FOODS FROM GENETICALLY MODIFIED ORGANISMS Wilna Jansen v Rijssen Food Control Department of Health Vrijsw@health.gov.za 25/04/2019

FOODS FROM GENETICALLY MODIFIED ORGANISMS Department of Health www.gov.za/department/health Cluster: Pharmaceutical: Policy and Planning Food Control 25/04/2019

LEGISLATION Genetically Modified Organisms Act, 1997 (Act 15 of 1997) 25/04/2019

GMO ACT Department of Agriculture Executive Council for GMOs DoA, DACST, DEAT, DoH, Do, DTI Advisory Committee - experts 25/04/2019

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 25/04/2019

DEPARTMENT OF HEALTH Food industry (processed foods) Consumers LEGISLATION DEPARTMENT OF HEALTH Food industry (processed foods) Consumers 25/04/2019

Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972) LEGISLATION Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972) Food safety 25/04/2019

FCD ACT Department of Health Directorate: Food Control Group: GMO food 4 professionals 5 Masters degrees (Biotechnology/Microbiology/ Plantbiochemistry/Toxicology and Nutrition) 25/04/2019

FCD ACT Group: GMO food Confidentiality clearance Ethical Boards Pharmacy Council SA Council for Natural Scientific Professions 25/04/2019

FCD ACT Roles, Functions and responsibilities of Group GMO food GMO - Food Safety GMO – Food Labelling GMO –Food Communicate 25/04/2019

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 25/04/2019

Director: Food Control FCD ACT / GMO ACT Dept of Health Director: Food Control Dept of Agriculture Exec Council for GMOs 25/04/2019

FOOD SAFETY Authorities Codex Alimentarius (FAO/WHO) Organization for Economic and Social Development ( OECD ) 22+ countries International Life Sciences (ILSI) Others 25/04/2019

FOOD SAFETY Codex Alimentarius (FAO/WHO) International Food Safety Standards and Guidelines based on science Facilitate trade World Trade Organization 25/04/2019

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) 25/04/2019

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 25/04/2019

RISK ANALYSIS CODEX ALIMENTARIUS Risk Assessment Risk Management Risk Communication 25/04/2019

RISK = HAZARD X EXPOSURE CODEX ALIMENTARIUS RISK = HAZARD X EXPOSURE 25/04/2019

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 25/04/2019

GMO RISK MANAGEMENT Legislation Policies Executive Council for GMO Implementation 25/04/2019

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 25/04/2019

CODEX Q&A What overarching scientific principles should be applied to the safety and nutritional assessment? 25/04/2019

CODEX Q&A Substantial equivalence? … Concept not a method Well established component of Risk Assessment No alternative strategies to provide a better assurance. 25/04/2019

CODEX Q&A Long-term effects? Pre-marketing safety assessment and methodology used are adequate to detect and evaluate any possible long-term effects. 25/04/2019

CODEX Q&A Potential allergenicity? Assessment of potential allergenicity to be conducted in all cases 25/04/2019

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 25/04/2019

ANTIBIOTIC RESISTANCE Gene transfer from plants and their food products to gut organisms or human cells only a rare possibility Alternative transformation technologies encouraged 25/04/2019

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” 25/04/2019

EUROPEAN UNION 9 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” 25/04/2019

EUROPEAN UNION 9 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” 25/04/2019

COMMUNICATION: FCD ACT LABELLING REGULATIONS A label not a warning but only a method to convey information and to provide a choice. 25/04/2019

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 25/04/2019

CONSULTATIONS FLAG sub committee FOOD LEGISLATION ADVISORY GROUP 5 MEETING FLAG sub committee 25/04/2019

CODEX ALIMENTARIUS Framework Codex Definitions 25/04/2019

DRAFT LABELLING REGULATIONS Mandate from the Minister 25/04/2019

DRAFT LABELLING REGULATIONS Mandatory – nutritional and natural toxin changes / allergens / genes from animals or humans Voluntary – Improved / enhanced characteristics Voluntary – Non-genetically modified 25/04/2019

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 25/04/2019

CODEX ALIMENTARIUS LABELLING 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 25/04/2019

CODEX ALIMENTARIUS LABELLING PROHIBITED CLAIMS are e.g. those that cannot be substantiated could give rise to doubt about the safety, or exploit fear in the consumer. 25/04/2019

SA Labelling Regulation MISLEADING Analytical Methods are NOT RELIABLE Few Methods validated No statistically acceptable sampling methods Paper trailing not reliable 25/04/2019

LABELLING COST Verification expensive 30 000 products of soybeans and maize only Increase in price with 8 to 18% (Australia) 25/04/2019

SA LABELLING Regulation CHOICE PRICE Small percentage consumers read the detail on labels Choice could decrease with increasing production /manufacturing of GM-food 25/04/2019

SA LABELLING Regulation NON –GM Food Identity preservation system (Segregation) Export channel 25/04/2019

SA LABELLING Regulation Recommendations SABS Code of Practice: IPS Guidelines 25/04/2019