KŽP - Agricultural food products

This document specifies methods for the determination of acrylamide in coffee and coffee products by extraction with water, clean-up by solid-phase extraction (SPE) and determination by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC-MS/MS) and gas chromatography with mass spectrometric detection (GC-MS) after derivatization. The methods were validated in a validation study for roasted coffee, soluble coffee, coffee substitutes and coffee products with ranges from 53 μg/kg to 612,1 μg/kg.

This document specifies a procedure for the analysis of residues of highly polar pesticides and metabolites, which are not amenable to common multiresidue methods, in various food commodities of plant and animal origin, including fruits, vegetables, cereals, pulses, oily seeds, nuts, milk, liver and honey. The method was developed at the EURL-SRM hosted at CVUA Stuttgart [1], [2], [3] and has been collaboratively studied on a large number of commodity/pesticide combinations. Guidelines for calibration are outlined in CEN/TS 17061:2019.

This document specifies requirements for dried saffron obtained from the pistils of Crocus sativus L. flowers.
It is applicable to saffron in filaments, cut filaments and powder forms.
Recommendations relating to storage and transport conditions are given in Annex A.

This document establishes general principles for the methods of the determination of hidden insect infestation in cereals and pulses.

This document specifies methods of sampling cereals and pulses, in bags or in bulk, for the determination of hidden insect infestation.
This document is applicable to grain in any form of storage structure or transit vehicle at any level of trade from producer to consumer.

1.1 This document specifies four rapid methods for estimating the degree of, or detecting the presence of, hidden insect infestation with sampling (see Clauses 4 to 6) or without sampling (on-site probing, see Clause 7) in a cereal or pulse lot.
NOTE The characteristics leading to the choice of rapid method are summarized in ISO 6639-1:2025, Table 1.
1.2 The method by determination of carbon dioxide production (see Clause 4) is applicable to testing whole grains. It does not apply to testing:
a) finely ground grain products, as there is a risk that particles of material will be sucked up with air samples; or
b) grain products with moisture contents greater than a mass fraction of 15 %, because of the risk of carbon dioxide produced by the products themselves and by microorganisms interfering with the results.
In addition, the method does not apply to the rapid testing of grain products onto which carbon dioxide has already been adsorbed in large quantities (e.g. grain stored in a confined atmosphere, when there are clear external indications of heavy infestation).
The method is applicable to coarsely milled or kibbled grain products, provided that they have been sieved before testing to remove fine particles and loose insects.
The method does not permit the presence of dead adults.
1.3 The whole grain flotation method (see Clause 5) is applicable to detecting hidden infestation in most cereals and pulses but only on a qualitative basis.
1.4 The acoustic method operating on a grain sample (see Clause 6) is applicable to detecting living (and active) insects (larvae and adults before their emergence from a kernel) inside grains in a sample. It does not permit dead adults and larvae or living eggs and pupae (non-feeding stages) to be detected.
1.5 The on-site assessment acoustic method (see Clause 7) is applicable to detecting adult insects and larvae feeding on the grain inside without taking samples. It does not apply to detecting inactive stages (eggs, nymph and moulting).

This document covers instrumental analysis by elemental analyser-isotope ratio mass spectrometry (EA-IRMS) of food materials to determine C and/or N isotope ratios.
The isotope ratios obtained by following this document are expressed as δ13C and/or δ15N values relative to international measurement standards.
Sample preparation is not included within this document. It is assumed that the food sample has been pre-treated as necessary and homogenized.
Similarly, the interpretation of the obtained isotope delta values is not covered by this document. Following this protocol will result only in isotope delta values for the sample materials.
Solid and/or liquid sample materials can be analysed following this document.
Although other instrumental techniques can be applied to determine δ13C and/or δ15N values in food materials, these other techniques are not covered by this document.

This document specifies a real-time PCR procedure for the quantitation of the amount of roe deer DNA relative to total mammalian DNA in meat and meat products.
Results of this roe deer assay are expressed in terms of roe deer (Capreolus capreolus) haploid genome copy numbers relative to total mammalian haploid genome copy numbers. The content of roe deer can also be expressed as mass fraction in % using gravimetrically prepared calibration material from meat mixtures or model samples.
The method has been previously validated in a collaborative study and applied to DNA extracted from samples that consist of raw roe deer meat in a raw pig meat background as well as raw and boiled sausages.
The limit of detection of the roe deer PCR has been determined experimentally to be at least 5 target gene copies or at least 0,1 % roe deer.
The compliance assessment process is not part of this document.

