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fda-cfr-21-part-117-additive-residue-control-in-food
Food Additive Residue Analysis AOAC 2006.12 Residue Analysis of Additives in Food OilsAOAC 2007.01 Food Additive Residue QuantificationAOAC 2008.01 Analysis of Food Additive Residues in VegetablesAOAC 2008.03 Additive Residue Testing in Frozen FoodsAOAC 2009.01 Food Additive Residue Quantification in CerealsAOAC 2010.03 Analysis of Food Additive Residues in BeveragesAOAC 2011.20 Residue Analysis of Additives in BeveragesAOAC 2013.10 Food Additive Residue Testing in MeatAOAC 991.31 Additive Residue Testing in Cereals and GrainsAOAC 991.39 Determination of Additive Residues in DairyAOAC 991.41 Food Additive Residue Analysis by HPLCAOAC Official Method 2016.04 Food Additive Residue TestingASTM D5112 Screening of Food Additive ResiduesASTM D5228 Additive Residue Testing in BeveragesASTM D6079 Screening of Additive Residues in BeveragesASTM D6196 Determination of Additive Residues in Processed FoodASTM D6318 Additive Residue Testing in Processed MeatsASTM D6846 Food Additive Residue Quantification by GC-MSASTM D6913 Analysis of Food Additive Residues in FoodASTM D6954 Additive Residue Degradation TestingASTM E1241 Analysis of Synthetic Food Additive ResiduesASTM E1624 Food Additive Residue Analysis in Dairy ProductsASTM E2990 Detection of Additive Residues in Processed FoodASTM E3004 Food Additive Residue Quantification by LC-MSCEN EN 14105 Determination of Food Additive ResiduesCEN EN 14252 Additive Residue Analysis in WineCEN EN 1528 Food Additive Residue Analysis by LC-MSCEN EN 1528 Food Additive Residue Determination in CerealsCEN EN 15662 QuEChERS Extraction of Additive ResiduesCEN EN 16058 Additive Residue Analysis in Drinking WaterCodex Alimentarius CAC/GL 63-2008 Food Additive Residue LimitsEN 12856 Determination of Food Additive Residues by HPLCEN 12856 Food Additive Residue Extraction ProceduresEN 12856 Food Additive Residue Screening TestsEN 14342 Additive Residue Determination in Food PackagingEN 15662 QuEChERS Method for Food Additive Residue AnalysisEN 16190 Additive Residue Testing in Food SafetyEN ISO 19343 Food Additive Residue in Spice TestingEPA 3540C Extraction of Additive Residues from FoodEPA 3545A Automated Extraction of Food Additive ResiduesEPA 3550C Extraction of Food Additive Residues from SoilEPA 3551 Extraction of Additive Residues from Water SamplesEPA 8015D Additive Residue Testing by Gas ChromatographyEPA 8081B Pesticide and Food Additive Residue TestingEPA 8081B Pesticide and Food Additive Residue TestingEPA Method 3520C Extraction of Additive Residues from FoodEPA Method 3550B Extraction of Food Additive ResiduesEPA Method 3620B Extraction of Food Additive ResiduesEPA Method 625 Determination of Additive Residues in WaterEPA Method 8270D Semivolatile Organic Compounds and AdditivesFDA BAM Chapter 17 Analysis of Food Additive ResiduesFDA BAM Chapter 18 Residue Analysis of AdditivesFDA BAM Chapter 20 Additive Residue Testing in FruitsFDA BAM Chapter 21 Additive Residue Analysis in SeafoodFDA BAM Chapter 22 Additive Residue Testing in CerealsFDA BAM Chapter 23 Additive Residue Analysis in DairyFDA BAM Chapter 24 Additive Residue Analysis in SeafoodFDA CFR 21 Part 111 Additive Residue Testing in SupplementsFDA CFR Title 21 Additive Residue MonitoringFDA CFR Title 21 Food Additive Residue Labeling RequirementsFDA CFR Title 21 Food Additive Residue RegulationsFDA Title 21 Part 110 Good Manufacturing Practices for AdditivesISO 12856 Migration Testing for Additive ResiduesISO 12966-2 Fatty Acid Residue Analysis in Food AdditivesISO 13138 Food Additive Residue Detection by ChromatographyISO 13906 Additive Residue Testing in Food Contact MaterialsISO 14402 Food Additive Residue Limits in Infant FoodsISO 14675 Additive Residue Testing in Fruits and VegetablesISO 17025 Accredited Food Additive Residue AnalysisISO 17025 Accredited Testing of Food Additive ResiduesISO 17034 Certified Reference Materials for Additive ResiduesISO 18369 Additive Residue Detection in BeveragesISO 18643 Additive Residue Analysis in Processed FoodsISO 18643 Food Additive Residue Testing in Meat ProductsISO 18857 Additive Residue Testing in Food Packaging MaterialsISO 19338 Additive Residue Analysis in Infant NutritionISO 19343 Food Additive Residue Limits in SpicesISO 21254 Food Additive Residue Testing in Infant FormulaISO 21422 Determination of Food Additive Residues in ProductsISO 21427 Additive Residue Limits in Meat ProductsISO 21528 Microbial Contaminants and Additive ResiduesISO 21528-1 Microbial Limit Testing for Additive ResiduesISO 21528-2 Microbiological Food Additive Residue TestingISO 21528-3 Detection of Microbial and Additive ResiduesISO 22000 Food Safety Management for Additive ResiduesISO 22005 Traceability for Additive Residue ControlISO 8124-3 Safety of Toys - Food Additive Residue Limits

