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.

Assessors price per product, and the range is wide because the variable is not the assessment, it is the state of your evidence. A straightforward rinse-off product with well-characterised raw materials and complete supplier dossiers is typically a few hundred pounds and turns round in one to two weeks. A leave-on product with novel actives, missing toxicological data, or a fragrance whose allergen breakdown has to be chased from the supplier can run into the low thousands and take six to eight weeks, most of it waiting.

The cost driver worth managing is the chase. Assessors commonly report that the majority of elapsed time is spent requesting raw material specifications, allergen declarations, stability results and challenge test reports that the brand already owns but cannot locate. Every one of those is a data-availability problem rather than a scientific one, which is why brands with the same portfolio can see a threefold difference in their annual safety assessment bill.

Regulation 1223/2009 does not prescribe a fixed test list. The assessor decides what evidence is needed for that product. In practice a standard pack contains:

• Stability and compatibility. Accelerated and real-time stability, plus packaging compatibility, supporting the period after opening or the durability date.
• Challenge test. Preservative efficacy to ISO 11930 for products at microbiological risk.
• Microbiological quality. Total viable counts and specified organisms to ISO 17516 limits.
• Raw material documentation. Specifications, certificates of analysis, allergen and impurity declarations, and toxicological profiles for each ingredient.
• Claim substantiation. Where claims are made, the supporting evidence, governed by Regulation (EU) 655/2013.

Animal testing is prohibited for cosmetic ingredients and finished products in the EU and UK, so the toxicological profile is built from existing data, read-across and validated alternative methods rather than new in-vivo studies.

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.