Article 1

These Provisions are formulated in accordance with the Regulations on the Supervision and Administration of Cosmetics and the Measures for the Registration and Filing of Cosmetics, in order to standardize the registration and filing of new raw materials for cosmetics and ensure the quality and safety of cosmetics.

Article 2

The materials submitted by the registrants or filers of new cosmetic raw materials when applying for registration or filing of new cosmetic raw materials shall meet the requirements of these Provisions.

Article 3

Registration and filing materials for new cosmetic raw materials shall be based on scientific research, and the characteristics, features and safe use requirements of the new raw materials shall be described objectively and accurately.

The registrant, filer or domestic responsible person in charge of the new cosmetic raw material shall submit the registration and filing data of the new cosmetic raw material as required, and be responsible for the legality, authenticity, accuracy, completeness and traceability of the submitted data.

Article 4

The registration and filing documents for new cosmetic ingredients shall use standardized Chinese characters as published by the state. Except for registered trademarks, URLs, patent names, names and addresses of foreign enterprises, and English abbreviations specified in Chinese laws and regulations, all documents using other languages shall be fully and properly translated into Chinese, with the original text appended after the translation.

Article 5

The signature and seal of the registration and filing documents for new cosmetic ingredients shall comply with the relevant laws and regulations of our country ensuring that the documents are complete and legally binding. For overseas enterprises and other organizations that do not use official seals, the legal representative or authorized signatory shall sign the documents. Where authorization is required for signing, the original power of attorney and the original notarized document shall be submitted, and the power of attorney shall specify the matters and scope of authorization.

In addition to the original documents issued by government authorities or relevant institutions, inspection and testing organizations, notary offices, etc., all registration and filing documents shall be stamped page by page with the official seal by the domestic registrant, filer, or domestic responsible person. Users who use electronic encryption certificates with official seals can directly affix electronic seals on electronic documents.

Article 6

The registration and filing materials for new cosmetic raw materials shall use the legal units of measurement in China. If other units of measurement are used, they shall be converted into the legal units of measurement in China; punctuation marks, charts, terms, etc. shall be used in a standardized manner; references shall be cited accurately and effectively, and the source shall be indicated to ensure effective traceability.

Article 7

The main text color of the Chinese text of the registration and filing documents for new cosmetic raw materials shall be black, and the content shall be easy to identify. The line spacing and page margins shall be set appropriately to ensure that the text information is not lost during printing or binding.

The paper for registration and filing shall be in accordance with the international standard A4 size, and the contents shall be complete and clear without alteration. The carrier and writing material of paper documents shall meet the requirements of durability.

Article 8

The registrant or filer of a new cosmetic raw material or the domestic responsible person shall, in accordance with the provisions, apply for registration or file through the information service platform for new cosmetic raw materials (hereinafter referred to as the information service platform). The electronic version of the registration and filing materials filled in and uploaded in the information service platform shall be consistent with the paper version.

Article 9

Before applying for registration or filing of a new cosmetic raw material, the registrant or filer of the new cosmetic raw material shall, through the information service platform, fill in the following information and register user information:

1. Information of the registrant or filing person of the new cosmetic raw material;
2. An overview of the safety risk monitoring and evaluation system for the registrants and filer of new cosmetic raw materials (see Appendix 1);
3. Where the registrant or filer of a new cosmetic raw material is from outside China, the information shall be filled in by the domestic responsible person, and the original authorization letter and notarized document of the person responsible in China shall be submitted at the same time.

For domestic enterprises that simultaneously hold multiple identities such as registrants, filers, or domestic responsible person for new cosmetic ingredients, or are authorized to act as domestic responsible person for multiple overseas new cosmetic ingredient registrants or filers, they can obtain corresponding user permissions by submitting all relevant documents at once. Existing users can supplemental provide additional relevant documents to increase user permissions based on actual circumstances.

Article 10

When the following information of the registrant, filer or domestic responsible person in charge of the new cosmetic raw material changes, it shall be updated to ensure that the relevant information in the information service platform is true and accurate:

1. When the legal representative, contact information and other information of the registrant, filing person or domestic person responsible for the new cosmetic raw material change, users shall update by themselves on the information service platform in time;
2. If the registrant, filer, or domestic responsible person of a new cosmetic ingredient changes any other basic information, the safety risk monitoring and evaluation system for the new ingredient, the scope of authorization, or the duration of authorization changes, they shall submit an updated information form for the registrant or filer of the new cosmetic ingredient (see Appendix 2 for an example) and complete the update of relevant information after submitting the required documentation as per the requirements.

Among them, if the name or address of the overseas registrant or filer changes, they shall provide the original relevant proof document issued by the competent authority or relevant institution of the country (region) where they are located, indicating that the entity has not changed; if unable to submit the original document, they shall provide a copy authenticated by a Chinese notary office or confirmed by a Chinese embassy (consulate). If the name or address of the domestic responsible person changes, they shall provide the original relevant proof document issued by the competent authority or relevant institution of the Chinese government indicating that the entity has not changed.

If the scope of authorization of the domestic person in charge changes, the new scope of authorization shall include the original scope of authorization; if only the term of authorization is updated, the other contents of the authorization letter shall not be changed.

Where the domestic responsible person changes, a letter of commitment shall be submitted to the domestic responsible person who intends to change, undertaking all the responsibilities of the original domestic responsible person. At the same time, a letter of consent from the original domestic responsible person on the replacement of the domestic responsible person or an effective legal judgment document proving the change of the domestic responsible person shall be submitted.

