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"B COUNCIL DIRECTIVE
of 23 April 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
No page date
"M1 Commission Directive 94/15/EC of 15 April 1994 L 103 20 22.4.1994
"M2 Commission Directive 97/35/EC of 18 June 1997 L 169 72 27.6.19971990L0220 — EN — 28.06.1997 — 002.001 — 1
COUNCIL DIRECTIVE
of 23 April 1990
on the deliberate release into the environment of genetically modified
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 action should
be taken;
Whereas living organisms, whether released into the environment in large or
small amounts for experimental purposes or as commercial products, mayreproduce in the environment and cross national frontiers thereby affectingother Member States; whereas the effects of such releases 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 deliberate release of
genetically modified organisms (GMOs) into the environment;
Whereas disparity between the rules which are in effect or in preparation in
the Member States concerning the deliberate release into the environment ofGMOs may create unequal conditions of competition or barriers to trade in
products containing such organisms, thus affecting the functioning of the
common market; whereas it is therefore necessary to approximate the laws ofthe 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 functioning of the
internal market should, inasmuch as they concern health, safety, environ-
mental and consumer protection, be based on a high level of protectionthroughout 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 conventionally been
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 the deliberaterelease 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 derived from, or
containing, GMOs;
Whereas the introduction of GMOs into the environment should be carried out
according to the ‘step by step’ principle; whereas this means that thecontainment of GMOs is reduced and the scale of release increased gradually,
step by step, but only if evaluation of the earlier steps in terms of protection of
human health and the environment indicates that the next step can be taken;!B
(1) OJ No C 198, 28. 7. 1988, p. 19 and
OJ No C 246, 27. 9. 1989, p. 5.
(2) OJ No C 158, 26. 6. 1989, p. 225 and
OJ No C 96, 17. 4. 1990.
(3) OJ No C 23, 30. 1. 1989, p. 45.1990L0220 — EN — 28.06.1997 — 002.001 — 2
Whereas no product containing, or consisting of, GMOs and intended for
deliberate release shall be considered for placing on the market without it firsthaving been subjected to satisfactory field testing at the research anddevelopment stage in ecosystems which could be affected by its use;
Whereas it is necessary to establish a Community authorization procedure for
the placing on the market of products containing, or consisting of, GMOswhere the intended use of the product involves the deliberate release 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 product containing,or consisting of, GMOs, where the intended use of that product involves its
deliberate release into the environment, shall submit a notification to the
national competent authority;
Whereas that notification should contain a technical dossier of information
including a full environmental risk assessment, appropriate safety and
emergency response, and, in the case of products, precise instructions andconditions 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 been obtained;
Whereas the competent authority should give its consent only after it has been
satisfied that the release will be safe for human health and the environment;
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 information on
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 authorized under 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 properly authorized
under this Directive, a Member State may not on grounds relating to matters
covered by this Directive, prohibit, restrict or impede the deliberate release ofthe organism in that product on its territory where the conditions set out in the
consent are respected; whereas a safeguard procedure should be provided in
case of risk to human health or the environment;
Whereas the provisions of this Directive relating to placing on the market of
products should not apply to products containing, or consisting of, GMOs
covered by other Community legislation which provides for a specific
environmental risk assessment similar to that laid down 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 its adaptation to
technical progress,
HAS ADOPTED THIS DIRECTIVE:
PART A
General provisions
Article 1
1. The objective of this Directive is to approximate the laws, regulations and
administrative provisions of the Member States and to protect human 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 into the environment.
2. This Directive shall not apply to the carriage of genetically modified
organisms by rail, road, inland waterway, sea or air.!B1990L0220 — EN — 28.06.1997 — 002.001 — 3
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 not occur naturally bymating and/or natural recombination.
