1990L0220 — EN — 12.05.1994 — 001.001 — 1
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►B COUNCIL DIRECTIVE
of 23April 1990
on the deliberate release into the environment of genetically modified organisms
(90/220/EEC)
(OJ L 117, 8.5.1990, p. 15)
Amended by:
Official Journal
Nopage date
►M1Commission Directive 94/15/EC of 15 April 1994 L 103 20 22.4.1994
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COUNCIL DIRECTIVE
of 23April 1990
on the deliberate release into the environment of genetically modi-
fied organisms
(90/220/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission(1),
In cooperation with the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas, under the Treaty, action by the Community relating to the
environment should be based on the principle that preventive actionshould be taken;
Whereas living organisms, whether released into the environment in
large or small amounts for experimental purposes or as commercialproducts, may reproduce in the environment and cross national frontiersthereby affecting other Member States; whereas the effects of suchreleases on the environment may be irreversible;
Whereas the protection of human health and the environment requires
that due attention be given to controlling risks from the deliberaterelease of genetically modified organisms (GMOs) into the environ-ment;
Whereas disparity between the rules which are in effect or in prepara-
tion in the Member States concerning the deliberate release into theenvironment of GMOs may create unequal conditions of competition orbarriers to trade in products containing such organisms, thus affectingthe functioning of the common market; whereas it is therefore necessaryto approximate the laws of the Member States in this respect;
Whereas measures for the approximation of the provisions of the
Member States which have as their object the establishment and func-tioning of the internal market should, inasmuch as they concern health,safety, environmental and consumer protection, be based on a high levelof protection throughout the Community;
Whereas it is necessary to ensure the safe development of industrial
products utilizing GMOs;
Whereas this Directive should not apply to organisms obtained through
certain techniques of genetic modification which have conventionallybeen used in a number of applications and have a long safety record;
Whereas it is necessary to establish harmonized procedures and criteria
for the case-by-case evaluation of the potential risks arising from thedeliberate release of GMOs into the environment;
Whereas a case-by-case environmental risk assessment should always
be carried out prior to a release;
Whereas the deliberate release of GMOs at the research stage is in most
cases a necessary step in the development of new products derivedfrom, or containing, GMOs;
(1) OJ NoC 198, 28. 7. 1988, p. 19 and
OJ NoC 246, 27. 9. 1989, p. 5.
(2) OJ NoC 158, 26. 6. 1989, p. 225 and
OJ NoC 96, 17. 4. 1990.
(3) OJ NoC 23, 30. 1. 1989, p. 45.
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Whereas the introduction of GMOs into the environment should be
carried out according to the ‘step by step'principle; whereas this meansthat the containment of GMOs is reduced and the scale of releaseincreased gradually, step by step, but only if evaluation of the earliersteps in terms of protection of human health and the environmentindicates that the next step can be taken;
Whereas no product containing, or consisting of, GMOs and intended
for deliberate release shall be considered for placing on the marketwithout it first having been subjected to satisfactory field testing at theresearch and development stage in ecosystems which could be affectedby its use;
Whereas it is necessary to establish a Community authorization proce-
dure for the placing on the market of products containing, or consistingof, GMOs where the intended use of the product involves the deliberaterelease of the organism(s) into the environment;
Whereas any person, before undertaking a deliberate release into the
environment of a GMO, or the placing on the market of a productcontaining, or consisting of, GMOs, where the intended use of thatproduct involves its deliberate release into the environment, shall submita notification to the national competent authority;
Whereas that notification should contain a technical dossier of informa-
tion including a full environmental risk assessment, appropriate safetyand emergency response, and, in the case of products, precise instruc-tions and conditions for use, and proposed labelling and packaging;
Whereas, after notification, no deliberate release of GMOs should be
carried out unless the consent of the competent authority has beenobtained;
Whereas the competent authority should give its consent only after it
has been satisfied that the release will be safe for human health and theenvironment;
Whereas it may be considered appropriate in certain cases to consult the
public on the deliberate release of GMOs into the environment;
Whereas it is appropriate for the Commission, in consultation with the
Member States, to establish a procedure for the exchange of informationon deliberate releases of GMOs notified under this Directive;
Whereas it is important to follow closely the development and use of
GMOs; whereas a list should be published of all the products authorizedunder this Directive;
Whereas, when a product containing a GMO or a combination of GMOs
