GENTECH archive


Substatial Equivalence

Soory to be late. I hope it could help.

> Subject: Is substantial equivalence scientific ?
> Date: Tue, 15 Jun 1999 19:52:13 +0100
> From: Robert <>
> It appears that in reviewing GM foods for consumption the relevant bodies
> look to see if the novel food is "substantially equivalent" to an existing
> natural product.
> Is there a definition of exactly what "substantially equivalent" means in
> terms of a genetically modified organism.

The general approach for substantial equivalence has been
defined by several governmental and intergovernmental
organizations as follows:

OECD - Organisation for Economic Co-operation and

The concept of substantial equivalence embodies the idea
that existing organisms used as food, or as a source of
food, can be used as the basis for comparison when assessing
the safety of human consumption of a food or food component
that has been modified or is new. If one considers a
modified traditional food about which there is extensive
knowledge on the range of possible toxicants, critical
nutrients or other relevant characteristics, the new product
can be compared with the old in simple ways. These ways can
include, inter alia, appropriate traditionally performed
analytical measurements (for example, alkaloid levels in
potatoes, cucurbatin in vegetable squash cultivars, and
psoralens in celery) or crop-specific markers, for
comparative purposes. The situation becomes more complex as
the origins/composition/exposure experience decreases, or if
the new products lack similarity to old established products
or, in fact, have no conventional counterpart.[

CFIA Canada - Canadian Food Inspection Agency: 

Substantial Equivalence: the equivalence of a novel trait
within a particular plant species, in terms of its specific
use and safety to the environment and human health, to those
in that same species, that are in use and generally
considered as safe in Canada, based on valid scientific

DG XXIV - EU - European Union - Scientific Committee on

The concept of "substantial equivalence" in the context of
the SCF Opinions on the Assessment of Novel Foods (SCF
1996a,1996b,1996c) embodies the idea that existing organisms
or products used as foods or food sources, can serve as a
basis for comparison when assessing the safety and
nutritional value of a food or food ingredient that has been
modified or is new. If a new food or food ingredient is
found to be substantially equivalent to an existing food or
food ingredient, it can be treated in the same manner with
respect to safety and nutritional value, keeping in mind
that establishment of substantial equivalence is not a
safety or nutritional assessment in itself, but an approach
to compare a potential new food with its conventional
Giovanni Ferraiolo -     
ICGEB Biosafety -

International Centre for Genetic Engineering and Biotechnology
Area Science Park, Padriciano 99,  I-34012 Trieste (Italy)  
Tel: +39 040 3757364 - Fax: +39 040 226555