Regulations for Cosmetic Product Information File (PIF) Management

This Act is enacted to maintain the hygiene and safety of cosmetics in order to safeguard national health.
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:

Product Information File

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.

Evidentiary documents of completing product notification.

Full ingredient names and the individual content.

The outer packaging of the products, containers, labels or leaflets.

GMP compliance certificates or self-declarations which the manufacturing facilities comply with cosmetic Good Manufacturing Practice Regulations

Manufacturing methods and procedures.

Usage methods, body parts, dosage, frequencies, and the targeted population.

Adverse effects of the product application.

Physical and chemical characteristics of the products and individual ingredients.

Toxicological data of the ingredients.

The product stability test reports.

The microbiological test reports.

The antimicrobial effectiveness test reports.

Supporting information of the functional assessments.

Information about the packaging materials which have contact with the products.

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.

Health Industry Services (TAIPEI)
No.38,Wu Chyuan 7th Rd., New Taipei Industrial Park,Wu Ku Dist., New Taipei City 248020, Taiwan
Health Industry Services (TAICHUNG)
No. 9, 14th Rd., Taichung Industrial Park, Taichung City 407271, Taiwan
Health Industry Services (KAOSHIUNG)
No.61, Kai Fa Rd., Nanzih District, Kaohsiung City 811637, Taiwan