The challenges of the PIF (Product Information File)
The European regulation (EC) No 1223/2009 on cosmetic products requires industry professionals to provide a Product Information File (PIF) for each marketed product.
According to regulation 1223/2009 article 2.11, the product information file shall be kept at the disposal of the competent authorities at least ten years after the last product batch has been placed on the market.
The health authorities can review the PIF at any time, and if they notice that a cosmetic product presents any non-conformity, they will require the immediate withdrawal of the product.
Creating and monitoring the progress of a Product Information File represent major challenges for cosmetics manufacturers and distributors. They need to have reliable and automated key stages: retrieve, organize, edit, secure and monitor the information and chapters of the PIF to be able to provide a complete file at any time.
What should the PIF (Product Information File) include?
The Product Information File contains various chapters whose information are provided internally or from suppliers and partners:
- A product description establishing a clear link between the information file and the cosmetic product
- Cosmetic Product Safety Report (CPSR), which should, as a minimum, include:
- Cosmetic product safety information (qualitative and quantitative formula, physical/chemical characteristics, microbiological quality, normal and reasonably foreseeable use, etc.)
- Cosmetic product safety assessment (assessment conclusion, labelled warnings and instructions of use, assessor’s credentials and approval of the safety report, etc.)
- Manufacturing method in compliance with Good Manufacturing Practice (GMP)
- The proof of the effect claimed for the cosmetic product
- Data regarding animal testing
To create the PIF chapters, different information needs to be retrieved from both a company’s internal departments and its suppliers and partners (toxicology experts, laboratories, etc.).
Automate and secure the PIF creation and management thanks to an adaptable process designed for each client’s methods and processes. Indeed, companies have set specific processes to comply with regulation 1223/2009 requirements, depending on their business and interactions with partners.
Lascom CPG structures and automates all processes related to the PIF creation and management. This process includes all functionalities guaranteeing a high level of quality and reliability: automatic notification of internal and external stakeholders, system of approval and information dissemination, alerts, etc.
The relevant information and chapters are directly retrieved from suppliers and sub-contractors through the process in place. Tracking communication and approvals enforce stakeholders’ accountability. Internally, these different steps improve collaboration across the departments; this process also allows them to submit the PIF information they are responsible for, with the required follow-up and traceability.
An alert system ensures the PIF is complete and up-to-date: the persons in charge are notified when information is missing or incomplete; they also receive periodic reminders when file’s updates are required. At the end of the process, the Product Information File can be exported either entirely or by chapters to disseminate it to the persons concerned.
The PIF creation process of Lascom CPG has great quality, reliability and productivity benefits:
- Retrieving information from its source (suppliers, laboratories, partners, etc.) enforces the various stakeholders’ accountability, the company also considerably reduces re-keying errors while saving time
- The entire process is automated, which speeds up the various stages and tasks to be performed
- All the PIF information is secured and the company is guaranteed to have a complete and up-to-date file thanks to an alert system
- Progress indicators ensure the monitoring of the PIF process and allows to identify delays and bottlenecks