This document specifies minimum requirements and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied to the detection of specific DNA sequences present in foods.
The document is applicable to any single-laboratory validation of a qualitative real-time PCR method used for the detection of specific DNA sequences in food and food products (e.g. for the detection of genetically modified foodstuffs and for species determination, including species known to produce allergenic proteins).
The document does not apply to single laboratory validation of qualitative microbiological real-time PCR methods.
The document does not apply to the evaluation of applicability and practicability with respect to the specific scope of the PCR method.

This document specifies requirements for dried ginger (Zingiber officinale Roscoe) in whole/pieces and ground forms.
Annex A specifies a method for the determination of calcium.
Recommendations for storage and transport conditions are given in Annex B.

This document specifies a method for the determination of total mercury in foodstuffs by cold vapour atomic absorption spectrometry (AAS) after pressure digestion.
This method was tested in an interlaboratory study carried out in connection with the pressure digestion method EN 13805 on seven different materials with a mercury concentration in the range from 0,005 mg/kg to 5,06 mg/kg and successfully validated in the range from 0,015 mg/kg to 5,06 mg/kg.
The following foodstuffs were analysed:
—   Saithe (dried);
—   Celery (dried);
—   Wheat noodle powder;
—   Wild mushrooms (dried);
—   Pig liver (dried);
—   Cacao powder;
—   Tuna fish (dried).
The lower limit of the method’s applicability varies depending on the food matrix and the water content of the foodstuff. It is a laboratory-specific value and is defined by the laboratory when calculating the limit of quantification (see 9.2).

This document specifies a method for the determination of total mercury (Hg) in foodstuffs using direct atomic absorption spectrometry after thermal decomposition in an oxygen or air flow and concentration by amalgam formation. The method is applicable for solid and liquid samples.
This method was tested in a interlaboratory study carried out on seven different materials with a mercury concentration in the range from 0,005 mg/kg to 5,20 mg/kg and successfully validated in this range.
The following foodstuffs were analysed:
—   Saithe (dried);
—   Celery (dried);
—   Wheat noodle powder;
—   Wild mushrooms (dried);
—   Pig liver (dried);
—   Cacao powder;
—   Tuna fish (dried).
The lower limit of the method’s applicability varies depending on the food matrix and the water content of the foodstuff. It is a laboratory-specific value and is defined by the laboratory when calculating the limit of quantification (see 9.2).

This document specifies a method for the determination of total mercury in foodstuffs by cold vapour atomic fluorescence spectrometry (AFS) after pressure digestion.
This method was tested in an interlaboratory study carried out in connection with the pressure digestion method EN 13805 on seven different materials with a mercury concentration in the range from 0,006 mg/kg to 5,38 mg/kg and successfully validated in this range.
The following foodstuffs were analysed:
—   Saithe (dried);
—   Celery (dried);
—   Wheat noodle powder;
—   Wild mushrooms (dried);
—   Pig liver (dried);
—   Cacao powder;
—   Tuna fish (dried).
The lower limit of the method’s applicability varies depending on the food matrix and the water content of the foodstuff. It is a laboratory-specific value and is defined by the laboratory when calculating the limit of quantification (see 9.2).

This document specifies a horizontal in vitro method for the molecular identification and differentiation of the monophasic variant of Salmonella enterica subsp. enterica serovar Typhimurium (1,4,[5],12:i:-) lacking the second H phase H:1,2, starting from isolates. The method detects specific DNA sequences of an intergenic region of the first H phase flagellin cluster for identification of Salmonella enterica subsp. enterica serovar Typhimurium (further called Salmonella Typhimurium) and specific DNA sequences of genes associated with second H phase flagellar antigen expression.
The method is applicable for:
—     differentiation of the isolate under analysis between monophasic Salmonella Typhimurium and the monophasic variant of another Salmonella non-Typhimurium serovar that has the same antigenic formula;
—     identification of the isolate under analysis being either monophasic Salmonella Typhimurium or (biphasic) Salmonella Typhimurium.
This document is applicable for the analysis of a pure culture belonging to the genus Salmonella, isolated from:
—     products intended for human consumption;
—     products intended for animal feeding;
—     environmental samples in the area of food and feed production and handling;
—     samples from the primary production stage.
This document can also be applied in other domains for identification of monophasic Salmonella Typhimurium (e.g. environmental, human health, animal health).
NOTE            This method has been validated in a method evaluation study and in an interlaboratory study with a large set of different strains (target and non-target strains), isolated from different sources (food products, animals, animal feed, primary production samples and humans). For detailed information on the validation, see Annex E.

