Technical Guidelines for Determination and Research of New Cosmetic Ingredients (Draft for Comments) 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.

Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers 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

Administrative Measures on Cosmetic Registration and Notification 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

Instructions for New Cosmetic Ingredient Registration and Notification Dossiers (Second Draft for Comment) On Aug. 28, 2020, China National Institutes for Food and Drug Control (NIFDC) released the first draft Instructions for New Cosmetic Ingredient Registration and Notification Dossiers for public consultation. 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 Instructions.Based on the collected public opinions, National Medical Products Administration (NMPA) drafted and released the second edition of the Instructions on Nov. 5. The second draft modifies new cosmetic ingredients registration and notification dossiers requirements and refines the requirements for testing institutions qualification and testing method.*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 Consults on the draft Measures for the Management of Cosmetic Supplementary Testing MethodsChina Toothpaste Regulations Unveiled: Follow a Comparable Management Scheme of CosmeticsChina Modifies Requirements for New Cosmetic Ingredients Registration and Notification DossiersChina Deletes One Exceptional Circumstance for Animal Testing ExemptionChina 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[Featured Page]Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking

Instructions for Cosmetic New Ingredient Registration and Notification Dossiers (Draft for Comments) On August 28, 2020, China National Institutes for Food and Drug Control (NIFDC) released the draft Instructions for New Cosmetic Ingredient Registration and Notification Dossiers for public consultation, which is one of the subsidiary regulations of CSAR. The Instruction is formulated to guide and regulate the NCI registration and notification in China.Some Key Points of the InstructionDossiers categories required for registration and notification are consistent.Dossiers requirements for nanomaterials and biotechnology sources ingredients are newly added.Conditional acceptance of alternative method data.Detailed test data, laboratory qualification analysis, etc. shall be attached if the safety assessment report is issued by an international authoritative safety assessment agency.*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 Consults on the Draft Instruction for New Cosmetic Ingredient Registration and Notification DossiersChina Indicates the End of Mandatory Animal Testing for Imported General CosmeticsChina Consults on the Draft Administrative Measures on Cosmetic RegistrationChina Releases the Draft Cosmetic Classification Rules and CatalogKey Points in China Cosmetic Supervision and Administration Regulation (CSAR)China Consults on the Draft Technical Guidelines for Cosmetic Safety Assessment[Webinar]Understanding China's New Draft Subsidiary Measures of CSARInterpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)[English Translation]Administrative Measures on Cosmetic RegistrationCosmetic Classification Rules and CatalogTechnical Guidelines for Cosmetic Safety Assessment[Featured Page]Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking

Administrative Measures on Cosmetic Registration (Draft for Comments) On July 21, China Ministry of Justice opened a public consultation on the Administrative Measures on Cosmetic Registration, one of the subsidiary regulations of the Cosmetic Supervision and Administration Regulation (CSAR). The deadline for the consultation is August 20, 2020.The Administrative Measures on Cosmetic Registration clarifies the basic requirements for registration and filing management of cosmetics and new cosmetic ingredients, including some new concepts, "patent protection" for the new ingredients, ingredient traceability management, cosmetic efficacy claims, annual reporting, 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:News 1: China Finalized the Long-Awaited Cosmetic Supervision and Administration RegulationNews 2: Finalization of CSAR: A Milestone on Road to Modernization of China's Cosmetic SectorNews 3: Key Points in China Cosmetic Supervision and Administration Regulation (CSAR)News 4: Chinese Cosmetic Officials Disclose the Content and Release Schedule of Subsidiary Regulations of CSARNews 5: Will China Remove Mandatory Animal Testing for Imported General Cosmetics?News 6: CSAR Subsidiary Regulations: China Cosmetics Manufacture and Operation Supervision and Management Measures Unveiled News 7: CSAR Subsidiary Regulations: China Consults on the Draft Administrative Measures on Cosmetic RegistrationWebinar: Understanding China's New Draft Subsidiary Measures of CSARWebinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)English Translation: Cosmetic Supervision and Administration RegulationEnglish Translation: China Supervision and Administration Measures on Cosmetics Manufacture and Operation (Draft for Comments)Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking

Cosmetic Supervision and Administration Regulation EN On Jan.1, 2021, China implemented the final version of Cosmetic Supervision and Administration Regulation.The regulation gives clear provisions for filing or registration of cosmetic ingredients and finished products, production of cosmetics, labeling and advertisement as well as supervision over cosmetics throughout the supply chain. Once this regulation comes into effect, the Regulations concerning the Hygiene Supervision over Cosmetics shall be repealed simultaneously.Other Languages:Korean Version: Cosmetic Supervision and Administration Regulation$299FreeJapanese Version: Cosmetic Supervision and Administration Regulation$299FreeRelated Resources:News 1: China Finalized the Long-Awaited Cosmetic Supervision and Administration RegulationNews 2: Finalization of CSAR: A Milestone on Road to Modernization of China's Cosmetic SectorArticle: Key Points in China Cosmetic Supervision and Administration Regulation (CSAR)Webinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking

Japanese Version: Cosmetic Supervision and Administration Regulation China State Council released the final version of Cosmetic Supervision and Administration Regulation on June 29, 2020 and will implement on January 1, 2021.The regulation gives clear provisions for filing or registration of cosmetic ingredients and finished products, production of cosmetics, labeling and advertisement as well as supervision over cosmetics throughout the supply chain. Once this regulation comes into effect, the Regulations concerning the Hygiene Supervision over Cosmetics shall be repealed simultaneously.Other Languages:English Version: Cosmetic Supervision and Administration Regulation$299FreeKorean Version: Cosmetic Supervision and Administration Regulation$299FreeRelated Resources:News 1: China Finalized the Long-Awaited Cosmetic Supervision and Administration RegulationNews 2: Finalization of CSAR: A Milestone on Road to Modernization of China's Cosmetic SectorWebinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking

Korean Version: Cosmetic Supervision and Administration Regulation China State Council released the final version of Cosmetic Supervision and Administration Regulation on June 29, 2020 and will implement on January 1, 2021.The regulation gives clear provisions for filing or registration of cosmetic ingredients and finished products, production of cosmetics, labeling and advertisement as well as supervision over cosmetics throughout the supply chain. Once this regulation comes into effect, the Regulations concerning the Hygiene Supervision over Cosmetics shall be repealed simultaneously.Other Languages:English Version: Cosmetic Supervision and Administration Regulation$299FreeJapanese Version: Cosmetic Supervision and Administration Regulation$299FreeRelated Resources:News 1: China Finalized the Long-Awaited Cosmetic Supervision and Administration RegulationNews 2: Finalization of CSAR: A Milestone on Road to Modernization of China's Cosmetic SectorWebinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking

Guidelines for the Risk Assessment of Cosmetic Raw Materials A Commission from the Ministry of Health of the People's Republic of China to produce 'Guidelines for Risk Assessment of Cosmetic Raw Materials (draft)' was undertaken by the Chinese Center for Disease Control and Prevention (CDC) in 2008. After compilation of the Guidelines, the CDC allowed consultation until 30th April, 2011. Now the draft version of the Guidelines has been released and has been translated by REACH24H.Released in Mandarin Chinese, there are a total of 5 chapters, including the scope, terms and definitions, data required for risk assessment, risk assessment procedure of cosmetic raw materials and risk assessment report of cosmetic raw materials. The Guideline stipulates the China cosmetic raw material risk assessment terms, general principles, technology and requirements. The Guideline also applies to China cosmetic raw materials and finished cosmetics products that create impurities during progress by raw material or in the production process.