Annexes to COM(1999)139 - Amendment of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms

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dossier COM(1999)139 - Amendment of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms.
document COM(1999)139 EN
date March 12, 2001
ANNEX I A


TECHNIQUES REFERRED TO IN ARTICLE 2(2)

PART 1

Techniques of genetic modification referred to in Article 2(2)(a) are inter alia:

(1) recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;

(2) techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation;

(3) cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

PART 2

Techniques referred to in Article 2(2)(b) which are not considered to result in genetic modification, on condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms made by techniques/methods other than those excluded by Annex I B:

(1) in vitro fertilisation,

(2) natural processes such as: conjugation, transduction, transformation,

(3) polyploidy induction.


ANNEX I B


TECHNIQUES REFERRED TO IN ARTICLE 3

Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are:

(1) mutagenesis,

(2) cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods.


ANNEX II


PRINCIPLES FOR THE ENVIRONMENTAL RISK ASSESSMENT

This Annex describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the environmental risk assessment (e.r.a.) referred to in Articles 4 and 13. It will be supplemented by guidance notes to be developed in accordance with the procedure laid down in Article 30(2). These guidance notes shall be completed by 17 October 2002.

With a view to contributing to a common understanding of the terms "direct, indirect, immediate and delayed" when implementing this Annex, without prejudice to further guidance in this respect and in particular as regards the extent to which indirect effects can and should be taken into account, these terms are described as follows:

- "direct effects" refers to primary effects on human health or the environment which are a result of the GMO itself and which do not occur through a causal chain of events;

- "indirect effects" refers to effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management.

Observations of indirect effects are likely to be delayed;

- "immediate effects" refers to effects on human health or the environment which are observed during the period of the release of the GMO. Immediate effects may be direct or indirect;

- "delayed effects" refers to effects on human health or the environment which may not be observed during the period of the release of the GMO, but become apparent as a direct or indirect effect either at a later stage or after termination of the release.

A general principle for environmental risk assessment is also that an analysis of the "cumulative long-term effects" relevant to the release and the placing on the market is to be carried out. "Cumulative long-term effects" refers to the accumulated effects of consents on human health and the environment, including inter alia flora and fauna, soil fertility, soil degradation of organic material, the feed/ food chain, biological diversity, animal health and resistance problems in relation to antibiotics.

A. Objective

The objective of an e.r.a. is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of GMOs may have. The e.r.a. should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used.

B. General Principles

In accordance with the precautionary principle, the following general principles should be followed when performing the e.r.a.:

- identified characteristics of the GMO and its use which have the potential to cause adverse effects should be compared to those presented by the non-modified organism from which it is derived and its use under corresponding situations;

- the e.r.a. should be carried out in a scientifically sound and transparent manner based on available scientific and technical data;

- the e.r.a. should be carried out on a case by case basis, meaning that the required information may vary depending on the type of the GMOs concerned, their intended use and the potential receiving environment, taking into account, i.a., GMOs already in the environment;

- if new information on the GMO and its effects on human health or the environment becomes available, the e.r.a. may need to be readdressed in order to:

- determine whether the risk has changed;

- determine whether there is a need for amending the risk management accordingly.

C. Methodology

C.1. Characteristics of GMOs and releases

Depending on the case the e.r.a. has to take into account the relevant technical and scientific details regarding characteristics of:

- the recipient or parental organism(s);

- the genetic modification(s), be it inclusion or deletion of genetic material, and relevant information on the vector and the donor;

- the GMO;

- the intended release or use including its scale;

- the potential receiving environment; and

- the interaction between these.

Information from releases of similar organisms and organisms with similar traits and their interaction with similar environments can assist the e.r.a.

C.2. Steps in the e.r.a.

In drawing conclusions for the e.r.a. referred to in Articles 4, 6, 7 and 13 the following points should be addressed:

1. Identification of characteristics which may cause adverse effects:

Any characteristics of the GMOs linked to the genetic modification that may result in adverse effects on human health or the environment shall be identified. A comparison of the characteristics of the GMO(s) with those of the non-modified organism under corresponding conditions of the release or use, will assist in identifying the particular potential adverse effects arising from the genetic modification. It is important not to discount any potential adverse effect on the basis that it is unlikely to occur.