This document specifies an amperometric method to determine the content of damaged starch in flour.
It is applicable to all flour samples from the industrial or laboratory milling of wheat (Triticum aestivum L.).
NOTE 1        Wheat can be milled in the laboratory in accordance with the methods described in ISO 27971[9] or in the BIPEA guidance document BY.102.D[10].
NOTE 2        In the absence of validity studies, the results on semi-wholemeal or wholemeal flour, although able to meet the conditions of repeatability given in Clause 9, require careful interpretation.

This document specifies a method using a farinograph for the determination of the water absorption of flours and the mixing behaviour of doughs made from them by a constant flour mass procedure or by a constant dough mass procedure.
The method is applicable to experimental and commercial flours from wheat (Triticum aestivum L.).
NOTE            This document is related to ICC 115/1[5] and AACC Method 54-21.02[6].

This document specifies a method using an extensograph for the determination of the rheological properties of wheat flour doughs in an extension test. The recorded load–extension curve is used to assess the general quality of flour and its response to improving agents.
The method is applicable to experimental and commercial flours from wheat (Triticum aestivum L.).
NOTE 1        This document is related to ICC 114[5] and AACC Method 54-10[6].
NOTE 2        For dough preparation, a farinograph is used (see 6.2)

This document specifies a procedure for the parallel determination of glycidol together with 2-MCPD and 3-MCPD present in bound or free form in oils and fats. The method is based on alkaline-catalysed ester cleavage, transformation of the released glycidol into monobromopropanediol (MBPD) and derivatisation of the derived free diols (MCPD and MBPD) with phenylboronic acid (PBA). Though free MCPD and glycidol are supposed to be present in fats and oils in low to negligible quantities only, in the event that free analytes are present, they would contribute proportionately to the results. The results always being the sum of the free and the bound form of a single analyte.
This method is applicable to solid and liquid fats and oils. This document can also apply to animal fats and used frying oils and fats, but a validation study is undertaken before the analysis of these matrices.
Milk and milk products (or fat coming from milk and milk products) are excluded from the scope of this document.

This document specifies a reference method for the determination of the iodine value (commonly known in the industry as IV) of animal and vegetable fats and oils, hereinafter referred to as fats.
Annex B describes a method for the calculation of the IV from fatty acid compositional data. This method is not applicable to fish oils. Furthermore, cold-pressed, crude and unrefined vegetable oils as well as (partially) hydrogenated oils can give different results by the two methods. The calculated IV is affected by impurities and thermal degradation products.
NOTE            The method in Annex B is based upon the AOCS Official method Cd 1c-85[10].

This document specifies a real-time PCR procedure for the quantitation of the amount of equine DNA relative to total mammalian DNA in a raw meat sample.
Results of this equine assay are expressed in terms of equine (Equus genus) haploid genome copy numbers relative to total mammalian haploid genome copy numbers. This assay is specific for representatives of the genus Equus and therefore detects horse, mule, donkey and zebra DNA.
The method has been previously validated in a collaborative study and applied to DNA extracted from samples that consist of raw horse meat in a raw beef (meat) background.
The limit of detection has been determined experimentally to be at least 17 horse haploid genome equivalents (HGE) for both the equine PCR and the mammalian PCR based on the lowest dilution on the respective calibration curves through single laboratory validation. The lowest relative horse content of the target sequence included in the collaborative study was a mass fraction of 0,1 % based on gravimetrically prepared raw horse muscle tissue in a raw beef muscle tissue background.
The compliance assessment process is not part of this document.

