Opinion of the scientific panel on genetically modified organisms (GMO Panel) of the European Food Safety Authority (EFSA)
Adopted
20/04/2005
Conclusion
Bt11 maize is as safe as conventional maize, and releasing Bt11 for processing and food and feed use is unlikely to cause adverse effects on human health and the environment.
Comparative analysis
Basis of comparison
Conventional counterpart (isogenic line). No difference in the physical properties of kernels
and forage could be found.
Compositional analysis
Several parameters were compared, including:
i.e. moisture, protein, acid detergent fibre, total digestible nutrients,
minerals such as calcium, phosphorous, potassium, magnesium, zinc, manganese,
copper, iron, and energy. No differences were observed.
Safety of food and feed
New proteins(CRY1A(b)+PAT)
Comparison with known toxins: No correspondence
The results of the compositional analysis did not reveal unintended differences
between Bt11 maize and non-transgenic maize. Therefore no additional subchronic
toxicity studies are necessary.
Allergenicity of the new proteins(PAT+Cry1A(b))
Maize is
not considered a major allergenic food. In addition the present application is
for feed only and allergy is not a relevant issue for animal health.
Feeding studies
Tests on
laying hens, broiler chicken and dairy cows did not show signs of negative health effects.
Environmental safety
Surviveability
Maize is highly domesticated and is not viable outside of cultivation.
Bt11 maize has no altered survival, multiplication or dissemination
characteristics except in the presence of glufosinate ammonium.
Out-crossing
Maize has no cross-compatible wild relatives in Europe. Out-crossing is only possible with maize in neighbouring fields.
Non-target organisms
The
Panel has no reason to consider that Bt11 maize will cause changes to
non-target organisms that differ significantly from those
caused by conventional farming.
Field trials
Evaluation of field trials in France,
Italy, Portugal (1994, 2005, 2003) and
USA (1995-1996).
Summary of risk assessment
isogenic line