Potential adverse effects of GMOs will vary from case to case, and may include:

- disease to humans including allergenic or toxic effects (see for example items II.A.11. and II.C.2(i) in Annex III A, and B 7 in Annex III B);

- disease to animals and plants including toxic, and where appropriate, allergenic effects (see for example items II.A.11. and II.C.2(i) in Annex III A, and B 7 and D 8 in Annex III B);

- effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations (see for example items IV B 8, 9 and 12 in Annex III A);

- altered susceptibility to pathogens facilitating the dissemination of infectious diseases and/or creating new reservoirs or vectors;

- compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine (see for example items II.A.11(e) and II.C.2(i)(iv) in Annex III A);

- effects on biogeochemistry( biogeochemical cycles), particularly carbon and nitrogen recycling through changes in soil decomposition of organic material (see for example items II.A.11(f) and IV.B.15 in Annex III A, and D 11 in Annex III B).

Adverse effects may occur directly or indirectly through mechanisms which may include:

- the spread of the GMO(s) in the environment,

- the transfer of the inserted genetic material to other organisms, or the same organism whether genetically modified or not,

- phenotypic and genetic instability,

- interactions with other organisms,

- changes in management, including, where applicable, in agricultural practices.

2. Evaluation of the potential consequences of each adverse effect, if it occurs

The magnitude of the consequences of each potential adverse effect should be evaluated.

This evaluation should assume that such an adverse effect will occur. The magnitude of the consequences is likely to be influenced by the environment into which the GMO(s) is (are) intended to be released and the manner of the release.

3. Evaluation of the likelihood of the occurrence of each identified potential adverse effect

A major factor in evaluating the likelihood or probability of adverse effects occurring is the characteristics of the environment into which the GMO(s) is intended to be released, and the manner of the release.

4. Estimation of the risk posed by each identified characteristic of the GMO(s)

An estimation of the risk to human health or the environment posed by each identified characteristic of the GMO which has the potential to cause adverse effects should be made as far as possible, given the state of the art, by combining the likelihood of the adverse effect occurring and the magnitude of the consequences, if it occurs.

5. Application of management strategies for risks from the deliberate release or marketing of GMO(s)

The risk assessment may identify risks that require management and how best to manage them, and a risk management strategy should be defined.

6. Determination of the overall risk of the GMO(s)

An evaluation of the overall risk of the GMO(s) should be made taking into account any risk management strategies which are proposed.

D. Conclusions on the potential environmental impact from the release or the placing on the market of GMOs

On the basis of an e.r.a. carried out in accordance with the principles and methodology outlined in sections B and C, information on the points listed in sections D1 or D2 should be included, as appropriate, in notifications with a view to assisting in drawing conclusions on the potential environmental impact from the release or the placing on the market of GMOs:

D.1. In the case of GMOs other than higher plants

1. Likelihood of the GMO to become persistent and invasive in natural habitats under the conditions of the proposed release(s).

2. Any selective advantage or disadvantage conferred to the GMO and the likelihood of this becoming realised under the conditions of the proposed release(s).

3. Potential for gene transfer to other species under conditions of the proposed release of the GMO and any selective advantage or disadvantage conferred to those species.

4. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the GMO and target organisms (if applicable).

5. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the GMO with non-target organisms, including impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens.

6. Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the GMO and persons working with, coming into contact with or in the vicinity of the GMO release(s).

7. Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the GMO and any product derived from it, if it is intended to be used as animal feed.

8. Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the GMO and target and non-target organisms in the vicinity of the GMO release(s).

9. Possible immediate and/or delayed, direct and indirect environmental impacts of the specific techniques used for the management of the GMO where these are different from those used for non-GMOs.

D.2. In the case of genetically modified higher plants (GMHP)

1. Likelihood of the GMHP becoming more persistent than the recipient or parental plants in agricultural habitats or more invasive in natural habitats.

2. Any selective advantage or disadvantage conferred to the GMHP.

3. Potential for gene transfer to the same or other sexually compatible plant species under conditions of planting the GMHP and any selective advantage or disadvantage conferred to those plant species.

4. Potential immediate and/or delayed environmental impact resulting from direct and indirect interactions between the GMHP and target organisms, such as predators, parasitoids, and pathogens (if applicable).