Article 11

An authorization letter of the domestic responsible person shall contain at least the following contents and information:

1. the name of the registrant or filer of new cosmetic raw materials and the domestic responsible person;
2. the relationship between authorization and being authorized;
3. scope of authorization;
4. The term of authorization.

The same cosmetic new ingredient shall not authorize multiple domestic responsible persons. The domestic responsible persons shall carry out registration and filing work within the authorized scope. After the expiration of the authorization term stated in the authorization letter, the domestic responsible person shall submit a new authorization letter for extending the authorization term or change the domestic responsible persons as required 30 days before the expiration of the authorization term.

Article 12

When an applicant for registration or filing of a new cosmetic raw material applies for registration or filing of a new cosmetic raw material, he/she shall submit the following information:

1. The name, address and contact information of the registrant, filer and domestic responsible person;
2. New raw material development report;
3. Research data on preparation process, stability and quality control standards of new raw materials;
4. New raw material safety assessment data.

The registrant, filer or domestic responsible person in charge of the new cosmetic raw material shall classify the new raw material to be registered or filed according to the specific circumstances of the new raw material declared for registration or filing, and organize and submit the corresponding registration and filing data in accordance with the requirements for the registration and filing of new cosmetic raw material (Appendix 3).

The registrants, filers, or domestic responsible persons of new cosmetic ingredients shall combine the relevant technical information from the registration and filing documents of the new ingredients to prepare and provide technical documents for the disclosure of new cosmetic ingredient information (see Appendix 4 for examples). After the new ingredients are approved or the filing is completed, these documents shall be published as attachments to the approval certificate or filing receipt for public reference and inspection by the general public.

Article 13

The research report on the development of new cosmetic raw materials shall be prepared in accordance with the requirements (Appendix 5), and generally shall include the following contents:

1. Background of raw material research and development, including background of research and development, purpose of research and development, research and development process and results of research and development;
2. Basic information of raw materials, including the name, source, composition, relative molecular weight, molecular formula, chemical structure, physical and chemical properties and other information;
3. Information on the use of raw materials, including the specifications of raw materials used in cosmetics, the purpose of use, the scope of application, the safe usage amount, the usage period, the precautions and warning words; the usage status and the approval status of the use of raw materials in cosmetics overseas ;
4. Functional basis of cosmetics new raw materials. The functional basis of cosmetics refers to the relevant data which can prove that the raw material has a consistent relationship with the purpose of use, which generally includes scientific literature, regulatory data, laboratory research data, human efficacy evaluation test data, etc.;
5. other materials related to the development of new raw materials.

Article 14

The brief description of the preparation process for new cosmetic raw materials shall combine the characteristics of the raw material sources, briefly describe the main steps and parameters of the production process, and explain whether the production process may introduce substances posing safety risks and the corresponding control measures. The requirements for preparing brief descriptions of the preparation processes for new raw materials from different sources are as follows:

1. The raw materials for chemical synthesis shall list the specific starting materials, reaction conditions, auxiliary agents used, intermediate products and by-products in the reaction process, and impurities or auxiliary agents remaining in the final product;
2. The natural raw materials shall state the source of raw materials, processing technology, extraction method, etc., including pretreatment method, extraction conditions, impurity removal or separation/purification method, solvents used, possible residual impurities or solvents, etc.;
3. The raw materials from which the biotechnology originates shall state the preparation process of the raw materials such as cultivation, extraction, separation and purification. It shall include the impurities that may be produced in the process, the impurities that may be contained in the raw materials and the harmful microorganisms that may exist;
4. Other sources of raw materials, submit relevant information according to the characteristics of raw materials and the specific preparation process.

Article 15

The quality control standards for new cosmetic raw materials shall be prepared in accordance with the requirements (Appendix 6), and shall generally include the following contents:

1. Stability test data;
2. Quality specification indicators and inspection methods;
3. Potential safety risk substances and their control standards, etc.

Article 16

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

1. Toxicological safety evaluation data shall be compiled in accordance with the requirements of the corresponding toxicological test items, taking into account the characteristics of the new raw materials to be declared and registered, and determining the specific circumstances to which the new raw materials should belong;
2. Safety risk assessment data, including assessment data on the safe usage amounts of raw materials and potential safety risk substances in raw materials and their control measures. Such assessments should be conducted according to the principles and procedures for cosmetic safety assessment established by the National Medical Products Administration and other relevant requirements.

Article 17

Samples of new cosmetic raw materials shall have complete packaging and labels, which shall include the name of the registrant or filer of the new raw material, the Chinese name, the INCI name, the production date and usage period, storage conditions and other information of the raw material.

The registrant, filer, or domestic responsible person in charge of new cosmetic raw materials shall retain samples of the new raw materials for inspection. If the technical review institution needs to examine the samples during the technical review process, the registrant, filer, or domestic responsible person in charge shall submit the samples within the time limit.

Article 18

The registrant, filer or domestic responsible person in charge of the new cosmetic raw material shall collect and sort out the following materials in accordance with the relevant requirements of the safety monitoring period of the new raw material, and prepare the annual report on the safety monitoring of the new cosmetic raw material (Appendix 7) based on the collected and sorted materials:

1. Information on the registrants, filers or entrusted manufacturers of cosmetics produced with new raw materials;
2. Information on cosmetics produced with new raw materials, including product name, product registration certificate number or filing number, quantity of production or import and sale of products, etc.;
3. Supervision, sampling, investigation and recall of cosmetics produced with new raw materials;
4. the adverse reaction monitoring system of cosmetic production enterprises for cosmetics produced with new raw materials, the statistical analysis of adverse reactions of products and the measures taken;
5. The risk monitoring and evaluation management system for cosmetics produced by cosmetics manufacturers and measures taken for cosmetics produced by new raw materials.

