Cosmetic Product Safety Report (CPSR): What It Is and How to Get One

Every cosmetic product sold in the European Union must have a Cosmetic Product Safety Report (CPSR) before it can legally be placed on the market. No CPSR means no legal EU sales — it’s that simple. Yet the CPSR is one of the most misunderstood documents in cosmetic compliance, and brands frequently either delay getting one or commission one that doesn’t meet regulatory requirements. This guide explains exactly what a CPSR is, what it must contain, who is qualified to write it, and what the process looks like from start to finish.

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What Is a CPSR?

A Cosmetic Product Safety Report (CPSR) is a formal safety assessment document required by Article 10 of EU Regulation 1223/2009. It must be completed before a cosmetic product is placed on the EU market and must be kept as part of the Product Information File (PIF) for 10 years after the last batch is sold.

The CPSR serves one purpose: to demonstrate that the cosmetic product is safe for human health when used under normal or reasonably foreseeable conditions of use.

It is not a marketing document. It is not a summary of your supplier’s safety data sheets. It is a professional scientific assessment, signed by a qualified safety assessor, that takes legal responsibility for the conclusion that your product is safe.

Expert note: “We review CPSRs from brands entering the EU market regularly, and the most common problem is a document that looks like a CPSR but doesn’t actually meet the requirements of Annex I of Regulation 1223/2009. A non-compliant CPSR is worse than no CPSR — it gives false confidence while leaving the brand legally exposed.” — Nour Abochama, Quality & Regulatory Advisor, Care Europe

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The Two Parts of a CPSR

EU Regulation 1223/2009 Annex I specifies that a CPSR must contain two distinct parts:

Part A — Cosmetic Product Safety Information

Part A is the data compilation. It must include:

1. Quantitative and qualitative composition The full ingredient list with exact concentrations (not ranges). This must match your actual formula — not the formula you plan to use or the formula you used for a previous batch.

2. Physical/chemical characteristics and stability pH, viscosity, appearance, color, odor, and stability data (accelerated stability testing results or real-time stability data). For water-containing products, microbiological stability data is required.

3. Microbiological quality Total aerobic count, yeast and mold, and absence of specified pathogens (Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, E. coli). For preservative-containing products, Preservative Efficacy Testing (PET/Challenge Test) results.

4. Impurities, traces, and information about the packaging material Potential impurities from raw materials (e.g., heavy metals in mineral ingredients, nitrosamines from certain preservatives), and any migration from packaging into the product.

5. Normal and reasonably foreseeable use How the product is intended to be used, by whom (including vulnerable populations like children or pregnant women), and what reasonably foreseeable misuse looks like.

6. Exposure to the cosmetic product Calculated exposure assessment: how much of the product is applied, to what body surface area, how frequently, and what percentage is retained vs. rinsed off.

7. Exposure to the substances contained in the cosmetic product Systemic exposure dose (SED) calculations for each ingredient, based on the exposure assessment above.

8. Toxicological profile of the substances For each ingredient: available toxicological data (acute toxicity, skin irritation, sensitization, mutagenicity, carcinogenicity, reproductive toxicity, endocrine disruption). This section draws on published literature, supplier safety data, and regulatory databases (SCCS opinions, CIR assessments).

9. Undesirable effects and serious undesirable effects Any known adverse effects associated with the product or its ingredients, and post-market surveillance data if the product has been sold previously.

10. Information on the cosmetic product Product category, intended use, target population, and any specific claims that affect the safety assessment.

Part B — Cosmetic Product Safety Assessment

Part B is the safety assessor’s professional conclusion. It must include:

• The assessor’s evaluation of the safety information in Part A
• The assessment methodology used
• The conclusion: whether the product is safe for human health under normal and reasonably foreseeable conditions of use
• Any specific warnings or conditions of use required
• Scientific reasoning and justification for the conclusion
• The assessor’s qualifications and signature

Part B cannot be written by anyone — it must be signed by a qualified cosmetic safety assessor.

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Who Can Write a CPSR?

The safety assessment in Part B must be performed and signed by a person who holds a diploma or other evidence of formal qualifications in pharmacy, toxicology, medicine, or a similar discipline, as specified in Article 10(2) of Regulation 1223/2009.

In practice, qualified safety assessors are typically:

• Toxicologists with cosmetic industry experience
• Pharmacists with regulatory affairs specialization
• Dermatologists with cosmetic formulation knowledge
• Chemists with postgraduate toxicology qualifications

The assessor must be able to demonstrate their qualifications if requested by a competent authority. Their name, qualifications, and signature must appear in Part B.

