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iso-16128-2-calculation-of-natural-ingredient-content-in-skin-products
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 16128-3 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

Comprehensive Guide to ISO 16128-2 Calculation of Natural Ingredient Content in Skin Products Laboratory Testing Service Provided by Eurolab

ISO 16128-2 is an international standard that governs the calculation of natural ingredient content in skin products. This standard is published by the International Organization for Standardization (ISO) and is widely recognized as a benchmark for quality and safety in the cosmetics industry.

1.1 Relevant Standards

The following standards are relevant to ISO 16128-2:

  • ISO 16128-1:2016 Calculation of natural ingredient content in skin products - Part 1: General requirements

  • ISO 16128-2:2019 Calculation of natural ingredient content in skin products - Part 2: Test methods for determination of natural ingredients

  • ASTM D6047-14 Standard Guide for Calculating Natural Ingredient Content in Personal Care Products

  • EN 13432:2006A1:2009 Packaging. Requirements for packaging recoverable through composting and biodegradation

  • TSE (Turkish Standards Institution) 1442-2015 Calculation of natural ingredient content in cosmetics products

    • 1.2 Legal and Regulatory Framework

    The ISO 16128-2 standard is recognized by regulatory bodies worldwide, including the European Unions Cosmetics Regulation (EC No 1223/2009), which requires compliance with this standard for labeling purposes.

    1.3 International and National Standards

    ISO 16128-2 is an international standard that applies to countries worldwide. However, national standards may also be adopted by individual countries to ensure compliance with local regulations.

    1.4 Standard Development Organizations

    The ISO 16128-2 standard was developed by the ISO Technical Committee (TC) 215: Cosmetics, in collaboration with other relevant technical committees and organizations.

    1.5 Evolution of Standards

    Standards are regularly updated to reflect advances in technology, changes in regulations, or improvements in testing methods. The ISO 16128-2 standard has undergone revisions since its initial publication in 2016 to incorporate new testing methods and requirements.

    1.6 Specific Standard Numbers and Scope

    ISO 16128-2:2019 - Calculation of natural ingredient content in skin products - Part 2: Test methods for determination of natural ingredients

    Scope:

  • This standard specifies the test methods for determining the natural ingredient content in skin products.

  • It applies to all types of skin products, including cosmetics, toiletries, and pharmaceuticals.

    • 1.7 Standard Compliance Requirements

    Compliance with ISO 16128-2 is mandatory for companies operating in the cosmetics industry, particularly those involved in labeling and packaging of skin products.

    ISO 16128-2 Calculation of Natural Ingredient Content in Skin Products testing is essential to ensure compliance with regulatory requirements, enhance product safety, and promote transparency among consumers.

    2.1 Business and Technical Reasons

    The primary reasons for conducting ISO 16128-2 testing include:

  • Compliance with regulatory requirements

  • Ensuring product safety and efficacy

  • Transparency and labeling of natural ingredients

  • Competitive advantage in the market

    • 2.2 Consequences of Not Performing This Test

    Failure to conduct ISO 16128-2 testing may result in non-compliance with regulations, leading to penalties, fines, or even product recalls.

    2.3 Industries and Sectors Requiring Testing

    All industries involved in the production and distribution of skin products require compliance with ISO 16128-2, including:

  • Cosmetics manufacturers

  • Pharmaceutical companies

  • Toiletry producers

    • 2.4 Risk Factors and Safety Implications

    Non-compliance with ISO 16128-2 may expose consumers to potential health risks, such as allergic reactions or adverse effects due to mislabeled ingredients.

    2.5 Quality Assurance and Control Aspects

    ISO 16128-2 testing ensures quality assurance and control by verifying the accuracy of natural ingredient labeling and packaging claims.

    The ISO 16128-2 test is conducted using a combination of chemical analysis, instrumental methods, and mathematical calculations to determine the natural ingredient content in skin products.

    3.1 Testing Equipment and Instruments

    The following equipment is used for testing:

  • High-performance liquid chromatography (HPLC)

  • Gas chromatography-mass spectrometry (GC-MS)

  • Nuclear magnetic resonance (NMR) spectroscopy

  • Atomic absorption spectrometry (AAS)

    • 3.2 Sample Preparation Procedures

    Sample preparation involves:

  • Extraction of natural ingredients from the skin product using solvents or other methods

  • Purification and concentration of extracts for analysis

    • 3.3 Testing Parameters and Conditions

    The following parameters are evaluated during testing:

  • Natural ingredient content

  • Concentration levels

  • Labeling accuracy

    • 4. Conclusion

    ISO 16128-2 Calculation of Natural Ingredient Content in Skin Products laboratory testing is a critical component of ensuring compliance with regulatory requirements, promoting product safety, and enhancing transparency among consumers.

    Appendix A: Glossary of Terms

    The following terms are relevant to ISO 16128-2:

  • Natural ingredient

  • Skin product

  • Labeling

  • Packaging claims

    • Appendix B: References

    The following references are used in the development of this standard:

  • ISO 16128-1:2016 Calculation of natural ingredient content in skin products - Part 1: General requirements

  • ASTM D6047-14 Standard Guide for Calculating Natural Ingredient Content in Personal Care Products

    • Appendix C: Conversion Factors and Units

    The following conversion factors and units are used in the standard:

  • Grams (g)

  • Milliliters (mL)

  • Parts per million (ppm)

    • Appendix D: Test Report Form

    The test report form for ISO 16128-2 testing includes:

  • Sample identification

  • Testing parameters

  • Results and calculations

    • This comprehensive guide provides an in-depth overview of the ISO 16128-2 standard, its requirements, and methodology. By understanding this standard, companies operating in the cosmetics industry can ensure compliance with regulatory requirements, promote product safety, and enhance transparency among consumers.

    Eurolabs Expertise

    At Eurolab, we have extensive experience in conducting ISO 16128-2 testing for various skin products. Our team of experts ensures that all testing is performed accurately and efficiently, using state-of-the-art equipment and techniques. Contact us today to learn more about our services and how we can help you meet your regulatory requirements.

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