Contribution to standards

Standardisation is a key issue to provide to stakeholders over the world harmonised rules and tools to implement national reliable and cost-effective traceability methods but also to prevent international disputes. Standardisation is also necessary to international bodies such as the WTO to resolve international disputes due to discrepancies in analysis results. It has to been outlined that WTO is considering Codex Alimentarius as the main source of standards for international disputes.

The QPCRGMOFOOD project which is one of the predecessors of the Co-Extra project focused on the development and validation of reliable quantitative real-time PCR methods for event specific detection of GMOs and species specific reference gene systems.
The GMOCHIPS program focused on the development of a kind of methods able to reduce the number of analyses to face the increasing number of approved GMO. The new detection methods of this project are currently under pre-validation but face some troubles regarding the ways to validate PCR methods followed by micro-arrays hybridisation. After validation, methods were or will be forwarded to CEN as proposals for European standards.
This approach will be followed also for methods developed within Co-Extra. Through the Vienna agreement, CEN standards could automatically become proposals for ISO standards as well. Codex Alimentarius is generally considering the ISO standards for its own implementation.

One of the important outcomes of the QPCRGMOFOOD and GMOCHIPS projects and work into the CEN/TC275/WG11, ISO/TC34/WG7 and ENGL was the contribution to the elaboration of detailed guidelines and recommendations for validation of such methods, further developed under the responsibility of ENGL and the EC-JRC, IHCP in the preparatory work for the establishment of the CRL.

  • A large part of the Co-Extra members are involved in national and international standardisation organisations:

    • National European standardisation bodies such as AFNOR (Association française de normalisation – French Association of Standardisation) or DIN (Deutsche Institut für Normung – German Institute for Standards).

    • International standardisation bodies such as CEN (Comité européen de normalisation - European Committee of Standardisation), ISO (International Standard Organisation) and Codex Alimentarius

    • Third countries organisations developing standards according to the American way such as AACC (American Association of Cereal Chemists)

  • Many Co-Extra partners are chairing or are member of, national accreditation bodies like:

    • COFRAC (Comité français d’accréditation - French Accreditation Committee)

  • A large part of the Co-Extra members also participate to organizations which greatly influence regulations and standardization such as:

    • ENGL which works on labelling threshold interpretation, performance criteria, accreditation criteria and procedures. In parallel, through the guidelines they issue, and the discussion forums they provide, ENGL has a major impact on the common European position in international forums and discussions with stakeholders of third countries.

    • EFSA whose advices can be relevant for international standardisation organisations such as CEN, ISO or OECD (consensus documents) in several standardisation fields.

  • At the technical level, a large part of Co-Extra outcomes will directly be embedded in standards – prEN ISO 21569, 21570, 21571 – in terms of validated methods.

    • Sampling along the supply chains

    • DNA extraction

    • GMO plant species and control PCR methods

    • Methods for calculating measurement uncertainty. In particular, the potential impact of the modular validation approach on the progress of validation of new methods, and consequently on the availability of validated methods that can become standards may be very high.

    • Guidelines for validating new detection methods through collaborative trials. Since one of the project aims is to develop several multiplex methods, parallel elaboration of guidelines for validation of multiplex methods will be one of the priorities of the proposed project.

    • International standards for documentary traceability with regard to the content, the structure of information flow and its management.