Specification for registration and filing of new cosmetic raw materials

(Draft for comment)

 

Chapter I basic requirements

1. Formulation basis

In order to regulate the preparation and submission of various materials for the registration and filing of new cosmetic raw materials, this code is formulated in accordance with the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Administration of Cosmetics Registration and the provisions of relevant laws and regulations.

2. Scope of application

The new raw materials of cosmetics produced and operated within the territory of the People's Republic of China shall be prepared for registration and filing in accordance with the requirements of this Code, and submitted in the prescribed form.

Third, general requirements

The content of the registration and filing of new raw materials of cosmetics shall comply with the requirements of the relevant regulatory regulations of cosmetics in China. The registrant/recordholder of new cosmetic raw materials shall be responsible for the authenticity, scientificity and completeness of the registration and recordkeeping materials, and bear the corresponding legal responsibilities. If the registrant/record of the new raw materials of cosmetics is an overseas enterprise, it shall cooperate with the domestic responsible person to provide registration and record information, and supervise the registration and record behavior of the domestic responsible person.

4. User permission requirements

If the reporting enterprise has the user authority of the cosmetics registrant/record holder or the domestic responsible person, and the role is consistent with the declaration of new raw materials, it can directly use the user authority. Otherwise, it should refer to the relevant requirements of the "Cosmetic Registration and Filing Data Specification", and first open the user rights of the registrant/filing person or the domestic responsible person, of which the information in (2) "Overview of the quality management system of the Registrant/filing person" need not be submitted.

In the event of subsequent changes in user information, permissions or submitted user permissions, maintenance shall be carried out in a timely manner in accordance with the relevant requirements of the "Cosmetic Registration and Filing Data Specification", and the relevant new raw material registration certificate/filing certificate shall be changed.

V. Form of data and submission requirements

The basic requirements and submission requirements for electronic and paper materials of new raw materials of cosmetics shall be implemented in accordance with special cosmetics. The registration and filing data of new raw materials shall comply with the form requirements stipulated in the "Cosmetic Registration and Filing Data Specification".

6. Test report requirements

Toxicology test reports and anti-corrosion, sun protection, freckle whitening and new function evaluation reports should have CMA or CNAS qualification, or comply with the internationally accepted "Good Clinical Practice" (GCP) or "Good Laboratory Practice" (Good Laboratory Practice) Practice,GLP) issued by laboratory; The laboratory shall provide its qualification certificate and shall be responsible for the authenticity of the test results issued by it.

Physical and chemical tests, microbial tests and functional evaluation tests other than anti-corrosion, sun protection, freckle whitening and new functions can be carried out by the registrant or the filing person himself or entrusted with the corresponding ability of the testing institution. The registrant or recordholder shall be responsible for the authenticity and completeness of the test samples and relevant materials provided by him. If the registrant or recordholder conducts its own inspection work, it shall provide a self-declaration to ensure that the results are true and objective.

7. Test method requirements

Toxicology test methods shall be tested using the methods included in the Technical Specification for Cosmetic Safety. If the methods not included in the Technical Specification for Cosmetic Safety are used, they shall be tested according to the internationally accepted methods or national standards. If the method used is inconsistent with the method in the Technical Code for Cosmetic Safety, evidence of the consistency of the results obtained by the two methods should be provided. Test methods such as physical and chemical, microbiological and functional evaluation should be preferentially adopted in accordance with standard methods such as "Technical Code for Cosmetic Safety", "Pharmacopoeia of the People's Republic of China" and national standards. Human trials for functional evaluation should be evaluated in accordance with the requirements of the Guiding Principles for Evaluation of Cosmetic Efficacy Claims.

Viii. Scientific literature/regulatory data requirements

Quoting the content of scientific literature/regulatory information as the basis for the application of data items or providing new raw material safety evaluation data exemption, should be logically related to the new raw materials declared, that is, the source of raw materials, purpose of use, use specifications, application or scope of use, safe use and other restrictions should be consistent with the new raw materials declared.

9. Record commitment

When filing new raw materials, the recordholder shall promise that according to the existing relevant literature or research data, the new raw materials of cosmetics filed do not have anti-corrosion, sunscreen, coloring, hair coloring, freckle whitening functions. If the new raw materials have anti-corrosion, sunscreen, coloring, hair coloring, freckle whitening functions, the registrant/recordholder should first register the new raw materials after passing, and then handle the record.

