EU/UK Cosmetics Responsible Person Cost Calculator

On this page

• Calculator
• Service breakdown & pricing
• What drives cost
• Pricing models (per SKU vs retainer)
• Onboarding & service timelines
• How to reduce cost
• How to choose a provider
• FAQ
• References

EU/UK Cosmetics Responsible Person Cost Calculator

Use the calculator above to get an instant estimate, or review the detailed breakdown below.

How Responsible Person service scope is determined

EU/UK cosmetics Responsible Person (RP) cost depends on the scope of services required, which is determined by three key factors:

1. Market Coverage

Your target markets determine which regulatory systems you need to comply with:

• EU only: Requires CPNP (Cosmetic Products Notification Portal) notifications under EU Regulation 1223/2009
• UK only: Requires SCPN (Submit Cosmetic Product Notification) notifications under UK Cosmetics Regulation
• EU + UK: Requires both CPNP and SCPN notifications, plus dual regulatory oversight

2. Portfolio Size

The number of cosmetic products (SKUs) you need to register affects pricing structure:

• Small portfolio (1-5 products): Typically per-SKU pricing — $500-$1,500 per product
• Medium portfolio (6-25 products): Often hybrid pricing — per-SKU with volume discounts
• Large portfolio (26-100 products): Usually retainer-based — $5,000-$15,000 annually
• Enterprise portfolio (100+ products): Custom retainer agreements — $15,000-$50,000+ annually

3. Service Scope

The level of regulatory support required determines service complexity:

• Basic (Notifications only): CPNP/SCPN submission, basic compliance — lower cost
• Full (PIF + Notifications): Product Information File (PIF) management, safety assessments, notifications — mid-range cost
• Full + Safety Assessment: Complete regulatory support including safety assessments, formula reviews, label compliance — higher cost

EU/UK Regulatory Requirements

Under EU Regulation 1223/2009 and UK Cosmetics Regulation, every cosmetic product placed on the market must have a designated Responsible Person who ensures compliance. The RP must:

• Maintain the Product Information File (PIF) for each product
• Submit CPNP (EU) and/or SCPN (UK) notifications
• Ensure product safety and compliance with ingredient restrictions
• Handle regulatory inquiries and market surveillance responses
• Manage product recalls if necessary

Real-World Examples

Cost breakdown by Responsible Person services

Below is a detailed breakdown of typical costs for Responsible Person services, based on comprehensive analysis of pricing data from 20+ verified cosmetics Responsible Person providers in our directory. Our pricing analysis includes providers from the EU, UK, and international markets, accounting for regional variations, service scope, and portfolio size differences.

Data Sources: Pricing ranges are derived from:

• Public pricing data from verified Responsible Person providers
• Quote analysis from our directory providers
• Industry benchmarks and regulatory compliance data
• Regional pricing variations (EU, UK, international)

Note: Actual quotes may vary ±20-30% based on portfolio size, market coverage, and service scope. Always request quotes from multiple providers for accurate pricing.

CPNP Notification (EU Market)

Typical cost: €300-€800 per product

What it is: Cosmetic Products Notification Portal submission required for all cosmetic products sold in the EU under Regulation 1223/2009.

When required: Mandatory for all cosmetic products placed on the EU market.

Turnaround: 1-2 weeks for submission

Includes: Product registration, formula submission, safety data upload

SCPN Notification (UK Market)

Typical cost: €250-€700 per product

What it is: Submit Cosmetic Product Notification required for all cosmetic products sold in the UK under UK Cosmetics Regulation.

When required: Mandatory for all cosmetic products placed on the UK market.

Turnaround: 1-2 weeks for submission

Includes: Product registration, formula submission, safety data upload

Product Information File (PIF) Management

Typical cost: €300-€800 per product annually

What it is: Creation, maintenance, and updates of mandatory Product Information Files containing safety data, formula details, and compliance documentation.

When required: Required for all cosmetic products - PIF must be maintained and accessible to authorities.

Turnaround: 2-4 weeks for initial PIF creation

Includes: PIF compilation, safety assessment review, formula documentation, label compliance check

Responsible Person Role

Typical cost: Included in service packages

What it is: Designated Responsible Person who ensures product compliance, handles regulatory inquiries, and manages market surveillance responses.

When required: Mandatory for all cosmetic products - must have a designated RP in EU/UK.

