China New Cosmetic Ingredients Registration and Notification Guidance

1. Background Introduction

On June 29, 2020, the State Council of China officially promulgated the Cosmetics Supervision and Administration Regulation (CSAR, State Council Order No. 727), which came into effect on January 1, 2021. The introduction of CSAR marks a new stage in the development of China’s cosmetics regulatory system, establishing a modern regulatory framework centered on safety, scientific supervision, and whole lifecycle management.

Under the CSAR framework, the regulatory system for new cosmetic ingredients has undergone significant reform. The National Medical Products Administration (NMPA) has successively issued supporting regulations, including the the Measures for the Administration of Cosmetic Registration and Filing and the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data, which clarify the classification, registration and notification requirements, as well as the safety monitoring system for new ingredients. In addition, CSAR introduced a three-year safety monitoring period, requiring enterprises to continuously submit safety data and adverse reaction reports after the new ingredient is launched on the market, in order to ensure long-term product safety. The implementation of the new regulations not only defines the market entry thresholds for new cosmetic ingredients but also promotes the industry toward a more scientific, transparent, and internationalized direction.

This guideline is intended to help cosmetic enterprises fully understand and strictly comply with the requirements of CSAR and its supporting regulations, ensuring the compliance and safety of new cosmetic ingredients in the Chinese market. By systematically interpreting the registration and notification procedures, dossier requirements, and testing requirements for new ingredients, this guideline provides clear compliance guidance for enterprises, reduces regulatory risks, enhances market competitiveness, and supports the healthy and sustainable development of the industry.

2. Definition of New Cosmetic Ingredient and How to Determine

To strengthen supervision and ensure consumer safety, enterprises should have a clear understanding of the definition of new cosmetic ingredients, accurately determine whether the ingredients used fall under this category, and fulfill the corresponding registration or notification obligations in accordance with the law.

2.1 Definition of New Cosmetic Ingredient

“A new cosmetic ingredient refers to a natural or synthetic ingredient that is used in cosmetics for the first time within the territory of China.” (Article 11, Chapter II of the Cosmetics Supervision and Administration Regulation)

2.2 How to Determine a New Cosmetic Ingredient?

Only ingredients whose intended method of use, site of application, and purpose of use comply with the relevant attributes of cosmetics may be registered or filed as new cosmetic ingredients. For example, if an ingredient is intended to exert its effect through oral administration or injection, it does not conform to the methods of application defined in the Cosmetics Supervision and Administration Regulation (CSAR), namely “application to the skin, spraying, or other similar methods.” Similarly, if the site or purpose of use of the ingredient falls outside the scope of the definition of cosmetics, it cannot be registered or filed as a new cosmetic ingredient.

Ingredients Used for the First Time Domestically and Internationally

These refer to ingredients that are newly discovered and confirmed to be applicable in cosmetics, or known ingredients that have not yet been used in cosmetics either domestically or internationally.

Ingredients Used for the First Time Within China

These are ingredients that have already been used in cosmetics abroad but have not yet been applied in cosmetics within the territory of China.

Improved and Innovative New Ingredients

Improved and innovative new ingredients mainly include the following two scenarios:

(1) Ingredients that are already used in cosmetics with clearly defined purposes and safe usage levels, but whose purpose of use is modified to serve as preservatives, UV filters, colorants, hair dyes, or whitening agents.

(2) Ingredients that are already used with clearly defined purposes and safe usage levels, but have undergone improvement and innovation-such as through the optimization of preparation techniques and manufacturing processes, or through substantive innovative research that alters the fundamental material basis of the ingredient-thereby enhancing safety, efficacy, stability, and quality controllability.

• Ingredients that are already listed in the Inventory of Existing Cosmetic Ingredients in China (hereinafter referred to as the "IECIC"), or specific substances included within ingredient categories already recorded in the IECIC, as well as ingredients whose functional components are consistent with those listed in the IECIC, are not considered new cosmetic ingredients.
• To more accurately determine the regulatory status of cosmetic ingredients, enterprises may utilize the global cosmetic regulatory database GlobalCosIng. GlobalCosIng integrates regulatory information on cosmetic ingredients from multiple countries and regions, including China, the European Union, the United States, Canada, ASEAN, South Korea, and Japan. Enterprises can efficiently search for the compliance status of a given ingredient across different markets, assess whether it qualifies as a new cosmetic ingredient under Chinese regulations, and identify the corresponding regulatory requirements. This not only supports enterprises in achieving compliance within the Chinese market, but also facilitates the development of global ingredient compliance strategies.

