Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applicatio... (32013R0503)
Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 Text with EEA relevance
- COMMISSION IMPLEMENTING REGULATION (EU) No 503/2013
- of 3 April 2013
- on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006
- (Text with EEA relevance)
- CHAPTER I
- GENERAL PROVISIONS
- Article 1
- Scope
- Article 2
- Definitions
- CHAPTER II
- GENERAL REQUIREMENTS
- Article 3
- Preparation and presentation of applications submitted under Articles 5(1) and 17(1)
- CHAPTER III
- SPECIFIC REQUIREMENTS
- Article 4
- Requirements for the performance of studies for applications submitted under Articles 5(3) and 17(3)
- Article 5
- Scientific requirements for the risk assessment of genetically modified food and feed for applications submitted under Articles 5(3) and 17(3)
- Article 6
- Additional information related to the risk assessment of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)
- Article 7
- Requirements applicable for post-market monitoring of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)
- Article 8
- Requirements concerning the methods of detection, identification and quantification and for control samples and reference material of genetically modified food or feed for applications submitted under Articles 5(3), 11(2), 17(3) and 23(2)
- CHAPTER IV
- TRANSITIONAL AND FINAL PROVISIONS
- Article 9
- Transitional provisions
- Article 10
- Amendments to Regulation (EC) No 641/2004
- ‘Article 1
- Article 11
- Amendments to Regulation (EC) No 1981/2006
- Article 12
- Review
- Article 13
- Entry into force
- ANNEX I
- PREPARATION AND PRESENTATION OF APPLICATIONS
- PART I
- GENERAL INFORMATION
- PART II
- SCIENTIFIC INFORMATION
- 1. HAZARD IDENTIFICATION AND CHARACTERISATION
- 1.1.
- Information relating to the recipient or (where appropriate) parental plants
- 1.2.
- Molecular Characterisation
- 1.2.1.
- Information relating to the genetic modification
- 1.2.2.
- Information relating to the genetically modified plant
- 1.2.3.
- Additional information relating to the genetically modified plant required for the environmental safety aspects
- 1.2.4.
- Conclusions of the molecular characterisation
- 1.3.
- Comparative analysis
- 1.3.1.
- Choice of the conventional counterpart and additional comparators
- 1.3.2.
- Experimental design and statistical analysis of data from field trials for comparative analysis
- 1.3.3.
- Selection of material and compounds for analysis
- 1.3.4.
- Comparative analysis of composition
- 1.3.5.
- Comparative analysis of agronomic and phenotypic characteristics
- 1.3.6.
- Effects of processing
- 1.3.7.
- Conclusion
- 1.4.
- Toxicology
- 1.4.1.
- Testing of newly expressed proteins
- 1.4.2.
- Testing of new constituents other than proteins
- 1.4.3.
- Information on natural food and feed constituents
- 1.4.4.
- Testing of the whole genetically modified food or feed
- 1.4.5.
- Conclusion of the toxicological assessment
- 1.5.
- Allergenicity
- 1.5.1.
- Assessment of allergenicity of the newly expressed protein
- 1.5.2.
- Assessment of allergenicity of the whole genetically modified plant
- 1.5.3.
- Conclusion of the allergenicity assessment
- 1.6.
- Nutritional assessment
- 1.6.1.
- Nutritional assessment of the genetically modified food
- 1.6.2.
- Nutritional assessment of the genetically modified feed
- 1.6.3.
- Conclusion of the nutritional assessment
- 2. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE OR EXTENT OF USE
- 3. RISK CHARACTERISATION
- 4. POST-MARKET MONITORING ON THE GENETICALLY MODIFIED FOOD OR FEED
- 5. ENVIRONMENTAL ASSESSMENT
- 6. ENVIRONMENTAL MONITORING PLAN
- 7. ADDITIONAL INFORMATION RELATED TO THE SAFETY OF THE GENETICALLY MODIFIED FOOD OR FEED
- PART III
- CARTAGENA PROTOCOL
- PART IV
- LABELLING
- PART V
- METHODS OF DETECTION, SAMPLING AND IDENTIFICATION AND REFERENCE MATERIAL
- PART VI
- ADDITIONAL INFORMATION TO BE PROVIDED FOR GENETICALLY MODIFIED PLANTS AND/OR FOOD OR FEED CONTAINING OR CONSISTING OF GENETICALLY MODIFIED PLANTS
- PART VII
- SUMMARY OF APPLICATIONS
- 1. GENERAL INFORMATION
- 1.1.
