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EIROPAS PARLAMENTA UN PADOMES DIREKTĪVA 2001/18/EK (2001. gada 12. marts) par ģenētiski modificētu organismu apzinātu izplatīšanu vidē un Padomes Direktīvas 90/220/EEK atcelšanu

EIROPAS PARLAMENTA UN PADOMES DIREKTĪVA 2001/18/EK

(2001. gada 12. marts)

par ģenētiski modificētu organismu apzinātu izplatīšanu vidē un Padomes Direktīvas 90/220/EEK atcelšanu

1. Pārskats

PART A GENERAL PROVISIONS

PART B DELIBERATE RELASE OF GMOs FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET

PART C PLACING ON THE MARKET OF GMOs AS OR IN PRODUCTS

PART D FINAL PROVISIONS

ANNEX I A TECHNIQUES REFERRED TO IN ARTICLE 2(2)

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

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

ANNEX II

PRINCIPLES FOR THE ENVIRONMENTAL RISK ASSESSMENT

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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. Technical guidance notes may be developed in accordance with the regulatory procedure referred to in Article 30(2) in order to facilitate the implementation and explanation of this Annex.

▼B

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.

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C. Methodology

Guidance issued by the European Food Safety Authority is available for the implementation of this section for Part C notifications.

C.1. General and specific considerations for the e.r.a.

1. Intended and unintended changes

As part of the identification and evaluation of the potential adverse effects referred to in Section A, the e.r.a shall identify the intended and unintended changes resulting from the genetic modification and shall evaluate their potential to cause adverse effects on human health and on the environment.

Intended changes resulting from the genetic modification are changes that are designed to occur and which fulfil the original objectives of the genetic modification.

Unintended changes resulting from the genetic modification are consistent changes which go beyond the intended change(s) resulting from the genetic modification.

Intended and unintended changes can have either direct or indirect, and either immediate or delayed effects on human health and on the environment.

2. Long-term adverse effects and cumulative long-term adverse effects in the e.r.a. of Part C notifications

Long-term effects of a GMO are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a GMO or from an extensive use of a GMO in time and space.

The identification and evaluation of the potential long-term adverse effects of a GMO on human health and on the environment shall take into account the following:

(a)

the long-term interactions of the GMO and the receiving environment;

(b)

the characteristics of the GMO which become important on a long-term basis;

(c)

data obtained from repeated deliberate releases or placings on the market of the GMO over a long period.

The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introductory part of Annex II shall also take into account the GMOs deliberately released or placed on the market in the past.

3. Quality of the data

In order to carry out an e.r.a. for a notification under Part C of this Directive, the notifier shall collate already available data from scientific literature or from other sources, including monitoring reports, and shall generate the necessary data by performing, where possible, appropriate studies. Where applicable, the notifier shall justify in the e.r.a. why generating data by studies is not possible.

The e.r.a. for notifications under Part B of the Directive shall be based at least on already available data from scientific literature or from other sources and may be supplemented by additional data generated by the notifier.

Where data generated outside Europe is provided in the e.r.a., its relevance to receiving environment(s) in the Union shall be justified.

Data provided in the e.r.a for notifications under part C of this Directive shall comply with the following requirements:

(a)

where toxicological studies carried out to assess risk to human or animal health are provided in the e.ra., the notifier shall provide evidence to demonstrate that they were conducted in facilities which comply with:

(i)

the requirements of Directive 2004/10/EC; or

(ii)

the ‘OECD Principles on Good Laboratory Practice’ (GLP), if carried out outside the Union;

(b)

where studies other than toxicological studies are provided in the e.r.a., they shall:

(i)

comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC, where relevant; or

(ii)

be conducted by organisations accredited under the relevant ISO standard; or

(iii)

in the absence of a relevant ISO standard, be conducted in accordance with internationally recognised standards;

(c)

information on the results obtained from the studies referred to in points (a) and (b) and on the study protocols used shall be reliable and comprehensive and shall include the raw data in an electronic format suitable for carrying out statistical or other analysis;

(d)

the notifier shall specify, where possible, the size of effect that each study performed intends to detect and justify it;

(e)

the selection of sites for field studies shall be based on relevant receiving environments in view of the potential exposure and impact that would be observed where the GMO may be released. The selection shall be justified in the e.r.a.;

(f)

the non-genetically modified comparator shall be appropriate for the relevant receiving environment(s) and shall have a genetic background comparable to the GMO. The choice of the comparator shall be justified in the e.r.a.

4. Stacked transformation events in Part C notifications

The following shall apply to the e.r.a. of a GMO containing stacked transformation events in Part C notifications:

(a)

the notifier shall provide an e.r.a. for each single transformation event in the GMO or refer to already submitted notifications for those single transformation events;

(b)

the notifier shall provide an assessment of the following aspects:

(i)

the stability of the transformation events;

(ii)

the expression of the transformation events;

(iii)

the potential additive, synergistic or antagonistic effects resulting from the combination of the transformation events;

(c)

where the progeny of the GMO can contain various subcombinations of the stacked transformation events, the notifier shall provide a scientific rationale justifying that there is no need to provide experimental data for the concerned subcombinations, independently of their origin, or, in the absence of such scientific rationale, shall provide the relevant experimental data.

C.2. Characteristics of the GMO and of the releases

The e.r.a. shall take into account the relevant technical and scientific details regarding characteristics of:

—

the recipient or parental organism(s),

—

the genetic modification(s), be it insertion 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(s) into which the GMO will be released and into which the transgene may spread, and

—

the interaction(s) between these characteristics.