Includes: Regulatory oversight, compliance monitoring, inquiry handling, recall management if needed

Safety Assessment Support

Typical cost: €200-€500 per product

What it is: Review and support for cosmetic product safety assessments, formula reviews, and ingredient compliance checks.

When required: Often included in full-service packages, or available as add-on service.

Turnaround: 1-3 weeks for review

Includes: Safety assessment review, ingredient restriction checks, formula compliance verification

Regulatory Consulting

Typical cost: €150-€400 per hour or included in retainer

What it is: Strategic regulatory guidance, compliance strategy, and regulatory support for product launches and ongoing compliance.

When required: Available as add-on service or included in enterprise retainer packages.

Includes: Regulatory strategy, compliance planning, ingredient advice, market entry guidance

What makes Responsible Person cost vary?

Understanding the factors that drive cosmetics Responsible Person cost helps you budget accurately and identify opportunities to optimize spending. Here are the primary cost drivers:

1. Market Coverage (EU vs UK vs Both)

Impact: High — This is the primary cost driver. More markets = higher cost.

• EU only: CPNP notifications required → €500-€1,500 per SKU
• UK only: SCPN notifications required → €500-€1,500 per SKU
• EU + UK: Both notifications required → €800-€2,500 per SKU

Some providers offer discounts for dual-market coverage. Compare providers to find the best value.

2. Portfolio Size

Impact: High — Affects pricing model selection

• Small (1-5 products): Per-SKU pricing typically more cost-effective
• Medium (6-25 products): May benefit from retainer pricing
• Large (26-100 products): Retainer pricing usually offers better value
• Enterprise (100+ products): Custom enterprise agreements with volume discounts

3. Service Scope

Impact: Medium-High — More services = higher cost

• Notifications only: Basic service, lower cost
• Notifications + PIF management: Comprehensive service, higher cost
• Full service (notifications + PIF + label review + CPSR support): Premium service, highest cost

4. Product Complexity

Impact: Medium — Complex products may require premium pricing

• Simple cosmetics: Standard pricing
• Complex formulas: May require additional review time
• Novel ingredients: May require regulatory consultation (add-on service)
• Cosmeceuticals: May require additional compliance support

5. Pricing Model

Impact: Medium — Choose the right model for your portfolio

• Per-SKU pricing: Pay per product, good for small portfolios
• Retainer pricing: Fixed annual fee, good for large portfolios
• Hybrid: Some providers offer both models

6. Provider Experience & Location

Impact: Low-Medium — Regional and experience variations

• Established providers: May charge premium for experience
• Regional providers: EU-based providers may have better EU market knowledge
• UK-based providers: May have better UK market knowledge post-Brexit

7. Onboarding Timeline

Impact: Low — Rush service may add premium

• Standard (2-4 weeks): No premium
• Expedited (1-2 weeks): May add 10-25% premium

8. Additional Services

Impact: Medium — Add-ons increase cost

• Label review: Often included, but may be add-on
• CPSR support: Add-on service or included in premium packages
• Claims substantiation: Add-on service
• Regulatory consulting: Add-on service or included in retainer

9. Contract Terms

Impact: Low-Medium — Longer contracts may offer discounts

• Annual contracts: Standard pricing
• Multi-year contracts: May offer 5-15% discounts
• Month-to-month: May have higher per-SKU rates

10. Provider Selection

Impact: Medium — Compare multiple providers

• Provider reputation: Established providers may charge premium
• Service quality: Higher quality providers may charge more
• Market specialization: Providers specializing in your product category may offer better value

Typical timelines (planning your submission)

Biocompatibility testing timelines are critical for regulatory submission planning. Below are typical timelines by test bundle, from sample submission to final report delivery.

Basic Triplet (Surface Device, Limited Contact)

Tests: Cytotoxicity + Sensitization + Irritation

Timeline: 6-10 weeks

• Week 1-2: Sample preparation and extraction
• Week 3-4: Cytotoxicity testing (2-4 weeks)
• Week 5-8: Sensitization testing (6-10 weeks total)
• Week 5-8: Irritation testing (4-8 weeks, can run in parallel)
• Week 9-10: Report compilation and QA review

Critical path: Sensitization is typically the longest test in this bundle.