is placed on the market, and where such a product has been properlyauthorized under this Directive, a Member State may not on groundsrelating to matters covered by this Directive, prohibit, restrict or impedethe deliberate release of the organism in that product on its territorywhere the conditions set out in the consent are respected; whereas asafeguard procedure should be provided in case of risk to human healthor the environment;
Whereas the provisions of this Directive relating to placing on the
market of products should not apply to products containing, orconsisting of, GMOs covered by other Community legislation whichprovides for a specific environmental risk assessment similar to that laiddown in this Directive;
Whereas a Committee should be set up to assist the Commission on
matters relating to the implementation of this Directive and to itsadaptation to technical progress,
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HAS ADOPTED THIS DIRECTIVE:
PART A
General provisions
Article 1
1. The objective of this Directive is to approximate the laws, regula-
tions and administrative provisions of the Member States and to protecthuman health and the environment:
— when carrying out the deliberate release of genetically modified
organisms into the environment,
— when placing on the market products containing, or consisting of,
genetically modified organisms intended for subsequent deliberaterelease intothe enviro nment.
2. This Directive shall not apply to the carriage of genetically modi-
fied organisms by rail, road, inland waterway, sea or air.
Article 2
For the purposes of this Directive:
(1) ‘organism' is any biological entity capable of replication or of
transferring genetic material;
(2) ‘genetically modified organism (GMO)' means an organism in
which the genetic material has been altered in a way that does notoccur naturally by mating and/or natural recombination.
Within the terms of this definition:(i) genetic modification occurs at least through the use of the
techniques listed in Anne x I A Part 1;
(ii) the techniques listed in Anne x I A Part 2 are not considered to
result in genetic modification;
(3) ‘deliberate release' means any intentional introduction into the
environment of a GMO or a combination of GMOs without provi-sions for containment such as physical barriers or a combination ofphysical barriers together with chemical and/or biological barriersused to limit their contact with the general population and theenvironment;
(4) ‘product'means a preparation consisting of, or containing, a GMO
or a combination of GMOs, which is placed on the market;
(5) ‘placing on the market' means supplying or making available to
third parties;
(6) ‘notification' means the presentation of documents containing the
requisite information to the competent authority of a Member State.The person making the presentation shall be referred to as ‘thenotifier';
(7) ‘use' means the deliberate release of a product which has been
placed on the market. The persons carrying out this use will bereferred toas ‘users';
(8) ‘environmental risk assessment'means the evaluation of the risk to
human health and the environment (which includes plants andanimals) connected with the release of GMOs or productscontaining GMOs.
Article 3
This Directive shall not apply to organisms obtained through the tech-
niques of genetic modification listed in Annex I B.
Article 4
1. Member States shall ensure that all appropriate measures are taken
to avoid adverse effects on human health and the environment which
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might arise from the deliberate release or placing on the market of
GMOs.
2. Member States shall designate the competent authority or authori-
ties responsible for carrying out the requirements of this Directive andits Annexes.
3. Member States shall ensure that the competent authority organizes
inspections and other control measures as appropriate, to ensure compli-ance with this Directive.
PART B
Deliberate release of GMOs into the environment for research anddevelopment purposes or for any other purpose than for placing on
the market
Article 5
Member States shall adopt the provisions necessary to ensure that:
(1) any person, before undertaking a deliberate release of a GMO or a
combination of GMOs for the purpose of research and development,or for any other purpose than for placing on the market, mustsubmit a notification to the competent authority referred to inArticle 4 (2) of the Member State within whose territory the releaseis totake place;
(2) the notification shall include:
(a) a technical dossier supplying the information specified in
Annex II necessary for evaluating the foreseeable risks, whetherimmediate or delayed, which the GMO or combination ofGMOs may pose to human health or the environment, togetherwith the methods used and the bibliographic reference to themand covering, in particular:
(i) general information including information on personnel
and training,
(ii) information relating to the GMO(s),(iii) information relating to the conditions of release and the
receiving environment,
(iv) information on the interactions between the GMO(s) and
the environment,
(v) information on monitoring, control, waste treatment and
emergency response plans;
(b) a statement evaluating the impacts and risks posed by the
GMO(s) to human health or the environment from the usesenvisaged;
(3) the competent authority may accept that releases of a combination
of GMOs on the same site or of the same GMO on different sitesfor the same purpose and within a limited period may be notified ina single notification;
(4) the notifier shall include in the notification information on data or
results from releases of the same GMOs or the same combination ofGMOs previously or currently notified and/or carried out by himeither inside or outside the Community.
