Food > Biotechnology > Labelling
Communiqué "Labelling of Novel Foods Derived Through
Genetic Engineering"
Summary of Comments
Released: December 1, 1995
Please note: The formal consultation for these guideline proposals has
closed but your comments are still welcome.
The following document contains proposed guidelines for the
labelling of novel foods derived through genetic engineering. Development of
the proposed guidelines are the result of a series of consultations with a wide
audience of interested participants.
Once finalized, the guidelines will serve as the Government of
Canada's policy on the requirements for labelling of novel foods derived
through genetic engineering.
The first foods and food ingredients developed through genetic engineering
have reached commercialization and more are nearing distribution. In response
to these developments, Canada and the other 143 member states of the joint
FAO/WHO international food standard
setting organization, the Codex Alimentarius Commission, are evaluating
questions regarding appropriate labelling requirements for novel foods derived
through genetic engineering. An initial series of consultations has been
completed in Canada on the labelling of novel foods derived through genetic
engineering. Based on the comments received from these fora, a series of points
of general consensus and a number of proposed guidelines have been developed.
These proposed guidelines, and the rationale underlying their development, are
outlined below in the"Discussion Summary, Points of General Consensus and
Guideline Proposals" section of this document.
The purpose of this communique is to elicit comment from a wide audience of
interested parties on the points of consensus and proposed guidelines respecting
consumer information that have been developed and applied to date on an interim
basis with respect to the labelling of novel foods derived through genetic
engineering.
The results of this consultative process will form the basis of the Canadian
position for the upcoming Codex Alimentarius Food Labelling Committee meeting
to be held in Ottawa in May 1996. In addition, it is anticipated that comments
received on the points of consensus will support the application of the
proposed guidelines, or serve as the basis for their appropriate
modification.
Novel foods are:
- Foods that have not previously been used as food,
- foods from a process not previously used for food in Canada, or
- foods modified such that:
- the food results from genetic manipulation and exhibits one or more
characteristics that were not previously identified in that food, or the food
results from production by a genetically manipulated organism exhibiting such
new characteristics,
- the food contains microorganisms not previously used as a food or to
process food, or
- the food is modified from the traditional product or produced by a process
that has been modified from the traditional process (Novel Food Guidelines,
September 1994).
Genetic engineering is:
- The transfer of characteristics, through specific genetic information,
from one organism to another. Genetic engineering is a relatively new technique
of biotechnology -- the umbrella term describing a broad spectrum of
applications used to produce new products. A combination of genetic engineering
with traditional methods allows for the development of plants, animals and
foods with novel characteristics.
Labels on food products in Canada serve three main functions:
- To ensure adequate and accurate information relative to health, safety and
economic concerns and to assist consumers in making food choices;
- To protect consumers and industry from fraudulent or deceptive labelling,
packaging, and advertising practices; and,
- To promote fair competition and product marketability.
The responsibility for the establishment of non-safety food labelling policy
in Canada lies with Agriculture and Agri-Food Canada (AAFC). For specific labelling
requirements based on health or safety considerations, Health Canada assumes the
principal responsibility for policy setting, while AAFC or Fisheries and Oceans
administers this policy.
Food labelling in Canada is regulated primarily under the authority of the
Food and Drugs Act. Regulations under this Act require that labels
contain, among other things, the following basic information: common name, list
of ingredients, name and address of manufacturer or other responsible party,
durable life information on products with a shelf life of up to 90 days, and
various other product specific information (such as % milk fat in certain dairy
products), and specific information in support of nutrition claims. In addition
to the basic information, there are comprehensive guidelines controlling
nutrition and marketing claims.
Regulations under the Consumer Packaging and Labelling Act require
net quantity designations.There are also specialized labelling requirements
under the Canada Agricultural Products Act,the Meat Inspection
Act and the Fish Inspection Act dealing with grade statements,
country of origin and other specific commodity information. Advertisements for
food and beverages are subject to the requirements of the Food and Drugs
Act and the Consumer Packaging and Labelling Act .
Prior to drafting this communique, several public consultations were
conducted.
- November 1993 -- At the Workshop on Regulating Agricultural
Products of Biotechnology held in Ottawa November 8-10, 1993, a range of views
was expressed regarding the labelling of genetically engineered foods.
Consensus was reached among participants regarding the need for appropriate
labelling for health and safety issues. It was apparent that further
consultation among all interested parties would be necessary, however, in order
to provide a clear outline of other fundamental principles that needed to be
considered when developing policy, guidelines or regulations for the labelling
of novel foods derived through genetic engineering.
