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Institute of Food Research. Current Safety Testing Procedures & The Relationship between GM foods and the Food Chain. Professor Mike Gasson Head of Food Safety Science. GM TECHNOLOGY IS STRINGENTLY REGULATED. EC NOVEL FOODS REGULATION 258/97. EU-wide pre-market approval system
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Institute of Food Research Current Safety Testing Procedures&The Relationship between GM foods and the Food Chain Professor Mike Gasson Head of Food Safety Science
GM TECHNOLOGY IS STRINGENTLY REGULATED EC NOVEL FOODS REGULATION 258/97 EU-wide pre-market approval system for novel foods and food ingredients including those containing or derived from genetically modified organisms.
UK Safety Committee ACNFP - Advisory Committee on Novel Foods and Processes Wide range of independent scientific expertise Genetic Modification Nutrition Microbiology Toxicology Food Technology Consumer Representative Ethicist
GM INVOLVES DISTINCT FOOD APPLICATIONS • Cell factories for enzymes and ingredients. • Viable or killed GM micro-organisms. • Fresh or processed GM plants. • Commodities derived from GM plants. CASE BY CASE SAFETY ASSESSMENT
SUBSTANTIAL EQUIVALENCE Recognises the limitations of conventional toxicological testing for use with whole foods Developed progressively by: WHO – World Health Organisation. FAO – Food and Agriculture Organisation of the United Nations. OECD – Organisation for Economic Co-operation and Development.
SUBSTANTIAL EQUIVALENCE • GM derivatives based on food materials with history of safe consumption. SE aims to establish that a GM derivative is as safe as its conventional counterpart. • SE not a safety evaluation in itself itdoes not identify hazard. • SE is start point that structures safety evaluation • relative to a conventional counterpart.
SUBSTANTIAL EQUIVALENCE • SE uses comparative approach to reveal intended and unintended differences between a GM derivative and its conventional counterpart. Differences become a focus for further safety evaluation. • Agronomic, genetic and chemical aspects are compared with a special focus on known toxins, allergens and antinutrients.
SAFETY ASSESSMENT INVOLVES: • TRANSFORMATION PROCESS • (gene delivery) • CHARACTERISATION INTRODUCED DNA • Stability. • Antibiotic Resistance Marker Genes. • Potential for Gene Transfer.
SAFETY ASSESSMENT INVOLVES: INTRODUCED TRAIT • Toxicity. • Physiological effect. • Allergenic effect. UNINTENDED EFFECTS NUTRITIONAL IMPACT