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colipa-guidelines-for-skin-compatibility-testing
Dermatological & Sensitivity Testing AFNOR BP X30-221 In Vivo Human Skin Testing ProceduresASTM D2979 Assessment of Skin Sensitization PotentialASTM D4236 Labeling of Cosmetic Products for Skin SafetyASTM D6125 Evaluation of Skin Sensitization Using In Vitro ModelsASTM D6977 Evaluation of Skin Contact AllergensASTM E1490 Evaluation of Allergic Contact DermatitisASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended ProtocolASTM E2753 Human Repeat Insult Patch Test (HRIPT)ASTM F2312 Evaluation of Patch Test Allergen ReleaseEN 16820 Test Method for Skin Sensitization PotentialEN 1811 Determination of Nickel Release from Skin-Contact ProductsEN ISO 10993-10 Assessment of Skin IrritationEN ISO 10993-18 Chemical Characterization for Dermal SafetyEN ISO 10993-21 Evaluation of Skin Irritation from Medical Device ExtractsEN ISO 10993-5 Cytotoxicity Testing on Skin CellsEP 5.1.6 Evaluation of Dermatological Safety of CosmeticsFDA 21 CFR 820 Quality System Regulation for Dermal DevicesFDA 21 CFR Part 807 Sensitivity Testing of Topical ProductsFDA Guidance for Dermatological Testing of Topical ProductsFDA Guidance on Dermal Sensitization Risk AssessmentISO 105-A02 Colorfastness to Artificial Light on SkinISO 10993-1 Biological Evaluation of Medical Devices - Dermal AspectsISO 10993-10 Evaluation of Skin Irritation and SensitizationISO 10993-11 Toxicity Testing Related to Skin ContactISO 10993-12 Sample Preparation for Dermal TestingISO 10993-16 Toxicokinetic Testing of Substances in Dermal ExposureISO 10993-17 Toxicological Risk Assessment for Dermal ProductsISO 10993-19 Evaluation of Allergic Contact Dermatitis in Skin ProductsISO 10993-20 Dermal Toxicology Testing MethodsISO 10993-22 Evaluation of Sensitization from Skin Contact DevicesISO 10993-23 Evaluation of Phototoxicity and PhotoallergyISO 11137 Sterilization Validation of Dermal DevicesISO 11930 Preservative Effectiveness for Sensitive Skin ProductsISO 14155 Clinical Investigation of Medical Devices on SkinISO 15223-1 Symbols for Dermal Medical DevicesISO 15223-1 Symbols for Indicating Skin Contact in Medical DevicesISO 16128 Guidelines on Natural and Organic Cosmetic IngredientsISO 16128-1 Guidelines on Natural and Organic Cosmetics Part 1ISO 16128-2 Calculation of Natural Ingredient Content in Skin ProductsISO 16128-3 Methodologies for Determining Organic Content in Skin CareISO 16134 Human Repeat Insult Patch Test GuidanceISO 16134-2 Guidance for Patch Test Interpretation in Skin TestingISO 17516 Microbiological Limits for Skin ProductsISO 21404 Testing for Skin Contact AllergensISO 21486 Risk Assessment for Skin Contact MaterialsISO 22444 Measurement of Skin Moisture ContentISO 22715 Labeling Requirements for Skin and Cosmetic ProductsISO 22716 Good Manufacturing Practices for Dermatological ProductsISO 22716-1 Good Manufacturing Practices for Skin Care ProductsISO 23975 Patch Test Protocols for Dermatological ProductsISO 24441 In Vitro Determination of Sun Protection Factor (SPF)ISO 24442 Evaluation of Human Skin Irritation PotentialISO 24443 In Vitro Assessment of Sunscreen Efficacy on SkinISO 24443 In Vitro SPF Testing for SunscreensISO 24443 In Vitro UV Protection Factor Testing for SunscreensISO 24443 UV Protection Testing for Sensitive Skin FormulationsISO 3160-2 Compression Testing on Skin Contact MaterialsISO 3175-4 Analysis of Volatile Components Affecting Skin SensitivityISO 8124-6 Safety Requirements for Toys Affecting SkinISO/TR 16181 Guidelines on Skin Compatibility of CosmeticsISO/TR 16271 Guidelines on Safety Assessment for Skin Contact MaterialsISO/TR 19218 Dermatological Safety Data ManagementISO/TR 19930 Development of Dermal Sensitization AssaysISO/TR 22219 Testing of Skin Barrier FunctionISO/TR 29622 Allergens in Cosmetics and Personal Care ProductsJIS K 5600-5-7 Patch Test Methods for Skin SensitivityOECD TG 405 Acute Dermal Irritation/Corrosion TestOECD TG 406 Skin Sensitization in AnimalsOECD TG 406 Skin Sensitization Testing in AnimalsOECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin SafetyOECD TG 439 In Vitro Skin Irritation Testing for CosmeticsOECD TG 442B Local Lymph Node Assay for Skin SensitizationOECD TG 442C In Chemico Skin Sensitization Assay (DPRA)OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens™)OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin SensitizationOECD TG 442E In Vitro Skin Sensitization Assay (h-CLAT)USP <151> Evaluation of Skin Irritation for Topical Dosage FormsUSP <151> Skin Sensitization Studies in Pharmaceuticals

COLIPA Guidelines for Skin Compatibility Testing: Laboratory Testing Services Provided by Eurolab

The COLIPA Guidelines for Skin Compatibility Testing are a set of internationally recognized standards that govern the testing of cosmetic products and their ingredients for skin compatibility. These guidelines are based on the ISO 10993-10 standard, which provides a framework for evaluating the safety and compatibility of materials with human skin.

