This document specifies a procedure for the detection of a DNA sequence present in a genetically modified linseed (Linum usitatissimum) line (event FP967, also named as “CDC Triffid”). For this purpose, extracted DNA is used in a real-time PCR and the genetic modification (GM) is specifically detected by amplification of a 105 bp DNA sequence representing the transition between the nopaline synthase gene terminator (Tnos) from Agrobacterium tumefaciens and the dihydrofolate reductase gene (dfrA1) from a Class 1 integron of Escherichia coli. The method described is applicable for the analysis of DNA extracted from foodstuffs. It can also be suitable for the analysis of DNA extracted from other products such as feedstuffs and seeds. The application of this method requires the extraction of an adequate amount of amplifiable DNA from the relevant matrix for the purpose of analysis.

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This document specifies a procedure for the determination of the citrinin content in food (cereals, red yeast rice (RYR)), herbs and food supplements by liquid chromatography tandem mass spectrometry (LC-MS/MS).
This method has been validated for citrinin in red yeast rice and in the formulated food supplements in the range of 2,5 µg/kg to 3000 µg/kg and in wheat flour in the range of 2,5 µg/kg to 100 µg/kg.
Laboratory experiences have shown that this method is also applicable to white rice, herbs such as a powder of ginkgo biloba leaves and the formulated food supplements in the range of 2,5 µg/kg to 50 µg/kg.

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This document describes a method for the determination of the sum total of six ergot alkaloids (ergocornine, ergometrine, ergocristine, ergotamine, ergosine and ergocryptine) and their  inine epimer pairs by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) after clean-up by dispersive solid phase extraction (SPE).
The method has been validated for cereals and cereal-based food products.
The method has been validated in the range 13,2 µg/kg to 168 µg/kg for the sum of the twelve ergot alkaloids, in rye flour, rye bread and cereal products (breakfast cereal, infant breakfast cereal, and crispbread) that contained rye as an ingredient, as well as seeded wholemeal flour and a barley and rye flour mixture.
Method performance was satisfactory in the range 24,1 µg/kg to 168 µg/kg, however at lower concentrations RSDR values were greater than 44 %, and HorRat values exceeded 2,0, indicating the method may not be fully suitable at concentrations below 24 µg/kg for sum of ergot alkaloids, although it is suitable for screening at these concentrations. Method performance may be improved by inclusion of an isotopically labelled internal standard, but this was not available at the time of the method validation study.

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This International Standard specifies a method for the determination of inulin-type fructans (including oligofructose, and fructooligosaccharides) in infant formula and adult nutritionals containing 0,03 g/100 g to 5,0 g/100 g of fructan in the product as prepared ready for consumption.
A high performance anion exchange chromatographic method in combination with pulsed amperometric detection (HPAEC-PAD) is applied.

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This document describes a procedure for the determination of aflatoxins B1, B2, G1 and G2 and total aflatoxins (sum of B1, B2, G1 and G2) in spices for which EU maximum levels are established, other than paprika, by high performance liquid chromatography (HPLC) with post-column derivatization (PCD) and fluorescence detection (FLD) after immunoaffinity column clean-up.
The method is applicable to the spices capsicum, pepper, nutmeg, ginger, turmeric and mixtures thereof.
The method has been validated for aflatoxins B1, B2, G1 and G2 and total aflatoxins in a range of test samples that comprised: ginger, pepper, nutmeg, chilli, turmeric as individual spices and mixed pepper+chilli+nutmeg (90+5+5, m+m+m), mixed spice+ginger (6+4, m+m) mixed spice, mixed turmeric+ginger (2+8, m+m).
The validation was carried out over the following concentration ranges: aflatoxin B1 = 1 µg/kg to 16 µg/kg and total aflatoxins = 2,46 µg/kg to 36,1 µg/kg.

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This document specifies a method for the simultaneous quantitative determination of four water-soluble vitamins in infant formula and related nutritional products, including relevant forms of vitamins B1, B2, B3 and B6 by enzymatic digestion and UHPLC-MS/MS. This document is not intended to be used on products where vitamins have not been added.

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This document specifies a method for the determination of total or free choline and carnitine in infant formula and adult nutritionals by liquid chromatography and tandem mass spectrometry (HPLC-MS/MS).

