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21-cfr-176170-substances-in-contact-with-aqueous-foods-extractables
Extractables and Leachables 21 CFR 174.5 General Requirements for Indirect Food Additives – E&L21 CFR 175.300 Resinous and Polymeric Coatings – Leachables Control21 CFR 177.1520 Leachable Migration Limits for Polyolefins21 CFR 177.1630 Polyethylene Terephthalate Polymers – Leachables LimitASTM D6288 Volatile Organic Compounds Determination by GC/MSASTM D6499 N-nitrosamines Extraction from Rubber ComponentsASTM D7823 Screening of Phthalates in Plastic ComponentsASTM D7896 Analysis of Leachables in Water by LC-MS/MSASTM D8147 Non-Volatile Extractables in Polymeric MaterialsASTM E2406 Leachables from Sterile Barrier SystemsASTM F1980 Accelerated Aging for Stability of ExtractablesASTM F2459 Extractable Residue from Metallic Medical ComponentsASTM F3136 Evaluation of Leachables in Drug Delivery DevicesEMA Guideline on Plastic Immediate Packaging Materials – E&LEP 2.9.47 Container Closure System Integrity Testing for ExtractablesEP 3.1.3 Polyolefins in Contact with Injectable PreparationsEP 3.1.4 Polypropylene for Containers in ParenteralsEP 3.1.5 Polyethylene Used in Pharmaceutical ContainersEP 3.1.6 Polyethylene Terephthalate Containers – Leachable SafetyEP 3.2.2 Plastic Containers and Closures for Pharmaceutical UseEP 3.2.8 Closures for Containers for Aqueous Parenteral PreparationsEP 3.2.9 Rubber Closures – Extractables AnalysisEP 5.1.1 Biological Safety – Leachables Toxicity AssessmentFDA 21 CFR 211.94 Container Closure System Suitability – Extractables RiskFDA Guidance: Container Closure Systems for Drug Products – E&L FocusFDA Guidance: Orally Inhaled and Nasal Drug Products – Leachables ReviewHealth Canada GUI-0069 Plastic Components in Contact with Drug ProductsICH Q3D Risk-Based Assessment of Elemental Impurities in LeachablesISO 10993-12 Sample Preparation for Extractables TestingISO 10993-13 Degradation Products Analysis for Polymeric Medical DevicesISO 10993-14 Identification of Degradation Products from CeramicsISO 10993-15 Identification of Degradation Products from MetalsISO 10993-17 Toxicological Risk Assessment for LeachablesISO 10993-18 Chemical Characterization of Medical Device MaterialsISO 11607-1 Package Integrity for Sterile Medical DevicesISO 11607-2 Manufacturing Validation for Sterile Barrier SystemsISO 11979-5 Extractables in Intraocular Lens MaterialsISO 14937 Sterilization and Extractables Safety AssuranceISO 15759 Analysis of Packaging for Contact with Parenteral DrugsISO 17664 Processing of Leachable-Safe Reusable Medical DevicesISO 18562-1 Leachables Testing for Breathing Gas Pathways in HealthcareISO 18562-2 Volatile Organic Compounds Testing from Medical DevicesISO 18562-3 Condensate Leachables Testing from Gas Pathway EquipmentISO 18562-4 Leachable Particulates in Medical Gas Pathway DevicesISO/TR 10993-33 Guidance on E&L Assessment Strategy for DevicesJP 2.20 Extractables from Rubber Stoppers by GC-MSJP 6.02 Aluminum Cap Material Leachables TestingJP 6.07 Plastic Containers for Aqueous Injections – Leachable StandardsJP 6.10 Gas Permeability and Volatile Leachable ReleaseJP 7.02 Residual Solvent and Leachable IdentificationJP 7.04 Container/Closure Leachable Migration EvaluationPDA TR No. 66 Defining Leachables Risk in Biologics ProductionPDA TR No. 85 Extractables and Leachables in Manufacturing SystemsPh. Int. General Method 3.10 Leachable Profiling of Packaging MaterialsUSP <1031.1> Analytical Instrument Qualification for Extractables StudiesUSP <1031> Analytical Method Validation for Extractables StudiesUSP <1058> Analytical Instrument Qualification for Leachables TestingUSP <1079> Good Storage and Distribution Practices – Leachable RiskUSP <1086> Impurities – Extractables Risk ProfilingUSP <1088> Inhalation and Nasal Drug Products – Leachables TestingUSP <1207> Container Closure Integrity and Leachable EntryUSP <1231> Water for Pharmaceutical Purposes – Leachables RiskUSP <1661> Evaluation of Plastic Packaging Systems for Drug ProductsUSP <1663> Extractables Testing for Plastic Components in Drug PackagingUSP <1664> Leachables Analysis for Container Closure SystemsUSP <381> Elastomeric Closures for Injections: Extractable ProfileUSP <601> Aerosols – Extractables in Metered Dose InhalersUSP <661.1> Physicochemical Testing of Plastic Packaging SystemsUSP <661.2> Biological Reactivity Tests for Plastic MaterialsUSP <661> Packaging System Suitability for ExtractablesUSP <671> Stability and Buffering Capacity in Plastic ContainersUSP <800> Hazardous Drug Handling – Leachables from PackagingUSP <87> Biological Reactivity Test: In Vitro CytotoxicityUSP <88> Biological Reactivity Test: In Vivo Irritation & ToxicityUSP <905> Uniformity of Dosage Units – Leachable InfluenceWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