- October 1994 -- The Codex Alimentarius Committee on Food Labelling
(CCFL) is the forum
that sets international food labelling standards and guidelines aimed at
protecting the health of consumers,ensuring fair practices in food trade, and
promoting harmonization of food standards and labelling requirements. The
standards established by the Codex Alimentarius Commission have been accepted
as the basis for the Sanitary and Phytosanitary agreement of the World Trade
Organization.
At the Codex Food Labelling Committee meeting on October 24-28, 1994, member
countries discussed the issue of the labelling of genetically engineered foods.
During these initial discussions, views were generally split among countries
favouring mandatory food labelling only for instances involving the introduction
of any potential health and/or safety concerns to food products, and those
countries advocating that labelling be required under all circumstances. All
countries were asked to develop a more definitive national position for
discussion at the next Labelling Committee meeting in Ottawa in May 1996.
During their July 1995 meeting, the 21st session of the Codex Alimentarius
Commission approved the principle that Codex Alimentarius food standards shall
be based on sound scientific analysis to assure the quality and safety of the
food supply.
- November 1994 -- The departments responsible for the labelling of
food in Canada - Agriculture and Agri-Food Canada, Industry Canada, Health
Canada, and the Department of Fisheries and Oceans convened a Technical
Workshop on the Labelling of Novel Foods Derived Through Genetic
Engineering in Ottawa on November 24-25, 1994. This workshop served as a
first step in the process of developing a Canadian labelling policy for novel
foods derived through genetic engineering. Participants represented a wide
range of stakeholders including universities, nutritionists, dietitians,
manufacturers, distributors, processors, producers, consumer groups,
advertisers, commodity organizations, organic growers, environmental and food
non-governmental organizations, provincial governments and the federal
government.
November 1994 workshop participants were asked to consider a number of
questions and points of fact. General consensus was reached on a number of
issues. Subsequently, these points of general consensus served as the basis for
the development of the proposed labelling guidelines. The background
discussion, points of general consensus and resulting guideline proposals are
as follows:
- Should Novel Foods Derived Through Genetic Engineering be
Labelled?
Health Canada is currently developing regulations which will require
notification prior to the sale, or advertising for sale, of novel foods,
including those developed using genetic engineering. Guidance regarding the
notification and information necessary to conduct a safety assessment of foods
derived from genetically modified plants and microorganisms is provided in the
document,"Guidelines for the Safety Assessment of Novel Foods, Volume
I and II". Safety
evaluations of genetically engineered products may include an assessment of:
the composition of the novel product and comparison to the composition of its
traditionally derived counterpart; the impact of the inserted genetic material
(novel trait) on the nutrient content of the food; and the toxicological
properties of the food as necessary. In addition, the issue of allergenicity
would be addressed where potential allergens are present in the food.
Workshop participants unanimously agreed that where there is an identified
health and/or safety risk for certain individuals or population segments
related to a novel food derived through genetic engineering, e.g. the introduction of an allergen, consumers need this
information, and it should be provided through labelling.
The allergens of concern are those causing severe adverse reactions. As part
of the regulatory review of the Food and Drug Regulations currently
underway, a priority list of foods causing adverse reactions, e.g., allergens, is being developed by Health Canada and
Agriculture and Agri-Food Canada with the aim of requiring their label
disclosure under all circumstances.
Participants also agreed that if a foods composition was altered
significantly, e.g. through a significant
nutrient change, this information should be indicated on the product label.
Nutrient changes could also be grounds for non-acceptance of a product if, for
example, a significant reduction in nutritional quality has occurred.
Alternately, consideration could be given to assigning a new common name for the
product, if changes were major. New names have been assigned to foods with
modified composition in the past. As an example, rapeseed was renamed
'canola' when certain varieties were transformed through the use of
traditional plant breeding techniques into edible food product(s).
- General Consensus:
The labelling of novel foods derived through genetic engineering should be
required to identify:
- potential health and/or safety risks for certain individuals or population
segments and
- significant compositional or nutritional changes from the traditional food
source(s).
- Guideline Proposal #1:
Labels of novel foods or novel food ingredients derived through genetic
engineering must identify the presence of:
- potential health and/or safety risks for individuals or population segments
(e.g. the introduction of food allergens);
and/or,
- significant compositional or nutritional changes from the traditional food
source which have occurred in the product (eg.
a change in the fatty acid profile of vegetable oil).
