The document discusses the key issues and process for assessing genetically modified organisms (GMOs) by the European Food Safety Authority (EFSA). It outlines the relevant EU legislation on GMOs and describes EFSA's role in conducting scientific risk assessments of GMOs to ensure food safety. The multi-step process involves applications, reviews by competent authorities and EFSA, and decisions by regulatory committees and the European Commission. EFSA provides guidance for assessing potential impacts of GMOs on human health and the environment.

1. Development of GM crops in the EU.
Key Issues for the Assessment of GMO by the
European Food Safety Authority (EFSA)
Lucía Roda Ghisleri
LRoda@mma.es
Dirección General de Calidad y Evaluación Ambiental

2. EU Legislation on GMOs in the EU
• Directive 2009/41/EC on the contained use of genetically modified
microorganisims.
• Directive 2001/18/EC on the deliberate release into the environment of
genetically modified organisms and repealing.
• Regulation (EC) Nº 178/2002 laying down the general principles and
requirements of food law, establishing the European Food Safety
Authority (EFSA) and laying down procedures in matters of food safety.
• Regulation (EC) Nº 1829/2003 on genetically modified food and feed.
• Regulation (EC) Nº 1830/2003 concerning the traceability and
labelling of genetically modified organisms and the traceability of food and
feed products produced from genetically modified organisms
• Regulation (EC) Nº 1946/2003 on transboundary movements of
genetically modified organisms.
• Recommendation (EU) (2010/C 200/01) on guidelines for the
development of national co-existence measures to avoid the unintended
presence of GMOs in conventional and organic crops.

3. Genetically Modified Organism
(GMO)
‘Genetically modified organism (GMO) means an
organism, with the exception of human beings, in
which the genetic material has been altered in a way
that does not occur naturally by mating and/or
natural recombination’
- Recombinant nucleic acid techniques
- Micro-injection, macro-injection and micro-encapsulation
- Cell fusion
(Artícle 2 of Directive 2001/18/EC)

4. Biosafety Food Safety
‘Put in place politics and
measures focused on the
health and the
environment protection’.
‘Protection of life and human
beings, of the human health and the
animal welfare, the environment
and the consumer interests’.
Risk Analysis based on available
scientific studies.
Risk Assessment based on
existing scientific data.
PRECAUTIONARY
PRINCIPLE
‘CASE BY CASE’
‘STEP BY STEP’
Confined use Experimental trials Commercialisation

5. Precautionary Principle in the EU:
Risk Analysis
Risk assessment: Identification of the
potential adverse effects in a
scientifically sound manner
(uncertainties),
Risk management: political decision
deciding the acceptable level of risk for
the society and deciding whether take
an action or not.
Risk communication: Decision making
process have to be transparent and take
into account all stakeholders.

6. Deliberate Release into the Environment
Field Trials with GMOs
Directive 2001/18/EC
‘Any intentional introduction into the environment of a GMO or
a combination of GMOs for which no specific containment
measures are used to limit their contact with and to provide a
high level of safety for the general population and the
environment (under controlled conditions(under controlled conditions))
GoalGoal: Identification and assessment , case by case, of potential
adverse effects of GMO, either by direct or indirect, immediate or delayed
effects, on human health and the environment.

7. National Assessment and Authorisation Procedure
Deliberate Release: Field Trials
ONE
MONTH
THREE
MONTHS

8. 0
50
100
150
200
250
300
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
4
66
89
166
213
239
264
244
238
129
88
56
82
72 78
139
95
90
110
77
45
Notificactions of Field Trials with GMO
by Year in the EU (November 2011)
www.gmoinfo.jrc.ec.europa.eu

9. 0
100
200
300
400
500
600
591
568
295
238
191
182
136
113
56 56
32 27 23 22 19 16 15 6 3 2 2 1
Notifications of Filed Trials by Countries in the EU
(November 2011)
www.gmoinfo.jrc.ec.europa.eu

10. 0
100
200
300
400
500
600
700
800
900
1000 929
388
337 319
77 82
62 35 37 31 22 19 15 10 9 8 8 8
GM Plants Tested in the Field in the EU
(2011)

