CEN/TC 275/WG 11 - Genetically modified foodstuffs

This document describes general requirements, procedures and performance criteria for evaluating the content of genetically modified (GM) seeds/grains in a lot by a group testing strategy that includes qualitative analysis of sub-sampled groups followed by statistical evaluation of the results.
This document is applicable to group testing strategy estimating the GM content on a percentage seed/grain basis for purity estimation, testing towards a given reject/accept criterion and for cases where seed/grain lots are carrying stacked events.
This document is not applicable to processed products.
NOTE       Description of the use of group testing strategy are available in References [1], [7], [8], [18], [19] and [20].

This document describes the performance characteristics and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods.
The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e.g. for species detection and identification.
The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.

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.

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.

This Technical Specification describes screening strategies for the detection of genetically modified (GM) DNA in food products by means of PCR methods. The strategies have been established for food matrices, but it can also be applied to other matrices (e.g. feed, seed and samples from field grown plants).
Detection of GM DNA is based on PCR methods targeting segments of transgenic DNA sequences (genetic elements, genetic constructs or insertion sites of transgenes). Various combinations of these PCR methods are involved in screening strategies. The methods are applied simultaneously or hierarchically. The general strategy is based on the matrix approach. Examples for the implementation and application of this approach are described.
In order to ensure reliable analytical results, the document also provides guidelines for the validation of the performance criteria of qualitative PCR methods applied in screening approaches.

2012-10-24 EMA: Draft for // vote received in ISO/CS (see notification of 2012-10-24 in dataservice).
2011-07-14 ANP: Text received in ISO/CS (see notification from 2011-07-14 in dataservice).

2012-10-30 GVN: Draft for // vote available in ISO/CS (see notification in dataservice from 2012-10-30)
2010-03-03 EMA: WI updated as ISO decided to proceed with an amendment instead of a revision (former ID 53576).

2012-08-27 GVN: Text for FV received at ISO/CS (see notification of 2012-08-27 in dataservice)
2011-12-06 EMA: Draft for //ENQ received in ISO/CS (see notification of 2011-12-02 in dataservice).
2010-03-03 EMA: WI updated as ISO decided to proceed with an amendment instead of a revision (former ID 53575).

2012-08-27 GVN: Text received for FV at ISO/CS (see notification from 2012-08-27 in dataservice)
2011-09-16 EMA: Draft for // Enquiry received in ISO/CS (see notification of 2011-09-14 in dataservice).
2010-03-03 EMA: WI updated as ISO decided to proceed with an amendment instead of a revision (former ID 53577).

ISO - Taking over of an ISO Technical Corrigendum

This Technical Specification gives guidance for setting up valid sampling strategies for food products that are to be analysed for the presence of genetically modified organisms and derived products.

ISO 24276:2006 specifies how to use the standards for sampling strategies (EN/TS 21568), nucleic acid extraction (ISO 21571), qualitative nucleic acid analysis (ISO 21569) and quantitative nucleic acid analysis (ISO 21570), and their relationship in the analysis of genetically modified organisms in foodstuffs, and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods and test reports.
It has been established for food matrices, but could also be applied to other matrices (e.g. seeds, feed and plant samples from the environment).

ISO 21570:2005 provides the overall framework of quantitative methods for the detection of genetically modified organisms (GMO) in foodstuffs, using the polymerase chain reaction (PCR).
It defines general requirements for the specific amplification of DNA target sequences in order to quantify the relative GMO-derived DNA content and to confirm the identity of the amplified DNA sequence.
Guidelines, minimum requirements and performance criteria laid down in ISO 21570:2005 are intended to ensure that comparable, accurate and reproducible results are obtained in different laboratories.
ISO 21570:2005 has been established for food matrices, but is also applicable to other matrices, e.g. feed and plant samples from the environment.

ISO 21569:2005 describes the procedure to qualitatively detect genetically modified organisms (GMOs) and derived products by analysing the nucleic acids extracted from the sample under study. The main focus is on polymerase chain reaction (PCR) based amplification methods.
It gives general requirements for the specific detection and identification of target nucleic acid sequences (DNA) and for the confirmation of the identity of the amplified DNA sequence.
Guidelines, minimum requirements and performance criteria laid down in ISO 21569:2005 are intended to ensure that comparable, accurate and reproducible results are obtained in different laboratories.
ISO 21569:2005 has been established for food matrices, but could also be applied to other matrices (e.g. feed and plant samples from the environment).
Specific examples of methods are provided in Annexes A to D.

ISO 21571:2005 provides general requirements and specific methods for DNA extraction/purification and quantification. These methods are described in Annexes A and B.
ISO 21571:2005 has been established for food matrices, but could also be applicable to other matrices, such as grains and feed.
It has been designed as an integral part of nucleic-acid-based analytical methods, in particular ISO 21569 on qualitative analytical methods, and ISO 21570 on quantitative analytical methods.

This document describes the performance characteristics and minimum performance criteria which should be taken into account when conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods.
The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e.g. for species detection and identification.
The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.

This document describes a procedure for the identification of single fish and fish fillets to the level of genus or 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. The methodology allows the identification of a large number of commercially important fish species.
The decision whether the cytb or cox1 gene segment or both are used for fish identification depends on the declared fish species, the applicability of the PCR method for the fish species and the availability of comparative sequences in the public databases.
This method has been successfully validated on raw fish fillets, however, laboratory experience is available that it can also be applied to processed, e.g. cold smoked, hot smoked, salted, frozen, cooked, fried, deep-fried samples.
This document 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 is not applicable for complex fish products containing mixtures of two or more fish species.

This document describes the performance characteristics and minimum performance criteria which should be taken into account when conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods.
The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e.g. for species detection and identification.
The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.

ISO 21572:2013 provides general guidelines and performance criteria for methods for the detection and/or quantification of specific proteins or protein(s) of interest [POI(s)] in a specified matrix.
These general guidelines address existing antibody based methods. Methods other than those described in Annex A or Annex B can also detect the POI. The same criteria as outlined in ISO 21572:2013 apply generally.

TC - Status of Annex A changed from normative to informative

ISO 21572:2004 provides general guidelines and performance criteria for methods for the detection and/or quantitation of specific proteins derived from genetically modified (GM) plant material in a specified matrix.
These general guidelines address existing antibody based methods. Methods other than those described in annex A may also detect the protein. The same criteria as outlined in this standard generally apply.