Q&As on Common Technical Issues for New Cosmetic Ingredients in China

We have collected the latest FAQs on the technical issues for new cosmetic ingredients registration and filing in China and translated them into English for your reference.

1. How to Compile the "Research and Development Background" section for a development report?

According to Article 13 of the "Regulations on the Management of Registration and Filing Data for New Cosmetic Ingredients," the "Research and Development Background" section in the new ingredient development report should include four parts:

• the research background,
• research objectives,
• research process, and
• the research results.

These information provides an overall summary of the new ingredient's development process and a comprehensive review of the registration/filing data. Registrants and filers of new ingredients should compile this section based on the actual circumstances of the ingredient's development by their company.

2. How to Fill in the "Ingredient Composition" section?

The "Ingredient Composition" should reflect the overall composition of the new ingredient being registered or filed. Any minor impurities or residual solvents present in the ingredients should be removed as much as possible during production. For those that substantially affect the quality and safety of the ingredient, scientifically reasonable indicators should be set within the quality control measures to manage them, and there is no need to include these details under the "Ingredient Composition" section. For example, for a well-defined single compound, the content of the ingredient can be specified along with necessary information such as "calculated on a dry basis," "calculated as anhydrous," or "calculated as anhydrous and solvent-free." For plant extracts, the "Ingredient Composition" can simply be listed as "XX extract." The characteristic components contained in the extract should be specified in the "Specifications for Use" section and do not need to be included under the "Ingredient Composition."

3. How to Fill in the "Specifications for Use" section?

The "Specifications for Use" refers to the specifications of the ingredient, which should represent the main indicator information that can define the quality standards of the new ingredient. This is to distinguish between ingredients of the same name based on quality characteristics, not the packaging specifications for the sale of the new ingredient. For example, for a well-defined single compound, the content of the ingredient can be specified along with necessary information such as "calculated on a dry basis," "calculated as anhydrous," or "calculated as anhydrous and solvent-free." For plant extracts, the characteristic components of the ingredient and their content range should be listed. If there are other necessary indicators, these should also be mentioned along with the reasons why they are considered part of the ingredient specifications. If necessary, corresponding research data should also be provided.

4. How to Fill in the "Physical and Chemical Properties/Constants" section?

The "Physical and Chemical Properties/Constants" should represent the inherent physicochemical properties of the new ingredient, and appropriate items should be filled in according to the characteristics of the new ingredient. For example, for a well-defined single compound, properties such as solubility and pH value are generally required; for solid ingredients, the melting point should generally be included; for liquid ingredients, the boiling point should generally be listed; and when the chemical structure includes chiral carbons, the specific optical rotation should be considered. It is important to note that some physicochemical indicators should specify the exact conditions under which they are measured. For example, for pH values, the solvent used for preparation and the concentration of the sample should be clearly defined.

5. How to ensure the accuracy of the source of new cosmetic ingredients derived from plants/animals?

For new ingredients derived from plants or animals, their quality and safety are closely related to the specific plants or animals used. Therefore, a species identification report should be issued by a professional institution (such as scientific research institutes, universities, etc.), specifying the species information and the Latin name. New ingredients derived from algae and macrofungi should follow this requirement as well.

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