Product Information File

To ensure that your cosmetic product launch in EU market is not hampered by in regulatory issues, it is important to maintain Product Information File for each of the cosmetic product you are placing in the market. It is a legal requirement for selling a product in the European market.

Product Information File (PIF) is that regulatory document that contains all the relevant information about the cosmetic product. This dossier must contain information regarding the raw material, qualitative analysis, safety report, finished product etc. It is mandatory for the product cosmetic company to create and maintain the PIF to enable the product to be placed in the market.

It’s not enough to have PIF; it has to be maintained by the Responsible Person for the brand for 10 years after date on which the last batch of the product was put in the market. Also if the product goes through any change – whether in composition, labelling or packaging – the PIF has to be updated immediately.

Key aspects of PIF

A Product Information File must contain every detail about the product, and it is open for inspection by the authorities. It proves the veracity of the claims about the product and enables the product to be placed in the market without any regulatory liabilities.

When preparing a PIF, remember the following:

It should be either in electronic or paper format as long as it is maintained
The language has to be comprehensible for the verifier of the PIF
It should be in the national language of the country where it is being created
All supporting documents like lab reports, research papers, and publications need to be kept in the original format

A PIF must contain

Product Description

It describes the product in detail including name, formula, identification, and code. The language has to be compatible to the region where the product is being sold.

Product Safety Report

This report is for evaluating the safety of the product. The report has to have the data needed for safety assessment, and the concluding report based on the assessment done.

Manufacturing Method

This is for declaration of the Good Manufacturing Practices and product’s compliance to manufacturing methods.

Proof of Claims

It should have documentation supporting the claims made by the product about its efficacy and effect.

Data on Animal Testing

There has to be clear documentation on whether the product has been tested on animals or not.

How we can help

If you want to be eligible for entering any of the markets in EU, it is important to have PIF of your products. Since it is not always easy to gather all the documents, you need expert support to create the file.

Here’s why you need our services:

We help you develop the right product description
We work with you on product claims and product safety report
We have qualified and experienced team to conduct the tests and studies
We can act as Responsible Person for the entire brand