The new regulations (cosmetic supervision and administration regulation/CSAR) apply from 1st January 2021.
What do you know about the transition period of the new regulations? In the following text, ZMUni will bring you our exclusive interpretation of it from five aspects: transitioning from old to current registration and notification platforms, cosmetic label, efficacy (freckle whitening and anti hair loss, etc.), raw materials and safety evaluation. But first of all, please pay attention to the key points of the NEW regulations:
Key points of the NEW regulations:
- The registrant and the person responsible for notification of cosmetics shall be responsible for the quality, safety and efficacy claim of cosmetics according to law
- Cosmetics and new cosmetic ingredients shall be subject to classified management, and the notification of cosmetics and new cosmetic ingredients shall be completed upon submission of notification materials
- Cosmetics categorised as Depilating, Deodorant, Hair Growth, Breast Beauty and Slimming products with an existing registration certificate have been granted an extension until 31st December, 2025. After this date, new certificates must be applied for under the new regulations before the products may be imported or sold.
- Enforcement of the new regulations will begin on 1st January 2021.
- The validity period of special cosmetics registration certificates has changed from 4 to 5 years.
- Soap products that promote specific efficacy claims must be granted a special cosmetic registration certificate before being introduced into the market.
- For toothpaste, refer to the regulations on management of general cosmetics (toothpaste supporting laws and regulations)
ZMUni Tips:
- The previous registration certificate of special cosmetics can still be used until 31 December 2025.
- Nourishing and anti wrinkle soaps do not need to be filed or notified, but efficacy certificates should be provided.
- Toothpaste is not categorised as a cosmetic, but toothpaste should be managed with reference to CSAR on general cosmetics.
Transition between old and new registration and notification platforms
- From 1 May 2021, applications for new cosmetics may only be registered or notified through the new registration and filing platform
- From 26 August 2021, a "notification data submission" may only be completed by the Company Account.
- Before 15 September 2021, the company or overseas responsible person account must have completed the rectification as required. Notifications not rectified or failing to meet the new regulatory requirements by this date shall be cancelled by the regulatory authorities.
- From 1 January 2022, general cosmetics that have been filed or notified under the new system for at least one year must be submitted on an annual report.
- By 1 January 2022, the temporary user authority system shall supplement the overview of quality management system and adverse cosmetic reactions monitoring system
- Before 1 May 2022, the information for products registered and filed/notified on the original registration and notification platform must be supplemented with the following data:(product executive standard, product label sample, domestic general product formula, uploading sales package pictures of special cosmetics, product classification code).
- On 30 November 2021, the original special system will be permanently shut down.
- Complete the data supplement at one time in combination with the specific review opinions issued before 30 November, 2021;
- If the data is not supplemented before 30 November, 2021, after the original system automatically terminates the declaration, the registration application for the special cosmetics shall be re-launched in the cosmetics intelligent declaration and review system.
ZMUni TIPS: 1.The company account may authorize other accounts to log in to the system, but the authorized accounts cannot submit notification materials 2.General cosmetics must be submitted on the annual report; however, special cosmetics are exempt from this requirement.
About cosmetic labels
- On 31 May 2021, the Measures for the Administration of Cosmetic Label swill be officially released, encouraging the registrant and the person responsible for cosmetic notification to label cosmetics in accordance with the Measures from that date.
- From 1 May 2022, the Measures for the Administration of Cosmetic Label swill be officially implemented. Cosmetics applying for registration or notification must comply with the provisions and requirements of the Measures;
- Before 1 May 2023, the registrant and the person responsible for notification of cosmetics must update the labels of cosmetics products that have previously applied for registration or notification, so as to make them comply with the provisions and requirements of the Measures.
About efficacy claims (freckle removal, whitening and hair loss prevention, etc.)
- From 1 January, 2021, the registrant and the person responsible for notification of cosmetics shall be responsible for the efficacy claims made by their cosmetics according to law.
- From 1 January 2022, when applying for registration of special cosmetics or filing/notification of general cosmetics, the registrant and the person responsible for notification of cosmetics shall evaluate the efficacy claims of their cosmetics according to the requirements of the regulations, and upload the abstract of the basis of product efficacy claim on the special website designated by NMPA(National Medical Products Administration).
- For cosmetics registered or filed/notified before 1 May 2022, from 1 May 2021 to 31 December 2021, evaluate the efficacy claim of cosmetics according to the requirements of the regulations, and upload the abstract of the basis of product efficacy claim.
- Before 1 May 2023, for cosmetics that have been registered or filed/notified before 1 May 2021, the efficacy claim of cosmetics shall be evaluated according to the requirements of the regulations, and the abstract of the basis of product efficacy claim shall be uploaded.
About raw materials
- From 1 May 2021, when applying for registration or notification, the source and trade name information of product formula raw materials shall be filled in, For raw materials involving quality specification requirements in the Safety Technical Specifications for Cosmetics, the quality specification certificate or safety related information of raw materials shall also be submitted.
- From 1 January 2022, when applying for registration or notification, safety related information of raw materials with anti-corrosion, sunscreen, colouring, hair dyeing, freckle removing and whitening functions shall be provided
- From 1 January 2023, when applying for registration or notification, safety related information of all raw materials shall be provided.
- For cosmetics that have been registered or filed/notified before 1 May 2023, the registrant and the person responsible for notification of cosmetics shall supplement the safety related information of all raw materials in the product formula.
- From 26 May 2021, the registrant and the person responsible for notification of cosmetics shall not produce or import cosmetics with prohibited raw materials specified in The Catalogue of Prohibited Raw Materials for Cosmetics and The Catalogue of Prohibited Plant (Animal) Raw Materials for Cosmetics.
- From 1 May 2021, The Catalogue of Used Cosmetic Raw Materials (2021 Version)will be implemented.
About safety evaluation
- From 1 May 2021, The Technical Guidelines for Safety Evaluation of Cosmetics (2021 Version) will be implemented, and the safety evaluation shall be submitted for animal testing exemption.
- From 1 January 2022, before applying for the registration of special cosmetics or the filing/notification of general cosmetics, the registrant and the person responsible for notification of cosmetics must carry out a cosmetics safety evaluation and submit product safety evaluation data in accordance with the requirements of the technical guidelines.
- Before 1 May 2024, the cosmetic registrant and the person responsible for notification of cosmetics may submit simplified product safety evaluation reports in accordance with the relevant requirements of the technical guidelines.
ZMUni regulatory compliance services in China include:
- Registration Service of Special Cosmetic Products
- Filing/Notification Service of General Cosmetic Products
- Infant/Children General Cosmetic Products Filing/Notification Service
- Infant/Children Sunscreen Cosmetic Products Registration Service
- New Cosmetic Ingredients (NCI) Filing/Notification and Registration Service
- Chinese responsible agency service
- Apply for CITIS permit or certificate of endangered speciesservice
- Toothpaste Filing/Notification Service
- Mouthwash etc. Dental Care Products regulatorycompliance Service
- Custom clearance service
- Disinfectionproducts Filing/Notification Service
- Anti-bacterial products Filing/Notification Service
- QMS (Quality Management System) service
- ACR (Adverse Cosmetic Reaction) Service
- Labelling Reviews
- Regulatory Dossiers
- Compliance Solutions
- Regulatory Support
————————————
ZMUni Chinese Cosmetic Regulation Compliance Centre 中贸合规中心
