Agriculture Reference
In-Depth Information
results, a guidance document for safety assessment was published in 2004
that served as a model for the guidelines later published by EFSA.
36
The
results of the ENTRANSFOOD project reassured the adequacy of the
comparative safety assessment strategy applied to GMO-derived foods.
The authors of the guidance document even argue “that foods from GM
crops are better characterized than other nonregulated plant-derived
foods, due to the additional rigor in the current regulatory require-
ments and testing regime compared to that for conventionally bred
crops.”
37
Common to all approaches to safety assessment of GMO is the con-
cept of substantial equivalence that was first described in the OECD
report that resulted from the work undertaken by a Group of National
Experts on Safety in Biotechnology and published in 1993.
38
It is based
on the idea that existing products used as foods or food sources can serve
as a basis for comparison when assessing the safety and the nutritional
value of a GMO-derived food. It implies that if the modified food is
found to be substantially equivalent to an existing food or food com-
ponent with regard to phenotypic and agronomic characteristics and
chemical composition, it can be treated in the same manner with respect
to safety. The concept of substantial equivalence is used as a starting
point and guiding concept for the safety assessment. It is considered a
pragmatic tool for identifying differences between a GMO and its non-
modified counterpart. Differences are then subject to further analyses
with regards to their impact on human health. The objective of the safety
assessment is to determine whether the new food is at least as safe as a
comparable food produced from conventional crops.
36
EFSA. 2004. Guidance Document of the Scientific Panel on GMO for the risk assess-
ment of genetically modified plants and derived food and feed. EFSA Journal 99, 1-94
(final, edited version of 28 April 2006, published in May 2006).
37
Konig, A. et al. 2004. Assessment of the safety of foods derived from genetically mod-
ified (GM) crops. Food and Chemical Toxicology 42 (7): 1047-1088.
38
OECD. 1993. Safety evaluation of foods derived by modern biotechnology - Concepts
and principles. Organisation for Economic Co-operation and Development (OECD),
Paris.