Relevant information from previous releases of the same or similar GMOs and organisms with similar traits and their biotic and abiotic interaction with similar receiving environments, including information resulting from the monitoring of such organisms, shall be considered in the e.r.a., subject to Article 6(3) or Article 13(4).

C.3. Steps in the e.r.a.

The e.r.a. referred to in Articles 4, 6, 7 and 13 shall be conducted for each relevant area of risk referred to in Section D1 or in Section D2 in accordance with the following six steps:

1. Problem formulation including hazard identification

The problem formulation shall:

(a)

identify any changes in the characteristics of the organism, linked to the genetic modification, by comparing the characteristics of the GMO with those of the chosen non-genetically modified comparator under corresponding conditions of release or use;

(b)

identify potential adverse effects on human health or the environment which are linked to the changes that have been identified under point (a) above;

Potential adverse effects shall not be discounted on the basis that they are unlikely to occur.

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

—

effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations leading to a potential decline in biodiversity,

—

altered susceptibility to pathogens facilitating the dissemination of infectious diseases 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,

—

effects on biogeochemistry (biogeochemical cycles), including carbon and nitrogen recycling through changes in soil decomposition of organic material,

—

disease affecting humans, including allergenic or toxic reactions,

—

disease affecting animals and plants, including toxic, and, in the case of animals, allergenic reactions, where appropriate.

Where potential long-term adverse effects of a GMO are identified, they shall be assessed in the form of desk based studies using, where possible, one or more of the following:

(i)

evidence from previous experiences;

(ii)

available data sets or literature;

(iii)

mathematical modelling;

(c)

identify relevant assessment endpoints.

Those potential adverse effects that could impact the identified assessment endpoints shall be considered in the next steps of the risk assessment;

(d)

identify and describe the exposure pathways or other mechanisms through which adverse effects may occur.

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

—

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

—

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

—

phenotypic and genetic instability,

—

interactions with other organisms,

—

changes in management, including, where applicable, in agricultural practices;

(e)

formulate testable hypotheses, and define relevant measurement endpoints, to allow, where possible, a quantitative evaluation of the potential adverse effect(s);

(f)

consider possible uncertainties, including knowledge gaps and methodological limitations.

2. Hazard characterisation

The magnitude of each potential adverse effect shall be evaluated. This evaluation shall assume that such an adverse effect will occur. The e.r.a shall consider that the magnitude is likely to be influenced by the receiving environment(s) into which the GMO is intended to be released and by the scale and conditions of the release.

Where possible, the evaluation shall be expressed in quantitative terms.

Where the evaluation is expressed in qualitative terms, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) shall be used and an explanation of the scale of effect represented by each category shall be provided.

3. Exposure characterisation

The likelihood or probability of each identified potential adverse effect occurring shall be evaluated to provide, where possible, a quantitative assessment of the exposure as a relative measure of probability, or otherwise a qualitative assessment of the exposure. The characteristics of the receiving environment(s) and the scope of the notification shall be taken into consideration.

Where the evaluation is expressed in qualitative terms, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) of the exposure shall be used and an explanation of the scale of effect represented by each category shall be provided.

4. Risk characterisation

The risk shall be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk.

Where a quantitative or semi quantitative estimation is not possible, a qualitative estimation of the risk shall be provided. In that case, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) of the risk shall be used and an explanation of the scale of effect represented by each category shall be provided.

Where relevant, the uncertainty for each identified risk shall be described and, where possible, expressed in quantitative terms.

5. Risk management strategies

Where risks are identified that require, on the basis of their characterisation, measures to manage them, a risk management strategy shall be proposed.

The risk management strategies shall be described in terms of reducing the hazard or the exposure, or both, and shall be proportionate to the intended reduction of the risk, the scale and conditions of the release and the levels of uncertainty identified in the e.r.a.

The consequent reduction in overall risk shall be quantified where possible.

6. Overall risk evaluation and conclusions

A qualitative and, where possible, quantitative evaluation of the overall risk of the GMO shall be made taking into account the results of the risk characterisation, the proposed risk management strategies and the associated levels of uncertainty.

The overall risk evaluation shall include, where applicable, the risk management strategies proposed for each identified risk.

The overall risk evaluation and conclusions shall also propose specific requirements for the monitoring plan of the GMO and, where appropriate, the monitoring of the efficacy of the proposed risk management measures.

For notifications under Part C of the Directive, the overall risk evaluation shall also include an explanation of the assumptions made during the e.r.a. and of the nature and magnitude of uncertainties associated with the risks, and a justification of the risk management measures proposed.

D. Conclusions on the specific areas of risk of the e.r.a.

Conclusions on the potential environmental impact in relevant receiving environments from the release or the placing on the market of GMOs shall be drawn for each relevant area of risk listed in Section D1 for GMOs other than higher plants or Section D2 for genetically modified higher plants, on the basis of an e.r.a. carried out in accordance with the principles outlined in Section B and following the methodology described in Section C, and on the basis of the information required pursuant to Annex III.

▼B

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

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

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

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.

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

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.

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).

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.

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).

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.

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

‘Higher plants’ shall mean plants which belong to the taxonomic group Spermatophytae (Gymnospermae and Angiospermae).

