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Dry goods! Common technical questions and answers on new raw materials for cosmetics
Release time:
2024-07-12 15:24
On July 8, 2024, the Chinese Academy of Inspection issued a (I) of common technical questions and answers on new raw materials for cosmetics and a (II) of common technical questions and answers on new raw materials for cosmetics.
1. How should the "R & D background" of the development report be prepared?
Answer:
According to Article 13 of the Regulations on the Administration of Registration and Filing Materials for New Cosmetics Raw Materials, the "R & D Background" information in the new raw material development report shall include four parts: R & D background, R & D purpose, R & D process and R & D results.This information is an overall overview of the new raw material development process and a comprehensive summary of the registration/filing information., the new raw material registrant, the filing person shall be based on the actual situation of the enterprise research and development of the raw material.
Among them, the research and development background part should generally include the reasons for the establishment of new raw materials, background sources, research and management status (including relevant regulations and standards, literature, patents, etc.), the application of foreign cosmetics, the application of other industries at home and abroad, the analysis and description of new raw materials, etc., and list the main references. The research and development process part should be combined with the registrant, the filing of the actual research and development of new raw materials, the production process, quality, efficacy, safety and other key research processes are briefly described. The purpose of research and development and the results of research and development should be objective and clear.
TIPs：
The filing of new raw materials includes two stages: formal review and technical verification. In the previously submitted materials, as long as the documents are divided into four headings: research and development background, research and development purpose, research and development process and research and development results, and are explained separately, the formal review can be passed. The detailed requirements of the development report are clarified in the current question, that is, the content of the data should cover the investigation data before the start of the new raw material project, the research data conducted during the production of raw materials and the summary of the filing data.
2. How to fill in the "raw material composition" in the basic information?
Answer:
"Raw material composition" shall reflect the overall composition of the new raw materials registered for the record. A small amount of impurities and residual solvents that may exist in raw materials should be removed as much as possible in production. If there is a substantial impact on the quality and safety of raw materials, scientific and reasonable indicators should be set in the quality control measures to control them, and there is no need to fill in the item of "raw material composition.
For example, for a single compound with a clear structure, the raw material content can be filled in and the necessary information can be specified, such as "calculated as dry", "calculated as anhydrous" or "calculated as anhydrous and solvent-free.
For plant extracts, the item "raw material composition" can be directly filled in as "XX extract". The index components contained in the extract are specified in the "use specification" and do not need to be filled in under the "raw material composition.
3. How to fill in the "usage specifications" in the usage information?
Answer:
The "use specification" here refers to the raw material specification, which should be the main index information that can represent the quality standard of the new raw material, so as to distinguish the raw material with the same name in terms of quality characteristics, rather than the packaging specification of the new raw material sales.
For example, for a single compound with a clear structure, the raw material content can be filled in and the necessary information can be specified, such as "calculated as dry", "calculated as anhydrous" or "calculated as anhydrous and solvent-free. For plant extracts, you can fill in the index ingredients of raw materials and their content range. If there are other necessary indicators, they can also be indicated together, and explain the reasons for the specifications of raw materials, and provide corresponding research data when necessary.
TIPs：
Questions 2 and 3 can be understood in connection with the following examples:
For example, a single compound with a clear structure (such as glycerol) can be filled with glycerol (>98%).
There is no unique structure of ingredients (such as **plant extract), the raw material composition is filled in as" **plant extract", the raw material composition should contain specifications such as "flavonoids" **" and so on.
4. How to fill in the "physical and chemical properties/physical and chemical constants" in the basic information?
Answer: "Physical and chemical properties/physical and chemical constants" should be the inherent physical and chemical properties of the new raw material itself, and appropriate items should be filled in combination with the characteristics of the new raw material. For example, for a single compound with a clear structure, it should generally have 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, specific rotation information should be considered.
It should be noted that some physical and chemical indicators should be clear about the specific determination conditions. Such as pH, should be clearly prepared solvent and sample concentration.
5. How to ensure the accuracy of the source of new cosmetic raw materials from plants/animals?
Answer:
The quality and safety of new raw materials derived from plants/animals is closely related to the plants/animals used. Therefore, professional institutions (such as scientific research institutes, institutions of higher learning, etc.) should issue species identification reports to clarify species information and Latin names. New feedstocks derived from algae and macrofungi are subject to this requirement.
