Substantial equivalence
In 1993 the Organisation for Economic Co-operation and Development (OECD)
introduced the concept of substantial equivalence into the discussion of the
safety evaluation of food from genetically modified organisms, a concept that
has been agreed upon by many countries.
Substantial equivalence in this regard means that a genetically modified plant,
or food derived therefrom, is equivalent to their conventional counterparts
and can be treated in the same manner with respect to safety as their conventional
counterparts.
Establishment of substantial equivalence is not a safety assessment in itself,
but a dynamic, analytical exercise in the assessment of the safety of a new
food relative to an existing food. The assessment of the safety of genetically
modified organisms must address both intentional and unintentional effects
that may result as a consequence of the genetic modification of the food source.
Products that are shown to be substantially equivalent to existing
foods or food components: These products are regarded as being as
safe as their counterpart and no further safety considerations other than
those for the counterpart are necessary.
Examples: Genetically modified bakers yeast, oil from genetically modified
oilseed rape
Products that are substantially equivalent to existing foods or food
components except for defined differences: In these cases a further
safety assessment should focus only on the defined differences. Typically,
the defined differences will result from the intended effect of the introduction
of genetic material that encodes for one or more proteins that may, or may
not, modify endogenous components or produce new components in the host organism.
Examples: Genetically modified bakers yeast, Triticale (a wheat/rye cross)
Products that are not substantially equivalent to existing foods or
food components: Up to now and probably for the near future, there
have been few examples of foods or food components produced using genetic
modification which could be considered to be not substantially equivalent
to existing foods or food components. Nevertheless, it is conceivable that,
with future developments in biotechnology, products could be developed which
could be considered to have no conventional counterpart and for which substantial
equivalent cannot be applied.
Examples: Carbohydrate polyesters, Kiwi fruit |