- Details of application
- 1.2.
- Applicant
- 1.3.
- Scope of the application
- 1.8.
- General description of the product
- 1.9.
- Measures suggested by the applicant to take in the case of unintended release or misuse of the product as well as measures for its disposal and treatment
- 2. INFORMATION RELATING TO THE RECIPIENT OR (WHERE APPROPRIATE) PARENTAL PLANTS
- 2.1.
- Complete name
- 2.2.
- Geographical distribution and cultivation of the plant, including the distribution within the Union
- 2.3.
- Information concerning reproduction (for environmental safety aspects)
- 2.4.
- Sexual compatibility with other cultivated or wild plant species (for environmental safety aspects)
- 2.5.
- Survivability (for environmental safety aspects)
- 2.6.
- Dissemination (for environmental safety aspects)
- 2.7.
- Geographical distribution within the Union of the sexually compatible species (for environmental safety aspects)
- 2.8.
- In the case of plant species not normally grown in the Union description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts (for environmental safety aspects)
- 2.9.
- Other potential interactions, relevant to the genetically modified plant, of the plant with organisms in the ecosystem where it is usually grown, or used elsewhere, including information on toxic effects on humans, animals and other organisms (for environmental safety aspects)
- 3. MOLECULAR CHARACTERISATION
- 3.1.
- Information relating to the genetic modification
- 3.2.
- Information relating to the genetically modified plant
- 3.2.1.
- Description of the trait(s) and characteristics which have been introduced or modified
- 3.2.2.
- Information on the nucleic acid(s) sequences actually inserted or deleted
- 3.2.3.
- Information on the expression of the insert
- 3.2.4.
- Genetic stability of the insert and phenotypic stability of the genetically modified plant
- 3.2.6.
- Any change to the ability of the genetically modified plant to transfer genetic material to other organisms (for environmental safety aspects)
- 4. COMPARATIVE ANALYSIS
- 4.1.
- Choice of the conventional counterpart and additional comparators
- 4.2.
- Experimental design and statistical analysis of data from field trials for comparative analysis
- 4.3.
- Selection of material and compounds for analysis
- 4.4.
- Comparative analysis of agronomic and phenotypic characteristics
- 4.5.
- Effect of processing
- 5. TOXICOLOGY
- 6. ALLERGENICITY
- 7. NUTRITIONAL ASSESSMENT
- 8. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE/EXTENT OF USE
- 9. RISK CHARACTERISATION
- 10. POST-MARKET MONITORING ON THE GENETICALLY MODIFIED FOOD OR FEED
- 11. ENVIRONMENTAL ASSESSMENT
- 11.1.
- Mechanism of interaction between the genetically modified plant and target organisms
- 11.2.
- Potential changes in the interactions of the genetically modified plant with the biotic environment resulting from the genetic modification
- 11.3.
- Potential interactions with the abiotic environment
- 11.4.
- Risk characterisation
- 12. ENVIRONMENTAL MONITORING PLAN
- 13. DETECTION AND IDENTIFICATION TECHNIQUES FOR THE GENETICALLY MODIFIED PLANT
- 14. INFORMATION RELATING TO PREVIOUS RELEASES OF THE GENETICALLY MODIFIED PLANT (FOR ENVIRONMENTAL RISK ASSESSMENT ASPECTS)
- 14.1.
- History of previous releases of the genetically modified plant notified under Part B of Directive 2001/18/EC or under Part B of Council Directive 90/220/EEC(3) by the same notifier
- 14.2.
- History of previous releases of the genetically modified plant carried out outside the Union by the same notifier
- ANNEX II
- SCIENTIFIC REQUIREMENTS FOR THE RISK ASSESSMENT OF GENETICALLY MODIFIED FOOD AND FEED
- I. INTRODUCTION
- 1. DEFINITIONS
- 2. SPECIFIC CONSIDERATIONS
- 2.1.
- Insertion of marker genes and other nucleic acid(s) sequences not essential to achieve the desired trait
- 2.2.
