EUROLAB
iso-21486-risk-assessment-for-skin-contact-materials
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 ReleaseCOLIPA Guidelines for Skin Compatibility TestingEN 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 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

Comprehensive Guide to ISO 21486 Risk Assessment for Skin Contact Materials Testing Service by Eurolab

ISO 21486 is a widely recognized international standard that specifies the requirements for risk assessment of skin contact materials. The standard is published by the International Organization for Standardization (ISO) and is available in multiple languages. In this section, we will provide comprehensive information about the relevant standards, legal and regulatory framework, and the industries that require ISO 21486 testing.

Relevant Standards

  • ISO 21486:2017 - Risk Assessment of Skin Contact Materials

  • EN 16446:2009 - Skin contact materials - Safety requirements and test methods for the assessment of safety

  • ASTM E1836-17 - Standard Guide for Evaluation of Chemical Sensitization Potential

  • TSE (Turkish Standards Institution) 1348:2013 - Skin Contact Materials

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding ISO 21486 testing is primarily governed by international and national standards. The European Unions (EU) Cosmetics Regulation, the U.S. Food and Drug Administrations (FDA) regulations, and the Turkish Standards Institutions (TSE) regulations are some of the key regulatory bodies that require compliance with ISO 21486.

    International and National Standards

  • EU: Annex VII to Directive 76/769/EEC

  • US: FDA Regulations Title 21 CFR Part 740

  • Turkey: TSE Regulation No. 1348

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN) are some of the key standard development organizations that develop and publish standards related to ISO 21486.

    Evolution of Standards

    Standards evolve and get updated periodically to reflect changes in technology, regulatory requirements, and industry best practices. The latest version of ISO 21486 is published in 2017, which supersedes all previous versions.

    Standard Numbers and Scope

  • ISO 21486:2017 - Risk Assessment of Skin Contact Materials

    • Scope: This standard specifies the general principles and procedures for the risk assessment of skin contact materials.

  • EN 16446:2009 - Skin contact materials - Safety requirements and test methods for the assessment of safety

    • Scope: This standard provides safety requirements and test methods for assessing the safety of skin contact materials.

    Standard Compliance Requirements

    Compliance with ISO 21486 is mandatory for manufacturers, importers, and distributors of skin contact materials. Failure to comply can result in regulatory penalties, product recalls, and damage to reputation.

    Industry-Specific Examples and Case Studies

  • Cosmetics industry: Manufacturers of cosmetics products must comply with EUs Cosmetics Regulation (EC No 1223/2009).

  • Personal care industry: Manufacturers of personal care products must comply with FDA regulations (Title 21 CFR Part 740).

    • In this section, we will explain the business and technical reasons for conducting ISO 21486 Risk Assessment for Skin Contact Materials testing.

    Why This Specific Test is Needed

    ISO 21486 risk assessment is necessary to ensure the safety of skin contact materials. The standard provides a systematic approach to identifying potential hazards and assessing their risks.

    Business and Technical Reasons for Conducting ISO 21486 Testing

  • Compliance with regulatory requirements

  • Protection of consumers from potential harm

  • Prevention of product recalls and regulatory penalties

  • Improvement of product quality and reliability

  • Enhancement of brand reputation and market positioning

    • Consequences of Not Performing This Test

    Failure to conduct ISO 21486 risk assessment can result in:

  • Regulatory penalties and fines

  • Product recalls and damage to reputation

  • Litigation and potential lawsuits

  • Loss of customer trust and confidence

    • Industries and Sectors That Require This Testing

  • Cosmetics industry

  • Personal care industry

  • Chemicals industry

  • Textiles industry

    • Risk Factors and Safety Implications

    The risk factors associated with skin contact materials include:

  • Skin irritation and allergic reactions

  • Eye irritation and vision impairment

  • Respiratory problems and other health issues

    • Quality Assurance and Quality Control Aspects

    ISO 21486 testing involves quality assurance and control measures to ensure the accuracy and reliability of test results.

    How This Test Contributes to Product Safety and Reliability

    ISO 21486 risk assessment contributes to product safety and reliability by:

  • Identifying potential hazards and assessing their risks

  • Ensuring compliance with regulatory requirements

  • Preventing product recalls and regulatory penalties

    • Competitive Advantages of Having This Testing Performed

    Conducting ISO 21486 risk assessment provides competitive advantages, including:

  • Compliance with regulatory requirements

  • Protection of consumers from potential harm

  • Prevention of product recalls and regulatory penalties

  • Improvement of product quality and reliability

  • Enhancement of brand reputation and market positioning

    • How to Conduct ISO 21486 Risk Assessment

    To conduct ISO 21486 risk assessment, manufacturers must follow the standards general principles and procedures. This includes:

  • Identifying potential hazards and assessing their risks

  • Evaluating the likelihood and severity of adverse effects

  • Implementing control measures to mitigate risks

  • Reviewing and updating the risk assessment periodically

    • Conclusion

    In conclusion, ISO 21486 risk assessment is a critical component of ensuring the safety of skin contact materials. Manufacturers must comply with regulatory requirements and conduct regular testing to protect consumers from potential harm.

    This section provides information on test methods for assessing the safety of skin contact materials, as specified in ISO 21486.