International Standards Governing COLIPA Guidelines

The international standards governing COLIPA Guidelines for Skin Compatibility Testing include:

  • ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

  • EN ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (European standard).

  • ASTM F2425: Standard guide for the biological evaluation of medical devices-related skin irritation.

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding COLIPA Guidelines for Skin Compatibility Testing is governed by various national and international regulations, including:

  • EU Cosmetics Regulation (EC) No 1223/2009: Requirements for safety assessment and testing of cosmetic products.

  • US FDA Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Cosmetic Ingredients.

    • Standard Development Organizations

    The standard development organizations responsible for COLIPA Guidelines include:

  • ISO (International Organization for Standardization): Develops and publishes international standards.

  • EN (European Committee for Electrotechnical Standardization): Develops and publishes European standards.

    • Evolution of Standards

    Standards evolve over time to reflect advances in technology, changes in regulatory requirements, and emerging industry needs. The COLIPA Guidelines have undergone several revisions since their inception, with the latest version being published in 2018.

    Standard Numbers and Scope

    The standard numbers and scope for COLIPA Guidelines are as follows:

  • ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

  • EN ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (European standard).

  • ASTM F2425: Standard guide for the biological evaluation of medical devices-related skin irritation.

    • Compliance Requirements

    Compliance with COLIPA Guidelines is mandatory for cosmetic products and their ingredients that are intended to come into contact with human skin. The following industries require compliance:

  • Cosmetics industry: Manufacturers of cosmetics, personal care products, and pharmaceuticals.

  • Medical device industry: Manufacturers of medical devices, including implants, diagnostic equipment, and surgical instruments.

    • Consequences of Non-Compliance

    Failure to comply with COLIPA Guidelines can result in severe consequences, including:

  • Regulatory actions: Fines, penalties, and even product recalls.

  • Reputational damage: Loss of customer trust and market share.

  • Financial losses: Costs associated with retesting, rebranding, and re-launching products.

    • Business and Technical Reasons for Conducting COLIPA Guidelines Testing

    The business and technical reasons for conducting COLIPA Guidelines testing include:

  • Ensuring product safety: Protecting consumers from potential skin irritation or allergic reactions.

  • Compliance with regulations: Meeting national and international regulatory requirements.

  • Competitive advantage: Differentiating products through rigorous testing and certification.

    • Consequences of Not Performing This Test

    Failure to perform COLIPA Guidelines testing can result in:

  • Regulatory non-compliance: Fines, penalties, and even product recalls.

  • Reputational damage: Loss of customer trust and market share.

  • Financial losses: Costs associated with retesting, rebranding, and re-launching products.

    • Risk Factors and Safety Implications

    The risk factors and safety implications associated with COLIPA Guidelines testing include:

  • Skin irritation: Potential skin reactions or allergic responses to product ingredients.

  • Allergic contact dermatitis: Severe skin reactions that can lead to long-term health issues.

    • Quality Assurance and Quality Control

    Quality assurance and quality control measures for COLIPA Guidelines testing include:

  • Laboratory accreditation: Certification by recognized accrediting bodies, such as ISO/IEC 17025.

  • Standard operating procedures (SOPs): Documented protocols for sample preparation, testing, and analysis.

    • Contributing to Product Safety and Reliability

    COLIPA Guidelines testing contributes to product safety and reliability through:

  • Risk assessment: Identifying potential hazards and mitigating risks.

  • Quality control: Ensuring that products meet regulatory requirements and industry standards.

    • Competitive Advantages

    The competitive advantages of performing COLIPA Guidelines testing include:

  • Differentiation: Demonstrating commitment to product safety and quality.

  • Market access: Enhancing market share through rigorous testing and certification.

  • Customer confidence: Building trust with customers through transparent and reliable testing practices.

    • Conducting COLIPA Guidelines Testing

    To conduct COLIPA Guidelines testing, manufacturers should:

    1. Consult relevant regulations and standards (e.g., ISO 10993-10).

    2. Identify potential hazards and risks associated with product ingredients.

    3. Develop standard operating procedures (SOPs) for sample preparation, testing, and analysis.

    4. Ensure laboratory accreditation through recognized accrediting bodies.

    5. Maintain records of testing and results in accordance with regulatory requirements.

    Conclusion

    COLIPA Guidelines testing is a critical component of ensuring product safety and quality in the cosmetics and medical device industries. By understanding the importance of these guidelines, manufacturers can avoid regulatory non-compliance, reputational damage, and financial losses while enhancing market share and customer trust through rigorous testing practices.

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