Q&As

Jun 30, 2025
China
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Q
China | What are the format requirements for documentation proving the history of use?
A

The notifier of a new cosmetic ingredient should collect, organize, analyze, and summarize relevant information in accordance with the basic requirements for documentation proving the history of safe use. A comprehensive summary of the ingredient’s history of safe use should be prepared, accompanied by relevant annexes (see sample Tables 1 to 3 in the Guideline), and supported by traceable supporting documents.

Considering that different countries have varying regulations and practices regarding product sales records and traceability, the Guideline does not impose specific restrictions on the format of supporting documents. The notifier should have a thorough understanding of the actual circumstances and independently compile supporting documentation based on the specific methods of sales and use. The submitted documentation must be relevant, traceable, and reflect key information related to production and business operations. If the marketed cosmetics were not manufactured by the notifier of the new ingredient, the source of the information should be clearly stated, and appropriate authorization should be obtained.

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