The notifier may also refer to data or results from notifications
previously submitted by other notifiers, provided that the latter havegiven their agreement in writing;
(5) in the case of a subsequent release of the same GMO or combina-
tion of GMOs previously notified as part of the same researchprogramme, the notifier shall be required to submit a new noti-fication. In this case, the notifier may refer to data from previousnotifications or results from previous releases;
(6) in the event of any modification of the deliberate release of GMOs
or a combination of GMOs which could have consequences withregard to the risks for human health or the environment or if newinformation has become available on such risks, either while thenotification is being examined by the competent authority or after
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that authority has given its written consent, the notifier shall imme-diately:
(a) revise the measures specified in the notification,(b) inform the competent authority in advance of any modification
or as soon as the new information is available,
(c) take the measures necessary topro tect human health and the
environment.
Article 6
1. On receipt and after acknowledgment of the notification the
competent authority shall:
— examine it for compliance with this Directive,
— evaluate the risks posed by the release,— record its conclusions in writing,
and, if necessary,
— carry out tests or inspections as may be necessary for control
purposes.
2. The competent authority, having considered, where appropriate,
any comments by other Member States made in accordance with Article9, shall respond in writing to the notifier within 90 days of receipt of thenotification by either:
(a) indicating that it is satisfied that the notification is in compliance
with this Directive and that the release may proceed, or
(b) indicating that the release does not fulfil the conditions of this
Directive and the notification is therefore rejected.
3. For the purpose of calculating the 90-day period referred to in
paragraph 2, any periods of time during which the competent authority:
— is awaiting further information which it may have requested from
the notifier,
or
— is carrying out a public inquiry or consultation in accordance with
Article 7
shall not be taken into account.
4. The notifier may proceed with the release only when he has
received the written consent of the competent authority, and inconformity with any conditions required in this consent.
5. If the competent authority considers that sufficient experience has
been obtained of releases of certain GMOs, it may submit to theCommission a request for the application of simplified procedures forreleases of such types of GMOs. The Commission shall, in accordancewith the procedures laid down in Article 21, establish appropriatecriteria and take a decision accordingly on each application. The criteriashall be based on safety to human health and the environment and onthe evidence available on such safety.
6. If information becomes available subsequently to the competent
authority which could have significant consequences for the risks posedby the release, the competent authority may require the notifier tomodify the conditions of, suspend or terminate the deliberate release.
Article 7
Where a Member State considers it appropriate, it may provide that
groups or the public shall be consulted on any aspect of the proposeddeliberate release.
Article 8
After completion of a release, the notifier shall send to the competent
authority the result of the release in respect of any risk to human healthor the environment, with particular reference to any kind of product thatthe notifier intends to notify at a later stage.
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Article 9
1. The Commission shall set up a system of exchange of the informa-
tion contained in the notifications. The competent authorities shall sendto the Commission, within 30 days of its receipt, a summary of eachnotification received. The format of this summary will be established bythe Commission in accordance with the procedure laid down in Article21.
2. The Commission shall immediately forward these summaries to
the other Member States, which may, within 30 days, ask for furtherinformation or present observations through the Commission or directly.
3. The competent authorities shall inform the other Member States
and the Commission of the final decisions taken in compliance withArticle 6 (2).
PART C
Placing on the market of products containing GMOs
Article 10
1. Consent may only be given for the placing on the market of
products containing, or consisting of, GMOs, provided that:
— written consent has been given to a notification under Part B or if a
risk analysis has been carried out based on the elements outlined inthat Part;
— the products comply with the relevant Community product legisla-
tion;
— the products comply with the requirements of this Part of this
Directive, concerning the environmental risk assessment.