This document specifies a method for the determination of the ratio of stable isotopes of carbon (13C/12C) of sugars contained in honey by using liquid chromatography coupled to an isotope ratio mass spectrometer (LC-IRMS) for compound separation and subsequent determination of the 13C/12C ratio of mono-, di-, and trisaccharides. These ratios can be used to assess honey authenticity by comparing them to guidance values of genuine honey, which have been previously agreed by subject matter experts, as the 13C/12C ratios of sugars of genuine honey and sugars contained in adulterants (syrups made from starch-rich plants or from sugar cane or sugar beet) differ to a certain extent.
The compliance assessment process is not part of this document.

This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, no method comparison study can be run. Therefore, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used.
This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from:
—     products intended for human consumption;
—     products for feeding animals;
—     environmental samples in the area of food and feed production and handling;
—     samples from the primary production stage.
Identification methods only validated in accordance with this document cannot be used instead of confirmation described in:
—     the reference method;
—     an alternative method validated in accordance with ISO 16140-2;
—     an alternative method validated in accordance with ISO 16140-6.
In these instances, the identification method is validated in accordance with ISO 16140-6 method that is used as a confirmation method.
This document is applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, which can be determined on a case-by-case basis.

This document specifies an isotopic method to control the authenticity of vinegar and food containing vinegar as an ingredient (for example Aceto Balsamico di Modena), with a density below 1,28 g/cm3. This method is applicable on acetic acid of vinegar (from wine, cider, agricultural alcohol, etc.) in order to characterize the botanical origin of acetic acid and to detect adulterations of vinegar using synthetic acetic acid or acetic acid from a non-allowed origin (together with the method described in EN 16466 2).
The isotopic analysis of the extracted acetic acid by 2H-NMR is based on a similar method already normalized for wine analysis[10].

This document specifies a method for the determination of soluble 16-O-Methylcafestol and 16-O-Methylkahweol content (the sum of free forms and derivatives, e.g. fatty acid esters, henceforth abbreviated as 16-OMD = “diterpenes”) in roasted coffee (beans or ground), using quantitative proton nuclear magnetic resonance spectroscopy (1H-qNMR).
If complying with the experimental parameters described below, this test procedure has been proven for the following mass fraction range:
w16-OMD:    20 mg/kg to 2 000 mg/kg.
The mass fraction range can be expanded by suitable changes of the experimental parameters, e.g. a different weighed portion of ground coffee or the accumulation of more NMR-transients.

This document specifies a high-performance liquid chromatography (HPLC) method for determining the 16-O-Methylcafestol content in green and roasted coffee.
The method is suitable for a content of 40 mg/kg to 1 600 mg/kg of 16-O-Methylcafestol of green and roasted coffee, respectively. The collaborative study has shown that mass fractions also between 20 mg/kg to 40 mg/kg can be successfully analysed depending on the laboratory equipment.
The compliance assessment process is not part of this document.

This document provides technical definitions of terms relating to authenticity and fraud when referring to food products. All terms and definitions are in the context of food supply chains, but most of them can also be applied when referring to feed products and the feed supply chain.

This document specifies a method to determine the free glycerol and residual mono-, di- and triglyceride contents in fatty acid methyl esters (FAME). The total glycerol content is then calculated from the obtained results.
Under the conditions described, the quantification limits are 0,001 % (m/m) for free glycerol, 0,10 % (m/m) for all glycerides (mono-, di- and tri-). This method is suitable for FAME prepared from rapeseed, sunflower, soybean, palm, animal oils and fats and mixture of them. It is not suitable for FAME produced from or containing coconut and palm kernel oils derivatives because of overlapping of different glyceride peaks.
NOTE 1   For the purposes of this document, the term "% (m/m)" is used to represent the mass fraction.
NOTE 2   Under the common EN 14105 GC conditions, squalene can coelute with alpha glycerol monostearate. If the presence of squalene is suspected, EN 17057 can be used to discriminate between squalene and glycerol monostearate.
WARNING - The use of this document can involve hazardous materials, operations and equipment. This document does not purport to address all of the safety problems associated with its use. It is the responsibility of users of this document to take appropriate measures to ensure the safety and health of personnel prior to application of the standard, and fulfil statutory and regulatory requirements for this purpose.