Within the terms of this definition:(i) genetic modification occurs at least through the use of the techniques
listed in Annex I A Part 1;
(ii) the techniques listed in Annex I A Part 2 are not considered to result
in genetic modification;
(3) ‘deliberate release’ means any intentional introduction into the environ-
ment of a GMO or a combination of GMOs without provisions for
containment such as physical barriers or a combination of physical
barriers together with chemical and/or biological barriers used to limittheir contact with the general population and the environment;
(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 ‘the notifier’;
(7) ‘use’ means the deliberate release of a product which has been placed on
the market. The persons carrying out this use will be referred to as
‘users’;
(8) ‘environmental risk assessment’ means the evaluation of the risk to
human health and the environment (which includes plants and animals)connected with the release of GMOs or products containing GMOs.
Article 3
This Directive shall not apply to organisms obtained through the techniques 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 might arise
from the deliberate release or placing on the market of GMOs.
2. Member States shall designate the competent authority or authorities
responsible for carrying out the requirements of this Directive and its
Annexes.
3. Member States shall ensure that the competent authority organizes
inspections and other control measures as appropriate, to ensure compliancewith this Directive.
PART B
Deliberate release of GMOs into the environment for research and
development 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, orfor any other purpose than for placing on the market, must submit a!B1990L0220 — EN — 28.06.1997 — 002.001 — 4
notification to the competent authority referred to in Article 4 (2) of the
Member State within whose territory the release is to take place;
(2) the notification shall include:
(a) a technical dossier supplying the information specified in Annex II
necessary for evaluating the foreseeable risks, whether immediate ordelayed, which the GMO or combination of GMOs may pose tohuman health or the environment, together with the methods used
and the bibliographic reference to them and 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 uses envisaged;
(3) the competent authority may accept that releases of a combination of
GMOs on the same site or of the same GMO on different sites for the
same purpose and within a limited period may be notified in a singlenotification;
(4) the notifier shall include in the notification information on data or results
from releases of the same GMOs or the same combination of GMOspreviously or currently notified and/or carried out by him either inside oroutside the Community.
The notifier may also refer to data or results from notifications previously
submitted by other notifiers, provided that the latter have given theiragreement in writing;
(5) in the case of a subsequent release of the same GMO or combination of
GMOs previously notified as part of the same research programme, thenotifier shall be required to submit a new notification. In this case, thenotifier may refer to data from previous notifications 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 with regard to the
risks for human health or the environment or if new information has
become available on such risks, either while the notification is beingexamined by the competent authority or after that authority has given itswritten consent, the notifier shall immediately:
(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 to protect 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 Article 9, shall!B1990L0220 — EN — 28.06.1997 — 002.001 — 5
respond in writing to the notifier within 90 days of receipt of the notification
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 in conformity with anyconditions 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 the Commission a
request for the application of simplified procedures for releases of such types
of GMOs. The Commission shall, in accordance with the procedures laiddown in Article 21, establish appropriate criteria and take a decision
accordingly on each application. The criteria shall be based on safety to
human health and the environment and on the evidence available on suchsafety.
6. If information becomes available subsequently to the competent authority
which could have significant consequences for the risks posed by the release,the competent authority may require the notifier to modify 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 proposed deliberate 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 health or the
environment, with particular reference to any kind of product that the notifierintends to notify at a later stage.
Article 9
1. The Commission shall set up a system of exchange of the information
contained in the notifications. The competent authorities shall send to the
Commission, within 30 days of its receipt, a summary of each notification
received. The format of this summary will be established by the Commissionin accordance with the procedure laid down in Article 21.
2. The Commission shall immediately forward these summaries to the other
Member States, which may, within 30 days, ask for further information orpresent 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 with Article 6 (2).!B1990L0220 — EN — 28.06.1997 — 002.001 — 6
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 in that Part;
— the products comply with the relevant Community product legislation;
— 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 risk assessmentsimilar to that laid down 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, shallestablish a list of Community legislation covering the products referred to in
paragraph 2. This list will be re-examined periodically and, 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 the Community shall submita notification to the competent authority of the Member State where such aproduct is to be placed on the market for the 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, including information
on data and results obtained from research and developmental releasesconcerning the ecosystems which could be affected by the use of theproduct and an assessent of any risks for human health and the
environment related to the GMOs or a combination of GMOs contained
in the product, including information obtained from the research anddevelopment stage on the impact of the release 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 for labelling and
packaging which should comprise at least the requirements 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 notifier considersthat the placing on the market and use of a product do not pose a risk tohuman health and the environment, he may propose not to comply with one or
more of the requirements of Annex III B.
