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Search for "Ingredients" 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
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
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
Technical Guidance for Submission of Cosmetic Ingredients Safety Information
Jan 07, 2022
EN
On December 30, 2021, China NMPA officially issued a notice on the launch of the cosmetic ingredient safety information submission platform, announcing that from 9 a.m. on December 31, 2021, cosmetic ingredient manufacturers or their authorized companies can log on to the platform to submit ingredient safety-related information.Along with the notice, a Technical Guidance for Submission of Cosmetic Ingredients Safety Information (“the Technical Guidance”) was issued to guide enterprises in the correct use of the submission platform and standardize the submission of cosmetic ingredient safety information.The Technical Guidance is composed of five parts: "Enterprise Information," "Ingredient Classification and Key Features Ticking," " Filling in Ingredient Safety Information," " Generation of Ingredient Submission Code," " Use of Ingredient Safety Information," and four annexes.
Chinese Mainland
Ingredients
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
COSMETICS ACT No.18448
Sep 15, 2021
EN
This Act is the overarching regulation for cosmetics in South Korea, providing measures for the manufacture, import and sale of cosmetics and cosmetic ingredients, including detailed requirements for the labeling and advertising of products, custom cosmetics definition and categories, etc.
South Korea
Natural/Organic
Children Cosmetics
Custom Cosmetics
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers
Mar 10, 2021
EN
After two rounds of public consultation, on Mar. 4, 2021, China NMPA finally released the finalized Instructions for New Cosmetic Ingredient Registration and Notification Dossiers and renamed it as Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers. The registration and notification dossiers of a natural or artificial ingredient that is applied in cosmetic products for the first time in China shall meet the requirements stipulated in the Provisions.The Provisions are scheduled to come into force on May 1, 2021. Starting from the date, companies shall submit the registration/notification dossiers in accordance with the requirements specified in the Provisions.*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’s Long-Anticipated Cosmetic Supervision and Administration Regulation (CSAR) Officially Takes EffectChina Publishes the Finalized Administrative Measures on Cosmetics Registration and NotificationChina Finalizes Dossier Requirements for Registration and Notification of Cosmetics and New Cosmetic IngredientsChina to Exempt Animal Testing for Imported General Cosmetics on May 1China Introduces Transitional Measures to Implement Cosmetic Supervision and Administration RegulationChina Consults on the Draft Administrative Measures on Cosmetics LabelingChina Amends Requirements for Cosmetic Efficacy Claim EvaluationChina Consults on the Draft Technical Guidelines for Cosmetic Safety AssessmentDraft Regulations on Cosmetic Adverse Reaction Monitoring UnveiledChina Clarifies the Requirements for Cosmetics GMPChina to Implement a Cosmetic Sampling Inspection SchemeChina Releases the Draft Cosmetic Classification Rules and CatalogChina Consults on the Draft Measures for the Management of Cosmetic Supplementary Testing Methods [Free Webinar Series]CSAR Series: Deciphering Dossiers Requirements for Cosmetic Registration and NotificationCSAR Series: Understanding Dossiers Requirements for New Cosmetic Ingredient Registration and NotificationCSAR Exclusive Interview: Animal Testing, New Ingredients and What Next?Understanding China's New Draft Subsidiary Measures of CSARInterpretation of China's Cosmetic Supervision and Administration Regulation[English Translations]Instructions for Cosmetic Registration and Notification DossiersInstructions for New Cosmetic Ingredient Registration and Notification DossiersAdministrative Measures on Cosmetic RegistrationCosmetic Classification Rules and CatalogTechnical Guidelines for Cosmetic Safety AssessmentAdministrative Measures on Cosmetic Labeling
Chinese Mainland
Pre-market Approval
Ingredients
Post-market Surveillance
Efficacy
Animal Testing
Safety Assessment
Testing
CSAR
New Ingredient Management
Administrative Measures on Cosmetic Registration and Notification
Jan 18, 2021
EN