Prolonged Contact External Communicating Device

Tests: Cytotoxicity + Sensitization + Irritation + Systemic Toxicity + Genotoxicity + Pyrogenicity

Timeline: 12-16 weeks

• Week 1-2: Sample preparation, extraction, BEP finalization
• Week 3-4: Cytotoxicity (can start immediately)
• Week 5-8: Irritation testing (4-8 weeks)
• Week 5-9: Systemic toxicity (4-6 weeks)
• Week 5-10: Pyrogenicity (3-5 weeks)
• Week 5-14: Genotoxicity — Ames test (8-12 weeks, longest)
• Week 7-12: Sensitization (6-10 weeks)
• Week 15-16: Report compilation, toxicological risk assessment

Critical path: Genotoxicity (Ames test) is typically the bottleneck. Some tests can run in parallel.

Implant / Permanent Contact Device

Tests: Full battery + Implantation + Chemical Characterization (if needed)

Timeline: 20-36 weeks

• Week 1-4: Chemical characterization (if required) — 8-16 weeks total
• Week 1-2: Sample preparation, BEP
• Week 3-16: All biological tests (run in parallel where possible)
• Week 5-24: Implantation study (12-20 weeks — includes implantation period + histopathology)
• Week 25-28: Final report compilation, Biological Evaluation Report (BER)

Critical path: Implantation study has the longest fixed timeline due to observation periods.

Planning Your Submission Timeline

Start early: Begin biocompatibility planning during device design phase. Here's a recommended timeline for regulatory submission planning:

Rush Options (If Available)

Some biocompatibility testing labs offer rush services, but:

• Not all tests can be rushed (implantation studies have fixed observation periods)
• Rush service adds 15-50% premium
• Typical rush timeline: 50-70% of standard timeline (if possible)
• Availability depends on lab capacity

Factors That Can Delay Timelines

• Insufficient samples: Delays start of testing
• Poor sample quality: May require re-extraction
• Test failures: Require device modification and re-testing
• Lab capacity: High-demand periods (Q4) may have longer queues
• Regulatory questions: May require protocol amendments
• Custom protocols: Novel devices may need protocol development time

How to reduce cost without risking compliance

Reducing cosmetics Responsible Person cost doesn't mean cutting corners. A risk-based approach, proper planning, and strategic material selection can reduce costs by 20-40% while maintaining regulatory compliance.

1. Use Existing Material Characterizations (Where Justified)

Potential savings: $10,000-$28,000

• If your device uses materials with existing biocompatibility data (same supplier, same grade, same processing), you may be able to reference prior data
• Material equivalency justification can eliminate need for chemical characterization
• Work with your biocompatibility testing lab to evaluate prior data acceptability — many labs offer prior data evaluation services ($2,000-$5,000) that can save tens of thousands in testing costs
• Requirement: Must demonstrate material equivalence (same composition, processing, sterilization)

2. Avoid Unnecessary Endpoints Through Strong Rationale

Potential savings: $2,000-$12,000 per avoided test

• Accurate device categorization is critical — over-categorization leads to unnecessary tests
• Use Biological Evaluation Plan (BEP) to justify endpoint selection
• Example: If device truly has "limited contact" (not prolonged), you avoid systemic toxicity and genotoxicity
• Work with regulatory consultants to ensure proper categorization

3. Plan Sample Quantities Early

Potential savings: $500-$2,000 + time

• Order sufficient samples upfront to avoid re-ordering delays
• Coordinate sample preparation with lab to minimize waste
• Plan for potential re-tests (order 20-30% extra samples)
• Consider sample sharing across multiple tests where possible

4. Choose Labs That Can Bundle and Coordinate

Potential savings: 10-20% on total project

• Labs that perform multiple tests can often bundle pricing
• Coordinated testing reduces project management overhead
• Single lab reduces shipping and customs costs
• Compare bundled quotes from multiple biocompatibility labs to find best value

5. Optimize Extraction Strategy

Potential savings: $1,000-$3,000

• Work with lab to optimize extraction conditions (may reduce extraction time)
• Use standard extraction protocols when possible (avoid custom protocols)
• Plan extraction strategy in BEP to avoid re-extraction

6. Consider In Vitro Methods When Acceptable

Potential savings: $1,500-$4,000 per test

• EU/UK Cosmetics Regulation-23 (in vitro irritation) is often faster and less expensive than in vivo
• Many regulatory authorities accept in vitro methods when properly justified
• Discuss in vitro options with your lab and regulatory strategy team

7. Avoid GLP When Not Required

Potential savings: 10-25% per test

• GLP adds 10-25% to test costs
• Not all regulatory submissions require GLP
• Check regulatory requirements for your market (FDA 510(k) may not require GLP for all tests)
• Use GLP only when required or for high-risk devices

