Opinion of the scientific panel on genetically modified organisms (GMO Panel) of the European Food Safety Authority (EFSA).
Adopted
05/12/2006
Conclusion
Products originating from H7-1 sugar beets are safe as conventional beets and therefore the placing on the market for processing and food and feed use is not likely to cause adverse effects on human health and the environment.
Comparative study
Basis of comparsion
H7-1 sugar beets were compared with conventional sugar beets.
Qualities
Different parameters, such as cultivation properties, pollen production, plant development, outer characteristics, and susceptibility to pests and diseases were compared.
Compositional analysis
Different nutrients (fats, proteins, carbohydrates) as well as secondary elements (saponine, oxalic acid, malonic acid), mineral elements and also amino acid concentrations were investigated:
There were no differences with the comparison conventional plants observed.
Safety of food and feed
New proteins
(CP4 EPSPS)
In the comparison with known toxicologically questionable substances, no correlation was found.
In a 90-day feeding study with rats, no indications of health damages were observed.
Allergenicity of new proteins
No correlation was found with any known allergens (comparison of the amino acid sequences.
Simulations in an artificial digestive tract showed that the new proteins are rapidly decomposed.
Stability during processing
The new Protein could not be detected in the sugar and the molasses of the processed GM-sugar beet.
In the sugar beet pulp, the protein is demonstrably existent.
Assessment for food and feed
In a feed study with sheep, the health tolerance of the sugar beet pulp was tested. The animals were fed with diets of various compositions:
No indications of health damages were found.
Enviromental safety
Out-crossing
The application refers to processed food and feedstuffs produced from the GM-sugar beet H7-1, however, not to the cultivation in the EU. Therefore, a detailed assessment of the environmental safety is not deemed as being necessary.
Field trails
The plant material which was used for the safety evaluation originates from field release trials in Europe and the USA (1998, 1999 and 2003).