2. Articles 11 to 18 shall not apply to any products covered by
Community legislation which provides for a specific environmental riskassessment similar tothat laid do wn in this Directive.
3. Not later than 12 months after notification of this Directive, the
Commission, in accordance with the procedure laid down in Article 21,shall establish a list of Community legislation covering the productsreferred toin paragraph 2. This list will be re-examined perio dicallyand, as necessary, revised in accordance with the said procedure.
Article 11
1. Before a GMO or a combination of GMOs are placed on the
market as or in a product, the manufacturer or the importer to theCommunity shall submit a notification to the competent authority of theMember State where such a product is to be placed on the market forthe first time. This notification shall contain:
— the information required in Annex II, extended as necessary to take
into account the diversity of sites of use of the product, includinginformation on data and results obtained from research and develop-mental releases concerning the ecosystems which could be affectedby the use of the product and an assessent of any risks for humanhealth and the environment related to the GMOs or a combination ofGMOs contained in the product, including information obtainedfrom the research and development stage on the impact of therelease on human health and the environment;
— the conditions for the placing on the market of the product,
including specific conditions of use and handling and a proposal forlabelling and packaging which should comprise at least the require-ments laid down in Annex III.
If on the basis of the results of any release notified under Part B of this
Directive, or on substantive, reasoned scientific grounds, a notifierconsiders that the placing on the market and use of a product do notpose a risk to human health and the environment, he may propose not tocomply with one or more of the requirements of Annex III B.
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2. The notifier shall include in this notification information on dataor results from releases of the same GMOs or the same combination ofGMOs previously or currently notified and/or carried out by the notifiereither inside or outside the Community.
3. The notifier may also refer to data or results from notifications
previously submitted by other notifiers, provided that the latter havegiven their agreement in writing.
4. Each new product which, containing or consisting of the same
GMO or combination of GMOs, is intended for a different use, shall benotified separately.
5. The notifier may proceed with the release only when he has
received the written consent of the competent authority in accordancewith Article 13, and in conformity with any conditions, including refer-ence to particular ecosystems/environments, required in that consent.
6. If new information has become available with regard to the risks
of the product to human health or the environment, either before or afterthe written consent, the notifier shall immediately:
— revise the information and conditions specified in paragraph 1,
— inform the competent authority, and— take the measures necessary topro tect human health and the envir-
onment.
Article 12
1. On receipt and after acknowledgement of the notification referred
to in Article 11, the competent authority shall examine it for compliancewith this Directive, giving particular attention to the environmental riskassessment and the recommended precautions related to the safe use ofthe product.
2. At the latest 90 days after receipt of the notification, the
competent authority shall either:
(a) forward the dossier to the Commission with a favourable opinion,
or
(b) inform the notifier that the proposed release does not fulfil the
conditions of this Directive and that it is therefore rejected.
3. In the case referred to in paragraph 2 (a), the dossier forwarded to
the Commission shall include a summary of the notification togetherwith a statement of the conditions under which the competent authorityproposes to consent to the placing on the market of the product.
The format of this summary shall be established by the Commission in
accordance with the procedure laid down in Article 21.
In particular where the competent authority has acceded to the request
of the notifier, under the terms of the last subparagraph of Article 11(1), not to comply with some of the requirements of Annex III B, itshall at the same time inform the Commission thereof.
4. If the competent authority receives additional information pursuant
to Article 11 (6), it shall immediately inform the Commission and theother Member States.
5. For the purpose of calculating the 90-day period referred to in
paragraph 2, any periods of time during which the competent authorityis awaiting further information which it may have requested from thenotifier shall not be taken into account.
Article 13
1. On receipt of the dossier referred to in Article 12 (3), the Commis-
sion shall immediately forward it to the competent authorities of allMember States together with any other information it has collectedpursuant to this Directive and advise the competent authority respon-sible for forwarding the document of the distribution date.
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2. The competent authority, in the absence of any indication to the
contrary from another Member State within 60 days following thedistribution date referred to in paragraph 1, shall give its consent inwriting to the notification so that the product can be placed on themarket and shall inform the other Member States and the Commissionthereof.
