Update: China’s National Medical Products Administration Releases Guidance Documents
23 Apr 2021
Intertek, a leading Total Quality Assurance provider to industries worldwide, is pleased to support companies in understanding and preparing for the upcoming deadlines outlined in the following guidance documents released by China’s National Medical Products Administration (NMPA) on 09 April 2021:
- Cosmetic Classification Rules and Catalogue
- Technical Guidance for Cosmetic Safety Assessment
- Standards for Cosmetic Efficacy and Claim Evaluation
The above listed documents will come into effect from 01 May 2021.
Roadmap of Upcoming Deadlines
As companies prepare for the new guidance to take effect on 01 May 2021, Intertek’s experts have provided a roadmap below for the cosmetic industry to assist companies in staying ahead and complying with the new cosmetic deadlines.
Beginning 01 May 2021
- The trade name and source of the raw material is required.
- The Clinical Outcome Assessment (CoA) or safety assessment information for the raw material is required, including potential risk substances indicated in the STSC 2015.
- The cosmetic product classification code is required according to the Cosmetic Classification Rules and Catalogue.
From 01 May 2021 to 01 May 2023
- For dark spot removal & whitening and/or anti-hair loss cosmetic products that were registered and approved before 01 May 2021, human efficacy testing is required before 01 May 2023.
- According to the Standards for Cosmetic Efficacy and Claim Evaluation and the summary of the efficacy testing/evidence, all cosmetic products notified/registered and approved prior to 01 May 2021 must have their evaluation of the efficacy claim uploaded to the public website.
Beginning 01 January 2022
- The annual report is required for all general cosmetic products. Annual submission will take place from 01 January to 31 March.
- The safety information identified in Annex XIV of the Administrative Provisions for Cosmetic Registration and Notification Documentation, including the CoA, production process, etc., is required for preservative, sunscreen colorant, hair dyeing, and dark spot removal & whitening raw materials (ingredients).
- For dark spot removal & whitening and/or anti-hair loss cosmetic products registered and approved before 01 May 2021, human efficacy testing is required before 01 May 2023.
- According to the Standards for Cosmetic Efficacy and Claim Evaluation, all cosmetic products notified/registered and approved by 01 May 2021 must have their evaluation of the efficacy claim and summary of the efficacy testing/evidence uploaded to the public website.
- According to the Technical Guidance for Cosmetic Safety Assessment, a safety assessment report for all cosmetic products and new ingredients is required.
No later than 01 May 2022
- For dark spot removal & whitening and/or anti-hair loss cosmetic products registered and approved between 01 May 2021 and 31 December 2021, human efficacy testing is required before 01 May 2023.
- According to the Standards for Cosmetic Efficacy and Claim Evaluation, cosmetic products notified/registered and approved between 01 May 2021 and 31 December 2021 must have their evaluation of the efficacy claim and summary of the efficacy testing/evidence uploaded to the public website.
- According to the Cosmetic Classification Rules and Catalogue, all cosmetic products notified/registered and approved by 01 May 2021 must include cosmetic classification codes.
- Like with all the cosmetic products registered or notified in the former online platform, the executive standard, label, formula of domestic general products, and picture of the label and package for sales of special cosmetics must be uploaded or submitted through the new online platform.
Beginning 01 January 2023
- The safety information identified in Annex XIV of the Administrative Provisions for Cosmetic Registration and Notification Documentation, including the CoA, production process, etc., is required for all cosmetic products.
- For cosmetic products registered and notified before 01 January 2023, the above-mentioned safety information must be submitted no later than 01 May 2023.
No later than 01 May 2023
- For dark spot removal & whitening and/or anti-hair loss cosmetic products that have been registered and approved between 01 May 2021 and 31 December 2021, human efficacy testing is required by 01 May 2023.
- According to the Standards for Cosmetic Efficacy and Claim Evaluation, cosmetic products notified/registered and approved by 01 May 2021 must have their evaluation of the efficacy claim and summary of the efficacy testing/evidence uploaded to the public website.
No later than 01 May 2024
- According to the Technical Guidance for Cosmetic Safety Assessment, a simplified version of the safety assessment report is required.
Beginning 01 May 2024
- According to the Technical Guidance for Cosmetic Safety Assessment, a full version of the safety assessment report is required.
Disclaimer: The above is the work product of the authors’ from Intertek Health, Environmental, & Regulatory Services (HERS), which is not associated with a regulatory body. The information in this release is for informational purposes only. HERS and its affiliates assume no liability for any inaccurate, incomplete information, or for any actions taken in reliance thereon. The information has been obtained from publicly available sources and does not constitute legal advice.
Intertek Solutions
Intertek provides a comprehensive range of services for beauty and personal care products to ensure quality, safety and efficacy, in addition to helping companies understand and comply with regulations around the world. Our services include:
- Toxicological & Raw Material Safety Assessments
- Toxicological Profiles of Ingredients
- Registration & Notification of New Cosmetic Ingredients
- Registration & Notification of Domestic/Imported Cosmetic Products
- Labelling Reviews
- Literature Review & Data Collection
- Regulatory Dossiers
- Microbiology & Stability Testing
- Cosmetic Packaging Analysis
- Causality Assessment
- Compliance Solutions
- Regulatory Support
- Sustainability Solutions
Our experts are available to address the regulatory and compliance needs of the cosmetics, home, and personal care industry.
If you have any questions or concerns, we’re here to help.
For more information about Intertek’s cosmetic services, please visit: www.intertek.com/beauty-personal-care/
For Media Information
Please contact:
Tracy Veale
Global Marketing and Communications Director
T: +1 905 542 2900
E: tracy.veale@intertek.com
For Technical Information
Please contact:
Rainbow Zhang
Senior Manager, China
T: +86 21 5339 7903
E: rainbow.zhang@intertek.com
About Intertek
TOTAL QUALITY. ASSURED.
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers' operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.