EUROLAB
iso-16128-guidelines-on-natural-and-organic-cosmetic-ingredients
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 16128-1 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

Comprehensive Guide to ISO 16128 Guidelines on Natural and Organic Cosmetic Ingredients Laboratory Testing Service Provided by Eurolab

The ISO 16128 guidelines on natural and organic cosmetic ingredients testing are a set of standards that provide a framework for the evaluation and verification of natural and organic cosmetic ingredients. These guidelines are developed and maintained by the International Organization for Standardization (ISO) in collaboration with the European Cosmetics Industry Federation (Federchimica).

The ISO 16128 guidelines are based on the principles of good laboratory practice (GLP), which ensure that laboratory tests are conducted accurately, reliably, and consistently. The guidelines cover various aspects of natural and organic cosmetic ingredients testing, including:

  • Identification and characterization of raw materials

  • Evaluation of chemical composition

  • Determination of physical properties

  • Assessment of biological activity

    • The legal and regulatory framework surrounding ISO 16128 guidelines is governed by national and international laws and regulations. In the European Union (EU), for example, the Cosmetics Regulation (EC) No 1223/2009 sets out the requirements for the safety assessment of cosmetic ingredients.

    At an international level, the ISO 16128 guidelines are recognized as a global standard for natural and organic cosmetic ingredients testing. This means that companies operating in multiple countries can rely on the results of tests conducted according to these guidelines.

    The European Commission has designated Eurolab as a Notified Body for the evaluation of conformity with EU regulations. As such, Eurolab is responsible for ensuring that its laboratory testing services comply with the relevant standards and regulations.

    Conducting ISO 16128 guidelines on natural and organic cosmetic ingredients testing is essential for several reasons:

  • Business Reasons: Companies must demonstrate compliance with national and international regulations to avoid legal and financial penalties. Conducting these tests ensures that products meet the required standards.

  • Technical Reasons: Natural and organic cosmetic ingredients can be complex and difficult to analyze, requiring specialized equipment and expertise. The ISO 16128 guidelines provide a framework for testing these ingredients accurately and reliably.

    • The consequences of not performing this test include:

  • Regulatory non-compliance

  • Financial penalties and reputational damage

  • Risk of product contamination or adulteration

    • Industries that require natural and organic cosmetic ingredients testing include:

  • Cosmetics manufacturers

  • Personal care companies

  • Food producers (for natural food colorings)

  • Pharmaceutical companies (for herbal extracts)

    • Risk factors associated with not conducting this test include:

  • Product safety risks to consumers

  • Regulatory non-compliance

  • Financial losses due to product recalls or contamination

    • Quality assurance and quality control aspects of the ISO 16128 guidelines ensure that tests are conducted accurately, reliably, and consistently. These standards contribute to product safety and reliability by:

  • Ensuring accurate identification and characterization of raw materials

  • Evaluating chemical composition and physical properties

  • Assessing biological activity

    • Conducting these tests provides several competitive advantages, including:

  • Demonstrated compliance with national and international regulations

  • Enhanced customer confidence and trust

  • Improved market positioning and brand reputation

  • Increased efficiency and cost savings through reduced testing times and costs

    • The ISO 16128 guidelines on natural and organic cosmetic ingredients testing involve a series of steps, including:

    1. Sample Preparation: Raw materials are collected and prepared for analysis.

    2. Testing Equipment and Instruments: Specialized equipment is used to analyze the chemical composition and physical properties of raw materials.

    3. Testing Environment Requirements: Laboratory conditions must be controlled to ensure accurate results (e.g., temperature, humidity).

    4. Measurement and Analysis Methods: Various analytical techniques are employed to evaluate the chemical composition, physical properties, and biological activity of raw materials.

    The testing parameters and conditions for each test are specified in the ISO 16128 guidelines, ensuring that tests are conducted consistently and accurately.

    Eurolabs laboratory is equipped with state-of-the-art equipment and facilities, including:

  • HPLC (High-Performance Liquid Chromatography) systems

  • GC-MS (Gas Chromatography-Mass Spectrometry) systems

  • ICP-OES (Inductively Coupled Plasma Optical Emission Spectrometry) systems

    • The laboratory is accredited by the European Accreditation Council for Conformity Assessment and Surveillance (EA), ensuring that tests are conducted according to international standards.

    Test results are documented and reported in a comprehensive report, which includes:

  • Test parameters and conditions

  • Sample identification and characterization

  • Results of testing, including chemical composition, physical properties, and biological activity

  • Interpretation of test results

  • Certification and accreditation details

    • The reporting standards and formats for the ISO 16128 guidelines are specified in the relevant standards.

    Results are validated and verified through:

  • Inter-laboratory comparisons: Eurolab participates in inter-laboratory comparisons to ensure accuracy and consistency.

  • Internal quality control: Regular internal audits and quality control measures are implemented to ensure compliance with international standards.

    • Conclusion

    Conducting ISO 16128 guidelines on natural and organic cosmetic ingredients testing is essential for businesses operating in the cosmetics industry. Eurolabs laboratory testing services comply with these guidelines, ensuring that products meet national and international regulations.

    By conducting these tests, companies can:

  • Demonstrate compliance with national and international regulations

  • Enhance customer confidence and trust

  • Improve market positioning and brand reputation

  • Increase efficiency and cost savings through reduced testing times and costs

    • Eurolab is committed to providing high-quality laboratory testing services that meet the requirements of the ISO 16128 guidelines. If you require natural and organic cosmetic ingredients testing, please contact us today to learn more about our services.

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