The registrant, filing person or domestic responsible person of a new cosmetic raw material shall submit an annual report on the safety monitoring of the new cosmetic raw material through the information service platform within 30 working days before each year expires.

Article 19

The registrants, filers, or domestic responsible persons of new cosmetic ingredients shall immediately collect and organize information on the basic information of the new ingredient, production and usage conditions, analysis of causes for safety issues or emergencies, measures taken, and the results of handling when they discover situations that should be reported to the technical review institution as stipulated in the “Cosmetic Registration and Filing Management Measures,” or other circumstances they deem necessary to report. They shall prepare a safety risk control report for the new cosmetic ingredient (Appendix 8) and submit it to the technical review institution through the information service platform.

Article 20

These Provisions shall come into force as of May 1, 2021.

Appendix

Appendix 1
Safety risk monitoring and evaluation system overview of the registrants/filer of new cosmetic raw materials (example)

Appendix 2
Information update form for registrants/filers of new cosmetic raw materials (example)

Appendix 3
Requirements for registration and filing of new cosmetic raw materials

Appendix 4
Technical requirements for new cosmetic raw materials (example)

Appendix 5
Requirements for preparation of development reports of new cosmetic raw materials

Appendix 6
Requirements for preparation of quality control standards for new cosmetic raw materials

Appendix 7
Requirements for preparation of annual reports on safety monitoring of new cosmetic raw materials

Appendix 8
Requirements for preparation of safety risk control report for new cosmetic raw materials

 

Appendix 1

Safety Risk Monitoring and Evaluation System Overview of the Registrants/Filers of New Cosmetic Raw Materials (Example)

Item	Content or measures (summary)
Position statement	Please briefly describe the position setting of safety risk monitoring and evaluation of cosmetic new raw material registrants/filers, including at least: Related institutions and position settings;Basic requirements for relevant personnel.
Safety risk monitoring	Please briefly describe the relevant safety risk monitoring system, including at least: The overall composition and operation mode of the safety risk monitoring system;Please briefly describe all active or passive information collection channels for the use and safety of new cosmetic ingredients, as well as the frequency of information collection.
Safety risk assessment	Please briefly describe the relevant safety risk assessment system, including at least: The completion mode of safety risk assessment, such as the completion by the registrant or filer of new cosmetic raw materials themselves or by entrusting relevant professional institutions to complete; 2. Safety risk assessment criteria; 3. Safety risk assessment and corresponding measures.
The overseas registrant or filer of new cosmetic ingredients should also briefly describe the mechanisms and measures for information exchange, data sharing, and risk linkage regarding safety risk monitoring and evaluation with the domestic responsible person. The domestic responsible person should briefly describe the specific measures taken to cooperate with the registrant or filer of new cosmetic ingredients in safety risk monitoring and evaluation, including the setup of job responsibilities and relevant systems for safety risk monitoring and evaluation.
(Stamp of the registrant/filer of new cosmetic raw materials) Year  Month  Date

Appendix 2

Information Update Form for Registrants/Filers of New Cosmetic Raw Materials (example)

New raw material registrant and filer: Responsible person in China:
Data item	Specific modules	Specific items	Updated content	Information to be submitted
(1) Information sheet of the registrant/filer	Essential information	□ Name (Chinese)		If the name or address changes, the original relevant certification documents issued by the competent department or relevant institution of the government of the country (region) where the subject is located shall be provided to prove that the subject has not changed
		□ Name (foreign language)
		□ Address
		□ Country/region of residence
(2) Overview sheet of safety risk monitoring and evaluation system	□ Overview table of safety risk monitoring and evaluation system			Overview of safety risk monitoring and evaluation system
(3) Information sheet of domestic responsible person	Essential information	□ The name of enterprise
		□ Address
		□ Actual location
(4) Letter of authorization of domestic responsible persons	□ Authorization scope		(The scope of the new authorization shall include the original scope of the authorization)	Resubmit the authorization letter of the domestic responsible person and related materials
	□ Authorization period		(The contents of the letter of authorization shall not be changed)
(Seal of the registrant or filer of new cosmetic raw materials) Year  Month  Date

Appendix 3

Requirements for Registration and Filing of New Cosmetic Raw Materials

To scientifically and reasonably determine the safety risk level of new cosmetic ingredients, based on their usage history and consumption history in cosmetics both domestically and internationally, combined with the functions and characteristics of the ingredients, new ingredients should be classified. Cosmetic registrants, filers, or domestic responsible persons should classify the specific circumstances of the new ingredients they are applying for registration or filing according to the following requirements and submit the necessary registration and filing documents.

I. General Requirements

The registration and filing documents of new cosmetic raw materials shall clearly state the source and research and development of the new raw materials, the preparation process and quality control and safety assessment of the new raw materials, and shall be able to fully prove that under the limited usage conditions, the safety and risk control of the new raw materials used in the production of cosmetics.

The scientific literature or regulatory materials cited in the registration and filing documents of the new cosmetic raw materials shall be relevant to the new raw materials for registration or filing. The restrictive conditions such as the source of raw materials, usage purpose, specifications of use and application scope stated in the documents shall apply to the new raw materials for registration or filing.

II. Inspection Requirements for Relevant Data

1 Requirements for inspection reports

(1). Requirements for the issuing institution of the inspection report. The registrant or filer of new raw materials shall, in accordance with the relevant requirements for inspection, conduct necessary inspection on the new raw materials by themselves or entrust relevant inspection and testing institutions, and provide true and effective samples for inspection to the inspection institutions undertaking the inspection tasks according to the needs of the inspection items.