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This document specifies a method for the determination of inulin-type fructans (including oligofructose, fructooligosaccharides) in infant formula and adult nutritionals (both powder and liquid) containing 0,03 g/100 g to 5,0 g/100 g of fructans in the product as prepared ready for consumption. The method has been validated in a multi laboratory study[1] with reconstituted standard reference material (SRM), infant/adult nutritional formula at a level of 0,204 g/100 g, adult nutritionals ready-to-feed (RTF) at levels of 1,28 g/100 g and 2,67 g/100 g, infant formula RTF at a level of 0,300 g/100 g, reconstituted follow-up formula at levels of 0,209 g/100 g to 0,275 g/100 g, reconstituted infant formula at levels from 0,030 8 g/100 g to 0,264 g/100 g. During the single laboratory validation study[2], spike-recovery experiments were performed up to 5 g/100 g in reconstituted infant formula powders (milk-based, partially hydrolysed milk-based and soy-based), adult nutritional RTF and reconstituted adult nutritional powders.

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This document specifies a real-time polymerase chain reaction (real-time PCR) method for the qualitative detection of bovine-specific DNA derived from food and feed. It requires the extraction of an adequate amount of PCR amplifiable DNA from the relevant matrix and can be applied to the detection of bovine material derived from cattle including taurine (Bos taurus) and zebu (Bos indicus). The assay also detects the species bison (Bison bison) and yak (Bos mutus). The target sequence is a partial fragment of the bovine nuclear beta actin gene in chromosome 25 (i.e. GenBank accession number NC_037352.1)[1][2][3], which is present as a single copy per haploid genome. The provided PCR assay for this target has an absolute limit of detection of five copies per reaction, with ≥ 95 % replicability at this concentration (LOD95 %).

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This document specifies a real-time polymerase chain reaction (real-time PCR) method for the qualitative detection of donkey-specific DNA derived from food and feed. It requires the extraction of an adequate amount of PCR amplifiable DNA from the relevant matrix and can be applied to the detection of donkey material derived from donkey (Equus asinus), mule (Equus caballus ♀ × Equus asinus ♂) and hinny (Equus caballus ♂ × Equus asinus ♀). The assay also detects the species zebra (Equus burchellii). The target sequence is a partial fragment of the Equus asinus isolate Maral har breed Guanzhong donkey unplaced genomic scaffold, ASM130575v1 scaffold786, whole genome shotgun sequence (i.e. GenBank accession number NW_014638576.1)[1], which is present as a single copy per haploid genome. The provided PCR assay for this target has an absolute limit of detection of five copies per reaction, with ≥ 95 % replicability at this concentration (LOD95 %).

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This document specifies a real-time polymerase chain reaction (real-time PCR) method for the qualitative detection of horse-specific DNA derived from food and feed. It requires the extraction of an adequate amount of PCR amplifiable DNA from the relevant matrix and can be applied to the detection of horse material derived from domestic horse (Equus caballus), mule (Equus caballus ♀ × Equus asinus ♂), hinny (Equus caballus ♂ × Equus asinus ♀) and zebroid (Equus caballus × Equus simplicidens). The assay also detects the species Przewalski's horse (Equus przewalskii) and zebra (Equus burchellii). The target sequence is an Equus caballus isolate Twilight breed thoroughbred chromosome 28, EquCab3.0, whole genome shotgun sequence (i.e. GenBank accession number NC_009171.3)[1], which is present as a single copy per haploid genome. The provided PCR assay for this target has an absolute limit of detection of five copies per reaction, with ≥ 95 % replicability at this concentration (LOD95 %).

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This document specifies a real-time polymerase chain reaction (real-time PCR) method for the qualitative detection of chicken-specific DNA derived from food and feed. It requires the extraction of an adequate amount of PCR amplifiable DNA from the relevant matrix and can be applied to the detection of chicken material derived from chicken (Gallus gallus domesticus) and jungle fowl (Gallus gallus). The target sequence is a partial fragment of the Gallus gallus transforming growth factor beta 3, intron 4 (TGF-β3) gene (i.e. GenBank accession number AY685072.1)[1], which is present as a single copy per haploid genome. The provided PCR assay for this target has an absolute limit of detection of five copies per reaction, with ≥ 95 % replicability at this concentration (LOD95 %).

