Pre-market Safety Assessment of GM Food 2013


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Pre-market Safety Assessment of GM Food 2013

  1. 1. 1 What is Pre-market Safety Assessment of Genetically Modified Food ? 20 Jun 2013
  2. 2. 2 Presentation Outline  Introduction to genetically modified (GM) food  Pre-market safety assessment of GM food
  3. 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. 4 Genetic Modification Bt protein (natural pesticide) produced by a bacterium Modified plant can produce the Bt protein GM plant
  5. 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. 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. 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. 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. 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. 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. 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. 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. 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. 14 For Further Information  LegCo paper on “Proposed Regulation of Genetically Modified Food”  13/english/panels/fseh/papers/fe0312cb2- 742-5-e.pdf
  15. 15. 15 ~Thank you~