Ensure EU/UK compliance with our comprehensive CPSR preparation and qualified safety assessor certification services
Achieve market entry in Europe through our expert Cosmetic Product Safety Report services, backed by qualified safety assessors and comprehensive regulatory expertise for complete EU/UK compliance.
A Cosmetic Product Safety Report (CPSR) is a mandatory document under EU Regulation (EC) No 1223/2009 and UK Cosmetics Regulation that demonstrates product safety through comprehensive evaluation. Our services include Part A (safety information) and Part B (safety assessment) preparation by qualified safety assessors, ensuring complete regulatory compliance for European market entry.
CPSR certification is legally required before any cosmetic product can be marketed in the EU or UK. It provides scientific evidence of safety under normal use conditions, protects consumers, ensures regulatory compliance, and enables successful market entry. The report demonstrates due diligence and builds consumer confidence in product safety.
Cosmetic manufacturers, brand owners, private label companies, and importers planning to market products in the EU/UK. Our services benefit companies requiring qualified safety assessor certification, regulatory compliance documentation, and expert validation for cosmetic products including skincare, haircare, makeup, and personal care items.
Our CPSR preparation process begins with detailed product analysis, ingredient evaluation, and regulatory requirements assessment. We work with qualified safety assessors holding degrees in pharmacy, toxicology, medicine, or similar disciplines from EU-recognized institutions to ensure compliance with Article 10 requirements.
We conduct comprehensive ingredient safety analysis including toxicological profile evaluation, exposure assessment calculations, and margin of safety (MoS) determinations. Our approach includes systematic review of scientific literature, evaluation of restricted substances compliance, and assessment of potential allergens and sensitizers.
Microbiological quality assessments are performed following ISO standards including enumeration of aerobic mesophilic bacteria, yeast and mold counts, and detection of specific pathogens. We coordinate stability testing, preservative efficacy evaluations, and challenge testing to ensure product safety throughout shelf life.
For Product Information File (PIF) compilation, we gather all required documentation including manufacturing details, quality control data, safety assessments, and post-market surveillance information. Our team ensures complete documentation meets Annex I requirements and regulatory expectations.
We provide ongoing post-market surveillance support including serious undesirable effects (SUE) monitoring, regulatory updates, and compliance maintenance. Our approach includes CPNP notification assistance, labeling review, and market expansion guidance for additional jurisdictions.
Complete CPSR Part A - Comprehensive safety information including quantitative/qualitative composition, physicochemical properties, microbiological quality, and packaging details
CPSR Part B Assessment - Expert safety evaluation by qualified assessor with scientific reasoning, conclusions, warnings, and professional certification
Ingredient Safety Analysis - Detailed toxicological profiles, exposure assessments, margin of safety calculations, and regulatory compliance verification
Microbiological Quality Report - Complete microbiological testing results, preservative efficacy evaluation, and stability assessment documentation
Product Information File (PIF) - Fully compiled regulatory documentation including manufacturing details, quality control data, and safety assessments
CPNP Notification Support - Assistance with Cosmetic Product Notification Portal submission and European database registration requirements
Labeling Compliance Review - Detailed review of product labeling, claims validation, and mandatory warning statements for EU/UK markets
Post-Market Surveillance Framework - Implementation guidelines for ongoing safety monitoring, adverse event reporting, and regulatory compliance maintenance
Our CPSR services strictly adhere to EU Regulation (EC) No 1223/2009 and UK Cosmetics Regulation requirements, ensuring all assessments meet European standards for cosmetic product safety. We follow SCCS Notes of Guidance for ingredient testing and safety evaluation methodologies.
All safety assessments are conducted by qualified safety assessors meeting Article 10(2) requirements, with appropriate academic credentials in pharmacy, toxicology, medicine, or equivalent disciplines from EU-recognized institutions or equivalent qualifications.
Microbiological testing protocols follow established ISO standards including ISO 21149 (aerobic mesophilic bacteria), ISO 16212 (yeast and mold), and pathogen-specific detection methods to ensure product safety and compliance with established limits.
Our CPSR services support diverse cosmetic product categories including skincare formulations, makeup products, haircare treatments, personal hygiene products, baby care items, and specialized cosmetic formulations across all market segments and price points.
EU market entry applications benefit manufacturers seeking regulatory compliance for new product launches, existing product reformulations, or market expansion initiatives requiring comprehensive safety documentation and qualified assessor certification.
UK post-Brexit compliance services address specific requirements under the UK Cosmetics Regulation, ensuring continued market access and regulatory compliance for products distributed in Great Britain and Northern Ireland markets.
Our services extend to multi-jurisdiction compliance supporting products requiring safety assessments for EU, UK, and other international markets with similar regulatory frameworks, providing efficient documentation strategies for global market entry.
Achieving successful CPSR certification requires specialized expertise, qualified safety assessors, and deep understanding of EU/UK cosmetic regulations. Indivirtus Healthcare Services combines regulatory experience with comprehensive safety assessment capabilities to deliver compliant CPSR documentation.
Our qualified team includes certified safety assessors with appropriate academic credentials and extensive experience across diverse cosmetic product categories, supported by advanced testing capabilities and strategic regulatory guidance for European markets.
From initial product evaluation through final regulatory approval, our team provides end-to-end support ensuring your cosmetic products achieve CPSR compliance efficiently while meeting the highest safety and regulatory standards for successful European market entry.
A Cosmetic Product Safety Report (CPSR) is a mandatory document under EU Regulation (EC) No 1223/2009 and UK Cosmetics Regulation that demonstrates cosmetic product safety through scientific evaluation. It must be prepared by a qualified safety assessor before any cosmetic product can be marketed in the EU or UK.
Only qualified safety assessors can prepare CPSR Part B. They must hold a degree in pharmacy, toxicology, medicine, or similar discipline from an EU university, or have equivalent qualifications recognized by an EU member state, as specified in Article 10(2) of the Cosmetics Regulation.
CPSR preparation typically takes 4-8 weeks depending on product complexity and data availability. Required testing may include microbiological quality assessment, stability testing, preservative efficacy testing, and ingredient safety evaluations based on product formulation and intended use.
A complete CPSR includes Part A (safety information with product composition, microbiological quality, stability data) and Part B (safety assessment by qualified assessor), Product Information File compilation, CPNP notification support, and post-market surveillance framework.