3. In cases where the competent authority of another Member State
raises an objection — for which the reasons must be stated — andshould it not be possible for the competent authorities concerned toreach an agreement within the period specified in paragraph 2, theCommission shall take a decision in accordance with the procedure laiddown in Article 21.
4. Where the Commission has taken a favourable decision, the
competent authority that received the original notification shall giveconsent in writing to the notification so that the product may be placedon the market and shall inform the other Member States and theCommission thereof.
5. Once a product has received a written consent, it may be used
without further notification throughout the Community in so far as thespecific conditions of use and the environments and/or geographicalareas stipulated in these conditions are strictly adhered to.
6. Member States shall take all necessary measures toensure that
users comply with the conditions of use specified in the written consent.
Article 14
Member States shall take all necessary measures toensure that pro ducts
containing, or consisting of, GMOs will be placed on the market only iftheir labelling and packaging is that specified in the written consentreferred toin Articles 12 and 13.
Article 15
Member States may not, on grounds relating to the notification and
written consent of a deliberate release under this Directive, prohibit,restrict or impede the placing on the market of products containing, orconsisting of, GMOs which comply with the requirements of thisDirective.
Article 16
1. Where a Member State has justifiable reasons to consider that a
product which has been properly notified and has received writtenconsent under this Directive constitutes a risk to human health or theenvironment, it may provisionally restrict or prohibit the use and/or saleof that product on its territory. It shall immediately inform the Commis-sion and the other Member States of such action and give reasons for itsdecision.
2. A decision shall be taken on the matter within three months in
accordance with the procedure laid down in Article 21.
Article 17
The Commission shall publish in the Official Journal of the European
Communities a list of all the products receiving final written consent
under this Directive. For each product, the GMO or GMOs containedtherein and the use or uses shall be clearly specified.
Article 18
1. Member States shall send to the Commission, at the end of each
year, a brief factual report on the control of the use of all productsplaced on the market under this Directive.
2. The Commission shall send to the European Parliament and the
Council, every three years, a report on the control by the Member Statesof the products placed on the market under this Directive.
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3. When submitting this report for the first time, the Commissionshall at the same time submit a specific report on the operation of thisPart of this Directive including an assessment of all its implications.
PART D
Final provisions
Article 19
1. The Commission and the competent authorities shall not divulge
to third parties any confidential information notified or exchanged underthis Directive and shall protect intellectual property rights relating to thedata received.
2. The notifier may indicate the information in the notification
submitted under this Directive, the disclosure of which might harm hiscompetitive position, that should therefore be treated as confidential.Verifiable justification must be given in such cases.
3. The competent authority shall decide, after consultation with the
notifier, which information will be kept confidential and shall informthe notifier of its decisions.
4. In no case may the following information when submitted
according to Articles 5 or 11 be kept confidential:
— description of the GMO or GMOs, name and address of the notifier,
purpose of the release and location of release;
— methods and plans for monitoring of the GMO or GMOs and for
emergency response;
— the evaluation of foreseeable effects, in particular any pathogenic
and/or ecologically disruptive effects.
5. If, for whatever reasons, the notifier withdraws the notification,
the competent authorities and the Commission must respect the confi-dentiality of the information supplied.
Article 20
According to the procedure laid down in Article 21, the Commission
shall adapt Annexes II and III totechnical pro gress in particular byamending the notification requirements to take into account the poten-tial hazard of the GMOs.
Article 21
The Commission shall be assisted by a committee composed of the
representatives of the Member States and chaired by the representativeof the Commission.
The representative of the Commission shall submit to the committee a
draft of the measures to be taken. The committee shall deliver itsopinion on the draft within a time limit which the chairman may laydown according to the urgency of the matter. The opinion shall bedelivered by the majority laid down in Article 148 (2) of the Treaty inthe case of decisions which the Council is required to adopt on aproposal from the Commission. The votes of the representatives of theMember States within the committee shall be weighted in the mannerset out in that Article. The chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the committee.
If the measures envisaged are not in accordance with the opinion of the
committee, or if no opinion is delivered, the Commission shall, withoutdelay, submit to the Council a proposal relating to the measures to betaken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to
the Council, the Council has not acted, the proposed measures shall beadopted by the Commission.