2. The notifier shall include in this notification information on data or
results from releases of the same GMOs or the same combination of GMOs
previously or currently notified and/or carried out by the notifier either insideor outside the Community.
3. The notifier may also refer to data or results from notifications previously
submitted by other notifiers, provided that the latter have given theiragreement 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 be notified
separately.
5. The notifier may proceed with the release only when he has received the
written consent of the competent authority in accordance with Article 13, and
in conformity with any conditions, including reference to particularecosystems/environments, required in that consent.!B1990L0220 — EN — 28.06.1997 — 002.001 — 7
6. If new information has become available with regard to the risks of the
product to human health or the environment, either before or after the writtenconsent, the notifier shall immediately:
— revise the information and conditions specified in paragraph 1,— inform the competent authority, and
— take the measures necessary to protect human health and the environ-
ment.
Article 12
1. On receipt and after acknowledgement of the notification referred to in
Article 11, the competent authority shall examine it for compliance with thisDirective, giving particular attention to the environmental risk assessment andthe recommended precautions related to the safe use of the 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 together with a
statement of the conditions under which the competent authority proposes 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 tocomply with some of the requirements of Annex III B, it shall at the sametime inform the Commission thereof.
4. If the competent authority receives additional information pursuant to
Article 11 (6), it shall immediately inform the Commission and the other
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 authority is awaiting
further information which it may have requested from the notifier shall not betaken into account.
Article 13
1. On receipt of the dossier referred to in Article 12 (3), the Commission
shall immediately forward it to the competent authorities of all Member States
together with any other information it has collected pursuant to this Directive
and advise the competent authority responsible for forwarding the documentof the distribution date.
2. The competent authority, in the absence of any indication to the contrary
from another Member State within 60 days following the distribution datereferred to in paragraph 1, shall give its consent in writing to the notification
so that the product can be placed on the market and shall inform the other
Member States and the Commission thereof.
3. In cases where the competent authority of another Member State raises an
objection — for which the reasons must be stated — and should it not bepossible for the competent authorities concerned to reach an agreement within
the period specified in paragraph 2, the Commission shall take a decision in
accordance with the procedure laid down in Article 21.
4. Where the Commission has taken a favourable decision, the competent
authority that received the original notification shall give consent in writing tothe notification so that the product may be placed on the market and shallinform the other Member States and the Commission thereof.
5. Once a product has received a written consent, it may be used without
further notification throughout the Community in so far as the specific
conditions of use and the environments and/or geographical areas stipulated inthese conditions are strictly adhered to.!B1990L0220 — EN — 28.06.1997 — 002.001 — 8
6. Member States shall take all necessary measures to ensure that users
comply with the conditions of use specified in the written consent.
Article 14
Member States shall take all necessary measures to ensure that products
containing, or consisting of, GMOs will be placed on the market only if their
labelling and packaging is that specified in the written consent referred to inArticles 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 orimpede the placing on the market of products containing, or consisting of,GMOs which comply with the requirements of this Directive.
Article 16
1. Where a Member State has justifiable reasons to consider that a product
which has been properly notified and has received written consent under this
Directive constitutes a risk to human health or the environment, it may
provisionally restrict or prohibit the use and/or sale of that product on itsterritory. It shall immediately inform the Commission and the other MemberStates of such action and give reasons for its decision.
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 contained therein 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 products placed on themarket 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 States of the products
placed on the market under this Directive.
3. When submitting this report for the first time, the Commission shall at
the same time submit a specific report on the operation of this Part of thisDirective 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 under thisDirective and shall protect intellectual property rights relating to the datareceived.
2. The notifier may indicate the information in the notification submitted
under this Directive, the disclosure of which might harm his competitiveposition, that should therefore be treated as confidential. Verifiablejustification 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 inform the notifier of itsdecisions.!B1990L0220 — EN — 28.06.1997 — 002.001 — 9
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 confidentiality of
the information supplied.
