EUROLAB
iso-16128-3-methodologies-for-determining-organic-content-in-skin-care
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 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

ISO 16128-3 Methodologies for Determining Organic Content in Skin Care Testing Services

ISO 16128-3 is an international standard that governs the methodologies for determining organic content in skin care products. The standard is developed and published by the International Organization for Standardization (ISO) in collaboration with other standard development organizations such as ASTM, EN, TSE, and others.

The legal and regulatory framework surrounding ISO 16128-3 testing is based on various national and international regulations that require manufacturers to provide accurate information about the organic content of their products. In the European Union, for example, the Cosmetics Regulation (EC) No 1223/2009 requires that all cosmetics sold in the EU must comply with this regulation, which includes requirements for labeling and packaging.

Internationally, ISO 16128-3 testing is applied to various industries such as cosmetics, pharmaceuticals, food, and textiles. The standard provides a framework for manufacturers to determine the organic content of their products, ensuring compliance with regulatory requirements and maintaining consumer trust.

The standard development organizations involved in developing ISO 16128-3 include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations work together to develop and maintain standards that promote global trade, innovation, and consumer safety.

    The ISO 16128-3 standard is essential for manufacturers of skin care products who need to determine the organic content of their products. The business and technical reasons for conducting this testing include:

  • Compliance with regulatory requirements

  • Maintaining consumer trust through accurate labeling and packaging

  • Ensuring product safety and efficacy

  • Reducing risk factors associated with non-compliance

    • The consequences of not performing ISO 16128-3 testing can be severe, including fines, penalties, and damage to reputation.

    Various industries and sectors require this testing, including:

  • Cosmetics manufacturers

  • Pharmaceutical companies

  • Food producers

  • Textile manufacturers

    • Risk factors and safety implications associated with non-compliance include:

  • Consumer harm due to incorrect labeling or packaging

  • Product contamination or adulteration

  • Regulatory penalties and fines

  • Damage to reputation and brand image

    • The quality assurance and quality control aspects of ISO 16128-3 testing are critical, ensuring that results are accurate, reliable, and consistent.

    The test conditions for ISO 16128-3 involve a series of steps and procedures that ensure accuracy and reliability. These include:

    1. Sample preparation: The skin care product sample is prepared according to the standards requirements.

    2. Testing equipment and instruments: The testing equipment and instruments used must be calibrated and validated before use.

    3. Testing environment requirements: The testing environment must meet specific temperature, humidity, pressure, and other conditions specified in the standard.

    4. Measurement and analysis methods: The measurement and analysis methods used to determine organic content must be accurate and reliable.

    5. Calibration and validation procedures: The testing equipment and instruments are calibrated and validated before each test.

    The quality control measures during testing include:

  • Regular calibration and maintenance of testing equipment

  • Verification of sample preparation procedures

  • Validation of measurement and analysis methods

    • The test report for ISO 16128-3 testing includes detailed information about the testing process, results, and interpretation. The report format and structure are specified in the standard.

    The certification and accreditation aspects of ISO 16128-3 testing involve ensuring that the laboratory performing the test is accredited by a recognized accrediting body.

    The benefits and advantages of performing ISO 16128-3 testing include:

  • Compliance with regulatory requirements

  • Maintaining consumer trust through accurate labeling and packaging

  • Ensuring product safety and efficacy

  • Reducing risk factors associated with non-compliance

    • Risk assessment and mitigation through testing are essential to ensure product quality and safety.

    Eurolab, as a leading laboratory testing service provider, has the expertise, experience, and capabilities to perform ISO 16128-3 testing accurately and efficiently. Our state-of-the-art equipment and facilities ensure that our results are reliable and consistent.

    Our qualified and certified personnel, combined with our accreditation and certification details, provide confidence in our testing services.

    Conclusion

    ISO 16128-3 Methodologies for Determining Organic Content in Skin Care testing is a critical laboratory test that ensures compliance with regulatory requirements and maintains consumer trust. Eurolabs expertise and experience in this field make us the ideal partner for manufacturers seeking accurate and reliable results.

    By performing ISO 16128-3 testing, manufacturers can ensure product safety and efficacy, reducing risk factors associated with non-compliance.

    We invite you to contact us today to learn more about our ISO 16128-3 testing services.

    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