidelines for Legal LiabilityArticle XXII Legal Liability for Engagement in Personalized Cosmetics Production Activities without PermissionArticle XXIII Legal Liability for being Contact with or Expose Cosmetic Contents against ProvisionsArticle XXIV Implementation Date
Chinese Mainland
Measures for the Management of Cosmetic Sampling Testing (Draft for Comments)
Jun 30, 2022
EN
The Measures for the Management of Cosmetic Sampling Inspection was released for public consultation on June 24, 2022, which spells out the requirements and procedures for sampling inspection, and corresponding obligations of all stakeholders.This regulation consists of 8 chapters with 63 articles, as shown below:Chapter I General ProvisionsChapter II PlanningChapter III SamplingChapter IV Inspection and Result SubmissionChapter V Re-inspection and ObjectionsChapter VI Verification and DisposalChapter VII Information DisclosureChapter VIII Supplementary Provisions
Chinese Mainland
Testing
CSAR
Technical Guidelines for Children Cosmetics (Draft for Comments)
Apr 20, 2022
EN
China’s first regulation on children cosmetics, Supervision and Administration Provisions on Children Cosmetics (hereafter referred to as “Provisions”), came into effect on Jan. 1, 2022. Four months later, on Apr. 11, 2022, China National Institutes for Food and Drug Control released the draft of Technical Guidelines for Children Cosmetics (hereafter referred to as “Guidelines”) for public consultation. Any suggestions can be mailed to hzppjzx@nifdc.org.cn before Apr. 28, 2022.Main ContentThe Guidelines is formulated to provide technical guidance for the registrant, notifier, and Chinese domestic responsible person when applying for the registration and notification of children cosmetics, as well as provide the basis for the competent authorities’ technical review of special children cosmetics and post-notification review of general children cosmetics. The Guidelines consists of 7 parts and an annex:1. Basic Requirements2. Requirements for Product Name and Related Dossiers3. Requirements for Product Formula and Ingredient Use4. Requirements for Product Executive Standard5. Labeling Requirements6. Requirements for Product Testing Report7. Requirements for Product Safety Assessment ReportAnnex: 26 Fragrance AllergensIt is worth noting that the Guidelines clarifies the specific requirements for safety assessment, products designed for the Chinese market, children sunscreens; more stringent requirements for ingredient use, labeling, and claims, etc. The Guidelines is in the process of translation and will be available on Apr. 20.
Chinese Mainland
Children Cosmetics
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Efficacy
Safety Assessment
CSAR
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
Formulation and Revision Instructions and Revision Comparison Table of Safety and Technical Standards for Cosmetics 2022 (Draft for Comments)
Apr 01, 2022
EN
On March 31, 2022, China National Institutes for Food and Drug Control (NIFDC) released a draft of the Safety and Technical Standard for Cosmetics 2022 (STSC 2022) for public comments. The consultation will end on Apr. 30, 2022. Stakeholders with any suggestions can fill out the feedback form and send it back by email at hzpbwh@nifdc.org.cn before that.Along with the draft STSC 2022, the Formulation and Revision Instructions and Revision Comparison Table of Safety and Technical Standards for Cosmetics 2022 (Draft for Comments) was also published. If you need the translation service of the full text or certain parts STSC 2022, please feel free to contact us at cosmetic@chemlinked.com.STSC is the overarching technical standard for cosmetics safety supervision and testing in China. It contains the prohibited, restricted, and permitted cosmetic ingredients, physical and chemical testing methods for cosmetics, microbiological testing methods, toxicological testing methods, human body safety testing methods, and human body efficacy evaluation testing methods.Under China’s new cosmetic regulatory regime, STSC 2015 is lagging behind in some aspects and can no longer fully meet the needs of industry development and supervision work. Therefore, China NIFDC plans to introduce a more systematic and comprehensive version of STSC to supersede the existing 2015 version and make the standards further consistent with the current industry situation.STSC 2022 inherits the basic framework of STSC 2015 and overhauls the content, which includes revising the content that is not suitable for the current regulatory requirements, retaining the content that is still applicable, including the previous dynamic revisions, as well as standardizing and improving some terms and expressions.Table of Content:List 1 Revision Comparison Table of Chapter 1 OverviewList 2 Revision Comparison Table of Chapter 2 Prohibited/Restricted Ingredients Used in CosmeticsList 3 Revision Comparison Table of Chapter 3 Permitted Ingredients Used in CosmeticsList 4 Revision Comparison Table of Chapter 4 Physical and Chemical Testing Methods for CosmeticsList 5 Revision Comparison Table of Chapter 5 Methods of Microbiological TestList 6 Revision Comparison Table of Chapter 6 Methods of Toxicological TestList 7 Revision Comparison Table of Chapter 7 Human Body Safety Testing MethodList 8 Revision Comparison Table of Chapter 8 Human Body Efficacy Evaluation Testing Method1 General Principles of Human Body Efficacy Evaluation Testing Method
Chinese Mainland
Ingredients
Efficacy
Animal Testing
Testing
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
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