Opinion of the scientific panel on genetically modified organisms (GMO Panel) of the European Food Safety Authority (EFSA).
Adopted
14/09/2005
Conclusion
MS8xRF3-rapeseed is as safe as conventional rapeseed, and releasing MS8xRF3 for processing and food and feed use is unlikely to cause adverse effects on human health and the environment.
Several parameters were compared such as agronomic traits and external features.
Compositional analysis
Levels of critical toxins including proximates, micronutrients such as minerals and tocopherols, anti-nutrients such as phytic acid and glucosinolates, and the total spectrum of amino acids and fatty acids were examined: No indication of unintended effects.
Safety of food and feed
New proteins
(PAT+
BARSTAR+
BARNASE)
The PAT protein can be detected in very low amounts in dry seed (0.1 µg/ mg seed protein).
The Barnase and Barstar proteins are not detected in processed products.
Allergenicity of new proteins
In vitro digestibility studies have shown that the PAT protein is quickly broken down both in simulated gastric fluid and in simulated intestinal fluid.
No amino acid sequence correspondence between the three newly-expressed proteins and known allergens and toxins.
Assessment for food and feed
Feeding studies on mice, rats and quail:
Evidence is provided that there is no acute toxicity from the new proteins.
The expression level of the PAT protein in the transgenic rapeseed is very low.
Enviromental safety
Out-crossing
MS8xRF3-rapeseed will not be grown in the EU. It will only be imported as seed for processing. Therefore, the only potential release is by spillage during transport and processing. Any subsequent germination and establishment of feral plants, which would probably be limited to roadsides, will not experience a selective advantage in the absence of glufosinate ammonium and is unlikely to have any impact on the environment.
Summary of risk assessment
isogenic line