What is a CPSR, and what evidence does it require?

Part A is the dossier of safety-relevant data: qualitative and quantitative composition, physical and chemical characteristics, microbiological quality, impurities and traces of forbidden substances, stability, packaging, normal and reasonably foreseeable use, exposure to the product and to each substance, toxicological profile of each substance, undesirable and serious undesirable effects, and any other information on the product. It is a structured evidence file, not a marketing document.

Part B is the qualified safety assessor's reasoned conclusion: a safety assessment based on Part A, with warnings and instructions for use, a justified statement on the safety of the product when used under normal or reasonably foreseeable conditions, and the assessor's credentials, signature and date. Without a signed Part B the PIF is incomplete and the product is not lawfully placed on the market.

The safety assessor must hold a qualification in pharmacy, toxicology, medicine or a similar related discipline, recognised in a Member State. The assessor can be in-house or external, but cannot be the same person whose work is being assessed without independence safeguards.

A CPSR is not a one-time document. It must be updated when the formulation changes, new toxicological evidence becomes available, an ingredient is restricted, or undesirable effects accumulate. For a brand with hundreds of SKUs, this is structural data work, not legal work. Worldover holds the composition, the ingredient toxicology and the test results once, and re-generates the Part A draft whenever a relevant change is detected, so the assessor's time goes on judgement, not on assembly.

A CPSR requires a complete and up-to-date product record: formula, safety assessment inputs, INCI list, clinical and toxicological data, and stability results. Managing this across multiple SKUs and markets in disconnected systems is where teams fall behind.

Worldover maintains a live CPSR-ready product record for every SKU: formula, safety assessment inputs, INCI list and test results in one place. When a formula changes, the record updates automatically, and Willow flags when a CPSR needs review based on formulation or regulatory changes.