Differences between PIF, CPSR, and Safety Assessment

The terms Product Information File (PIF), Cosmetic Product Safety Report (CPSR), and Safety Assessment are frequently misused or used interchangeably, leading to misunderstandings and compliance challenges.

Distinctions Between the PIF, CPSR, and Safety Assessment

While these terms are connected, they serve distinct roles under both the EU and UK cosmetics regulations.

Product Information File (PIF)

Article 11 of the EU Cosmetics Regulation 1223/2009 describes the PIF as a set of documents the Responsible Person must make available to the authorities, upon request, for a period of ten years following the date of the last batch of the cosmetic product placed on the market. It contains essential information about the cosmetic product, including:

- A description of the product

- The product’s manufacturing process

- The Cosmetic Product Safety Report (CPSR)

- Evidence of the effect claimed for the cosmetic product.

- Data on any animal testing performed by the manufacturer, his agents or suppliers

Cosmetic Product Safety Report (CPSR)

The CPSR is a critical part of the PIF. As outlined in the Annex I of the Cosmetics Regulation, the CPSR is divided into two sections:

- Part A: Cosmetic Product Safety Information

This section gathers and organises all available data on the product, such as the toxicological profile of ingredients, the product’s formulation, microbiological quality, and exposure information. It consists of a compilation and analysis of the data from the PIF to ensure the product’s safety.

- Part B: Cosmetic Product Safety Assessment

Part B contains the conclusion on the product’s safety based on the analysis conducted in Part A. This section represents the final safety assessment report, including any warnings, usage conditions, or other limitations that should be considered when marketing the product.

While Part B often receives the most attention, relying on it alone without the accompanying Part A is not sufficient leading to non-compliance. For example, authorities may inspect the PIF and CPSR, and failure to include all required sections, such as Part A, could lead to the product being rejected for market entry.

Safety Assessment Report

The term “safety assessment report” is frequently used in the industry as a shorthand for the entire CPSR, but this is misleading. The safety assessment report refers specifically to Part B of the CPSR, which concludes the product’s safety. Thus, using “safety assessment” as a substitute for the CPSR is inaccurate and may cause misunderstandings regarding regulatory compliance.

Please see below a diagram that capturing the differences between these key terms