3. Classification of New Cosmetic Ingredients

New cosmetic ingredients are classified into two main categories:

• High-risk new cosmetic ingredients: These include preservatives, colorants, whitening/spot-removing agents, sunscreens, and hair dyes.
• Non-high-risk new cosmetic ingredients

4. Regulatory Authorities for New Cosmetic Ingredients

In China, the regulation of new cosmetic ingredients is primarily overseen by the National Medical Products Administration (NMPA), which is responsible for the centralized management of ingredient registration, filing, and safety monitoring. In addition, local medical products administrations at various levels are tasked with conducting supervision and inspections to ensure the compliant use of new ingredients and safeguard market safety.

National Medical Products Administration (NMPA)

The NMPA is mainly responsible for the review and approval of new cosmetic ingredient registration and filing. It also organizes the development and issuance of relevant regulations and technical standards for the management of new cosmetic ingredients, and supervises the safety assessment of such ingredients.

Local Medical Products Administrations

These authorities are primarily responsible for supervising and inspecting the use of new cosmetic ingredients in products within their jurisdictions. They assist the NMPA in safety monitoring, collect adverse reaction reports, and oversee whether enterprises have registered or filed new cosmetic ingredients in accordance with regulatory requirements.

5. Market Access Requirements for New Cosmetic Ingredients in China

In China, the market entry of new cosmetic ingredients must comply with the Cosmetic Supervision and Administration Regulation (CSAR) and relevant supporting regulations. Following a preliminary safety assessment of the cosmetic ingredient, enterprises are required to complete either registration or filing procedures, along with safety monitoring, depending on the risk category of the ingredient, to ensure its safety and regulatory compliance.

According to the CSAR, the state implements a registration-based management system for high-risk new cosmetic ingredients, and a filing-based management system for other new cosmetic ingredients. Specifically, new cosmetic ingredients with functions such as preservation, sun protection, coloring, hair dyeing, and whitening/spot-removing must be registered with the National Medical Products Administration (NMPA) before they can be used in cosmetic products. Other new cosmetic ingredients are subject to filing with the NMPA prior to use.

Follows are the registration and filing procedures for two categories of new cosmetic ingredients.

High-risk new cosmetic ingredients

Non-high-risk new cosmetic ingredients

Note: Cosmetic ingredients are also regulated under China’s chemical management laws. If considered a new chemical substance, registration with the Ministry of Ecology and Environment (MEE) is required.

6. Responsibilities and Qualification Requirements for Domestic Responsible Person for New Cosmetic Ingredients

According to the Cosmetics Supervision and Administration Regulation (CSAR) and relevant regulatory requirements, overseas enterprises applying for the registration or notification of new cosmetic ingredients in China must designate a domestic enterprise legal entity as the Domestic Responsible Person. This entity is responsible for compliance management and safety monitoring of the new ingredient within China.

Responsibilities of the Domestic Responsible Person:

• Handle the registration or notification of new cosmetic ingredients in the name of the registrant or notifier;
• Assist the registrant or notifier in conducting safety monitoring and reporting of the new cosmetic ingredient;
• Assist the registrant or notifier in implementing recall procedures for the new cosmetic ingredient;
• Undertake corresponding responsibilities for the quality and safety of the new cosmetic ingredient placed on the domestic market, in accordance with the agreement with the registrant or notifier;
• Cooperate with the supervision and inspection work of the drug regulatory authorities.

7. Documentation Requirements for the Registration and Notification of New Cosmetic Ingredients

7.1 Overview of Documentation Requirements

The documentation for the registration or notification of new cosmetic ingredients should clearly describe the source and development background of the ingredient, its manufacturing process, quality control measures, and safety assessment. The submitted materials must sufficiently demonstrate the safety and controllable risk of using the new ingredient in cosmetic products under specified conditions. In accordance with the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data, applicants (registrants or notifiers) of new cosmetic ingredients shall submit the following documents when applying for registration or notification:

• Name, address, and contact information of the registrant, notifier, and the domestic responsible person;
• Research and development report of the new ingredient;
• Research data on the manufacturing process, stability, and quality control standards of the new ingredient;
• Safety assessment data of the new ingredient.

The registrant, notifier, or domestic responsible person of a new cosmetic ingredient shall classify the ingredient based on its specific characteristics, and organize and submit the corresponding registration or notification dossiers in accordance with the requirements for new cosmetic ingredient registration and notification documentation.

At the same time, based on the technical information included in the registration or notification dossiers, the registrant or notifier shall compile and provide the Technical Requirements Document for New Cosmetic Ingredients, which will be used for public disclosure of registration or notification information. This document shall be published as an annex to the registration certificate or notification certificate once the new ingredient is approved or the notification is completed, and shall be made available to the public for reference.

