The name and address of the applicant, and the name, qualifications and experience of the scientist and of every other person who will be responsible for planning and carrying out the release of the organisms, and for the supervision, monitoring and safety of the release.

The title of the project.

The geographical distribution of the plant.

Where the application relates to a plant species which is not normally grown in the United Kingdom, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

Information concerning any other potential interactions, relevant to the genetically modified organism, 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.

A description of the methods used for the genetic modification.

The nature and source of the vector used.

The size, intended function and source (name) of the donor organism or organisms of each constituent fragment of the region intended for insertion.

A description of the trait or traits and characteristics of the genetically modified plant which have been introduced or modified.

The genetic stability of the insert and phenotypic stability of the genetically modified higher plant.

Any change to the ability of the genetically modified higher plant to transfer genetic material to other organisms.

Information on any toxic, allergenic or other harmful effects on human health arising from the genetic modification.

Information on the safety of the genetically modified higher plant to animal health, particularly regarding any toxic, allergenic or other harmful effects arising from the genetic modification, where the genetically modified higher plant is intended to be used in animal feedstuffs.

The mechanism of interaction between the genetically modified plant and target organisms, if applicable.

The potential changes in the interactions of the genetically modified higher plant with non-target organisms resulting from the genetic modification.

The potential interactions with the abiotic environment.

A description of detection and identification techniques for the genetically modified plant.

Information about previous releases of the genetically modified plant, if applicable.

A description of the methods used or a reference to standardised or internationally recognised methods used to compile the information required by this Schedule, and the name of the body or bodies responsible for carrying out the studies.

The name and address of the applicant, and the name, qualifications and experience of the scientist and of every other person who will be responsible for planning and carrying out the release of the organisms, and for the supervision, monitoring and safety of the release.

The title of the project.

Scientific name and taxonomy.

Usual strain, cultivar or other name.

Phenotypic and genetic markers.

The degree of relatedness between donor and recipient or between parental organisms.

The description of identification and detection techniques.

The sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques.

The description of the geographic distribution and of the natural habitat of the organisms including information on natural predators, prey, parasites and competitors, symbionts and hosts.

The organisms with which transfer of genetic material is known to occur under natural conditions.

Verification of the genetic stability of the organisms and factors affecting that stability.

The sequence, frequency of mobilisation and specificity of indigenous vectors, and the presence in those vectors of genes which confer resistance to environmental stresses.

The history of genetic modifications.

The nature and source of the vector.

The sequence of transposons, vectors and other non-coding genetic segments used to construct the genetically modified organisms and to make the introduced vector and insert function in those organisms.

The frequency of mobilisation, genetic transfer capabilities and/or methods of determination of the inserted vector.

Information on the degree to which the vector is limited to the DNA required to perform the intended function.

The methods used for the modification.

The description of any insert and/or vector construction.

The purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function.

The methods and criteria used for selection.

The sequence, functional identity and location of the altered, inserted or deleted nucleic acid segment or segments in question, and in particular any known harmful sequence.

The description of genetic traits or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed.

The structure and amount of any vector or donor nucleic acid remaining in the final construction of the modified organism.

The stability of the organism in terms of genetic traits.

The rate and level of expression of the new genetic material in the organism, and the method and sensitivity of measurement of that rate and level.

The activity of the expressed protein.

The description of identification and detection techniques, including techniques for the identification and detection of the inserted sequence and vector.

The sensitivity, reliability (in quantitative terms), and specificity of detection and identification techniques.

The history of previous releases or uses of the genetically modified organisms.

The description of the proposed deliberate release, including the purpose of the release and the foreseen products of the release.

The foreseen dates of the release and time planning of the experiment including frequency and duration of releases.

The preparation of the site before the release.

The size of the site.

The methods to be used for the release.

The quantity of organisms to be released.

The disturbance of the site, including the type and method of cultivation, mining, irrigation or other activities.

The worker protection measures taken during the release.

The post-release treatment of the site.

The techniques foreseen for elimination or inactivation of the genetically modified organisms at the end of the experiment or other purpose of the release.

Information on, and the results of, previous releases of the organisms, and in particular, releases on a different scale or into different ecosystems.

The geographical location and national grid reference of the site onto which the release will be made, or in the case of applications for consent to market or renewed consent to market the foreseen areas of use of the product.

The physical or biological proximity of the site of the organisms to humans and other significant biota.

The proximity to significant biotopes, protected areas or drinking water supplies.

The climatic characteristics of the region or regions likely to be affected.

The geographical, geological and pedological characteristics.

The flora and fauna, including crops, livestock and migratory species.

The description of the target and non-target ecosystems likely to be affected.

A comparison of the natural habitat of the recipient organism with the proposed site or sites of release.

Any known planned developments or changes in land use in the region which could influence the environmental impact of the release.

