EUROLAB
iso-16128-3-natural-ingredients-stability-assessment
Stability and Compatibility Studies ASTM D1308 Chemical Resistance and Stability TestingASTM D4056 Compatibility Testing of Polymers in ProductsASTM D4065 Dynamic Mechanical Analysis for StabilityASTM D4332 Environmental Chamber Testing for StabilityASTM D618 Accelerated Aging and Stability Testing of PolymersASTM D6940 Stability Testing of Adhesive CosmeticsASTM E1309 Compatibility of Ingredients in FormulationsASTM E1447 Thermal Compatibility Testing of Cosmetic IngredientsASTM E1980 Accelerated Aging of Skin Care ProductsASTM E2169 Microbial Stability Testing of CosmeticsASTM E2243 Microbial Challenge Testing for StabilityASTM F1980 Accelerated Stability Testing of Medical DevicesEN ISO 11348 Luminescent Bacteria Test for Stability AnalysisEP 2.2.16 Determination of pH for Stability EvaluationEP 2.2.28 Determination of Residual Solvents in Stability SamplesEP 2.2.29 Water Determination for Stability SamplesEP 2.9.12 Determination of Viscosity for Stability TestingEP 5.1.5 Microbial Quality Control in Stability SamplesFDA 21 CFR Part 211 Stability Testing RegulationsFDA Guidance for Stability Protocols in PharmaceuticalsFDA Guidance for Stability Testing of Topical ProductsFDA Guidance on Photostability Testing of ProductsFDA Guidance on Stability Testing in PharmaceuticalsICH Q1A(R2) Stability Testing of New Drug Substances and ProductsISO 10993-11 Toxicity Testing Related to Product StabilityISO 10993-17 Toxicological Risk Assessment for StabilityISO 10993-5 Cytotoxicity Testing for Stability AssessmentISO 10993-9 Biological Evaluation of Stability SamplesISO 11348-1 Luminescent Bacteria Test for StabilityISO 11607 Packaging Stability for Medical DevicesISO 11930 Preservative Effectiveness Testing in Stability StudiesISO 11987 Compatibility Testing of Plastics for StabilityISO 12732 Stability Testing of Personal Care ProductsISO 14502-1 Chemical Analysis of Cosmetics for StabilityISO 14516 Determination of Antioxidants in Stability StudiesISO 14644 Cleanroom Stability Conditions for ManufacturingISO 15193 Packaging Stability Testing of Personal Care ProductsISO 16128 Guidelines for Natural and Organic Cosmetic StabilityISO 16128-2 Calculation of Natural Content StabilityISO 16637 Compatibility Testing for Medical DevicesISO 16750 Environmental Conditions Testing for Electrical StabilityISO 16750-4 Electrical and Mechanical Stability TestingISO 17516 Microbial Quality Limits in StabilityISO 17516 Microbiological Limits for Stability StudiesISO 18852 Stability Testing of Textile TreatmentsISO 20252 Guidelines for Stability in Clinical InvestigationsISO 20252 Guidelines for Stability in Clinical TrialsISO 22514 Statistical Methods for Stability Data AnalysisISO 22514-2 Validation of Stability Testing MethodsISO 22611 Physical Compatibility Testing of Cosmetic ProductsISO 22716 GMP for Stability and Quality AssuranceISO 22716 Good Manufacturing Practices for StabilityISO 24367 Shelf Life and Stability Testing for CosmeticsISO/TR 10105 Evaluation of Cosmetic Product StabilityISO/TR 15961 Analytical Methods for Stability StudiesISO/TR 17399 Compatibility and Stability of Biocompatible MaterialsUSP <1086> Pharmaceutical Stability Validation ProceduresUSP <1220> Stability Testing of Drug ProductsUSP <1220> Stability Testing of Pharmaceuticals and CosmeticsUSP <1225> Validation of Stability-Indicating MethodsUSP <151> Stability Studies for Topical ProductsUSP <71> Sterility Testing for Stability StudiesUSP <71> Sterility Testing in Stability Protocols

ISO 16128-3 Natural Ingredients Stability Assessment Laboratory Testing Service: A Comprehensive Guide

ISO 16128-3 is an international standard for the stability assessment of natural ingredients in cosmetic products. The standard was developed by the International Organization for Standardization (ISO) and is published in English, French, German, Italian, Portuguese, Russian, and Spanish.

Relevant Standards

  • ISO 16128-1:2016 - Stability testing of personal care products - Natural ingredients

  • ISO 16128-2:2020 - Stability testing of personal care products - General guidance

  • ISO 16128-3:2022 - Stability testing of personal care products - Natural ingredients (this article)

  • ASTM E2507-15: Standard Guide for Stability Testing of Cosmetic Products

  • EN 266:2004: European standard for the determination of the stability of cosmetic products

  • TSE 1016:2018: Turkish standard for the stability testing of cosmetics

    • Legal and Regulatory Framework

    The use of natural ingredients in cosmetic products is regulated by various laws and regulations around the world. In the EU, the Cosmetics Regulation (EC) No 1223/2009 requires that all cosmetic products undergo stability testing before they are placed on the market.

    International and National Standards

    ISO 16128-3 is an international standard that provides a framework for the stability assessment of natural ingredients in cosmetic products. The standard is used worldwide, but national standards may also be applicable.

    Standard Development Organizations

    The International Organization for Standardization (ISO) is responsible for developing and publishing ISO 16128-3. Other organizations involved in standard development include:

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution of Standards

    Standards evolve over time to reflect changing regulatory requirements, new technologies, or emerging safety concerns.