Persistence and invasiveness of the GMHP, including plant to plant gene transfer

Plant to micro-organisms gene transfer

Interactions of the GMHP with target organisms

Interactions of the GMHP with non-target organisms

Impacts of the specific cultivation, management and harvesting techniques

Effects on biogeochemical processes

Effects on human and animal health.

III PIELIKUMS

PAZIŅOJUMĀ IEKĻAUJAMĀ INFORMĀCIJA

Šīs direktīvas B un C daļā minētajos paziņojumos parasti iekļauj III A pielikumā norādīto informāciju, ja paziņojums attiecas uz ĢMO, kas nav augstākie augi, vai III B pielikumā norādīto informāciju, ja paziņojums attiecas uz ģenētiski modificētiem augstākajiem augiem.

Konkrēta III A vai III B pielikumā norādītās informācijas apakškopa nav obligāti jāsniedz, ja tā konkrēta paziņojuma kontekstā nav relevanta vai nepieciešama riska novērtēšanai, it sevišķi ņemot vērā ĢMO īpašības, izplatīšanas mērogu un apstākļus un plānotos izmantošanas apstākļus.

Turklāt katrai informācijas apakškopai vajadzīgais detalizācijas līmenis var mainīties atkarībā no paredzamās izplatīšanas veida un mēroga.

Par katru prasīto informācijas apakškopu sniedz šādas ziņas:

paziņojumā minēto pētījumu kopsavilkumi un rezultāti, arī skaidrojums, kāpēc tie ir relevanti vides risku novērtējumam (attiecīgā gadījumā);

ii)

attiecībā uz šīs direktīvas C daļā minētajiem paziņojumiem: pielikumi ar detalizētu informāciju par minētajiem pētījumiem, arī izmantoto metožu un materiālu apraksts vai atsauce uz standartizētām vai starptautiski atzītām metodēm un par pētījumu veikšanu atbildīgās struktūras vai struktūru nosaukumi.

Tālāka ģenētiskās modifikācijas attīstība var radīt vajadzību šo pielikumu pielāgot tehniskajai attīstībai vai par to izstrādāt norādes. Kad Savienībā būs uzkrāta pietiekama pieredze darbā ar paziņojumiem par konkrētu ĢMO izplatīšanu, var būt iespējama sīkāka informācijas prasību diferenciācija attiecībā uz dažādu tipu ĢMO, piemēram, daudzgadīgajiem augiem un kokiem, vienšūnas organismiem, zivīm vai insektiem, vai īpašiem ĢMO lietojumiem, piemēram, vakcīnu izstrādi.

▼B

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

ANNEX III A

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

I. GENERAL INFORMATION

Name and address of the notifier (company or institute)

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

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):

scientific name,

taxonomy,

other names (usual name, strain name, etc.),

phenotypic and genetic markers,

degree of relatedness between donor and recipient or between parental organisms,

description of identification and detection techniques,

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

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,

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

nature and source of the vector,

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,

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

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

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.

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

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

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

preparation of the site previous to the release,

size of the site,

method(s) to be used for the release,

quantities of GMOs to be released,

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

worker protection measures taken during the release,

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):

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),

physical or biological proximity to humans and other significant biota,

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

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

geographical, geological and pedological characteristics,

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

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

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

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

biological features which affect survival, multiplication and dispersal,

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

sensitivity to specific agents.

B. Interactions with the environment

predicted habitat of the GMOs,

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,

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,

likelihood of postrelease selection leading to the expression of unexpected and/or undesirable traits in the modified organism,

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,

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

description of ecosystems to which the GMOs could be disseminated,

potential for excessive population increase in the environment,

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

methods for tracing the GMOs, and for monitoring their effects,

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,

techniques for detecting transfer of the donated genetic material to other organisms,

duration and frequency of the monitoring.

B. Control of the release

methods and procedures to avoid and/or minimise the spread of the GMOs 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.

C. Waste treatment

type of waste generated,

expected amount of waste,

description of treatment envisaged.

D. Emergency response plans

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

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

methods for disposal or sanitation of plants, animals, soils, etc., that were 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.

▼M5

ANNEX III B

INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND ANGIOSPERMAE)

I. INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND 7

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

4. Information relating to the release

(a)

Purpose of the release

(b)

Foreseen date(s) and duration of the release

(c)

Method by which the GMHP will be released

(d)

Method for preparing and managing the release site, prior to, during and post release, including cultivation practices and harvesting methods

(e)

Approximate number of plants (or plants per m2).

5. Information relating to the site of release

(a)

Location and size of the release site(s).

(b)

Description of the release site ecosystem, including climate, flora and fauna.

(c)

Presence of sexually compatible wild relatives or cultivated plant species.

(d)

Proximity to officially recognised biotopes or protected areas which may be affected.

B. Scientific information

1. Information relating to the recipient plant or, where appropriate, to the parental plants

(a)

Complete name:

(i)

family name

(ii)

genus

(iii)

species

(iv)

subspecies

(v)

cultivar or breeding line

(vi)

common name.

(b)

Geographical distribution and cultivation of the plant within the Union.

(c)

Information concerning reproduction:

(i)

mode(s) of reproduction

(ii)

specific factors affecting reproduction, if any

(iii)

generation time.

(d)

Sexual compatibility with other cultivated or wild plant species, including the distribution in Europe of the compatible species.

(e)

Survivability:

(i)

ability to form structures for survival or dormancy

(ii)

specific factors affecting survivability, if any.

