M/383 - Mycotoxins in food

This Technical Report gives criteria for single laboratory validated methods of analysis for the determination of mycotoxins. The criteria and topics covered are accuracy, trueness, recovery, precision, measurement uncertainty, selectivity, applicability, linearity, limit of detection, limit of quantification, sensitivity, ruggedness, specificity. This report also contains information on terms and definitions, validation, standardization procedures and interlaboratory studies by international organizations (e.g. AOAC, CEN, ISO, IUPAC, IDF). Confirmatory methods and screening methods are described. The validation criteria specified for mycotoxins in general are given.

This European Standard specifies a method for the determination of patulin in fruit juices and fruit-based purée, such as baby food purée, using high performance liquid chromatography with ultra-violet detection (HPLC-UV). Using naturally contaminated and spiked samples this method has been validated for the determination of patulin in apple juice, at levels ranging from 3,0 μg/kg to 15,5 μg/kg, and in fruit-based baby food purée, at levels ranging from 3,4 μg/kg to 17,9 μg/kg. Baby food fruit purée (commercially available on the European market) used in this study contained the following ingredients: blueberry; apple; banana; lemon; wheat biscuits; wheat syrup; whole milk; and vegetable oil. A detailed listing, including the fractions, of each product used in this study is given in [1].
Further information on validation, see Clause 9 and Annex B.

This European Standard specifies a method for the determination of deoxynivalenol (DON) in cereals (grain and flour), cereal based foods and cereal based foods for infants and young children by high performance liquid chromatography (HPLC) with immunoaffinity cleanup and UV detection. This method has been validated in three interlaboratory studies. The first study was for the analysis of samples of wheat, rice flour, oat flour, maize, polenta, and wheat based breakfast cereal ranging from 85,4 µg/kg to 1 768 µg/kg, the second study was for wheat and maize ranging from 165 µg/kg to 4 700 µg/kg and the third study was for cereal based foods for infants and young children ranging from 58 µg/kg to 452 µg/kg.
For further information on the validation, see Clause 9 and Annex B.
WARNING — The use of this standard can involve hazardous materials, operations and equipment. This standard does not purport to address all the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

This European Standard specifies a method for the determination of zearalenone in maize based baby food, barley flour, maize flour, polenta, wheat flour and cereal based foods for infants and young children by high performance liquid chromatography (HPLC) with immunoaffinity cleanup and fluorescence detection. This method has been validated in two interlaboratory studies. The first study was for the analysis of samples of maize based baby food, barley flour, maize flour, polenta and wheat flour ranging from 10 µg/kg to 335 µg/kg, and the second study was for samples of cereal based foods for infants and young children ranging from 9 µg/kg to 44 µg/kg.

This European Standard specifies a method for the determination of aflatoxin B1 in baby food by high performance liquid chromatography (HPLC) with immunoaffinity cleanup and fluorescence detection. This method has been validated in an interlaboratory study via the analysis of both naturally contaminated and spiked samples ranging from 0,07 µg/kg to 0,18 µg/kg.
For further information on the validation, see Clause 9 and Annex B.

This Technical Report gives criteria for single laboratory validated methods of analysis for the determination of mycotoxins. The criteria and topics covered are accuracy, trueness, recovery, precision, measurement uncertainty, selectivity, applicability, linearity, limit of detection, limit of quantification, sensitivity, ruggedness, specificity. This report also contains information on terms and definitions, validation, standardization procedures and interlaboratory studies by international organizations (e.g. AOAC, CEN, ISO, IUPAC, IDF). Confirmatory methods and screening methods are described. The validation criteria specified for mycotoxins in general are given.

This European Standard specifies a method for the determination of patulin in fruit juices and fruit-based purée, such as baby food purée, using high performance liquid chromatography with ultra-violet detection (HPLC-UV). Using naturally contaminated and spiked samples this method has been validated for the determination of patulin in apple juice, at levels ranging from 3,0 μg/kg to 15,5 μg/kg, and in fruit-based baby food purée, at levels ranging from 3,4 μg/kg to 17,9 μg/kg. Baby food fruit purée (commercially available on the European market) used in this study contained the following ingredients: blueberry; apple; banana; lemon; wheat biscuits; wheat syrup; whole milk; and vegetable oil. A detailed listing, including the fractions, of each product used in this study is given in [1].
Further information on validation, see Clause 9 and Annex B.

