The document discusses the legislation and assessment processes for genetically modified organisms (GMOs) in the European Union, highlighting key directives, regulations, and the role of the European Food Safety Authority (EFSA). It covers the methodologies for risk assessment, including environmental and food safety evaluations, and outlines procedures for the approval and commercialization of GMOs. Additionally, it presents data on GM crop trials and approvals in the EU, particularly focusing on Spain's experiences with various genetically modified crops from 1993 to 2011.

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 ‘Protection of life and human
measures focused on the beings, of the human health and the
health and the animal welfare, the environment
environment protection’. and the consumer interests’.
Risk Assessment based on Risk Analysis based on available
existing scientific data. scientific studies.
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)
Goal: 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 THREE
MONTH MONTHS

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

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

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

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

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

13. Main Traits introduced in GMP in Spain
(1993-2011)
HT + IR
1%
2% 2% 2% Herbicide tolerance
3%
Changes in composition
32% Insect resistance
15%
Virus resistance
Androsterility
15% Fertility
26% 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
7) Decisio by the Yes
Approval
European Commision
No
No
Commitology after 6) Decision of the Counsil of Ministers of the Yes
‘Lisboa Treaty’ Approval
March 2011
Environment of the Member States
No
5) Decision of the Regulatory Committee Yes
Approval
de los Estados Miembros
Yes
4) EFSA Opinion
No (European Food Safety Authority)
No
3) Study and Yes
1) Submission 2) Study and assessment
Sí revision by the
of the by the Competent
Competent Approval
Application Authority of the
Authorities of all
by the Member State
Member States
Notifier (Lead country)
No

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

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
VEMIE VETERINAR
AUJESZKY DISEASE
CHEMIE
VACCINATION
ENFERMEDAD AUJESZKY
VACCINES
RABORAL ORAL LIVE VACCINE AGAINST
RHONE-MERIEUX RABIE IN FOX
KIT OF ANÁLYSIS VALIO LTD. DETECTION OF ANTIBIOTICS IN
(Streptococcus thermophilus) MILK
TOBACCO SEEDS
SEITA
(Cultivation/Tobacco Industry) BROMOXINIL TOLERANCE FROM
1992
6 OILSEED RAPE PLANT
GLUFOSINATE TOLERANCE
(Seed production) GENETIC SYSTEMS TO
SOYA (A 5403) 1998
MONSANTO GLIFOSATE TOLERANCE
(Import and processing)
ANDROESTERILITY/
CHICCORY BEJO ZADEN
GLUFOSINATE TOLERANCE
(Cultivation)
MONSANTO
8 MAIZES
SYNGENTA RESISTENCIA AL TALADRO
(Import and processing)
PIONEER/DOW HERBICIDE TOLERANCE
(Only 3 for Cultivation)
BAYER CROPSCIENCE
4 CARNATIONS
FLORIGENE EUROPE B.V. LONGEVITY
(Cultivation)
1 POTATO
BASF PLANT SCIENCE CHANGES IN STARCH CONTENT 2010
(Cultivation /industrial uses)

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 x 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)
EVENT: Unique DNA recombination used for the regeneration of a whole
genetically modified plant
http://ec.europa.eu/food/dyna/gm_register/index_en.cfm

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

23. Methodology for Environmental Risk
Assessment (Field Trials)
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 Step 3: Evaluation of the likelihood of
consequences of each adverse effects if the occurrence of each identified
it occurs. 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.

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

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

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

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

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

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

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

38. Post-market monitoring for Bt maize in Spain
Requirements for Applicants
Spanish legislation for the registration of commercial varieties since 1998 going
ahead of what was included later in the Directive 2001/18/EC.
Bt176 varieties MON810 varieties
(1998-2005) (from 2003)
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

39. Public Research Studies for Bt-maize.
Bt-176 (1998-2005) and MON810 (2003-2010)
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).
MARM (CNB) + public research institutions (CSIC, Universities)

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. Potential effects on non-target arthropods
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.

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 De la Poza et al. (2005) Crop Protection 24: 677-684
Farinós et al. (2008). Biological Control 44: 362-371
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
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 Positive
spots
rhizobacterial communities of Bt maize
(genetic microarrays) Fingerprinting
Val, G., Marín, S. and Mellado, R.P. 2009. Microbial
Ecology 58,108-115.
CNB

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