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This document specifies a real-time polymerase chain reaction (real-time PCR) method for the qualitative detection of porcine-specific DNA derived from food and feed. It requires the extraction of an adequate amount of PCR amplifiable DNA from the relevant matrix and can be applied to the detection of porcine material derived from pig (Sus scrofa domesticus) and wild boar (Sus scrofa). The target sequence is a partial fragment of the Sus scrofa beta actin (ACTB) gene, partial cds. (i.e. GenBank accession number DQ452569.1)[1], which is present as a single copy per haploid genome. The provided PCR assay for this target has an absolute limit of detection of five copies per reaction, with ≥ 95 % replicability at this concentration (LOD95 %).

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This document specifies a real-time polymerase chain reaction (real-time PCR) method for the qualitative detection of goat-specific DNA derived from food and feed. It requires the extraction of an adequate amount of PCR amplifiable DNA from the relevant matrix and can be applied to the detection of goat material derived from goat (Capra hircus). The target sequence is a partial fragment of the goat chromosome 9 DNA sequence (i.e. GenBank accession number NC_030816.1)[1], which is present as a single copy per haploid genome. The provided PCR assay for this target has an absolute limit of detection of five copies per reaction, with ≥ 95 % replicability at this concentration (LOD95 %).

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This document specifies a real-time polymerase chain reaction (real-time PCR) method for the qualitative detection of ovine-specific DNA derived from food and feed. It requires the extraction of an adequate amount of PCR amplifiable DNA from the relevant matrix and can be applied to the detection of ovine material derived from sheep (Ovis aries). The target sequence is a partial fragment of the ovine nuclear prolactin receptor short form mRNA gene (PRLR) (i.e. GenBank accession number AF041979.1)[1], which is present as a single copy per haploid genome. The provided PCR assay for this target has an absolute limit of detection of five copies per reaction, with ≥ 95 % replicability at this concentration (LOD95 %).

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This document specifies a method for the quantitative determination of β-carotene and lycopene in infant formula and adult nutritionals in solid (i.e. powders) or liquid (i.e. ready-to-feed liquids and liquid concentrates) forms using reversed-phase ultra-high performance liquid chromatography (RP-UHPLC) and UV-visible detection. The application range runs from 1 μg/100 g to 1 500 μg/100 g for lycopene and from 1 μg/100 g to 2 250 μg/100 g for β-carotene. Based on the single-laboratory validation, the limit of detection (LOD) was 0,1 μg/100 g and the limit of quantification (LOQ) was 0,3 μg/100 g for each carotenoid. The method does not apply to materials that contain measurable levels of β-apo-8′-carotenal. The reproducibility data meets the requirements given in References [8] and [10]. Annex C specifies the determination of lutein. The reproducibility data does not meet the requirements given in Reference [9].

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This document describes a procedure for the detection of the DNA transition sequence between the 35S promotor (P35S) from Cauliflower mosaic virus and a modified phoshinothricin-acetyltransferase gene (pat) from Streptomyces viridochromogenes. The P35S-pat construct is frequently found in genetically modified plants with tolerance for phosphinothricin-containing herbicides. The P35S-pat construct specific method is based on a real-time PCR and can be used for qualitative and quantitative screening purposes. For identification and quantification of a specific event, a follow-up analysis can be carried out. This document is applicable to the analysis of DNA extracted from foodstuffs. It can also be suitable for the analysis of DNA extracted from other products such as feedstuffs and seeds. The application of this method requires the extraction of an adequate quantity and quality of amplifiable DNA from the relevant matrix.

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ISO 20647:2015 specifies a method for the quantitative determination of total iodine in infant formula and adult nutritional formula.[1] The method is applicable to the measurement of total iodine in infant formula and adult nutritional formula from 0,5 µg/100g to 1 500 µg/100g reconstituted final product and for ready-to-feed products from 2,5 µg/100 g to 1 000 µg/100 g using ICP-MS.
Using various infant formula and adult nutritional products, the method was subjected to an interlaboratory study. Levels obtained ranged from 3,47 µg/100 g to 124 µg/100 g. For all precision data related to the interlaboratory study, see Table A.1 located in Annex A.