11. 0
10
20
30
40
50
60
70
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
3
12
9
19
41
47
42
11
18 18
41
20
26
43
46
49
63
49
28
Experimental Field Trialswith GMOs conducted in Spain
(1993 - 2011)

12. 58%13%
8%
5%
5% 3%
2% 1%
GMP tested in the field (1993-2011)
Maize
Cotton
Sugar beet
Rice
Potato
Tomato
Wheat
Citrus
Soybean
Melon
Tobacco
Sunflower
Poplar
Prunus
Oilseed rape
Strawberry
Eucalyptus

13. Main Traits introduced in GMP in Spain
(1993-2011)
32%
26%
15%
15%
3%
2% 2% 2%
1%
HT + IR
Herbicide tolerance
Changes in composition
Insect resistance
Virus resistance
Androsterility
Fertility
Drought tolerance
Antibiotic resistance
Fungal resistance
Heat stress
Biofuel

14. Placing on the Market of GMP
The Notifier has two options to submit the Application:
Under the Part C procedure of Directive 2001/18/EC
on deliberate release of GMO, or
Under Regulation (CE) Nº 1829/2003 on genetically
modified food and feed.

15. Directive 2001/18/EC
Decentralised procedure for the approval of import, processing and/or cultivation
1) SubmissionSubmission
of theof the
ApplicationApplication
by theby the
NotifierNotifier
2) Study and assessment2) Study and assessment
by theby the CompetentCompetent
Authority of theAuthority of the
Member StateMember State
(Lead country)(Lead country)
3) Study and3) Study and
revision by therevision by the
CompetentCompetent
Authorities of allAuthorities of all
Member StatesMember States
YesYes
No
4)4) EFSA OpinionEFSA Opinion
(European Food Safety Authority)(European Food Safety Authority)
Sí
Approval
No
No
5) Decision of the5) Decision of the Regulatory CommitteeRegulatory Committee
de losde los EstadosEstados MiembrosMiembros
YesYes
Yes
Approval
No
6) Decision of the6) Decision of the CounsilCounsil of Ministersof Ministers of theof the
EnvironmentEnvironment of the Member Statesof the Member States
7)7) DecisioDecisio by theby the
EuropeanEuropean CommisionCommision
No
YesYes
Approval
Yes
Approval
No
Commitology after
‘Lisboa Treaty’
March 2011

16. Regulation (EC) Nº 1829/2003
Centralised Procedure for the la Commercialisation of
GM Food and Feed (can include cultivation)
1) Notifier complete1) Notifier complete
the Application:the Application:
Technical Dossier +Technical Dossier +
Risk AssessmentRisk Assessment
EFSA Opinion
European Food Safety Authority))
No
4) Decision of the Scientific Committee of the Food4) Decision of the Scientific Committee of the Food
Chain and Animal Health of the Member StatesChain and Animal Health of the Member States
(SCFCAH)(SCFCAH)
Sí
Yes
Approval
No
5) Decision of the Council of Ministers of the5) Decision of the Council of Ministers of the
Agriculture of the Member StatesAgriculture of the Member States
6) Decision by the European Commission
No
Yes
Approval
Yes
Approval
No
2) Submission to all
Member States
Competent Authorities
Consultation to all
Competent
Authorities
‘One door-one key’
Commitology after
‘Lisboa Treaty’
March 2011