The biological features which affect survival, multiplication and dispersal.

The known or predicted environmental conditions which may affect survival, multiplication and dissemination, including wind, water, soil, temperature and pH.

The sensitivity to specific agents.

The predicted habitat of the genetically modified organisms.

The studies on the behaviour and characteristics of the genetically modified organisms and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms and greenhouses.

The likelihood of post-release selection leading to the expression of unexpected and/or undesirable traits in the genetically modified organism.

The measures employed to ensure and to verify genetic stability, the description of genetic traits which may prevent or minimise dispersal of genetic material, and methods to verify genetic stability.

The routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact and burrowing.

The description of ecosystems to which the genetically modified organisms could be disseminated.

The potential for excessive population increase of the genetically modified organisms in the environment.

The competitive advantage of the genetically modified organisms in relation to the unmodified recipient or parental organisms.

The identification and description of the target organisms if applicable.

The anticipated mechanism and result of interaction between the released genetically modified organisms and the target organisms, if applicable.

The identification and description of non-target organisms which may be adversely affected by the release of the genetically modified organism, and the anticipated mechanisms of any identified adverse interaction.

The likelihood of post release shifts in biological interactions or in the host range.

The known or predicted interactions with non-target organisms in the environment, including competitors, preys, hosts, symbionts, predators, parasites and pathogens.

The known or predicted involvement of the genetically modified organisms in biogeochemical processes.

Any other potential interactions of the organisms with the environment.

Methods for tracing the genetically modified organisms and for monitoring their effects.

Specificity (to identify the genetically modified organisms, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques.

Techniques for detecting transfer of the donated genetic material to other organisms.

Duration and frequency of the monitoring.

Methods and procedures to avoid and/or minimise the spread of the genetically modified organisms beyond the site of release or the designated area for use.

Methods and procedures to protect the site from intrusion by unauthorised individuals.

Methods and procedures to prevent other organisms from entering the site.

Type of waste generated.

Expected amount of waste.

Description of treatment envisaged.

Methods and procedures for controlling the genetically modified organisms in case of unexpected spread.

Methods, such as eradication of the genetically modified organisms, for decontamination of the areas affected.

Methods for disposal or sanitation of plants, animals, soils, and any other thing exposed during or after the spread.

Methods for the isolation of the area affected by the spread.

Plans for protecting human health and the environment in case of the occurrence of an undesirable effect.

A description of the methods used or a reference to standardised or internationally recognised methods used to compile the information required by this Schedule, and the name of the body or bodies responsible for carrying out the studies.

The proposed commercial name of the product and names of the genetically modified organisms in the product, and any specific identification, name or code used by the applicant to identify the genetically modified organism.

The name and address in the F1European Union of the person who is responsible for the placing on the market, whether it be the manufacturer, importer or distributor.

The name and address of the supplier of control samples.

A description of how the product and the genetically modified organism as or in the product are intended to be used, highlighting any differences in use or management of the genetically modified organism compared to similar non-genetically modified products.

A description of the geographical area and types of environment where the product is intended to be used within the F1European Union, including, where possible, an estimate of the scale of use in each area.

A description of the intended categories of users of the product, such as industry, agriculture, skilled trades or consumer use by the public at large.

Information on the genetic modification for the purposes of placing on one or several registers modifications in organisms, which can be used for the detection and identification of particular genetically modified organism products to facilitate post marketing control and inspection. This information should include where appropriate the lodging of samples of the genetically modified organism or its genetic material with the Scottish Ministers, and details of nucleotide sequences or other type of information which is necessary to identify the genetically modified organism product and its progeny, for example the methodology for detecting and identifying the genetically modified organism product, including experimental data demonstrating the specificity of the methodology. Information that cannot be placed, for confidentiality reasons, in the publicly accessible part of the register should be identified.

Information regarding proposed labelling, which must include, in a label or an accompanying document, at least in summarised form, a commercial name of the product, a statement that “This product contains genetically modified organisms”, the name of the genetically modified organism and the name and address of the person established in the F1European Union who is responsible for the placing on the market, and how to access the information in the publicly accessible part of the register.

The measures to be taken in the event of the escape of the organisms in the product or misuse of the product.

Specific instructions or recommendations for storage and handling of the product.

Specific instructions for carrying out monitoring and reporting to the applicant and, if required, the Scottish Ministers, which are consistent with Part C of Annex VII of the Deliberate Release Directive, so that the Scottish Ministers can be effectively informed of any adverse effect.

The proposed restrictions in the approved use of the genetically modified organism, such as where the product may be used and for what purposes.

The proposed packaging.

The estimated production in and/or imports to the F1European Union.

Any proposed additional labelling, which may include, at least in summarised form, the information referred to in paragraphs 4 and 5 of Part I of this Schedule, or paragraphs 9 to 12 of this Part.