The Product Information File (PIF) is one of the key elements for ensuring successful market entry of a cosmetic product in the European market. As per the Cosmetic Regulation 1223/2009, a PIF helps the concerned authorities of the European Union (EU) to monitor the safety of cosmetic products available in the market. Therefore, it is crucial for cosmetic product manufacturers to file it compliantly by collating all the necessary information.
However, before authoring and filing a PIF, manufacturers must be well-aware of the following aspects to overcome errors, if any:
What is a PIF?
A PIF is a Regulatory document required by the EU and its Member States. It outlines the essential elements necessary to demonstrate the safety of a cosmetic product. It is a mandatory requirement in the EU, under Regulation 1223/2009. The Responsible Person (RP) appointed by the manufacturer is accountable for maintaining the PIF for ten (10) years, post the marketing of the last batch of the product.
What should be included in a PIF?
A PIF must consist of five essential sections:
- Description of the product
- Cosmetic Product Safety Report – CPSR (with Part A and Part B)
- Manufacturing method
- Proof of the claimed effect
- Animal testing data
What is the importance of choosing the right safety assessor?
Choosing the right safety assessor is very crucial for manufacturers, as they help draw the correct conclusions from the safety assessments. In Europe, to carry out a safety assessment, an individual must be trained in pharmacy, toxicology, medicine or similar discipline. The aim of choosing the right safety assessor is not only to meet the mere Regulatory requirement but also to ensure the safety of the product.
Who can author the PIF?
Any in-house expert or a valued partner can author the PIF. The only mandatory requirement for this is to appoint a safety assessor. However, considering the importance of the PIF, most of the manufacturers choose to partner with a Regulatory expert with local presence in the EU to avoid any challenges.
Being a key element in ensuring the safety of any cosmetic product, PIF requires a meticulous understanding of the EU cosmetic regulations. Therefore, manufacturers should be very keen in compiling it for sure shot compliance. Consider assigning it to an expert with in-depth knowledge. Stay compliant.