17. PLACING ON THE MARKET OF GMO IN THE EUROPEAN UNION
(DIR. 90/220/EEC and DIR. 2001/18/EC)
(http://ec.europa.eu/environment/biotechnology/authorised_prod_1.htm)
GMO/USES COMPANY/SCOPE GENETIC MODIFICATION YEAR
VACCINES
VEMIE VETERINAR
CHEMIE
ENFERMEDAD AUJESZKY
AUJESZKY DISEASE
VACCINATION
FROM
1992
TO
1998
RABORAL
RHONE-MERIEUX
ORAL LIVE VACCINE AGAINST
RABIE IN FOX
KIT OF ANÁLYSIS VALIO LTD.
(Streptococcus thermophilus)
DETECTION OF ANTIBIOTICS IN
MILK
TOBACCO SEEDS
(Cultivation/Tobacco Industry)
SEITA
BROMOXINIL TOLERANCE
6 OILSEED RAPE
(Seed production)
PLANT
GENETIC SYSTEMS
GLUFOSINATE TOLERANCE
SOYA (A 5403)
(Import and processing)
MONSANTO GLIFOSATE TOLERANCE
CHICCORY
(Cultivation)
BEJO ZADEN
ANDROESTERILITY/
GLUFOSINATE TOLERANCE
8 MAIZES
(Import and processing)
(Only 3 for Cultivation)
MONSANTO
SYNGENTA
PIONEER/DOW
BAYER CROPSCIENCE
RESISTENCIA AL TALADRO
HERBICIDE TOLERANCE
4 CARNATIONS
(Cultivation)
FLORIGENE EUROPE B.V. LONGEVITY
1 POTATO
(Cultivation /industrial uses)
BASF PLANT SCIENCE CHANGES IN STARCH CONTENT 2010

18. COMMUNITY REGISTER OF GENETICALLY MODIFIED
FOOD AND FEED
REGULATION (EC) Nº 1829/2003
AUTHORISZATION 40 transformation events (import/processing, food and
feed; only 2 for cultivation):
7 COTTONS (MON1445, MON15985, MON15985 x MON1445, MON531, MON 531 x MON1445,
LLCotton25 y GHB614)
23 MAIZES (Bt11, DAS1507, DAS1507 x MON863, DAS59122, GA21, MON810, MON863,
MON863 x NK603, MON863 x MON810, NK603, NK603 xx MON810, T25, etc...)
3 OILSEED RAPE (GT73, MS8-RF3-MS8 x RF3 y T45)
3 SOYA BEENS (MON40-3-2, A2704-12 y MON89788)
1 SUGAR BEET (H7-1)
1 POTATO (EH92-527-1)
2 MICROORGANISMS (pCABL- Brevibacterium lactofermentum y pMT742 o pAK729 –
Saccharomyces cerevisiae)
http://ec.europa.eu/food/dyna/gm_register/index_en.cfm
EVENT: Unique DNA recombination used for the regeneration of a whole
genetically modified plant

22. Sequential Scientific Risk Assessment
(‘step by step’)
Post Market
monitoring (C) to
measure effects
(adverse or not)
Lab/greenhouse
assays (A)
to identify hazards
Field trials (B)
To assess Risks
(hazard x exposure)
Deliberate release into the environmentConfined use
Directive 2009/41/EC
Directive 2001/18/EC
Directive 2001/18/EC and/or
Regulation (EC) Nº 1829/2003

23. Step 1: Identification of characteristics which may cause adverse effects (direct,
indirect, immediate or delayed, and cumulative effects) on the human health and the
environment.
(Characteristics of the GMO, intended release or use including its scale, the receiving
environment and the interaction between these).
Step 2: Evaluation of the potential
consequences of each adverse effects if
it occurs.
Step 3: Evaluation of the likelihood of
the occurrence of each identified
adverse effects.
Step 4: Estimation of the risk posed by each characteristic of the GMO
Step 5: Application of management strategies for risk from deliberate release of the
GMO.
Step 6: Determination of the global risk of the GMO.
Methodology for Environmental Risk
Assessment (Field Trials)

24. Potential Impact of the GMO on the Human
Health and the Environment
1. Survival and invasiveness increased
2. The spread of the GMO(s) in the environment
3. The transfer of the inserted genetic material to other organisms
4. Phenotypic and genetic instability
5. Interactions with other organisms (target or non-target organisms)
6. Disease to humans, animals and plants including allergenic or toxic effects
7. Effects on the dynamics of populations of species in the receiving
environment and the genetic diversity of each of these populations
8. Altered susceptibility to pathogens facilitating the dissemination of
infectious diseases and/or creating new reservoirs or vectors
9. Compromising prophylactic or therapeutic medical, veterinary, or plant
protection treatments
10. Effects on biogeochemistry (biogeochemical cycles), particularly carbon
and nitrogen recycling through changes in soil composition of organic
material
11. Changes in management, including, where applicable, in agricultural
practices

