How much does a CPSR cost?

CPSR costs typically range from €1,250-€2,500 for simple products to €4,500-€9,000+ for complex products. This includes the safety assessment fee (€300-€2,500), stability testing (€400-€3,000), microbiological testing (€150-€800), and challenge testing (€250-€1,200). Complex products requiring additional testing (patch tests, SPF) will cost more.

How long does it take to get a CPSR?

The minimum timeline is typically 4-6 months when running tests in parallel. This includes 3-6 months for accelerated stability testing, 4-6 weeks for challenge testing, and 2-6 weeks for the safety assessment once all data is complete. Products requiring real-time stability data may take 12-18 months.

Can I prepare my own CPSR?

You can prepare Part A (technical documentation) yourself. However, Part B (the safety assessment) must be prepared and signed by a qualified safety assessor with credentials meeting Article 10(2) requirements — typically a university degree in pharmacy, toxicology, medicine, or similar discipline recognized in an EU Member State.

Do I need a new CPSR for each product shade or variant?

It depends on the differences between variants. Minor variations (fragrance at same concentration, different colors within the same colorant system) may be covered under one CPSR with variant documentation. Significant formula differences typically require separate CPSRs. Consult your safety assessor for guidance on your specific product range.

What qualifications must a safety assessor have?

Under Article 10(2) of Regulation 1223/2009, the safety assessor must hold a diploma or other evidence of formal qualifications in pharmacy, toxicology, medicine, or a similar discipline, as recognized by a Member State. 'Similar discipline' typically includes chemistry, biochemistry, dermatology, and related life sciences.

Is the CPSR publicly available?

No. The CPSR is part of the Product Information File (PIF) maintained by the Responsible Person and must be available to competent authorities upon request. It is not publicly disclosed. However, a summary may be requested in some circumstances.

Can I use one CPSR for multiple EU countries?

Yes. The CPSR is valid across the entire EU/EEA market. EU Regulation 1223/2009 is directly applicable in all Member States, so one CPSR covers all EU countries where you sell the product.

What happens if my formulation changes after the CPSR?

Any formulation change requires CPSR update. Minor changes may only need the assessor to review and approve the modification. Significant changes (new active ingredients, concentration changes affecting safety) may require new testing and a full reassessment.

How to Get CPSR: Cost, Requirements & Step-by-Step Guide

What is a CPSR and Why Do You Need One?

The Cosmetic Product Safety Report (CPSR) is the mandatory safety documentation required for every cosmetic product sold in the European Union. According to EU Regulation 1223/2009, no cosmetic product may be placed on the EU market without a valid CPSR demonstrating its safety for human health under normal and reasonably foreseeable conditions of use.

No Exemptions

Unlike US MoCRA which provides small business exemptions, the EU requires a CPSR for every cosmetic product regardless of company size, product type, or sales volume. There are no shortcuts.

The CPSR serves multiple critical functions:

Legal requirement for EU market access
Safety documentation demonstrating the product won't harm consumers
Regulatory evidence that can be requested by competent authorities
Part of the Product Information File (PIF) maintained by the Responsible Person

CPSR Structure Overview

Per Annex I of Regulation 1223/2009, the CPSR consists of two parts:

CPSR Parts A and B
Aspect	Part A: Safety Information	Part B: Safety Assessment
Purpose	Compile all technical data	Expert safety evaluation
Who Prepares	Manufacturer/Responsible Person	Qualified Safety Assessor
Content	Facts, data, test results	Scientific analysis, conclusions
Signature	Not required	Mandatory (Safety Assessor)
Updates	Ongoing as data changes	When significant changes occur

Step-by-Step: How to Get a CPSR

Complete CPSR Process

Finalize Your Formulation

Lock in your complete formula with exact ingredient percentages. The CPSR is formulation-specific — any changes require updates. Include all ingredients including fragrances (with full IFRA breakdown).