(f)

Dissemination:

(i)

ways and extent of dissemination

(ii)

specific factors affecting dissemination, if any.

(g)

Where a plant species is not normally grown in the Union, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

(h)

Potential interactions of the plant, that are relevant to the GMHP, with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

2. Molecular characterisation

(a)

Information relating to the genetic modification

(i)

Description of the methods used for the genetic modification.

(ii)

Nature and source of the vector used.

(iii)

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

(b)

Information relating to the GMHP

(i)

General description of the trait(s) and characteristics which have been introduced or modified.

(ii)

Information on the sequences actually inserted/deleted:

—

size and copy number of all insert(s) and methods used for its/their characterisation,

—

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

—

subcellular location(s) of the insert(s) in the plant cells (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its/their determination.

(iii)

Parts of the plant where the insert is expressed.

(iv)

Genetic stability of the insert and phenotypic stability of the GMHP.

(c)

Conclusions of the molecular characterisation

3. Information on specific areas of risk

(a)

Any change to the persistence or invasiveness of the GMHP, and its ability to transfer genetic material to sexually compatible relatives and the adverse environmental effects thereof.

(b)

Any change to the ability of the GMHP to transfer genetic material to microorganisms and the adverse environmental effects thereof.

(c)

Mechanism of interaction between the GMHP and target organisms (if applicable) and the adverse environmental effects thereof.

(d)

Potential changes in the interactions of the GMHP with non-target organisms resulting from the genetic modification and the adverse environmental effects thereof.

(e)

Potential changes in agricultural practices and management of the GMHP resulting from the genetic modification and the adverse environmental effects thereof.

(f)

Potential interactions with the abiotic environment and the adverse environmental effects thereof.

(g)

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

(h)

Conclusions on the specific areas of risk.

4. Information on control, monitoring, post-release and waste treatment plans

(a)

Any measures taken, including:

(i)

spatial and temporal isolation from sexually compatible plant species, both wild and weedy relatives and crops;

(ii)

any measures to minimise or prevent the dispersal of any reproductive part of the GMHP.

(b)

Description of methods for post-release treatment of the site.

(c)

Description of post-release treatment methods for the genetically modified plant material including wastes.

(d)

Description of monitoring plans and techniques.

(e)

Description of any emergency plans.

(f)

Description of the methods and procedures to:

(i)

avoid or minimise the spread of the GMHPs beyond the site of release;

(ii)

protect the site from intrusion by unauthorised individuals;

(iii)

prevent other organisms from entering the site or minimise such entries.

5. Description of detection and identification techniques for the GMHP.

6. Information about previous releases of the GMHP, if applicable.

II. INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLE 13

A. General information

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

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

3. Designation and specification of the GMHP.

4. Scope of the notification.

(a)

Cultivation

(b)

Other uses (to be specified in the notification).

B. Scientific information

1. Information relating to the recipient plant or, where appropriate, to the parental plants

(a)

Complete name:

(i)

family name

(ii)

genus

(iii)

species

(iv)

subspecies

(v)

cultivar/breeding line

(vi)

common name.

(b)

Geographical distribution and cultivation of the plant within the Union.

(c)

Information concerning reproduction:

(i)

mode(s) of reproduction

(ii)

specific factors affecting reproduction, if any

(iii)

generation time.

(d)

Sexual compatibility with other cultivated or wild plant species, including the distribution in the Union of the compatible species.

(e)

Survivability:

(i)

ability to form structures for survival or dormancy

(ii)

specific factors affecting survivability, if any.

(f)

Dissemination:

(i)

ways and extent of dissemination;

(ii)

specific factors affecting dissemination, if any.

(g)

Where a plant species is not normally grown in the Union, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

(h)

2. Molecular characterisation

(a)

Information relating to the genetic modification

(i)

Description of the methods used for the genetic modification.

(ii)

Nature and source of the vector used.

(iii)

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

(b)

Information relating to the genetically modified plant

(i)

Description of the trait(s) and characteristics which have been introduced or modified.

(ii)

Information on the sequences actually inserted or deleted:

—

size and copy number of all detectable inserts, both partial and complete, and methods used for its characterisation,

—

the organisation and sequence of the inserted genetic material at each insertion site in a standardised electronic format,

—

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

—

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

—

in the case of modifications other than insertion or deletion, 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,

—

sequence information in a standardised electronic format for both 5′ and 3′ flanking regions at each insertion site,

—

bioinformatic analysis using up-to-date databases, to investigate possible interruptions of known genes,

—

all Open Reading Frames, (hereafter referred to as ‘ORFs’) within the insert (either due to rearrangement or not) and those created as a result of the genetic modification at the junction sites with genomic DNA. ORF is defined as a nucleotide sequence that contains a string of codons that is uninterrupted by the presence of a stop codon in the same reading frame,

—

bioinformatic analysis using up-to-date databases, to investigate possible similarities between the ORFs and known genes which may have adverse effects,

—

primary structure (amino acid sequence) and, if necessary, other structures, of the newly expressed protein,

—

bioinformatic analysis using up-to-date databases, to investigate possible sequence homologies and, if necessary, structural similarities between the newly expressed protein and known proteins or peptides which may have adverse effects.

