From Wikipedia,
the free encyclopedia.
In the early-to mid
1990s, with the development
and commercialisation of
genetically modified food
becoming an imminent possibility,
national and
international authorities
began to consider a suitable
regulatory framework for the
new technologies. The "substantial
equivalence" approach was
eventually adopted. The exact
definition of "substantial
equivalence" in this context is
hard to pin-down and this has led
to several conflicting
interpretations.
Initially, it was thought that
if a genetically modified food was
"substantially equivalent" to its
traditional counterpart, a
risk assessment would not be
necessary. The test compared
attributes such as
protein,
carbohydrate and
fatty acid levels between the
novel food and its traditional
counterpart. However, there were
no clear and universal guidelines
stipulating what to test and how
similar the items in question
should be. It has been said that
the amount of comparative data
required to establish "substantial
equivalence" involved "a somewhat
subjective judgement" (Royal
Society 2002: 5-6).
So, the approach proved
immensely controversial. Consumer
organisations, environmental
groups and a few leading
scientists criticised "substantial
equivalence" for helping to play
down the novelty of
genetic engineering and
facilitating its commercialisation.
Over the years, the approach has
come to mean something very
different and it has ultimately
been demoted in the regulatory
framework - albeit implicitly.
Europe and the United States
currently differ in their
implementation of "substantial
equivalence". In Europe, the
capability to classify a novel
food as being "substantially
equivalent" no longer justifies a
lack of safety assessments. The
European regulatory process now
places much more emphasis on
identifying the unintended
consequences of genetic
modification. Moves are being made
to develop better methods for
testing composition,
metabolic activity,
toxicity,
allergenicity, etc. Presently,
the official European consensus is
that "substantial equivalence"
should only be used to guide or
inform safety assessments. It
should be seen as a starting point
in the regulatory process rather
than an end point. However, in the
United States "substantial
equivalence" still plays a
significant (if slightly
diminished) role in the regulation
and commercialisation of
genetically modified foods.
See also
Bibliography