 

Chapter II Data requirements for registration and filing

1. Application Form

1. Application for registration or filing

The registrant or filing person shall complete the relevant contents of the application form for registration or filing of new cosmetic raw materials in the system (see Annex 1).

Ii. Development report

The registrant or filing person shall submit a new raw material development report, which generally includes the following:

2. R&d background

Including the background and process of raw material research and development and related technical information including intellectual property content.

2.1 Briefly describe the purpose, significance and management classification of R&D (registration or filing).

2.2 The intellectual property status of the declared raw materials at home and abroad should be elaborated, and the relevant statement of non-infringement of the intellectual property rights of raw materials should be provided.

2.3 Elaborate the latest research progress of raw materials at home and abroad.

3. Basic information

Including name, source, relative molecular mass, molecular formula, chemical structure, etc.

3.1 Name: including INCI name and its ID number, INCI standard Chinese translation name, chemical name, plant and animal raw materials name (Latin scientific name), Pharmacopoeia of the People's Republic of China name, common alias or abbreviation, CAS number and EINECS/ELINCS registration number.

3.1.1 INCI name and ID
If the raw material has been included in the "International Cosmetic Ingredients Dictionary and Manual" of the American Personal Care Products Association (PCPC), the INCI English name and INCI ID number of the raw material should be clearly defined.
3.1.2 INCI standard Chinese translation
If the raw material has been translated into Chinese by INCI standard, it should be specified according to the Catalogue of Chinese Names of International Cosmetic Raw Material Standards.
3.1.3 Chemical name
3.1.3.1 If the raw material is organic (including polymers), it should be clear that its chemical name conforms to the Principles of Organic Chemical Nomenclature.
3.1.3.2 If the raw material is inorganic, it should be clear that its chemical name conforms to the Principles of Inorganic Chemical Nomenclature.
3.1.3.3 If the raw material is mineral, its chemical name should be specified in accordance with the corresponding naming principle.
3.1.4 Names of animal and plant raw materials (Latin scientific names)

If the raw material is of natural origin, such as animals or plants, it shall be named according to the format of "Chinese name + Latin scientific name + use part + use form" in the Catalogue of Chinese Names of International Standards for Cosmetic Raw Materials, and shall include the Latin scientific name of the plant from which it is derived and its use part. When the purity of a single ingredient extracted from a plant is ≥80%, it should be registered or filed according to the name of the ingredient.

3.1.5 Name of the Pharmacopoeia of the People's Republic of China
If the raw material has no standard Chinese name but has been included in the People's Republic of China Pharmacopoeia, the name used in the People's Republic of China Pharmacopoeia should be clear, and the version information of the People's Republic of China Pharmacopoeia should be clear.
3.1.6 Common aliases or abbreviations
If the formulated raw materials have aliases, common names, trade names, abbreviations, etc., which are more commonly used or widely used by the cosmetics industry, they should be clarified at the same time.

3.2 Source

3.2.1 Chemical raw materials should provide molecular formula and chemical structure formula information, if can be clear molecular weight, should be clear; The basis for the confirmation of the chemical structure (such as the structure identification map and the analytical process) should be provided, and the relative average molecular weight of the polymer and its determination method should also be provided.

3.2.2 Natural raw materials refer to raw materials derived from natural substances (plants, animals, minerals). Natural raw materials should be of a single source, that is, multi-base plants and animals should be declared as a single species.

Basic information on plant, animal and mineral resources: clear biological characteristics, parts used and origin information (including plant and animal resource species, plant and animal, mineral base location or source area), wild or cultivated sources. Wild sources should meet the requirements of China's flora and fauna regulations. Plants and other sources should also indicate whether there is a risk of pesticide residues and how to control them.

Large fungal raw materials (such as ganoderma lucidum, cordyceps, etc.) refer to the requirements of plant raw materials to provide relevant information.

3.2.3 Raw materials from biotechnology include raw materials from genetic engineering, cell engineering, fermentation engineering, enzyme engineering and protein engineering.

3.2.3.1 Raw materials from genetic engineering, cell engineering and fermentation engineering should describe the detailed information of gene source, carrier construction, engineered bacteria (strains, cells) used in production. If the strain should provide the strain name, strain name and strain number, and provide the corresponding Latin scientific name; Provide the source of strains, identification reports (including phenotypic characteristics and strain level identification results based on genotyping) and biological, genetic, and ergonomic characteristics of strains (strains), and provide data for their stability studies. Other raw materials from biotechnology sources should be provided with relevant research data in accordance with the above requirements.

