What is a CPSR and why do I need one?

A CPSR (Cosmetic Product Safety Report) is a mandatory document required by EU Regulation 1223/2009 for every cosmetic product sold in the EU. It demonstrates that your product is safe for human health when used normally. Without a valid CPSR, you cannot legally sell cosmetics in the EU market.

How much does a CPSR cost?

CPSR costs typically range from €1,500-€4,000 for simple products to €4,000-€10,000 for complex products. This includes safety assessment fees (€300-€2,000), stability testing (€500-€4,000), microbiological testing (€200-€1,000), and challenge testing (€300-€1,200). Costs vary by product complexity and testing requirements.

How long does it take to get a CPSR?

A typical CPSR takes 4-8 months to complete. The longest phase is usually stability testing (3-6 months with accelerated protocols). Part A preparation takes 2-4 weeks, testing runs concurrently, and the safety assessment (Part B) takes 2-6 weeks once all data is available.

Only a qualified safety assessor can sign Part B of the CPSR. Article 10(2) of Regulation 1223/2009 requires the assessor to hold a diploma in pharmacy, toxicology, medicine, or a similar discipline. The qualification must be recognized in an EU Member State.

CPSR Cosmetics Guide: EU Safety Report Requirements 2026

What is a CPSR?

The Cosmetic Product Safety Report (CPSR) is a mandatory document 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.

The CPSR is Non-Negotiable

Unlike the US where safety substantiation requirements are less prescriptive, the EU requires a formal, structured safety report following a specific format defined in Annex I of the Cosmetic Regulation. There are no exemptions based on company size or product type.

The CPSR serves as the cornerstone of EU cosmetic compliance, providing documented evidence that:

All ingredients have been assessed for safety
The finished product is safe under normal and reasonably foreseeable use
A qualified safety assessor has reviewed and approved the product
The manufacturing process meets Good Manufacturing Practice (GMP) standards

CPSR Structure: Part A and Part B

The CPSR consists of two distinct parts, as defined in Annex I of Regulation 1223/2009:

CPSR Part A vs Part B
Section	Part A: Product Information	Part B: Safety Assessment
Purpose	Compile technical data	Expert safety evaluation
Who Prepares	Manufacturer/Responsible Person	Qualified Safety Assessor
Content Type	Factual information & data	Scientific assessment & conclusions
Signature Required	No	Yes (Safety Assessor)
Updates	Ongoing as data changes	When formulation changes

Part A: Cosmetic Product Safety Information

Part A contains all the technical information and data about the product. According to European Commission CPSR guidance, Part A must include:

Part A Required Elements

Quantitative and qualitative composition of the cosmetic product
Physical/chemical characteristics and stability data
Microbiological quality specifications and challenge test results
Impurities, traces, and packaging material information
Normal and reasonably foreseeable use
Exposure assessment (application area, amount, frequency, duration)
Toxicological profile of all ingredients
Undesirable effects and serious undesirable effects reported
Any other relevant information (e.g., existing studies on volunteers)

Part B: Cosmetic Product Safety Assessment

Part B is the expert evaluation conducted by a qualified safety assessor. Per Article 10 of Regulation 1223/2009, Part B must include:

Part B Required Elements

Assessment conclusion stating whether the product is safe
Labeled warnings and instructions for use (if necessary)
Reasoning behind the safety conclusion
Assessor credentials (name, address, qualifications)
Date and signature of the safety assessor
Any restrictions or conditions on use

Part B Cannot Be Self-Certified

The safety assessment in Part B must be carried out by a person who holds a diploma or other evidence of formal qualifications in pharmacy, toxicology, medicine, or a similar discipline. The assessor must be independent and cannot simply be an employee signing off on their own work.

Safety Assessor Requirements

The safety assessor is the critical expert who evaluates the CPSR and signs off on product safety. According to Article 10(2) of Regulation 1223/2009, the safety assessor must hold:

Safety Assessor Qualification Requirements
Qualification	Accepted Disciplines	Notes
University Diploma	Pharmacy, Toxicology, Medicine, or similar	Must be recognized in EU Member State
Formal Qualification	Equivalent professional certification	Subject to Member State recognition
Practical Experience	Recommended but not legally mandated	Industry experience valuable

* 'Similar discipline' typically includes chemistry, biochemistry, dermatology, and related life sciences

* Member States may have additional national requirements

CPSR Costs

CPSR costs vary significantly based on product complexity, testing requirements, and service provider. Based on Cosmetics Europe industry guidelines:

Typical CPSR Cost Ranges (2026)
Component	Simple Product	Complex Product
Safety Assessment (Part B)	€300 - €800	€800 - €2,000
Stability Testing	€500 - €1,500	€1,500 - €4,000
Microbiological Testing	€200 - €500	€500 - €1,000
Challenge Test (PET)	€300 - €600	€600 - €1,200
Toxicological Dossier	€200 - €500	€500 - €1,500
Total Estimated Cost	€1,500 - €3,900	€3,900 - €9,700

* Simple products: basic formulations, well-known ingredients, standard claims

* Complex products: novel ingredients, specialized claims, sensitive areas (eye, baby)

Key Takeaways

The CPSR is mandatory for every cosmetic product sold in the EU — no exceptions

Part A contains technical data; Part B is the safety assessor's evaluation and signature

Only qualified professionals (pharmacy, toxicology, medicine degrees) can sign Part B

Typical CPSR costs range from €1,500-€10,000 depending on product complexity

Timeline is typically 4-8 months including stability testing

The CPSR must be updated whenever formulations, manufacturing, or regulations change

Need Help with Your CPSR?

Connect with qualified EU safety assessors and regulatory consultants who can prepare your Cosmetic Product Safety Report.

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2026 Regulatory Update: Omnibus VIII

Omnibus VIII Published January 2026

On January 13, 2026, the European Commission published Regulation EU 2026/78 (Omnibus VIII), introducing new restrictions on CMR substances. Key points: - Compliance deadline: May 1, 2026 for non-compliant stock removal - Impact: New CMR classifications affect commonly used ingredients - Required action: Brands must reassess CPSRs for affected formulations CPSR validity may require updates when new hazard classifications are published. Monitor SCCS opinions and Official Journal publications for emerging restrictions.