- Risk assessment of genetically modified food and feed containing stacked transformation events
- II. SCIENTIFIC REQUIREMENTS
- 1. HAZARD IDENTIFICATION AND CHARACTERISATION
- 1.1.
- Information relating to the recipient or (where appropriate) parental plants
- 1.2.
- Molecular Characterisation
- 1.2.1.
- Information relating to the genetic modification
- 1.2.1.1. Description of the methods used for the genetic modification
- 1.2.1.2. Nature and source of vector used
- 1.2.1.3. Source of nucleic acid(s) used for transformation, size and intended function of each constituent fragment of the region intended for insertion
- 1.2.2.
- Information relating to the genetically modified plant
- 1.2.2.1. General description of the trait(s) and characteristics which have been introduced or modified
- 1.2.2.2. Information on the sequences actually inserted/deleted
- 1.2.2.3. Information on the expression of the insert(s)
- 1.2.2.4. Genetic stability of the insert and phenotypic stability of the genetically modified plant
- 1.2.2.5. Potential risk associated with horizontal gene transfer
- 1.2.3.
- Conclusions of the molecular characterisation
- 1.3.
- Comparative analysis
- 1.3.1.
- Choice of the conventional counterpart and additional comparators
- 1.3.2.
- Experimental design and statistical analysis of data from field trials for comparative analysis
- 1.3.2.1. Description of the protocols for the experimental design
- (a) Principles of experimental design
- (b) Specific protocols for experimental design
- 1.3.2.2. Statistical analysis
- 1.3.3.
- Selection of material and compounds for analysis
- 1.3.4.
- Comparative analysis of composition
- 1.3.5.
- Comparative analysis of agronomic and phenotypic characteristics
- 1.3.6.
- Effects of processing
- 1.3.7.
- Conclusion
- 1.4.
- Toxicology
- 1.4.1.
- Testing of newly expressed proteins
- 1.4.2.
- Testing of new constituents other than proteins
- 1.4.3.
- Information on altered levels of food and feed constituents
- 1.4.4.
- Testing of the whole genetically modified food and feed
- 1.4.4.1. 90-day feeding study in rodents with whole genetically modified food/feed
- 1.4.4.2. Animal studies with respect to reproductive and developmental toxicity testing
- 1.4.4.3. Other animal studies to examine the safety and the characteristics of genetically modified food and feed (see also Sections 1.6.1 and 1.6.2)
- 1.4.4.4. Interpretation of relevance of animal studies
- 1.4.5.
- Conclusion of the toxicological assessment
- 1.5.
- Allergenicity
- 1.5.1.
- Assessment of allergenicity of the newly expressed protein
- 1.5.2.
- Assessment of allergenicity of the genetically modified food or feed
- 1.5.3.
- Adjuvanticity
- 1.5.4.
- Conclusion of the allergenicity assessment
- 1.6.
- Nutritional assessment
- 1.6.1.
- Objectives of the nutritional assessment
- 1.6.2.
- Points to consider for the nutritional assessment of genetically modified food and feed
- 1.6.3.
- Nutritional studies of genetically modified food
- 1.6.4.
- Nutritional studies of genetically modified feed
- 1.6.5.
- Conclusion of the nutritional assessment
- 1.7.
- Standardised guidelines for toxicity tests
- 2. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE/EXTENT OF USE
- 3. RISK CHARACTERISATION
- 3.1.
- Introduction
- 3.2.
- Issues to be considered for risk characterisation
- 3.2.1.
- Molecular characterisation
- 3.2.2.
- Comparative analysis
- 3.2.3.
- Food and feed safety in relation to intake
- 3.3.
- The result of risk characterisation
- ANNEX III
- VALIDATION OF METHODS FOR THE DETECTION, IDENTIFICATION AND QUANTIFICATION OF THE TRANSFORMATION EVENT, AND REQUIREMENTS FOR CONTROL SAMPLES AND THE CERTIFIED REFERENCE MATERIAL
- 1. INTRODUCTION
- 2. DEFINITIONS
- 3. METHOD VALIDATION
- 3.1.
- Information about the method
- 3.2.
- Information about the method testing carried out by the applicant
- 3.3.
- Samples of the food and feed and their control samples
- 4. CERTIFIED REFERENCE MATERIAL
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