Provisions for Supervision of New Cosmetic Ingredient Registration and Notification Dossiers

Created on:2021-06-08 14:40

 

Provisions for Supervision of New Cosmetic Ingredient Registration and Notification Dossiers

 

Article 1 For the purpose of standardizing the administration of new cosmetic ingredient registration and notification, ensuring the quality and safety of cosmetics, these Provisions are formulated in accordance with the requirements of “Cosmetic Supervision and Administration Regulations (CSAR)” and “Administrative Measures on Cosmetics Registration and Notification”.

Article 2 The documents submitted by the registrant and notifier of new cosmetic ingredient at the time of applying for registration or notification of the new cosmetic ingredient shall meet the requirements of these Provisions.

Article 3 The registration and notification documents of new cosmetic ingredient shall be based on scientific research, and objectively and accurately describe the traits, characteristics and safety use requirements of the new ingredient.

The registrant, notifier or domestic responsible person of new cosmetic ingredient shall submit the registration and notification documents of new cosmetic ingredient as required, and be responsible for the legality, authenticity, accuracy, completeness and traceability of the documents submitted.

Article 4 The registration and notification documents of new cosmetic ingredient shall use standardized Chinese characters published by the State. Except registered trademarks, website addresses, patent names, names and addresses of overseas enterprises, etc., which must use other languages, as well as English abbreviations that have been used in China’s regulations, all other texts shall be translated into Chinese in a complete and standardized way, and the original text shall be attached to the corresponding translation.

Article 5 The registration and notification documents of new cosmetic ingredient shall comply with the relevant national laws and regulations on the use of signature and seal, be with complete signature and seal, and have legal effect. If overseas enterprises and other organizations do not use official seals, the documents shall be signed by the legal representative or authorized signatory. In case of authorized signature, the original authorization letter and the original notarial certificate shall be submitted. The authorization letter shall specify the matters and scope of the authorized signature.

Except the original of documents issued by the competent government departments or relevant institutions, testing institutions, Notary Public, etc., the registration and notification documents shall be stamped with the official seal page by page by the domestic registrant, notifier or domestic responsible person. The user who uses the official seal with the electronic encryption certificate can directly stamp the electronic official seal on the electronic documents.

Article 6 China’s legal measurement unit shall be used in the registration and notification documents of new cosmetic ingredient. If other measurement units are used, they shall be converted into China’s legal measurement unit; the use of punctuation marks, charts, terminology, etc. shall be standardized; references shall be quoted accurately and validly with the source indicated to ensure valid traceability.

Article 7 The main text in the registration and notification documents of new cosmetic ingredient shall be black, and the contents shall be easy to identify. Appropriate line spacing and page margins shall be set to ensure that no text information is lost during printing or binding.

The paper documents for registration and notification shall use the international standard A4 size paper with complete and clear contents, which shall not be altered. The carrier and writing materials of paper documents shall meet the durability requirements.

Article 8 The registrant, notifier or domestic responsible person of new cosmetic ingredient shall apply for registration or notification through an information service platform for the registration and notification of new cosmetic ingredient (hereinafter referred to as the information service platform) as prescribed, and electronic version of the registration and notification documents uploaded to the information service platform shall be consistent with the paper version.

Article 9 The registrant and notifier of new cosmetic ingredient shall fill in the following information through the information service platform to register user information before applying for new ingredient registration or notification.

(I) Information of registrant and notifier of new cosmetic ingredient;

(II) Safety risk monitoring and evaluation system overview of registrant and notifier of new cosmetic ingredient (see Annex 1 for the template);

(III) If the registrant and notifier of new cosmetic ingredient are of overseas ones, the domestic responsible person shall fill in the information, and submit the original authorization letter of the domestic responsible person and the original notarial certificate.

Where the same domestic enterprise has multiple identities such as the registrant, notifier of new cosmetic ingredient or domestic responsible person, or is authorized to be the domestic responsible person for multiple overseas new cosmetic ingredient registrants and notifiers, it may submit all relevant documents at one time and obtain the corresponding user authority. Existing users may supplement relevant documents to increase the user authority according to the actual situation.

Article 10 When the following information and documents of the registrant, notifier or domestic responsible person of new cosmetic ingredient are subject to any change, update shall be made to ensure that the relevant information and documents in the information service platform are true and accurate:

(I) When the information such as the legal representative and contact information of the registrant, notifier or domestic responsible person of new cosmetic ingredient are changed, users shall update in a timely manner themselves on the information service platform;

(II) When other basic information of the registrant, notifier or domestic responsible person of new cosmetic ingredient, safety risk monitoring and evaluation system overview of new ingredient, and authorization scope and authorization period of the domestic responsible person are changed, the information update form of the registrant and notifier of new cosmetic ingredient (see Annex 2 for the template) shall be submitted. After submitting the relevant documents as required, the update of the relevant information and documents will be completed.

Among them, if the name and address of the overseas registrant or notifier are changed, the relevant original certification documents issued by the competent governments department or relevant institutions of its country (region) proving that the subject has not been changed shall be provided. If the original cannot be submitted, a copy notarized by a Chinese Notary Public or confirmed by a Chinese embassy (consulate) shall be provided; if the name and address of the domestic responsible person are changed, the relevant original certification documents issued by the Chinese competent governments department or relevant institutions proving that the subject has not been changed shall be provided.

If the authorization scope of the domestic responsible person is changed, the new authorization scope shall cover the original authorization scope; if only the authorization period is updated, the other contents of the authorization letter shall not be changed.

If the domestic responsible person is changed, a commitment letter for that the domestic responsible person to be changed will assume various responsibilities of the original domestic responsible person shall be submitted, and the informed consent from the original domestic responsible person on the replacement of the domestic responsible person or an effective legal judgment document that can prove that the domestic responsible person has been changed shall be submitted.