- The Consumers' Right To Know
There was unanimous agreement among workshop participants that consumers
have a right to information in order to make informed choices about the purchase
of food products. Government and industry were seen to have an obligation to
provide information that would assist consumers to make these choices.
Some participants asserted that only full disclosure on a label of all
components of a product would satisfy the right to know. Others were concerned
that it may not be possible for Health Canada to determine all long-term risks
during pre-market assessments and that the labelling of all foods subjected to
genetic engineering would therefore be necessary for those who wished to avoid
such foods.
However, while participants agreed that consumers should have access to this
information and that manufacturers have an obligation to provide it, it was
also recognized that providing it on the label could be highly impractical, and
that the label itself should be generally reserved for identifying health and
safety concerns. The label was seen as only one option for making information
available to consumers related to the production techniques used in the
development of the food and not necessarily the most appropriate vehicle in all
cases. It was considered that alternative methods should be examined. Workshop
participants identified a number of additional means of providing information of
this nature to the consumer, including:
- Point of sale information
- Centralized databanks of information
- Internet
- 1-800 telephone numbers on the label
- Advertising
- Public service announcements
- Mass media
For those wishing to avoid novel foods derived through genetic engineering,
access to organic foods was suggested as an alternative option. Organic methods
of production do not permit the use of genetically engineered products.
Production standards for organic foods are currently being placed in federal
regulations under the Canada Agricultural Products Act. Workshop participants
felt it might also be possible for individuals or organizations to establish
additional mechanisms, such as certification boards, to ensure that only
traditionally derived food sources were used in certain foods and food
products.
A general consensus emerged that a blanket statement on the label of all
novel foods derived through genetic engineering to indicate that they have been
developed utilizing the process of genetic engineering, was unnecessary.
Participants believed that if the food had undergone a safety review by Health
Canada and been determined to be safe, and no specific labelling was required
to identify the presence of potential allergens or to indicate that significant
compositional changes had occurred, blanket labelling should not be
required.
A concern with blanket labelling was that such requirements, especially if
required to appear on products that are used to produce a wide range of other
foods (eg. tomatoes used to make tomato paste,
soups, sauces, ketchup, pizza, etc.) could
eventually result in the great majority of all food product labels bearing a
statement regarding genetic engineering. This situation could potentially cause
important health or safety information to be overlooked by those individuals
who require it, e.g., persons with severe food
allergies or hypersensitivities. An added consideration was the increased costs
that companies and ultimately consumers would likely face in the form of higher
product prices, if a blanket labelling policy were adopted.
- General Consensus:
While acknowledging the right of consumers to information regarding the
composition of the foods they purchase, a blanket labelling policy to
specifically identify novel foods derived through genetic engineering would not
provide the consumer any additional information regarding the safety of the
food.
- Guideline Proposal #2:
Unless potential health and/or safety, or significant nutritional or
compositional changes have occurred, (as per proposal #1) the fact that the
process of genetic engineering has been utilized need not be identified on food
labels.
- What Should Appear on a Label?
Participants at the November 1994 workshop agreed that labels should:
- be kept as simple as possible,
- be relevant and understandable, and
- be truthful and not misleading.
Workshop participants also believed that for those companies that wished to
label their food products as 'derived through genetic engineering'
(voluntary positive labelling) or 'not derived through genetic
engineering' (voluntary negative labelling), it was important that clear
criteria be developed to ensure consistency. Once the criteria are in place,
labels should be reviewed as required by the responsible department, to
determine their appropriateness.
From a regulatory stand point, negative labelling of non-genetically
engineered foods, e.g., 'this product was
not produced using genetic engineering', can be used in accordance with
current policy, provided the statement is truthful and not misleading. Such
labelling, however, was seen by many to convey an unnecessarily negative image
about comparable foods which have been derived through genetic engineering.
Some participants suggested that an alternative, more positive statement,
indicating that the food was produced using conventional technologies, would be
a more appropriate approach.
As indicated earlier, participants believed that labels should be reserved
for providing critical information on identified health and safety risks for
certain individuals or population segments, e.g., allergens. In addition, there was general consensus
that if there was significant compositional alterations to the food, e.g., altered fatty acid composition of vegetable
oil, this fact should require declaration on the label. A major compositional
change to the product may also require a new common name.
