What is Substantial Equivalence?
AgCare Fact Sheet Reference: FS008
The attempt to improve any plant or food can lead to
unexpected consequences. Therefore, the safety of any plant with novel traits
or any novel food is carefully assessed before it is allowed to be released
into the environment or food system without restriction. When the safety of a
new product is assessed, it is first compared with the familiar plant or
product to which it is most similar or most closely related that has been
traditionally grown or used safely in this country. For example, a potato
variety into which genes for resistance to Colorado potato beetle had been
introduced would be compared against that same variety without the added
genes.
To be considered substantially equivalent, a particular
plant species with a novel trait must be the same, with respect to its specific
use and safety to the environment and human health, as types of that same
species that are in use and generally considered to be safe in Canada, based on
valid scientific rationale.
If it can be demonstrated that a new product will not affect
the environment, including human health, differently than its traditional
counterpart, then the new product is considered substantially equivalent to the
existing product. A new product that is substantially equivalent to its
traditional counterpart is treated in the same manner as the traditional food
with respect to safety, and no additional requirements are imposed. On the
other hand, when a novel food differs from its traditional counterpart, a
detailed safety assessment must be undertaken. Products that have no familiar
counterparts are required to undergo full-scale safety assessments.
In Canada, the determination of substantial equivalence is
made by the Canadian Food Inspection Agency (CFIA). In its assessment, CFIA
reviews a wide spectrum of information relating to the novel trait and the
modified organism that encompasses current knowledge of:
·
the composition and characteristics of the traditional or parental
product or organism
·
the new characteristic derived from information concerning:
o
the manner in which the characteristic is expressed in the
organism from which it was transferred
o
the effect of transformation techniques as they relate to
understanding the characteristics of the product, including the vector(s) and
any marker genes used
o
possible secondary effects of the modification
o
the description of the characteristic as expressed in the
new organism
·
the new product/organism, including the characteristics and
composition as compared with the conventional counterpart(s) (i.e., the
existing food or food component).
Internet Resources:
The Safety-Based Approach to Regulation (CFIA)
http://www.cfia-acia.agr.ca/english/ppc/biotech/safety.html
Biotechnology and Food Safety: Long Term Testing/Substantial
Equivalence (CFIA)
http://www.cfia-acia.agr.ca/english/ppc/biotech/longe.html
Regulatory Directive Dir94-08: Assessment Criteria for
Determining Environmental Safety of Plants With Novel Traits (CFIA)
http://www.cfia-acia.agr.ca/english/plant/pbo/dir9408e.html
July 19, 1999