Article 11 The authorization letter of domestic responsible person shall at least contain the following content and information:

(I) Names of the registrant, notifier of new cosmetic ingredient and domestic responsible person;

(II) The relationship between authorizing and authorized;

(III) The authorization scope;

(IV) The authorization period.

The same new cosmetic ingredient shall not be authorized to multiple domestic responsible persons. The domestic responsible person shall carry out registration and notification work in accordance with the authorization scope. Where the authorization period specified in the authorization letter of domestic responsible person expires, the authorization letter with the extended authorization period shall be resubmitted within 30 days before the authorization period expires or the domestic responsible person shall be changed as required.

Article 12 Registrants and notifiers of new cosmetic ingredients shall submit the following documents when applying for registration and handling notification of such new ingredient:

(I) The name, address, and contact information of the registrant, notifier, and domestic responsible person;

(II) New ingredient research and development report;

(III) Research documents on preparation process, stability and quality control standards of the new ingredient;

(IV) New ingredient safety assessment documents.

The registrant, notifier or domestic responsible person of new cosmetic ingredient shall, according to the specific situation classifications of the new ingredient applied for registration or notification and the registration and notification document requirements for the new cosmetic ingredient (Annex 3), sort and submit the corresponding registration and notification documents.

The registrant, notifier or domestic responsible person of new cosmetic ingredient shall, in combination with the technical information related to the registration and notification documents of new ingredient, prepare and provide the technical requirement documents for the new cosmetic ingredient for registration and notification information disclosure (see Annex 4 for the template). After the new ingredient is approved or notified, it will be published as an attachment to the hygiene permit for public inquiry and reference.

Article 13 The R&D report of new cosmetic ingredients shall be prepared in accordance with the requirements (Annex 5), and shall generally include the following contents:

(I) R&D background of ingredients, including R&D background, R&D purpose, R&D process and R&D results, etc.;

(II) Basic information of ingredients, including ingredient name, source, composition, relative molecular mass, molecular formula, chemical structure, physical and chemical properties, etc.;

(III) Use information of ingredients, including the use specification, use purpose, application or use scope, safety usage level, shelf life, precautions, warnings, etc. of ingredients in cosmetics; the information of such ingredient used in cosmetics overseas, as well as foreign approval status of such ingredient;

(IV) Functional basis documents. The functional basis of a new cosmetic ingredient refers to relevant documents that can prove that the ingredient is consistent with the use purpose, generally including scientific literature, regulatory documents, laboratory research data, human body efficacy evaluation testing documents, etc.;

(V) Other documents related to new ingredient R&D.

Article 14 A brief description of the preparation process of new cosmetic ingredient shall be given to the main process steps and process parameters, etc., of the ingredient production in combination with the characteristics of the ingredient source, and the description of whether safety risk substances will be introduced in production process and control measures thereof shall be given. The compilation requirements for the briefly described preparation process of new ingredient from different sources are specified as follows:

(I) For chemically synthesized ingredients, specific starting ingredient, reaction conditions, used auxiliaries, intermediate products and by-products of the reaction process, and impurities or auxiliaries remaining in the final product and so on shall be listed.

(II) For natural ingredients, the source of ingredients, processing technology, and extraction methods, including pretreatment methods, extraction conditions, impurity removal or separation/purification methods, solvents used, and possibly residual impurities or solvents, etc., shall be stated.

(III) For the ingredients from biotechnology sources, ingredient preparation process such as cultivation, extraction, separation and purification, etc., shall be stated. In addition, a description shall be given to the impurities that may be generated during the process, the impurities that may be contained in ingredient, as well as the possible harmful microorganisms;

(IV) For ingredients of other sources, relevant documents shall be submitted according to the characteristics of the ingredients and the specific preparation process.

Article 15 The quality control standards for new cosmetic ingredient shall be compiled in accordance with the requirements (Annex 6), and generally shall include the following contents:

(I) Stability test data;

(II) Quality specification indexes and testing methods;

(III) Documents of possible safety risk substances and their control standards, etc.

Article 16 The safety assessment documents of new cosmetic ingredients shall generally include toxicological safety assessment documents and safety risk assessment documents, and be compiled in accordance with the following requirements:

(I) Toxicological safety assessment documents shall be prepared in combination with the characteristics of new ingredient subject to registration and notification, based on the judgement of the specific situation under which the new ingredient shall belong, and in accordance with the document requirements for the corresponding toxicological test items;

(II) Safety risk assessment documents, including assessment documents of ingredient safety usage level and assessment documents of safety risk substances that may exist in the ingredients, and control measures thereof, etc. The new ingredients and possible safety risk substances shall be assessed in accordance with the relevant requirements of the cosmetic safety assessment principles and procedures formulated by the NMPA.

Article 17 The sample of new cosmetic ingredient shall have complete packaging and labels. The labels shall indicate the name of the registrant, notifier or domestic responsible person of the new ingredient, Chinese name of the ingredient, INCI name, production date and the shelf life, storage conditions, etc.

The registrant, notifier or domestic responsible person of new cosmetic ingredient shall reserve the sample of new ingredient for future reference. If the technical review institution needs to check the sample during the technical review process, the registrant, notifier or domestic responsible person shall submit the sample within the prescribed time limit.

Article 18 The registrant, notifier or domestic responsible person of new cosmetic ingredient shall collect and collate the following information and documents in accordance with the relevant requirements of the safety monitoring period of new ingredient, and based on which, prepare the annual safety monitoring report for the new cosmetic ingredient (Annex 7):

(I) Information about the registrant, notifier or entrusted production enterprise of cosmetics produced using new ingredient;

(II) Information about cosmetics produced using new ingredients, including product name, product hygiene permit number, product production or import, and sales quantity, etc.;

(III) Supervision and random inspection, investigation and recall situation of cosmetics produced by using new ingredients;

(VI) Adverse reaction monitoring system, statistical analysis of product adverse reactions, and measures taken, etc., of cosmetics production enterprise for cosmetics produced by using new ingredients;

(V) Risk monitoring and assessment supervision system and measures taken, etc., of cosmetics production enterprise for cosmetics produced by using new ingredients.