7.2 New Cosmetic Ingredient Development Report

The development report for a new cosmetic ingredient should generally include the following contents:

• Background of Ingredient Research and Development
• Basic Information of the Ingredient
• Usage Information of the Ingredient
• Supporting Information for Claimed Function
• Other Relevant Information Related to the Development of the New Ingredient

7.3 Brief Description of the Preparation Process of the New Cosmetic Ingredient

The brief description of the preparation process of the new cosmetic ingredient shall be provided in accordance with the characteristics of the ingredient source, including a concise description of the main production steps, process parameters, etc., and an explanation of whether any safety risk substances may be introduced during the production process and the corresponding control measures.

7.4 Quality Control Standards for the New Cosmetic Ingredient

The quality control standards for the new cosmetic ingredient shall generally include the following contents:

• Stability test data;
• Quality specification indicators and their test methods;
• Potential safety risk substances and their control standards.

7.4 Safety Assessment Data of the New Cosmetic Ingredient

The safety assessment data of the new cosmetic ingredient shall generally include toxicological safety evaluation data and safety risk assessment data, and shall be compiled in accordance with the following requirements:

• Toxicological safety evaluation data shall be compiled based on the characteristics of the new ingredient intended for registration or notification, by determining the specific applicable category of the ingredient and preparing the corresponding toxicological test data as required.
• Safety risk assessment data shall include the assessment of the safe use level of the ingredient, as well as the assessment of potential safety risk substances that may be present in the ingredient and their control measures. The assessment shall be conducted in accordance with the principles and procedures for cosmetic safety assessment formulated by the National Medical Products Administration (NMPA) and other relevant requirements, covering both the new ingredient itself and any potential safety risk substances.

8. Testing Requirements for Registration and Notification of New Cosmetic Ingredients

In accordance with the Cosmetics Supervision and Administration Regulation (CSAR) and the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data, new cosmetic ingredients are required to undergo relevant safety assessments and testing to ensure their safety and regulatory compliance. The safety assessment of new ingredients generally requires testing in the following areas: physicochemical properties, microbiological testing, efficacy evaluation, toxicological studies, and stability testing.

8.1 Toxicological Testing

In principle, the following toxicological test data shall be provided for new cosmetic ingredients subject to registration or notification:

• Acute oral or acute dermal toxicity test
• Skin and eye irritation/corrosion test
• Skin sensitization test
• Phototoxicity test (required if the ingredient has ultraviolet absorption properties)
• Photoallergenicity test (required if the ingredient has ultraviolet absorption properties)
• Mutagenicity test (should include at least one gene mutation test and one chromosomal aberration test)
• Subchronic oral or dermal toxicity test (if the ingredient is likely to be ingested through cosmetic use, a subchronic oral toxicity test should be provided)
• Teratogenicity test
• Combined chronic toxicity/carcinogenicity test
• Inhalation toxicity test (required if the ingredient may be exposed via inhalation)
• Long-term human safety trial

Other toxicological test data may be required based on the characteristics and intended use of the ingredient.

8.2 Laboratory Qualifications

In China, tests involved in the registration and notification of new cosmetic ingredients must be conducted by laboratories with appropriate qualifications. The regulatory authority (National Medical Products Administration, NMPA) imposes strict requirements on laboratory qualifications to ensure the scientific validity and reliability of test data.

Laboratories issuing toxicological test reports and test reports for efficacy evaluations such as preservative, sunscreen, freckle-removing and whitening, and anti-hair loss must meet one of the following requirements:

• Accredited for cosmetic testing by obtaining the China Metrology Accreditation (CMA)
• Accredited by the China National Accreditation Service for Conformity Assessment (CNAS)
• Compliant with internationally accepted Good Clinical Practice (GCP) standards
• Compliant with Good Laboratory Practice (GLP) standards

Physicochemical and microbiological test reports, as well as efficacy evaluation reports other than for preservative, sunscreen, freckle-removing and whitening, and anti-hair loss:

Shall be issued by the cosmetic new ingredient registrant or notifier themselves, or by a testing institution with corresponding testing capabilities entrusted by them.

8.3 Requirements for Test Methods

Physicochemical, Microbiological, and Efficacy Evaluation Methods:

The physicochemical and microbiological tests, as well as tests for human safety and efficacy evaluation of cosmetic new ingredients, shall, in principle, follow the test methods specified in the Safety and Technical Standards for Cosmetics or the Pharmacopoeia of the People's Republic of China. For test items not specified in the Safety and Technical Standards for Cosmetics or the Pharmacopoeia of the People's Republic of China, testing shall be conducted in accordance with national standards, internationally accepted methods, or self-developed methods. If self-developed test methods are used, relevant documentation demonstrating the applicability and reliability of the methods shall be submitted.