Who cannot write a CPSR:

• Your formulator (unless they also hold the required qualifications)
• Your regulatory affairs manager (unless qualified)
• A consultant without the specific academic qualifications
• You, the brand owner (unless you hold the required degree)

Care Europe provides CPSR preparation services with qualified safety assessors. Request a CPSR assessment →

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What Data You Need Before a CPSR Can Be Written

Before a safety assessor can complete your CPSR, they need:

From you (the brand):

• Full formula with exact ingredient concentrations (not INCI list alone — actual percentages)
• Product description and intended use
• Target consumer population (adults, children, pregnant women, etc.)
• Application method and frequency
• Packaging specification and material safety data

From your raw material suppliers:

• Safety Data Sheets (SDS) for each ingredient
• Certificates of Analysis (CoA) for each ingredient
• Toxicological data where available (especially for novel or unusual ingredients)
• Heavy metal specifications for mineral-derived ingredients

From laboratory testing:

• Microbiological test results (finished product)
• Preservative Efficacy Test (PET) results (for water-containing products)
• Stability testing data (accelerated or real-time)
• Heavy metal testing results (especially for eye products, lip products, products for children)

The more complete your data package, the faster and less expensive the CPSR process will be. Assessors charge for time spent chasing missing data.

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How Long Does a CPSR Take?

Timeline depends on data completeness and product complexity:

Scenario	Typical Timeline
Complete data package, simple formula	2–4 weeks
Complete data package, complex formula (many actives)	4–6 weeks
Incomplete data — missing stability or micro data	6–12 weeks (waiting for test results)
Novel ingredients requiring literature review	8–16 weeks
Products for children or vulnerable populations	Add 2–4 weeks

The most common delay: missing Preservative Efficacy Test results. PET takes 28 days by the standard ISO 11930 method. If you haven’t started PET before commissioning your CPSR, add a month to your timeline.

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What a CPSR Costs

CPSR fees vary by assessor, product complexity, and data completeness:

Product Type	Typical CPSR Fee
Simple leave-on product (lotion, cream)	€800–€1,500
Rinse-off product (shampoo, cleanser)	€600–€1,200
Complex formula (multiple actives, claims)	€1,500–€3,000
Product for children	€1,500–€2,500
Sunscreen (UV filter assessment required)	€2,000–€4,000
Product range (multiple variants, same formula)	Reduced rate per variant

These fees cover the safety assessment only. Laboratory testing (micro, stability, heavy metals) is separate and typically costs €500–€2,000 per product depending on the test panel required.

For brands also selling in the USA, Qalitex provides ISO 17025 accredited cosmetic testing in California. For Canadian market compliance, Androxa handles Health Canada NHP and cosmetic requirements.

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Frequently Asked Questions

Does a CPSR expire?

A CPSR does not have a fixed expiry date, but it must be updated whenever there is a change to the product formula, a change in the intended use, new safety data becomes available for an ingredient, or regulatory requirements change (e.g., a new restriction on an ingredient you use). In practice, most assessors recommend reviewing CPSRs every 2–3 years.

Can I use one CPSR for multiple product variants?

If variants share the same formula with only minor differences (e.g., different fragrance, different colorant), a single CPSR with variant-specific appendices is often possible. If the formulas differ significantly, separate CPSRs are required. Your assessor will advise based on the specific variants.

Does my CPSR need to be in English?

The CPSR must be available in a language that is understandable to the competent authorities of the EU member states where the product is sold. In practice, English is widely accepted across the EU. Some member states (notably France and Germany) may require translation for certain enforcement purposes.

What happens if my product is found non-compliant after the CPSR is issued?

If new safety data emerges after the CPSR is issued — for example, a new SCCS opinion restricting an ingredient in your formula — you must update the CPSR and, if necessary, reformulate the product. The Responsible Person is legally obligated to ensure the product remains safe throughout its market life.

Can I get a CPSR before my formula is finalized?

No — the CPSR requires exact ingredient concentrations. A preliminary safety review or “pre-CPSR consultation” can identify potential issues before you finalize your formula, which is useful for avoiding reformulation costs. Care Europe offers pre-CPSR formula reviews as a separate service.

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The Bottom Line

A CPSR is not optional, not a formality, and not something you can produce yourself unless you hold the required scientific qualifications. It is a legal prerequisite for EU cosmetic market entry — and a genuine safety document that protects both your consumers and your brand.

Start the CPSR process early. Commission your stability and microbiological testing before you approach a safety assessor. Have your full formula with exact concentrations ready. The brands that get to market fastest are the ones that treat the CPSR as part of product development, not an afterthought before launch.

Need a CPSR for your EU cosmetic launch? Care Europe provides CPSR preparation with qualified safety assessors, CPNP notification, and full EU regulatory support. Request a CPSR assessment →