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fda-bam-mycotoxin-analytical-methods-for-regulatory-monitoring
Mycotoxin Testing AOAC 2000.02 Patulin Testing in Apple PureeAOAC 2000.03 Determination of Patulin in Apple JuiceAOAC 2000.05 Patulin Detection in Fermented BeveragesAOAC 2003.01 Testing for Deoxynivalenol in Corn-Based ProductsAOAC 2003.02 Measurement of Deoxynivalenol in Wheat FlourAOAC 2003.03 Quantitative Analysis of Mycotoxins in Animal FeedAOAC 2005.06 Determination of Fumonisins by Immunoaffinity and LCAOAC 2005.07 Quantification of Aflatoxins in Tree NutsAOAC 2005.08 Determination of Zearalenone in Animal FeedAOAC 2005.09 Determination of Zearalenone in MaizeAOAC 2007.01 Quantitative Determination of Zearalenone in CornAOAC 2008.01 Fumonisin Testing in Corn GritsAOAC 2008.02 Detection of Fumonisins in Corn Using HPLC-FLDAOAC 2008.02 Quantification of Fumonisin B1 and B2 in MaizeAOAC 2008.03 Multi-Residue Detection of Mycotoxins in Animal FeedAOAC 986.16 Testing of Total Aflatoxins in Corn Using FluorometryAOAC 991.31 Aflatoxin Screening in Feed IngredientsAOAC 991.31 Determination of Aflatoxin B1 in Peanut ButterAOAC 991.31 Testing for Total Aflatoxins in Peanuts and CornAOAC 994.08 Screening of Aflatoxins by TLCAOAC 994.09 Detection of Aflatoxins in AlmondsAOAC 998.03 Screening for Aflatoxins in Maize Using Test KitsAOAC 999.07 Detection of Aflatoxin B1 in RiceCEN/TR 16059 General Protocol for Mycotoxin Testing in Food ChainsEN 14123 Determination of Ochratoxin A in Wine by Immunoaffinity ColumnEN 15289 Determination of Ochratoxin A in Cocoa by LCEN 15662 Multimycotoxin Detection in Fruits and Vegetables Using LC-MSEN 15788 Determination of Deoxynivalenol in Baby FoodEN 15792 Detection of Mycotoxins in Tomato PureeEN 15891 Determination of Trichothecenes in Food Using LC-MSEN 15891 HT-2/T-2 Detection in Baby FoodsEN 15891 Measurement of HT-2 and T-2 Toxins in CerealsEN 15891 T-2 and HT-2 Toxin Detection in OatsEN 16571 Testing of Aflatoxin M1 in Milk Products by ELISAEN 16619 Detection of Mycotoxins in Edible OilsEN 17193 Determination of Aflatoxicol in Milk and DairyEN 17194 Determination of Citrinin in Red Yeast Rice Food SupplementsEN 17200 Determination of Mycotoxins in SpicesEN 17201 Determination of Alternaria Toxins in Tomato ProductsEN 17250 Determination of Ergot Alkaloids in Feed by LC-MSEN 17299 Testing of Modified Mycotoxins in Animal FeedEN 17461 Determination of Fusarenon-X in Cereals by LC-MSEN 17462 Rapid Testing of Citrinin in Red Fermented ProductsEN 17463 Screening of Ergot Alkaloids in GrainEN 17521 Mycotoxin Profiling in Complex Matrices Using LC-MS/MSEU 2006/401/EC Mycotoxin Control in Import CommoditiesEU Regulation 1881/2006 Compliance Testing for Mycotoxin Levels in FoodFAO Recommended Methods for Mycotoxin Sampling and DetectionFDA BAM Chapter 19 Mycotoxins Analysis ProtocolsFDA CFR 21 Part 556 Testing for Mycotoxin Tolerances in Animal FeedISO 14501 Determination of Patulin in Fruit Juices by HPLCISO 15141 Determination of Deoxynivalenol in Cereals by GC-MSISO 16050 Determination of Aflatoxin B1, B2, G1, G2 in CerealsISO 16050 Determination of Aflatoxins in Foodstuffs Using HPLCISO 16050 Testing for Aflatoxins in Herbs and SpicesISO 17375 Determination of Ochratoxin A in Roasted Coffee by HPLCISO 18787 Guidelines for Mycotoxin Sampling in GrainsISO 18856 Determination of Ochratoxin A in Foodstuffs by LC-MS/MSISO 21527 Mold Enumeration for Mycotoxin-Prone FoodsISO 21527-1 Enumeration of Yeasts and Molds for Spoilage RiskISO 24276 Guidelines for Validation of Mycotoxin Detection MethodsISO 24276 Method Validation for Zearalenone DetectionJECFA Limits-Based Mycotoxin Testing in Dried FruitsJECFA Maximum Levels of Mycotoxins in Cereal GrainsJECFA Toxicity Testing for Aflatoxin M1 in Milk

FDA BAM Mycotoxin Analytical Methods for Regulatory Monitoring: Laboratory Testing Services by Eurolab

Standard-Related Information

The FDA BAM (Bacteriological Analytical Manual) Mycotoxin Analytical Methods for Regulatory Monitoring testing is governed by various international and national standards. These standards ensure that the testing service meets the required quality, safety, and regulatory compliance.

