GENTECH archive


RE: substantial equivalence


See e.g.
Food Safety Considerations, Safety Assessment

This document seems to be describing the report of the 1990 joint FAO/WHO

I've extracted a few phrases ; perhaps someone can tell us how much sense
they make.


"The presence in foods of new or introduced genes per se was not
considered by the Consultation to present a unique food safety risk since
all DNA is composed of the same elements."

"When a food product is determined to be substantially equivalent to an
existing counterpart except for defined differences, it was concluded by
the Consultation that further safety assessment should focus only on those
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. This category could also
include products from genetic modification and that have been shown to
produce an unintended substance(s) if that unintended substance(s) is
clearly defined. The safety of introduced DNA and messenger RNA (mRNA) per
se is not an issue. However, the stability of introduced genetic material
and the potential for gene transfer are relevant issues in the assessment.
The potential for gene transfer is addressed in Section 6.2. Stability of
introduced genetic material should be addressed during both the molecular
characterization and the performance evaluation of the genetically
modified organism in the development process. These processes minimize the
likelihood of unintended effects in subsequent generations.

The Consultation considered that the majority of genetically modified
products will result from the introduction of genetic material and
therefore concentrated on the safety assessment of these types of
products. However, the approaches described herein are equally applicable
to the assessment of the safety of products which have been genetically
modified by other means. The approach to assessing the safety of food
products having inserted genetic material should focus on the gene
product(s) and their function, including the products produced as a result
of their function. The introduced genetic material will typically encode
one or more proteins. The safety assessment should concentrate on both the
safety of the expressed protein(s) as well as the products produced as a
result of the expressed protein(s). These products will most likely
include; fats, carbohydrates or modified or new small molecule components
(modification of endogenous components or production of new components)."