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Registration and notification of new cosmetic ingredients
Technical amendments for new cosmetic ingredients
Experimental supervision for ingredient applications
Application for ingredient submission codes
Safety assessment reports for ingredients
Analysis of toxicological data gaps
Annual monitoring reports and safety risk control report services during the monitoring period
In China, cosmetic ingredients are classified into two categories:
Existing Cosmetic Ingredients - listed in Inventory of Existing Cosmetic Ingredients in China (IECIC)
New Cosmetic Ingredients (NCIs) - not included in IECIC and subject to pre-market approval
The Inventory of Existing Cosmetic Ingredients in China (IECIC) objectively catalogs ingredients that have been used in cosmetics produced and sold in China.
If an ingredient classified as an existing cosmetic ingredient and intended for use in finished products, the exporter must apply for an ingredient submission code in China or provide complete safety information for all ingredients used in the product formula.
On June 24, 2025, China NMPA issued Announcement No. 61 (2025), establishing a dynamic adjustment mechanism for IECIC, which is now divided into List I and List II. List I includes revisions and improvements to the IECIC 2021 Edition. List II covers NCIs that have completed their three-year safety monitoring period and are now officially included in IECIC.
Besides IECIC, the the Safety and Technical Standards for Cosmetics (STSC) is another key regulatory reference for compliant cosmetic ingredients in China. The STSC sets out Tables 1-7, which define:
Prohibited ingredients (Table 1),
Prohibited plant/animal-derived ingredients (Table 2),
Restricted ingredients (Table 3),
Permitted preservatives (Table 4),
Permitted UV filters (Table 5),
Permitted colorants (Table 6),
Permitted hair dyes (Table 7)
These tables also specify the exact conditions of use for restricted and permitted ingredients.
Together, the IECIC and STSC form the primary basis for determining whether an ingredient can be used, under what conditions, and whether it is classified as an existing cosmetic ingredient.
Any natural or synthetic ingredient used for the first time in cosmetics within China is subject to NCI management.
Changes to the intended use, safe usage level, or other conditions of existing ingredients must comply with NCI management.
NCIs that have been registered or notified remain under NCI management until they are officially included in the IECIC.
*Note: Ingredients already in the IECIC, including those listed as category ingredients(e.g., "collagen" as a category ingredient covering all sources and types (animal-derived, recombinant, Type I, Type III), and "ginseng extract" representing the whole plant and all its extracts), are not considered NCIs.
In China, NCIs are regulated based on their risk level.
Registration is required for high-risk NCIs, such as those with preservative, UV-filtering, coloring, hair-dyeing, or whitening functions.
Notification (Filing) applies to low-risk NCIs without significant safety concerns.
Registered or notified NCIs are subject to a three-year safety monitoring period. Registrants and notifiers must submit an annual safety monitoring report each year. If any safety risk is identified, a risk control report must be submitted immediately. At the end of the monitoring period, ingredients without safety issues will be added to the IECIC, while those with safety concerns will have their registration canceled or notification withdrawn.
Registrants or notifiers must submit documentation in accordance with the Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers. For overseas companies, a designated domestic responsible person must handle the relevant matters. The same NCI cannot be assigned to multiple domestic responsible persons.
For non-high-risk NCIs: 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 notification certificate.
For NCIs 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.
Names, addresses, and contact information of the registrant, filer, and responsible person within China
Research report on the development of the new ingredient
Research materials on the preparation process, stability, and quality control standards of the new ingredient
Safety assessment data for the new ingredient
Technical requirements for the new ingredient
Cosmetic Supervision and Administration Regulation (CSAR)
Safety and Technical Standards for Cosmetics (STSC)
Administrative Measures on Cosmetics Registration and Notification
Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers
......
In response to China's dynamic regulatory landscape, ZMUni Compliance Centre continues to support clients with successful notifications of diverse ingredient types, including peptides, plant extracts, synthetic molecules, animal-derived substances, and functional chemical compounds. With authorization from relevant clients, we are pleased to share the following representative cases:
For more information, please refer to previous article.
How should we understand the registration and notification of new cosmetic ingredients?
The actual meaning of notification 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 notification 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 notification 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 notification period for new cosmetic ingredients?
The notification 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 notification 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 notification. 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 notification of new cosmetic ingredients?
According to the Management Regulations for the Registration and Notification Documents of New Cosmetic Ingredients, Article 4, the registration and notification 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 Notification 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.
Last Updated on: December 4, 2025
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