- General Consensus:
Food labels should be understandable, truthful and not misleading. Voluntary
labelling is acceptable but it must be truthful. Criteria for labels to ensure
consistency should be developed and put in place. The required labelling
information should address any health/safety, nutritional or compositional
change to the food that may be of concern to consumers, rather than focussing
on the process used to obtain the change.
- Guideline Proposal #3:
- The labelling of novel foods or food ingredients derived through genetic
engineering should be understandable, truthful and not misleading;
- Voluntary positive labelling that is intended to indicate that a novel food
or novel food ingredient has been produced by, or has particular attributes
resulting from, genetic engineering is acceptable, on condition that the claim
is not misleading or deceptive and the claim itself is factual. Responsible
parties should be in a position to support the claim(s) being made. (Violations
would be subject to the enforcement measures and penalties provided under the
Food and Drugs Act).
- Voluntary negative labelling that is intended to indicate that a novel food
or novel food ingredient has been produced without the use of genetic
engineering, is acceptable, on condition that the claim is not misleading or
deceptive and the claim itself is factual. Responsible parties should be in a
position to support the claim(s) being made. (Violations would be subject to
the enforcement measures and penalties provided under the Food and Drugs
Act).
- How Should Dietary Restrictions Based on Religious Requirements Be
Addressed?
The general view of the participants was that the role of government is to
address health, safety and fraud issues, and that dietary preferences based on
religious grounds should be accommodated through existing control mechanisms
established by the religious groups concerned, e.g., food production, handling and processing systems
based on the requirements of Jewish (Kosher) or Islamic (Halal) law.
- General Consensus:
Dietary restrictions based on religious requirements could adequately be
addressed within the existing regulatory framework of religious groups with no
additional procedures required.
- Guideline Proposal #4:
Dietary restrictions based on religious requirements is outside the current
mandate of government and is being adequately addressed within the present
regulatory framework of religious groups. A guideline provision is not
therefore required.
- How should Canada proceed with respect to its international trading
partners?
In view of Canada's international trade commitments, it was felt that
Canada's ultimate approach to the labelling of novel foods derived through
genetic engineering should be harmonized, where possible, with international
standards.
- General Consensus:
In the development of its labelling policy, in addition to considering
domestic labelling needs, Canada should also consider the need for consistency,
where possible, with the principles of its major trading partners and
international standards.
- Guideline Proposal #5:
Canada must consider both domestic and international needs in food labelling
matters.
The proposed guidelines outlined above have been used in Canada on an
interim basis to determine what, if any, labelling requirements should be
applied to those novel foods derived through genetic engineering which have
been approved for sale in Canada.
For example, microbial enzymes are used in cheese production. Previously,
all of the commercial rennin, a milk clotting enzyme used to make cheese, came
from rennet taken from the lining of slaughtered calves' stomachs.
Recently, a rennin (chymosin) derived from genetically modified
microorganisms has been introduced into the marketplace. Chymosin is produced
through a fermentation process that does not require calves' stomachs, and
offers a more consistent, reliable supply. Chymosin is utilized in numerous
processed dairy products, e.g., cheese, in the
same manner as calves' rennet. Health Canada conducted a thorough safety
evaluation of this enzyme. No specific labelling was determined to be required
to indicate that the chymosin was derived through genetic engineering, based on
health, safety or compositional changes.
Health Canada has recently concluded its safety evaluation of a new tomato
variety genetically engineered in a manner that delays softening upon ripening.
No special labelling will be required based on health, safety or composition
reasons. Health Canada had no objection to factual statements made in
promotional materials accompanying the tomato at point of sale which explained
that the novel trait was achieved through genetic engineering.
Several genetically engineered canola varieties have recently undergone food
and environmental safety reviews. The modifications were agronomic traits and
conferred no change to the edible portion (vegetable oil) of the plant and thus
no special labelling was required.
New canola and other edible oilseed crops are on the horizon
wherein there will be changes to the composition of the edible oil, e.g., oil modified to reduce the saturated fat content.
Because a significant compositional change is involved these modifications would
be made known to the consumer on the product label.- - - -
-
This bulletin is published by the Food Inspection Directorate. For further
information, please contact:
- Associate Director
- Biotechnology Strategies and Coordination Office
- Food Inspection Directorate
- Food Production & Inspection Branch
- Agriculture and Agri-Food Canada
- 59 Camelot Drive
- Nepean, Ontario, K1A 0Y9
- Telephone: (613) 952-8000
- Facsimile: (613) 941-9421
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