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Article 22
1. Member States and the Commission shall meet regularly and
exchange information on the experience acquired with regard to theprevention of risks related to the release of GMOs into the environment.
2. Every three years, Member States shall send the Commission a
report on the measures taken to implement the provisions of thisDirective, the first time being on 1 September 1992.
3. Every three years, the Commission shall publish a summary based
on the reports referred to in paragraph 2, the first time being in 1993.
Article 23
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive before23 October 1991.
2. Member States shall immediately inform the Commission of all
laws, regulations and administrative provisions adopted in implementa-tion of this Directive.
Article 24
This Directive is addressed tothe Member States.
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ANNEXI A
TECHNIQUES REFERRED TO IN ARTICLE 2 (2)
PART 1
Techniques of genetic modification referred to in Article 2 (2) (i) are inter alia:
(1) recombinant DNA techniques using vector systems as previously covered by
Council Recommendation 82/472/EEC (1);
(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 hybridization techniques where
live cells with new combinations of heritable genetic material are formedthrough the fusion of two or more cells by means of methods that do notoccur naturally.
PART 2
Techniques referred to in Article 2 (2) (ii) which are not considered to result in
genetic modification, on condition that they do not involve the use of recombi-nant DNA molecules or GMOs, are:
(1)in vitrofertilization,
(2) conjugation, transduction, transformation or any other natural process,(3) polyploidy induction.
(1) OJ NO L 213, 21. 7. 1982, p. 15.
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ANNEXI B
TECHNIQUES REFERRED TO IN ARTICLE 3
Techniques of genetic modification to be excluded from this Directive, on
condition that they do not involve the use of GMOs as recipient or parentalorganisms, are:
(1) mutagenesis,(2) cell fusion (including protoplast fusion) of plant cells where the resulting
organisms can also be produced by traditional breeding methods.
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ANNEXII
INFORMATION REQUIRED IN THE NOTIFICATION
The notification for a deliberate release referred to in Article 5 and of the placing
on the market referred to in Article 11 is to include, as appropriate, the informa-tion set out below in the sub-Annexes.
Not all points included will apply to every case. It is to be expected that
individual notifications will address only the particular subset of considerationswhich 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 scale of the proposed release.
Annex II A applies to releases of all types of genetically modified organisms
other than higher plants. Annex II B applies to releases of genetically modifiedhigher plants.
The term ‘higher plants' means plants which belong to the taxonomic groups
Gymnospermae andAngiospermae .
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ANNEXII 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 appro-
priate) 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 detec-
tion and identification techniques;
8. description of the geographic distribution and of the natural habitat
of the organism including information on natural predators, preys,parasites and competitors, symbionts and hosts;
9. potential for genetic transfer and exchange with other organisms;10. verification of the genetic stability of the organisms and factors
affecting it;
11. pathological, ecological and physiological traits:
(a) classification of hazard according to existing Community rules
concerning the protection of human health and/or the environ-ment;
(b) generation time in natural ecosystems, sexual and asexual repro-
ductive cycle;
(c) information on survival, including seasonability and the ability
to form survival structures e.g.: seeds, spores or sclerotia;
(d) pathogenicity: infectivity, toxigenicity, virulence, allergenicity,
carrier (vector) of pathogen, possible vectors, host rangeincluding non-target organism. Possible activation of latentviruses (proviruses). Ability to colonize other organisms;
(e) antibiotic resistance, and potential use of these antibiotics in
humans and domestic organisms for prophylaxis and therapy;
(f) involvement in environmental processes: primary production,
nutrient turnover, decomposition of organic matter, respiration,etc.
12. Nature of indigenous vectors:
(a) sequence;(b) frequency of mobilization;(c) specificity;(d) presence of genes which confer resistance.
13. History of previous genetic modifications.
B. Characteristics of the vector:
1. nature and source of the vector;2. sequence of transposons, vectors and other non-coding genetic
segments used toco nstruct the GMO and tomake the intro ducedvector and insert function in the GMO;
3. frequency of mobilization of inserted vector and/or genetic transfer
capabilities and methods of determination;
4. information on the degree to which the vector is limited to the DNA
required to perform the intended function.