The reports on physical and chemical tests and microbial tests, as well as the evaluation reports on functions other than preservative, sun protection, skin whitening, hair loss prevention, etc., can be issued by the registrants or filers of new cosmetic raw materials themselves or by inspection and testing institutions with corresponding inspection capabilities.

The toxicology test reports and inspection reports for the evaluation of preservative, sun protection, skin lightening, anti-hair loss effects, etc., should be issued by inspection institutions that have obtained accreditation (CMA) or recognition from the China National Accreditation Service for Conformity Assessment (CNAS) in the cosmetics field, or that comply with internationally recognized Good Clinical Practice (GCP) or Good Laboratory Practice (GLP).

(2).Requirements for inspection reports and style requirements. Inspection institutions undertaking the task of inspecting new cosmetic raw materials shall, in accordance with the relevant provisions of the “Cosmetic Registration and Filing Inspection Work Specifications” issued by the National Medical Products Administration, issue inspection reports on corresponding inspection items.

2 Requirements for inspection methods

(1). Requirements for Physicochemical Microorganisms and Evaluation Methods. For the physicochemical and microbial testing of new cosmetic ingredients, as well as human safety and efficacy evaluation tests, the testing methods stipulated in the “Cosmetic Safety Technical Specifications” or the “Pharmacopoeia of the Peoples Republic of China” should generally be referred to. For items not specified in the “Cosmetic Safety Technical Specifications” or the “Pharmacopoeia of the Peoples Republic of China,” testing should be conducted according to national standards, internationally recognized methods, or self-developed experimental methods. When using self-developed experimental methods, relevant materials on the applicability and reliability of these methods must also be submitted.

(2). Toxicological methods requirements. Toxicological test items for new raw materials shall be carried out in accordance with the test methods specified in the Technical Specifications for Safety of Cosmetics. For items not specified in the Technical Specifications for Safety of Cosmetics, tests shall be conducted in accordance with national standards or internationally accepted methods.

(3). Requirements for animal alternative methods. When using animal alternative methods for toxicological safety evaluation, appropriate integrated testing and assessment methods (IATA) should be selected based on the structural characteristics of the raw materials and specific toxicological endpoints to evaluate the toxicity of new raw materials. If the applied animal alternative test methods have not been included in Chinas “Cosmetic Safety Technical Specifications,” these alternative test methods should be those already documented by internationally recognized alternative method validation organizations, and proof that the method can accurately predict the toxicological endpoint must be submitted simultaneously. The proof should include a brief description of the research process of the alternative test method and data from studies involving no fewer than 10 known toxic test substances, along with results analysis and research conclusions.

III. Requirements for Toxicological Safety Evaluation Related Data

1 General requirements

The registrants or filers of new cosmetic ingredients shall select appropriate toxicological test items based on the specific circumstances of applying for registration or filing new cosmetic ingredients, conduct toxicological safety evaluations, and provide corresponding toxicological safety evaluation data. They shall combine the toxicological test items conducted for the new ingredient, summarize the methods, procedures, and toxicological endpoints of each toxicological test item by item, provide a comprehensive review of the toxicological safety evaluation of the new ingredient, and derive the safety evaluation results.

The toxicological safety evaluation data of new cosmetic raw materials can be the test reports of toxicological test projects conducted by the registrants or filers of new cosmetic raw materials themselves or on their behalf, scientific literature and content released by official websites of domestic and foreign governments and international organizations.

2 Requirements for toxicological test items

For new cosmetic ingredients that are subject to application for registration or filing, the following toxicological test items shall in principle be provided. Depending on the purpose, physicochemical properties, quantitative structure-activity relationships, toxicological data, clinical studies, population epidemiological surveys, and toxicity of similar compounds of the new ingredients, additional or reduced toxicological test items may be added or reduced accordingly.

• Acute oral or acute percutaneous toxicity test;
• Skin and eye irritation/corrosion test;
• Skin allergic reaction test;
• Skin photoactivity test (the raw material has ultraviolet absorption characteristics, which needs to be tested);
• Skin photoallergy test (the raw material has ultraviolet absorption characteristics, so this test should be done);
• Mutagenicity test (at least one gene mutation test and one chromosomal aberration test);
• Subchronic oral or dermal toxicity test (if the substance is likely to be ingested orally in cosmetics, a subchronic oral toxicity test should be provided);
• Teratogenicity test;
• Combined chronic toxicity/carcinogenicity test;
• Inhalation toxicity test (the test shall be performed when the raw material may be exposed to inhalation);
• Long-term human trial safety test;
• Toxicological test data for other items shall be provided according to the characteristics and uses of raw materials.

For new raw materials used for the first time at home and abroad with health hazard effects (excluding local toxicity), the toxicological test data of items 1~12 mentioned above shall be provided, and the test data of toxic metabolization and kinetics shall also be submitted.

For the first time used at home and abroad, new raw materials with high biological activity such as oligopeptides, peptides and proteins shall provide the toxicological test data of items 1~12 mentioned above, and shall also submit the skin absorption/transdermal test and immunotoxicity test data.

Nanomaterials should provide the toxicological test data listed in items 1 to 12 above, and also provide an explanation of the applicability of each toxicological test method for nanomaterials. For nanomaterials intended for use on the skin, skin absorption/permeation absorption test data should also be provided; for nanomaterials that may be inhaled, inhalation toxicity test data should also be provided.