Article 20
According to the procedure laid down in Article 21, the Commission shall
adapt Annexes II and III to technical progress in particular by amending the
notification requirements to take into account the potential hazard of theGMOs.
Article 21
The Commission shall be assisted by a committee composed of the
representatives of the Member States and chaired by the representative ofthe Commission.
The representative of the Commission shall submit to the committee a draft of
the measures to be taken. The committee shall deliver its opinion on the draftwithin a time limit which the chairman may lay down according to the
urgency of the matter. The opinion shall be delivered by the majority laid
down in Article 148 (2) of the Treaty in the case of decisions which theCouncil is required to adopt on a proposal from the Commission. The votes ofthe representatives of the Member States within the committee shall be
weighted in the manner set 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, without delay,
submit to the Council a proposal relating to the measures to be taken. 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 be adopted bythe Commission.
Article 22
1. Member States and the Commission shall meet regularly and exchange
information on the experience acquired with regard to the prevention of risksrelated 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 this Directive, the first timebeing 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 before 23October 1991.
2. Member States shall immediately inform the Commission of all laws,
regulations and administrative provisions adopted in implementation of this
Directive.
Article 24
This Directive is addressed to the Member States.!B1990L0220 — EN — 28.06.1997 — 002.001 — 10
ANNEX I 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 andmicro-encapsulation;
(3) cell fusion (including protoplast fusion) or hybridization techniques where live
cells with new combinations of heritable genetic material are formed through thefusion of two or more cells by means of methods that do not occur 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 recombinant DNAmolecules or GMOs, are:
(1) in vitro fertilization,
(2) conjugation, transduction, transformation or any other natural process,
(3) polyploidy induction.!
B
(1) OJ NO L 213, 21. 7. 1982, p. 15.1990L0220 — EN — 28.06.1997 — 002.001 — 11
ANNEX I 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 parental organisms, are:
(1) mutagenesis,
(2) cell fusion (including protoplast fusion) of plant cells where the resulting
organisms can also be produced by traditional breeding methods.!B1990L0220 — EN — 28.06.1997 — 002.001 — 12
ANNEX II
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 information set outbelow 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 considerations which is
appropriate to individual situations.
The level of detail required in response to each subset of considerations is also likely to
vary according to the nature and 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 modified higher plants.
The term ‘higher plants’ means plants which belong to the taxonomic groups
Gymnospermae andAngiospermae .!
M11990L0220 — EN — 28.06.1997 — 002.001 — 13
ANNEX II A
INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES
OF GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER
PLANTS
I. GENERAL INFORMA TION
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. INFORMA TION RELATING TO THE GMO
A. Characteristics of (a) the donor, (b) the recipient or (c) (where appropriate)
parental organism(s):
1. scientific name;
2. taxonomy;
3. other names (usual name, strain name, etc.);4. phenotypic and genetic markers;
5. degree of relatedness between donor and recipient or between parental
organisms;
6. description of identification and detection techniques;7. sensitivity, reliability (in quantitative terms) and specificity of detection
and identification techniques;
8. description of the geographic distribution and of the natural habitat of the
organism including information on natural predators, preys, parasites andcompetitors, symbionts and hosts;
9. potential for genetic transfer and exchange with other organisms;
10. verification of the genetic stability of the organisms and factors affecting
it;
11. pathological, ecological and physiological traits:
(a) classification of hazard according to existing Community rules
concerning the protection of human health and/or the environment;
(b) generation time in natural ecosystems, sexual and asexual
reproductive cycle;
(c) information on survival, including seasonability and the ability to
form survival structures e.g.: seeds, spores or sclerotia;
(d) pathogenicity: infectivity, toxigenicity, virulence, allergenicity,
carrier (vector) of pathogen, possible vectors, host range including
non-target organism. Possible activation of latent viruses (pro-viruses). Ability to colonize other organisms;
(e) antibiotic resistance, and potential use of these antibiotics in
humans and domestic organisms for prophylaxis and therapy;
(f) involvement in environmental processes: primary production,
nutrient turnover, decomposition of organic matter, respiration, etc.