(iii)

Information on the expression of the insert:

—

method(s) used for expression analysis together with their performance characteristics,

—

information on the developmental expression of the insert during the life cycle of the plant,

—

parts of the plant where the insert/modified sequence is expressed,

—

potential unintended expression of new ORFs identified under the seventh indent of point (ii), which raise a safety concern,

—

protein expression data, including the raw data, obtained from field studies and related to the conditions in which the crop is grown.

(iv)

Genetic stability of the insert and phenotypic stability of the GMHP.

(c)

Conclusions of molecular characterisation

3. Comparative analysis of agronomic and phenotypic characteristics and of composition

(a)

Choice of conventional counterpart and additional comparators.

(b)

Choice of sites for field studies.

(c)

Experimental design and statistical analysis of data from field trials for comparative analysis:

(i)

Description of field studies design

(ii)

Description of relevant aspect of the receiving environments

(iii)

Statistical analysis.

(d)

Selection of plant material for analysis, if relevant.

(e)

Comparative analysis of agronomic and phenotypic characteristics.

(f)

Comparative analysis of composition, if relevant.

(g)

Conclusions of comparative analysis.

4. Specific information for each area of risk

For each of the seven areas of risk referred to in Section D.2 of Annex II the notifier shall first describe the pathway to harm explaining in a chain of cause and effect how the release of the GMHP could lead to harm, taking into account both hazard and exposure.

The notifier shall submit the following information, except where it is not relevant in view of the intended uses of the GMO:

(a)

Persistence and invasiveness including plant to plant gene transfer

(i)

Assessment of the potential for the GMHP to become more persistent or invasive and the adverse environmental effects thereof;

(ii)

Assessment of the potential for the GMHP to transmit transgene(s) to sexually compatible relatives and the adverse environmental effects thereof;

(iii)

Conclusions on the adverse environmental effect(s) of persistence and invasiveness of the GMHP including the adverse environmental effect(s) of plant-to-plant gene transfer.

(b)

Plant to micro-organism gene transfer

(i)

Assessment of the potential for transfer of newly inserted DNA from the GMHP to microorganisms and the adverse effects thereof;

(ii)

Conclusions on the adverse effect(s) of the transfer of newly inserted DNA from the GMHP to microorganisms for human and animal health and the environment;

(c)

Interactions of the GMHP with target organisms, if relevant

(i)

Assessment of the potential for changes in the direct and indirect interactions between the GMHP and target organisms and the adverse environmental effect(s);

(ii)

Assessment of the potential for evolution of resistance of the target organism to the expressed protein (based on the history of evolution of resistance to conventional pesticides or transgenic plants expressing similar traits) and any adverse environmental effect(s) thereof;

(iii)

Conclusions on adverse environmental effect(s) of interactions of the GMHP with target organisms.

(d)

Interactions of the GMHP with non-target organisms.

(i)

Assessment of the potential for direct and indirect interactions of the GMHP with non-target organisms, including protected species, and the adverse effect(s) thereof.

The assessment shall also take into account the potential adverse effect(s) on relevant ecosystem services and on the species providing those services.

(ii)

Conclusions on adverse environmental effect(s) of interactions of the GMHP with non-target organisms.

(e)

Impacts of the specific cultivation, management and harvesting techniques

(i)

For GMHPs for cultivation, assessment of the changes in the specific cultivation, management and harvesting techniques used for the GMHP and the adverse environmental effect(s) thereof;

(ii)

Conclusions on adverse environmental effect(s) of the specific cultivation, management and harvesting techniques.

(f)

Effects on biogeochemical processes

(i)

Assessment of the changes in the biogeochemical processes within the area in which the GMHP is to be grown and in the wider environment, and the adverse effects thereof;

(ii)

Conclusions on adverse effects on biogeochemical processes.

(g)

Effects on human and animal health

(i)

Assessment of potential direct and indirect interactions between the GMHP and persons working with or coming into contact with the GMHPs, including through pollen or dust from a processed GMHP, and assessment of the adverse effects of those interactions on human health;

(ii)

For GMHPs not destined for human consumption, but where the recipient or parental organism(s) may be considered for human consumption, assessment of the likelihood of and possible adverse effects on human health due to accidental intake;

(iii)

Assessment of the potential adverse effects on animal health due to accidental consumption of the GMHP or of material from that plant by animals;

(iv)

Conclusions on the effects on human and animal health.

(h)

Overall risk evaluation and conclusions.

A summary of all the conclusions under each area of risk shall be provided.

The summary shall take into account the risk characterisation in accordance with steps 1 to 4 of the methodology described in Section C.3 of Annex II and the risk management strategies proposed in accordance with point 5 of Section C.3 of Annex II.

5. Description of detection and identification techniques for the GMHP.

6. Information about previous releases of the GMHP, if applicable.

▼B

IV PIELIKUMS PAPILDU INFORMĀCIJA

IV PIELIKUMS

PAPILDU INFORMĀCIJA

▼M3

Šajā pielikumā ir vispārīgi aprakstīta papildu informācija, kas jāsniedz sakarā ar paziņojumu par laišanu tirgū, un informācija par marķējuma prasībām attiecībā uz tirgū laižamiem produktiem, kas satur ĢMO vai sastāv no tiem, un ĢMO, uz kuriem saskaņā ar 2. panta 4. punkta otro daļu minētās prasības neattiecas. Piezīmes attiecībā uz tehniskajiem norādījumiem saistībā ar, inter alia, produkta plānotās izmantošanas aprakstu var izstrādāt saskaņā ar 30. panta 2. punktā minēto regulatīvo procedūru, lai sekmētu šā pielikuma īstenošanu un skaidrošanu. Prasības, kas 26. pantā noteiktas to organismu etiķetēm, uz kuriem minētās prasības neattiecas, izpilda, norādot attiecīgus lietošanas ieteikumus un ierobežojumus:

