May 22, 2012 | 3:44 pm

Maize MON863 (MON863 x MON810)

Summary of risk assessment

Opinion of the scientific panel on genetically modified organisms (GMO Panel) of the European Food Safety Authority (EFSA).
Adopted 02/04/2004
Conclusion MON863 maize is as safe as conventional maize, and releasing MON863 for processing and food and feed use is unlikely to cause adverse effects on human health and the environment.

 

Comparative study
Basis of comparison Several conventional maize cultivars and the non-transgenic line MON846 (isogenic line)
Qualities Several parameters were compared, including agronomic traits, seed size, and external features.
Compositional analysis Levels of macronutrients (basic plant nutrients e.g. phosphorous), micronutrients (trace elements), metabolites, and undesired substances (e.g. trypsin inhibitors) were measured.
No differences were observed.

 

Safety of food and feed
New proteins
(CRY3Bb1+ NPTII)		 Comparison with known toxins: No correspondence.
Allergenicity of the new protein(s) No correspondence with known allergens. (Amino acid sequence comparison)

There are no known cases of allergies to maize or to Bt proteins. Therefore, it is considered highly unlikely that Bt maize could cause allergies.

Marker gene The nptII marker gene (kanamycin resistence) poses no risk to human or animal health or to the environment.
Assessment for food and feed A 90 day feeding study was conducted on rats. Male rats fed MON863 maize had slightly elevated white blood cells counts. Their livers also weighed slightly less than those of rats fed conventional maize.

After extensive consultation incorportating many different reports and opinions, EFSA experts did not consider the findings to be indicative of a health risk. According to EFSA, the differences obvserved in rats fed MON863 lie within natural, biological variability.

EFSA consultants demanded that the MON863xMON810 feeding studies be repeated. Again, no acute toxic effects were reported.

Nutritional equivalence Feeding studies on chickens fed a diet consisting of NK603 maize flour did not report negative effects.

 

Enviromental safety
Survivebility Maize is highly domesticated and is not viable outside of cultivation.
Out-crossing Maize has no cross-compatible wild relatives in Europe. Out-crossing is only possible with maize in neighbouring fields.
Field trails Evaluation of field trials in the USA und Argentina