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This document specifies a method for the quantitative determination of calcium (Ca), copper (Cu), iron (Fe), magnesium (Mg), manganese (Mn), phosphorus (P), potassium (K), sodium (Na), zinc (Zn), chromium (Cr), molybdenum (Mo) and selenium (Se) using inductively coupled plasma and mass spectrometry (ICP-MS).
The method is applicable for the determination of all 12 elements in infant formula and adult nutritional products. The method is also applicable for milk, milk powder, whey powder, butter and cheese excluding the determination of Cr, because all Cr results were below the quantification limit and reproducibility could not be determined in these matrices[1]. The present method is an extension of ISO 20649 | IDF 235 (AOAC 2011.19[2]) which was validated only for Cr, Mo and Se in infant formula and adult nutritional products.

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ISO 16958:2015 specifies a method for the quantification of individual and/or all fatty acids in the profile of milk, milk products, infant formula and adult nutritional formula, containing milk fat and/or vegetable oils, supplemented or not supplemented with oils rich in long chain polyunsaturated fatty acids (LC-PUFA). This also includes groups of fatty acids often labelled [i.e. trans fatty acids (TFA), saturated fatty acids (SFA), monounsaturated fatty acids (MUFA), polyunsaturated fatty acids (PUFA), omega-3, omega-6 and omega-9 fatty acids] and/or individual fatty acids [i.e. linoleic acid (LA), α-linolenic acid (ALA), arachidonic acid (ARA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)].
The determination is performed by direct transesterification in food matrices, without prior fat extraction, and consequently it is applicable to liquid samples or reconstituted powder samples with water having total fat ≥ 1,5 % m/m.
The fat extracted from products containing less than 1,5 % m/m fat can be analysed with the same method after a preliminary fat extraction using methods referenced in Clause 2. Dairy products, like soft or hard cheeses with acidity level ≤ 1 mmol/100 g of fat, can be analysed after a preliminary fat extraction using methods referenced in Clause 2. For products supplemented or enriched with PUFA with fish oil or algae origins, the evaporation of solvents should be performed at the lowest possible temperature (e.g. max. 40 °C) to recover these sensitive fatty acids.

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This document specifies a method for the quantitative determination of calcium (Ca), copper (Cu), iron
(Fe), magnesium (Mg), manganese (Mn), phosphorus (P), potassium (K), sodium (Na) and zinc (Zn)
using inductively coupled plasma atomic emission spectrometry (ICP-AES). The method is applicable
for milk, dried milk, butter, cheese, whey, dried whey, infant formula and adult nutritional formula in
the ranges given in Table 1.

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This Standard specifies performance criteria for immunochemical methods for the detection and/or quantification of a specific protein or protein(s) of interest [POI(s)] in a specified matrix. The methods discussed are applicable to the analysis of proteins from a variety of sample types. Some uses for these methods include, but are not limited to, analysing proteins involved in crop and food production, food processing, food marketing, food safety, biotechnology or disease indexing.

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This document specifies minimum method performance requirements for enzyme-linked immunosorbent assays that quantify non-fragmented or fragmented gluten from wheat (e.g. Triticum aestivum), rye, and barley in raw and processed foodstuffs..

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This document specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens; and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods, and test reports.
This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. The term "reference materials" in this document includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination are available. As new materials become accepted and validated, they can be appended as an annex to this document.
This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result.

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This document describes a screening method for the determination of aflatoxin B1, deoxynivalenol, fumonisin B1 and B2, ochratoxin A, HT-2 and T-2 toxins, and zearalenone in foodstuffs by high performance liquid chromatography (HPLC) coupled with tandem mass spectrometry (MS/MS).
The aim of the screening method is to test compliance of foodstuff with regulatory limits or to determine whether a certain pre-defined level (the screening target concentration, STC) is exceeded or not. The result of the screening is either "negative" or "suspect". "Negative" (screen negative) means that the targeted mycotoxins are not detected or potentially present but below the STC. "Suspect" (screen positive) means that the established cut-off level is exceeded and the sample can contain one or more mycotoxins at a level higher than the STC.
For full identification and accurate quantification a second confirmatory quantitative analysis method is required which is outside the scope of this document.
The method is suitable for various types of foodstuff and has been validated for representative matrices from four commodity groups:
-   high starch and/or protein content and low water and fat content: wheat, cereal mixture, wheat flour and cornflakes;
-   high oil content: peanuts;
-   high sugar low water content: figs;
-   high water content: grape juice.
During validation, cut-off levels were established for the following screening target concentrations:
-   aflatoxin B1: 2 µg/kg to 5 µg/kg;
-   deoxynivalenol: 250 µg/kg to 865 µg/kg;
-   fumonisin B1: 200 µg/kg to 790 µg/kg;
-   fumonisin B2: 110 µg/kg to 230 µg/kg;
-   ochratoxin A: 4 µg/kg to 9 µg/kg;
-   T-2 toxin: 25 µg/kg;
-   HT-2 toxin: 25 µg/kg to 50 µg/kg;
-   zearalenone: 30 µg/kg to 100 µg/kg.