The registrant, notifier or domestic responsible person of new cosmetic ingredient shall submit an annual safety monitoring report for the new ingredient through the information service platform within 30 working days before the expiration of the annual safety monitoring period of the new cosmetic ingredient.

Article 19 Where the registrant, notifier or domestic responsible person of new cosmetic ingredient find any situation that shall report to the technical review institution as required by the “Administrative Measures for Cosmetic Registration and Notification” in the process of using new ingredient, or other situations that it think it is necessary to report, it shall immediately collect and collate the basic information of new ingredient, production and use situations, safety issues or reason analysis of emergencies, disposal measures taken and treatment results, etc., prepare a safety risk control report for new cosmetic ingredient (Annex 8), and submit to the technical review institution through the information service platform.

Article 26 These Provisions shall come into effect as of May 1, 2021.

 

Annexes: 1. Safety Risk Monitoring and Evaluation System Overview of Registrant/Notifier of New Cosmetic Ingredients (Template)

2. Information Update Form of Registrant/Notifier of New Cosmetic Ingredients (Template)

3. Requirements for Registration and Notification Documents of New Cosmetic Ingredients

  1. Technical Requirements for New Cosmetic Ingredients (Template)

5. Requirements for Preparation of R&D Reports for New Cosmetic Ingredients

6. Requirements for Preparation of Quality Control Standards for New Cosmetic Ingredients

7. Requirements for Preparation of Annual Safety Monitoring Reports for New Cosmetic Ingredients

8. Requirements for Preparation of Safety Risk Control Reports for New Cosmetic Ingredients

 

Annex 1

Safety Risk Monitoring and Evaluation System Overview of Registrant/Notifier of New Cosmetic Ingredients

(Template)

 

Items

Contents or Measures (Overview)

Position Responsibilities

Please briefly describe the post setting related to safety risk monitoring and evaluation of registrants/notifiers of new cosmetic ingredient, which at least includes:

1. Setting of relevant institutions and positions;

2. Basic requirements for relevant personnel.

Safety Risk Monitoring

Please briefly describe the relevant system of safety risk monitoring, which at least includes:

1. The overall composition and operation mode of the safety risk monitoring system;

2. Please briefly describe all active or passive information collection channels of the use and safety of new cosmetic ingredients and the frequency of information collection.

Safety Risk Evaluation

Please briefly describe the relevant system of safety risk evaluation, which at least includes:

1.The completion method of safety risk evaluation, such as the self-completion by registrant/notifier of new cosmetic ingredient or completion by entrusting relevant professional institutions;

2. Safety risk evaluation standard;

3. Corresponding treatment measures after safety risk evaluation.

Overseas registrant/notifier of new cosmetic ingredient shall also briefly describe the mechanisms and measures for information exchange, data sharing, and risk linkage in safety risk monitoring and evaluation with the domestic responsible person. The domestic responsible person shall briefly describe the specific measures taken to cooperate with the registrant/notifier of new cosmetic ingredient in safety risk monitoring and evaluation, including the setting of position responsibilities, safety risk monitoring and evaluation related systems.

(Seal of the registrant/notifier of new cosmetic ingredient)

MM/DD/YY

 

Annex 2

Information Update Form of Registrant/Notifier of New Cosmetic Ingredients

(Template)

 

Registrant/notifier of new cosmetic ingredient:

Domestic responsible person:

Document items

Specific modules

Specific items

Updated contents

Documents required

  1. Information form for registrant/notifier

Basic information

□Name (Chinese)

 

If the name and address are changed, the relevant original certification documents issued by the competent governments department or relevant institutions of its country (region) proving that the subject has not been changed shall be provided.

□Name (foreign language)

 

□Home address

 

□County/region

 

  1. Safety risk monitoring and evaluation system overview form

□Safety risk monitoring and evaluation system overview form

Safety risk monitoring and evaluation system overview form

  1. Information form for domestic responsible person

Basic information

□Enterprise name

 

 

□Home address

 

□Location

 

  1. Authorization letter of domestic responsible person

□Authorization scope

(The new authorization scope shall cover the original authorization scope.)

The authorization letter of domestic responsible person and relevant documents shall be resubmitted.

□Authorization period

(Other contents of the authorization letter shall not be changed.)

 

(Seal of the registrant/notifier of new cosmetic ingredient)

MM/DD/YY

 

Annex 3

Requirements for Registration and Notification Documents of New Cosmetic Ingredients

 

In order to determine the safety risk degree of new cosmetic ingredient more scientifically and reasonably, the new ingredients are classified according to the use history in cosmetics and consumption history at home and abroad, and in combination with the functions and traits of ingredients. The registrant, notifier or domestic responsible person of cosmetics shall, according to the specific situation classifications of the new ingredient applied for registration or notification and the following requirements, submit the registration and notification documents of new ingredient.

I. General Requirements

The registration and notification documents of new ingredient shall clearly state the source and R&D of the new ingredient, the preparation process and quality control thereof, and safety assessment, etc., and shall be able to fully prove the safety and risk controllability of using the new ingredient in the production of cosmetics under defined use conditions.

The scientific literature or regulatory documents quoted in the registration and notification documents of new cosmetic ingredient shall be relevant to the new ingredient applied for registration or notification. Restrictive conditions such as the source, use purpose, use specification, and application scope specified of ingredient therein shall apply to the new ingredient registered or notified.

II. Document Requirements for Testing

(I) Requirements for testing report.

1. Requirements for testing report issuance institutions. The registrant and notifier of new cosmetic ingredient shall, in accordance with relevant testing requirements, carry out necessary tests on the new ingredient by themselves or by entrusting relevant testing institution, and provide the testing institution undertaking the testing task with true and valid testing samples according to the needs of the testing items.