5. Possible immediate and/or delayed environmental impact resulting from direct and indirect interactions of the GMHP with non-target organisms, (also taking into account organisms which interact with target organisms), including impact on population levels of competitors, herbivores, symbionts (where applicable), parasites and pathogens.

6. Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the GMHP and persons working with, coming into contact with or in the vicinity of the GMHP release(s).

7. Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the GMO and any products derived from it, if it is intended to be used as animal feed.

8. Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the GMO and target and non-target organisms in the vicinity of the GMO release(s).

9. Possible immediate and/or delayed, direct and indirect environmental impacts of the specific cultivation, management and harvesting techniques used for the GMHP where these are different from those used for non-GMHPs.


ANNEX III


INFORMATION REQUIRED IN THE NOTIFICATION

A notification referred to in part B or part C of the Directive is to include, as appropriate, the information set out below in the sub-Annexes.

Not all the points included will apply to every case. It is to be expected that individual notifications will address only the particular subset of considerations which is appropriate to individual situations.

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.

Future developments in genetic modification may necessitate adapting this Annex to technical progress or developing guidance notes on this Annex. Further differentiation of information requirements for different types of GMOs, for example single celled organisms, fish or insects, or for particular use of GMOs like the development of vaccines, may be possible once sufficient experience with notifications for the release of particular GMOs has been gained in the Community.

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

Annex III A applies to releases of all types of genetically modified organisms other than higher plants. Annex III B applies to release of genetically modified higher plants.

The term "higher plants" means plants which belong to the taxonomic group Spermatophytae (Gymnospermae and Angiospermae).


ANNEX III A


INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS

I. GENERAL INFORMATION

A. Name and address of the notifier (company or institute)

B. Name, qualifications and experience of the responsible scientist(s)

C. Title of the project

II. INFORMATION RELATING TO THE GMO

A. Characteristics of (a) the donor, (b) the recipient or (c) (where appropriate) parental organism(s):

1. scientific name,

2. taxonomy,

3. other names (usual name, strain 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. organisms with which transfer of genetic material is known to occur under natural conditions,

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 and asexual reproductive cycle;

(c) information on survival, including seasonability and the ability to form survival structures;

(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 colonise 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 mobilisation;

(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 mobilisation 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) methods and criteria used for selection;

(f) 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) considerations for human health and animal health, as well as plant health:

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

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

(iii) capacity for colonisation;

(iv) 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.

(v) other product hazards.

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

A. Information on the release

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, protected areas, or drinking water supplies,

4. climatic characteristics of the region(s) likely to be affected,

5. geographical, geological and pedological characteristics,

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

7. description of target and non-target ecosystems likely to be affected,

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

9. 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

A. Characteristics affecting survival, multiplication and dissemination

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 behaviour 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) postrelease transfer of genetic material from GMOs into organisms in affected ecosystems;

(b) postrelease transfer of genetic material from indigenous organisms to the GMOs;

4. likelihood of postrelease 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 minimise 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,

8. potential for excessive population increase in the environment,

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

10. identification and description of the target organisms if applicable,

11. anticipated mechanism and result of interaction between the released GMOs and the target organism(s) if applicable,

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

13. likelihood of postrelease shifts in biological interactions or in host range,

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

15. known or predicted involvement in biogeochemical processes,

16. other potential interactions with the environment.

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

A. Monitoring techniques

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.

B. Control of the release

1. methods and procedures to avoid and/or minimise 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 unauthorised individuals,

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

C. Waste treatment

1. type of waste generated,

2. expected amount of waste,

3. description of treatment envisaged.

D. Emergency response plans

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

2. methods for decontamination of the areas affected, for example eradication of the GMOs,

3. methods for disposal or sanitation of plants, animals, 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.


ANNEX III B


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 (for example 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 (for example 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 postrelease, including cultivation practices and harvesting methods.

5. Approximate number of plants (or plants per m2).

G. INFORMATION ON CONTROL, MONITORING, POSTRELEASE 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 (for example pollen, seeds, tuber).

