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)
PREPARATION AND PRESENTATION OF APPLICATIONS
1. Name and address of the applicant (company or institute).
2. Name, qualification and experience of the responsible scientist(s) and contact...
3. Designation and specification of the genetically modified plant and its...
6. Where applicable, a detailed description of the method of production...
7. Where appropriate, the conditions for the placing on the market...
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
1.2.2. Information relating to the genetically modified plant
1.2.3. Additional information relating to the genetically modified plant required for...
2. EXPOSURE ASSESSMENT — ANTICIPATED INTAKE OR EXTENT OF USE
4. POST-MARKET MONITORING ON THE GENETICALLY MODIFIED FOOD OR FEED
7. ADDITIONAL INFORMATION RELATED TO THE SAFETY OF THE GENETICALLY MODIFIED...
PART V METHODS OF DETECTION, SAMPLING AND IDENTIFICATION AND REFERENCE MATERIAL
PART VII SUMMARY OF APPLICATIONS
1.5. Has the genetically modified plant been notified under Part B...
1.6. Has the genetically modified plant or derived products been previously...
1.7. Has the product been subject to an application and/or authorised...
1.8. General description of the product
(a) Name of the recipient or parental plant and the intended...
(d) Any specific instructions and recommendations for use, storage and handling,...
(e) If applicable, geographical areas within the Union to which the...
(f) Any type of environment to which the product is unsuited...
(h) Any proposed labelling requirements in addition to those required by...
(j) Unique identifier in accordance with Regulation (EC) No 65/2004.
1.9. Measures suggested by the applicant to take in the case...
2. INFORMATION RELATING TO THE RECIPIENT OR (WHERE APPROPRIATE) PARENTAL PLANTS...
2.2. Geographical distribution and cultivation of the plant, including the distribution...
2.3. Information concerning reproduction (for environmental safety aspects)
2.4. Sexual compatibility with other cultivated or wild plant species (for...
2.7. Geographical distribution within the Union of the sexually compatible species...
2.9. Other potential interactions, relevant to the genetically modified plant, of...
3.2. Information relating to the genetically modified plant
3.2.1. Description of the trait(s) and characteristics which have been introduced...
3.2.2. Information on the nucleic acid(s) sequences actually inserted or deleted...
(a) The copy number of all detectable inserts, both complete and...
(c) Subcellular location(s) of insert(s) (nucleus, chloroplasts, mitochondria, or maintained in...
(d) The organisation of the inserted genetic material at the insertion...
(e) In the case of modifications other than insertion or deletion,...
3.2.4. Genetic stability of the insert and phenotypic stability of the...
3.2.5. Information (for environmental safety aspects) on how the genetically modified...
3.2.6. Any change to the ability of the genetically modified plant...
10. POST-MARKET MONITORING ON THE GENETICALLY MODIFIED FOOD OR FEED
11.1. Mechanism of interaction between the genetically modified plant and target...
11.2. Potential changes in the interactions of the genetically modified plant...
13. DETECTION AND IDENTIFICATION TECHNIQUES FOR THE GENETICALLY MODIFIED PLANT
14. INFORMATION RELATING TO PREVIOUS RELEASES OF THE GENETICALLY MODIFIED PLANT...
SCIENTIFIC REQUIREMENTS FOR THE RISK ASSESSMENT OF GENETICALLY MODIFIED FOOD AND FEED
1. HAZARD IDENTIFICATION AND CHARACTERISATION
1.1. Information relating to the recipient or (where appropriate) parental plants...
1.2. Molecular Characterisation
1.2.2. Information relating to the genetically modified plant
1.4.3. Information on altered levels of food and feed constituents
1.4.4. Testing of the whole genetically modified food and feed
3.1. Information about the method
A. The method(s) shall refer to all the methodological steps needed...
B. The applicant shall be allowed to refer to validated protocols,...
C. The applicant shall demonstrate that the method(s) fulfils the following...
D. For the purpose of implementing Articles 5(3)(i) and 17(3)(i) of...
E. The applicant shall provide a complete and detailed description of...
3.2. Information about the method testing carried out by the applicant...
3.3. Samples of the food and feed and their control samples...