Agriculture Reference
In-Depth Information
considered carefully to make clear whether or not it encodes a toxin or
allergen. In case of a new protein with no history of food use, its proper-
ties are compared to those of known toxicants and allergens. A compar-
ison of the amino acid sequences will reveal homologies. Food allergens
share further specific characteristics, such as stability of digestion by pro-
teolytic enzymes. Digestion studies are among the relevant tests applied
to newly expressed proteins.
Further toxicological test requirements, such as animal feeding tri-
als, need to be considered on a case-by-case basis, taking into account
the source, familiarity, and characteristics of the protein. For instance,
proteins that have not been previously consumed with foods are gener-
ally to be subjected to a 28-day toxicity study in rodents, conducted in
accordance with the protocol elaborated by the OECD.
WholeGMFoodsandFeeds
If the composition of the GM plant is substantially modified, or if there
are any indications for the potential occurrence of unintended effects
based on the preceding molecular, compositional, or agronomic anal-
yses, the whole GM food or feed should be tested in a 90-day toxic-
ity study in rodents. Special attention must be paid to the selection of
doses to avoid nutritional imbalances as well as to an adequate interpre-
tation of statistical analyses. The importance of the latter is highlighted
by the controversy caused by a publication of S eralini and colleagues
in March 2007.
41
Supported by Greenpeace Germany, S eralini and col-
leagues reanalyzed the statistical data of a ninety-day feeding study in
rats and came to the conclusion that “with the present data it cannot be
concluded that GM cornMON863 is a safe product.” The EFSA
42
as well
as the Agence Fran¸aise de Securite Sanitaire des Aliments (AFSSA)
41
Seralini G.-E., Cellier, D., Spiroux de Vendomois, J. (2007): New Analysis of a Rat
Feeding Study with a Genetically Modified Maize Reveals Signs of Hepatorenal Toxi-
city. Arch. Environ. Contam. Toxicol., Online-First Ausgabe 13Marz 2007 (http://www
.springerlink.com/content/02648wu132m07804/fulltext.html).
42
See http://www.efsa.europa.eu/en/scdocs/doc/GMO statement MON863.pdf.