2. Description of methods for postrelease treatment of the site.

3. Description of postrelease 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.


ANNEX IV


ADDITIONAL INFORMATION

This Annex describes in general terms the additional information to be provided in the case of notification for placing on the market and information for labelling requirements regarding GMOs as or in product to be placed on the market, and GMO exempted under Article 2(4), second subparagraph. It will be supplemented by guidance notes, as regards i.a. the description of how the product is intended to be used, to be developed in accordance with the procedure laid down in Article 30(2). The labelling of exempted organisms as required by Article 26 shall be met by providing appropriate recommendations for, and restrictions on, use:

A. The following information shall be provided in the notification for placing on the market of GMOs as or in product in addition to that of Annex III:

1. proposed commercial names of the products and names of GMOs contained therein, and any specific identification, name or code used by the notifier to identify the GMO. After the consent any new commercial names should be provided to the competent authority,

2. name and full address of the person established in the Community who is responsible for the placing on the market, whether it be the manufacturer, the importer or the distributor,

3. name and full address of the supplier(s) of control samples,

4. description of how the product and the GMO as or in product are intended to be used. Differences in use or management of the GMO compared to similar non-genetically modified products should be highlighted,

5. description of the geographical area(s) and types of environment where the product is intended to be used within the Community, including, where possible, estimated scale of use in each area,

6. intended categories of users of the product e.g. industry, agriculture and skilled trades, consumer use by public at large,

7. 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 GMO products to facilitate post-marketing control and inspection. This information should include where appropriate the lodging of samples of the GMO or its genetic material, with the competent authority and details of nucleotide sequences or other type of information which is necessary to identify the GMO product and its progeny, for example the methodology for detecting and identifying the GMO 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,

8. proposed labelling on a label or in an accompanying document. This must include, at least in summarised form, a commercial name of the product, a statement that "This product contains genetically modified organisms", the name of the GMO and the information referred to in point 2, the labelling should indicate how to access the information in the publicly accessible part of the register.

B. The following information shall be provided in the notification, when relevant, in addition to that of point A, in accordance with Article 13 of this Directive:

1. measures to take in case of unintended release or misuse,

2. specific instructions or recommendations for storage and handling,

3. specific instructions for carrying out monitoring and reporting to the notifier and, if required, the competent authority, so that the competent authorities can be effectively informed of any adverse effect. These instructions should be consistent with Annex VII part C,

4. proposed restrictions in the approved use of the GMO, for example where the product may be used and for what purposes,

5. proposed packaging,

6. estimated production in and/or imports to the Community,

7. proposed additional labelling. This may include, at least in summarised form, the information referred to in points A 4, A 5, B 1, B 2, B 3 and B 4.


ANNEX V


CRITERIA FOR THE APPLICATION OF DIFFERENTIATED PROCEDURES (ARTICLE 7)

The criteria referred to in Article 7(1) are set out below.

1. The taxonomic status and the biology (for example mode of reproduction and pollination, ability to cross with related species, pathogenecity) of the non-modified (recipient) organism shall be well-known.

2. There shall be sufficient knowledge about the safety for human health and the environment of the parental, where appropriate, and recipient organisms in the environment of the release.

3. Information shall be available on any interaction of particular relevance for the risk assessment, involving the parental, where appropriate, and recipient organism and other organisms in the experimental release ecosystem.

4. Information shall be available to demonstrate that any inserted genetic material is well characterised. Information on the construction of any vector systems or sequences of genetic material used with the carrier DNA shall be available. Where a genetic modification involves the deletion of genetic material, the extent of the deletion shall be known. Sufficient information on the genetic modification shall also be available to enable identification of the GMO and its progeny during a release.

5. The GMO shall not present additional or increased risks to human health or the environment under the conditions of the experimental release that are not presented by releases of the corresponding parental, where appropriate, and recipient organisms. Any capacity to spread in the environment and invade other unrelated ecosystems and capacity to transfer genetic material to other organisms in the environment shall not result in adverse effects.


ANNEX VI


GUIDELINES FOR THE ASSESSMENT REPORTS

The assessment report provided for by Articles 13, 17, 19 and 20 should include in particular the following:

1. Identification of the characteristics of the recipient organism which are relevant to the assessment of the GMO(s) in question. Identification of any known risks to human health and the environment resulting from the release into the environment of the recipient non-modified organism.

2. Description of the result of the genetic modification in the modified organism.

3. Assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating any risks to human health and the environment.

4. Identification of any new risks to human health and the environment that may arise from the release of the GMO(s) in question as compared to the release of the corresponding non-modified organism(s), based on the environmental risk assessment carried out in accordance with Annex II.

