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FOODS FROM GENETICALLY MODIFIED ORGANISMS. Wilna Jansen v Rijssen Food Control Department of Health Vrijsw@health.gov.za. FOODS FROM GENETICALLY MODIFIED ORGANISMS. Department of Health www.gov.za/department/health Cluster: Pharmaceutical: Policy and Planning Food Control.
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FOODS FROM GENETICALLY MODIFIED ORGANISMS Wilna Jansen v Rijssen Food Control Department of Health Vrijsw@health.gov.za
FOODS FROM GENETICALLY MODIFIED ORGANISMS Department of Health www.gov.za/department/health Cluster: Pharmaceutical: Policy and Planning Food Control
LEGISLATION Genetically Modified Organisms Act, 1997 (Act 15 of 1997) Genetically modified organisms
GMO ACT • Department of Agriculture • Executive Council for GMOs DoA, DACST, DEAT, DoH, Do, DTI • Advisory Committee - experts
FOOD FROM GMO • GMO – maize kernels • Not a GMO but obtained from GMO and containing GM-material– maize meal • Not a GMO but obtained from GMO and not containing GMO material – glucose
LEGISLATION DEPARTMENT OF HEALTH Food industry (processed foods) Consumers
LEGISLATION Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972) Food safety
FCD ACT Department of Health Directorate: Food Control Group: GMO food 4 professionals 5 Masters degrees (Biotechnology/Microbiology/ Plantbiochemistry/Toxicology and Nutrition)
FCD ACT Group: GMO food • Confidentiality clearance • Ethical Boards • Pharmacy Council • SA Council for Natural Scientific Professions
FCD ACT Roles, Functions and responsibilities of Group GMO food GMO - Food Safety GMO – Food Labelling GMO –Food Communicate
FCD ACT/GMO ACT FOOD SAFETY Roles, Functions and responsibilities of Group GMO food Verify compliance of applications with SA legislation and policies, international standards and guidelines • Risk assessments • Write reports • Advise the Director: Food Control
FCD ACT / GMO ACT Dept of Health Director: Food Control Dept of Agriculture Exec Council for GMOs
FOOD SAFETY • Authorities • Codex Alimentarius (FAO/WHO) • Organization for Economic and Social Development ( OECD ) 22+ countries • International Life Sciences (ILSI) • Others
FOOD SAFETY • Codex Alimentarius (FAO/WHO) • International Food Safety Standards and Guidelines based on science • Facilitate trade World Trade Organization
CODEX ALIMENTARIUS • General Principles for the Risk Analysis of Foods derived from Modern Biotechnology • Guidelines for the conduct of safety assessment of foods derived from recombinant-DNA plants • Micro-0rganisms (in preparation) • ( fish)
FOOD SAFETY • FCD Act • Policy Guidelines for toxicological assessments • OECD Guidelines for tests • Chemicals (pesticides) • Microbial pest control agents • Botanical pest control agents (prep) • GMO-foods based on CODEX (new) website
CODEX ALIMENTARIUS • RISK ANALYSIS • Risk Assessment • Risk Management • Risk Communication
CODEX ALIMENTARIUS RISK = HAZARD X EXPOSURE
GMO – SAFETY AND RISK ASSESSMENT Case – by – case • Expressed substances (non-nucleic acid substances) • Compositional analysis of key components • Evaluation of metabolites • Food processing • Nutritional modification • others
GMO RISK MANAGEMENT • Legislation • Policies • Executive Council for GMO • Implementation
GMO RISK MANAGEMENT • Policies - DOH • Codex Alimentarius standards and guidelines • Departmental Guidelines for chemicals/pesticides • Full assessments of GMO and products • Full assessment of GMOs for food and for feed • Antibiotic resistant genes – phased out
CODEX Q&A • What overarching scientific principles should be applied to the safety and nutritional assessment?
CODEX Q&A • Substantial equivalence? … • Concept not a method • Well established component of Risk Assessment • No alternative strategies to provide a better assurance.
CODEX Q&A • Long-term effects? • Pre-marketing safety assessment and methodology used are adequate to detect and evaluate any possible long-term effects.
CODEX Q&A • Potential allergenicity? • Assessment of potential allergenicity to be conducted in all cases
CODEX Q&A • Risks arising from the use of antibiotic resistance marker genes in plants and micro-org? • Subject to standard safety assessment as for any other introduced gene product
ANTIBIOTIC RESISTANCE • Gene transfer from plants and their food products to gut organisms or human cells only a rare possibility • Alternative transformation technologies encouraged
FAO DIRECTOR-GENERAL: Dr Jacques Diouf, Manilla, 7 December 1999 • “We have no problem with GMOs as long as they are proven to be safe to human beings and have no negative impact on the environment”
EUROPEAN UNION9 OCTOBER 2001 • 81 research projects financed by the EU over the last 15 years, at a cost of $64 million on GM crops and products made from. Research has not found “any new risks to human health or the environment beyond the usual uncertainties of conventional plant breeding”
EUROPEAN UNION9 OCTOBER 2001 • Research has not found “any new risks to human health or the environment beyond the usual uncertainties of conventional plant breeding” • “Indeed, the use of more precise technology and greater regulatory scrutiny probably make them even safer than conventional plants and food”
COMMUNICATION:FCD ACT • LABELLING REGULATIONS • A label not a warning but only a method to convey information and to provide a choice.
CONSULTATIONS Total 35 • Port Folio: 3 • Interviews: radio, TV, journals, telephone, others • Conferences: 4 • Groups: 9 • Workshop#1 (71 representatives) • Workshops#2 #3 #4 (food industry) • Workshop: comments
CONSULTATIONS • FOOD LEGISLATION ADVISORY GROUP • 5 MEETING • FLAG sub committee
CODEX ALIMENTARIUS • Framework • Codex Definitions
DRAFT LABELLING REGULATIONS • Mandate from the Minister
DRAFT LABELLING REGULATIONS • Mandatory – nutritional and natural toxin changes / allergens / genes from animals or humans • Voluntary – Improved / enhanced characteristics • Voluntary – Non-genetically modified
FOOD FROM GMO • GMO – maize kernels • Not a GMO but obtained from GMO and containing GM-genetic material – maize meal • Not a GMO but obtained from GMO and not containing GMO material – glucose
CODEX ALIMENTARIUSLABELLING PRINCIPLES “ No food should be described or presented in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character in any respect”. Must substantiate a claim
CODEX ALIMENTARIUSLABELLING PROHIBITED CLAIMS are e.g. those that cannot be substantiated could give rise to doubt about the safety, or exploit fear in the consumer.
SA Labelling Regulation • MISLEADING • Analytical Methods are NOT RELIABLE • Few Methods validated • No statistically acceptable sampling methods • Paper trailing not reliable
LABELLING COST • Verification expensive • 30 000 products of soybeans and maize only • Increase in price with 8 to 18% (Australia)
SA LABELLING Regulation • CHOICE • PRICE • Small percentage consumers read the detail on labels • Choice could decrease with increasing production /manufacturing of GM-food
SA LABELLING Regulation NON –GM Food • Identity preservation system (Segregation) • Export channel
SA LABELLING Regulation • Recommendations • SABS Code of Practice: IPS • Guidelines