Physical and chemical and microbiological testing reports and efficacy evaluation reports other than preservative, sunscreen, freckle-removing and whitening, anti-hair loss efficacies, etc. may be issued by the registrant and notifier of new cosmetic ingredient themselves or by entrusting a testing institution with corresponding testing capabilities.

Toxicological testing reports and testing reports on preservative, sunscreen, freckle-removing and whitening, anti-hair loss efficacy evaluation items, etc., shall be issued by a testing institution that is approved by China Inspection Body and Laboratory Mandatory Approval (CMA) in the field of cosmetics or accredited by China National Accreditation Service for Conformity Assessment (CNAS), or that comply with the internationally accepted Good Clinical Practice (GCP) or Good Laboratory Practice (GLP).

2. Requirements for testing reports and styles. The testing institution that undertakes the task of testing new cosmetic ingredient shall refer to the relevant provisions and requirements of the “Working Rules for Cosmetic Registration and Notification Testing” promulgated by the NMPA to issue the testing reports for corresponding testing items.

(II) Requirements for testing methods.

1. Requirements for physical and chemical testing, microbiological testing and efficacy evaluation methods. In principle, the items of the physical and chemical testing, microbiological testing, human trial safety testing and efficacy evaluation of new cosmetic ingredient shall refer to the testing methods prescribed in the “Safety and Technical Standards for Cosmetics” (STSC) or “Pharmacopoeia of the People’s Republic of China”. Items that have no available methods prescribed in the STSC and “Pharmacopoeia of the People’s Republic of China” shall be tested in accordance with the national standards, internationally accepted methods or by using self-developed testing methods. If a self-developed testing method is used, relevant documents on the applicability and reliability of the method shall be submitted at the same time.

2. Requirements for toxicological testing methods. The toxicological testing items of new ingredient shall be carried out in accordance with the testing methods prescribed in the STSC. Items that have no available methods prescribed in the STSC shall be tested in accordance with the national standards or internationally accepted methods.

3. Requirements for animal testing alternative methods. Where an animal testing alternative method is used for toxicological safety assessment, appropriate integrated approaches to testing and assessment (IATA) shall be selected to evaluate the toxicity of the new ingredient according to the structural characteristics of the ingredient and specific toxicological end points. If the animal testing alternative method used has not been included in China’s STSC, the alternative method shall be a method that has been included by the international authoritative validation institution of alternative methods, and the certification documents proving that the method can accurately predict the toxicological end point shall be submitted at the same time. The certification documents shall include a brief description of the research process of the alternative method and the research data, result analysis, research conclusions, etc. of no less than 10 tested substances of known toxicity.

III. Document Requirements for Toxicological Safety Assessment

(I) Overall requirements.

The registrant and notifier of new cosmetic ingredient shall select appropriate toxicological test items to conduct toxicological safety assessment based on the specific situations of the new cosmetic ingredient applied for registration or notification, and provide corresponding toxicological safety assessment documents. The toxicological safety assessment of new ingredient shall be reviewed in combination with the toxicological test items carried out for the new ingredient and on the basis of summarizing the toxicological test method, testing process, and toxicological end point of each toxicological test one by one, and the results of safety assessment shall be concluded.

The toxicological safety assessment documents of new cosmetic ingredient may be the testing reports of toxicological test items carried out by registrant and notifier of new cosmetic ingredient themselves or by entrustment, scientific literature, and contents published on official websites of domestic and overseas governments and international organizations.

(II) Requirements for toxicological test items.

In principle, the following toxicological test item documents shall be provided for new cosmetic ingredient that is applied for registration or notification. The corresponding toxicological test items may be increased or reduced in accordance with the use, physical and chemical properties, quantitative structure-activity relationship, toxicological data, clinical research, population epidemiological investigation and toxicity of similar compounds of the new ingredient that is applied for registration or notification:

1. Acute oral or acute dermal toxicity test;

2. Skin and eye irritation/corrosion test;

3. Skin sensitization test;

4. Skin phototoxicity test (such test is required for ingredients having ultraviolet absorption characteristics);

5. Skin photoallergy test (such test is required for ingredients having ultraviolet absorption characteristics);

6. Mutagenicity test (at least one gene mutation test and one chromosome aberration test shall be included);

7. Subchronic oral or dermal toxicity test (if the ingredient used in cosmetics has a high possibility of oral intake, a subchronic oral toxicity test shall be provided);

8. Teratogenicity test;

9. Chronic toxicity/carcinogenicity combined test;

10. Inhalation toxicity test (such test is required when inhalation exposure is possible for ingredients);

11. Long-term human trial safety test;

12. According to the characteristics and uses of ingredients, other toxicological test documents of other items shall be provided.

For new ingredients with health hazard effects (excluding local toxicity) used for the first time at home and abroad, in addition to the above-mentioned toxicological test documents from Items 1 to 12, the toxicological metabolism and toxicokinetics test data shall also be submitted.

For new ingredients with higher biological activity such as oligopeptides, polypeptides, and proteins used for the first time at home and abroad, in addition to the above-mentioned toxicological test documents from Items 1 to 12, the skin absorption/dermal test and immunotoxicity test data shall also be submitted.

For new nano ingredients, in addition to the above-mentioned toxicological test documents from Items 1 to 12, the explanations on the applicability of the various toxicological test methods to the detection of nano ingredients shall also be provided. For new nano ingredients intended to be used on the skin, the skin absorption/dermal absorption test data shall also be provided; for new nano ingredients with possible inhalation exposure, the inhalation toxicity test data shall also be provided.