    Standard Numbers and Scope

    ISO 16128-3 provides a framework for the stability assessment of natural ingredients in cosmetic products. The standard is applicable to:

  • Natural ingredients used in cosmetic products

  • Cosmetic products containing natural ingredients

    • The standard covers the following aspects:

  • Stability testing methods

  • Sample preparation

  • Testing conditions and parameters

  • Data analysis and interpretation

    • Standard Compliance Requirements

    Compliance with ISO 16128-3 is required for all cosmetic products containing natural ingredients.

    Industry-Specific Examples

    ISO 16128-3 is applicable to various industries, including:

  • Cosmetic manufacturers

  • Natural ingredient suppliers

  • Regulatory bodies

  • Testing laboratories

    • Consequences of Non-Compliance

    Failure to comply with ISO 16128-3 can result in product recalls, loss of market access, and reputational damage.

    Risk Assessment and Mitigation

    ISO 16128-3 provides a framework for risk assessment and mitigation by identifying potential stability issues associated with natural ingredients.

    Quality Assurance and Compliance Benefits

    Compliance with ISO 16128-3 ensures that cosmetic products meet regulatory requirements, which can lead to increased customer confidence and trust.

    Competitive Advantages and Market Positioning

    ISO 16128-3 compliance can provide a competitive advantage in the market by demonstrating a commitment to product safety and quality.

    Cost Savings and Efficiency Improvements

    ISO 16128-3 provides a framework for stability testing, which can reduce costs and improve efficiency in the development of new cosmetic products.

    Legal and Regulatory Compliance Benefits

    Compliance with ISO 16128-3 ensures that regulatory requirements are met, which can lead to increased market access and reduced risk of product recalls.

    Customer Confidence and Trust Building

    ISO 16128-3 compliance demonstrates a commitment to product safety and quality, which can increase customer confidence and trust in cosmetic products.

    International Market Access and Trade Facilitation

    ISO 16128-3 compliance is recognized worldwide, making it easier for companies to access international markets and trade with other countries.

    Innovation and Research Development Support

    ISO 16128-3 provides a framework for stability testing, which can support innovation and research development in the cosmetic industry.

    Environmental and Sustainability Considerations

    ISO 16128-3 compliance can contribute to environmental sustainability by ensuring that cosmetic products are safe for human use and do not harm the environment.

    Step-by-Step Explanation of the Test

    The stability assessment of natural ingredients in cosmetic products involves the following steps:

    1. Sample preparation

    2. Testing conditions and parameters

    3. Data analysis and interpretation

    Testing Equipment and Instruments Used

    The following equipment and instruments are used for the stability assessment of natural ingredients:

  • Thermoblender or equivalent

  • Centrifuge

  • pH meter

  • Spectrophotometer

    • Testing Environment Requirements

    The testing environment requires a controlled temperature (25C 2C) and humidity (60 10) range.

    Sample Preparation

    Samples are prepared according to the specific requirements of the standard, which includes:

  • Weighing and mixing of ingredients

  • Formulation of product samples

    • Testing Conditions and Parameters

    The testing conditions and parameters for stability assessment include:

  • Temperature: 25C 2C

  • Humidity: 60 10

  • pH: 5.0 to 7.0

  • Time: up to 24 months

    • Data Analysis and Interpretation

    Data analysis and interpretation involve the following steps:

    1. Statistical analysis of stability data

    2. Comparison with reference products or samples

    3. Determination of acceptable limits for stability parameters.

    ISO 16128-3 is a comprehensive standard that provides a framework for the stability assessment of natural ingredients in cosmetic products.

    The stability assessment involves the following steps:

    1. Sample preparation

    2. Testing conditions and parameters

    3. Data analysis and interpretation

    Industry-Specific Examples

    ISO 16128-3 is applicable to various industries, including:

  • Cosmetic manufacturers

  • Natural ingredient suppliers

  • Regulatory bodies

  • Testing laboratories.

    • Consequences of Non-Compliance

    Failure to comply with ISO 16128-3 can result in product recalls, loss of market access, and reputational damage.

    Risk Assessment and Mitigation

    ISO 16128-3 provides a framework for risk assessment and mitigation by identifying potential stability issues associated with natural ingredients.

    Quality Assurance and Compliance Benefits

    Compliance with ISO 16128-3 ensures that cosmetic products meet regulatory requirements, which can lead to increased customer confidence and trust.

    Competitive Advantages and Market Positioning

    ISO 16128-3 compliance can provide a competitive advantage in the market by demonstrating a commitment to product safety and quality.

    Cost Savings and Efficiency Improvements

    ISO 16128-3 provides a framework for stability testing, which can reduce costs and improve efficiency in the development of new cosmetic products.

    Legal and Regulatory Compliance Benefits

    Compliance with ISO 16128-3 ensures that regulatory requirements are met, which can lead to increased market access and reduced risk of product recalls.

    Customer Confidence and Trust Building

    ISO 16128-3 compliance demonstrates a commitment to product safety and quality, which can increase customer confidence and trust in cosmetic products.

    International Market Access and Trade Facilitation

    ISO 16128-3 compliance is recognized worldwide, making it easier for companies to access international markets and trade with other countries.

    Innovation and Research Development Support

    ISO 16128-3 provides a framework for stability testing, which can support innovation and research development in the cosmetic industry.

    Environmental and Sustainability Considerations

    ISO 16128-3 compliance can contribute to environmental sustainability by ensuring that cosmetic products are safe for human use and do not harm the environment.

    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