Taiwan Further Specifies Requirements for Compilation of PIF

The three documents are as follows:

No.	Name	Introduction
1	PIF Checklist	Lists all the documents required by PIF
2	Guidelines on the Establishment of PIF	Template on how to compile PIF
3	Manual for the Establishment of PIF	It details the basic principles, requirements and notes for the establishment of PIF

Compared to the Regulations for Cosmetic Product Information File Management, the three documents supplement more detailed requirements for PIF.

No.	Required Document of PIF	Detailed Requirements
1	Product basic information (name, category, formulation, usage, name, and address of the manufacturer, importer’s information)	Include entrusted distribution certifications from overseas manufacturers
2	A notification certificate	Related data shall be consistent with the notification documents
3	Full ingredients and concentration	Require the name and concentration of every ingredient
4	Product label, instruction, outer packaging or container	Require clear labeling or instructions if there are other colors or types.
5	GMP certificate or self-commitment
6	Manufacture method and process	Describe the method and process by texts or figures
7	Use method, application area, usage amount, frequency and target users	Include precautions for use
8	Adverse reaction data	Include adverse reaction records
9	Physical and chemical properties of products and ingredients	Include specifications of each ingredient and the product
10	Ingredients’ toxicological data	If there are new R&D or new usage ingredients, the safety data signatory shall assess appropriate safety testing
11	*Product stability test report	Including testing method, basis and reports
12	*Microbiological test report	Include microbiological specifications, testing method, testing reports
13	*Anticorrosion efficacy test report	Include testing method and testing report and supporting documents for low-risk products exempted from preservative efficacy testing
14	Functional assessment supporting data	Require supporting report or documents for products containing specific purpose ingredients or claiming special efficacy
15	Packaging materials information in contact with products	Include specification and volume of secondary packaging and related certifications or testing reports
16	Product safety data 1) safety assessment conclusions and advice signed by safety data signatory 2) certificate of safety data signatory’qualifications	1) Include the assessment conclusion and advice, and signature date. 2) Name, education background and safety assessment training qualifications

Note 1: * means that these 3 documents are not required if safety data signatory clarify reasons based on product attribute or characteristics assessment results.

Note 2: The detailed requirements above are just a summary. Further information can be found in Manual for the Establishment of PIF. Please contact us at cosmetic@chemlinked.com if you need a translation.

All data of PIF is permitted to be obtained from any reliable sources, such as raw materials providers, scientific literature, lessons from similar products, additives research results, product research results and data of similar formula. But the PIF must provide sufficient information for the safety data signatory to identify the hazard which could be generated from raw materials, production process, packaging process, product usage, etc. and assess the potential risk to human health posed by the product.