3 Classification of circumstances and corresponding requirements for data items

According to the functions and characteristics of new raw materials, as well as their usage history in cosmetics both domestically and internationally, or their consumption history, etc., new raw materials are categorized into six scenarios. The registrants or filers of new raw materials should combine the characteristics of the new raw materials being declared or filed to determine the specific scenario to which the new raw materials belong and submit corresponding toxicological test project data (see attached table):

Situation 1: For the first use at home and abroad of cosmetics with anti-corrosion, sun protection, coloring, hair dyeing, spot removal and whitening, hair loss prevention, acne removal, anti-wrinkle (excluding physical anti-wrinkle), dandruff removal, deodorizing function and other new raw materials with high biological activity at home and abroad, the toxicological test data of items 1~12 mentioned above shall be submitted;

Situation 2: For new raw materials that are used for the first time at home and abroad, which do not have anti-corrosion, sun protection, coloring, hair dyeing, spot removal and whitening, hair loss prevention, acne treatment, anti-wrinkle (except physical anti-wrinkle), dandruff removal, odor removal functions, the toxicological test data of items 1~7 mentioned above shall be submitted;

Situation 3: For new raw materials that do not have anti-corrosion, sun protection, coloring, hair dyeing, spot removal and whitening, anti-hair loss, acne treatment, anti-wrinkle (excluding physical anti-wrinkle), dandruff removal, and deodorizing functions, and can provide sufficient evidence to prove that the raw material has been safely used in cosmetics marketed overseas for more than three years, the toxicological test data listed in items 1-6 above shall be submitted;

If the safety assessment report or the human safety test report under ethical conditions can be provided at the same time, which can provide the evaluation conclusion of an international authoritative safety evaluation agency that the use in cosmetics is safe, the data of acute oral or acute dermal toxicity test can be omitted;

Situation 4: New raw materials with functions of anti-corrosion, sun protection, coloring, hair dyeing, spot removal and whitening, anti-hair loss, acne treatment, anti-wrinkle (excluding physical anti-wrinkle), dandruff removal, and deodorization, and which can provide sufficient evidence to prove that the raw material has been safely used in cosmetics marketed overseas for more than three years, shall submit the toxicological test data items 1-7 mentioned above;

Situation 5: For new cosmetic raw materials with a history of safe consumption (the parts used by the raw materials should be consistent with the parts used for consumption), the toxicological test data mentioned in items 2 to 5 above shall be submitted, and the risk assessment of the raw materials shall be carried out according to the exposure amount and use mode of the raw materials;

Situation 6: A polymer with a low molecular weight content of less than 10% and stable structure and properties (except for materials with high biological activity), which is synthesized chemically from one or more structural units connected by covalent bonds and has an average molecular weight greater than 1000 Daltons but less than 1000 Daltons, shall submit the toxicological test data for items 2 and 4 above.

The evaluation conclusions of international authoritative institutions have identified that the use of new ingredients in cosmetics is considered safe, or that the new ingredients have been approved for use by overseas cosmetic regulatory authorities. In such cases, the relevant content from the assessment reports of international authoritative safety evaluation institutions, approval certificates from overseas cosmetic regulatory authorities, and other relevant documents should be organized and submitted according to the classification requirements.

4 Requirements for safe use of historical data

If all the following conditions are met, it can be regarded as a new raw material that has been used safely for more than three years in cosmetics listed overseas. For new raw materials that meet the above circumstances 3 and 4, the corresponding information shall be provided at the same time:

• The quality specifications, purposes and applicable or usage scope of the new raw materials and the raw materials used in cosmetics marketed overseas are the same; the safe usage amount of the new raw materials is not higher than that used in cosmetics listed overseas;
• The cosmetics containing the raw material shall not be listed overseas for less than 3 years;
• Be able to prove that there are sufficient users of cosmetics containing the raw material in overseas;
• The cosmetics containing the raw material listed overseas have not experienced any serious adverse reactions or group adverse reactions caused by the raw material;
• No literature reports related to the raw material that may be harmful to human health have been found.

5 Requirements for historical data related to safe consumption

If any of the following conditions are met, it can be regarded as a new raw material with a history of safe consumption. If the new raw material meets the above circumstances 5, it shall also provide corresponding information:

• Food raw materials that have obtained food safety certification or other corresponding qualifications from relevant supervision and management departments in China;
• Raw materials that can be safely consumed as released by relevant supervision and management departments, technical institutions or other authoritative institutions at home and abroad.

Appendix table: Classification of new cosmetic raw materials and requirements for data items

Scenario classification Information requirements		Scenario 1	Scenario 2	Scenario 3	Scenario 4	Scenario 5	Scenario 6
I. Basic information	1. Registration or filing of raw material information form	○	○	○	○	○	○
II. Research report	2. Research and development background	○	○	○	○	○	○
	3. Basic information of raw materials	○	○	○	○	○	○
	4. Raw material usage information①	○	○	○	○	○	○
	5. Functional basis data	○	○	○	○	○	○
	6. Develop other relevant materials	○	○	○	○	○	○
III. Preparation process and quality control standards	7. Brief description of preparation process	○	○	○	○	○	○
	8. Stability test data	○	○	○	○	○	○
	9. Quality specification indicators and inspection methods	○	○	○	○	○	○
	10. Information on possible safety risk substances and their control②
IV. Safety evaluation	11. Summary of toxicological safety evaluation	○	○	○	○	○	○
	12. Acute oral or acute percutaneous toxicity tests③	○	○	○	○
	13. Skin and eye irritation/corrosion tests	○	○	○	○	○	○
	14. Skin allergy test	○	○	○	○	○
	15. Skin photoactivity test④
	16. Skin photoallergy test⑤
	17. Mutagenicity test	○	○	○	○
	18. Subacute oral or percutaneous toxicity tests	○	○		○
	19. Teratogenicity test	○
	20. Combined chronic toxicity/carcinogenicity test	○
	21. Inhalation toxicity test⑥
	22. Long-term human trial safety tests	○
	23. Other toxicological tests⑦
	24. Safety assessment report	○	○	○	○	○	○
V. Other Materials	25. Technical requirements for new raw materials	○	○	○	○	○	○
	26. Other information that may be helpful for the registration and filing of new cosmetic ingredients⑦

Note: The items marked with “○” in the above table indicate that the information must be submitted. The meaning of the items required is explained as follows:

① For new raw materials that have been used overseas, the situation of their use in cosmetics should be explained.