3.2.3.2 Raw materials derived from biotechnology shall be clearly defined in terms of microbial pollution control and determination methods, host pathogenicity, and control standards for toxic components including biological metabolites and toxins produced.

3.2.3.3 Raw materials of biotechnology origin shall not have the high biological activity to which the drug belongs.

Hydrolyzed plant ingredients (acid, alkali or enzymatic hydrolysis) refer to the requirements for raw materials of biotechnological origin.

3.3 Composition, form and specification of new raw materials.

3.3.1 In principle, new raw materials should not be combined, except for additives (such as solvents, preservatives, stabilizers, etc.) added to the raw materials in order to protect the stability of the raw materials or facilitate the use of the raw materials, but the reason why it must be added should be explained.

3.3.2 New raw materials that must be used as compound raw materials in cosmetics should be declared as a single raw material.

4. Key information such as purpose of use

It should explain the purpose, adaptation or scope of use of raw materials in cosmetics, use specifications, safety-based use limits and basis, precautions, warnings, etc.

5. Foreign (regional) usage

It should indicate whether the raw material is used in cosmetics abroad (region). Including in the selling country (region), the name of the product, has used the raw material brand, name, use history, efficacy, usage and dosage, whether there are adverse reaction reports, foreign approval status of the raw material and relevant regulations and management, the latest research progress and so on.

3. Preparation process

The preparation process of the new raw material should be provided, including the whole process of the production of the raw material, the main process steps, process parameters, the final form of the raw material (consistent with the form of the declaration), and explain whether safety risk substances will be introduced and its control measures.

6. Preparation process

6.1 Chemical synthesis raw materials should list the specific starting material, reaction conditions (temperature, pressure range, etc.), additives used (solvents, catalysts, stabilizers, etc.), intermediate products and by-products of the reaction process, residual impurities or additives in the final product, etc.

6.2 Natural raw materials should indicate the source of raw materials, processing technology, extraction method (including pre-treatment method, extraction conditions, impurity removal or separation/purification method, solvent used, possible residual impurities or solvents, etc.).

6.3 Raw materials from biotechnology should explain the preparation process of raw materials such as culture, extraction, separation and purification. The impurities that may be produced during the process, such as enzymes, chemical reagents, solvents, carriers, antibodies, etc., should be explained; Material related impurities such as modified forms (deamidation, isomers, glycosylation, etc.), polymers, polymers, etc., should be described; Contaminants such as bacterial endotoxins, possible viruses and harmful microorganisms should be described.

Seven. Identification of structure and composition

7.1 Raw materials with clear structural formula (including plant components with purity ≥80%) should provide structural determination basis, including structural identification map and analytical process (focusing on identification of key structural fragments), and provide molecular structure formula and relative molecular weight; The polymer shall also provide methods and results for determining the degree of polymerization, as well as the average molecular weight and its distribution.

7.2 For raw materials without a clear structural formula, the specific form of the final raw material should be provided, including the additives added (such as solvents, preservatives, stabilizers, etc.), the amount used, and the determination method and results; Describe the possible chemical composition of the new raw material, such as the main chemical components or chemical composition categories that may be contained (polyphenols, flavonoids, polysaccharides, peptides, saponins, etc.). The structural characteristics and spatial conformation of raw materials of biotechnology origin should be identified as far as possible.

8. Physical and chemical properties

8.1 The physical and chemical properties of raw materials mainly include color, odor, state, and other significant characteristics (such as flammability, solubility, moisture absorption, etc.), and combined with the properties of raw materials, other common and based physical and chemical indicators should be selected. 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.

8.2 Nanometer raw materials: means insoluble and biodegradable artificial materials with at least one dimension of 1 to 100 nanometers in a three-dimensional spatial structure or consisting of them as basic units.

Nano raw materials in addition to the above physical and chemical indicators, Specific parameters such as particle size and distribution, aggregation and agglomeration characteristics of the raw material, surface chemical information (including Zeta potential/surface charge, surface coating, modified and catalytic activity, etc.), morphological information (including shape, specific surface area, surface topology, crystal structure, etc.), porosity, porosity, etc., should also be provided.

Iv. Stability

Information on the stability of new raw materials should be provided, including stability test data, shelf life, storage conditions, etc.

(1) Design stability tests according to the characteristics of raw materials. Stability test generally includes destructive test, accelerated test and long-term preservation test. Stability focus on the items of raw material appearance (color, odor, etc.), viscosity, hygroscopicity, efficacy, composition content, etc.

