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FOODS FROM GENETICALLY MODIFIED ORGANISMS

Wilna Jansen v RijssenFood Control

Department of Health

Vrijsw@health.gov.za

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FOODS FROM GENETICALLY MODIFIED ORGANISMS

Department of Health

www.gov.za/department/health

Cluster: Pharmaceutical: Policy and PlanningFood Control

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LEGISLATION

Genetically Modified Organisms Act, 1997 (Act

15 of 1997)

Genetically modified organisms

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GMO ACT

Department of Agriculture Executive Council for GMOs

DoA, DACST, DEAT, DoH, Do, DTI

Advisory Committee - experts

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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

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LEGISLATION

DEPARTMENT OF HEALTH

Food industry (processed foods)

Consumers

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LEGISLATION

Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act

54 of 1972)

Food safety

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FCD ACT

Department of HealthDirectorate: Food Control

Group: GMO food 4 professionals

5 Masters degrees (Biotechnology/Microbiology/

Plantbiochemistry/Toxicology and Nutrition)

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FCD ACT

Group: GMO food

Confidentiality clearance

Ethical Boards Pharmacy Council SA Council for Natural

Scientific Professions

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FCD ACT

Roles, Functions and responsibilities of Group GMO food

GMO - Food SafetyGMO – Food LabellingGMO –Food Communicate

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FCD ACT/GMO ACT

FOOD SAFETYRoles, 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

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FCD ACT / GMO ACT

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FOOD SAFETY

Authorities

Codex Alimentarius (FAO/WHO)

Organization for Economic and Social Development ( OECD ) 22+ countries

International Life Sciences (ILSI)

Others

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FOOD SAFETY

Codex Alimentarius (FAO/WHO)

International Food Safety Standards and Guidelines based on science

Facilitate trade

World Trade Organization

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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)

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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

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CODEX ALIMENTARIUS

RISK ANALYSIS Risk Assessment

Risk Management Risk Communication

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CODEX ALIMENTARIUS

RISK = HAZARD X EXPOSURE

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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

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GMO RISK MANAGEMENT

Legislation Policies Executive Council for GMO Implementation

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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

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CODEX Q&A

What overarching scientific principles should be applied to the safety and nutritional assessment?

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CODEX Q&A

Substantial equivalence? … Concept not a method Well established component of

Risk Assessment No alternative strategies to

provide a better assurance.

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CODEX Q&A

Long-term effects? Pre-marketing safety assessment and

methodology used are adequate to detect and evaluate any possible long-term effects.

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CODEX Q&A

Potential allergenicity? Assessment of potential

allergenicity to be conducted in all cases

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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

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ANTIBIOTIC RESISTANCE

Gene transfer from plants and their food products to gut organisms or human cells only a rare possibility

Alternative transformation technologies encouraged

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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”

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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”

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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”

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COMMUNICATION:FCD ACT

LABELLING REGULATIONS A label not a warning but only a

method to convey information and to provide a choice.

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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

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CONSULTATIONS

FOOD LEGISLATION ADVISORY GROUP

5 MEETING

FLAG sub committee

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CODEX ALIMENTARIUS

Framework Codex Definitions

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DRAFT LABELLING REGULATIONS

Mandate from the Minister

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DRAFT LABELLING REGULATIONS

Mandatory – nutritional and natural toxin changes / allergens / genes from animals or humans

Voluntary – Improved / enhanced characteristics

Voluntary – Non-genetically modified

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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

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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

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CODEX ALIMENTARIUSLABELLING

PROHIBITED CLAIMSare e.g. those that

cannot be substantiatedcould give rise to doubt about the

safety, orexploit fear in the consumer.

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SA Labelling Regulation

MISLEADING Analytical Methods are NOT

RELIABLE Few Methods validated No statistically acceptable

sampling methods Paper trailing not reliable

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LABELLING

COST Verification expensive 30 000 products of soybeans and

maize only Increase in price with 8 to 18%

(Australia)

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SA LABELLING Regulation

CHOICEPRICESmall percentage consumers read the detail on labels

Choice could decrease with increasing production /manufacturing of GM-food

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SA LABELLING Regulation

NON –GM Food Identity preservation system (Segregation) Export channel

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SA LABELLING Regulation

Recommendations SABS Code of Practice: IPS Guidelines