The Table of Contents is as follows:

I CONTENTS

II ZUSAMMENFASSUNG

III SUMMARY

IV INDEX OF TABLES

V ACRONYMS

1 THIS REPORT

1.1 Background and aim of this report
1.2 Structure of this report
1.3 GMO notifications selected and documents analysed
1.4 Approach of the analysis of GMO notifications
1.4.1 Selection of assessment categories of potential environmental effects
1.4.1.1 Molecular characterisation of the GMP
1.4.1.2 Expression assessment of the GMP
1.4.1.3 Assessment of agronomic behaviour of the GMP
1.4.1.4 Assessment of composition of the GMP
1.4.1.5 Assessment of dissemination and related processes
1.4.1.6 Assessment of target effects
1.4.1.7 Assessment of interactions of the GMO with non-target organisms and the biotic environment
1.4.1.8 Assessment effects of the GMP on biogeochemical cycles and the abiotic
environment
1.4.1.9 Assessment of effects related to changes in land use or cultivation techniques
1.4.1.10 Risk management and monitoring plan
1.4.2 Criteria for the evaluation of assessment categories

2 REVIEW OF NOTIFICATIONS

2.1 Molecular characterisation
2.1.1 Information relating to the transgenic construct
Contents
2.1.2 Characterisation of the genetic modification
2.1.3 Number of integration sites and copy number of inserts
2.1.4 Localisation of inserts
2.1.5 Stability of insertions
2.1.6 Characterisation of Insert(s)
2.1.7 Size and organisation of the inserts and insert integrity
2.1.8 Information on flanking sequences
2.1.9 Absence of vector backbone sequences from the GMO
2.2 Field trials used for the assessment of expression, agronomic parameters and plant composition
2.3 Assessment of expression
2.3.1 Studies conducted for the expression assessment of the GMP
2.3.1.1 Field trials for the determination of expression of transgenes
2.3.1.2 Tissues analysed
2.3.1.3 Developmental expression
2.3.1.4 Expression over several generations
2.3.1.5 Expression in different genetic backgrounds
2.3.1.6 Presentation and statistical analysis of expression data
2.3.1.7 Expression of potential fusion proteins
2.4 Assessment of agronomic parameters
2.4.1 Studies conducted for the assessment of agronomic parameters
2.4.1.1 Field trials conducted for the assessment of agronomic parameters
2.4.1.2 Agronomic parameters evaluated
2.4.1.3 Statistical analysis and presentation of results
2.4.1.4 Interpretation of agronomic data by the notifier
2.5 Assessment of plant composition
2.5.1 Studies conducted for the evaluation of plant composition
2.5.1.1 Compositional parameters evaluated
2.5.1.2 Design of field trials for the assessment of plant composition
2.5.1.3 Statistic analysis and presentation of results
2.5.1.4 Interpretation of data on anti-nutrients and toxins by the notifiers
2.6 Assessment of traits with relevance for dissemination and related processes
2.6.1 Assessment of reproduction, dissemination and survivability
2.6.2 Assessment of persistence, invasiveness and potential selective disadvantages/advantages
2.7 Assessment of effects mediated via target organisms
Contents
2.7.1 Studies conducted for the assessment of effects on target organisms
2.7.2 Argumentation of the notifiers
2.8 Assessment of interactions with non-target organisms and the biotic environment
2.8.1 Studies conducted for the assessment of interactions of GMPs with non-target organisms
2.8.1.1 Assessment of exposure of non-target organisms to the GMP
2.8.1.2 Assessment of effects of the GMP on non-target organisms
2.8.2 Argumentation of the notifiers
2.9 Assessment of effects on biogeochemical cycles and the abiotic environment
2.9.1 Studies conducted for the assessment of effects on biogeochemical cycles and the
abiotic environment
2.9.2 Argumentation of the notifiers
2.10 Assessment of effects related to changes in land use or cultivation techniques
2.10.1 Arguments provided for the assessment of effects related to changes in land use or cultivation techniques
2.11 Proposed risk management and monitoring
2.11.1 Risk management measures and monitoring plans proposed