TIPs: Species identification report is required for new materials involving plants/animals/algae/macrofungi.
6. What are the requirements for the selection of toxicology methods?
Answer:
According to the "Regulations on the Administration of Registration and Filing Materials of New Cosmetics Raw Materials", the toxicology test items of new raw materials shall be carried out in accordance with the test methods specified in the "Cosmetic Safety Technical Specifications. Items for which methods are not specified in the Safety Technical Specifications for Cosmetics shall be inspected in accordance with national standards or internationally accepted methods.
Where animal surrogate methods are used for toxicological safety evaluation, the appropriate integrated testing and evaluation method (IATA) should be selected to evaluate the toxicity of the new raw material according to the structural characteristics of the raw material and the specific toxicological endpoint. If the animal substitution test method used has not been included in China's Cosmetic Safety Technical Specification, the substitution test method shall be a method that has been included in the international authoritative substitute method verification agency, and proof that the method can accurately predict the toxicological endpoint shall be submitted at the same time. The supporting data shall include a brief description of the research process of the alternative test method and the research data, result analysis and research conclusions of not less than 10 known toxic subjects.
7. What are the requirements for the subject when conducting toxicology tests?
Answer:
In order to fully prompt the possible safety risks of new raw materials, the corresponding toxicological tests should be carried out with the new raw materials registered for the record as the research object. If the actual commercial sales form of the new raw material is its diluted solution, the new raw material should also be the object of study,Toxicological tests should not be carried out directly on commercial diluted solutions.. When carrying out toxicological tests, the form and dose level of the test substance should meet the requirements of relevant methods and fully reflect the toxicity of the new raw material substance itself.
8. How to carry out exposure assessment in combination with the "scope of application and use" of raw materials?
Answer:
According to the Technical Guidelines for the Safety Assessment of Cosmetics, exposure assessment should take into account the location, amount, concentration, frequency and duration of use of the product containing the raw material or risk substance. Therefore, the exposure assessment and risk assessment of new raw materials should be carried out in combination 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 evaluation should be based on the total exposure of each type of product, taking into account inhalation risks, etc., rather than evaluating several types of products separately.
TIPs: It is clear that the total body exposure in the safety assessment is calculated according to the total exposure of various products that may be involved, and the final MOS value is obtained, instead of evaluating several types of products separately to obtain multiple MOS values.
9. How to carry out a safety assessment of the risks associated with inhalation toxicity of raw materials?
Answer:
According to the Technical Guidelines for Safety Assessment of Cosmetics, when there is a possibility of inhalation exposure, the health hazards caused by inhalation exposure should be considered; according to the Regulations on the Administration of Registration and Filing of New Cosmetic Raw Materials, when the raw materials are likely to be inhaled, inhalation toxicity tests should be carried out. The risk assessment of inhalation exposure should not only consider the physical and chemical properties of the raw materials themselves, but also combine the product dosage form and use method of the raw materials when used in cosmetics. For new raw materials that are not expected to be used in products with possible inhalation exposure risk, the registrant and filer of the new raw materials shall specify in the "scope of application and use" of the new raw materials (e. g., indicate "shall not be used in products with possible inhalation exposure risk").
TIPs: Provides an exemption from the inhalation toxicity test, that is, it is stated that "shall not be used for products that may have the risk of inhalation exposure". However, it is important to note that this label focuses more on the inhalation risks associated with the dosage form/mode of use of the finished product.
10. How should the possible risk substances in new raw materials be identified and evaluated?
A: The risk substances in new raw materials may come from the starting materials, production process, storage and use process, etc., which should be fully analyzed in combination with relevant information and research data. In the production process of new raw material registration and filing materials, the specific starting materials, solvents or additives used, intermediate products and by-products of the reaction process should be listed in combination with the reaction principle, preparation process and actual production process. In combination with the characteristics of new raw materials and stability test data, the possible degradation products during storage and use should be comprehensively analyzed. 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.
TIPs: Identifies information of concern for the identification and assessment of risk substances, starting materials, by-products, and product degradation.
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