The new raw materials that may pose safety risks should submit such information.

③ In case 3, if the safety assessment report of an internationally authoritative safety evaluation agency can be provided at the same time, which considers that the use of cosmetics is safe, or the safety test report under ethical conditions, the information shall not be submitted.

④ When the raw material has UV absorption characteristics, the test data shall be submitted.

⑤ Except for case 6, the test data shall be submitted when the raw material has UV absorption characteristics.

⑥ The data must be submitted if inhalation exposure is possible with the raw material.

⑦ Other information submitted according to the actual situation of each new material.

Appendix 4

Technical Requirements for New Cosmetic Raw Materials

(Example)

I. Basic information

1 Name

• Standard Chinese name
• INCI name and ID number, or English and other foreign names
• Chemical name, or name of plant and animal raw materials (Latin name)
• Product name, alternative name, abbreviation, etc.

2 Registration number

• CAS registration number
• EINECS/ELINCS registration number
• Other relevant registration numbers

3 Source of raw materials

4 Raw material composition, molecular formula, chemical structure and relative molecular mass, etc

5 Physical and chemical properties

II. Technical requirements

1 Purpose of raw material use

2 Applicable or scope of use of raw materials

3 Safe usage

III. Other requirements

1 Precautions and warning words

2 Storage conditions

3 Duration of use

Appendix 5

Requirements for Preparation of Reports on the Development of New Cosmetic Raw Materials

The report on the research and development of new cosmetic raw materials shall generally include the following contents:

I. Background of Research and Development

Including the background of raw material research and development, the purpose if research and development, the process of research and development and the results of research and development

II. Basic information

Including raw material name, source, composition, relative molecular mass, molecular formula, chemical structure, physical and chemical properties, etc.

1 Name of raw materials

The name of raw materials generally includes the standard Chinese name of raw materials, INCI name and its ID number, chemical name, animal and plant raw material name (Latin name), the name of the Pharmacopoeia of the Peoples Republic of China, common alternative names or abbreviations, CAS number and EINECS/ELINCS registration number, etc.

(1) Chinese names of raw materials standards

For raw materials already included in the “Directory of Chinese Names of International Cosmetic Ingredients,” their standards should be clearly defined according to the directory; for raw materials not included, their Chinese names can be referred to from authoritative directories such as the “Pharmacopoeia of the Peoples Republic of China” and other relevant sources and formulated in accordance with commonly accepted nomenclature principles.

(2) INCI name and ID number of raw materials

For raw materials that have been included in the International Dictionary and Handbook of Cosmetics Ingredients, the INCI English name and corresponding ID number of raw materials should be specified; for those not included, the corresponding English name should be provided.

(3) Other names, including chemical names, names of animal and plant raw materials (latin names), mineral names, widely used alternative names, common names, trade names, abbreviations, etc.

2 Source of raw materials

(1) New raw material sources include chemical raw materials, plant raw materials, mineral raw materials, biotechnology raw materials (such as genetic engineering, cell engineering, fermentation engineering, enzyme engineering and protein engineering sources, etc.).

The registrant or filer of a new cosmetic raw material shall specify the source of the new cosmetic raw material applied for registration and filing, and provide corresponding basic information according to the source of the raw material.

(2) New raw materials should be of a single origin and not compound materials formed by physical mixing; exceptions are made when multiple components coexist due to unavoidable technical reasons during the production or preparation process of the raw material. For example: solvents, preservatives, stabilizers, and other components added to protect the raw material, or other components inevitably present alongside the raw material through chemical reactions or fermentation processes.

In the process of production or preparation of raw materials, if a variety of components are inevitably caused by unavoidable technical reasons, the registrant or filing person of new cosmetic raw materials shall also provide relevant research data on the inevitable coexistence of two or more components, composition of raw materials and related proportions.

3 Composition, structure and composition identification

(1) For raw materials with a clear chemical structure, provide the chemical structure and molecular weight, as well as evidence confirming the chemical structure (such as NMR spectra, elemental analysis, mass spectrometry, infrared spectra, etc.), and test reports; polymers should also provide the degree of polymerization and the method and results for determining the average molecular weight and its distribution; biotechnological source materials should have identification methods established based on their inherent characteristics.

(2) For raw materials without clear chemical structure, the composition of raw materials should be explained, and identification parameters, identification methods and identification reports should be provided.

4 Physical and chemical properties

(1) According to the properties of the raw materials, the characteristic indicators include color, odor, state, and other significant properties (such as flammability, solubility, hygroscopicity, etc.), and other physicochemical indicators should be selected based on the properties of the raw materials, such as melting point, boiling point, specific gravity, viscosity, pH value, refractive index, optical rotation, hydroxyl value, iodine value, saponification value, acid value, pKa value, partition coefficient (LogPow), etc.

(2) Nano raw materials: In addition to providing the above physicochemical indicators, specific parameters such as particle size and distribution, aggregation and agglomeration characteristics of raw materials, surface chemical information, morphology information should also be provided.

Nanomaterials are artificial materials that are insoluble or biodegradable or not biodegradable in three-dimensional space structures in which at least one dimension is 1 to 100 nanometers or is composed of them as basic units.

