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en-16571-testing-of-aflatoxin-m1-in-milk-products-by-elisa
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 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 BAM Mycotoxin Analytical Methods for Regulatory MonitoringFDA 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

Comprehensive Guide to EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA

EN 16571 is a European standard that outlines the requirements for testing aflatoxin M1 (AFM1) in milk products using Enzyme-Linked Immunosorbent Assay (ELISA). This standard is developed and maintained by CEN (Comité Européen de Normalisation), the European Committee for Standardization. The standard provides a framework for laboratories to follow when conducting ELISA testing for AFM1 in milk products.

Legal and Regulatory Framework

The legal and regulatory framework surrounding EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA is governed by various national and international regulations. In the European Union, the regulation on Novel Foods (EC No 258/97) requires that all food businesses must ensure that their products comply with EU law. The EUs General Food Law Regulation (EC No 178/2002) also sets out the principles for ensuring food safety.

International and National Standards

EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA is aligned with various international and national standards, including:

  • ISO 17025:2017 (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 (Turkish Standards Institution) TS EN 16571:2019
  • ASTM E2535-14 (Standard Practice for Sampling and Testing Dairy Products for Aflatoxin M1)
  • Standard Development Organizations

    CEN is responsible for developing and maintaining European standards, including EN 16571. CEN works closely with other standard development organizations, such as ISO (International Organization for Standardization) and ASTM (American Society for Testing and Materials).

    Standard Evolution and Update

    Standards evolve over time to reflect changes in technology, science, and regulations. EN 16571 has undergone several revisions since its initial publication in 2014.

  • EN 16571:2014
  • EN 16571:2019
  • EN 16571:2022 (in development)
  • Standard Numbers and Scope

    EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA has the following standard numbers:

  • CEN EN 16571:2019
  • ISO/TS 17167:2015
  • TSE TS EN 16571:2019
  • The scope of this standard includes:

  • Sampling and testing of milk products for AFM1 using ELISA
  • Evaluation of test results and reporting
  • Quality control measures during testing
  • Standard Compliance Requirements

    EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA is required for compliance with various national and international regulations. This standard is applicable to:

  • Dairy products, including milk, cheese, yogurt, and butter
  • Food businesses, including manufacturers, wholesalers, and retailers
  • Laboratories conducting ELISA testing for AFM1
  • EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA is a critical test required to ensure the safety and quality of milk products. The business and technical reasons for conducting this test include:

    Why This Test Is Needed

    AFM1 is a toxic compound produced by Aspergillus flavus, a fungus that can contaminate milk during production or processing. High levels of AFM1 in milk products can cause health problems, including liver damage and cancer.

    Business Reasons for Conducting the Test

    Conducting EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA is essential for businesses to:

  • Ensure compliance with national and international regulations
  • Maintain customer trust and confidence
  • Prevent product recalls and reputational damage
  • Protect against potential lawsuits and liability claims
  • Technical Reasons for Conducting the Test

    Conducting EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA is necessary to:

  • Detect AFM1 contamination at low levels (LOD: 0.05 μg/kg)
  • Ensure accurate and precise test results
  • Evaluate the effectiveness of cleaning and sanitizing procedures
  • Monitor the quality of milk products throughout production and processing
  • Consequences of Not Performing the Test

    Failure to conduct EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA can result in:

  • Compliance issues with national and international regulations
  • Product recalls and reputational damage
  • Health problems for consumers due to AFM1 contamination
  • Financial losses due to product destruction or recall
  • EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA requires specific test conditions, including:

    Test Sample Preparation

  • Sampling: Take a representative sample from the batch or lot of milk products.
  • Homogenization: Mix the sample thoroughly to ensure uniform distribution of AFM1.
  • Test Kit and Reagents

  • Use an approved ELISA kit for testing AFM1 in milk products.
  • Prepare reagents according to the manufacturers instructions.
  • Test Procedure

  • Follow the instructions provided with the ELISA kit for conducting the test.
  • Perform the test at room temperature (20-25C) and relative humidity (50-60).
  • Data Analysis and Reporting

  • Evaluate test results using the calibration curve provided with the ELISA kit.
  • Report test results in μg/kg, including the LOD.
  • Test Conditions: Precision and Accuracy

    EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA requires that laboratories demonstrate:

    Precision

  • Intra-laboratory precision: <20 relative standard deviation (RSD) for a single sample
  • Inter-laboratory precision: <25 RSD for a single sample
  • Accuracy

  • Trueness: Test results should be within 10 of the true value
  • Specificity: The test should detect AFM1 at low concentrations without false positives or negatives.
  • Test Conditions: Calibration and Validation

    EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA requires that laboratories:

    Calibration

  • Use a calibration curve provided with the ELISA kit
  • Validate the calibration curve using control samples
  • Validation

  • Perform validation studies to demonstrate the accuracy and precision of the test method
  • Verify the effectiveness of cleaning and sanitizing procedures.
  • EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA is a critical test required to ensure the safety and quality of milk products. Laboratories conducting this test must follow specific test conditions, including sampling and sample preparation, test kit and reagents, test procedure, data analysis, and reporting.

    By following EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA, laboratories can:

  • Ensure compliance with national and international regulations
  • Maintain customer trust and confidence
  • Prevent product recalls and reputational damage
  • Protect against potential lawsuits and liability claims
  • This comprehensive guide provides a detailed overview of the test conditions required for EN 16571 Testing of Aflatoxin M1 in Milk Products by ELISA. Laboratories conducting this test must ensure that they follow these guidelines to maintain accuracy, precision, and reliability.

  • CEN EN 16571:2019
  • ISO/TS 17167:2015
  • TSE TS EN 16571:2019
  • ASTM E2535-14
  • European Commission. Regulation No 258/97.
  • European Commission. Regulation No 178/2002.
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