9. Destructive testing

Stability test data of at least 1 batch of raw materials under high temperature (such as 60℃), low temperature (such as -20℃), high humidity (such as 90%± 5%RH) or strong light irradiation, storage period of 10 days. The setting conditions of the above parameters can be changed according to the characteristics of the raw materials.

10. Accelerate the test

Stability test data of 3 batches of raw materials stored at 40℃±2℃, 75%RH±5%RH, with a storage period of at least 6 months.

11. Long-term preservation test

Stability test data of 3 batches of raw materials stored at 25℃±2℃, 60%RH±10%RH until the expiration date.

(2) Data requirements

When registering or filing new raw materials, nano-raw materials and raw materials from biotechnology sources with anti-corrosion, sunscreen, coloring, hair coloring, freckle whitening, hair loss prevention, acne, anti-wrinkle, anti-dandruff and anti-perspirant functions, the data, results and conclusions of destructive tests, accelerated tests and long-term preservation tests of at least one year shall be provided. According to the stability test, the storage conditions and shelf life of the raw materials are determined, and the long-term storage test data of the remaining 3 batches of large-scale production raw materials are supplemented year by year during the 3-year monitoring period.

When registering or filing other new raw materials, data, results and conclusions of destructive tests and accelerated tests should be provided to determine the storage conditions and shelf life of raw materials, and long-term storage test data of 3 batches of large-scale production raw materials that initially passed production verification should be provided during the 3-year monitoring period.

5. Quality control standards

Quality control standards shall include the name of new raw materials, raw material quality control indicators and testing methods, safety control indicators and testing methods.

12. Quality specifications and testing methods

12.1 Sensory indexes of raw materials and their testing methods. Sensory indicators include traits, colors, smells, etc.

12.2 Raw material composition and test method thereof. In addition to a single raw material, other materials containing auxiliaries and compound components, shall provide including new raw materials and all auxiliaries or compound components of the addition amount and testing methods.

12.3 Physical and chemical indexes of raw materials and their testing methods. In the quality specification of raw materials should be set according to the characteristics of raw materials to control the quality of raw materials, such as melting point, boiling point, specific gravity, viscosity, pH value, refractive index, optical rotation, hydroxylation value, iodine value, saponification value, acid value, pKa value, distribution coefficient (LogPow). The control range of the set physical and chemical indexes and the test methods and results are provided.

12.4 Qualitative identification methods. Appropriate qualitative identification methods should be set according to the structural characteristics of the chemical components contained in the raw materials, such as spectral analysis, chemical reaction method, chromatography, etc.

12.4.1 For raw materials containing characteristic functional groups, spectral analysis methods that are easier to obtain identification information, such as infrared spectroscopy, ultraviolet spectroscopy, nuclear magnetic resonance spectroscopy, etc., should be set.

12.4.2 If the chemical composition of the raw material can be specifically judged by appropriate chemical reaction, chemical reaction method, such as color reaction, precipitation reaction, etc., can be selected.

12.4.3 When it is difficult to set up spectroscopic analysis or specific chemical reaction methods, chromatographic methods, such as thin-layer chromatography, may be considered.

12.5 Quantitative control index and test method. For a single raw material with clear chemical structure, its purity and test method should be provided; For other raw materials, and with anti-corrosion, sunscreen, coloring, hair coloring, freckle whitening, anti-hair loss, acne, anti-wrinkle, anti-dandruff, antiperspirant function, it is recommended to choose the appropriate indicator ingredients for quantitative testing, and can also choose the total composition, evaporation residue/solid content, dry weight loss/moisture, incandescent residue and other indicators for quantitative testing. The control range of the set quantitative indicators and their testing methods and results should be provided.

12.6 For nanometer raw materials, the particle size and distribution, aggregation and agglomeration characteristics of raw materials, surface chemical information (including Zeta potential/surface charge, surface coating, modified and catalytic activity, etc.), morphological information (including shape, specific surface area, surface topology, crystal structure, etc.), porosity, porosity and other specific parameter control indicators should be specified Its test method.

12.7 Biotechnology source Raw materials should be provided raw material sources including donor organisms, recipient organisms, modified microorganisms, etc. The amino acid sequence and spatial conformation of the new oligopeptides, polypeptides and proteins derived from biotechnology should be defined, and the relationship between the function of the raw materials and the amino acid sequence and spatial structure should be clarified.