III. Raw material usage information

Including the specifications of raw materials used in cosmetics, the purpose of use, the scope of application or use, the safe amount of use, the period of use, the precautions and warning words; the status of raw materials used in cosmetics overseas and the approval status.

IV. Raw material function based on data

The function of the new raw material is generally based on scientific literature, regulatory data, laboratory research data, human efficacy evaluation test data, etc., and the specific requirements are as follows:

1 Scientific literature

Scientific literature mainly includes relevant research papers or scientific works published publicly that are not of a review nature. The literature provided should be positively correlated with the function of the new raw material registered or filed.

When submitting literature, the raw material research process summary, research results, result analysis and conclusion corresponding to the relevant content of the literature shall be submitted at the same time.

2 Regulations and materials

Regulatory materials mainly include standards, catalogs, classics and works issued by domestic and foreign regulatory authorities or technical departments, etc., and the specific information of raw materials indicated by regulatory materials should be provided, such as usage concentration, scope of use, other restrictions, etc.

When citing the positive list of functional ingredients specified in cosmetic regulations issued by foreign regulatory authorities, the name of the regulation, the issuing country (region) and issuer, the issuance time and its relevant full text of the regulation shall be submitted, along with a statement that the new ingredient used for registration or filing fully complies with all the requirements specified in the relevant regulations regarding the usage concentration, scope, and other restrictions.

3 Laboratory research data

The research data mainly include the results of physico-microbial tests, in vitro tests or animal tests. The selected test models should reasonably present and simulate the in vitro use of new raw materials.

Where the results of in vitro or animal tests are used as research data, the registrant or filer of a new cosmetic ingredient shall provide relevant test data, results and conclusions on the effective amount and safe use amount of the new ingredient with respect to its registered or filed functions, and explain the mechanism by which the new ingredient has the relevant functions.

4 Human functional evaluation test data

The evaluation of cosmetic efficacy claims should be conducted in accordance with the principles and procedures established by the National Medical Products Administration, providing relevant experimental data including test methods, number of subjects, design of control groups, effective and safe usage amounts of the efficacy claims of new ingredients, experimental results, and analyses. The efficacy components in the test substances should be exclusively new ingredients that have been registered or filed. Before conducting human trials, it should be ensured that the toxicological data and exposure conditions of the test substances meet the safety requirements for human use, and the use of substances with potential safety hazards in human efficacy evaluation trials is prohibited.

The functional basis of the above-mentioned new raw materials can be concluded through single-item or combined methods, providing a clear conclusion that the new raw materials claimed to have the declared functions. The functional basis materials for new raw materials claiming to have anti-corrosion, sun protection, skin lightening and whitening, anti-hair loss, acne treatment, anti-wrinkle (excluding physical anti-wrinkle), dandruff removal, and deodorizing functions should at least include laboratory research data or human efficacy evaluation test data.

V. Other information related to the development of new raw materials

Other information not included in the above research and development materials shall be provided according to the actual situation.

Appendix 6

Requirements for the Preparation of Quality Control Standards for New Cosmetic Raw Materials

The quality control standards of new cosmetic raw materials include stability test data, quality specification indicators and their inspection methods, as well as possible safety risk substances and the control.

I. Stability test data

The key items to be examined in the stability test of new cosmetic raw materials shall be those that are prone to change during storage and may affect the quality and safety of new raw materials, including but not limited to observing the characteristics of raw materials (color, odor, etc.), physical and chemical properties, composition content, etc., and the regularity of change over time under the influence of temperature, humidity, light, etc.

Stability testing generally includes destructive testing, accelerated testing, long-term testing, and other experimental methods. The registrants or filers of new cosmetic ingredients shall select the type of stability test data to be provided based on the characteristics of the new ingredients they are registering or filing, and determine the storage conditions and usage period of the ingredients according to the results of the stability tests.

For new raw materials used for the first time at home and abroad, at least three batches of raw materials shall be submitted for accelerated test or long-term storage test data for more than one year, and according to the service life of raw materials, the remaining long-term storage test data for the remaining service life shall be provided in one batch or annually within the three-year monitoring period.

(1) Destruction test.

At least one batch of raw material stability test data shall be provided under high temperature (such as 60℃), low temperature (such as-20℃), high humidity (such as 90%RH ± 5% RH) or strong light exposure storage conditions. The influencing factors and specific parameter settings can be selected according to the characteristics of the raw material.

(2) Acceleration test.

At least three batches of raw materials shall be provided for stability test data under certain temperature and humidity (such as 40℃±2℃,75%RH ± 5% RH) storage conditions and storage periods. The test conditions and storage periods shall be determined according to the characteristics of the raw materials.

(3) Long-term storage test.

At least three batches of raw materials shall be provided to test the stability of long-term storage under certain temperature and humidity conditions (such as 25℃±2℃,60%RH ± 10% RH). The test conditions and storage period can be determined according to the characteristics of raw materials.

II. Quality specification indicators and inspection methods

(1) Characteristics of raw materials and their inspection methods.

The characteristics of raw materials include color, odor, state, etc.

(2) Physicochemical properties of raw materials.

Appropriate physical and chemical indexes and testing methods, such as melting point, boiling point, specific gravity, viscosity, pH value, optical rotation, etc., should be provided according to the characteristics of raw materials.

(3) Qualitative identification method.

The appropriate identification methods should be set according to the structural characteristics of raw materials, such as infrared spectroscopy, ultraviolet spectroscopy, nuclear magnetic resonance spectroscopy, chemical reaction method, chromatography, etc.

(4) Control index of raw material purity and inspection method.

