This Guideline supports the Principles for the Risk Analysis of
Foods Derived from Modern Biotechnology. It addresses safety and
nutritional aspects of foods consisting of, or derived from, plants
that have a history of safe use as sources of food, and that have
been modified by modern biotechnology to exhibit new or altered
expression of traits.
This document does not address animal feed or animals fed with the
feed. This document also does not address environmental
The Codex principles of risk analysis, particularly those for risk
assessment, are primarily intended to apply to discrete chemical
entities such as food additives and pesticide residues, or a
specific chemical or microbial contaminant that have identifiable
hazards and risks; they are not intended to apply to whole foods as
such. Indeed, few foods have been assessed scientifically in a
manner that would fully characterise all risks associated with the
food. Further, many foods contain substances that would likely be
found harmful if subjected to conventional approaches to safety
testing. Thus, a more focused approach is required where the safety
of a whole food is being considered.
This approach is based on the principle that the safety of foods
derived from new plant varieties, including recombinant-DNA plants,
is assessed relative to the conventional counterpart having a
history of safe use, taking into account both intended and
unintended effects. Rather than trying to identify every hazard
associated with a particular food, the intention is to identify new
or altered hazards relative to the conventional counterpart.
This safety assessment approach falls within the risk assessment
framework as discussed in Section 3 of the Principles for the Risk
Analysis of Foods Derived from Modern Biotechnology. If a new or
altered hazard, nutritional or other food safety concern is
identified by the safety assessment, the risk associated with it
would first be assessed to determine its relevance to human health.
Following the safety assessment and if necessary further risk
assessment, the food would be subjected to risk management
considerations in accordance with the Principles for the Risk
Analysis of Foods Derived from Modern Biotechnology before it is
considered for commercial distribution.
Risk management measures such as post-market monitoring of consumer
health effects may assist the risk assessment process. These are
discussed in paragraph 20 of the Principles for the Risk Analysis
of Foods derived from Modern Biotechnology.
The Guideline describes the recommended approach to making safety
assessments of foods derived from recombinant-DNA plants where a
conventional counterpart exists, and identifies the data and
information that are generally applicable to making such
assessments. While this Guideline is designed for foods derived
from recombinant-DNA plants, the approach described could, in
general, be applied to foods derived from plants that have been
altered by other techniques.