INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPS) (GYMNOSPERMAE AND ANGIOSPERMAE)
A. GENERAL INFORMATION
1. Name and address of the notifier (company or institute)
2. Name, qualifications and experience of the responsible scientist(s)
3. Title of the project
B. INFORMATION RELATING TO (A) THE RECIPIENT OR (B) (WHERE APPROPRIATE) PARENTAL PLANTS
1. Complete name:
(a) family name;
(b) genus;
(c) species;
(d) subspecies;
(e) cultivar/breeding line;
(f) common name.
2. (a) Information concerning reproduction:
(i) mode(s) of reproduction;
(ii) specific factors affecting reproduction, if any;
(iii) generation time.
(b) Sexual compatibility with other cultivated or wild plant species, including the distribution in Europe of the compatible species.
3. Survivability:
(a) ability to form structures for survival or dormancy;
(b) specific factors affecting survivability, if any.
4. Dissemination:
(a) ways and extent (e.g. an estimation of how viable pollen and/or seeds declines with distance) of dissemination;
(b) specific factors affecting dissemination, if any.
5. Geographical distribution of the plant.
6. In the case of plant species not normally grown in the Member State(s), description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.
7. Other potential interactions, relevant to the GMO, of the plant with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.
C. INFORMATION RELATING TO THE GENETIC MODIFICATION
1. Description of the methods used for the genetic modification.
2. Nature and source of the vector used.
3. Size, source (name) of donor organism(s) and intended function of each constituent fragment of the region intended for insertion.
D. INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT
1. Description of the trait(s) and characteristics which have been introduced or modified.
2. Information on the sequences actually inserted/deleted:
(a) size and structure of the insert and methods used for its characterisation, including information on any parts of the vector introduced in the GMHP or any carrier or foreign DNA remaining in the GMHP;
(b) in case of deletion, size and function of the deleted region(s);
(c) copy number of the insert;
(d) location(s) of the insert(s) in the plant cells (integrated in the chromosome, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its determination;
3. Information on the expression of the insert:
(a) information on the developmental expression of the insert during the lifecycle of the plant and methods used for its characterisation;
(b) parts of the plant where the insert is expressed (e.g. roots, stem, pollen, etc.).
4. Information on how the genetically modified plant differs from the recipient plant in:
(a) mode(s) and/or rate of reproduction;
(b) dissemination;
(c) survivability.
5. Genetic stability of the insert and phenotypic stability of the GMHP.
6. Any change to the ability of the GMHP to transfer genetic material to other organisms.
7. Information on any toxic, allergenic or other harmful effects on human health arising from the genetic modification.
8. Information on the safety of the GMHP to animal health, particularly regarding any toxic, allergenic or other harmful effects arising from the genetic modification, where the GMHP is intended to be used in animal feedstuffs.
9. Mechanism of interaction between the genetically modified plant and target organisms (if applicable).
10. Potential changes in the interactions of the GMHP with non-target organisms resulting from the genetic modification.
11. Potential interactions with the abiotic environment.
12. Description of detection and identification techniques for the genetically modified plant.
13. Information about previous releases of the genetically modified plant, if applicable.
E. INFORMATION RELATING TO THE SITE OF RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 and 7)
1. Location and size of the release site(s).
2. Description of the release site ecosystem, including climate, flora and fauna.
3. Presence of sexually compatible wild relatives or cultivated plant species.
4. Proximity to officially recognised biotopes or protected areas which may be affected.
F. INFORMATION RELATING TO THE RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 and 7)
1. Purpose of the release.
2. Foreseen date(s) and duration of the release.
3. Method by which the genetically modified plants will be released.
4. Method for preparing and managing the release site, prior to, during and post-release, including cultivation practices and harvesting methods.
5. Approximate number of plants (or plants per m2).
G. INFORMATION ON CONTROL, MONITORING, POST-RELEASE AND WASTE TREATMENT PLANS (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 and 7)
1. Any precautions taken:
(a) distance(s) from sexually compatible plant species, both wild relatives and crops
(b) any measures to minimise/prevent dispersal of any reproductive organ of the GMHP (e.g. pollen, seeds, tuber).
2. Description of methods for post-release treatment of the site.
3. Description of post-release treatment methods for the genetically modified plant material including wastes.
4. Description of monitoring plans and techniques.
5. Description of any emergency plans.
6. Methods and procedures to protect the site.