25. The EFSA Role in Risk Assessment
• Establishment of EFSA in 2002 (Regulation (EC)
Nº 178/2002) and located in Parma, Italy
Main goals:
• Improving EU food safety
• Re-building consumer confidence in EU food safety
http://www.efsa.europa.eu

26. EFSA Tasks and Approach
EFSA’s tasks:
• Deliver sound scientific opinion on food safety to the risk managers
• Ensuring close collaboration between national bodies (National Biosafety
Committees and Competent Authorities)
• Engage and exchange information with the many different stakeholders
• Risk communication: Providing the right information to consumers,
government, industrial, NGO and other stakeholders at the right time
EFSA Approach:
• Scientific excellence
• Independence
• Transparency/openness
• Close collaboration with Member States
• Building consumer confidence
EFSA Structure:
• Management Board
• Advisory Forum
• Executive Director and Staff
• Scientific Committee and Panels

27. EFSA Scientific Panels
• Additives and products or substances used in animal feed
(FEEDAP)
• Animal health and welfare (AHAW)
• Biological hazards (BIOHAZ), including BSE-TSE-related risks
• Contaminants in the food chain (CONTAM)
• Dietetic products, nutrition and allergies (NDA)
• Food additives and nutrient sources added to food (ANS)
• Food contact materials, enzymes, flavourings and processing aids
(CEF)
• Genetically modified organisms (GMO)
• Plant health (PLH)
• Plant protection products and their residues (PPR)
• Scientific Committee (SC)

28. EFSA Guidance for the RA of GMOs
EFSA Scientific Panel on GMO
• Guidance on post-market environmental monitoring of GM Plants (2011).
Updated version of 2006.
• Guidance on the risk assessment of genetically modified microorganisms and
their products intended for food and feed use (2011). Updated version of 2006.
• Guidance for risk assessment of food and feed from GM plants (2011)
• Guidance on selection of comparators for the risk assessment of GM plants
(2011).
• EFSA Guidance Document on the Environmental Risk Assessment of GM
plants (2010).
• Working Document of the GMO Panel on the interplay between Directive
2001/18/EC (GMOs) and Directive 91/414/EEC (Plant Protection Products)
(2008).
• Guidance Document for the risk assessment of genetically modified plants
containing stacked transformation events by the Scientific Panel on Genetically
Modified Organisms (GMO) (2007)
• Guidance document for the renewal of authorisations of existing GMO
products by the Scientific Panel on Genetically Modified Organisms (GMOs)
(2006

29. Principles for ERA of GM Plants
Scientifically sound
Transparency
Sequential steps
Comparative approach
Case-specific
Tiered approach
Iterative
Scientific incertitude

30. Food and Feed Safety Assessment
in the EU
Main criteria:
1. Identification of differences between the GM and non-GM crop
2. Assessment of the environmental and/or food/feed safety and
nutritional impact of identified differences
• Concept of Familiarity
• Concept of Substantial Equivalence
• Comparative Safety Assessment

31. Safety and Nutritional Assessment - I
Parental Plant
History of use,
Origin, Habitat, Characteristics
Donor organism
DNA with new genes
Genetic Modification
Process
Genetically Modified Plant
Comparative analysis of GM plants and derived food and feed and conventional counterpart(s)
compositional, phonotypical and agronomical analysis
HAZARD IDENTIFICATION

32. Safety and Nutritional Assessment - II
Intended differences
New gene products
Compositional alterations
Unintended differences?
Agronomical and compositional
alterations
Safety evaluation of
single compounds
RISK CHARACTERISATION
Safety and nutritional evaluation
of the whole GM plant and
derived food and feed
Toxicity in vivo/in vitro,
allergenicity, bioinformatics
90-daysrodent feeding trials
Livestock feeding trials
EXPOSURE ASSESSMENT
CONCLUSIONS ON SAFETY
HAZARD CHARACTERISATION