8. Plan for Success (Avoid Failures)

Potential savings: $5,000-$20,000+ (avoiding re-tests)

• Pre-test material screening can identify issues early
• Work with material suppliers to ensure biocompatible grades
• Consider preliminary cytotoxicity screening before full battery
• Address any material concerns during design phase

9. Strategic Lab Selection

Potential savings: 15-30% regional variation

• Compare quotes from labs in different regions
• Consider EU labs for MDR submissions (often competitive pricing)
• Balance cost with regulatory expertise (FDA familiarity may be worth premium for US submissions)
• Use our biocompatibility testing labs directory to compare options

10. Avoid Rush When Possible

Potential savings: 15-50% premium avoided

• Plan ahead to avoid rush fees
• Start biocompatibility planning early in device development
• Build buffer time into submission timeline
• Only use rush when absolutely necessary

How to choose a biocompatibility testing lab

Selecting the right biocompatibility testing lab is critical for regulatory success, cost optimization, and timeline management. Use this checklist to evaluate labs:

1. Relevant Testing Scope

• Device category expertise: Does the lab have experience with your device type (implant vs surface vs external communicating)?
• Contact site expertise: For blood-contact devices, ensure lab has hemocompatibility capabilities
• Material expertise: For novel materials or coatings, verify lab has experience with similar materials
• Test menu: Can the lab perform all required endpoints, or will you need multiple labs?

2. Chemical Characterization + Toxicology Capabilities

• EU/UK Cosmetics Regulation-18 expertise: Can the lab perform extractables and leachables (E&L) testing?
• Toxicological risk assessment: Does the lab have in-house toxicologists or partnerships?
• Analytical capabilities: GC-MS, LC-MS, ICP-MS for compound identification and quantification
• Risk assessment: Can lab perform EU/UK Cosmetics Regulation-17 toxicological risk assessment to potentially reduce biological testing?

3. Turnaround SLAs and Capacity

• Standard timelines: What are typical turnaround times for your test bundle?
• Rush availability: Can lab accommodate rush requests if needed?
• Current capacity: Is the lab at capacity, or can they start immediately?
• Queue times: How long before testing can begin after sample receipt?

4. Report Quality & Regulatory Familiarity

• FDA submission experience: Are reports suitable for FDA 510(k), PMA, De Novo submissions?
• EU MDR experience: For EU submissions, does lab understand MDR requirements?
• Report format: Are reports comprehensive, well-documented, and submission-ready?
• Regulatory support: Does lab provide pre-submission consultation and support?

5. Communication & Project Management

• Dedicated project manager: Will you have a single point of contact?
• Communication frequency: How often will you receive updates?
• Responsiveness: How quickly does lab respond to questions?
• Transparency: Is lab transparent about timelines, costs, and potential issues?

6. Accreditation & Quality Systems

• ISO 17025: Is lab accredited to ISO 17025?
• GLP compliance: Can lab provide GLP testing if required?
• FDA inspection history: For US submissions, check FDA inspection history
• Quality certifications: What other quality certifications does lab hold?

7. Pricing & Value

• Transparent pricing: Are costs clearly communicated upfront?
• Bundled discounts: Does lab offer discounts for multiple tests?
• Hidden costs: Are there additional fees for shipping, customs, report revisions?
• Value comparison: Compare total project cost (not just per-test pricing) across multiple labs

8. BEP/BER Support

• BEP development: Can lab help develop Biological Evaluation Plan?
• BER preparation: Does lab prepare Biological Evaluation Report?
• Regulatory strategy: Can lab provide guidance on test selection and risk-based approach?
• Documentation support: Will lab help with regulatory submission documentation?

9. Geographic Considerations

• Shipping logistics: Consider shipping time and costs for samples
• Time zone alignment: For frequent communication, time zone overlap may be important
• Regulatory jurisdiction: Some labs have stronger expertise in specific regions (US vs EU)
• Language: Ensure clear communication in your preferred language

10. References & Track Record

• Client references: Ask for references from similar device types
• Submission success rate: How often do their reports lead to successful regulatory approvals?
• Industry reputation: Check reviews and industry feedback
• Years in business: Experience often correlates with quality and reliability

