FOODS FROM GENETICALLY MODIFIED ORGANISMS Wilna Jansen v

FOODS FROM GENETICALLY MODIFIED ORGANISMS Wilna Jansen v Rijssen Food Control Department of Health Vrijsw@health. gov. za 09/01/2022 1

FOODS FROM GENETICALLY MODIFIED ORGANISMS Department of Health www. gov. za/department/health Cluster: Pharmaceutical: Policy and Planning Food Control 09/01/2022 2

LEGISLATION Genetically Modified Organisms Act, 1997 (Act 15 of 1997) Genetically modified organisms 09/01/2022 3

GMO ACT w Department of Agriculture n Executive Council for GMOs Do. A, DACST, DEAT, Do. H, Do, DTI l 09/01/2022 Advisory Committee - experts 4

FOOD FROM GMO w GMO – maize kernels w Not a GMO but obtained from GMO and containing GM-material – maize meal w Not a GMO but obtained from GMO and not containing GMO material – glucose 09/01/2022 5

LEGISLATION DEPARTMENT OF HEALTH Food industry (processed foods) Consumers 09/01/2022 6

LEGISLATION Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972) Food safety 09/01/2022 7

FCD ACT Department of Health Directorate: Food Control Group: GMO food 4 professionals 5 Masters degrees (Biotechnology/Microbiology/ Plantbiochemistry/Toxicology and Nutrition) 09/01/2022 8

FCD ACT Group: GMO food w Confidentiality clearance w Ethical Boards n n 09/01/2022 Pharmacy Council SA Council for Natural Scientific Professions 9

FCD ACT Roles, Functions and responsibilities of Group GMO food GMO - Food Safety GMO – Food Labelling GMO –Food Communicate 09/01/2022 10

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 n Risk assessments n Write reports n Advise the Director: Food Control 09/01/2022 11

FCD ACT / GMO ACT 09/01/2022 12

FOOD SAFETY w Authorities n n Codex Alimentarius (FAO/WHO) Organization for Economic and Social Development ( OECD ) 22+ countries n International Life Sciences (ILSI) n Others 09/01/2022 13

FOOD SAFETY n Codex Alimentarius (FAO/WHO) l International Food Safety Standards and Guidelines based on science l Facilitate trade World Trade Organization 09/01/2022 14

CODEX ALIMENTARIUS w General Principles for the Risk Analysis of Foods derived from Modern Biotechnology w Guidelines for the conduct of safety assessment of foods derived from recombinant-DNA plants w Micro-0 rganisms (in preparation) w ( fish) 09/01/2022 15

FOOD SAFETY w FCD Act w Policy Guidelines for toxicological assessments n n OECD Guidelines for tests Chemicals (pesticides) Microbial pest control agents Botanical pest control agents (prep) w GMO-foods based on CODEX (new) website 09/01/2022 16

CODEX ALIMENTARIUS w RISK ANALYSIS w Risk Assessment n Risk Management l Risk Communication 09/01/2022 17

CODEX ALIMENTARIUS RISK = HAZARD X EXPOSURE 09/01/2022 18

GMO – SAFETY AND RISK ASSESSMENT Case – by – case w Expressed substances (non-nucleic acid substances) w Compositional analysis of key components w Evaluation of metabolites w Food processing w Nutritional modification w others 09/01/2022 19

GMO RISK MANAGEMENT w Legislation w Policies w Executive Council for GMO w Implementation 09/01/2022 20

GMO RISK MANAGEMENT w Policies - DOH n n n 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 09/01/2022 21

CODEX Q&A w What overarching scientific principles should be applied to the safety and nutritional assessment? 09/01/2022 22

CODEX Q&A w Substantial equivalence? … n n n Concept not a method Well established component of Risk Assessment No alternative strategies to provide a better assurance. 09/01/2022 23

CODEX Q&A w Long-term effects? n Pre-marketing safety assessment and methodology used are adequate to detect and evaluate any possible long-term effects. 09/01/2022 24

CODEX Q&A w Potential allergenicity? n Assessment of potential allergenicity to be conducted in all cases 09/01/2022 25

CODEX Q&A w Risks arising from the use of antibiotic resistance marker genes in plants and micro-org? n Subject to standard safety assessment as for any other introduced gene product 09/01/2022 26

ANTIBIOTIC RESISTANCE w Gene transfer from plants and their food products to gut organisms or human cells only a rare possibility w Alternative transformation technologies encouraged 09/01/2022 27

FAO DIRECTOR-GENERAL: Dr Jacques Diouf, Manilla, 7 December 1999 w “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” 09/01/2022 28

EUROPEAN UNION 9 OCTOBER 2001 w 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” 09/01/2022 29

EUROPEAN UNION 9 OCTOBER 2001 w Research has not found “any new risks to human health or the environment beyond the usual uncertainties of conventional plant breeding” w “Indeed, the use of more precise technology and greater regulatory scrutiny probably make them even safer than conventional plants and food” 09/01/2022 30

COMMUNICATION: FCD ACT w LABELLING REGULATIONS w A label not a warning but only a method to convey information and to provide a choice. 09/01/2022 31

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 09/01/2022 32

CONSULTATIONS § FOOD LEGISLATION ADVISORY GROUP § 5 MEETING § FLAG sub committee 09/01/2022 33

CODEX ALIMENTARIUS § Framework § Codex Definitions 09/01/2022 34

DRAFT LABELLING REGULATIONS Ø Mandate from the Minister 09/01/2022 35

DRAFT LABELLING REGULATIONS Ø Mandatory – nutritional and natural toxin changes / allergens / genes from animals or humans Ø Voluntary – Improved / enhanced characteristics Ø Voluntary – Non-genetically modified 09/01/2022 36

FOOD FROM GMO w GMO – maize kernels w Not a GMO but obtained from GMO and containing GM-genetic material – maize meal w Not a GMO but obtained from GMO and not containing GMO material – glucose 09/01/2022 37

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 09/01/2022 38

CODEX ALIMENTARIUS LABELLING PROHIBITED CLAIMS are e. g. those that Øcannot be substantiated Øcould give rise to doubt about the safety, or Øexploit fear in the consumer. 09/01/2022 39

SA Labelling Regulation w MISLEADING n n Analytical Methods are NOT RELIABLE Few Methods validated No statistically acceptable sampling methods Paper trailing not reliable 09/01/2022 40

LABELLING COST n Verification expensive n 30 000 products of soybeans and maize only n Increase in price with 8 to 18% (Australia) 09/01/2022 41

SA LABELLING Regulation n CHOICE l PRICE l Small percentage consumers read the detail on labels l Choice could decrease with increasing production /manufacturing of GM-food 09/01/2022 42

SA LABELLING Regulation NON –GM Food w Identity preservation system (Segregation) w Export channel 09/01/2022 43

SA LABELLING Regulation w Recommendations w SABS Code of Practice: IPS w Guidelines 09/01/2022 44