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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
o n the degree towhich the inserted sequence is limited totheDNA required to perform the intended function;
(e) sequence, functional identity and location of the altered/inserted/
deleted nucleic acid segment(s) in question with particular refer-ence toany kno wn 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 beexpressed 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 insertedsequence and vector;
(g) sensitivity, reliability (in quantitative terms) and specificity of
detection and identification techniques;
(h) history of previous releases or uses of the GMO;(i) health considerations:
(i) toxic or allergenic effects of the non-viable GMOs and/or
their metabolic products;
(ii) product hazards;(iii) comparison of the modified organism to the donor, recipient
or (where appropriate) parental organism regarding pathoge-nicity;
(iv) capacity for colonization;(v) if the organism is pathogenic to humans who are immuno-
competent:
— diseases caused and mechanism of pathogenicity
including invasiveness and virulence,
— communicability,— infective dose,— host range, possibility of alteration,— possibility of survival outside of human host,— presence of vectors or means of dissemination,— biological stability,— antibiotic-resistance patterns,— allergenicity,— availability of appropriate therapies.
III. INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND
THE RECEIVING ENVIRONMENT
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;
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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 inactivition 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 foreseenareas of use of the product);
2. physical or biological proximity to humans and other significant
biota;
3. proximity to significant biotopes or protected areas;4. size of local population;5. economic activities of local populations which are based on the
natural resources of the area;
6. distance to closest areas protected for drinking water and/or environ-
mental purpose;
7. climatic characteristics of the region(s) likely to be affected;8. geographical, geological and pedological characteristics;9. flora and fauna, including crops, livestock and migratory species;10. description of target and non-target ecosystems likely to be affected;11. a comparison of the natural habitat of the recipient organism with
the proposed site(s) of release;
12. any known planned developments or changes in land use in the
region which could influence the environmental impact of therelease.
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 tospecific 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, suchas microcosms, growth rooms, greenhouses;
3. genetic transfer capability:
(a) post-release transfer of genetic material from GMOs into organ-
isms in affected ecosystems;
(b) post-release transfer of genetic material from indigenous organ-
isms tothe GMOs;
4. likelihood of post-release selection leading to the expression of unex-
pected and/or undesirable traits in the modified organism;
5. measures emplo yed toensure and toverify genetic stability. Descrip-
tion of genetic traits which may prevent or minimize dispersal ofgenetic material. Methods to verify genetic stability;
6. routes of biological dispersal, known or potential modes of interac-
tion with the disseminating agent, including inhalation, ingestion,surface contact, burrowing, etc.;
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7. description of ecosystems to which the GMOs could be disseminated.
C. Potential environmental impact:
1. potential for excessive population increase in the environment;2. competitive advantage of the GMOs in relation to the unmodified
recipient or parental organism(s);
3. identification and description of the target organisms;4. anticipated mechanism and result of interaction between the released
GMOs and the target organism;
5. identification and description of non-target organisms which may be
affected unwittingly;
6. likelihood of post-release shifts in biological interactions or in host
range;
7. known or predicted effects on non-target organisms in the environ-
ment, impact on population levels of competitors: preys, hosts,symbionts, predators, parasites and pathogens;
8. known or predicted involvement in biogeochemical processes;9. other potentially significant interactions with the environment.
V. INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT
AND EMERGENCY RESPONSE PLANS
A. Monitoring techniques:
1. methods for tracing the GMOs, and for monitoring their effects;2. specificity (toidentify the GMOs, and todistinguish them fro m the
donor, recipient or, where appropriate, the parental organisms), sensi-tivity 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 minimize the spread of the
GMOs beyond the site of release or the designated area for use;
2. methods and procedures to protect the site from intrusion by unau-
thorized 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. possible risks;4. description of treatment envisaged.
D. Emergency response plans:
1. methods and procedures for controlling the GMOs in case of unex-
pected spread;
2. methods for decontamination of the areas affected, e.g. eradication of
the GMOs;
3. methods for disposal or sanitation of plants, animals, etc., that were
exposed during or after the spread;
4. methods for the isolation of the area affected by the spread;5. plans for protecting human health and the environment in case of the
occurrence of an undesirable effect.
