Regulations for Cosmetic Product Information File (PIF) Management
Ministry of Health and Welfare(hereinafter called TFDA) Notice is hereby given, to commence Cosmetic Hygiene and Safety Act shall be enforced from July 1st, 2019. This Act is establishes of ＂Regulations for Cosmetic Product Information File Management (hereinafter called PIF)＂ and ＂Categories of Cosmetics and the Enforcement Date that Business Shall Establish Product Information File”. TFDA implements PIF established system.
SGS HIS department collected and organized PIF
Cosmetic product information file shall establish the following information in Chinese or English:
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Product Information File |
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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. |
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Evidentiary documents of completing product notification. |
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Full ingredient names and the individual content. |
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The outer packaging of the products, containers, labels or leaflets. |
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GMP compliance certificates or self-declarations which the manufacturing facilities comply with cosmetic Good Manufacturing Practice Regulations |
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Manufacturing methods and procedures. |
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Usage methods, body parts, dosage, frequencies, and the targeted population. |
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Adverse effects of the product application. |
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Physical and chemical characteristics of the products and individual ingredients. |
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Toxicological data of the ingredients. |
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The product stability test reports. |
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The microbiological test reports. |
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The antimicrobial effectiveness test reports. |
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Supporting information of the functional assessments. |
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Information about the packaging materials which have contact with the products. |
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Product safety information: |