A Comprehensive Guide to 21 CFR 176.170 Substances in Contact with Aqueous Foods Extractables Testing Services Provided by Eurolab

Introduction

The testing of substances in contact with aqueous foods, specifically extractables, is a critical aspect of ensuring the safety and quality of food products. The 21 CFR 176.170 regulation outlines specific requirements for substances that come into contact with aqueous foods, emphasizing the need for thorough evaluation of potential contaminants and leachates.

Relevant Standards

The following standards govern 21 CFR 176.170 Substances in Contact with Aqueous Foods Extractables testing:

  • ISO 10993-18:2002 Biological Evaluation of Medical Devices - Part 18: Chemical characterization requirements (extractable substances)

  • ASTM F963-16: Standard Consumer Safety Specification for Toy Safety (toys and juvenile products)

  • EN 71:2018 A1:2020 Safety of Toys (EU toy safety standard)

  • TSE (Turkish Standards Institution) TS ISO 10993-18:2002

  • FDA Guidance on Extractables and Leachables in Pharmaceutical Packaging

    • Standard Development Organizations

    The development and maintenance of these standards are overseen by various organizations, including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Electrotechnical Standardization (CENELEC)

  • Turkish Standards Institution (TSE)

    • These organizations regularly review and update standards to reflect the latest scientific research and advancements.

    Consequences of Non-Compliance

    Failure to comply with 21 CFR 176.170 Substances in Contact with Aqueous Foods Extractables testing can lead to severe consequences, including:

  • Product recalls

  • Regulatory fines and penalties

  • Damage to reputation and brand image

  • Loss of market share and revenue

    • Industries Requiring This Testing

    The following industries require 21 CFR 176.170 Substances in Contact with Aqueous Foods Extractables testing:

  • Food and Beverage Manufacturers

  • Pharmaceutical Packaging Suppliers

  • Medical Device Manufacturers (implantable devices)

  • Toy and Juvenile Product Manufacturers

  • Cosmetic and Personal Care Products Manufacturers

    • Why This Specific Test is Needed

    The 21 CFR 176.170 Substances in Contact with Aqueous Foods Extractables testing serves several purposes:

  • Ensures compliance with regulatory requirements

  • Identifies potential contaminants and leachates

  • Evaluates the safety of substances coming into contact with aqueous foods

  • Provides assurance to customers, stakeholders, and regulatory bodies

    • Business and Technical Reasons for Conducting This Test

    Conducting 21 CFR 176.170 Substances in Contact with Aqueous Foods Extractables testing provides numerous benefits:

  • Prevents costly product recalls

  • Enhances customer trust and confidence

  • Supports innovation and new product development

  • Demonstrates commitment to quality and safety

    • Quality Assurance and Quality Control Aspects

    Eurolabs 21 CFR 176.170 Substances in Contact with Aqueous Foods Extractables testing adheres to rigorous quality control measures:

  • ISO/IEC 17025:2017 accredited laboratory

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

    • Consequences of Not Performing This Test

    Failure to conduct this test can result in:

  • Unintended leachates and contaminants

  • Regulatory non-compliance

  • Reputation damage

  • Economic losses

    • Competitive Advantages

    Performing 21 CFR 176.170 Substances in Contact with Aqueous Foods Extractables testing provides competitive advantages:

  • Enhances market reputation and brand image

  • Supports innovation and product development

  • Demonstrates commitment to quality and safety

  • Improves supply chain reliability

    • Risk Assessment and Mitigation through Testing

    This test helps mitigate risks associated with:

  • Chemical contaminants and leachates

  • Regulatory compliance

  • Product recalls

  • Reputation damage

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

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