Commission Implementing Regulation (EU) No 503/2013Show full title

PART VII SUMMARY OF APPLICATIONS

This Part specifies the standardised form, which the summary of the application dossier must follow.

Depending on the scope of the application, some of the requested information may not be applicable.

The summary shall not contain parts considered to be confidential in accordance with Article 30 of Regulation (EC) No 1829/2003.

1. GENERAL INFORMATION

1.1. Details of application

(a) Member State of application

(b) Application number

(c) Name of the product (commercial and any other names)

(d) Date of acknowledgement of valid application

1.2. Applicant

(a) Name of applicant

(b) Address of applicant

(c) Name and address of the representative of the applicant established in the Union (if the applicant is not established in the Union)

1.3. Scope of the application

(a) Genetically modified food



Food containing or consisting of genetically modified plants



Food produced from genetically modified plants or containing ingredients produced from genetically modified plants

(b) Genetically modified feed



Feed containing or consisting of genetically modified plants



Feed produced from genetically modified plants

(c) Genetically modified plants for food and feed use



Products other than food and feed containing or consisting of genetically modified plants with the exception of cultivation



Seeds and plant propagating material for cultivation in the Union

1.4. Is the product or the uses of the associated plant protection product(s) already authorised or subject to another authorisation procedure within the Union?

No	
Yes		(in that case, specify)

1.5. Has the genetically modified plant been notified under Part B of Directive 2001/18/EC?

Yes	
No		(in that case, provide risk analysis data on the basis of the elements of Part B of Directive 2001/18/EC)

1.6. Has the genetically modified plant or derived products been previously notified for marketing in the Union under Part C of Directive 2001/18/EC?

No	
Yes		(in that case, specify)

1.7. Has the product been subject to an application and/or authorised in a third country either previously or simultaneously to this application?

No	
Yes		In that case, specify the third country, the date of application and, where available, a copy of the risk assessment conclusions, the date of the authorisation and the scope of the application

1.8. General description of the product

(a) Name of the recipient or parental plant and the intended function of the genetic modification

(b) Types of products planned to be placed on the market according to the authorisation applied for and any specific form in which the product must not be placed on the market (such as seeds, cut-flowers, vegetative parts) as a proposed condition of the authorisation applied for

(c) Intended use of the product and types of users

(d) Any specific instructions and recommendations for use, storage and handling, including mandatory restrictions proposed as a condition of the authorisation applied for

(e) If applicable, geographical areas within the Union to which the product is intended to be confined under the terms of the authorisation applied for

(f) Any type of environment to which the product is unsuited

(g) Any proposed packaging requirements

(h) Any proposed labelling requirements in addition to those required by other applicable EU legislation than Regulation (EC) No 1829/2003 and when necessary a proposal for specific labelling in accordance with Article 13(2) and (3), Article 25(2)(c) and (d) and Article 25(3) of Regulation (EC) No 1829/2003

In the case of products other than food and feed containing or consisting of genetically modified plants, a proposal for labelling which complies with the requirements of point A(8) of Annex IV to Directive 2001/18/EC must be included.

(i) Estimated potential demand

(i)

In the EU

(ii)

In EU export markets

(j) Unique identifier in accordance with Regulation (EC) No 65/2004.

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

(a) Family name

(b) Genus

(c) Species

(d) Subspecies

(e) Cultivar/breeding line

(f) Common 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)

(a) Mode(s) of reproduction

(b) Specific factors affecting reproduction

(c) Generation time

2.4. Sexual compatibility with other cultivated or wild plant species (for environmental safety aspects)

2.5. Survivability (for environmental safety aspects)

(a) Ability to form structures for survival or dormancy

(b) Specific factors affecting survivability

2.6. Dissemination (for environmental safety aspects)

(a) Ways and extent of dissemination

(b) Specific factors affecting dissemination

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

(a) Description of the methods used for the genetic modification

(b) Nature and source of the vector used

(c) Source of donor nucleic acid(s) used for transformation, size and intended function of each constituent fragment of the region intended for insertion

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

(a) The copy number of all detectable inserts, both complete and partial

(b) In the case of deletion(s), size and function of the deleted region(s)

(c) Subcellular location(s) of insert(s) (nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form) and methods for its/their determination

(d) The organisation of the inserted genetic material at the insertion site

(e) In the case of modifications other than insertion or deletion, describe function of the modified genetic material before and after the modification, as well as direct changes in expression of genes as a result of the modification

3.2.3. Information on the expression of the insert

(a) Information on developmental expression of the insert during the life cycle of the plant

(b) Parts of the plant where the insert is expressed

3.2.4. Genetic stability of the insert and phenotypic stability of the genetically modified plant

3.2.5. Information (for environmental safety aspects) on how the genetically modified plant differs from the recipient plant in:

(a) Mode(s) and/or rate of reproduction

(b) Dissemination

(c) Survivability

(d) Other differences

3.2.6. Any change to the ability of the genetically modified plant to transfer genetic material to other organisms (for environmental safety aspects)

(a) Plant to bacteria gene transfer

(b) Plant to plant gene transfer

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

Description of the experimental design (number of locations, growing seasons, geographical spread, replicates and number of commercial varieties in each location) and of the statistical 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

(a) Toxicological testing of newly expressed proteins

(b) Testing of new constituents other than proteins

(c) Information on natural food or feed constituents

(d) Testing of the whole genetically modified food and feed

6. ALLERGENICITY

(a) Assessment of allergenicity of the newly expressed protein

(b) Assessment of allergenicity of the whole genetically modified plant

7. NUTRITIONAL ASSESSMENT

(a) Nutritional assessment of the genetically modified food

(b) Nutritional assessment of the genetically modified feed

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

(a) Persistence and invasiveness

(b) Selective advantage or disadvantage

(c) Potential for gene transfer

(d) Interactions between the genetically modified plant and target organisms

(e) Interactions of the genetically modified plant with non-target organisms

(f) Effects on human health

(g) Effects on animal health

(h) Effects on biogeochemical processes

(i) Impacts of the specific cultivation, management and harvesting techniques

11.3. Potential interactions with the abiotic environment

11.4. Risk characterisation

12. ENVIRONMENTAL MONITORING PLAN

(a) General (risk assessment, background information)

(b) Interplay between environmental risk assessment and monitoring

(c) Case-specific genetically modified plant monitoring (approach, strategy, method and analysis)

(d) General surveillance of the impact of the genetically modified plant (approach, strategy, method and analysis)

(e) Reporting the results of monitoring

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(1) by the same notifier

(a) Notification number

(b) Conclusions of post-release monitoring

(c) Results of the release with respect to any risk to human health and the environment, submitted to the competent authority in accordance with Article 10 of Directive 2001/18/EC

14.2. History of previous releases of the genetically modified plant carried out outside the Union by the same notifier

(a) Release country

(b) Authority overseeing the release

(c) Release site

(d) Aim of the release

(e) Duration of the release

(f) Aim of post-releases monitoring

(g) Duration of post-releases monitoring

(h) Conclusions of post-release monitoring

(i) Results of the release with respect to any risk to human health and the environment

(1)

OJ L 117, 8.5.1990, p. 15.