Common Position (EC) No 12/2000 of 9 December 1999 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
Date: 1999-12-09
Institutions: Council of the European Union
Subjects: exchange of information, genetically modified organism, labelling, marketing standard, public awareness campaign

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 12/2000

adopted by the Council on 9 December 1999

with a view to adopting Directive 2000/.../EC of the European Parliament and of the Council of ...
on the deliberate release into the environment of genetically modified organisms and repealing
Council Directive 90/220/EEC

(2000/C 64/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,

(3) Directive 90/220/EEC has been amended; now that new
amendments are being made to the said Directive, it is
desirable, for reasons of clarity and rationalisation that
the provisions in question should be recast.

Having regard to the proposal from the Commission (1),

(4)

Having regard to the opinion of the Economic and Social
Committee (2),

Acting in accordance with the procedure laid down in
Article 251 of the Treaty (3),

Whereas:

(1) The Report of the Commission on the Review of Council
Directive 90/220/EEC of 23 April 1990 on the deliberate
release into the environment of genetically modified
organisms (4), adopted on 10 December 1996, identified
a number of areas where improvement is needed.

(2) There is a need for clarification of the scope of Directive

90/220/EEC and of the definitions therein.

(1) OJ C 139, 4.5.1998, p. 1.
(2) OJ C 407, 28.12.1998, p. 1.
(3) Opinion of the European Parliament of 11 February 1999 (OJ
C 150, 28.5.1999, p. 363), Council Common Position of
9 December 1999 and Decision of the European Parliament of ...
(not yet published in the Official Journal).

(4) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Com-

mission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).

Living organisms, whether released into the environment
in large or small amounts for experimental purposes or as
commercial products, may reproduce in the environment
and cross national frontiers thereby affecting other Mem-
ber States; the effects of such releases on the environment
may be irreversible.

(5) The protection of human health and the environment
requires that due attention be given to controlling risks
from the deliberate release into the environment of
genetically modified organisms (GMOs).

(6) Under the Treaty, action by the Community relating to
the environment should be based on the principle that
preventive action should be taken.

(7)

It is necessary to approximate the laws of the Member
States concerning the deliberate release into the environ-
ment of GMOs and to ensure the safe development of
industrial products utilising GMOs.

(8) The precautionary principle has been taken into account
in the drafting of this Directive and must be taken into
account when implementing it.

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(9) Respect for ethical principles recognised in a Member
State is particularly important; Member States may take
into consideration ethical aspects when GMOs are deliber-
ately released or placed on the market as or in products.

(21) The issue of antibiotic-resistance genes should be taken
into particular consideration when conducting the risk
assessment of GMOs containing such genes.

(10) For a comprehensive and transparent legislative frame-
work, it is necessary to ensure that the public is consulted
by either the Commission or the Member States during
the preparation of measures and that they are informed
of the measures taken during the implementation of this
Directive.

(11) Placing on the market also covers import; products
containing and/or consisting of GMOs covered by this
Directive cannot be imported into the Community if they
do not comply with its provisions.

(12) Making GMOs available to be imported or handled in
bulk quantities, such as agricultural commodities, should
be regarded as placing on the market for the purpose of
this Directive.

(13) The content of this Directive duly takes into account
international experience in this field and international
trade commitments.

(14) Guidance on the implementation of provisions related to
the definition of the placing on the market
in this
Directive should be provided by the Regulatory Com-
mittee.

(15) When defining ‘genetically modified organism’ for the
purpose of this Directive human beings should not be
considered as organisms.

(16) The provisions of this Directive be without prejudice to

national legislation in the field of liability.

(17) This Directive should not apply to organisms obtained
through certain techniques of genetic modification which
have conventionally been used in a number of appli-
cations and have a long safety record.

(18) It is necessary to establish harmonised procedures and
criteria for the case-by-case evaluation of the potential
risks arising from the deliberate release of GMOs into the
environment.

(19) A case-by-case environmental risk assessment should

always the carried out prior to a release.

(20) It is necessary to establish a common methodology to
carry out the environmental risk assessment based on
independent scientific advice;
is also necessary to
establish common objectives for the monitoring of GMOs
after their deliberate release or placing on the market as
or in products.

it

(22) The deliberate release of GMOs at the research stage is in
most cases a necessary step in the development of new
products derived form, or containing, GMOs.

(23) The introduction of GMOs into the environment should
be carried out according to the ‘step by step’ principle;
this means that the containment 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 indi-
cates that the next step can be taken.

