Pat OMahony

Chief Specialist, Biotechnology

EU Authorisation of GM Food & Feed

2005

Food Safety Authority of Ireland

Government agency responsible for enforcing food law in Ireland Came into being on 01 January 1999 FSAI Act Statutory, independent and science-based (Department of Health and Children)

2005

GMO Regulation in Ireland

Implementation Policy

FSAI/DoHC
(Food)
Policy & Implementation

Implementation

Policy

GM Analysis
(State Lab & Cork PAL)

DAFF
(Feed and Seed)

EPA/DEHLG
(Live GMOs)

2005

Advances in Food Science & Technology

Pasteurisation Ionising radiation

GMOs

Edible packaging

Functional Food

Nanotechnology

2005

GMOs/GM Products

Pharmaceuticals

Medical Treatments (Insulin, 1982-USA)

Food Chymosin (early 1990s) Riboflavin

2005

Global Biotech Crops

2005

GM Animals

Enviropigs Express phytase in their saliva and excrete up to 75% less Phosphorous

GM goats Spider silk in goats milk Antithrombin in goats milk

GM salmon Grow 3 times faster

GM cow Increased casein in milk improving cheese production

2005

FSAI Food Surveys - GM Ingredients

75 out of 333 (~23%) food samples tested (mainly maize soya & rice) between 2000 and 2006 contained low levels of GM ingredients No unauthorised GM ingredients (except the illegal GM rice) were identified and none were above the 0.9% labelling threshold GM free/Non GM labels were frequently found to be misleading
(Any level of GM ingredient present in a food carrying such labelling is misleading to consumers and in breach of the General Labelling Directive 2000/13/EC)

2005

FSAI Helpline Queries - 2006

Total 7,656 Information requests - 1,966 Food safety related complaints - 1,584 Food labelling queries - 845

GMO/GM Food Issues 30 (0.4%) enquiries (17 telephone, 11 emails & 2 personal)

2005

Health Effects from GMOs?

No substantiated reports of ill health resulting from the consumption of GM food

2005

FSAI View on GM Food

GM food authorised for consumption in the EU is as safe as its non-GM counterpart Case by case assessments appropriate
Genuine concerns about GMOs or GM food? Non-food GM (biopharma) crops/GM animals

2005

GM Food & Feed Ingredients Authorised/Pending in the EU

(12) Maize (25) (5) Cotton seed (7) (3) Oilseed Rape (1) (1) Soya (3) (1) Bacterial product (2) (1) Yeast product Rice (1) (1) Sugar beet Amylopectin potato (1)

24 = Total = 40
2005

Pest Resistance in Maize (Bt)

European corn borer
European corn borer RIP
Bacillus thuringiensis (Soil bacterium)

European corn borer

Cry gene
2005

Herbicide (Roundup) Tolerance

3-Phosphoshikimate Phospoenoylpyruvate

+ Maize 3-phosphoshikimate-1-carboxyvinyl transferase (EPSP synthase)

Pi

5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) (Agrobacterium sp. strain CP4)

Tyrosine, Tryptophan Phenylalanine

+
3-Phospho-5-enoylpyruvylshikimate

Cotton

2005

Antibiotic Resistance in the Selection of Transgenics

No selection

Selection

2005

Antibiotic Resistance in the Selection of Transgenics

anti-HSP21 HSP17.6 prom
TR Lac Z

CryIA gene

Antibiotic resistance gene

Lac I

35S

pZP211/anti-HSP21 10364 bp

NPT2 35S PA TL

Promoter elements

Terminator elements

2005

Terminator Genes (GURTs)

No Treatment Seed

Treatment Seed

2005

EU GM Food Regulations

Novel Food Regulation (EC) No. 258/97 Regulation (EC) No 1829/2003 Authorisation & Labelling of GM Food and Feed Regulation (EC) No 1830/2003 Traceability and Labelling of GMOs and derived food and feed Directive 2001/18/EC Authorisation of GMOs for cultivation/contained use Regulation (EC) No 1946/2003 Transboundary movements of genetically modified organisms

2005

GM Food & Feed Legislation

Regulation EC No. 1829/2003

Authorisation
Safety assessment carried out by EFSA Authorisation for a period of 10 years, renewable Emergency withdrawals permitted for valid health or environmental reasons

Labelling
1. 2. 3. 4. Labelling required where > 0.9% of a food or ingredient is GM Labelling not dependent on the presence of GM DNA or protein No EU requirement for mass caterers to label GM ingredients GM labelling not required for cheese made with GM chymosin, or fermentation products where the GMM is not present in the final product (riboflavin)

2005

GM Food/Feed Authorisation

Draft Decision

DG SANCO
6 months

3 months

EFSA
14 days

Decision

Council of Ministers
3 months

Dossier Decision Dossier

Competent Authority

Applicant

DG SANCO
2005

No Decision

No Decision

Safety Opinion

Member States (SCFCAH)

Country

Population

Votes

Country

Population

Votes

Germany

82m

16.7%

29

Austria

8.3m

1.7%

10

France

63m

12.8%

29

Bulgaria

7.7m

1.6%

10

UK

60m

12.3%

29

Denmark

5.4m

1.1%

Italy

59m

11.9%

29

Slovakia

5.4m

1.1%

From 1 November 2004, a qualified majority will be reached if the following two conditions are met: a majority of member states approve (in some cases two-thirds); a minimum of 255 votes is cast in favour of the proposal, (73.9 %). In addition, a member state may ask for confirmation that the votes in favour represent at least 62% of the total population of the Union. If this is found not to be the case, the decision will not be adopted.

Spain

44m

8.9%

27

Finland

5.3m

1.1%

Poland

38m

7.7%

27

Ireland

4.2m

0.9%

Romania

22m

4.4%

14

Lithuania

3.4m

0.7%

Netherlands

16m

3.3%

13

Latvia

2.3m

0.5%

Greece

11m

2.3%

12

Slovenia

2.0m

0.4%

Portugal

11m

2.1%

12

Estonia

1.3m

0.3%

Belgium

11m

2.1%

12

Cyprus

0.77m

0.2%

Czech Rep.

10m

2.1%

12

Luxembourg

0.46m

0.1%

Hungary

10m

2.0%

12

Malta

0.40m

0.1%

Sweden

9.0m

1.8%

10

EU

493m

100%

345

2005

Qualified Majority Voting (QMV)

27 Member States QMV = 255 (74%)
GM maize DAS 59122 vote taken at Standing Committee on June 25th

Total votes = 345

FOR 15 Member States (197 votes 57%) AGAINST 7 Member States (52 votes 15%) ABSTAINED 4 Member States (69 votes 20%) Absent 1 Member State absent (27 votes 8%)

2005

Regulation EC No. 178/2002 Scientific Committee 11 Specialist Panels

2005

Evolving Concerns
Health & environmental concerns Allergenicity Antibiotic resistance marker genes Coexistence Biological v statistical significance Transparency of the process Fate of input from Member States Food from animals fed GM feed

2005

Status of the Authorisation Process

Division between & within Member States

Political impasse at EU level

Authorisations ongoing but slow

2005