This document specifies an automatic method for the reference method (see ISO 712-1) for the determination of moisture content of cereals and cereal products using an automatic drying oven.
This document is applicable to wheat, rice (paddy, husked and milled), barley, millet (Panicum miliaceum), rye, oats, triticale, sorghum in the form of grains, milled grains, semolina and flour.
The method does not apply to maize and pulses.
NOTE            For moisture content determination in maize, see ISO 6540, and for pulses, see ISO 24557.

This document specifies a routine reference method for the determination of the moisture content of cereals and cereal products.
This document applies to: wheat, rice (paddy, husked and milled), barley, millet (Panicum miliaceum), rye, oats, triticale, sorghum in the form of grains, milled grains, semolina or flour.
The method is not applicable to maize and pulses.
NOTE            For moisture content determination in maize, see ISO 6540[5]; and for pulses, see ISO 24557[7].

This document specifies a method for the identification of single fish and fish fillets to the level of genus or species. It allows the identification of a large number of commercially important fish species using DNA barcoding.
This method was validated on raw fish. Laboratory experience indicates additional applicability to processed fish products (e.g. cold smoked, hot smoked, salted, frozen, cooked, fried and deep-fried samples).
The described method is usually unsuitable for the analysis of highly processed foods (e.g. tins of fish with highly degraded DNA where the fragment lengths are not sufficient for amplification of the targets). Furthermore, it does not apply to complex fish products containing mixtures of two or more fish species.
The identification of fish species is carried out by PCR amplification of either a segment of the mitochondrial cytochrome b gene (cytb) or the cytochrome c oxidase I gene (cox1, syn COI), or both, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

This document specifies the general requirements for the in vitro amplification of nucleic acid sequences (DNA or RNA).
This document is applicable to the testing for microorganisms and viruses from the food chain using the polymerase chain reaction (PCR). This document, or parts of it, is applicable to other fields of PCR diagnostics based on a case-by-case evaluation.
The minimum requirements 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 microorganisms from the food chain and is applicable to:
—     products intended for human consumption;
—     products for feeding animals;
—     environmental samples in the area of food and feed production and handling;
—     samples from the primary production stage.

This document specifies a procedure for the simultaneous determination of 2-MCPD esters (bound 2-MCPD), 3‐MCPD esters (bound 3‐MCPD) and glycidyl esters (bound glycidol) in a single assay, based on acid catalysed ester cleavage and derivatization of cleaved (free) analytes with phenylboronic acid (PBA) prior to GC/MS analysis.
This document is applicable to solid and liquid fats and oils. For all three analytes the limit of quantification (LOQ) is 0,1 mg/kg and the limit of detection (LOD) is 0,03 mg/kg.

This document specifies a method for the taxonomic identification of a single bivalve or piece of bivalve to the genus or species level using DNA barcoding. It allows the identification of a large number of commercially important bivalve species.
This method was validated on raw mussels. Laboratory experience indicates additional applicability to processed bivalve products, e.g. cold smoked, hot smoked, salted, frozen, cooked, fried, and deep-fried samples.
The described method is usually unsuitable for the analysis of highly processed foods, e.g. tins of mussels, with highly degraded DNA where the fragment lengths are not sufficient for amplification of the target. Furthermore, it is not applicable for complex seafood products containing mixtures of two or more bivalve species.
The identification of bivalve species is carried out by PCR amplification of a segment of the mitochondrial 16S rRNA gene, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

This document specifies a method for the identification of meat derived from mammals and birds to the level of genus or species and allows the identification of a large number of commercially important as well as exotic meat species using DNA barcoding.
This method was validated on DNA isolated from single pieces of raw meat. This method can also be used for the identification of single meat animal species in some processed products.
The described method is unsuitable for the analysis of highly processed foods with highly degraded DNA where the fragment lengths are not sufficient for amplification of the targets. Furthermore, it is not applicable for complex meat products containing mixtures of two or more meat species.
The identification of meat species is carried out by PCR amplification of either a segment of the mitochondrial cytochrome b gene (cytb) or the cytochrome c oxidase I gene (cox1, syn COI) or both, followed by sequencing of the PCR products and subsequent sequence comparison with entries in databases.

