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Cosmetic ingredients are classified into new ingredients and used ingredients in China.
New cosmetic ingredients refer to natural or synthetic ingredients that are used in cosmetics for the first time within the territory of China.
Ingredients that are not included in the Catalog of Used Cosmetic Ingredients (2021 Edition) are considered new cosmetic ingredients and require registration/filing before they can be used in cosmetics.
Adjustments to the purpose of use, safe usage levels, etc., of used cosmetic ingredients should be registered or filed according to the requirements for new ingredients.
China implements a registration management system for new cosmetic ingredients with higher risk levels (including preservative, sunscreen, coloring, hair dye, freckle removal, and whitening functions) and a filing management system for other new cosmetic ingredients (including anti-hair loss, acne treatment, dandruff removal, and deodorizing).
Post-Market: 3-year safety monitoring period. During the safety monitoring period, registrants or filers of new ingredients are required to report the usage and safety of the new ingredients to the State Drug Administration annually. For new cosmetic ingredients with safety issues, the authority may revoke the registration or cancel the filing. New cosmetic ingredients without safety issues after the 3-year period will be included in the Catalog of Used Cosmetic Ingredients.
For non-high-risk new cosmetic ingredients: account application, data collection, analysis of data gaps, testing arrangements, preparation and submission of dossiers, review by the drug regulatory authority (5 working days), obtain electronic filing certificate.
For new cosmetic ingredients with higher risk levels: account application, data collection, analysis of data gaps, testing arrangements, preparation and submission of dossiers, review by the drug regulatory authority (128 working days), obtain registration certificate.
How should we understand the registration and filing of new cosmetic ingredients?
The actual meaning of filing is that the filer submits documents to the regulatory authority for reference. When a new cosmetic ingredient is filed, it means that the filer has completed the submission of the filing documents, meeting the formal requirements. However, the authenticity, scientific basis, and adequacy of the information in the documents may not have been verified. The publication of information on filed new cosmetic ingredients does not imply recognition of the safety and functionality of the ingredient or the notion of "successfully approved and filed."
After completing the registration and filing of a new ingredient, what obligations do the registrant and filer have?
According to the regulations, the registrant and filer of a new cosmetic ingredient are responsible for the quality and safety of the ingredient. New cosmetic ingredients that have been registered or filed are subject to a safety monitoring period. During this period, the registrant and filer should closely monitor the safe use of the ingredient, collect and organize relevant information on its use as required by the regulations, and prepare an annual report on the safety monitoring of the new cosmetic ingredient. Within 30 working days before the end of each monitoring year, the report should be submitted to the technical evaluation organization via the information service platform. If the registrant or filer discovers any situation during the use of the new ingredient that should be reported to the technical evaluation organization according to the regulations or deems it necessary to report, they should immediately prepare a report on the safety risk control of the new cosmetic ingredient and submit it to the technical evaluation organization via the information service platform.
How long is the filing period for new cosmetic ingredients?
The filing period varies depending on the classification and circumstances of the ingredient and cannot be generalized. Factors such as the thoroughness of the pre-declaration basic research and the conduct of stability analysis are taken into account. If not, the shortest period for accelerated testing is around 6 months. Additionally, the toxicology testing period can vary greatly depending on the circumstances. For example, the toxicology testing period for Situation 2 is 8-10 months, while for Situation 6, it is less than 1 month. The official review time for filing is within 5 working days, while for registration, it is within 90 working days. Therefore, the specific declaration period needs to be assessed comprehensively.
Can other companies still apply for a new ingredient that has already been applied for?
Yes, other companies can still apply. For example, for ingredients like NMN, multiple companies have already completed the filing. There is no exclusive protection for the application of new ingredients. If Company A has completed the application for a new ingredient, Company B can still apply. However, they must submit all the required documents according to the regulations and can only use and sell the ingredient after it has been approved by the NMPA.
What are the requirements for foreign language documents in the registration and filing of new cosmetic ingredients?
According to the Management Regulations for the Registration and Filing Documents of New Cosmetic Ingredients, Article 4, the registration and filing documents for new cosmetic ingredients should be in standard Chinese characters published by the government. Except for mandatory use of other languages for registered trademarks, websites, patent names, names, and addresses of overseas companies, as well as English abbreviations used in Chinese regulations, all materials written in other languages should be translated into Chinese accurately and properly, with the original text attached after the corresponding translation.
What should be done if the authorization letter for the responsible person within China expires?
According to Article 11 of the Management Regulations for the Registration and Filing Documents of New Cosmetic Ingredients, when the authorization period stated in the authorization letter for the responsible person within China expires, the renewal of the authorization period or the change of the responsible person within China should be resubmitted within 30 days before the expiration of the authorization period.
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+86 180 5841 8258
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