Safety Assessment of GM Foods - ANBio


21 Φεβ 2013 (πριν από 5 χρόνια και 4 μήνες)

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Food Biotechnology in Canada

Regulation and Safety Assessment Approach

Workshop on Food Safety Assessment of Foods derived from Recombinant
DNA Plants
(Rio de Janeiro, Brazil

Sept. 8
11, 2002)

Mireille Prud’homme

Acting Associate Director

Bureau of Food Policy Integration

Food Directorate,

Health Canada


Regulation of Biotechnology Products

Health Canada

Food and Drugs Act


foods, drugs, cosmetics, medical devices

Pest Control Products Act


Canadian Food Inspection Agency (CFIA)

Seeds Act



Feeds Act


animal feeds

Fertilizers Act



Health of Animals Act


veterinary biologics

Environment Canada

Canadian Environmental Protection Act

new substances


Regulation of Novel Foods

(including GM Foods)

Food & Drugs Act

Novel Foods Regulation

Canada Gazette Part II, October 27, 1999

Notification prior to sale or advertising

Allows Health Canada to assess the safety and
nutritional quality of novel foods before they can be
sold or advertised for sale in Canada


What is a novel food?

A substance, including a microorganism, that does not
have a history of safe use as a food

A food that has been manufactured, prepared,
preserved or packaged by a process that:

has not been previously applied to that food, and

causes the food to undergo a major change

A food that is derived from a plant, animal or
microorganism that has been genetically modified


Why do we Regulate Novel Foods?

market notification in order to assess:

potential introduction of toxic compounds and allergens

changes in nutritional and compositional characteristics

potential for beneficial and adverse effects (short term
and long term)


Safety Assessment of GM Foods

Provides assurance that food will not cause harm to
the consumer when it is prepared and/or consumed
according to its intended use

Existing traditional foods are considered to be
safe through their long history of use even though they
may contain anti
nutritional factors or toxic substances
(e.g., trypsin inhibitors in soybean)


Safety Assessment of GM Foods

Health Canada Guidelines for the Safety Assessment
of Novel Foods (1994)

wise, scientific evaluation

data and scientific protocols are critically examined

house expertise in molecular biology, toxicology,
chemistry, nutritional sciences and microbiology

intended and unintended changes considered


Safety Assessment of GM Foods

We examine how the food crop was developed,
including a full description of the genes involved and
their integration into the modified product;

Composition of the novel food compared to non
modified counterpart foods;

Nutritional information for the novel food compared to
modified counterparts;

Potential for production of new toxins; and

Potential for causing allergic reaction


Development and Production of the
Modified Organism

This part of the assessment considers:

Host and donor organisms

Introduced DNA and its expression

Modified organism and its metabolism

Data to characterize the modified organism and
permit comparison to the traditional counterpart


Dietary Exposure

This part of the assessment considers:

Details of the levels of the modified organism and/or its
metabolites in the finished food

Anticipated use pattern and dietary intake estimates for
the food in question

Level of exposure plays a key role in determining
the extent of data (nutritional and toxicological)
that may be required


Nutritional Assessment

Foods undergo nutritional assessments to determine
the potential for any nutritional changes (may require
animal studies).

Identification of micro and macro
nutrients relevant to
the food (e.g., vitamins, specific amino acids, lipids).

Any differences are evaluated for the risk to human
health when consumed as a food.


Toxicity Assessment

of Newly Expressed Proteins

The toxicity assessment focuses on the human safety of
introduced proteins and on the potential for unintended
changes in known toxins or anti
nutrients in the food

We consider:

Potential for the protein to be a toxin in humans

Enzymes could produce metabolites of unknown


Toxicological Data

Traditional approaches to toxicological studies are
applicable to assessment of individual compounds or
simple mixtures.

Evaluation of whole foods using traditional approaches
provides technical difficulties. Work is underway to
develop appropriate methods.


Allergenicity Assessment

of Newly Expressed Proteins

Potential to be allergenic:

Is the source of the transferred genetic material
known to be allergenic?

Sequence homology to known allergens?

Stability to trypsin treatment

Heat and processing stability




Molecular biology


Additional Information

Required for Evaluation?



Assessment Completed by all


Food Rulings Proposal


Food Directorate Senior

Management Review

Letter of No Objection sent

to Petitioner

Decision Document posted

on Health Canada Website



Request for



of Novel Food


Safety Assessment

Key Concepts

Based upon scientific principles developed through expert
international consultations with WHO, FAO and OECD.

Comparative approach to existing foods with a history of
safe use in the diet.

Differences identified in the comparison are subjected to
further studies as appropriate.

Assessment considers impact of new trait or component
in the modified organism, and the final food.


GM foods

What have we assessed so far?

More than 50 GM foods approved to date

Most are derived from 10 common food crop species:


canola, corn, soybean, potato, tomato, etc.

First Generation of Modified Food Plants

Agronomic traits: improved pest resistance, herbicide

tolerance, etc.

Other traits: slow ripening and modified oil composition


Independent Expert Advice

on the Regulation of Food Biotechnology

Report of the Royal Society of Canada’s Expert Panel on
the Future of Food Biotechnology (February 2001)

Government action plan and first two progress reports available
on website. Next progress report to be published in December.

Report of the Canadian Biotechnology Advisory Committee
on the regulation of GM foods (August 2002)

Detailed government response anticipated to be published by the
end of this year.




Novel Food Decision Documents


Novel Foods Regulation and Guidelines for the Safety
Assessment of Novel Foods


Questions and Answers


Action plan in response to recommendations of the
Expert Panel on the Future of Food Biotechnology