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This document provides the overall framework for detection of sequences corresponding to species containing allergens using the polymerase chain reaction (PCR). It relates to the requirements for the specific amplification of target nucleic acid sequences (DNA) and for the confirmation of the identity of the amplified nucleic acid sequence.
Guidelines, minimum requirements and performance criteria laid down in this document are intended to ensure that comparable and reproducible results are obtained in different laboratories. This document has been established for food matrices.

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This document provides an overall framework covering qualitative and quantitative methods for the determination of food allergens and allergenic ingredients using antibody-based methods in foods. This European Standard specifies general guidelines and performance criteria for antibody-based methods for the detection and quantification of proteins that serve as markers for the presence of allergy provoking foods or food ingredients. Other methods than those described can also detect and identify the proteins. Guidelines, minimum requirements and performance criteria laid down in this European Standard are intended to ensure that comparable and reproducible results are obtained by different analysts in food premises and laboratories.

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This document specifies performance criteria for immunochemical methods for the detection and/or quantification of a specific protein or protein(s) of interest [POI(s)] in a specified matrix.
The methods discussed are applicable to the analysis of proteins from a variety of sample types. Some uses for these methods include, but are not limited to, analysing proteins involved in crop and food production, food processing, food marketing, food safety, biotechnology or disease indexing.

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This Technical Specification gives guidelines for the execution of calibration and quantitative evaluation of chromatographic procedures for the determination of pesticides and organic contaminants in residue analysis. In addition, the essential requirements for calibration are outlined.
The calibration of analytical procedures and the evaluation of analytical results need to be conducted according to uniform principles in order to allow for a comparison of analytical results (even from different analytical procedures). They constitute the basis of any method validation and of the quality assurance within laboratories [1], [2], [3].
This Technical Specification does not consider issues of identification/qualification and extraction efficiency.

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This document specifies a method for the determination of aluminium in food by inductively coupled plasma mass spectrometry (ICP-MS) after pressure digestion. This method is suitable for mass fractions in the range of 1 mg/kg to 200 mg/kg. At concentrations above 200 mg/kg digestion temperatures higher than 220 °C can be necessary to recover the aluminium as completely as possible.

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This document describes a method for the determination of aluminium in food by inductively coupled plasma optical emission spectrometry (ICP-OES) after pressure digestion. This method is suitable for mass fraction in the range of 15 mg/kg to 200 mg/kg. At concentrations above 200 mg/kg digestion temperatures higher than 220 °C can be necessary to recover the aluminium as completely as possible.

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This Technical Specification describes a method for the analysis of pesticide residues in fatty oils of plant origin (essential oils are excluded). It has been validated in an interlaboratory test with olive oil. However, laboratory experiences have shown that this method is also applicable to other kinds of oils such as sunflower seed oil, sesame oil, flax seed oil, rape seed oil, grape seed oil, thistle oil and pumpkin seed oil.

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This document specifies performance criteria for immunochemical methods for the detection and/or quantification of a specific protein or protein(s) of interest [POI(s)] in a specified matrix. The methods discussed are applicable to the analysis of proteins from a variety of sample types. Some uses for these methods include, but are not limited to, analysing proteins involved in crop and food production, food processing, food marketing, food safety, biotechnology or disease indexing.