Verify Ingredient Compliance

Check every ingredient against EU Annexes II-VI using the CosIng database. Ensure no prohibited substances and all restrictions are met. This step prevents costly reformulation later.

Gather Raw Material Documentation

Collect specifications, SDSs, allergen declarations, and certificates of analysis for every ingredient. Safety assessors need this data to complete their evaluation.

Conduct Required Testing

Complete stability testing (accelerated and/or real-time), microbiological testing, and challenge testing (PET). Some products may need additional testing like patch tests or SPF validation.

Compile Part A Documentation

Assemble all technical data into the Part A format specified in Annex I. This includes formula, manufacturing details, stability data, exposure calculations, and toxicological profiles.

Engage a Qualified Safety Assessor

Find a safety assessor with the qualifications specified in Article 10(2). Provide them with your complete Part A documentation for review.

Address Assessor Questions

The safety assessor may request additional data, clarifications, or testing. Be prepared to provide supplementary information or conduct additional studies.

Receive Signed Part B

Once satisfied with product safety, the assessor prepares Part B with their conclusions and signature. This completes your CPSR.

Maintain and Update

Keep the CPSR current whenever formulations change, new safety data emerges, or regulations are updated. The CPSR is a living document.

CPSR Costs: What to Expect

CPSR costs vary significantly based on product complexity, existing documentation, and service provider. Based on industry surveys:

Typical CPSR Cost Breakdown (2026 Estimates)
Component	Simple Product	Standard Product	Complex Product
Part B Safety Assessment	€300 - €600	€600 - €1,200	€1,200 - €2,500
Stability Testing (accelerated)	€400 - €800	€800 - €1,500	€1,500 - €3,000
Microbiological Testing	€150 - €300	€300 - €500	€500 - €800
Challenge Test (PET)	€250 - €450	€450 - €700	€700 - €1,200
Toxicological Dossier (if needed)	€150 - €300	€300 - €600	€600 - €1,500
Total Estimated Cost	€1,250 - €2,450	€2,450 - €4,500	€4,500 - €9,000+

* Simple: Basic formulation, well-known ingredients, standard claims

* Standard: Moderate complexity, some specialized ingredients, typical claims

* Complex: Novel ingredients, specialized claims (SPF, anti-aging), sensitive areas

* Costs exclude additional testing (patch tests, clinical studies, SPF testing)

Cost-Saving Strategies

Bundle multiple products with the same assessor for volume discounts. Use well-documented ingredients with established safety profiles. Prepare thorough Part A documentation to minimize back-and-forth with the assessor.

Timeline: How Long Does It Take?

Typical CPSR Timeline
Phase	Typical Duration	What Affects Duration
Formula Finalization	1-4 weeks	Internal R&D decisions
Ingredient Compliance Check	1-2 weeks	Complexity of formulation
Documentation Gathering	2-4 weeks	Supplier responsiveness
Stability Testing	3-6 months	Accelerated vs. real-time
Challenge Test (PET)	4-6 weeks	Product type, preservative system
Part A Preparation	2-4 weeks	Data completeness
Safety Assessment (Part B)	2-6 weeks	Assessor availability, complexity
Total Minimum (parallel testing)	4-6 months	Running tests simultaneously
Total with Real-Time Stability	12-18 months	For long shelf-life products

Parallel Processing

Run stability testing, challenge testing, and documentation gathering simultaneously to minimize total timeline. The safety assessment can only begin once all data is complete.

Finding a Qualified Safety Assessor

Per Article 10(2) of Regulation 1223/2009, the safety assessor must hold:

Safety Assessor Qualifications

University diploma in pharmacy, toxicology, medicine, or similar discipline
Qualification recognized in an EU Member State
Practical experience in cosmetic safety assessment (recommended)
Professional liability insurance (industry standard)
Independence from the manufacturer (for credibility)

Where to Find Safety Assessors

Types of Safety Assessor Services
Provider Type	Advantages	Typical Cost Range
Independent Consultants	Personal service, specialized expertise	€400 - €1,500 per product
Testing Laboratories	One-stop shop (testing + assessment)	€600 - €2,000 per product
Regulatory Consultancies	Full compliance support	€500 - €2,500 per product
Contract RP Services	Combined RP + assessment services	Often bundled pricing

Verify Qualifications

Always verify the assessor's qualifications match Article 10(2) requirements. Request copies of their degree/diploma and ask about their experience with your product type. Unqualified assessors can invalidate your entire CPSR.

