Nov 20, 2008

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11:17 pm

Rapeseed T45

Summary of risk assessment

Opinion of the scientific panel on genetically modified organisms (GMO Panel) of the European Food Safety Authority (EFSA).
Adopted	30/01/2008
Conclusion	T45 rapeseed is as safe as conventional rapeseed, and releasing T45 for processing and food and feed use is unlikely to have an adverse effect on human or animal health and the environment.

Comparative analysis
Basis of comparison	Several non-GM parent varieties like AC Excel, Cyclone, Legend, Innovator
Qualities	The compositional analysis of T45 oilseed rape and the respective non-transgenic counterparts was carried out with respect to proximates and fibre compounds, micro-nutients, such as minerals and tocopherols, antinutrients such as phytic acid and glucosinolates, and a whole spectrum of amino acids and fatty acids. No biologically significant differences were measured between T45 and its conventional counterpart.

Safety of food and feed
New proteins (PAT)	In vitro studies showed that the transgenic protein is easily degraded in simulated gastric fluid containing pancreatin (degraded within 30 sec).
Allergenicity of the new protein	Neither protein came from a source with known allergenicity, had sequence homology with known allergens, or resisted degradation in an acid environment. The amino acidsequence of the PAT protein was compared to the sequences of known allergens. No correspondence was reported.
Assessment of food and feed	The applicant provided a single dose toxicity study on female mice intravenously injected of the PAT protein. Animals were observed for 15 days after dosing and macroscopic examination of internal organs was carried out at necropsy. No signs of systemic toxicity were observed.
Nutrient content and feed quality	The main uses of animal feed containing rapeseed meal are for poultry, swine, and cattle production. Feeding studies were conducted to determine the effects of T45 on the health of livestock. No differences between T45 and conventional rapeseed were observed.

Enviromental safety
Survivability	Rapeseed is prolific and its seed is robust. Its seed can persist in soil, remaining viable for many years. It often exists as a volunteer weed among other crops, and it can colonise semi-natural habitats. Studies with T45 rapeseed have not shown any enhanced weediness or fitness, except with the use of glyphosate herbicide.
Out-crossing	There are many wild species of Brassica in Europe that are related to the cultivated rapeseed (Brassica napus). This makes out-crossing a possibility. Rape is predominantly self pollinating, but it can also cross-pollinate via wind or insects.
Summary	T45 rapessed 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 for processing. Any subsequent germination and establishment of feral plants, which will 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.