    Test Methods

    The standard specifies several test methods for assessing the safety of skin contact materials, including:

  • Skin irritation and allergic reactions tests

  • Eye irritation and vision impairment tests

  • Respiratory problems and other health issues tests

    • Test Procedures

    Manufacturers must follow the standards general principles and procedures to conduct test methods. This includes:

  • Preparation of test samples and equipment

  • Conducting test procedures under controlled conditions

  • Recording and evaluating test results

  • Reporting and documenting test findings

    • The following are some of the key test methods specified in ISO 21486:

  • Skin irritation and allergic reactions tests: These tests evaluate the potential for skin irritation and allergic reactions to occur after repeated exposure to a substance.

  • Eye irritation and vision impairment tests: These tests evaluate the potential for eye irritation and vision impairment to occur after exposure to a substance.

  • Respiratory problems and other health issues tests: These tests evaluate the potential for respiratory problems and other health issues to occur after inhalation of a substance.

    • Manufacturers must select test methods that are relevant to their products intended use and take into account any specific regulatory requirements. The standard specifies several factors to consider when selecting test methods, including:

  • Substance properties

  • Product formulation

  • Intended use and duration of exposure

  • Regulatory requirements and industry standards

    • Conclusion

    In conclusion, ISO 21486 risk assessment is a critical component of ensuring the safety of skin contact materials. Manufacturers must comply with regulatory requirements and conduct regular testing to protect consumers from potential harm.

    This section provides information on how to choose the right test method for assessing the safety of skin contact materials, as specified in ISO 21486.

    Choosing the Right Test Method

    Manufacturers must select a test method that is relevant to their products intended use and takes into account any specific regulatory requirements. The standard specifies several factors to consider when selecting a test method, including:

  • Substance properties

  • Product formulation

  • Intended use and duration of exposure

  • Regulatory requirements and industry standards

    • Factors to Consider When Selecting a Test Method

    Manufacturers must consider the following factors when selecting a test method:

  • Accuracy and reliability of test results

  • Sensitivity and specificity of test methods

  • Duration and cost of testing

  • Availability of resources and expertise

  • Compliance with regulatory requirements and industry standards

    • The standard specifies several test methods for assessing the safety of skin contact materials, including:

  • Skin irritation and allergic reactions tests

  • Eye irritation and vision impairment tests

  • Respiratory problems and other health issues tests

    • Conclusion

    In conclusion, manufacturers must select a test method that is relevant to their products intended use and takes into account any specific regulatory requirements. The standard specifies several factors to consider when selecting a test method.

    This section provides information on risk assessment of skin contact materials, as specified in ISO 21486.

    General Principles and Procedures

    The standard specifies general principles and procedures for conducting risk assessment. This includes:

  • Identifying potential hazards and assessing their risks

  • Evaluating the likelihood and severity of adverse effects

  • Implementing control measures to mitigate risks

  • Reviewing and updating the risk assessment periodically

    • Steps in Risk Assessment Process

    Manufacturers must follow the standards general principles and procedures to conduct a risk assessment. This includes:

    1. Identifying potential hazards

    2. Assessing their risks

    3. Evaluating the likelihood and severity of adverse effects

    4. Implementing control measures to mitigate risks

    5. Reviewing and updating the risk assessment periodically

    Manufacturers must also consider the following steps when conducting a risk assessment:

  • Identifying potential hazards that may arise during use, storage, or disposal of products

  • Assessing the likelihood and severity of adverse effects on human health and safety

  • Evaluating the effectiveness of control measures to mitigate risks

  • Reviewing and updating the risk assessment periodically

    • Risk Assessment Matrix

    The standard specifies a matrix for conducting a risk assessment. This includes:

    Potential Hazard Severity of Adverse Effect

    --- --- ---

    Likelihood of Adverse Effect Low High

    Conclusion

    In conclusion, manufacturers must conduct a risk assessment to identify potential hazards and assess their risks. The standard specifies general principles and procedures for conducting a risk assessment.

    In conclusion, ISO 21486 is an international standard that provides guidance on the safe use of skin contact materials. Manufacturers must comply with regulatory requirements and conduct regular testing to protect consumers from potential harm.

    The standard specifies several test methods for assessing the safety of skin contact materials, including:

  • Skin irritation and allergic reactions tests

  • Eye irritation and vision impairment tests

  • Respiratory problems and other health issues tests

    • Manufacturers must select a test method that is relevant to their products intended use and takes into account any specific regulatory requirements. The standard specifies several factors to consider when selecting a test method, including:

  • Accuracy and reliability of test results

  • Sensitivity and specificity of test methods

  • Duration and cost of testing

  • Availability of resources and expertise

  • Compliance with regulatory requirements and industry standards

    • Manufacturers must also conduct a risk assessment to identify potential hazards and assess their risks. The standard specifies general principles and procedures for conducting a risk assessment, including:

  • Identifying potential hazards

  • Assessing their risks

  • Evaluating the likelihood and severity of adverse effects

  • Implementing control measures to mitigate risks

  • Reviewing and updating the risk assessment periodically

    • Manufacturers must also consider the following steps when conducting a risk assessment:

  • Identifying potential hazards that may arise during use, storage, or disposal of products

  • Assessing the likelihood and severity of adverse effects on human health and safety

  • Evaluating the effectiveness of control measures to mitigate risks

  • Reviewing and updating the risk assessment periodically

    • In conclusion, manufacturers must comply with regulatory requirements and conduct regular testing to protect consumers from potential harm. The standard specifies several factors to consider when selecting a test method and conducting a risk assessment.

    References

  • ISO 21486:2019 Skin contact materials - Safety requirements

  • OSHA Regulations (29 CFR Part 1910.120)

  • EPA Guidelines for Exposure Assessment

    • Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers