With the promulgation of a series of new cosmetic-related regulations in China, the NMPA’s control over cosmetics and cosmetic ingredients has become more and more stringent. Many cosmetic ingredient manufacturers have started to register new ingredients or declare cosmetic ingredient safety codes. According to the “New Cosmetic Ingredients Frequently Asked Questions” (I) and “New Cosmetic Ingredients Frequently Asked Questions” (II) issued by China Academy of Food and Drug Administration on July 8, 2024, we summarize the frequently asked questions in the process of registration of new cosmetic ingredients under NMPA for your reference. Please feel free to contact us.

 

Q1.How to prepare the “R & D background” of the development report?

According to “new cosmetic ingredients registration and filing information management regulations” Article XIII, the development of new raw materials in the report of the “R & D background” information should include R & D background, R & D purposes, R & D process and R & D results and other four parts. The information is an overall overview of the R & D process of the new raw materials and registration / filing of a comprehensive summary of the information, new raw materials registrants, filers should be based on the actual situation of the enterprise research and development of the raw material for the preparation.

Among them, the R & D background section should generally include the reasons for the project of the new raw materials, background sources, research and management of the current situation (including relevant regulations and standards, literature, patents, etc.), the application of foreign cosmetics, domestic and foreign applications in other industries, the analysis of new raw materials judged to be a description, and list the main references. R & D process part should be combined with the registrant, the filer of the actual research and development of new raw materials, the production process, quality, efficacy, safety and other key research process is briefly described. R & D purposes and research and development results should be objective and clear.

 

Q2 How to fill in the basic information of the “composition of raw materials”?

“Raw material composition” should reflect the registration of new raw materials for the record the overall composition of the situation. For raw materials may exist in a small amount of impurities, residual solvents, etc., should be removed as far as possible in the production, quality and safety of raw materials have a substantial impact on the quality and safety of the quality control measures should be set up in the scientific and reasonable indicators to be controlled, without the need to fill in the “composition of raw materials” item.

For example, for a single compound with a clear structure, you can fill in the raw material content, and clarify the necessary information, such as “calculated according to the dry product”, “calculated according to the anhydrous material” or “calculated according to the anhydrous, solvent-free material “etc.

For plant extracts, the item of “composition of raw materials” can be directly filled in as “XX extract”. Indicator components contained in the extracts are specified in the “specifications for use” and need not be filled in under “composition of raw materials”.

 

Q3 How to fill in the “use specification” in the use information?

The “use specifications” refers to the specifications of the raw material, which should be the main index information that can represent the quality standard of the new raw material, in order to distinguish the same name of the raw material in terms of quality characteristics, rather than the specifications of the packaging of the new raw material for sale.

For example, for a single compound with a clear structure, the content of the raw material can be filled in and the necessary information can be specified, such as “calculated as dry product”, “calculated as anhydrous material” or “calculated as anhydrous, solvent-free material “etc. For plant extracts, the index components of raw materials and their content range can be filled in. If there are other necessary indicators, can also be indicated, and explain the reasons for raw material specifications as indicators, if necessary, together with the corresponding research information.

 

Q4 How to fill in the “physical and chemical properties/physical and chemical constants” in the basic information?

“Physical and chemical properties / physical and chemical constants” should be the new material’s own inherent physical and chemical properties, should be combined with the new material characteristics to fill in the appropriate items. For example, for a single compound with a clear structure, there should be a general solubility, pH, etc.; solid raw materials should generally have a melting point; liquid raw materials should generally have a boiling point; when the chemical structure contains chiral carbon should be considered when the specific spin information.

It should be noted that some of the physical and chemical indicators should be clear and specific measurement conditions. For example, for pH value, the preparation solvent and sample concentration should be specified.

 

Q5 For new cosmetic ingredients derived from plants/animals, how to ensure the accuracy of the source?

The quality and safety of new ingredients derived from plants/animals are closely related to the plants/animals used. Therefore, the species identification report should be issued by professional organizations (such as research institutes, institutions of higher learning, etc.) to clarify the species information, Latin name. New ingredients derived from algae and macrofungi refer to this requirement.

 

Q6 What are the requirements for the selection of toxicological methods?

According to “new cosmetic raw materials registration filing information management regulations”, new raw materials toxicology test items should be carried out in accordance with the “Cosmetic Safety Technical Specification” specified test methods. Cosmetics Safety Technical Specification” does not specify the method of the project, should be in accordance with national standards or internationally accepted methods of testing.

The use of animal alternative methods for toxicological safety evaluation, should be based on the structural characteristics of raw materials, specific toxicological endpoints to choose the appropriate integrated test and evaluation methods (IATA) to evaluate the toxicity of new raw materials. The use of animal alternative test methods have not been included in China’s “Technical Code for Cosmetic Safety”, the alternative test method should be an authoritative international alternative validation agency has been included in the method, and should be submitted at the same time the method can accurately predict the toxicological endpoints of the supporting information. Supporting information should include a brief description of the research process of the alternative test method and not less than 10 known toxicity of the subject of research data, analysis of results, conclusions and other content.

 

Q7 What are the requirements for subjects when conducting toxicological tests?

In order to fully suggest the possible safety risks of new raw materials, should be registered for the record new raw materials as the research object, to carry out the corresponding toxicological tests. If the actual commercialization of new raw materials in the form of its diluted solution, should also be the new raw materials as the object of study, should not be directly commercialized diluted solution as the object of study to carry out toxicological tests. To carry out toxicological tests, the form of subjects, dose levels should be consistent with the relevant methodological requirements, fully reflect the toxicity of the new raw material substance itself.

 

Q8 How to evaluate the exposure of an ingredient in relation to its “scope of application and use”?

According to the “Technical Guidelines for Cosmetic Safety Assessment”, when conducting exposure assessment, factors such as the location, amount, concentration, frequency and duration of use of products containing the raw material or risk substance should be considered. Therefore, the exposure assessment and risk assessment of new raw materials should be conducted in conjunction with the “scope of application and use” of new raw materials. For example, for new raw materials whose “scope of application and use” is “all types of skin cosmetics”, the analysis and assessment should be based on the total exposure of all types of products and take into account the risk of inhalation, etc., rather than evaluating several types of products separately.

 

Q9 How to evaluate the risk of inhalation toxicity of raw materials?

According to the “Technical Guidelines for the Safety Assessment of Cosmetics”, when there is a possibility of inhalation exposure, need to consider the health hazards caused by inhalation exposure; according to the “Cosmetics New Raw Material Registration Record Information Management Regulations”, raw materials may be exposed by inhalation, inhalation toxicity test should be carried out. Risk assessment of inhalation exposure should take into account both the physical and chemical properties of the raw materials themselves, but also with the use of raw materials in cosmetics, product formulations, methods of use and other factors. For new raw materials are not expected to be used in products that may be at risk of inhalation exposure, new raw materials registrants, filers should be clear in the new raw materials “application and scope of use” (eg, “shall not be used in products that may be at risk of inhalation exposure”).

 

Q10 How to identify and assess possible risk substances in new raw materials?

Risky substances in new raw materials may come from starting materials, production process and storage, use process, etc., should be fully analyzed with relevant information and research data. In the production process of new raw material registration information, should be combined with the principle of reaction, preparation process, the actual production process, etc., listing the specific starting materials, solvents or additives used, intermediate products and by-products of the reaction process. Combined with the characteristics of new raw materials and stability test data, etc., should be comprehensively analyzed in the storage and use of degradation products that may occur in the process. On this basis, identify the possible safety risk substances in the new raw materials, explain the control measures, and analyze and evaluate in the safety assessment report.

 

 

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