Product Information File

The Product Information File (PIF) is the mandatory compilation of  technical documentation required for each cosmetic product to be placed  on the EU market. According to the EU Cosmetics Regulation 1223/2009/EC, the elements of the PIF include but are not limited to:

• Product Description
• Safety Report:

Part A: Cosmetic Product Safety Information

Part B: Cosmetic Product Safety Assessment Report

• Method of Manufacturing
• Evidence of compliance with Good Manufacturing Practices (GMP)
• Proof of the effect claimed (where justified)
• Data on Animal Testing
• Labeling (taking into account the primary packaging and outer/ secondary packaging)
• Data on Serious Undesirable Effects
• And more…

The PIF is kept by the Responsible Person at the address specified on the label (must indicate its address within  the European Community) for 10 years after the last batch was placed on  the market. The PIF should be held in a safe storage location, readily  accessible to the Competent Authorities in electronic or other format.

The  RP must ensure that the PIF comprehends all the necessary documentation  to meet the requirements set by Regulation 1223/2009. It is also a task  of the RP to ensure that compliancy of artwork and claims on the  packaging is met and that the language of the PIF is easily understood  by the Competent Authorities, updating the documentation within the PIF  when necessary.

It is fundamental for manufacturers to appoint an  RP before starting the compilation of the PIF. Appointing an RP in an  early phase of the CPNP Notification process will guarantee the maximum level of compliance and ensure that products will successfully undergo a Safety Assessment.

In addition to the standard PIF review, Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will be glad to provide support regarding the PIF compilation and also Safety Assessor selection.

Learn More:

• Scope & Classification
• The Regulation: EC 1223/2009
• EU Responsible Person
• Good Manufacturing Practices
• Cosmetic Product Safety Report (CPSR) - Part A & B
• Mandatory Safety Testing
• EU Labeling
• Pre-Market Notification: Cosmetic Product Notification Portal (CPNP)
• Nanomaterials
• Post-Market Surveillance
• Risks of Non-Compliance

Do you need more information on how to compile your Technical Information File? Contact us now!