(III) Situation classification and corresponding document item requirements

According to the functions and traits of new ingredients applied for registration or notification, as well as the domestic and overseas history of use in cosmetics, or the history of consumption, the new ingredients are divided into the following six situations. The registrant and notifier of new ingredient shall, in combination with the characteristics of the new ingredient applied for registration and notification, judge the specific situation to which the new ingredient shall belong, and submit the corresponding toxicological test item documents respectively (see the annexes for details):

Situation 1: For new cosmetic ingredients intended for functions of preservative, sunscreen, coloring, hair dyeing, freckle-removing and whitening, anti-hair loss, anti-acne, anti-wrinkle (except for physical anti-wrinkle), anti-dandruff, deodorant efficacy and other new cosmetic ingredients with higher biological activity that are used for the first time at home and abroad, the above-mentioned toxicological test documents from Items 1 to 12 shall be submitted;

Situation 2: For new cosmetic ingredients not intended for functions of preservative, sunscreen, coloring, hair dyeing, freckle-removing and whitening, anti-hair loss, anti-acne, anti-wrinkle (except for physical anti-wrinkle), anti-dandruff, deodorant efficacy that are used for the first time at home and abroad, the above-mentioned toxicological test documents from Items 1 to 7 shall be submitted;

Situation 3: For new cosmetic ingredients that are not intended for functions of preservative, sunscreen, coloring, hair dyeing, freckle-removing and whitening, anti-hair loss, anti-acne, anti-wrinkle (except for physical anti-wrinkle), anti-dandruff, deodorant efficacy and provided with sufficient evidence proving that the ingredients have safety use history of more than three years in cosmetics marketed overseas, the above-mentioned toxicological test documents from Items 1 to 6 shall be submitted;

If a safety report from the international authoritative safety assessment institution concluding it as safe ingredient used in cosmetics or human trial safety testing report that conforms to ethical conditions can be provided, the acute oral and dermal toxicity test documents may not be provided;

Situation 4: For new cosmetic ingredients that are intended for functions of preservative, sunscreen, coloring, hair dyeing, freckle-removing and whitening, anti-hair loss, anti-acne, anti-wrinkle (except for physical anti-wrinkle), anti-dandruff, deodorant efficacy and provided with sufficient evidence proving that such ingredient has safety use history of more than three years in cosmetics marketed overseas, the above-mentioned toxicological test documents from Items 1 to 7 shall be submitted;

Situation 5: For new cosmetic ingredients having a history of safe consumption (be consistent in application areas), the above-mentioned toxicological test documents from Items 2 to 5 shall be submitted, and the ingredients shall be subject to the risk assessment according to the exposure and use method;

Situation 6: For chemically synthesized polymers stable in structure and properties (excl. ingredients with higher biological activity) composed of one or more structural units linked together by covalent bonds, where average molecular weight is greater than 1000 Daltons, and the content of oligomers with a molecular weight less than 1000 Daltons is less than 10%, the above-mentioned toxicological test documents Items 2 and 4 shall be submitted.

For new ingredients for which the international authoritative institution has already concluded as safe ingredient used in cosmetics, or new ingredients that have been approved for use by an overseas cosmetics regulatory department, the corresponding contents in the evaluation reports of the international authoritative safety assessment institution, approval certificate of the overseas cosmetics regulatory department and other relevant documents shall be sorted and submitted based on the document requirements of the above-mentioned situation classifications.

(IV) Document requirements for safety use history

New ingredients that meet all of the following conditions can be regarded as the new ingredients that have safety use history of more than three years in cosmetics marketed overseas. For new ingredients that meet the above situations 3 and 4, the corresponding documents shall be provided at the same time:

1. The new ingredients have the same quality specifications, purpose of use, application or use scope as the ingredients used in cosmetics marketed overseas, and the safety usage level of new ingredients is not higher than that used in cosmetics marketed overseas;

2. The cosmetics containing such ingredient shall be marketed overseas for at least 3 years;

3. Relevant evidence documents proving that there are enough people overseas that use the cosmetics containing the ingredients shall be provided;

4. Cosmetics containing the ingredients marked overseas have not caused serious adverse reactions or group adverse reactions related to the use of the ingredients;

5. There is no literature or report about such ingredient that may cause harm to human health.

(V) Document requirements for safety consumption history

If one of the following conditions is met, the ingredient can be regarded as a new ingredient with a safe consumption history, and for the new ingredient that meets the above-mentioned situation 5, the corresponding documents shall be provided at the same time:

1. Food ingredients that have obtained food safety certification or other corresponding qualifications from the relevant supervisory and administrative departments of China;

2. Ingredients that can be consumed safely issued by relevant supervisory and administrative departments, technical institutions or other authoritative institutions at home and abroad

 

Schedule: Situation Classifications of New Cosmetic Ingredients and Document Item Requirements

 

 

Schedule:

Situation Classifications of New Cosmetic Ingredients and Document Item Requirements

 

Situation classification

 

Document requirements

Situation 1

Situation 2

Situation 3

Situation 4

Situation

5

Situation

6

I. Basic Information

1. Information form for registered or notified ingredient

II. R&D report

2. R&D background

  1. Basic information of ingredient

  1. Use information of ingredient

  1. Functional basis documents

  1. Other R&D documents

III. Preparation process and quality control standards

7. Brief description of preparation process

8.Stability test data

  1. Quality specification indicators and testing methods

10 Documents on possible risk substances and their control measures

 

 

 

 

 

 

IV. Safety assessment

11. Toxicological safety assessment review

  1. Acute oral and dermal toxicity test

 

 

  1. Skin and eye irritation/corrosion test

  1. Skin sensitization test

 

15.Skin phototoxicity test

 

 

 

 

 

 

16. Skin photoallergy test

 

 

 

 

 

 

17. Mutagenicity test

 

 

  1. Subchronic oral or dermal toxicity test

 

 

 

  1. Teratogenicity test

 

 

 

 

 

  1. Chronic toxicity/carcinogenicity combined test

 

 

 

 

 

  1. Inhalation toxicity test

 

 

 

 

 

 

  1. Long-term human trial safety test

 

 

 

 

 

23. Other toxicological tests

 

 

 

 

 

 

24. Safety assessment report

V. Other documents

25. Technical requirements of new ingredient

 

 

 

 

 

 

26. Other documents helpful for registration and notification of new cosmetic ingredients

 

 

 

 

 

 

Note: “○” indicates the documents needed to be submitted. The meanings of the notes on top right corner are interpreted as follows:

For new ingredients having use history overseas, the situation of such ingredients used in cosmetics overseas shall be explained.