12.8 Requirements for packaging, transportation and storage of raw materials.

12.9 Purpose of use, application or scope of use, specifications and safe use limits, precautions, warnings, etc.

13. Safety control indicators and detection methods

Set appropriate safety limit indicators and detection methods in the raw material quality specifications, such as microorganisms, heavy metals, harmful substances (such as harmful impurities, harmful solvents, etc.) control indicators.

6. Safety evaluation

Safety evaluation data of new cosmetic raw materials should include toxicological safety evaluation data and risk assessment data.

Toxicological safety evaluation data should include a review of toxicological safety evaluation and necessary toxicological test data.

14. Review of toxicological safety evaluation

The application for new raw materials for cosmetics should generally provide the following toxicological test data in line with China's "Cosmetic Safety Technical Specifications" or international methods, national standards and other requirements:

15. Acute oral or acute percutaneous tests;

16. Skin and acute eye irritation/corrosion tests;

17. Skin allergy test;

18. Skin phototoxicity test (including photoirritation and photoallergy, raw materials with UV absorption characteristics need to do this test);

19. Skin photoallergy test (raw materials with UV absorption characteristics need to do this test);

20. Mutagenicity tests (which should include at least one gene mutation test and one chromosome aberration test);

21. Repeated dose oral or transdermal toxicity test (if the raw material is used in cosmetics with high probability of oral ingestion, repeated dose oral toxicity test should be provided);

22. Teratogenic tests;

23. Chronic toxicity/carcinogenicity combination tests;

24. Toxicant metabolism and kinetics test (plant raw materials with a single ingredient purity < 80% do not need to submit the test);

25. Inhalation toxicity test (this test is required when the raw material is likely to be exposed by inhalation);

Toxicology test data may be the applicant's test data, scientific literature, and the content published on the official websites of domestic and foreign governments and websites of international organizations. The above test contents are general requirements, and the toxicological test items can be added or reduced according to the use of the raw material, physical and chemical properties, quantitative structure-activity relationship, toxicological data, clinical studies, population epidemiological investigations, and toxicity of similar compounds.

For the application of animal alternative methods, appropriate Integrated Approaches to Testing and Assessment (IATA) should be selected to evaluate the toxicity of new raw materials according to their structural characteristics and specific toxicological endpoints. Integrated test and assessment method is a scientific and practical method to describe chemical hazard characteristics, that is, according to the comprehensive analysis of existing information and the use of combination test strategy to evaluate the toxicity of the tested substance.

If the applied toxicology test method is not included in China's "Cosmetic Safety Technical Code", it should submit proof that the toxicology test method is consistent with the results obtained by China's current method, and the toxicology test method should be included by the international authoritative alternative method verification body. Supporting materials should be submitted to the published, non-review related research papers or scientific works on the comparison of the toxicology test method with the current toxicology test method in China, or the test report issued by the internationally accepted good Laboratory Management laboratory (GLP). The supporting materials include brief description of the research process of the test method, comparative study data of no less than 10 subjects, result analysis, conclusion and original text.

To apply for new raw materials for cosmetics, the toxicological safety evaluation data of all the above-mentioned toxicological test items should generally be submitted. Under any of the following circumstances, toxicology test data may be submitted in accordance with the following provisions. According to the characteristics and uses of raw materials, the relevant test data can be added or reduced if necessary.

(a) To be used for anti-corrosion, sunscreen, coloring, hair coloring, freckle whitening, anti-hair loss, acne, anti-wrinkle, anti-dandruff, antiperspirant function of new raw materials, should submit the following toxicology test data:

15. Acute oral or acute percutaneous toxicity tests;

16. Skin and acute eye irritation/corrosion tests;

17. Skin allergy test;

18. Skin phototoxicity test (including photoirritation and photoallergy, raw materials with UV absorption characteristics need to do this test);

19. Photoallergy test (this test should be done when the raw material has ultraviolet absorption characteristics);

20. Mutagenicity tests (which should include at least one gene mutation test and one chromosome aberration test);

21. Repeated dose oral or percutaneous toxicity tests (if the raw material is used in cosmetics with a high probability of oral ingestion, repeated dose oral toxicity tests are provided).