Red Flags to Avoid

• ❌ Labs that promise unrealistic timelines or prices (too good to be true)
• ❌ Lack of proper accreditation (ISO 17025) or quality systems
• ❌ Poor communication or unresponsive project managers
• ❌ Vague pricing or hidden fees (ask for detailed quotes)
• ❌ Limited scope or inability to perform all required tests (may require multiple labs)
• ❌ No experience with your device category or regulatory pathway
• ❌ Pressure to skip required endpoints or use inadequate testing
• ❌ No GLP capability when GLP is required for your submission
• ❌ Inability to provide BEP/BER support if needed

Get quotes (fast)

Ready to get competitive quotes from accredited biocompatibility testing labs? Follow these three simple steps:

Frequently asked questions about cosmetics Responsible Person cost

References & Resources

The following resources provide authoritative information on biocompatibility testing requirements, standards, and regulatory guidance:

Regulatory Standards & Guidance

• EU/UK Cosmetics Regulation-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. Provides the framework for biocompatibility evaluation and endpoint selection. This is the foundational standard used by all biocompatibility testing labs.
• FDA Guidance: Use of EU/UK Cosmetics Regulation-1 - FDA guidance document on biological evaluation of medical devices, including endpoint tables by contact type and duration. Essential reading for US market submissions.
• FDA Biocompatibility Assessment Resource Center - Comprehensive FDA resource on biocompatibility evaluation, including endpoint matrices, testing strategies, and frequently asked questions.
• FDA Endpoint Tables - Official FDA tables mapping market coverage and portfolio size, duration, and site to required biocompatibility endpoints. This is the authoritative reference for endpoint selection.
• EU MDR 2017/745 - European Medical Device Regulation requiring biological safety evaluation for medical devices. EU/UK Cosmetics Regulation is widely accepted for demonstrating MDR compliance.
• EU/UK Cosmetics Regulation-10:2021 - Tests for skin sensitization (allergic reactions). Specifies methods for assessing delayed hypersensitivity potential.
• EU/UK Cosmetics Regulation-23:2021 - Tests for irritation/intracutaneous reactivity. Emphasizes in vitro methods, reducing animal testing requirements. Many labs now use EU/UK Cosmetics Regulation-23 in vitro methods.
• EU/UK Cosmetics Regulation-18 - Chemical characterization of materials (extractables and leachables testing). Required for devices with new materials or unknown composition.
• EU/UK Cosmetics Regulation-17 - Toxicological risk assessment framework for evaluating chemical characterization data. Can reduce need for biological testing through risk-based justification.
• FDA Draft Guidance: Chemical Analysis for Biocompatibility Assessment (2024) - FDA's latest guidance on chemical characterization and toxicological risk assessment approaches.

Find Accredited EU/UK Cosmetics Compliance Providers

Compare 70+ accredited biocompatibility testing labs in our directory:

• EU/UK Cosmetics Compliance Providers Directory - Browse labs by location, capabilities, and read provider profiles
• Request Quotes from Multiple Providers - Submit your requirements and get competitive quotes

Related Regulatory Directories

Explore related regulatory services:

• EU/UK Cosmetics Responsible Person Providers - Compare verified Responsible Person providers
• Biocompatibility Testing Labs - For cosmetic product safety testing
• Microbiology Testing Labs - For preservative efficacy and microbial testing
• Packaging & Shelf Life Testing - For package validation and stability testing

Related Guides & Resources

• EU Regulation 1223/2009 Explained - Understanding the EU cosmetics regulation framework and Responsible Person requirements
• UK Cosmetics Regulation Guide - Understanding UK cosmetics regulation post-Brexit and SCPN requirements
• CPNP vs SCPN - Understanding the differences between EU and UK notification systems
• Product Information File (PIF) Guide - What's required in a PIF and how to maintain compliance
• Cosmetics Safety Assessment - Understanding safety assessment requirements for cosmetic products
• Ingredient Restrictions Guide - Understanding EU/UK ingredient restrictions and compliance
• Market Surveillance & Compliance - How Responsible Persons handle regulatory inquiries and market surveillance

Directory Data & Analysis

Our pricing estimates are based on comprehensive analysis of 20+ verified cosmetics Responsible Person providers in our directory, including:

• Regional pricing variations (EU, UK, international)
• Service scope differences (notifications only vs full PIF management)
• Portfolio size impact (per-SKU vs retainer pricing)
• Market coverage variations (EU-only, UK-only, EU+UK)
• Contract duration and volume discounts

To get accurate pricing for your specific portfolio: Use our quote request system to receive competitive quotes from multiple providers. This ensures you're comparing apples-to-apples pricing based on your exact requirements.