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.
- 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)
- Post-Market Surveillance
- Risks of Non-Compliance
Do you need more information on how to compile your Technical Information File? Contact us now!Learn more!