CPSR Safety Report Drafter

The CPSR Safety Report Drafter is an AI assistant purpose-built for one of the most critical documents in EU cosmetic compliance: the Cosmetic Product Safety Report. Required under Article 10 of Regulation (EC) No 1223/2009, the CPSR must be completed before a cosmetic product can be placed on the EU market, and it must be maintained throughout the product's commercial life. Despite its importance, preparing a CPSR is time-consuming, technically demanding, and often a bottleneck in product launch timelines.

This assistant helps regulatory professionals, safety assessors, and brand compliance teams structure and populate both parts of the CPSR. Part A — the Cosmetic Product Safety Information — covers quantitative and qualitative composition, physicochemical characteristics, microbiological quality, impurities and traces, packaging information, normal and reasonably foreseeable use, exposure to the product, ingredient exposure calculations, toxicological profile of ingredients, and undesirable effects data. Part B — the Cosmetic Product Safety Assessment — provides the safety assessor's conclusions, including the statement of safety, labeling recommendations, and the qualified assessor's declaration.

The assistant helps users compile ingredient toxicological summaries, draft exposure assessments, structure literature review sections, and format the document according to SCCS guidelines. It flags common gaps in CPSRs that lead to rejection by notified bodies or challenges during inspections, such as missing SED calculations, incomplete INCI coverage, or unsupported safety conclusions.

This tool is ideal for in-house regulatory teams managing multiple product launches, safety assessors looking to accelerate their drafting workflow, and SME cosmetic brands preparing their first CPSR. It does not replace the qualified safety assessor who must sign Part B, but it significantly reduces the time and effort required to reach a review-ready document.