Background Paper
Biotechnology and Labeling for Prepackaged Foods
The Issue: The application of modern biotechnology to food and relevant labeling policy has
been the subject of a global debate for several decades. Yet there has not evolved a harmonized
approach to labeling policy for foods derived from biotechnology. The U.S., Canada and other
countries have developed voluntary labeling regimes. The European Union requires the labeling
of any product and/or ingredient that may be derived from biotechnology. Other nations have
required labeling according to thresholds, for primary ingredients only or for a limited list of
products.
Background: Discussion on the appropriate labeling of foods derived from biotechnology was
initiated by the Executive Committee of Codex in 1988. The 19th Session (July 1991) of the
Codex Alimentarius Commission requested the Codex Committee on Food Labelling (CCFL) to
“provide guidance on how the fact that a food was derived from ‘modern’ biotechnology could
be made known to the consumer.”1 This prompted a debate that lasted over twenty years.
During this time, the Commission twice created an ad hoc intergovernmental task force under the
leadership of Japan that found consensus to complete several important science based texts on:
 Principles for the Risk Analysis of Food Derived from Modern Biotechnology;
 Guidelines for the Conduct of Food Safety Assessment of Food Derived from
Recombinant-DNA Plants;
 Guidelines for the Conduct of Food Safety Assessment of Foods Produced using
Recominant-DNA Micro-organisms; and
 Guideline for the Conduct of Food Safety Assessment of Foods Derived from
Recombinant-DNA Animals.
Codex Status: In 2011, after years of controversial discussion including several physical
working groups and a facilitated session, Codex reached consensus on how Codex should
address labeling of foods derived from biotechnology. The compromise reached endorses
neither a voluntary or mandatory approach but recognizes the different approaches of national
governments. The Codex text underscores that national labeling approaches must be consistent
with other Codex standards and references the relevant Codex standards and guidelines including
the general standards on labeling and claims and the work produced by the ad hoc task force.
The Codex language underscores that it is “not intended to suggest or imply that foods derived
from modern biotechnology are necessarily different from other foods simply due to their
method of production.”
1
ALINORM 91/40, Report of the 19th Session of the Codex Alimentarius Commission, 1st-10th July 1991, Rome,
para 90.
August 2012
Industry Engagement: ICGMA and other industry NGOs were very outspoken on this issue.
Industry agrees that for consumers buying packaged foods, the label is the single most important
resource because it contributes to their first impression about the product and it communicates
information that helps them make their purchase decisions. Labels list essential information such
as ingredients and quantities, describe features, give instructions, explain benefits, and deliver
advisories and warnings. Information considered critical to health and safety is mandated by law
to appear on the label.
Nonetheless, the amount of material that can be incorporated on a label is limited by its size and
by the ability of consumers to absorb information. The label cannot tell every consumer
everything he or she might want to know about every product, because consumers have different
priorities. Label space must effectively convey material information about nutrition, ingredients
and safe use. Unnecessary information on a label can drown out critical messages, or worse,
confuse consumers.
Over a century of experience at regulatory agencies around the world has yielded the basic
elements of successful consumer protection regulation. The legal system should prohibit product
claims that deceive consumers. It should expect manufacturers to have the evidence appropriate
to substantiate claims that they make
The protection of the consumer requires essential information to be displayed on labels of foods
including such basics as the quantity, ingredients, nutrition and appropriate use of the contents of
a package. A label that effectively meets the needs of targeted consumers may also
communicate other information. That information may be voluntary in nature but any claims
A sound labeling policy can and should recognize the rights of consumers to a safe and nutritious
food supply, while facilitating consumer choice based on meaningful information about the
product itself. A policy should mandate essential information and allow voluntary claims about
modern biotechnology that are accurate and can be substantiated. The language adopted by
Codex in 2011 does not guarantee that national governments will not mandate labeling for foods
of biotechnology but should ensure that labeling is accurate and truthful, does not create an
erroneous impression of the character of the food and that principles of risk analysis are
considered.
International Council of Grocery Manufacturer Associations
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Washington, DC 20005 USA
tel: +1 (202) 337 9400 · fax: +1 (202) 337 4508
August 2012