1. 1
What is Pre-market Safety
Assessment of Genetically
Modified Food ?
20 Jun 2013

2. 2
Presentation Outline
 Introduction to genetically modified (GM) food
 Pre-market safety assessment of GM food

3. 3
What is GM food?
 Use biotechnology to
modify the genetic make-up
of an organism
 Genetically modified
organisms (GMOs)
 Any food which is, or is
derived from, these GMOs
is called "GM food"

4. 4
Genetic Modification
Bt protein
(natural pesticide)
produced by a
bacterium
Modified plant
can produce the
Bt protein
GM plant

5. 5
Genetic Modification vs
Traditional Breeding
GENETIC MODIFICATION TRADITIONAL BREEDING
 Isolate and transfer of well-
defined genes
 Introduction of desired
genes across the species
barrier
 Desired change can be
achieved in one generation
 Crossing of thousands of
genes at one time
 Gene transfer usually
within-species
 More time consuming in
the process of
observation and natural
selection to achieve the
desired characteristics

6. 6
Examples of GM Food
CROP GM TRAIT EXAMPLES OF FOOD PRODUCTS
Soyabean Herbicide tolerance soy beverages, tofu, soy oil, soy
flour, emulsifiers (i.e. lecithin), and
as ingredients in breads, pastries
and edible oil
Corn Insect resistance
Herbicide tolerance
corn oil, flour, sugar or syrup, and as
ingredients in snacks, bakery,
confectionery and soft drinks
Need to submit for pre-
market safety assessment,
but not the food products

7. 7
Biotech company
(Producer) Pre-market safety
assessment
Manufacturers for
e.g. corn chips
•Product details
•Safety assessment
•Detection methodology
Approved
List of Approved GM Food
Traders
GM corn
Ensure!
Consumers
GM Food Approval Process
(Proposed)

8. 8
Pre-market Safety Assessment
 Assessment of whole foods
 Based on the principle of
"substantial equivalence” ,
i.e. as safe as the
conventional counterpart
Toxicity 
Composition 
Allergenicity 
Nutritional value

9. 9
GM Food Safety Assessment
 Safety of GM food is assessed relative to the
conventional counterpart having a history of safe
use
 Taking into account both intended and unintended effects
 Identifying new or altered hazards
 Identifying changes, relevant to human health, in key
nutrients

10. 10
Codex Framework of Food
Safety Assessment
 Expressed substances
 Potential toxicity
 Potential allergenicity
 Compositional analyses of key components
 Food processing
 Nutritional modification
 Evaluation of metabolites (applicable to GM plants and microorganisms)
 Health status of the recombinant-DNA animal
(applicable to GM animal)
 Other considerations
 E.g. use of antibiotic resistance markers

11. 11
Assessment Results
 If a new food or component is found to be
substantially equivalent to an existing food
or component
 As safe as its conventional counterpart
 Where differences are identified, additional
assessments and animal studies will be
carried out
 Biotech company has to provide additional
information

12. 12
International Scenario
 WHO has recommended their Member Governments to
set up regulatory framework for pre-market safety
assessment of GM food
 Different GM organisms include genes inserted in different ways and
thus the safety of individual GM foods should be assessed on a case-
by-case basis
 With a view to protect public health, many countries have
put in place a mandatory pre-market safety assessment
scheme for GM food

13. 13
Summary
 GM food is any food which is, or is derived from
GMOs
 Food safety assessment of GM food focuses on
the safety of identified differences between a GM
food and its conventional counterpart
 Many countries have put in place a mandatory
pre-market safety assessment scheme that bases
on the principles of Codex

14. 14
For Further Information
 LegCo paper on “Proposed Regulation of
Genetically Modified Food”
 http://www.legco.gov.hk/yr12-
13/english/panels/fseh/papers/fe0312cb2-
742-5-e.pdf

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~Thank you~