On April 3, 2024, the National Institutes for Food and Drug Control (NIFDC) issued a draft of Guidelines for the Use of Cosmetic Ingredient Date, aiming to standardize the process of cosmetic safety assessments and promote the orderly implementation of the cosmetic safety assessment system. The draft is now seeking public comments until April 10, 2024.
The Guidelines specifies the main types of ingredient information that can be used in cosmetics safety assessments and defines the information usage requirements by cosmetic registrants and filers in conducting safety assessments, as well as the supporting documentation that should be provided:
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No. |
Category |
|
1 |
Restricted components, permitted preservatives, permitted sunscreen agents, permitted colorants and permitted hair dye agents in the Cosmetic Classification Rules and Catalog. |
|
2 |
Evaluation conclusions published by authoritative cosmetic safety assessment agencies. |
|
3 |
Safety limits or conclusions published by authoritative organizations such as the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), etc. |
|
4 |
Information on the use of ingredients published by cosmetic regulatory authorities. |
|
5 |
Three-year usage history of ingredients. |
|
6 |
History of safe consumption. |
|
7 |
Structurally and chemically stable high molecular weight polymers (excluding ingredients with high biological activity). |
The Guidelines especially emphasizes the scope of application, requirements, and alternative assessment contents for the last three types of supporting documentation listed above.
At the end, the Guidelines provides further explanations regarding the safety assessment of certain special ingredients.
1. As ingredients used in whitening and spot-reducing agents, the assessment evidence cannot rely on the ingredient usage information published by cosmetic regulatory authorities or the three-year usage history of the ingredients.
2. For ingredients used as anti-hair loss agents, anti-acne agents, anti-wrinkle agents (excluding physical anti-wrinkle agents), dandruff agents, deodorants, and those with high biological activity, the usage information published by cosmetic regulatory authorities cannot support assessments. However, in cases where these ingredients are used for the same purpose as before, their three-year usage history can be utilized for assessments.