12. Nature of indigenous vectors:
(a) sequence;
(b) frequency of mobilization;(c) specificity;
(d) presence of genes which confer resistance.
13. History of previous genetic modifications.
B. Characteristics of the vector:
1. nature and source of the vector;
2. sequence of transposons, vectors and other non-coding genetic segments
used to construct the GMO and to make the introduced vector and insertfunction in the GMO;
3. frequency of mobilization of inserted vector and/or genetic transfer
capabilities and methods of determination;!
M11990L0220 — EN — 28.06.1997 — 002.001 — 14
4. information on the degree to which the vector is limited to the DNA
required to perform the intended function.
C. Characteristics of the modified organism:
1. Information relating to the genetic modification:
(a) methods used for the modification;
(b) methods used to construct and introduce the insert(s) into the
recipient or to delete a sequence;
(c) description of the insert and/or vector construction;
(d) purity of the insert from any unknown sequence and information on
the degree to which the inserted sequence is limited to the DNArequired to perform the intended function;
(e) sequence, functional identity and location of the altered/inserted/
deleted nucleic acid segment(s) in question with particular
reference to any known harmful sequence.
2. Information on the final GMO:
(a) description of genetic trait(s) or phenotypic characteristics and in
particular any new traits and characteristics which may be expressed
or no longer expressed;
(b) structure and amount of any vector and/or donor nucleic acid
remaining in the final construction of the modified organism;
(c) stability of the organism in terms of genetic traits;
(d) rate and level of expression of the new genetic material. Method
and sensitivity of measurement;
(e) activity of the expressed protein(s);(f) description of identification and detection techniques including
techniques for the identification and detection of the inserted
sequence and vector;
(g) sensitivity, reliability (in quantitative terms) and specificity of
detection and identification techniques;
(h) history of previous releases or uses of the GMO;
(i) health considerations:
(i) toxic or allergenic effects of the non-viable GMOs and/or their
metabolic products;
(ii) product hazards;
(iii) comparison of the modified organism to the donor, recipient or
(where appropriate) parental organism regarding pathogeni-city;
(iv) capacity for colonization;
(v) if the organism is pathogenic to humans who are immuno-
competent:
— diseases caused and mechanism of pathogenicity includ-
ing 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. INFORMA TION 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;!
M11990L0220 — EN — 28.06.1997 — 002.001 — 15
2. foreseen dates of the release and time planning of the experiment
including frequency and duration of releases;
3. preparation of the site previous to the release;
4. size of the site;5. method(s) to be used for the release;
6. quantities of GMOs to be released;
7. disturbance on the site (type and method of cultivation, mining,
irrigation, or other activities);
8. worker protection measures taken during the release;
9. post-release treatment of the site;
10. techniques foreseen for elimination or 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 foreseen areas
of use of the product);
2. physical or biological proximity to humans and other significant biota;
3. proximity to significant biotopes or protected areas;4. size of local population;
5. economic activities of local populations which are based on the natural
resources of the area;
6. distance to closest areas protected for drinking water and/or 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 the release.
IV . INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE
GMOs AND THE ENVIRONMENT
A. Characteristics affecting survival, multiplication and dissemination:
1. biological features which affect survival, multiplication and dispersal;
2. known or predicted environmental conditions which may affect survival,
multiplication and dissemination (wind, water, soil, temperature, pH,etc.);
3. sensitivity to specific agents.
B. Interactions with the environment:
1. predicted habitat of the GMOs;2. studies of the behaviour and characteristics of the GMOs and their
ecological impact carried out in simulated natural environments, such asmicrocosms, growth rooms, greenhouses;
3. genetic transfer capability:
(a) post-release transfer of genetic material from GMOs into organisms
in affected ecosystems;
(b) post-release transfer of genetic material from indigenous organisms
to the GMOs;
4. likelihood of post-release selection leading to the expression of
unexpected and/or undesirable traits in the modified organism;!