(b) To be used for anti-corrosion, sunscreen, coloring, hair coloring, freckle whitening, hair loss prevention, acne, anti-wrinkle, anti-dandruff, antiperspirant functions, can provide sufficient evidence to prove that the raw material has been used in overseas listed cosmetics for more than three years of safe history, should submit the following toxicology test data:

15. Acute oral or acute percutaneous toxicity tests;

16. Skin and acute eye irritation/corrosion tests;

17. Skin allergy test;

18. Skin phototoxicity test (including photoirritation and photoallergy, raw materials with UV absorption characteristics need to do this test);

19. Photoallergy test (this test should be done when the raw material has ultraviolet absorption characteristics);

20. Mutagenicity tests (which should include at least one gene mutation test and one chromosome aberration test).

The certification materials for the safe use of cosmetics listed abroad for more than three years should include: (1) the purchase volume or sales volume and direction of the raw materials with the same quality specifications as the registered or filed raw materials; (2) the scope of use of raw materials and the amount used in the product; (3) including the product type of the raw material, production enterprises, product packaging information, related product listing records or registration records, product sales countries, sales and adverse reactions after the market description and other information.

(3) For new cosmetic raw materials that can provide sufficient evidence to prove that they have a history of safe consumption (the same parts need to be used), the following toxicology test data should be submitted, and the raw materials should be evaluated according to the exposure amount and use method of the raw materials.

16. Skin and acute eye irritation/corrosion tests;

17. Skin allergy test;

18. Skin phototoxicity test (including photoirritation and photoallergy, raw materials with UV absorption characteristics need to do this test);

19. Photoallergy test (this test should be done if the raw material has ultraviolet absorption characteristics).

The following raw materials can be regarded as raw materials with a history of safe consumption: raw materials for food that have obtained food safety certification or other corresponding qualifications from relevant supervision and management departments of China; Or safe edible raw materials issued by relevant supervision and management departments, technical institutions or other authorities at home and abroad.

(4) Chemically synthesized polymers consisting of one or more structural units, connected by covalent bonds, with an average molecular weight greater than 1000 Dalton, and a molecular weight less than 1000 Dalton oligomer content less than 10%, structure and properties of stable polymers (except raw materials with high biological activity), shall submit the following toxicological test data:

16. Skin and acute eye irritation/corrosion tests;

18. Skin phototoxicity test (including photoirritation and photoallergy, raw materials with UV absorption characteristics need to do this test);

(5) International authoritative safety evaluation institutions have concluded that the use of cosmetics is a safe new raw material, should submit the original and complete translation of the evaluation report, evaluation process, evaluation conclusions and laboratory qualification analysis and other relevant information. New raw materials for cosmetics that have been approved abroad should also be submitted with approval certificates.

Toxicology test items in the evaluation report should meet the requirements of toxicology test data in the above different situations. Toxicology test data should be separately separated from the evaluation report and submitted separately (see Table 1). The test content should include the state and concentration of raw materials; Strain; Cell line; Animal species, strain, grade, quantity and other information; Test methods, data, results, conclusions, etc.

(6) In addition to all toxicological test data of 15-25 items, nano raw materials should also provide skin absorption or transdermal absorption test data for those intended to be used in the skin; For possible inhalation exposure, inhalation toxicity test data should be provided.

(7) In addition to all toxicological test data of 15-25 oligopeptides, polypeptides and protein raw materials from biotechnology sources, skin absorption/transdermal absorption test data should also be provided for those intended for skin use; Immunogenicity/toxicity test data were also provided.

26. Risk assessment report

The risk assessment of new raw materials shall be carried out in accordance with the risk assessment principles and procedures in the Technical Guidelines for Cosmetic Safety Assessment. The content of the risk assessment data shall include the determination of the safe usage and the risk assessment of the possible safety risk substances such as the safety risk substances that may be generated or inevitably brought into the production and storage of raw materials.

7. Functional basis

(A) shall be submitted to prove that the raw material has the same functional basis as the purpose of use. Functional basis data generally include:

27. Scientific literature/regulatory information

27.1 If the function and mechanism of the raw material in cosmetics can be explained according to the chemical structure and characteristics of the raw material, the relevant papers or scientific works that are logically related to the new raw material registered or filed can be submitted as supplementary explanations.

27.2 Where the content of scientific literature/regulatory information is cited as the application material item, relevant research papers or scientific works of a non-review nature that are of the same origin, the same specifications of use, the functions of which are logically related and published should be submitted as the new raw materials registered or filed. A brief description of the research process, research results, analysis of results and conclusions should be submitted.

