China new cosmetic ingredients research guidelines – draft was released by the National Institute for Food and Drug Control (NIFDC) under the National Medical Products Administration (NMPA) on December 1, 2023.
The guidelines have been developed to guide research on new cosmetic ingredients scientifically and in compliance with regulations such as the “Cosmetic Supervision and Administration Regulations,” the “Cosmetic Registration and Filing Management Measures,” and the “NMPA Announcement No. 143/ 2023 on Encouraging Innovation and Standardized Management of Cosmetic New Ingredients “, This guidance applies to registrants and filers of cosmetic new ingredients who are involved in defining and researching new ingredients.
This summary provides an overview of the guidance for regulatory affairs professionals working with cosmetic new ingredients in China, outlining the classification, properties, categories, general requirements, and key terminology involved in the regulatory process.
Classification:
New ingredients, whether natural or synthetic, used for the first time in cosmetics within China are considered cosmetic new ingredients. They can be classified based on their properties and intended uses into:
- ingredients that affect the cosmetic product
- they influence the product’s form, stability, color, scent, and more
- they should be safe for use and mainly include matrix ingredients and auxiliary ingredients.
- ingredients that affect the human body’s surface
- they have practical effects on the skin, hair, nails, lips, etc., to achieve cleansing, protection, beautification, or modification purposes.
- ingredients that affect both the product and the human body’s surface
- they have dual roles, affecting both the cosmetic product and the human body’s surface.
Depending on the level of innovation in their development, cosmetic new ingredients can further be categorized as:
- globally new
- these are newly discovered or confirmed ingredients suitable for cosmetics or known ingredients not previously used in cosmetics in China
- domestically new
- these are ingredients used in cosmetics abroad but not yet used in China
- or innovative improvements to existing cosmetic ingredients of which there are two scenarios:
- adjusting the purpose of an already used cosmetic ingredient to functions like preservatives, sunscreens, colorants, hair dyes, or skin whitening agents.
- substantial innovative research on an already used ingredient to enhance safety, efficacy, stability, and quality control.
General Requirements:
Cosmetic new ingredient registrants and filers should thoroughly research the ingredient:
- source,
- characteristics,
- purpose,
- mechanisms of action,
- intended use,
- application areas,
- actual functions,
- compositional features,
- origin,
- manufacturing processes.
They should also assess related risks to ensure the safety and intended functionality of these ingredients.
Research Content:
Research should encompass the source, characteristics, and safety requirements of the ingredient. It should explain the ingredient’s purpose, actual functions, manufacturing processes, quality control, and safety assessment. Efficacy evaluations should be conducted for ingredients affecting the human body’s surface. Additionally, transdermal absorption studies, toxicology tests, and safety risk assessments are necessary.
Naming Requirements:
Ingredients should be accurately named based on their characteristics, source attributes, and manufacturing processes. If isomers exist, they should be clearly identified in the name. Compliance with international naming conventions, such as the INCI name, is important.
General Requirements:
Registrants and filers must conduct comprehensive research and categorize ingredients based on their properties and innovation levels. Safety assessments, including toxicology and safety risk assessments, must be carried out in accordance with guidelines. Documentation should be truthful, accurate, complete, and traceable, adhering to legal and regulatory requirements.
How to submit comments:
Please send your suggestions, comments and feedback directly to hzppjzx@nifdc.org.cn before December 18, 2023.
Further information
Read the original China new cosmetic ingredients research guidelines – draft for comments.
Read our previous articles on New cosmetic ingredients filed for China registration: 77 in total as of July 2023 and Guidelines on Cosmetic Ingredient Safety Information via Annex 14.
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