M11990L0220 — EN — 28.06.1997 — 002.001 — 16
5. measures employed to ensure and to verify genetic stability. Description
of genetic traits which may prevent or minimize dispersal of geneticmaterial. Methods to verify genetic stability;
6. routes of biological dispersal, known or potential modes of interaction
with the disseminating agent, including inhalation, ingestion, surfacecontact, burrowing, etc.;
7. description of ecosystems to which the GMOs could be disseminated.
C. Potential environmental impact:
1. potential for excessive population increase in the environment;2. competitive advantage of the GMOs in relation to the unmodified
recipient or parental organism(s);
3. identification and description of the target organisms;
4. anticipated mechanism and result of interaction between the released
GMOs and the target organism;
5. identification and description of non-target organisms which may be
affected unwittingly;
6. likelihood of post-release shifts in biological interactions or in host
range;
7. known or predicted effects on non-target organisms in the environment,
impact on population levels of competitors: preys, hosts, symbionts,
predators, parasites and pathogens;
8. known or predicted involvement in biogeochemical processes;
9. other potentially significant interactions with the environment.
V . INFORMA TION ON MONITORING, CONTROL, WASTE TREATMENT AND
EMERGENCY RESPONSE PLANS
A. Monitoring techniques:
1. methods for tracing the GMOs, and for monitoring their effects;
2. specificity (to identify the GMOs, and to distinguish them from the
donor, recipient or, where appropriate, the parental organisms),sensitivity and reliability of the monitoring techniques;
3. techniques for detecting transfer of the donated genetic material to other
organisms;
4. duration and frequency of the monitoring.
B. Control of the release:
1. methods and procedures to avoid and/or minimize the spread of the
GMOs beyond the site of release or the designated area for use;
2. methods and procedures to protect the site from intrusion by
unauthorized individuals;
3. methods and procedures to prevent other organisms from entering the
site.
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 unexpected
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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ANNEX II B
INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES
OF GENETICALL Y MODIFIED HIGHER PLANTS (GMHPs)
(GYMNOSPERMAE ANDANGIOSPERMAE)
A. GENERAL INFORMA TION
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. INFORMA TION 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 on naturalpredators, 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 information ontoxic effects on humans, animals and other organisms.
C. INFORMA TION RELATING TO THE GENETIC MODIFICA TION
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. INFORMA TION RELATING TO THE GENETICALL Y 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 characterization,
including information on any parts of the vector introduced in the GMHPor 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), andmethods for its determination;
(d) copy number of the insert.!
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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 recipient
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 (ONL Y 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 . INFORMA TION RELATING TO THE RELEASE (ONL Y FOR NOTIFICA-
TIONS 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 (ONL Y FOR NOTIFICATIONS SUBMITTEDPURSUANT 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 modified
plant material including wastes.
4. Description of monitoring plans and techniques.5. Description of any emergency plans.
H. INFORMA TION ON THE POTENTIAL ENVIRONMENTAL IMP ACT FROM
THE RELEASE OF THE GENETICALL Y MODIFIED PLANTS
1. Likelihood of the GMHP becoming more persistent than the recipient or
parental plants in agricultural habitats or more invasive in natural habitats.
2. Any selective advantage or disadvantage conferred to other sexually
compatible plants species, which may result from genetic transfer from thegenetically 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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ANNEX III
ADDITIONAL INFORMATION REQUIRED IN THE CASE OF NOTIFICA-
TION 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
appropriate, 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;
5. information relating to the introduced genetic modification which could be of
relevance to the establishment of a possible register of modificationsintroduced in organisms (species). This may include nucleotide sequences orother type of information which is relevant to the inclusion in such a register.
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.
C. The following information shall be provided in the notification, in accordance with
Article 11 of this Directive:
Proposed labelling. This must include in a label or an accompanying document an
indication that the product contains, or consists of genetically modified organisms.In the case of products to be placed on the market in mixtures with non-geneticallymodified organisms, information on the possibility that the genetically modified
organisms may be present, is sufficient.!
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