▼B

Paziņojumā par to produktu laišanu tirgū, kas satur ĢMO vai sastāv no tiem, papildus III pielikumā norādītajai informācijai sniedz šādu informāciju:

▼M5

ierosinātos produktu komercnosaukumus un attiecīgajos produktos ietilpstošo ĢMO nosaukumus, kā arī ierosināto ĢMO unikālo identifikatoru, kas izveidots saskaņā ar Komisijas Regulu (EK) Nr. 65/2004 ( 8 ). Pēc piekrišanas saņemšanas par jauniem komercnosaukumiem, ja tādi ir, būtu jāinformē kompetentā iestāde;

▼B

tās Kopienā reģistrētās personas vārdu (nosaukumu) un pilnu adresi, kas atbild par laišanu tirgū, neatkarīgi no tā, vai tas ir ražotājs, importētājs vai izplatītājs;

kontrolparaugu iesniedzēja(-u) vārdu (nosaukumu) un pilnu adresi;

aprakstu, kā produktu, kas satur ĢMO vai sastāv no tiem, paredzēts lietot. Būtu jāakcentē atšķirības ĢMO un līdzīgu ģenētiski nemodificētu produktu lietošanā un pārvaldībā;

tā(-o) ģeogrāfiskā(-o) apgabala(-u) vides tipu aprakstu, kurā(-os) produktu paredzēts lietot Kopienā, ja iespējams, iekļaujot ziņas par paredzamo lietojuma mērogu katrā apgabalā;

paredzamās produkta lietotāju kategorijas, piemēram, rūpniecība, lauksaimniecība un amatniecības nozares, sabiedriskie patērētāji plašā nozīmē;

▼M5

transformācijas notikuma atklāšanas, identificēšanas un attiecīgā gadījumā kvantificēšanas metodes; ĢMO paraugus un to kontrolparaugus, un informāciju par vietu, kur atsauces materiālam var piekļūt. Informācija, ko konfidencialitātes apsvērumu dēļ nevar ievietot publiski piekļūstamajā 31. panta 2. punktā minētā(-o) reģistra(-u) daļā, būtu jāidentificē;

▼B

ierosināto marķējumu uz etiķetes vai pavaddokumentā. Tajā vismaz kopsavilkuma veidā jāiekļauj produkta tehniskais nosaukums, paziņojums, ka “šis produkts satur ģenētiski modificētus organismus”, ĢMO nosaukums un 2. punktā minētā informācija, marķējumā būtu jānorāda, kā piekļūt informācijai tajā reģistra daļā, kas ir pieejama atklātībai.

Vajadzības gadījumā saskaņā ar šīs direktīvas 13. pantu papildus A punktā norādītajai informācijai paziņojumā sniedz šādu informāciju:

nejaušas vai ļaunprātīgas izplatīšanas gadījumā veicamos pasākumus;

specifiskus norādījumus vai ieteikumus glabāšanai un apstrādei;

specifiskus monitoringa un ziņošanas norādījumus paziņojuma iesniedzējam un vajadzības gadījumā kompetentajai iestādei, lai kompetentās iestādes var efektīvi saņemt informāciju par visām nelabvēlīgajām iedarbēm. Šiem norādījumiem nevajadzētu būt pretrunā VII pielikuma C daļai;

ierosinātos ierobežojumus ĢMO apstiprinātajā lietojumā, piemēram, attiecībā uz produkta lietošanas jomu un mērķiem;

priekšlikumus par iesaiņojumu;

aprēķināto ražošanas un/vai importa apjomu Kopienā;

ierosināto papildu marķējumu. Tajā vismaz kopsavilkuma veidā var iekļaut A.4., A.5., B.1., B.2., B.3. un B.4. punktā minēto informāciju.

V PIELIKUMS DIFERENCĒTO PROCEDŪRU PIEMĒROŠANAS KRITĒRIJI (7. PANTS)

V PIELIKUMS

DIFERENCĒTO PROCEDŪRU PIEMĒROŠANAS KRITĒRIJI (7. PANTS)

Šajā pielikumā ir izklāstīti 7. panta 1. punktā minētie kritēriji.

Nemodificēta (recipienta) organisma taksonomiskais dalījums un bioloģija, piemēram, reprodukcijas veids un apputeksnēšana, spēja krustoties ar radniecīgām sugām, patogenitāte, ir labi zināma.

Ir pietiekamas zināšanas par drošību cilvēku veselībai, ja vajadzīgs, un vecāku organismu videi un recipienta organismiem izplatīšanas vidē.

Ir pieejama informācija par jebkuru mijiedarbību, kurai ir īpaša nozīme, novērtējot riskus saistībā ar vecāku augiem, ja vajadzīgs, un recipienta organismu un citiem organismiem eksperimentālajā izplatības ekosistēmā.

Ir pieejama informācija, kas liecina, ka visam iestarpinātajam ģenētiskajam materiālam ir labi rādītāji. Ir pieejama informācija par visu nesējsistēmu vai insertu ģenētisko materiālu, kas lietots kopā ar nesošo DNS. Ja ģenētiskā modifikācija ir saistīta ar ģenētiskā materiāla likvidāciju, ir zināms likvidācijas apmērs. Ir pietiekama informācija arī par ģenētisko modifikāciju, lai izplatīšanas laikā varētu identificēt ĢMO un tā pēcnācējus.

