Cosmetic Manufacturers need a Product Information File to comply with the Cosmetic regulations of the European Union and United Kingdom in order to legally sell their cosmetic products in these regions. It is a compendium of all the Product relevant information and is a dynamic document that has to be regularly updated and kept with the responsible person. Read more to know about the risks of non-compliance and how can you safeguard yourself from heavy penalties.
All the relevant and necessary information regarding the cosmetic which is important in ensuring its safety, efficacy, and quality along with data compiled in one large massive dossier (file) is known as the Product Information File.
It contains valuable information about the composition of the cosmetic product, ingredients to the material used for packaging, and Claims made to market your product.
It is an important document :
to get approval for registering cosmetic products and
comply with Cosmetic regulations in the UK and EU
According to European Union Regulation 1223/2009, The Document is to be kept available at all times with the responsible person for up to 10 years after the market launch and should be accessible to authorities. Also, it should be in the language easily understood by the authority of the member state in which it is present.
All the relevant and necessary information regarding the cosmetic which is important in ensuring its safety, efficacy, and quality along with data compiled in one file is known as the Product Information File.
It contains valuable information about the composition of the cosmetic product, ingredients to the material used for packaging, and Claims made to market your product.
Why is the Product Information File Important?
It is an important document :
to get approval for registering cosmetic products and
comply with Cosmetic regulations in the UK and EU
builds trust in your brand
serves as an invaluable proof of due diligence and adherence to regulations
Benefits the sustainability of your business and consumers
The Document is to be kept available at all times with the responsible person for up to 10 years after the market launch and should be accessible to authorities.
It is a ‘dynamic document’ which means it should be updated as the Cosmetic product is launched, tested and any changes are made to the product.
Non-compliance with regulations concerning the information mentioned in the file can lead to high penalties and loss of product reputation or even Product Recall.
What does a Product Information File Contain?
The following are the contents of a Typical Product Information File:
Description of the product
Formula (Composition) to make
a Safety Assessment Report
Method of manufacturing
Proof of Compliance with Good manufacturing practices
List of ingredients used to make the product
Labelling information
Packaging information
Details of the Manufacturing Processes used
Safety Data Sheets
Lab test certificates
Animal Testing Data (if present)
Quantity of Nanomaterials, Allergens if there are any
Manufacturing process details
Labelling information
Safety data sheets
Packaging mock-ups
Post-marketing adverse reactions
What are the risks of Non compliance with PIF?
In case for some reason, the PIF ‘s content does not comply with regulations, then strict actions are taken against the manufacturer by the relevant authorities.
These actions can be high penalties, Product recalls or even bans for a certain duration in severe noncompliance. These can result in loss of brand reputation and limited market access to Cosmetic Manufacturers.
Here are some Conditions when there can be a serious Compliance:
If your data points are missing then it is a serious issue that can have harsh consequences for the product.
For Example, Information about the quality of packaging materials and their effects on the product composition is not present.
If the information is not updated for a long time, then it can also be rejected as there are no records of the changes made to the cosmetic product over the prescribed time.
The Information is Factually Incorrect and False, For example: If you state in the file that the product contains “A” ingredient but in reality it does not contain that. then it can lead to high penalties and noncompliance issues.
There have been instances when Companies have been fined thousands or even millions of Euros in some cases for Non-Compliance with Product Information File regulations.
How To Reduce Risk of Non-Compliance with PIF as a Cosmetic Manufacturer?
Complying with the regulations of the European Union and the United Kingdom requires a careful eye fueled with experience and competence. We at Cert3global have been fortunate to assist successful brands in helping them prepare their Product Information File.
Our team consists of specialised experts and has technically streamlined processes in place with high standards for data security and confidentiality. Hence providing all the assistance you need at the right time.For Instance, one of the reasons for rejecting PIF is unsatisfactory/false claims. We have our specialists and regulatory experts who can help you assess the backing of your claims with objective scientific standards. In case needed, our team will help you review therapeutic claims about the components used in your products.