Such information shall be submitted for new ingredients having possible safety risk substances.

For situation 3, if a safety report from the international authoritative safety assessment institution concluding it as safe ingredient used in cosmetics or human trial safety testing report that conforms to ethical conditions can be provided, such information is not required.

Such testing data shall be submitted when the ingredient has ultraviolet absorption characteristics.

Except for situation 6, such testing data shall be submitted when the ingredient has ultraviolet absorption characteristics.

Such information shall be submitted when the ingredient has possible inhalation exposure.

Other documents submitted according to the actual situation of each new ingredient.

 

Annex 4

Technical Requirements for New Cosmetic Ingredients

(Template)

 

I. Basic Information

(I) Name

1. Standard Chinese name

2. INCI name and ID number thereof, or English and other foreign name

3. Chemical name, or names (Latin scientific name) of animal and plant ingredients

4. Trade name, common aliases and abbreviations

(II) Registration number

1. CAS registration number

2. EINECS/ELINCS registration number

3. Other relevant registration numbers

(III) Source of ingredients

(IV) Ingredient composition, molecular formula, chemical structure and relative molecular mass, etc.

(V) Physical and chemical properties

II. Technical Requirements

(I) Use purpose of ingredient

(II) Application or use scope of ingredient

(III) Safety usage level

III. Other Requirements

(I) Precautions and warnings, etc.

(II) Storage conditions

(III) Shelf life

 

Annex 5

Requirements for Preparation of R&D Reports for New Cosmetic Ingredients

 

The R&D reports for new cosmetic ingredients shall generally include the following contents:

I. R&D Background

Including ingredient R&D background, R&D purpose, R&D process and R&D results, etc.

II. Basic Information

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

(I) Ingredient name.

Generally including ingredient standard Chinese name, INCI name and ID number thereof, chemical name, animal and plant ingredient name (Latin scientific name), name in “Pharmacopeia of the People’s Republic of China”, common alias or abbreviation, CAS number and EINECS/ELINCS registration number, etc.

  1. Standard Chinese name of ingredient. If the ingredient has been included in the “Catalogue of Standard Chinese Name of International Cosmetic Ingredient”, it shall be specified according to the Catalogue; if the ingredient has not been included, its standard Chinese name shall be formulated by referring to the Chinese name included in the “Pharmacopoeia of the People’s Republic of China” and other authoritative catalogues and based on the common naming principles.
  2. Ingredient INCI name and ID number thereof. If the ingredient has been included in the “International Cosmetic Ingredient Dictionary and Handbook”, the INCI English name and INCI ID number of the ingredient shall be specified; if the ingredient has not been included, its English name shall be provided.

3. Other names. Including chemical names, names (Latin scientific name) of animal and plant ingredients, mineral names, aliases, common names, trade names, abbreviations, etc., that are commonly used or widely used.

(II) Ingredient source

1. The new ingredient sources include ingredients derived from chemicals, plants, minerals, biotechnology sources (e.g. ingredients derived from genetic engineering, cell engineering, fermentation engineering, enzyme engineering and protein engineering).

The registrant and notifier of new cosmetic ingredient shall specify the source of the new cosmetic ingredient applied for registration and notification, and provide corresponding basic information according to the ingredient source.

2. New ingredient shall be of single source, and shall not be mix raw materials that are mixed through physical methods, except for those with coexistence of multiple components due to technically unavoidable reasons during the production or preparation of the ingredient, such as solvents, preservatives, stabilizers, etc. added to protect the ingredient, or other situations where the components that are unavoidably produced through chemical reactions or fermentation processes exist with the ingredient.

In case of the coexistence of multiple components due to technically unavoidable reasons during the production or preparation of the ingredient, the registrant and notifier of new cosmetic ingredient shall also provide relevant research documents for the unavoidable coexistence of two or more components, ingredient composition and relevant proportions.

(III) Composition, structure and component identification

1. Ingredients with a clear chemical structure shall be provided with the chemical structure and relative molecular mass, as well as the basis for confirmation of the chemical structure (such as nuclear magnetic resonance spectroscopy, elemental analysis, mass spectrometry, infrared spectroscopy, etc.), testing reports; the polymers shall also be provided with methods for testing the degree of polymerization and average molecular mass and its distribution and results thereof; ingredients of biotechnology sources shall be provided with methods for identification according to their own characteristics.

2. Ingredients without a clear chemical structure shall be indicated with the ingredient composition, and provided with the parameters, methods and reports of identification.

(IV) Physical and chemical properties

1. According to the properties of ingredients, trait indicators shall be provided, mainly including color, odor, state and other significant characteristics (e.g. flammability, solubility, hygroscopicity, etc.), and other physical and chemical indicator items, e.g. melting point, boiling point, specific gravity, viscosity, pH value, refractive index, optical rotation, hydroxyl value, iodine value, saponification value, acid value, pKa value, distribution coefficient (LogPow), etc., shall also be selected in combination with the properties of ingredients.

2. Nano ingredients shall also be provided with particle size and distribution, aggregation and agglomeration characteristics of the ingredients, surface chemical information, morphology information and other specificity parameters, in addition to the above physical and chemical indicators.

Nano ingredients are insoluble or non-biodegradable artificial ingredients that have at least one dimension at the size of 1~100 nanometers in the three-dimensional structure or are composed of aforesaid dimension as basic units.

III. Use Information of Ingredients

Including use specification, use purpose, application or use scope, safety usage level, shelf life, precautions and warnings, etc., of ingredients in cosmetics; the information of such ingredient used in cosmetics overseas, as well as foreign approval status of such ingredient

IV. Functional Basis Documents of Ingredients

The functional basis documents of new ingredients generally include scientific literature, regulatory documents, laboratory research data, and human body efficacy evaluation test documents and so on. The specific requirements are as follows:

(I)  Scientific literature.