Regulatory materials should be logically related to the functions of new raw materials, including authoritative standards, catalogs, classics, and works with certain legal or regulatory status in China, and should provide specific information about the inclusion of regulations/works, such as the concentration of use, scope of use, and other restrictions; The positive list of functional raw materials included by foreign regulatory authorities should fully comply with the requirements of relevant regulations for concentration, scope and all other restrictions, and the relevant information such as the issuing country (region), the name of the regulations, the publisher and the release time should be stated when quoting the regulations.

28. In vitro testing

Divided into organ tissue level, cell level, non-living system (such as in vitro physicochemical experiment), the selected model should be as reasonable as possible to present and simulate the function of the new raw material in vitro use. The test model, test method, relevant test data, results and conclusions of new raw materials with declared functional effective amount and safe usage should be provided, and the mechanism of new raw materials with relevant functions should be clarified.

29. Animal testing

The animal experimental model, test method, relevant test data, results and conclusions of the effective amount and safe usage of the new raw material with declared function should be provided.

30. Human testing

The tested material is a cosmetic containing only one functional component of the new raw material. Before conducting human trials, it should be ensured that the toxicology data, exposure conditions and information obtained by the subject matter can meet its safety in human use, and the subject matter with potential safety risks shall not be evaluated in human trials. Test method, number of subjects, control group design, relevant test data, test results and analysis of new raw materials with declared functional effective amount and safe usage should be provided.

(2) Data requirements

New raw materials with anti-corrosion, sun protection, freckle whitening, anti-hair loss, acne, anti-wrinkle, anti-dandruff, antiperspirant functions should submit at least one of the above 28-30 data test data, and explain the mechanism of new raw materials with declaration function.

New raw materials for other functions shall submit at least one of the above 27-30 materials.

8. Technical requirements for raw materials

31. Technical requirements for raw materials

Technical requirements for new raw materials shall be submitted in accordance with the sample requirements in Annex 2.

9. Sample

32. Sample

A sample of the new raw material should be provided, and the label of the sample should include the Chinese name of the raw material, the name of INCI, the purpose of use, the safe amount of use, the scope of application or use, the shelf life, storage conditions and other information.

The registrant or filing person shall, according to the actual situation of the new raw materials, state in the application form that the new raw materials belong to the category of circumstances in Table 1, and submit registration or filing information in accordance with the requirements of the data items in Table 1.

 

Chapter III Management data requirements for the monitoring period

1. Monitoring report

The registrant or recordholder of new raw materials shall submit a monitoring report annually to the registration and recordkeeping system during the three-year monitoring period, including:

(A) The use of new raw materials of cosmetics enterprises should be submitted to the raw material registrant or recordholder information includes:

1. Enterprise information: including name, address, production license number, etc.

2. Cosmetics using new raw materials: the number of new raw materials purchased, the number of products produced, product information, the amount of new raw materials used, etc.

3. Supervise the sampling, investigation and recall of cosmetics containing new raw materials.

4. Monitoring system for adverse reactions of products containing new raw materials, statistical analysis of adverse reactions of products and measures taken by enterprises.

5. Risk monitoring and evaluation management system and measures for products containing new raw materials.

(b) the registrant or recordholder summarizes and collates the information submitted by the cosmetics company to form a monitoring report, including:

1. Basic information of new raw materials:

1.1 Raw material name, purpose of use, applicable product type, safe usage, registration or filing number, registrant or filing person and domestic responsible person information.

1.2 Raw material source, relative molecular weight, molecular formula, chemical structure, composition, physical and chemical properties, form and specification, etc.

2. Production of new raw materials: the name, address, production license number and annual production of new raw materials should be explained.

3. Cosmetics using new raw materials: Information of all cosmetics companies using new raw materials, the number of new raw materials purchased, the number of products produced, product information, and the amount of new raw materials used should be explained.

4. Supervise the sampling, investigation and recall of cosmetics containing new raw materials.

5. Adverse reaction monitoring system of enterprises using new raw materials, statistical analysis of adverse product reactions and measures taken.

6. Risk monitoring and evaluation management system and measures for enterprises producing new raw materials and using new raw materials.

A sample of the new raw material monitoring report is shown in Annex 3.

Ii. Emergency report

In the event of an emergency, the registrant or recordholder shall submit an emergency report on new raw materials, including:

(A) Cosmetic enterprises should submit to the raw material registrant or recordholder information includes:

1. Enterprise information: including name, address, production license number, etc.

2. Cosmetics using new raw materials: the number of new raw materials purchased, the number of products produced, product information, the amount of new raw materials used, etc.