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This document describes a screening method for the determination of aflatoxin B1, deoxynivalenol, fumonisin B1 and B2, ochratoxin A, HT-2 and T-2 toxins, and zearalenone in foodstuffs by high performance liquid chromatography (HPLC) coupled with tandem mass spectrometry (MS/MS).
The aim of the screening method is to test compliance of foodstuff with regulatory limits or to determine whether a certain pre-defined level (the screening target concentration, STC) is exceeded or not. The result of the screening is either "negative" or "suspect". "Negative" (screen negative) means that the targeted mycotoxins are not detected or potentially present but below the STC. "Suspect" (screen positive) means that the established cut-off level is exceeded and the sample can contain one or more mycotoxins at a level higher than the STC.
For full identification and accurate quantification a second confirmatory quantitative analysis method is required which is outside the scope of this document.
The method is suitable for various types of foodstuff and has been validated for representative matrices from four commodity groups:
-   high starch and/or protein content and low water and fat content: wheat, cereal mixture, wheat flour and cornflakes;
-   high oil content: peanuts;
-   high sugar low water content: figs;
-   high water content: grape juice.
During validation, cut-off levels were established for the following screening target concentrations:
-   aflatoxin B1: 2 µg/kg to 5 µg/kg;
-   deoxynivalenol: 250 µg/kg to 865 µg/kg;
-   fumonisin B1: 200 µg/kg to 790 µg/kg;
-   fumonisin B2: 110 µg/kg to 230 µg/kg;
-   ochratoxin A: 4 µg/kg to 9 µg/kg;
-   T-2 toxin: 25 µg/kg;
-   HT-2 toxin: 25 µg/kg to 50 µg/kg;
-   zearalenone: 30 µg/kg to 100 µg/kg.

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This document specifies minimum method performance requirements for enzyme-linked immunosorbent assays that quantify non-fragmented or fragmented gluten from wheat (e.g. Triticum aestivum), rye, and barley in raw and processed foodstuffs.
This document is intended to be used in addition to EN 15842.

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This document provides an overall framework covering qualitative and quantitative methods for the determination of food allergens and allergenic ingredients using antibody-based methods in foods. This document specifies general guidelines and performance criteria for antibody-based methods for the detection and quantification of proteins that serve as markers for the presence of allergy provoking foods or food ingredients. Other methods than those described can also detect and identify the proteins. Guidelines, minimum requirements and performance criteria laid down in this document are intended to ensure that reproducible results are obtained by different analysts in private and/or official control laboratories or when conducting onsite food testing.
This document is intended to be used in addition to EN 15842.
NOTE   This document could also be applicable to other sample types where the same principles for method validation and verification would apply.

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This document specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens; and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods, and test reports.
This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. The term "reference materials" in this document includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination are available. As new materials become accepted and validated, they can be appended as an annex to this document.
This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result.

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This document specifies a method for the determination of aluminium in food by inductively coupled plasma mass spectrometry (ICP-MS) after pressure digestion. This method was validated for infant formula, wheat noodle, cheese, liver, beetroot and cocoa powder at mass fractions in the range of 1 mg/kg to 200 mg/kg. At concentrations above 200 mg/kg, digestion temperatures higher than 220 °C can be necessary to recover the aluminium as completely as possible.

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This document specifies a method for the determination of aluminium in food by inductively coupled plasma optical emission spectrometry (ICP-OES) after pressure digestion. This method was validated for wheat noodle, cheese, liver, beetroot and cocoa powder at mass fractions in the range of 15 mg/kg to 200 mg/kg. At concentrations above 200 mg/kg digestion temperatures higher than 220 °C can be necessary to recover the aluminium as completely as possible.

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This Technical Specification gives guidelines for the execution of calibration and quantitative evaluation of chromatographic procedures for the determination of pesticides and organic contaminants in residue analysis. In addition, the essential requirements for calibration are outlined.
The calibration of analytical procedures and the evaluation of analytical results need to be conducted according to uniform principles in order to allow for a comparison of analytical results (even from different analytical procedures). They constitute the basis of any method validation and of the quality assurance within laboratories [1], [2], [3].
This Technical Specification does not consider issues of identification/qualification and extraction efficiency.

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  • Technical specification
    40 pages
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This Technical Specification describes a method for the analysis of pesticide residues in fatty oils of plant origin (essential oils are excluded). It has been validated in an interlaboratory test with olive oil. However, laboratory experiences have shown that this method is also applicable to other kinds of oils such as sunflower seed oil, sesame oil, flax seed oil, rape seed oil, grape seed oil, thistle oil and pumpkin seed oil.

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  • Technical specification
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This document provides information on how the performance characteristics of qualitative (binary) real-time polymerase chain reaction (PCR) methods for detection of specific DNA sequences present in foods should be evaluated and validated by conducting a collaborative study.
The guidelines are applicable for validation of qualitative PCR methods used for detection of DNA sequences derived from genetically modified foodstuffs. They can be applicable also for PCR methods used for detection of other target sequences in foodstuffs, e.g. for species detection and identification.