ĢMO nerada papildu vai paaugstinātus riskus cilvēku veselībai vai videi eksperimentālās izplatīšanas apstākļos, ko neizraisa attiecīgo vecāku organismu, ja vajadzīgs, un recipienta organismu izplatīšana. Nekāda spēja izplatīties vidē un pārņemt citas neradniecīgas ekosistēmas un spēja nodot ģenētisko materiālu citiem organismiem vidē nerada nelabvēlīgas iedarbes.

VI PIELIKUMS PAMATNOSTĀDNES, KAS ATTIECAS UZ NOVĒRTĒJUMIEM

VI PIELIKUMS

PAMATNOSTĀDNES, KAS ATTIECAS UZ NOVĒRTĒJUMIEM

Novērtējumā, kas paredzēts 13., 17., 19. un 20. pantā, jo īpaši būtu jāiekļauj:

To recipienta organisma rādītāju identifikācija, kas attiecas uz attiecīgā(-o) ĢMO novērtējumu. Visu to zināmo cilvēku veselības un vides risku identifikācija, ko rada nemodificētā recipienta organisma izplatīšana vidē.

Modificētā organisma ģenētiskās modifikācijas rezultāta apraksts.

Novērtējums, kas rāda, vai ģenētiskā modifikācija ir raksturota pietiekami, lai novērtētu visus riskus cilvēku veselībai un videi.

Visu to no jauna radušos risku identifikācija, kas attiecas uz cilvēku veselību un vidi un ko var radīt attiecīgā(-o) ĢMO izplatīšana salīdzinājumā ar attiecīgā(-o) nemodificētā(-o) organisma(-u) izplatīšanu, un kas pamatojas uz vides risku novērtējumu, kuru izdara saskaņā ar II pielikumu.

Slēdziens par to, vai un ar kādiem nosacījumiem attiecīgais(-ie) ĢMO vai tā(-o) produkts(-i) būtu laižams(-i) tirgū, vai arī attiecīgos ĢMO nelaiž tirgū, vai par specifiskiem vides risku novērtējuma jautājumiem lūdz citu kompetento iestāžu un Komisijas viedokli. Šie aspekti būtu jānorāda. Slēdzienam būtu skaidri jāattiecas uz ierosināto lietojumu, riska pārvaldību un ierosināto monitoringa plānu. Ja saskaņā ar slēdzienu ĢMO nebūtu laižami tirgū, tad kompetentā iestāde motivē savu slēdzienu.

VII PIELIKUMS MONITORINGA PLĀNS

VII PIELIKUMS

MONITORINGA PLĀNS

▼M3

Šajā pielikumā ir vispārīgi aprakstīts 13. panta 2. punktā, 19. panta 3. punktā un 20. pantā minētā monitoringa plāna izstrādes mērķis un vispārīgie principi. Piezīmes attiecībā uz tehniskajiem norādījumiem var izstrādāt saskaņā ar 30. panta 2. punktā minēto regulatīvo procedūru, lai sekmētu šā pielikuma īstenošanu un skaidrošanu.

▼B

A. Mērķis

Monitoringa plāna mērķis ir:

—

apstiprināt, ka visi vides risku novērtējuma pieņēmumi, kas attiecas uz ĢMO vai tā lietojuma iespējamo nelabvēlīgo iedarbju rašanos un ietekmi, ir pareizi, un

—

identificēt to ĢMO vai tā lietojuma nelabvēlīgo iedarbju rašanos, kas skar cilvēku veselību vai vidi un kas nav paredzētas vides risku novērtējumā.

B. Vispārīgi principi

Monitorings, kas minēts 13., 19. un 20. pantā, notiek pēc tam, kad ir dota piekrišana ĢMO laišanai tirgū.

Monitoringā iegūtie dati būtu interpretējami, ņemot vērā citus vides apstākļus un darbības. Ja vidē novēro izmaiņas, tad būtu vajadzīgs turpmākais novērtējums, lai noteiktu, vai tās ir ĢMO vai tā lietojuma sekas, jo izmaiņas var izraisīt vides faktori, kas nav ĢMO laišana tirgū.

Pieredze un dati, kas iegūti ĢMO eksperimentālās izplatīšanas monitoringā, var noderēt, izstrādājot pārdoto preču monitoringa plānu, kas vajadzīgs, lai laistu tirgū produktus, kuri satur ĢMO vai sastāv no tiem.