3. Emergency handling: The enterprise shall explain the adverse effects and consequences caused by the emergency, measures taken, treatment results, and work plans and suggestions.

(2) After the registrant or recordholder summarizes and collates the information submitted by the cosmetics enterprise, the emergency situation report shall be formed, including:

1. New raw material Basic information:

1.1 Including the Chinese name, registration or record number of the new raw material.

1.2 Raw material source, relative molecular weight, molecular formula, chemical structure, composition, physical and chemical properties, form and specification, etc.

2. Production of new raw materials: the name, address, production license number and annual production of new raw materials should be explained.

3. Cosmetics using new raw materials: Information of all cosmetics companies using new raw materials, the number of new raw materials purchased, the number of products produced, product information, and the amount of new raw materials used should be explained.

4. Emergency situation: It should explain the cause analysis of the emergency situation, the adverse effects and consequences, the measures taken, the results of treatment, and the work plan and suggestions.

 

Note:

1. The classification of raw materials in different situations in the first row of the table includes:

1. It is a new cosmetic material with sunscreen, freckle whitening, hair loss prevention, acne, anti-wrinkle, anti-dandruff, anti-perspirant function and new functions.

2. A new cosmetic material with anti-corrosion, hair dyeing and coloring functions.

3. Intended for anti-corrosion, sunscreen, coloring, hair coloring, freckle whitening, anti-hair loss, acne, anti-wrinkle, anti-dandruff, antiperspirant function of the new raw material.

4. New raw materials intended to be used for anti-corrosion, sunscreen, coloring, hair coloring, freckle whitening, hair loss prevention, acne, anti-wrinkle, anti-dandruff, and antiperspirant functions, which can provide sufficient evidence to prove that the raw material has been used safely in overseas listed cosmetics for more than three years;

The certification materials for the safe use of cosmetics listed abroad for more than three years should include: (1) the purchase volume or sales volume and direction of the raw materials with the same quality specifications as the registered or filed raw materials; (2) the scope of use of raw materials and the amount used in the product; (3) including the product type of the raw material, production enterprises, product packaging information, related product listing records or registration records, product sales countries, sales and adverse reactions after the market description and other information.

5. A new cosmetic raw material that can provide sufficient evidence to prove that the raw material has a history of safe consumption and the same site of use;

Materials with a history of safe consumption: food raw materials that have obtained food safety certification or other corresponding qualifications from relevant supervision and management departments of our country; Or safe edible raw materials issued by relevant supervision and management departments, technical institutions or other authorities at home and abroad.

6. Chemically synthesized polymers consisting of one or more structural units, connected by covalent bonds, with an average molecular weight greater than 1000 Dalton, and less than 10% oligomers with molecular weight less than 1000 Dalton, with stable structure and properties (except raw materials with high biological activity).

7. International authorities have concluded that it is a safe new raw material for use in cosmetics.

Evaluation conclusions, evaluation reports and related materials shall be submitted. According to the requirements of 1-6 situations, 15 to 26 items of information in the evaluation report of the evaluation agency of the international authority should be submitted separately according to the list. If the toxicology test method used in the evaluation data is inconsistent with the toxicology test method in the current Technical Code for Cosmetic Safety in China, proof that the toxicology test method is consistent with the results obtained by the current method in China should be submitted. New raw materials for cosmetics that have been approved abroad should also be submitted with approval certificates.

8. In addition to all toxicological test data of 15-26 items of the sixth safety evaluation, nano raw materials should also provide skin absorption or transdermal absorption test data for those intended to be used in the skin; For possible inhalation exposure, inhalation toxicity test data should be provided.

9. Biotechnology-derived oligopeptides and polypeptides should provide, in addition to all toxicological test data for items 15-26 of the sixth safety assessment, skin absorption or transdermal absorption test data for intended skin sites should also be provided; Immunogenicity/toxicity test data were also provided.

2. Data submission requirements:

1. "+" : information that must be submitted;

2. "-" : No need to submit information;

3. "±" : according to the actual situation of each new raw material specific judgment.

Iii. Special Remarks:

1. (a) It is not required for initial registration or filing, but is required for long-term preservation of test data during the three-year monitoring period.

2. (b) If the raw material has ultraviolet absorption characteristics, the test data shall be submitted.

3. (c) Plant raw materials (except single ingredient purity ≥80%) do not need to submit toxicant metabolism and kinetic test data.