(24) No GMOs, as or in products, and intended for deliberate
release are to be considered for placing on the marked
without first having been subjected to satisfactory field
testing at the research and development stage in ecosys-
tems which could be affected by their use.

instruments

(25) The implementation of this Directive should be carried
out in close liaison with the implementation of other
relevant
as Council Directive
such
91/414/EEC of 15 July 1991 concerning the placing of
plant protection products on the market (1);
in this
context the competent authorities concerned with the
implementation of this Directive and of those instru-
level,
ments, within the Commission and at national
should coordinate their action as far as possible.

(26) Concerning the environmental risk assessment for Part C,
risk management, labelling, monitoring, information to
the public and safeguard clause, this Directive should be
a point of reference for GMOs as or in products
authorised by other Community legislation which should
therefore provide for a specific environmental risk assess-
ment, to be carried out in accordance with the principles
set out in Annex II and on the basis of information
specified in Annex III without prejudice to additional
requirements laid down by the Community legislation
mentioned above, and for requirements as regards risk
management, labelling, monitoring as appropriate, infor-
mation to the public and safeguard clause at
least
equivalent to that laid down in this Directive.

(27) It is necessary to establish a Community authorisation
procedure for the placing on the market of GMOs, as or
in products, where the intended use of the product
involves the deliberate release of the organism(s) into the
environment.

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Com-
mission Directive 1999/80/EC (OJ L 210, 10.8.1999, p. 13).

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(28) For sectoral

legislation, monitoring requirements may

have to be adapted to the product concerned.

(29) Part C of this Directive does not apply to products
covered by Council Regulation (EEC) No 2309/93 of
22 July 1993 laying down Community procedures for
the authorisation and supervision of medicinal products
for human and veterinary use and establishing a European
Agency for the Evaluation of medial Products (1), provided
that it includes an environmental risk assessment equiva-
lent to that provided for by this Directive.

(30) Any person, before undertaking a deliberate release into
the environment of a GMO, or the placing on the market
of GMOs, as or in products, where the intended use
of the product involves its deliberate release into the
environment, is to submit a notification to the national
competent authority.

(31) That notification should contain a technical dossier of
information including a full environmental risk assess-
ment, appropriate safety and emergency response, and,
in the case of products precise instructions and conditions
for use, and proposed labelling and packaging.

(32) After notification, no deliberate release of GMOs should
be carried out unless the consent of the competent
authority has been obtained.

(33) A notifier should be able to withdraw his dossier at any
stage of the administrative procedures laid down in this
Directive; the administration procedure should stop when
a dossier is withdrawn.

(34) Rejection of a notification for the placing on the market
of a GMO as or in products by a competent authority
should be without prejudice to the submission of a
notification of the same GMO to another competent
authority.

(35) An agreement should be reached at the end of the

mediation period when no objections remain.

(36) Rejection of a notification following a confirmed negative
assessment report should be without prejudice to future
decisions based on the notification of the same GMO to
another competent authority.

(37) In the interests of

the smooth functioning of

this
Directive, Member States should be able to avail them-
selves of the various provisions for the exchange of
information and experience before having recourse to the
safeguard clause of this Directive.

(1) OJ L 214, 24.8.1993, p. 1. Regulation as amended by Com-
mission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).

(38) In order to ensure that the presence of GMOs in products
containing, or consisting of, genetically modified organ-
isms is appropriately identified, the words ‘This product
contains genetically modified organisms’ should appear
clearly either on a label or in an accompanying document.

(39) A system should be designed using the appropriate
committee procedure, for the assignment of a unique
identifier to GMOs, taking into account relevant develop-
ments in international fora.

(40) It is necessary to ensure traceability at all stages of the
placing on the market of GMOs as or in products
authorised under Part C of this Directive.

(41) It is necessary to introduce into this Directive an obli-
gation to implement a monitoring plan in order to trace
and identify any direct or indirect, immediate, delayed or
unforeseen effects on human health or the environment
of GMOs as or in products after they have been placed
on the market.

(42) Member States should be able, in accordance with the
Treaty, to take further measures for monitoring and
inspection, for example by official services, of the GMOs
as or in products placed on the market.

(43) Means should be sought for providing possibilities for
facilitating the control of GMOs or their retrieval in the
event of severe risk.

(44) Comments by the public should be taken into consider-
ation in the drafts of measures submitted to the Regulat-
ory Committee.

(45) 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.

(46) The administrative procedure for granting consents for
the placing on the market of GMOs as or in products
should be made more efficient and more transparent and
first-time consent should be granted for a fixed period.