33. ERA Templ(at)e
Env.ironmental Risk Assessment
Parental plant & GM trait
Molecular characterization
Compositional Analysis
Agronomic/phenotyp. Characters.
Plant/environment interaction
‘Pillar Task‘: Decrease uncertainty
about unintended effects due to genetic
modification
Knowledge = Stone
(Graph Dr. Bartsch)

34. 6 steps
34Conclusions ERA & PMEM
Persistence &
invasiveness
HGT
TO
Impact of cultivation
practices
Impact on biogeochemical
processes
Human
and
animal
health
5 cross-cutting considerations
Comparators, Receiving environment, General statistics, Long-term effects, Stacked events
Step 1
Step 2
Step 6
Step 3
Step 5
Step 4
Strategies for ERA of GM plants
NTO

35. 4-5-6-7-8 Compendium of ERA
G. Human and animal health
F. Biogeochemical processes
E. Farming practices
D. Non‐target organisms (NTOs)
C. Target organisms (TO)
B. Horizontal gene transfer
A. Persistence and invasiveness
(6) Overall risk evaluation & conclusion
(5) Risk mitigation strategies
(4) Risk characterisation
(1) Problem formulation
(2) Hazard
characterisation
(3) Exposure
characterisation
Plant‐environment
interactions
Agronomic/
phenotypic data
Compositional data
Molecular data
Event‐specific data
sources (4)
Areas of risk or concern (7)
ERA strategies (8) ‐
Principles & approaches
I. Science‐based
II. Transparency
III. Sequential steps
IV. Comparative approach
V. Case‐specific
VI. Tiered approach
VII. Iterative
VIII. Scientific incertitude
Cross‐cutting considerations (5)
I. Choice of comparator
II. Receiving environment(s)
III. General statistical considerations
IV. Long‐term effects
V. Stacked transformation events
Graph by Yann Devos

36. Commercial Variety
Registration
Commercial cultivation
EPA ASSESSMENT
FDA ASSESSMENT
Commercial Cultivation in the USA
SAFETY
ASESSMENT BY
EU MMSS
Field Trial
in the UE
USDA ASSESMENT
Lead Country Assessment
+ 26 Member States
Directive 2001/18/EC
EFSA Assessment
Regulation (EC) Nº
1829/2003
GM
Food
GM
Feed
GMO Approval
Directive 2001/18/EC or
Regulation (EC) 1829/2003
GM
MONITORING PLANS
FOOD/FEED/CULTIVATION

37. % Bt maize
0 %
< 5 %
5-25 %
25-50 %
50-75 %
2010: 76.575 ha Bt maize (23% of the total maize, 329.000 ha of grain maize)
101 varieties of GM maize registered in the Spanish Catalogue
17 companies marketing these varieties in Spain.
1998: first 2 varieties of Bt maize (Bt 176 from Syngenta)
2010
GM maize crop in SpainGM maize crop in Spain
2011: 97.326 ha Bt maize (26.5% of the total grain maize)
106 varieties of GM maize registered in the Spanish Catalogue
Several companies marketing these varieties in Spain.
Area of GM maize
0
20.000
40.000
60.000
80.000
100.000
120.000
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011Year
Hectares

38. Spanish legislation for the registration of commercial varieties since 1998 going
ahead of what was included later in the Directive 2001/18/EC.
Monitoring Plan for Applicants
Case Specific
Monitoring of corn borer resistance
Potential effects on non-target arthropods
Potential effects on soil microorganisms
Potential effects on digestive tract bacteria (only for Bt-176)
General Surveillance
Farmer questionnaires (only MON810)
Seed sales by localities. Distribution. Buyers.
Information to farmers on specific measures for GM cultivation
Bt176 varieties
(1998-2005)
MON810 varieties
(from 2003)
PostPost--market monitoring for Bt maize in Spainmarket monitoring for Bt maize in Spain
Requirements for ApplicantsRequirements for Applicants

39. Public Research Studies for Bt-maize.
Bt-176 (1998-2005) and MON810 (2003-2010)
MARM (CNB) + public research institutions (CSIC, Universities)MARM (CNB) + public research institutions (CSIC, Universities)
Ecology of corn borers in Spain and susceptibility to Bt maize and Bt
toxin.
Ecological risk assessment of transgenic maize.
Assessment of the potential ecological risks of transgenic maize
Mid and long-term monitoring of the potential ecological risks of insect
resistant transgenic crops (maize and cotton)
Centro de Investigaciones Biológicas (CSIC).
Gene transfer from transgenic maize to the microbial population in the
planting soil and effects on soil populations.
Centro Nacional de Biotecnología (CSIC).