Mainly including openly-published, of non-review nature, related research papers or scientific books, the literature provided shall have a positive correlation with the function of new ingredient applying for registration or notification.

Upon submitting literature documents, a briefly described research process, research results, result analysis and conclusions, etc., of ingredient consistent with the relevant content stated in the literature documents shall be submitted at the same time;

(II) Regulatory documents.

Including standards, catalogues, ancient codes and books, etc., that are issued by the regulatory departments or technical departments at home and abroad; the specific information of ingredient specified in the regulatory documents, such as the use concentration, the use scope, other restricted conditions, etc., shall be provided.

If the functional ingredient positive list specified in the cosmetics regulations issued by foreign regulatory departments is cited, the regulation name, the release country (region), issuer, release time, the full text of the relevant regulations and other information shall be submitted, and at the same time, a description specifying that the new ingredient applying for registration or notification fully meets the use concentration, scope and all other restricted conditions specified in the relevant regulations shall also be submitted;

(III) Laboratory research data.

Mainly including physical and chemical and microbiological tests, in vitro or animal testing results. The selected testing model shall reasonably present and simulate in-vitro use of the new ingredient function.

Where the in vitro or animal testing results are used as the research data documents, the registrant and notifier of new cosmetic ingredient shall provide the test model, test method, as well as test data, results and conclusions concerning that the new ingredient possesses of effective dose of function applying for registration or notification and safety usage level shall be provided, and clarify the mechanism of new ingredient possesses of the relevant function.

(IV) Human body efficacy evaluation test documents.

The test shall be carried out in accordance with the relevant requirements of the cosmetic efficacy claim evaluation principles and procedures formulated by the NMPA, and documents of test methods, number of test subjects, control group design, as well as test data, results and analysis concerning that the new ingredient possesses of effective dose of efficacy applying for registration or notification and safety usage level shall be provided. The test substance shall only contain the functional component of new ingredient applying for registration or notification. Before human trial, it shall be ensured that the toxicological data obtained, exposure conditions and information, etc., of the test substance can meet the safety of its use in humans. The test substance having potential safety risks shall not be subjected to human body efficacy evaluation test.

The above-mentioned functional basis documents of new ingredient can be used individually or in combination to draw a clear conclusion that the new ingredient applied for registration or notification possesses the claimed functions. For functional basis documents of new ingredients claimed as functions of preservative, sunscreen, freckle-removing and whitening, anti-hair loss, anti-acne, anti-wrinkle (excl. physical anti-wrinkle), anti-dandruff and deodorant, at least laboratory research data or human body efficacy evaluation test documents shall be included.

V. Other R&D Documents of New Ingredients

Other documents that are not included in the above-mentioned R&D documents shall be provided according to actual conditions.

 

Annex 6

Requirements for Preparation of Quality Control Standards for New Cosmetic Ingredients

 

The quality control standards for new cosmetic ingredients include stability test data, quality specification indicators and testing methods, as well as documents of possible safety risk substances and their control measures.

I. Stability Test Data

The key investigation items for the stability test of new cosmetic ingredient shall be the items that are easy to change during storage and may affect the quality and safety of the new ingredient, including but not limited to observing the change law of ingredient traits (color, odor, etc.), physical and chemical properties, component content, etc. over time under the influence of temperature, humidity, light, etc.

Stability tests generally include testing methods such as destructive test, accelerated test, and long-term test. The registrant and notifier of new cosmetic ingredient shall select the type of stability test data according to the characteristics of the new ingredient applied for registration or notification, and determine the storage conditions and shelf life of the ingredient based on the stability test results of the ingredient.

For new ingredients used for the first time at home and abroad, the accelerated test data of at least 3 batches of the ingredient or the long-term preservation test data for more than 1 year shall be submitted, and the long-term preservation test data of the rest shelf life shall be provided at one time or supplemented annually within 3 years of monitoring period according to the shelf life of the ingredients.

(I)  Destructive test.

The stability test data of at least one batch of ingredients under the conditions of high temperature (e.g. 60), low temperature (e.g. -20), high humidity (e.g. 90%RH±5% RH) or strong light exposure shall be provided. The influencing factors and the setting conditions of specific parameters may be selected according to the characteristics of ingredients.

(II) Accelerated test.

The stability test data of at least 3 batches of ingredients stored under certain temperature and humidity (e.g. 40±2, 75%RH±5%RH) and period shall be provided. The testing conditions and storage period may be determined according to the characteristics of ingredients.

(III) Long-term preservation test.

The stability test data of at least 3 batches of ingredients stored under certain temperature and humidity (e.g. 25±2, 60%RH±10%RH) for a long term shall be provided. The testing conditions and storage period may be determined according to the characteristics of ingredients.

II. Quality Specification Indicators and Testing Methods

(I)  Ingredient traits and testing methods thereof.

Traits of ingredients include color, odor, state, etc.

(II) Physical and chemical properties of ingredients.

Appropriate physical and chemical indicators and testing methods shall be provided according to the characteristics of ingredients, e.g. melting point, boiling point, specific gravity, viscosity, pH value, optical rotation, etc.

(III) Qualitative identification method.

Appropriate identification methods, such as infrared spectrum method, ultraviolet spectrum method, nuclear magnetic resonance spectrum method, chemical reaction method and chromatographic method, etc., shall be set up according to the structural characteristics of ingredients.

(IV) Ingredient purity control indicators and testing methods thereof.

The purity or content of ingredients, the types of impurities and their respective control indicators and the testing methods thereof shall be provided, and a testing report shall be provided at the same time.

For new ingredients mixed with solvents, preservatives, stabilizers, etc. that are unavoidable due to technical reasons, control indicators of ingredient composition and relevant proportions shall be provided.

(V) Requirements for packaging, transportation and storage of ingredients.