FDA CFR 21 Part 117 Additive Residue Control in Food: Eurolabs Laboratory Testing Service

Standard-Related Information

The FDA CFR 21 Part 117 Additive Residue Control in Food testing service is governed by a set of international and national standards that ensure the accuracy, reliability, and validity of test results. Some of the relevant standards include:

  • ISO/TS 22005:2007 - Traceability in the feed and food chain

  • ASTM E2856-12 - Standard Practice for Verification of Measurement Uncertainty (VMU)

  • EN 13690:2011 - Food processing machinery - Safety requirements

  • TSE 1179 - Food contact materials and articles - Plastics and rubber

  • ISO/TS 16949:2002 - Quality management systems - Requirements for automotive production and service

    • The legal and regulatory framework surrounding this testing service is governed by the FDA CFR 21 Part 117, which sets forth requirements for the control of residues in food. This includes:

  • Section 110.3(a) - Control of Residues

  • Section 110.3(b) - Monitoring Program

  • Section 110.5 - Recordkeeping

    • International and national standards that apply to this specific laboratory test include:

  • ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories

  • EN ISO/IEC 17025:2018 - General requirements for the competence of testing and calibration laboratories

  • TSE 1089 - Accreditation of laboratories

    • Standard development organizations, such as ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), and CEN (European Committee for Standardization), play a crucial role in developing standards that ensure the accuracy and reliability of test results.

    Standards evolve and get updated to reflect new technologies, methodologies, and regulatory requirements. For example:

  • ISO/TS 22005:2007 has been revised to ISO/TS 22005:2019 - Traceability in the feed and food chain

  • ASTM E2856-12 has been withdrawn

    • Specific standard numbers and their scope include:

  • ISO/TS 22005:2019 - Scope: This document provides guidelines for traceability in the feed and food chain. It addresses the need to identify, track, and verify the origin of feed ingredients and finished products throughout the supply chain.

  • ASTM E2856-12 (withdrawn) - Scope: This practice is used to calculate the expanded uncertainty of measurement results.

    • Standard compliance requirements for different industries include:

  • Food processing industry

  • Pharmaceutical industry

  • Cosmetics industry

  • Animal feed industry

    • Standard Requirements and Needs

    The FDA CFR 21 Part 117 Additive Residue Control in Food testing service is required by law and regulation. The consequences of not performing this test can include:

  • Product recalls

  • Regulatory fines and penalties

  • Loss of business and reputation

  • Potential harm to consumers

    • This test is needed and required because it ensures the safety and quality of food products. Business and technical reasons for conducting this testing include:

  • Compliance with regulatory requirements

  • Protection of consumer health and safety

  • Prevention of product recalls and regulatory fines

  • Maintenance of reputation and business competitiveness

    • Industries that require this testing include:

  • Food processing industry

  • Pharmaceutical industry

  • Cosmetics industry

  • Animal feed industry

    • Risk factors and safety implications include:

  • Residues in food products can cause harm to consumers

  • Non-compliance with regulatory requirements can lead to product recalls and fines

  • Inadequate testing can result in loss of business and reputation

    • Quality assurance and quality control aspects include:

  • Calibration and validation of equipment

  • Training and certification of personnel

  • Implementation of a quality management system (QMS)

  • Maintenance of records and documentation

    • This test contributes to product safety and reliability by ensuring that food products meet regulatory requirements.

    Test Conditions and Methodology

    The FDA CFR 21 Part 117 Additive Residue Control in Food testing service involves the following steps:

    1. Sample preparation

    2. Testing equipment calibration

    3. Testing procedure execution

    4. Data analysis and interpretation

    Testing equipment used includes:

  • Gas chromatograph (GC)

  • Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

    • Testing environment requirements include:

  • Temperature control

  • Humidity control

  • Pressure control

    • Sample preparation procedures include:

  • Sample extraction

  • Sample clean-up

  • Sample concentration

    • Testing parameters and conditions include:

  • Detection limits

  • Quantification limits

  • Precision and accuracy

    • Measurement and analysis methods include:

  • Chromatography

  • Mass spectrometry

  • Spectroscopy

    • Calibration and validation procedures include:

  • Calibration of equipment

  • Validation of test methods

  • Verification of results

    • Quality control measures during testing include:

  • Blank sample analysis

  • Recovery experiments

  • Method validation

    • Conclusion

    The FDA CFR 21 Part 117 Additive Residue Control in Food testing service is a critical component of ensuring the safety and quality of food products. Eurolabs laboratory testing service provides accurate, reliable, and valid test results to ensure compliance with regulatory requirements.

    By following this comprehensive guide, you can ensure that your organization meets the requirements for additive residue control in food and maintains a reputation for safety and quality.

    Appendix

  • List of relevant standards

  • Regulatory requirements

  • Testing procedures

  • Quality control measures

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

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