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If you manufacture cosmetics outside the European Union and want to sell them in Spain, France, Germany, or any other EU member state, you need a Cosmetic Product Safety Report (CPSR) before placing your product on the market. This is not a recommendation — it is a legal requirement under Article 10 of Regulation (EC) No 1223/2009. Without a valid CPSR, the product cannot legally be sold in the EU.
The question we hear most often from manufacturers outside Europe is not «do I need a CPSR?» — they usually know they do — but «what exactly goes in it and how do I get one?» This guide answers both questions.
What the Cosmetic Product Safety Report contains
The CPSR is divided into two parts with very different purposes. Part A compiles all the factual safety data about the product: the full quantitative formula with ingredient concentrations, the physicochemical characteristics of the finished product, microbiological quality data including stability and challenge tests where required, impurity and trace data from raw materials, packaging safety data where relevant, and a complete toxicological profile for each ingredient. In practice, Part A is a documentation exercise — it assembles data that a competent manufacturer already has.
Part B is the actual safety assessment. This is where a qualified Safety Assessor evaluates the toxicological data in the context of the product’s specific use pattern — application area, frequency, rinse-off or leave-on, consumer population including children or elderly if applicable — and reaches a documented conclusion on whether the product is safe for human health under its intended and reasonably foreseeable conditions of use. Part B must include any warnings or conditions of use that need to appear on the label, and the reasoning behind the safety conclusion must be explicit. A generic statement that the product «is safe» without supporting reasoning does not constitute a valid assessment.
Who is qualified to sign a CPSR
The Safety Assessor signing Part B must hold a university degree in pharmacy, medicine, toxicology, chemistry, or a related scientific discipline, with at least two years of study specifically in toxicology or an equivalent qualification. This is a legal requirement, not a quality preference. A CPSR signed by someone without the required qualification has no legal value — the product is treated as having no CPSR at all.
For manufacturers outside the EU, this has a practical implication that is often underestimated: your internal regulatory team, however competent, cannot sign Part B unless they hold the required qualification and are established in the EU. In our experience, the typical setup for non-EU manufacturers is to work through the Responsible Person established in the EU, who coordinates the CPSR with a qualified Safety Assessor in the EU on your behalf.
Timeline and cost for a standard CPSR
For a conventional cosmetic formula — a moisturiser, a shampoo, a foundation — with standard ingredients and complete documentation, a CPSR typically takes 3 to 6 weeks from the moment the Safety Assessor receives everything they need. The cost for a standard formula is typically in the range of 300 to 600 euros per product. Complex formulas — those with novel ingredients, high-risk ingredient categories such as UV filters or preservatives approaching maximum limits, or products intended for use around the eyes or on children — take longer and cost more, typically 600 to 1,200 euros.
The most common cause of delays is not the assessment itself but documentation gaps. Missing stability data, incomplete raw material safety data sheets, or formulas provided as a generic ingredient list without concentrations all stop the process. The European Commission’s CPSR guidance document specifies what Part A must contain — reviewing it before sending documentation to a Safety Assessor saves weeks.
When a CPSR needs to be updated
The CPSR has no fixed expiry date, but it must be updated when the formula changes — any ingredient added, removed, or reformulated at a different concentration triggers an update. A change in the intended use also requires a new assessment: a formula assessed for adult use and then marketed as suitable for children needs a separate evaluation for that population. If new toxicological data becomes available for a key ingredient — a revised SCCS opinion, a new REACH restriction — and it materially affects the safety conclusion, the CPSR must be reviewed.
What does not require a new CPSR is a label-only change: updated packaging design, a new language version, or a modified marketing claim that does not affect the product’s composition or intended use. The Scientific Committee on Consumer Safety (SCCS) publishes updated opinions on ingredients regularly — it is worth checking these when your CPSR is more than three years old, even if nothing in your formula has changed.
The CPSR in the context of EU market entry
The CPSR is one of four requirements for a non-EU manufacturer entering the European market. The others are: appointing a Responsible Person established in the EU who takes legal responsibility for the product’s compliance; preparing the complete Product Information File (PIF), which includes the CPSR plus the manufacturing and safety records; and notifying the product in the CPNP (EU Cosmetic Products Notification Portal) before placing it on the market in any member state.
Of the four, the CPSR is consistently the most time-consuming. Starting it during product development — rather than waiting until the product is ready to ship — avoids the situation we see most often in practice: a manufacturer ready to launch who discovers they need a 6-week assessment before their first container can clear customs.
If you are planning your EU market entry and want to understand the documentation requirements and timeline for your specific product category, contact our regulatory team. We can give you a clear picture of what is needed and how long it will take before you commit to a launch date.