What is a PIF file?
I. Introduction
According to Article 4 of the “Cosmetics Hygiene and Safety Management Act” and the “Regulations Governing the Management of Cosmetics Product Information Files”, cosmetic manufacturers or importers of a certain scale that have been announced by the central competent authority shall establish a Product Information File (PIF) before supplying, selling, giving away, publicly displaying, or providing cosmetics to consumers for trial. This is to ensure that the cosmetics on the market have undergone appropriate safety assessments, proving that the cosmetics on the market can be used safely, and to store the product information file at the address indicated on the product label for verification by the competent authority.
II. Purpose
Establishing product information files involves cosmetic manufacturers or importers, manufacturing sites, raw material suppliers, and personnel who sign off on safety data. To assist businesses in understanding the product information file management system, this document provides the basic principles and precautions for creating product information files, serving as a reference for businesses to establish product information files.
The Food and Drug Administration (TFDA) of the Ministry of Health and Welfare implemented the “Regulations Governing the Management of Cosmetic Product Information Files” on July 1, 2019.
These regulations specify who is required to sign the cosmetic product information file.
Article 2 The term “cosmetics manufacturers or importers of a certain scale” as defined in Article 4, Paragraph 1 of this Act (hereinafter referred to as “cosmetics manufacturers or importers”) refers to the following entities engaged in the manufacture or import of cosmetics:
1. Companies or businesses required to register under the Company Act and the Commercial Registration Act.
2. Factories required to complete registration under Article 8, Paragraph 1 of this Act.
3. Other groups or legal entities that manufacture or import cosmetics, excluding handmade soap manufacturers exempt from factory registration.
The cosmetics product information file should also include the following:
Article 3 The cosmetic product information file shall include the following information in Chinese or English:
1. Basic product information: product name, product category, dosage form, uses, manufacturer’s name and address, and information of the manufacturer or importer.
2. Proof of product registration.
3. Full ingredient list and their individual amounts.
4. Product label, leaflet, outer packaging, or container.
5. Proof or declaration that the manufacturing site complies with Good Manufacturing Practices (GMP) for cosmetics.
6. Manufacturing method and process.
7. Method of use, application site, dosage, frequency, and target group.
VIII. Adverse reaction data of product use.
IX. Physical and chemical properties of the product and individual components.
X. Toxicological data of components.
XI. Product stability test report.
XII. Microbiological test report.
XIII. Anti-corrosion efficacy test report.
XIV. Functional evaluation supporting data.
XV. Information on packaging materials in contact with the product.
XVI. Product Safety Data:
(I) Safety assessment conclusions and recommendations, signed and dated by the personnel who signed the safety data.
(II) Qualification documents proving that the personnel who signed the safety data meet the requirements of Articles 4 to 6.
If the original documents in the preceding paragraph are not in Chinese or English, a Chinese or English translation should be provided. For cosmetic manufacturers that produce in segments, the name and address of the manufacturing plant in paragraph 1, subparagraph 1, should include all manufacturing plants involved in the process and the processes they execute.
If any information in Item 1 changes, the corresponding file should be updated.
If the information in Items 11 to 13 of Item 1 has been assessed by the safety data signatory based on the product attributes or characteristics, and the safety data signatory provides a reason in Item 16 of the same item regarding product safety data, then the information may be exempted from being created.