(VI) The use purpose, application or use scope, specifications and safety usage level, precautions, warnings, etc. of the ingredients.

III. Information on Possible Safety Risk Substances and Their Control Standards

In the ingredient quality specifications, appropriate quality and safety limit indicators and testing methods, e.g. control indicators for microorganisms, heavy metals, hazardous substances (e.g. hazardous components, hazardous impurities, hazardous solvents, etc.) shall be set up.

 

Annex 7

Requirements for Preparation of Annual Safety Monitoring Reports for New Cosmetic Ingredients

 

Registrant and notifier of new cosmetic ingredients shall, in accordance with the relevant monitoring requirements for new ingredients, collect relevant information on the use of new ingredient in a timely manner, and prepare the annual safety monitoring report on new ingredients in accordance with these Requirements.

I. Basic Information of Ingredients

Including the Chinese name, hygiene permit number of the new ingredient.

II. Information of Ingredient Production

(I) The name, address, and relevant qualification description, etc., of the production enterprise.

(II) Annual production volume and sales volume of ingredient, etc.

III. Information on Cosmetics Using New Ingredients

(I) Summary of cosmetic enterprises using new ingredients, including cosmetic enterprise name and quantity, quantity of new ingredients purchased, quantity of products sold, etc.

(II) In the form of a list (see Table 1 for details), list the names and hygiene permit number of products using new ingredients, name and addresses of cosmetic registrant, notifier, entrusted production enterprise and other information.

Table 1  Information of Cosmetics Using New Ingredients

Serial No.

Product name

Hygiene permit number

Name of cosmetic registrant and notifier

Address

Name of entrusted production enterprise

Production license number

Address

Rinse-off or leave-on product

Use purpose of new ingredient

Production and sales quantity of product

1

 

 

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

 

IV. Supervision, Random Inspection, Investigation and Recall Situation of Cosmetics Using New Ingredients

In the form of a list (see Table 2 for details), list the relevant information on supervision, random inspection, investigation and recall situation of cosmetics using new ingredients.

Table 2  Supervision, Random Inspection, Investigation and Recall Situation of Cosmetics Using New Ingredients

Time

Type of situation

Product name

Hygiene permit number

Registrant and notifier of cosmetics

Address

Brief description of the situation

Remarks

 

Supervision and random inspection

 

 

 

 

 

 

 

Investigation

 

 

 

 

 

 

 

Recall

 

 

 

 

 

 

V. Adverse Reaction Monitoring

The registrants and notifiers of new cosmetic ingredients respectively elaborated on the adverse reaction monitoring systems of registrants and notifiers of different cosmetics using new ingredients, as well as the statistical analysis of cosmetic adverse reactions and the measures taken, and formed a summary analysis report for the adverse reaction monitoring of new ingredients.

(I) The construction of the adverse reaction monitoring system of registrants and notifiers for cosmetics using new ingredients and the situation of the staff responsible for the monitoring and evaluation of the adverse reaction;

(II) Statistics of adverse reaction monitoring of cosmetics using new ingredients: total number of cases, number of serious adverse reactions, number of cases of adverse reactions of cosmetics that may cause greater social impact, whether to report to the adverse reaction monitoring agency, etc.;

(III) Analysis and evaluation of individual cases of adverse reactions for cosmetics using new ingredients: e.g. severity and relevance evaluation, etc.;

(IV) Investigations, evaluations and measures taken for the adverse reactions of cosmetics using new ingredients;

(V) Information related to the adverse reactions of the new ingredients: analysis and evaluation of patient's adverse reactions arising from new ingredients; situation of serious cosmetic adverse reactions or group adverse reaction events suspected of being caused by such ingredients in other countries (regions). Relevant documents can be attached at the same time.

VI. Risk Monitoring and Evaluation Supervision

(I) a description of the risk monitoring and evaluation supervision system of the enterprises producing and using new ingredients.

(II) Measures taken, etc.

VII. Other Contents that need to be stated

For new ingredients used for the first time at home and abroad, the long-term preservation test data of the rest shelf life shall be supplemented annually within 3 years of monitoring period according to the shelf life of the ingredients.

VIII. Summary Analysis and Conclusion of Monitoring Report

A summary analysis shall be conducted for the monitoring reports and corresponding conclusions shall be formed.

 

Annex 8

Requirements for Preparation of Safety Risk Control Reports for New Cosmetic Ingredients

 

Where a situation that shall be reported is discovered during the use of new cosmetic ingredient, the registrant and notifier of new cosmetic ingredient shall collect relevant information in a timely manner and prepare a safety risk control report for new cosmetic ingredient in accordance with these Requirements.

I. Basic Information

Including the Chinese name, hygiene permit number, etc., of the new ingredient.

II. Information of Production

(I) The name, address, and relevant qualification description, etc., of the production enterprise.

(II) Annual production volume and sales volume, etc.

III. Information on Cosmetics Using New Ingredients

(I) Summary of cosmetic enterprises using new ingredients, including enterprise name, use purpose of new ingredients, quantity of new ingredients purchased and used, etc.

(II) In the form of a list, list the names and hygiene permit number of products using new ingredients, name and addresses of cosmetic registrant, notifier, production enterprise, use purpose of new ingredients in products, usage level and other information.

Table 1 Information of Cosmetics Using New Ingredients

Serial No.

Product name

Hygiene permit number

Name of cosmetic registrant and notifier

Address

Name of entrusted production enterprise

Production license number

Address

Rinse-off or leave-on product

Use purpose and usage level of new ingredient

Production and sales  quantity of product

1

 

 

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

 

IV. Emergencies

(I) Description of emergencies

Including reason analysis of emergency adverse effects and consequences arising therefrom.

(II) Measures taken

(III) Handling results

(IV) Work plan and recommendations

V. Other Contents that need to be stated

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

VI. Summary Analysis and Conclusion

A summary analysis shall be conducted for the reports and corresponding conclusions shall be formed.