The European Network of Genetically Modified Organisms (GMO) Laboratories (ENGL)

Brussels, 4 December 2002

What are the duties of the Network?

The network is composed of laboratories appointed by national authorities. Each member has national control responsibilities. The laboratories came together to improve their tackling of scientific issues related to implementing the existing and forthcoming GMO-related legislation. The European Commissions' Joint Research Centre acted as a catalyst in bringing the Network together.

The main duties of ENGL are to look at the different GMOs put on the market, and to ensure that the control laboratories can trace GMOs throughout the food chain.

The ENGL will primarily have to develop and validate methods for detecting and quantifying GMOs in food and feed. Once a method has been optimised, ENGL will set up internal inter-laboratory tests to check if the methods are suitable for control purposes and if so, labs will use them in their control work.

Biotechnology industries will fully collaborate with ENGL on a voluntary basis. Industry will provide details on DNA sequences needed to detect their GM material, enabling the development of harmonised methods. Co-operation with industry is a key component of the network's activities.

The GMO laboratory of the JRC, based in Ispra (Italy), will co-ordinate ENGL's activities It will act as the EU reference laboratory for GMO food and feed legislation. It will test and validate the methods of detection and identification, proposed by those submitting applications for new GMO foods or feed. The laboratory will be responsible for:

• receiving, preparing, storing, maintaining and distributing appropriate positive and negative control samples for national reference laboratories;

• testing and validating detection methods, including sampling and identification of the transformation event and, where applicable, detecting and identifying the transformation event in the food or feed;

• evaluating the data supplied by the applicant for authorising the sale of food or feed in order to test and validate the method for sampling and detection;

• submitting full evaluation reports to the European Food Safety Authority (EFSA).
  Is ENGL developing a EU protocol for GMO detection?

Every GMO is unique and therefore it is very difficult to identify one single protocol for the detection of all GMOs. Therefore, ENGL must develop and validate a specific method for each new GMO that arrives on the market, or that is submitted for marketing authorisation. Once ENGL has validated a method (i.e. has determined the robustness of the control method), this is submitted to international standardisation bodies such as CEN (European Committee for Standardisation) to be codified into an international standard. Thereafter all laboratories can use it, be they private or public.

How many methods has the network provided?

ENGL has extended existing GMO detection methods for screening raw materials and final food products such as biscuits and baby food. Examples include insect-resistant maize and herbicide-tolerant soybean. In addition, methods for determining the quantity of GM maize in flour have been finalised.

What further outcome can be expected in one year from now?

ENGL will provide methods for detecting all GMOs currently awaiting authorisation. The amended Directive for marketing of GMOs will lead to an increased number of applications for GMO notifications. All of these GMOs have to be detected. This will be the main task of the Network. In addition, the network will:

• Produce reference materials for various marketed GMOs.

• Provide the best approaches for taking samples from large bulks of seeds, grain or food. The Commission will present a software developed to assist control authorities in calculating the amount and the size of the samples that are necessary for adequate analysis.

• Store all molecular information on GMOs in databases and design bioinformatics tools to precisely analyse all the information collected to develop even better methods for detection and quantification.

• Provide proposals for efficient monitoring of GMOs that are commercially grown in the EU. This is a technical requirement of the recently approved Directive on the deliberate release and marketing of GMOs.

• Train laboratory personnel to become acquainted with the most sophisticated techniques of DNA and protein work.

It should also be mentioned that all these advances will be transparently communicated on the web pages of the Network, allowing everybody in the food chain, from importers or retailers to distributors, to know how controls should best be carried out.

What is the impact of latest development in EU GMO-related legislation?

On November 28 the Council of Agriculture Ministers reached a political agreement on the draft Regulation on genetically modified food and feed. This will have major consequences for control authorities in its proposal for two GMO thresholds: the first being 0,9%, below which authorised GMOs would be exempted from the labelling requirements. The threshold for food containing traces of adventitious (accidental) GMOs would be 0,5 %.

A strong regulatory framework must go hand in hand with a good and transparent control mechanism that satisfies the expectations of the consumer. The ENGL will certainly help the introduction of a better control system and will benefit consumers. In addition, it will increase EU credibility with trade partners and it will play an important role in pan-European harmonisation.

What would happen if there were no ENGL GMO tests?

Without state-of-the-art tests and detection methods, it is not possible to control and enforce the regulations in place. However, it is key to have reference tests that are harmonised and validated across Europe, so that testing results are comparable and reliable and do not lead to confusion and litigation.

Up until now, GMO testing has mostly been carried out in EU countries and in Switzerland. Now all of these GMO laboratories have joined forces, working together within the ENGL network. The network is composed of official control laboratories, appointed by national governments, and is chaired by the JRC, a neutral Commission service. This ensures high quality standards. This network is well respected: for example, the biotechnology industry sees ENGL as a reference point for high quality scientific work.

It is anticipated that ENGL will finalise an agreement with major biotechnology companies in the very near future. This foresees biotech companies voluntarily providing ENGL with methods for detecting GMOs to comply with regulatory measures, as well as providing the necessary positive and negative control samples. The role of ENGL will be to validate these methods and ensure that they become an international reference. Once such an agreement is finalised, ENGL will become an important body for GMO testing world-wide.

What about the resources involved? Can we predict the amount of work that lies ahead?

The Network employs around 450 experts, but ENGL members are also working with other networks of GMO labs at regional level, for instance in Germany and Belgium. Every GMO test costs around €125,000. But it is very difficult to predict resources to be used. The amount of work does not depend on ENGL but rather on the development of the biotechnology industry, on the number of notifications submitted for marketing and on the progress made in the adoption of regulations, particularly the proposed GMO food and feed regulation and the traceability proposal. It will definitely be necessary to carry out a large number of tests and many methods will need to be developed and validated. The JRC has anticipated this increase in activities and has identified biotechnology work as one of its priorities in the 6 th EU Research Framework Programme (FP6 2003-2006).

Will this initiative have an impact on our relations with third countries, in particular with the US, as far as GMOs are concerned?

The Network will benefit Europe and will offer "best practice" solutions to a global audience. Therefore, it is the intention of ENGL to establish close collaborations from the outset, first of all with the Candidate Countries, that are already involved as full observers, and also with international trade partners such as the USA and Canada.

In addition, third countries are aware of EU legal requirements and of the analytical capacities of EU laboratories. They know the EU is well organised and follow ENGL activities with interest. For example, the most recent training course for GMO detection held at the JRC saw a US scientist participate for the first time in.

The Starlink case outlines the importance of creating ENGL-like structures. Starlink is a maize variety, that was approved in the US for feed but not for human consumption because some tests on allergenicity were missing. When Starlink was found in taco chips in America, all Starlink maize had to be removed from the market and the US proposed measures to prevent Starlink from being shipped overseas. The JRC and European GMO labs stopped this from happening in the EU. This has clearly illustrated the need for appropriate test and sampling methods.

DN: MEMO/02/9 Date: 04/12/2002