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ANNEXII 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.
3. Survivability:
(a) ability to form structures for survival or dormancy;(b) specific factors affecting survivability, if any.
4. Dissemination:
(a) ways and extent 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 onnatural predators, parasites, competitors and symbionts.
7. Potentially significant interactions of the plant with organisms other than
plants in the ecosystem where it is usually grown, including informationon 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 characteriza-
tion, including information on any parts of the vector introduced inthe 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) location of the insert in the plant cells (integrated in the chromosome,
chloroplasts, mitochondria, or maintained in a non-integrated form),and methods for its determination;
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(d) copy number of the insert.
3. Information on the expression of the insert:
(a) information on the expression of the insert and methods used for its
characterization;
(b) parts of the plant where the insert is expressed (e.g. roots, stem,
pollen etc.).
4. Information on how the genetically modified plant differs from the reci-
pient plant in:
(a) mode(s) and/or rate of reproduction;(b) dissemination;(c) survivability.
5. Genetic stability of the insert.6. Potential for transfer of genetic material from the genetically modified
plants to other organisms.
7. Information on any toxic or harmful effects on human health and the
environment, arising from the genetic modification.
8. Mechanism of interaction between the genetically modified plant and
target organisms (if applicable).
9. Potentially significant interactions with non-target organisms.
10. Description of detection and identification techniques for the genetically
modified plant.
11. 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 ARTICLE 5)
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 recognized biotopes or protected areas which may
be affected.
F. INFORMATION RELATING TO THE RELEASE (ONLY FOR NOTIFI-
CATIONS SUBMITTED PURSUANT TO ARTICLE 5)
1. Purpose of the release.2. Foreseen date(s) and duration of the release.3. Method by which the genetically modified plants will be released.4. Method for preparing and managing the release site, prior to, during and
post-release, including cultivation practices and harvesting methods.
5. Approximate number of plants (or plants per m
2).
G. INFORMATION ON CONTROL, MONITORING, POST-RELEASE AND
WASTE TREATMENT PLANS (ONLY FOR NOTIFICATIONSSUBMITTED PURSUANT TO ARTICLE 5)
1. Any precautions taken:
(a) distance(s) from sexually compatible plant species;(b) any measures to minimize/prevent pollen or seed dispersal.
2. Description of methods for post-release treatment of the site.3. Description of post-release treatment methods for the genetically modi-
fied plant material including wastes.
4. Description of monitoring plans and techniques.5. Description of any emergency plans.
H. INFORMATION ON THE POTENTIAL ENVIRONMENTAL IMPACT
FROM THE RELEASE OF THE GENETICALLY MODIFIED PLANTS
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1. Likelihood of the GMHP becoming more persistent than the recipient or
parental plants in agricultural habitats or more invasive in naturalhabitats.
2. Any selective advantage or disadvantage conferred to other sexually
compatible plants species, which may result from genetic transfer fromthe genetically modified plant.
3. Potential environmental impact of the interaction between the genetically
modified plant and target organisms (if applicable).
4. Possible environmental impact resulting from potential interactions with
non-target organisms.
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ANNEXIII
ADDITIONAL INFORMATION REQUIRED IN THE CASE OF NOTI-
FICATION FOR PLACING ON THE MARKET
A. The following information shall be provided in the notification for placing on
the market of products, in addition to that of Annex II:
1. name of the product and names of GMOs contained therein;2. name of the manufacturer or distributor and his address in the
Community;
3. specificity of the product, exact conditions of use including, when appro-
priate, the type of environment and/or the geographical area(s) of theCommunity for which the product is suited;
4. type of expected use: industry, agriculture and skilled trades, consumer
use by public at large.
B. The following information shall be provided, when relevant, in addition to
that of point A, in accordance with Article 11 of this Directive:
1. measures to take in case of unintended release or misuse;2. specific instructions or recommendations for storage and handling;3. estimated production in and/or imports to the Community;4. proposed packaging. This must be appropriate so as to avoid unintended
release of the GMOs during storage, or at a later stage;
5. proposed labelling. This must include, at least in summarized form, the
information referred to in points A. 1, A. 2, A. 3, B. 1 and B. 2.