5. A conclusion on whether the GMO(s) in question should be placed on the market or as (a) product(s) and under which conditions, whether the GMOs in question shall not be placed on the market or whether the views of other competent authorities and the Commission are sought for on specific issues of the e.r.a.. These aspects should be specified. The conclusion should clearly address the use proposed, risk management and the monitoring plan proposed. In the case that it has been concluded that the GMOs should not be placed on the market, the competent authority shall give reasons for its conclusion.


ANNEX VII


MONITORING PLAN

This Annex describes in general terms the objective to be achieved and the general principles to be followed to design the monitoring plan referred to in Articles 13(2), 19(3) and 20. It will be supplemented by guidance notes to be developed in accordance with the procedure laid down in Article 30(2).

These guidance notes shall be completed by 17 October 2002.

A. Objective

The objective of a monitoring plan is to:

- confirm that any assumption regarding the occurrence and impact of potential adverse effects of the GMO or its use in the e.r.a. are correct, and

- identify the occurrence of adverse effects of the GMO or its use on human health or the environment which were not anticipated in the e.r.a.

B. General principles

Monitoring, as referred to in Articles 13, 19 and 20, takes place after the consent to the placing of a GMO on the market.

The interpretation of the data collected by monitoring should be considered in the light of other existing environmental conditions and activities. Where changes in the environment are observed, further assessment should be considered to establish whether they are a consequence of the GMO or its use, as such changes may be the result of environmental factors other than the placing of the GMO on the market.

Experience and data gained through the monitoring of experimental releases of GMOs may assist in designing the post marketing monitoring regime required for the placing on the market of GMOs as or in products.

C. Design of the monitoring plan

The design of the monitoring plan should:

1. be detailed on a case by case basis taking into account the e.r.a.,

2. take into account the characteristics of the GMO, the characteristics and scale of its intended use and the range of relevant environmental conditions where the GMO is expected to be released,

3. incorporate general surveillance for unanticipated adverse effects and, if necessary, (case-) specific monitoring focusing on adverse effects identified in the e.r.a.:

3.1. whereas case-specific monitoring should be carried out for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed or indirect effects which have been identified in the e.r.a.,

3.2. whereas surveillance could, if appropriate, make use of already established routine surveillance practices such as the monitoring of agricultural cultivars, plant protection, or veterinary and medical products. An explanation as to how relevant information collected through established routine surveillance practices will be made available to the consent-holder should be provided.

4. facilitate the observation, in a systematic manner, of the release of a GMO in the receiving environment and the interpretation of these observations with respect to safety to human health or the environment.

5. identify who (notifier, users) will carry out the various tasks the monitoring plan requires and who is responsible for ensuring that the monitoring plan is set into place and carried out appropriately, and ensure that there is a route by which the consent holder and the competent authority will be informed on any observed adverse effects on human health and the environment. (Time points and intervals for reports on the results of the monitoring shall be indicated).

6. give consideration to the mechanisms for identifying and confirming any observed adverse effects on human health and environment and enable the consent holder or the competent authority, where appropriate, to take the measures necessary to protect human health and the environment.


ANNEX VIII


CORRELATION TABLE

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Commission Declaration


Article 32 (Amendment 28)

The Commission notes the agreement of the co-legislators relating to recital 13 and Article 30(a), on the basis of Amendments 1 and 28, in particular concerning the date by which a proposal should be presented for the implementation of the Cartagena Protocol and the content of any such proposal.

In the respect of its right of initiative, the Commission states that it cannot accept to be bound by the provisions of this article neither as to timing nor as to the content of a future proposal.

The Commission does however confirm its commitment, after a comprehensive examination of all the potential implications, to presenting a proposal with a view to full implementation of the Cartagena Protocol.

Commission Declaration with respect to Amendment 35

With a view to facilitating the obligation of Member States to take the necessary measures to ensure traceability and labelling at all the stages of the placing on the market of GMOs authorised in accordance with part C of a revised Directive 90/220/EEC, the Commission reaffirms its intention to present in the course of year 2001 appropriate proposals for this purpose.

In addition, the Commission at the same time having regard to the results of the meeting with the experts of the Member States on 29 November 2000, affirms its intention to present proposals aiming to provide appropriate traceability for products derived from GMOs, as well as to supplement the labelling regime in accordance with the White Paper on Food Safety.