Toxicological Test Methods:

Toxicological tests for new cosmetic ingredients shall be conducted in accordance with the test methods specified in the Technical Guidelines for Cosmetic Safety. For test items not specified in the Technical Guidelines for Cosmetic Safety, testing shall be conducted in accordance with national standards or internationally accepted methods.

Requirements for Alternative Methods to Animal Testing:

When alternative methods to animal testing are used for toxicological safety assessment, appropriate Integrated Approaches to Testing and Assessment (IATA) shall be selected based on the structural characteristics of the ingredient and the specific toxicological endpoint to evaluate the toxicity of the new ingredient.

If the applied alternative test method has not yet been included in China’s Technical Guidelines for Cosmetic Safety, it must be a method recognized by an internationally authoritative validation body for alternative methods. In addition, supporting documentation shall be submitted to demonstrate that the method can accurately predict the specific toxicological endpoint. The supporting documentation shall include a brief description of the research process of the alternative method, as well as research data, result analysis, and study conclusions for no fewer than 10 test substances with known toxicity.

9. Registration and Filing Timeline for New Cosmetic Ingredients

The registration and filing timeline for new cosmetic ingredients depends on the properties of the ingredient, applicable scenarios, and any data gaps. For professional consultation regarding data gap analysis or feasibility assessment, you may consult with CIRS Group (cosmetic@cirs-group.com) for professional advice. The following outlines the official review timelines for new ingredient registration and filing.

9.1 Low-Risk New Ingredients (Subject to Filing)

For low-risk new cosmetic ingredients, the filing is considered complete once the filer submits the required documentation in accordance with the requirements of the National Medical Products Administration (NMPA).

9.2 High-Risk New Ingredients (Subject to Registration)

• Formal Review: Upon submission of the registration application, the acceptance authority shall complete the formal review within 5 working days. Within 3 working days after accepting the application, the authority shall forward the application documents to the technical review institution.
• Technical Review: The technical review institution shall, within 90 working days from the date of receipt of the application documents, organize and carry out the technical review in accordance with relevant requirements. (Re-examination: If the conclusion of the technical review is that the application is not approved and the applicant has objections, the applicant may apply for a re-examination within 20 working days from the date of receipt of the technical review conclusion. The technical review institution shall issue a re-examination conclusion within 30 working days from the date of receiving the re-examination request.)
• NMPA Review: The National Medical Products Administration (NMPA) shall, within 20 working days from the date of receipt of the technical review conclusion, examine the legality, compliance, and completeness of the technical review procedures and conclusions, and make a decision on whether to approve the registration.
• Issuance of Decision: Within 10 working days from the date the NMPA makes the administrative approval decision, the acceptance authority shall issue the New Cosmetic Ingredient Registration Certificate or a Notice of Disapproval to the applicant.

10. Post-Market Supervision Requirements for New Cosmetic Ingredients

According to the Measures for the Administration of Cosmetic Supervision, the registrant or notifier of a new cosmetic ingredient shall establish a comprehensive system for post-market safety risk monitoring and assessment. They shall continuously conduct follow-up studies on the safety of the new ingredient and dynamically monitor and evaluate its usage and safety status.

A three-year safety monitoring period is implemented for new cosmetic ingredients that have been registered or filed. The monitoring period starts from the date when the cosmetic product using the new ingredient is first registered or filed. During this period, the registrant or notifier of the new cosmetic ingredient may use the ingredient for cosmetic production. The registrant or notifier shall, within 30 working days prior to the end of each year of the monitoring period, summarize and analyze the usage and safety data of the ingredient, prepare an annual safety report, and submit it to the National Medical Products Administration (NMPA). If any safety issues are identified, the NMPA may revoke the registration or cancel the notification of the ingredient.

If no safety issues are reported during the three-year monitoring period, the ingredient will be included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) formulated by the NMPA.

In addition, registrants or notifiers of cosmetic products that use new cosmetic ingredients shall promptly provide feedback to the ingredient registrant or notifier regarding the ingredient’s usage and safety. If any adverse reactions or other safety issues potentially related to the new ingredient are discovered, the cosmetic product registrant or notifier shall immediately take risk control measures, notify the ingredient registrant or notifier, and report the issue to the local provincial-level Medical Products Administration in accordance with relevant regulations.

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