Cosmetic Product Safety Report (CPSR)

The Cosmetic Product Safety Report (CPSR) is mandated by Annex I of the EU Cosmetics Regulation (EC 1223/2009) and is the core document within the Product Information File (PIF). It must be completed before a cosmetic product is placed on the market and serves as the formal safety assessment demonstrating that the product is safe for human health under normal or reasonably foreseeable conditions of use.

Part A — Cosmetic Product Safety Information compiles all the data needed for the safety assessment: the quantitative and qualitative composition of the product, physical and chemical characteristics, microbiological quality, impurities and traces, packaging material information, normal and reasonably foreseeable use, exposure to the product, exposure to individual substances, toxicological profiles of each substance, undesirable effects, and any other relevant product information.

Part B — Cosmetic Product Safety Assessment must be carried out by a qualified safety assessor who holds a university diploma in pharmacy, toxicology, medicine, or a similar discipline. The assessor evaluates the Part A data and provides a reasoned conclusion on whether the product is safe. The assessment must specifically address the overall product safety conclusion, labeled warnings and instructions, reasoning behind the conclusion, and the assessor's name, qualifications, and signature.

The cost of a CPSR varies from approximately 300 to 900 EUR per product depending on formulation complexity, number of ingredients, and whether the safety assessor requires additional testing data.