C. Monitoringa plāna izstrāde

Izstrādājot monitoringa plānu būtu:

katrā atsevišķā gadījumā sīki jāņem vērā vides risku novērtējums;

jāņem vērā ĢMO rādītāji, paredzētā lietojuma mērogs un rādītāji un attiecīgie apstākļi tajā vidē, kurā ĢMO paredzēts izplatīt;

jāiekļauj neparedzamas kaitīgas iedarbes vispārīga uzraudzība un, ja vajadzīgs, konkrētam gadījumam specifisks monitorings, ko koncentrē uz nelabvēlīgajām iedarbēm, kuras identificētas vides risku novērtējumā:

3.1.

ievērojot to, ka pietiekami ilgi būtu jāīsteno specifisks monitorings katram gadījumam, lai atklātu tūlītējas un tiešas, kā arī, ja vajadzīgs, kavētas un netiešas iedarbes, kas identificētas vides risku novērtējumā;

3.2.

ievērojot to, ka, īstenojot uzraudzību, pēc vajadzības varētu izmantot jau izstrādātus drošības standartpasākumus, piemēram, zemkopības šķirņu līniju, augu aizsardzības vai veterināro vai medicīnisko produktu monitoringu. Būtu jāizskaidro, kā piekrišanas īpašniekam būs pieejama attiecīgā informācija, kas iegūta drošības standartpasākumos;

sistemātiski jāveicina ĢMO izplatīšanas novērošana uztvērējvidē un novērojumu interpretācija attiecībā uz cilvēku veselības un vides drošību;

jānoteic, kas (paziņojuma iesniedzējs, lietotāji) izpilda dažādos uzdevumus, kuri noteikti monitoringa plānā, un kas atbild par monitoringa plāna izstrādi un pareizu īstenošanu, kā arī nodrošina to, ka piekrišanas īpašnieku un kompetento iestādi informē par visām novērotajām nelabvēlīgajām iedarbēm cilvēku veselībā un vidē. (Norāda laikus un intervālus ziņošanai par monitoringa rezultātiem.);

jāizskata mehānismi visu novēroto nelabvēlīgo iedarbju identifikācijai un apstiprināšanai cilvēku veselībā un vidē un jādod iespēja piekrišanas īpašniekam vai kompetentajai iestādei vajadzības gadījumā veikt pasākumus, kas vajadzīgi, lai aizsargātu cilvēku veselību un vidi.

VIII PIELIKUMS

ATBILSMJU TABULA

Direktīvā 90/220/EEK

Šajā direktīvā

1. panta 1. punkts

1. pants

1 panta 2. punkts.

3. panta 2. punkts

2. pants

3. pants.

3. panta 1 punkts

4. pants

—

5. pants

6. pants

6. panta 1. līdz 4. punkts

6. panta 5. punkts

7. pants

6. panta 6. punkts

8. pants

7. pants.

9. pants

8. pants

10. pants

9. pants

11. pants

10. panta 2. punkts

12. pants

11. pants

13. pants

12. panta 1. – 3. un 5. punkts

14. pants

13. panta 2. punkts

15. panta 3. punkts

—

15. panta 1., 2. un 4. punkts

—

16. pants

—

17. pants

13. panta 3. un 4. punkts

18. pants

13. panta 5. un 6. punkts

19. panta 1. un 4. punkts

12. panta 4. punkts

20. panta 3. punkts

14. pants

21. pants

15. pants

22. pants

16. pants

23. pants

—

24. panta 1. punkts

17. pants

24. panta 2. punkts

19. pants

25. pants

—

26. pants

20. pants

27. pants

—

28. pants

—

29. pants

21. pants

30. pants

22. pants

31. panta 1., 4. un 5. punkts

18. panta 2. punkts

31. panta 6. punkts

18. panta 3. punkts

31. panta 7. punkts

—

32. pants

—

33. pants

23. pants

34. pants

—

35. pants

—

36. pants

—

37. pants

24. pants

38. pants

I A pielikums

I B pielikums

—

II pielikums

III pielikums

II A pielikums

III A pielikums

II B pielikums

III B pielikums

III pielikums

IV pielikums

—

V pielikums

—

VI pielikums

—

VII pielikums

( 1 ) OV L 117, 8.5.1990., 1. lpp. Direktīvā jaunākie grozījumi izdarīti ar Direktīvu 98/81/EK (OV L 330, 5.12.1998., 13. lpp.).

( 2 ) OV L 292, 12.11.1994., 31. lpp.

( 3 ) OV L 268, 18.10.2003., 1. lpp.

( 4 ) Padomes Direktīva 70/457/EEK (1970. gada 29. septembris) par kopēju lauksaimniecības augu sugu šķirņu katalogu (OV L 225, 12.10.1970., 1. lpp.). Direktīvā jaunākie grozījumi izdarīti ar Direktīvu 98/96/EK (OV L 25, 1.2.1999., 27. lpp.).

( 5 ) Padomes Direktīva 70/458/EEK (1970. gada 29. septembris) par dārzeņu sēklas materiāla tirdzniecību (OV L 225, 12.10.1970., 7. lpp.). Direktīvā jaunākie grozījumi izdarīti ar Direktīvu 98/96/EK.

( 6 ) Padomes Direktīva 1999/105/EK (1999. gada 22. decembris) par meža sēklas materiāla tirdzniecību (OV L 11, 15.1.2000., 17. lpp.).

( 7 ) OV L 123, 12.5.2016., 1. lpp.

( 8 ) Komisijas 2004. gada 14. janvāra Regula (EK) Nr. 65/2004, ar ko nosaka sistēmu ģenētiski modificēto organismu unikālo identifikatoru izveidei un piešķiršanai (OV L 10, 16.1.2004., 5. lpp.).

1.1 Atsauces

1.2 Identificētās prasības

1.3 Saistītie standarti

2. Identificētās prasības

Prasības
Avots	Prasība

3. Saistītie standarti

Standarti
Avots	Prasība

Builddate: 27.03.2021 00:00:00 -Doknr: CELEX:32001L0018
EULAW -
European Regulation published on http://eur-lex.europa.eu/