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FP5

SAFOTEST Résumé de rapport

Project ID: QLK1-CT-1999-00651
Financé au titre de: FP5-LIFE QUALITY
Pays: Denmark

New methods for the safety testing of transgenic food - workshop

The results obtained in SAFOTEST as well as the overall test design was evaluated at the final project workshop in May 2004, where also recommendations for the future testing procedures to be applied to GM plant foods for the European market were discussed.

The discussion and interest in the workshop Plenary early on centred on the use of the tiered approach (and not a base-set) and thereby excluded a mandatory request for the 90-day safety study, which is an inherent part of the SAFOTEST approach. The conclusions of the plenary at the SAFOTEST workshop, as it went, only acknowledged the tiered approach where the 90-day safety study becomes an option on a case-by-case basis.

More specifically the plenary concluded that
- The requests for molecular characterisation in the Guidance Document should be revised in the light of the discussions at this Work Shop.

- Short term toxicity studies could be shorter than 28-days, even not necessary depending on the case.

- Guidelines should also be revised concerning request for data regarding agricultural performance.

- The use of nutritional adjustments of the overall diet in feeding trials should depend on the purpose of the test: Testing for toxicity assessment of the insert or for identification of unintended effects (it should be kept in mind that minor un-intended effects may not be discovered if obvious nutritional deficiencies in the GM-food group are not adjusted!).

- Development of a guideline for the use of defined animal diets designed for the inclusion of high amounts of food material should be considered by OECD.

- Spiking should not be used as a routine, but on indication.

- If spiking are used, it still is a matter of discussion and judgment if there should be both a spiked control group and a spiked GM group.

- Use of the Margin-Of-Safety approach, where intake of the GM-food in the animal test should be compared with the expected intake in man, should be considered in order to proceed in the risk characterisation.

- In the end it was stressed that the scientific assessment should not loose sight of the data available and thrive at reaching a comprehensive view of the safety of the GM-food.

Finally the Workshop Plenary felt that the segment of the SAFOTEST concept directed towards the spiking will need further experience and data in order to determine its future usefulness in the hazard characterisation of GM plants.

More information on the project can be found at: http://www.entransfood.com/RTDprojects/SAFOTEST/safotest.html

Reported by

Danish Institute for Food and Veterinary Research
Morkhoj Bygade 19
2860 Soborg
Denmark
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