On December 31, 2020, the draft Administrative Measures on Cosmetic Registration officially passed the State Administration for Market Regulation (SAMR) and was renamed Administrative Measures on Cosmetics Registration and Notification. On January 12, 2021, the finalized regulation's full text was officially published and will take effect on May 1, 2021. The new regulation includes a total of 6 chapters and 63 articles. Compared to the previous draft released in July 2020, the new regulation is further modified and simplified 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 Resources:[News]China Publishes the Finalized Administrative Measures on Cosmetics Registration and NotificationChina Toothpaste Regulations Unveiled: Follow a Comparable Management Scheme of CosmeticsChina Consults on the Draft Measures for the Management of Cosmetic Supplementary Testing MethodsChina Deletes One Exceptional Circumstance for Animal Testing ExemptionChina Relaxes Animal Testing Alternatives Use Conditions for New Cosmetic IngredientsChina Amends Requirements for Cosmetic Efficacy Claim EvaluationDraft Regulations on Cosmetic Adverse Reaction Monitoring UnveiledChina Clarifies the Requirements for Cosmetics GMP China to Implement a Cosmetic Sampling Inspection SchemeChina Consults on the Draft Administrative Measures on Cosmetics LabelingChina Releases the Draft Cosmetic Classification Rules and CatalogChina Consults on the Draft Technical Guidelines for Cosmetic Safety Assessment[Free Webinars]CSAR Series: Deciphering Dossiers Requirements for Cosmetic Registration and NotificationCSAR Series: Understanding Dossiers Requirements for New Cosmetic Ingredient Registration and NotificationCSAR Exclusive Interview: Animal Testing, New Ingredients and What Next?Understanding China's New Draft Subsidiary Measures of CSARInterpretation of China's Cosmetic Supervision and Administration Regulation[English Translations]Instructions for Cosmetic Registration and Notification Dossiers (Draft for Comments)Instructions for New Cosmetic Ingredient Registration and Notification DossiersAdministrative Measures on Cosmetic RegistrationCosmetic Classification Rules and CatalogTechnical Guidelines for Cosmetic Safety AssessmentAdministrative Measures on Cosmetic Labeling
Chinese Mainland
Pre-market Approval
Ingredients
Post-market Surveillance
Testing
CSAR
New Ingredient Management
Enterprise Obligations
Instructions for Cosmetic Registration and Notification Dossiers (Second Draft for Comment)
Nov 16, 2020
EN
On November 5, 2020, China released the second draft Instructions for Cosmetic Registration and Notification Dossiers for public comments. The new draft of the Instructions for Cosmetic Registration and Notification Dossiers aims to further clarify and refine the provisions in the previous draft and shift the focus of cosmetic supervision from pre-market assessment to in-and post-market management.*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:[News]China Deletes One Exceptional Circumstance for Animal Testing ExemptionChina Toothpaste Regulations Unveiled: Follow a Comparable Management Scheme of CosmeticsChina Relaxes Animal Testing Alternatives Use Conditions for New Cosmetic IngredientsChina Amends Requirements for Cosmetic Efficacy Claim EvaluationDraft Regulations on Cosmetic Adverse Reaction Monitoring UnveiledChina Clarifies the Requirements for Cosmetics GMP China to Implement a Cosmetic Sampling Inspection SchemeChina Consults on the Draft Administrative Measures on Cosmetics LabelingChina Consults on the Draft Administrative Measures on Cosmetic RegistrationChina Releases the Draft Cosmetic Classification Rules and CatalogChina Consults on the Draft Technical Guidelines for Cosmetic Safety Assessment[Free Webinars]CSAR Series: Deciphering Dossiers Requirements for Cosmetic Registration and NotificationCSAR Series: Understanding Dossiers Requirements for New Cosmetic Ingredient Registration and NotificationCSAR Exclusive Interview: Animal Testing, New Ingredients and What Next?Understanding China's New Draft Subsidiary Measures of CSARInterpretation of China's Cosmetic Supervision and Administration Regulation[English Translations]Instructions for Cosmetic Registration and Notification Dossiers (Draft for Comments)Instructions for New Cosmetic Ingredient Registration and Notification DossiersAdministrative Measures on Cosmetic RegistrationCosmetic Classification Rules and CatalogTechnical Guidelines for Cosmetic Safety AssessmentAdministrative Measures on Cosmetic Labeling
Chinese Mainland
Children Cosmetics
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Efficacy
Animal Testing
Safety Assessment
Testing
GMP
CSAR
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