The original annex hereunder has been revised and must be replaced by the new text given in the Commission directive 94/15/EC.

The notifications for a deliberate release referred to in Article 5 and for placing on the market referred to in Article 11 must provide the information set out below.

Not all the points included will apply to every case. It is to be expected, therefore, that individual notifications will address only the particular subset of considerations that are appropriate to individual situations. In each case where it is not technically possible or it does not appear necessary to give the information, the reasons shall be stated.

The level of detail required in response to each subset of considerations is also likely to vary according to the nature and the scale of the proposed release.

The description of the methods used or the reference to standardized or internationally recognized methods shall also be mentioned in the dossier, together with the name of the body or bodies responsible for carrying out the studies.

I. General Information - II. Information relating to the GMO - III. Information relating to the conditions of release and the receiving environment - IV. Information relating to the interactions between the GMOs and the environment - V. Information on monitoring, control, waste treatment and emergency response plans

I. GENERAL INFORMATION

B. Information on personnel and training

1. Name of person(s) responsible for planning and carrying out the release including those responsible for supervision, monitoring and safety, in particular, name and qualifications of the responsible scientist;

2. Information on training and qualifications of personnel involved in carrying out the release.

II. INFORMATION RELATING TO THE GMO

1. scientific name;

2. taxonomy;

3. other names (usual name, strain name, cultivar name, etc.);

4. phenotypic and genetic markers;

5. degree of relatedness between donor and recipient or between parental organisms;

6. description of identification and detection techniques;

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

8. description of the geographic distribution and of the natural habitat of the organism including information on natural predators, preys, parasites and competitors, symbionts and hosts;

9. potential for genetic transfer and exchange with other organisms;

10. verification of the genetic stability of the organisms and factors affecting it;

11. pathological, ecological and physiological traits:

    (a) classification of hazard according to existing Community rules concerning the protection of human health and/or the environment;

    (b) generation time in natural ecosystems, sexual reproductive cycle;

    (c) information on survival, including seasonability and the ability to form survival structures e.g.: seeds, spores or sclerotia;

    (d) pathogenicity: infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organism. Possible activation of latent viruses (proviruses). Ability to colonize other organisms;

    (e) antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy;

    (f) involvement in environmental processes: primary production, nutrient turnover, decomposition of organic matter, respiration, etc.

12. Nature of indigenous vectors:

    (a) sequence;

    (b) frequency of mobilization;

    (c) specificity;

    (d) presence of genes which confer resistance.

13. History of previous genetic modifications.

B. Characteristics of the vector:

1. nature and source of the vector;

2. sequence of transposons, vectors and other non-coding genetic segments used to construct the GMO and to make the introduced vector and insert function in the GMO;

3. frequency of mobilization of inserted vector and/or genetic transfer capabilities and methods of determination;

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

C. Characteristics of the modified organism:

1. Information relating to the genetic modification:

   (a) methods used for the modification;

   (b) methods used to construct and introduce the insert(s) into the recipient or to delete a sequence;

   (c) description of the insert and/or vector construction;

   (d) 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;

   (e) sequence, functional identity and location of the altered/inserted/deleted nucleic acid segment(s) in question with particular reference to any known harmful sequence.

2. Information on the final GMO:

   (a) description of genetic trait(s) or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed;

   (b) structure and amount of any vector and/or donor nucleic acid remaining in the final construction of the modified organism;

   (c) stability of the organism in terms of genetic traits;

   (d) rate and level of expression of the new genetic material. Method and sensitivity of measurement;

   (e) activity of the expressed protein(s);

   (f) description of identification and detection techniques including techniques for the identification and detection of the inserted sequence and vector;

   (g) sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques;

   (h) history of previous releases or uses of the GMO;

   (i) health considerations:

   (i) toxic or allergenic effects of the non-viable GMOs and/or their metabolic products;

   (ii) product hazards;

   (iii) comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;

   (iv) capacity for colonization;

   (v) if the organism is pathogenic to humans who are immunocompetent

   • diseases caused and mechanism of pathogenicity including invasiveness and virulence,

   • communicability,

   • infective dose,

   • host range, possibility of alteration,

   • possibility of survival outside of human host,

   • presence of vectors or means of dissemination,

   • biological stability,

   • antibiotic-resistance patterns,

   • allergenicity,

   • availability of appropriate therapies.

III. INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT

1. description of the proposed deliberate release, including the purpose(s) and foreseen products;

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

3. preparation of the site previous to the release;

4. size of the site;

5. method(s) to be used for the release;

6. quantities of GMOs to be released;

7. disturbance on the site (type and method of cultivation, mining, irrigation, or other activities);

8. worker protection measures taken during the release;

9. post-release treatment of the site;

10. techniques foreseen for elimination or inactivation of the GMOs at the end of the experiment;

11. information on, and results of, previous releases of the GMOs, especially at different scales and in different ecosystems.

B. Information on the environment (both on the site and in the wider environment):

1. geographical location and grid reference of the site(s) (in case of notifications under Part C the site(s) of release will be the foreseen areas of use of the product);

2. physical or biological proximity to humans and other significant biota;

3. proximity to significant biotopes or protected areas;

4. size of local population;

5. economic activities of local populations which are based on the natural resources of the area;

6. distance to closest areas protected for drinking water and/or environmental purpose;

7. climatic characteristics of the region(s) likely to be affected;

8. geographical, geological and pedological characteristics;

9. flora and fauna, including crops, livestock and migratory species;

10. description of target and non-target ecosystems likely to be affected;

11. a comparison of the natural habitat of the recipient organism with the proposed site(s) of release;

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

IV. INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GMOs AND THE ENVIRONMENT

1. biological features which affect survival, multiplication and dispersal;

2. known or predicted environmental conditions which may affect survival, multiplication and dissemination (wind, water, soil, temperature, pH, etc.);

3. sensitivity to specific agents.

B. Interactions with the environment:

1. predicted habitat of the GMOs;

2. studies of the behavior and characteristics of the GMOs and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms, greenhouses;

3. genetic transfer capability;

   (a) post-release transfer of genetic material from GMOs into organisms in affected ecosystems;

   (b) post-release transfer of genetic material from indigenous organisms to the GMOs;

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

5. measures employed to ensure and to verify genetic stability. Description of genetic traits which may prevent or minimize dispersal of genetic material. Methods to verify genetic stability;

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

7. description of ecosystems to which the GMOs could be disseminated.

C. Potential environmental impact:

1. potential for excessive population increase in the environment;

2. competitive advantage of the GMOs in relation to the unmodified recipient or parental organism(s);

3. identification and description of the target organisms;

4. anticipated mechanism and result of interaction between the released GMOs and the target organism;

5. identification and description of non-target organisms which may be affected unwittingly;

6. likelihood of post-release shifts in biological interactions or in host range;

7. known or predicted effects on non-target organisms in the environment, impact on population levels of competitors: preys, hosts, symbionts, predators, parasites and pathogens;

8. known or predicted involvement in biogeochemical processes;

9. other potentially significant interactions with the environment.

V. INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS

1. methods for tracing the GMOs, and for monitoring their effects;

2. specificity (to identify the GMOs, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques;

3. techniques for detecting transfer of the donated genetic material to other organisms;

4. duration and frequency of the monitoring.

1. methods and procedures to avoid and/or minimize the spread of the GMOs beyond the site of release or the designated area for use;

2. methods and procedures to protect the site from intrusion by unauthorized individuals;

3. methods and procedures to prevent other organisms from entering the site.

1. type of waste generated;

2. expected amount of waste;

3. possible risks;

4. description of treatment envisaged.

1. methods and procedures for controlling the GMOs in case of unexpected spread;

2. methods for decontamination of the areas affected, e.g. eradication of the GMOs;

3. methods for disposal or sanitation of plants, soils, etc. that were exposed during or after the spread;

4. methods for the isolation of the area affected by the spread;

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

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   BELGIAN BIOSAFETY SERVER : Directive 90/220/EEC
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