Part A Documentation Requirements

According to Annex I, Part A must include:

Part A Required Elements

Complete quantitative and qualitative composition (formula)
Physical and chemical characteristics of raw materials
Physical and chemical characteristics of finished product
Stability data (accelerated and/or real-time)
Microbiological quality specifications and results
Challenge test (PET) results
Impurity and trace element data
Packaging material information and compatibility
Normal and reasonably foreseeable use description
Exposure assessment (area, amount, frequency, duration)
Toxicological profiles of all ingredients
Undesirable effects and serious undesirable effects data
Relevant existing studies (human volunteers, etc.)

Part B Safety Assessment

Part B is the expert evaluation prepared and signed by the qualified safety assessor. Per European Commission guidance, Part B must include:

Part B Required Elements

Clear safety conclusion (safe/not safe)
Reasoning behind the safety conclusion
Any required label warnings or instructions
Assessment of individual ingredients
Assessment of the finished product
Assessment of exposure and use conditions
Safety assessor name, address, and qualifications
Date and signature of the safety assessor

Required Testing

Testing Requirements by Product Type
Test	When Required	Typical Cost	Duration
Stability (Accelerated)	All products	€400 - €1,500	3-6 months
Stability (Real-time)	Long shelf-life claims	€300 - €800/year	1-3 years
Microbiological	All products	€150 - €500	1-2 weeks
Challenge Test (PET)	Products with water	€250 - €700	4-6 weeks
Compatibility	Specific packaging	€200 - €400	1-3 months
Patch Test (HRIPT)	Sensitive products	€2,000 - €5,000	4-6 weeks
SPF Testing	Sunscreens	€1,500 - €4,000	4-8 weeks

Water Content = Challenge Test

Any product containing water or aqueous phase requires a Preservative Efficacy Test (challenge test) to demonstrate adequate preservation against microbial contamination.

Common Mistakes to Avoid

CPSR Pitfalls

Based on feedback from safety assessors, these are the most common issues that delay or complicate CPSR completion: 1. Incomplete ingredient data — Missing specifications, SDSs, or allergen declarations 2. Formula changes after testing — Requires new testing and assessment 3. Inadequate stability data — Insufficient duration or wrong conditions 4. Poor exposure calculations — Wrong assumptions about product use 5. Using unqualified assessors — Invalidates the entire CPSR 6. Not checking ingredient compliance first — Reformulation after assessment

Keeping Your CPSR Updated

The CPSR must be updated when:

Formulation changes — Any ingredient addition, removal, or concentration change
Manufacturing changes — New facility, process modifications affecting safety
New safety data — Published studies affecting ingredient assessment
Regulatory changes — Omnibus updates affecting your ingredients
Adverse events — Any serious undesirable effects reported

Per SCCS guidance, the Responsible Person must ensure the CPSR remains current throughout the product's market life.

Key Takeaways

The CPSR is mandatory for every EU cosmetic product — no exemptions based on company size

Part A contains technical data you prepare; Part B is the safety assessor's evaluation

Total costs typically range from €1,250 to €9,000+ depending on product complexity

Minimum timeline is 4-6 months with accelerated stability testing

The safety assessor must have specific qualifications per Article 10(2)

Always verify ingredient compliance before starting CPSR preparation

Need a CPSR?

Connect with qualified EU safety assessors who can prepare your Cosmetic Product Safety Report and guide you through the process.

Find Safety Assessors