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This document specifies minimum requirements of performance characteristics for the detection of nucleic acid sequences (DNA) by molecular methods, such as the polymerase chain reaction (PCR), including different post-PCR detection methods, real-time PCR, single and/or multiple probe-based detection techniques as well as the combination of such methods. The document is applicable to the detection, identification and quantification of DNA from animal species of higher and lower taxonomic groups in foodstuffs, and the validation of applicable methods. It is applicable to mammals, birds, reptiles, amphibians, fishes, molluscs, crustaceans and insects. Typical examples for each are listed in Annex A.

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    27 pages
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  • Standard
    29 pages
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This document provides information on how the performance characteristics of qualitative (binary) real-time polymerase chain reaction (PCR) methods for detection of specific DNA sequences present in foods should be evaluated and validated by conducting a collaborative study.
The guidelines are applicable for validation of qualitative PCR methods used for detection of DNA sequences derived from genetically modified foodstuffs. They can be applicable also for PCR methods used for detection of other target sequences in foodstuffs, e.g. for species detection and identification.

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    23 pages
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This document specifies methods that yield a binary result and are used for the determination in food or food products (including seeds of food crops) of the presence of molecular biomarkers. These methods are typically used where the measurand is expected to be present in very small amounts and concentrations at the limit of detection (LOD). Methods are validated in terms of the probability of detection (POD) and of the precision of the POD. They do not rely on the concept of false positive/false-negative results, or the concept of LOD. However, inferences about the precision of the classical LOD can be made. This document describes the extent of method validation. The annexes provide different statistical models that can be considered depending on the analytical method, structure of data and statistical experience. This document does not apply to quantitative methods that are used to make a detection decision by comparing the value of a response to a cut-off value using a quantitative method, where the methods are validated by using quantitative statistics on the responses. This document also does not apply to microbiological test methods, starch, essential oils or quantitative methods.

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    28 pages
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  • Technical specification
    29 pages
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This document specifies a method for the quantitative determination of trans and total (cis + trans) vitamin K1 in infant, pediatric and adult nutritionals using normal phase (NP) high-performance liquid chromatography (HPLC) with post-column reduction and fluorescence detection. The method demonstrated good linearity over a standard range of ~2 μg/l to 80 μg/l trans vitamin K1, and the limit of quantification (LOQ) was estimated to be 0,4 μg/l for standards and 0,09 μg/100 g ready to feed (RTF) for samples assuming 4 grams of sample are diluted to 10 ml.

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This document specifies a method for the quantitative determination of vitamin D2 and/or vitamin D3 in infant formula, and adult nutritionals in solid (i.e. powders) or liquid (i.e. ready-to-feed liquids and liquid concentrates) forms using liquid chromatography-mass spectrometry. The application range runs from 0,15 µg/100 g (limit of quantification) to 59 µg/100 g for vitamin D2 and from 0,25 µg/100 g to 65 µg/100 g for vitamin D3.

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    23 pages
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    24 pages
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This document specifies a method for the determination of vitamin C (L-ascorbic acid) present in all forms of infant and adult formulas (powders, ready-to-feed liquids and liquid concentrates), using (ultra) high performance liquid chromatography with ultraviolet detection (U)HPLC-UV. The application range runs from 2,5 mg/100 g (limit of quantification) to 50 mg/100 g expressed in the product as consumed. The method is able to distinguish between D-ascorbic acid (isoascorbic- or erythorbic acid) and L-ascorbic acid.

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    13 pages
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  • Standard
    13 pages
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This European Standard stipulates a method for the analysis of pesticide residues in foods of plant origin, such as fruits (including dried fruits), vegetables, cereals and many processed products thereof by using GC, GC-MS(/MS), and/or LC-MS(/MS). The method has been collaboratively studied on a large number of commodity/pesticide combinations. Precision data are summarized in FprCEN/TR 17063. Guidelines for calibration are outlined in FprCEN/TS 17061.

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    80 pages
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This European Standard stipulates a method for the analysis of pesticide residues in foods of plant origin, such as fruits (including dried fruits), vegetables, cereals and many processed products thereof by using GC, GC-MS(/MS), and/or LC-MS(/MS). The method has been collaboratively studied on a large number of commodity/pesticide combinations. Precision data are summarized in FprCEN/TR 17063. Guidelines for calibration are outlined in FprCEN/TS 17061.

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