This document specifies general requirements and gives guidance on microbiological examinations.
It is applicable to:
—     the implementation of specific horizontal or vertical International Standards developed by ISO/TC 34/SC 9 or ISO/TC 34/SC 5 for detection or enumeration of microorganisms, named hereafter “specific standards”;
—     good laboratory practices for microbiology laboratories testing samples from the food chain;
—     guidance for microbiological laboratories testing samples from the food chain on the technical requirements for conforming to ISO/IEC 17025.
The requirements of this general standard supersede corresponding ones in existing specific standards.
Additional instructions for examinations using the polymerase chain reaction (PCR) are specified in ISO 22174.
This document is applicable to examinations for bacteria, yeasts and moulds and can be used, if supplemented with specific guidance, for parasites and viruses. It does not apply to examinations for toxins or other metabolites (e.g. amines) from microorganisms.
This document is applicable to microbiology of the food chain, from primary production stage to food and animal feed products, including the premises where the food or feed production and handling takes place. It is also applicable to the microbiological examination of water where water is used in food production or is regarded as a food in national legislation.

This document specifies the detection of Clostridium (C.) perfringens.
This document is applicable to:
—     products intended for human consumption;
—     products intended for animal feeding;
—     environmental samples in the area of food and feed production and handling;
—     samples from the primary production stage.
This horizontal method was originally developed for the examination of all samples belonging to the food chain. Based on the information available at the time of publication of this document, this method is considered to be fully suited to the examination of all samples belonging to the food chain. However, because of the large variety of products in the food chain, it is possible that this horizontal method is not appropriate in every detail for all products. Nevertheless, it is expected that the required modifications are minimized so that they do not result in a significant deviation from this horizontal method.
NOTE          Interlaboratory studies with a small number of participating laboratories (<10) were conducted for the following food categories:
—      ready-to-eat, ready-to-reheat meat products;
—      eggs and egg products (derivates);
—      ready-to-eat, ready-to-reheat fishery products;
—      processed fruits and vegetables;
—      infant formula and infant cereals (with probiotics);
—      multi-component foods or meal components.
It has also been validated with a small number of participating laboratories for the following other category:
—      environmental samples (food or feed production).
Since the method is not commonly used for samples in the primary production stage, this category was not included in the interlaboratory study. Therefore, no performance characteristics were obtained for this category. The method has not been validated for the category ‘pet food and animal feed’, as the test samples used for the interlaboratory study were already naturally contaminated with C. perfringens. Given the limited number of participating laboratories in the interlaboratory studies, the calculated performance characteristics can be used as indicative values of the method performance. For detailed information on the validation, see Clause 11 and Annexes C to F.

This document specifies a reference method for the determination of the nitrogen content of meat and meat products by the Kjeldahl principle.

This document specifies requirements for bitter fennel seed (Foeniculum vulgare P. Miller var. vulgare), whole or ground.
Recommendations relating to storage and transport conditions are given in Annex A.
ISO 7927-2 specifies requirements for sweet fennel seed.
NOTE Although, botanically speaking, the product is a “fruit”, the term “seed” is in common commercial use.

This document specifies a method for the determination of crude ash of animal feeding stuffs.

This document specifies two reference methods for the determination of the moisture content of meat and meat products: a direct drying method and a distillation method.
The direct drying method is applicable to meat and meat products with low volatile substances in addition to moisture.
The distillation method is applicable to meat and meat products with high volatile substances in addition to moisture.

This document specifies minimum performance requirements for methods that quantify the food allergens milk, egg, peanut, hazelnut, almond, brazil nut, macadamia nut, cashew, pistachio nut, walnut, pecan nut, lupine, sesame, mustard, soy, celery, fish, molluscs, crustaceans, and wheat in raw and processed foodstuffs. Within the scope of this document, minimum requirements for an LOQ (Limit of Quantification) will be derived from threshold data of allergic consumers. For quantitative antibody-based methods, a normative annex will describe what specific information the method developer needs to deliver and how performance characteristics shall be validated. Regarding PCR and LC-MS/MS, information on performance characteristics are in parts covered by EN 15634-1 and EN 17644. This document does not apply to fragmented or hydrolysed food allergens, such as casein hydrolysates or soy sauce. It also does not apply to methods that deliver qualitative results only. Methods that cover gluten-containing cereals (wheat, rye, and barley) with regard to coeliac disease are covered by EN 17254.