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EC-sponsored Research on Safety of Genetically Modified Organisms - A Review of Results
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image New methods for the safety testing of transgenic food (SAFOTEST)

Background and objectives

In 1997, the European Union Scientific Committee on Food (SCF) issued a set of recommendations for the safety assessment of novel foods, including food that has been prepared using genetically modified (GM) organisms. The SCF suggested a decision tree approach, which for the toxicological part may include a demand for separate animal studies to provide the missing information. However, the SCF did not give specific advice on how to carry out these studies, but stated that the design should be determined on a case-by-case basis. As a consequence, in Europe, there is no precise harmonisation of methodologies to assure the safety of transgenic food products, it being difficult to use traditional animal feeding studies for toxicological assessments. This clearly raises biosafety issues for the use of GM products in food. In vivo and in vitro validated nutritional-toxicological testing procedures are urgently required. The overall objective of this project is to develop and validate the scientific methodology which is necessary for assessing the safety of foods from GM plants, in accordance with the European Union Regulation 258/97 of January 27, 1997, concerning novel foods and novel food ingredients. The project is designed to meet the immediate need for a sensitive and specific testing strategy for GM foods in a scientifically valid and economically feasible manner.

  image image Rice.

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Approach and methodology

The project, subdivided into seven different stages, will examine a safety testing procedure for food derived from GM plants. In stage I, three strains of GM rice, containing introduced genes will be developed and characterised. The genes that will be introduced encode three potentially insecticidal proteins: the snowdrop lectin GNA (which do not have any known mammalian toxicity, but which interact with the gut), the kidney bean lectin PHA-E (which has high mammalian toxicity) and a bacterial toxin from Bacillus thuringiensis (which has no known mammalian toxicity). In addition, recombinant proteins will be expressed and purified for later use as 'spiking materials' for the in vivo studies and test material for the in vitro studies. In stage II, the three strains of transgenic rice will be raised in sufficient quantities for in vivo testing, and their genetic identity and stability will be assured. Stage III involves identification and measurement of the critical nutrients, the critical toxic agents and other critical chemical changes in the transgenic rice strains. In stage IV, a study based on rat feeding and OECD 28 day toxicity measurements, will be performed to ensure optimal diet composition and to measure suspected lectin or Bt sensitive parameters for applications in stage VI. Stage V involves measurement of the effects of lectins and Bt toxin in a number of in vitro systems, in order to adjust the sensitivity and specificity of parameters which will be investigated in the animal study with the transgenic rice species in stage VI. Supplementary mechanistic and dose response studies will also be carried out in vitro to supplement the in vivo studies for the final risk assessment. In stage VI, a 90-day OECD toxicity study in rats will be carried out with the three transgenic strains of rice, with and without the relevant test protein. In this study, the measurements of the lectin and Bt sensitive parameters optimised in stages IV and V will be incorporated.

In the final stage, the results as well as the knowledge base acquired from the first six stages, will be evaluated in order to assess the sensitivity, specificity and efficacy of the safety testing approach recommended by the European Union SCF.


If the outcome of the studies of this project is as expected, the data will be of great re-assurance to European consumers, concerned over the safety and 'wholesomeness' of his/her food supply derived from genetically modified food plants. However, if the testing procedure investigated in this project does not allow assessment of the toxicity of the gene products introduced into the food product via the GM plants, the whole strategy for the safety assessment of novel foods from GM plants will need to be revised.


Background publications

Knudsen I., "Conventional foods versus genetically modified foods: Present knowledge and possible safety issues", in Gentechnik und Ernährung, Erbersdobler, Hammes, Jany (eds.), Wissenschaftliche Verlagsgesellshaft mbH, Stuttgart, 1995, pp. 103-116.

Engel K.-E., Gerstner G., Roß A., "Investigation of glycoalkaloids in potatoes as example for the principle of substantial equivalence", in Die Novel Foods Verordnung der Europäischen Union - Verläßlichkeit der gesundheitlichen Bewertung, M. Schauzu, K.-W. Bögl (Hrsg.), BgVV-Heft, 1998, pp. 197-209.

Rao K.V., Rathore K.S., Hodges T.K., Fu X.D., Stoger E., Sudhakar D., Williams S., Christou P., Bown D.P., Powell K.S., Spence J., Bharathi M., Gatehouse A.M.R., and Gatehouse J.A., "Expression of snowdrop lectin (GNA) in the phloem of transgenic rice plants confers resistance to rice brown planthopper".
The Plant Journal, 14, 1998, pp. 469-477.

Van Hal N.L.W., Vorst O., Kok E.J., Van Houwelingen A.M.M.L, Peijnenburg A.A.C.M., van Tunen A.J., and Keijer J., "The application of DNA micro-arrays in gene expression analysis".
J. Biotechnology, 78, 2000, pp. 271-280.

Taylor M.A., George L.A., Ross H.A., Davies H.V., "cDNA cloning and characterisation of an alpha-glucosidase gene from potato".
The Plant Journal, 13, 1998, pp. 419-425.

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Contract number

February 2000 - February 2004

I. Knudsen
Institute of Food Safety and Toxicology
Søborg (DK)




K-H. Engel
Technische Universität München
Freising-Weihenstephan (DE)

H. Davies
The Scottish Crop Research Institute
Dundee (UK)

A.M.R. Gatehouse
University of Newcastle (UK)

A.A.C.M. Peijnenburg
State Institute for Quality Control of Agricultural Products (RIKILT)
Wageningen (NL)

Morten Poulsen
Institute of Food Safety and Toxicology
Søborg (DK)
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