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Taiwan Further Specifies Requirements for Compilation of PIF

Taiwan FDA has recently promulgated and implemented three documents to guide cosmetic companies on how to compile the Product Information File (PIF) of cosmetics.

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.

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