3 CRITICAL APPRAISAL OF THE ENVIRONMENTAL RISK ASSESSMENT IN GMO
NOTIFICATIONS
3.1 General remarks
3.2 Cross sectional issues
3.2.1 The environmental risk assessment (ERA) model
3.2.2 Lack of consideration of different exposure pathways
3.2.3 Risk assessments often based on arguments rather than data
3.2.4 Shortcomings with respect to the compilation and presentation of information
3.2.4.1 Lack of distinction of published and unpublished studies
3.2.4.2 Identification of the specific GMO-event in submitted studies
3.2.4.3 Insufficient labeling of and cross referencing between different parts of the notification
3.2.4.4 Reiteration of information
3.2.4.5 Insufficient documentation and traceability of information
3.2.5 Limitations of field trials for the phenotypic characterisation of the GMP
3.2.5.1 Shortcomings in the design of field trials
3.2.5.2 Data evaluation and presentation of results generated from field trials
3.2.6 Insufficient specification of organisms, methods and parameters
3.2.7 One species of conservation concern does not fit all
Contents
3.2.8 Step-by-step-principle not realized
3.2.9 Case-by-case principle ignored
3.2.10 Lack of specification and consideration of different environments
3.2.11 Lack of consideration of trait interactions
3.2.12 Conclusions on environmental risks – role of uncertainties
3.2.13 Long-term and cumulative effects
3.2.14 Guidance and assessment by EFSA
3.3 Shortcomings in specific assessment categories
3.3.1 Molecular characterisation
3.3.2 Expression assessment
3.3.3 Agronomic assessment
3.3.4 Assessment of plant composition of the GMP
3.3.5 Assessment of survivability, selective advantage, dissemination, invasiveness and persistence
3.3.6 Assessment of effects mediated via target organisms
3.3.7 Assessment of interactions of the GMP with non-target organisms and the biotic environment
3.3.8 Assessment of effects of the GMP on biogeochemical processes and the abiotic environment
3.3.9 Assessment of effects related to land use and cultivation techniques
3.3.10 Proposed risk management and monitoring
3.3.11 Conclusions: Presended data do not support the conclusion of the ERA

4 RECOMMENDATIONS FOR IMPROVEMENTS AND STANDARDIZATION OF THE
ENVIRONMENTAL RISK ASSESSMENT OF GMOS
4.1 General Remarks
4.2 General Recommendations
4.2.1 The Environmental Risk Assessment (ERA) Model
4.2.2 Exposure assessment as the starting point in the ERA
4.2.3 Data requirements for the ERA
4.2.4 Compilation and presentation of information
4.2.5 Field trials for the phenotypic characterization of the GMO
4.2.5.1 Design of field trials
4.2.5.2 Data evaluation and presentation of results generated from field trials
4.2.6 Specification of organisms, methods, parameters
4.2.7 Consideration of Species of Conservation Concern
4.2.8 Consideration of the Step-by-Step Principle
4.2.9 Consideration of the Case-by-Case principle
Contents
4.2.10 Consideration of Different Environments
4.2.11 Consideration of trait interactions
4.2.12 Interpretation of results and consideration of uncertainty
4.2.13 Long-term and cumulative effects
4.3 Specific recommendations for individual assessment categories
4.3.1 Molecular Characterisation
4.3.2 Expression assessment
4.3.3 Agronomic assessment
4.3.4 Assessment of plant composition of the GMP
4.3.5 Assessment of dissemination and related processes
4.3.5.1 GM crops without wild relatives in Europe
4.3.5.2 GM crops with wild relatives in Europe
4.3.5.3 Improve data presentation and referencing
4.3.6 Assessment of effects mediated via target organisms
4.3.7 Assessment of interactions of the GMP with non-target organisms and the biotic environment
4.3.8 Assessment of effects on biogeochemical processes and the abiotic environment
4.3.9 Assessment of effects related to land use and cultivation techniques
4.3.10 Proposed risk management and monitoring

5 OVERALL CONCLUSIONS AND RECOMMENDATIONS

6 REFERENCES

7 ANNEX: TABLES A1-A14