40. Susceptibility to Cry1Ab in Spanish populations
Sesamia nonagrioides
LC50 values of field populations collected from 1999 to 2009 ranged
between 3 and 30 ng Cry1Ab/cm2
Ostrinia nubilalis
LC50 values of field populations collected from 1999 to 2009 ranged
between 3 and 40 ng Cry1Ab/cm2
No significant changes in the susceptibility to Cry1Ab over time
González-Núñez et al., 2000. J. Econ. Entomol. 93: 459-463
Farinós et al., 2004. Entomol. Exp. Appl. 110: 23-30

41. Pedro Castañera, Félix Ortego, CSIC
(Agreement MARM-CSIC)
Compa CB (Bt-176): 2000-2005
Varieties MON810: 2005-2010
Objectives:
-Arthropod fauna in maize fields.
-Exposure of non-target arthropods to Bt toxins.
-Field trials to assess abundance and diversity of non-target arthropods.
-Laboratory assays to test worst-case scenarios.
Potential effects on non-target arthropods

42. Arthropod fauna in maize fields
The abundance and composition
of non-target arthropods in
maize fields vary between years
and localities
Natural enemies are exposed to
the Cry1Ab toxin expressed in Bt
maize
No detrimental effects have
been found in field trials on
commercial Bt-maize fields
No negative effects on “worst-
case scenario” laboratory assays
De la Poza et al. (2005) Crop Protection 24: 677-684
Farinós et al. (2008). Biological Control 44: 362-371
Alvarez-Alfageme et al. (2008). Transgenic Research, 17: 943-954
Alvarez-Alfageme et al. (2009). J. Insect Physiol. 55: 143-149
García et al. (2010). Biological Control 55: 225-233

43. Potential effects on soil microorganisms
(2004-2009)
1) A lack of detection of gene transfer from
Bt-maize to culturable soil bacteria was
demonstrated by PCR analysis.
Badosa et al, 2004. FEMS Microbiology Ecology 48:
169-178.
2) Development of a detection system of
molecular structure differences in
rhizobacterial communities of Bt maize
(genetic microarrays) Fingerprinting
Val, G., Marín, S. and Mellado, R.P. 2009. Microbial
Ecology 58,108-115.
CNB
Positive
spots

44. http://ec.europa.eu/research/biosociety/
pdf/a_decade_of_eu-
funded_gmo_research.pdf
http://www.marm.es/es/calidad-y-
evaluacion-
ambiental/temas/biotecnologia/PL
AN_DE_SEGUIMIENTO_mar_2
011_tcm7-147305.pdf

45. New Politics on GMO in the EU
Conclusions of the Council of December 2008 under the French Presidency
• The legal framework was comprehensive
• The need to better implement the existing provisions, notably as concerns cultivation.
• Need to evaluate the current legislation
• Need to evaluate the socio-economic impact of GMO
• EFSA Guidance for the assessment of environmental risks
New approach of the Commission with regards GMO cultivation
13 Member States called the Commission to prepare proposals to give freedom to Member
States to decide on cultivation of GMO
Barroso, in September 2009, indicated that it should be possible to combine an EU
authorisation system, based on science, with freedom for Member States to decide whether or not
they wish to cultivate GM crops in their territory
In July 2010, the Commission makes a proposal compound by three steps:
• New Recommendation on coexistence (already published)
• Legislative amendment: Regulation that amends the Directive 2001/18 that increase
flexibility to Member States on GMO cultivation in all or part of their territory
• Revision of all the existing legislation

46. THANK YOU!THANK YOU!