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories

  • ASTM E2584-14 - Standard Practice for Sampling and Testing Cereals and Other Grains for Aflatoxins

  • EN ISO 21530:2005 - Foodstuffs - Determination of aflatoxin B1 in milk, dairy products and other foods

  • TSE (Turkish Standards Institution) EN 12820-2:2019 - Cereals and cereal products - Aflatoxins and ochratoxin A - Part 2: Sampling

    • The legal and regulatory framework surrounding this testing service is governed by the US FDA, which regulates the safety of food products. The EU also has similar regulations, including the EU Food Law (Regulation (EC) No 178/2002).

    Standard development organizations, such as ISO and ASTM, play a crucial role in developing and updating standards for laboratory testing.

  • ISO - International Organization for Standardization

  • ASTM - American Society for Testing and Materials

    • Standards evolve and get updated to reflect new technologies, methods, and requirements. The process involves:

    1. Reviewing existing standards

    2. Identifying areas for improvement or change

    3. Developing a new standard or revising an existing one

    Some relevant standard numbers and their scope include:

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories

  • ASTM E2584-14 - Standard Practice for Sampling and Testing Cereals and Other Grains for Aflatoxins

    • Standard compliance is mandatory for various industries, including food processing, agriculture, and pharmaceuticals. Failure to comply can result in:

  • Regulatory penalties

  • Product recalls

  • Damage to reputation

    • The consequences of not performing this test include:

  • Risk of contamination

  • Health risks for consumers

  • Economic losses due to product recalls or regulatory penalties

    • Industries that require this testing include:

  • Food processing

  • Agriculture

  • Pharmaceuticals

  • Cosmetic manufacturers

    • This testing contributes to product safety and reliability by detecting aflatoxins, which can be harmful to human health.

    The cost-benefit analysis of performing this test includes:

  • Initial investment: Purchasing equipment and training personnel

  • Ongoing costs: Consumables, maintenance, and calibration

  • Benefits: Improved product safety, reduced regulatory penalties, and increased customer confidence

    • Test Conditions and Methodology

    This section provides a detailed explanation of how the FDA BAM Mycotoxin Analytical Methods for Regulatory Monitoring testing is conducted.

    1. Sample preparation: Collecting and preparing samples for analysis

    2. Testing equipment and instruments: Using specialized equipment, such as HPLC or GC-MS

    3. Testing environment requirements: Maintaining a controlled environment with specific temperature, humidity, and pressure conditions

    The testing parameters and conditions include:

  • Temperature: Typically between -20C to 40C

  • Humidity: Between 30 to 70

  • Pressure: Normal atmospheric pressure

    • The measurement and analysis methods involve using various techniques, such as chromatography or spectroscopy.

    Test Reporting and Documentation

    This section explains how test results are documented and reported.

    1. Report format and structure: Following a standardized report format

    2. Interpretation of test results: Understanding the meaning of test results in relation to regulatory limits

    3. Certification and accreditation aspects: Ensuring that testing is performed by accredited laboratories

    The reporting standards and formats include:

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories

  • ASTM E2584-14 - Standard Practice for Sampling and Testing Cereals and Other Grains for Aflatoxins

    • Results are validated and verified through a combination of:

  • Internal validation: Using in-house methods to validate results

  • External verification: Comparing results with external reference materials or laboratories

    • The electronic reporting systems used include:

  • Laboratory information management systems (LIMS)

  • Electronic data interchange (EDI)

    • Why This Test Should Be Performed

    This section provides a comprehensive explanation of the benefits and advantages of performing this testing.

    1. Risk assessment and mitigation: Identifying potential risks and taking measures to mitigate them

    2. Product safety and reliability: Ensuring that products meet regulatory requirements

    3. Regulatory compliance: Meeting legal and regulatory obligations

    Performing this test can help:

  • Reduce the risk of product recalls or regulatory penalties

  • Improve customer confidence in products

  • Enhance a companys reputation by demonstrating commitment to safety and quality

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

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