The three documents are as follows:
Lists all the documents required by PIF
Guidelines on the Establishment of PIF
Template on how to compile PIF
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.
Required Document of PIF
Product basic information (name, category, formulation, usage, name, and address of the manufacturer, importer’s information)
Include entrusted distribution certifications from overseas manufacturers
A notification certificate
Related data shall be consistent with the notification documents
Full ingredients and concentration
Require the name and concentration of every ingredient
Product label, instruction, outer packaging or container
Require clear labeling or instructions if there are other colors or types.
GMP certificate or self-commitment
Manufacture method and process
Describe the method and process by texts or figures
Use method, application area, usage amount, frequency and target users
Include precautions for use
Adverse reaction data
Include adverse reaction records
Physical and chemical properties of products and ingredients
Include specifications of each ingredient and the product
Ingredients’ toxicological data
If there are new R&D or new usage ingredients, the safety data signatory shall assess appropriate safety testing
*Product stability test report
Including testing method, basis and reports
*Microbiological test report
Include microbiological specifications, testing method, testing reports
*Anticorrosion efficacy test report
Include testing method and testing report and supporting documents for low-risk products exempted from preservative efficacy testing
Functional assessment supporting data
Require supporting report or documents for products containing specific purpose ingredients or claiming special efficacy
Packaging materials information in contact with products
Include specification and volume of secondary packaging and related certifications or testing reports
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 email@example.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.