Regulations for Cosmetic Product Information File Management｜第 3 條｜Food and Drug Administration｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2022-06-16
Cosmetic product information file shall establish the following information in Chinese or English: 1. Basic information of the product: the name of the product, the category of the product, dosage form, purpose, the names and addresses of manufacturing facilities, information of product manufacturers or importers. 2. Evidentiary documents of completing product notification. 3. Full ingredient names and the individual content. 4. The outer packaging of the products, containers, labels or leaflets. 5. GMP compliance certificates or self-declarations which the manufacturing facilities comply with cosmetic Good Manufacturing Practice Regulations 6. Manufacturing methods and procedures. 7. Usage methods, body parts, dosage, frequencies and the targeted population. 8. Adverse effects of the product application. 9. Physical and chemical characteristics of the products and individual ingredients. 10. Toxicological data of the ingredients. 11. The product stability test reports. 12. The microbiological test reports. 13. The antimicrobial effectiveness test reports. 14. Supporting information of the functional assessments. 15. Information about the packaging materials which have contact with the products. 16. Product safety information: (1) Safety evaluation conclusion and suggestion which has the signature of the signatory for the safety report and the date. (2) Qualification certificates which the signatory for the safety report complies with Article 4, 5 and 6. If the original information of the file in the preceding paragraph is established in the language other than Chinese or English, the Chinese or English translation shall be attached Cosmetic products which are manufactured in separate processes, the names and addresses of manufacturing facilities mentioned in the Subparagraph 1 of the previous paragraph shall include all of the manufacturing facilities in the processes and their operation procedures. Cosmetic product information file shall be renewed in accordance with Paragraph 1 when it changes. The information mentioned Subparagraph 11 to 13 of Paragraph 1, when the signatory for the safety report evaluates the characteristics or specialty of the product and makes reasoning in Subparagraph 16 of the same Paragraph, may be exempt from establishment.