The purity or content of raw materials, the types of impurities and their control indicators and testing methods shall be provided, and the test report shall be provided.

The new raw materials such as solvents, preservatives and stabilizers that are inevitably present due to technical reasons should provide control indicators for the composition and related proportions of raw materials.

(5) Requirements for packaging, transportation and storage of raw materials.

(6) The purpose of the use of raw materials, the scope of application or use, the specifications and safe usage amount, precautions, warning words, etc.

III. Possible safety risk substances and the control standards

Set appropriate quality and safety limit indicators and testing methods in the raw material quality specifications, such as microbial, heavy metal, harmful substances (such as harmful components, harmful impurities, harmful solvents, etc.) control indicators.

Appendix 7

Requirements for the Preparation of Annual Reports on Safety Monitoring of New Cosmetic Raw Materials

The registrants and filers of new cosmetic raw materials shall collect relevant information on the use of new raw materials in a timely manner according to the relevant requirements for monitoring new raw materials and prepare annual safety monitoring reports on new raw materials in accordance with these requirements.

I. Basic information of raw materials

Including the Chinese name of new raw materials, filing number, etc.

II. Production of raw materials

(1) Name, address and relevant qualification of the production enterprise.

(2) Annual production and sales volume of new raw materials, etc.

III. Information on cosmetics using new raw materials

(1) Summary of cosmetics enterprises using new raw materials, including the name and quantity of cosmetics enterprises, the quantity of new raw materials purchased, the quantity of products sold, etc.

(2) List the product names, approval number/record number, cosmetic registrant, recorder, name and address of the entrusted manufacturer using new raw materials in the form of a list (see Table 1 for details).

Table 1 Summary information on cosmetics using new ingredients

Order number	Product name	Approval number / Note Case number	Name of the registrant or filing person of cosmetics	Address	Entrusted production the name of firm	Production license number	Address	Wash or stay	Purpose of use of new raw materials	Product production and sales volume
1
2
3

IV. Supervision, sampling inspection, investigation and recall of cosmetics using new raw materials

The relevant information of supervision and sampling inspection, investigation or recall of cosmetics using new raw materials shall be listed in the form of list (see Table 2 for details).

Table 2 Supervision and sampling inspection, investigation or recall of cosmetics using new raw materials

time	Type of situation	product name	Approval number/record number	Cosmetic registrants and filers	address	Brief description of the situation	remarks
	Supervision and spot check
	investigate and treat
	recall

V. Monitoring of adverse reactions

The registrants and recordal holders of new cosmetic raw materials shall respectively describe the adverse reaction monitoring system and the statistical analysis of adverse reactions of cosmetics registered by the registrants and recordal holders using the new raw materials, and take measures, and form a summary analysis report on the adverse reaction monitoring of the new raw materials.

(1) The construction of adverse reaction monitoring system for registrants and recordal persons of cosmetics using new raw materials, and the situation of staff responsible for adverse reaction monitoring and evaluation;

(2) Statistics on adverse reaction monitoring of cosmetics using new raw materials: total number of cases, number of serious adverse reactions, number of adverse reactions that may cause great social impact, whether adverse reactions are reported to adverse reaction monitoring institutions, etc.;

(3) Analysis and evaluation of adverse reactions of cosmetics using new raw materials: such as severity and correlation evaluation;

(4) Investigate, evaluate and take measures against adverse reactions to cosmetics using new raw materials;

(5) Information related to adverse reactions of new raw materials: analysis and evaluation of adverse reactions between new raw materials and patients; cases of suspected serious adverse reactions or group adverse reactions caused by the raw materials found in other countries (regions). Relevant information can be attached at the same time.

VI. Risk monitoring and evaluation management

(1) Description of the risk monitoring and evaluation management system for enterprises producing new raw materials and using new raw materials.

(2) Take measures etc.

VII. Other matters requiring explanation

For new raw materials used for the first time at home and abroad, long-term storage test data with the remaining service life should be provided annually during the 3-year monitoring period according to the service life of the raw materials.

VIII. Summary analysis and conclusion of monitoring reports

Summarize and analyze the monitoring report to form corresponding conclusions.

Appendix 8

Requirements for Preparation of Safety Risk Control Report of New Cosmetic Raw Materials

If the use of new cosmetic raw materials is found to be subject to reporting, the registrant or filing person of the new cosmetic raw materials shall collect relevant information in time and prepare a safety risk control report for the new raw materials in accordance with these requirements.

I. Basic information

Including the Chinese name of the new raw material, filing number, etc.

II. Production situation

(1) Name, address and relevant qualification of the production enterprise.

(2) Annual production volume, sales volume, etc.

III. Information on cosmetics using new raw materials

(1) Summary of cosmetics enterprises using new raw materials. It includes the name of the enterprise, the purpose of using new raw materials, the purchase and usage quantity, etc.

(2) List in table form the product name, registration number/filing number, cosmetic registrant, filer, name and address of the manufacturer, purpose and amount of use of the new raw material in the product, etc.

Table 1 Summary information of cosmetics using new raw materials

Order number	Product name	Approval number/Note Case number	Name of the registrant or filing person of cosmetics	Address	Entrusted production the name of firm	Production license number	Address	Wash or stay	Purpose and amount of new raw material use	Product production and sales volume
1
2
3

IV. Emergency situations

(1) Description of emergency situation

Including the analysis of the causes of emergencies, the adverse effects caused and the consequences.

(2) Take measures

(3) Handling results

(4) Work plans and suggestions

V. Other matters to be explained

If there are other contents that need to be explained in addition to the above contents, they shall be explained according to the actual situation.

VI. Summary analysis and conclusion

Summarize and analyze the report to form corresponding conclusions.