This European Standard specifies a method for the determination of deoxynivalenol (DON) in cereals (grain and flour), cereal based foods and cereal based foods for infants and young children by high performance liquid chromatography (HPLC) with immunoaffinity cleanup and UV detection. This method has been validated in three interlaboratory studies. The first study was for the analysis of samples of wheat, rice flour, oat flour, maize, polenta, and wheat based breakfast cereal ranging from 85,4 µg/kg to 1 768 µg/kg, the second study was for wheat and maize ranging from 165 µg/kg to 4 700 µg/kg and the third study was for cereal based foods for infants and young children ranging from 58 µg/kg to 452 µg/kg.
For further information on the validation, see Clause 9 and Annex B.
WARNING — The use of this standard can involve hazardous materials, operations and equipment. This standard does not purport to address all the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

This European Standard specifies a method for the determination of ochratoxin A in currants, raisins, sultanas, mixed dried fruit and dried figs by high performance liquid chromatography (HPLC) with immunoaffinity cleanup and fluorescence detection. This method has been validated in an interlaboratory study via the analysis of both naturally contaminated and spiked samples ranging from 1,1 µg/kg to 11 µg/kg.
For further information on the validation, see Clause 9 and Annex B.
WARNING - The use of this standard can involve hazardous materials, operations and equipment. This standard does not purport to address all the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

This European Standard specifies a method for the determination of ochratoxin A in cereal based foods for infants and young children by high performance liquid chromatography (HPLC) with immunoaffinity column cleanup and fluorescence detection. This method has been validated in an interlaboratory study via the analysis of both naturally contaminated and spiked samples ranging from 0,050 µg/kg to 0,217 µg/kg. For further information on the validation see Clause 8 and Annex B. Additional studies have shown that this method is applicable to cereal based baby foods containing 8 different types of cereals, honey and cocoa, at levels up to 3,540 µg/kg, see Annex C and [6].

This European Standard specifies a method for the determination of zearalenone in maize based baby food, barley flour, maize flour, polenta, wheat flour and cereal based foods for infants and young children by high performance liquid chromatography (HPLC) with immunoaffinity cleanup and fluorescence detection. This method has been validated in two interlaboratory studies. The first study was for the analysis of samples of maize based baby food, barley flour, maize flour, polenta and wheat flour ranging from 10 µg/kg to 335 µg/kg, and the second study was for samples of cereal based foods for infants and young children ranging from 9 µg/kg to 44 µg/kg.

This European Standard specifies a method for the determination of aflatoxin B1 in baby food by high performance liquid chromatography (HPLC) with immunoaffinity cleanup and fluorescence detection. This method has been validated in an interlaboratory study via the analysis of both naturally contaminated and spiked samples ranging from 0,07 µg/kg to 0,18 µg/kg.
For further information on the validation, see Clause 9 and Annex B.

This European Standard specifies a method for the determination of ochratoxin A in cereal based foods for infants and young children by high performance liquid chromatography (HPLC) with immunoaffinity column cleanup and fluorescence detection. This method has been validated in an interlaboratory study via the analysis of both naturally contaminated and spiked samples ranging from 0,050 µg/kg to 0,217 µg/kg. For further information on the validation see Clause 8 and Annex B. Additional studies have shown that this method is applicable to cereal based baby foods containing 8 different types of cereals, honey and cocoa, at levels up to 3,540 µg/kg, see Annex C and [6].

This European Standard specifies a method for the determination of ochratoxin A in currants, raisins, sultanas, mixed dried fruit and dried figs by high performance liquid chromatography (HPLC) with immunoaffinity cleanup and fluorescence detection. This method has been validated in an interlaboratory study via the analysis of both naturally contaminated and spiked samples ranging from 1,1 µg/kg to 11 µg/kg.
For further information on the validation, see Clause 9 and Annex B.
WARNING - The use of this standard can involve hazardous materials, operations and equipment. This standard does not purport to address all the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

This Technical Specification specifies a method for the determination of fumonisin B1 (FB1) and fumonisin B2 (FB2) in processed maize-containing foods for infants and young children by high performance liquid chromatography (HPLC) with immunoaffinity cleanup and fluorescence detection (FLD). This method has been validated in an interlaboratory study via the analysis of both naturally contaminated and spiked samples ranging from 112 µg/kg to 458 µg/kg for FB1+FB2, 89 µg/kg to 384 µg/kg for FB1 and 22 µg/kg to 74 µg/kg for FB2.
For further information on the validation see Clause 8 and Annex B.

This Technical Specification specifies a method for the determination of fumonisin B1 (FB1) and fumonisin B2 (FB2) in processed maize-containing foods for infants and young children by high performance liquid chromatography (HPLC) with immunoaffinity cleanup and fluorescence detection (FLD). This method has been validated in an interlaboratory study via the analysis of both naturally contaminated and spiked samples ranging from 112 µg/kg to 458 µg/kg for FB1+FB2, 89 µg/kg to 384 µg/kg for FB1 and 22 µg/kg to 74 µg/kg for FB2.
For further information on the validation see Clause 8 and Annex B.