(47) For products for which consent has been granted for a
fixed period a streamlined procedure should apply as
regards the renewal of consent.

(48) The

granted

existing

consents

under Directive
90/220/EEC have to be renewed in order to avoid
disparities between consents granted under that Directive
and those pursuant to this Directive and in order to take
full account of the conditions of consent under this
Directive.

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(49) Such renewal requires a transitional period during which
existing consents granted under Directive 90/220/EEC
remain unaffected.

(59) In order to increase the effective implementation of the
provisions adopted under this Directive it is appropriate
to provide for penalties to be applied by Member States.

(50) When a consent is renewed, it should be possible to
revise all the conditions of the original consent, including
those related to monitoring and the time limitation of the
consent.

(60) The regulatory framework for biotechnology should be
reviewed so as to identify the feasibility of improving
further the consistency and efficiency of that framework;
procedures may need to be adapted so as to optimise
efficiency, and all options which might achieve that
should be considered,

(51) Provision should be made for consultation of the relevant
scientific
established by Commission
Decision 97/579/EC (1) on matters which are likely to
have an impact on human health and/or the environment.

committee(s)

HAVE ADOPTED THIS DIRECTIVE:

(52) The system of exchange of information contained in
notifications, established under Directive 90/220/EEC,
has been useful and should be continued.

(53) It is important to follow closely the development and use

of GMOs.

(54) When a product containing a GMO, as, or in products, is
placed on the market, and where such a product has been
properly authorised under this Directive, a Member State
may not prohibit, restrict or impede the placing on the
market of GMOs, as or in products, which comply with
the requirements of the Directive; a safeguard procedure
should be provided in case of risk to human health or the
environment.

(55) The Commission’s European group on ethics in science
and new technologies should be consulted with a view to
obtaining advice on ethical issues of a general nature
regarding the deliberate release or placing on the market
of GMOs; such consultations should be without prejudice
to the competence of Member States as regards ethical
issues.

PART A

GENERAL PROVISIONS

Article 1

Objective

In accordance with the precautionary principle 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 into the environment of
genetically modified organisms for any other purposes
than placing on the market within the Community

— placing on the market genetically modified organisms as

or in products within the Community.

Article 2

Definitions

(56) Member States should be able to consult any committee
they have established with a view to obtaining advice on
the ethical implications of biotechnology.

For the purposes of this Directive:

(57) The measures necessary for the implementation of this
Directive are to be adopted in accordance with Council
Directive 1999/468/EC of 28 June 1999 laying down the
procedures for the exercise of
implementing powers
conferred on the Commission (2).

(58) The information exchange set up under this Directive
should also cover experience gained with the consider-
ation of ethical aspects.

(1) OJ L 237, 28.8.1997, p. 18.
(2) OJ L 184, 17.7.1999, p. 23.

1.

2.

‘organism’ is any biological entity capable of replication or
of transferring genetic material;

‘genetically modified organism (GMO)’ means an organism,
with the exception of human beings, in which the genetic
material has been altered in a way that does not occur
naturally by mating and/or natural recombination.

Within the terms of this definition:

(a) genetic modification occurs at least through the use of

the techniques listed in Annex IA, Part 1,

(b) the techniques listed in Annex IA, Part 2, are not

considered to result in genetic modification;

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3.

‘deliberate release’ means any intentional introduction into
the environment of a GMO or a combination of GMOs for
which no specific containment measures are used to limit
their contact with and to provide a high level of safety for
the general population and the environment;

4.

‘placing on the market’ means making available to third
parties, whether in return for payments or free of charge;

The following operations shall not be regarded as placing
on the market:

activities

— making available genetically modified micro-organisms
for
regulated under Council Directive
90/219/EEC of 23 April 1990 on the contained use
of genetically modified micro-organisms (1) including
culture collections,

— making available GMOs other than micro-organisms
referred to in the first indent, to be used exclusively for
activities where appropriate stringent containment
measures are used to limit their contact with and to
provide a high level of safety for the general population
and the environment; the measures should be based on
the same principles of containment as laid down in
Directive 90/219/EEC,

— making available GMOs to be used exclusively for
deliberate releases complying with the requirements
laid down in Part B of this Directive;

5.

‘notification’ means the submission of the information
required under this Directive to the competent authority
of a Member State;

6.

‘notifier’ means the person submitting the notification;

7.

8.

‘product’ means a preparation consisting of, or containing,
a GMO or a combination of GMOs, which is placed on the
market;

‘environmental risk assessment’ means the evaluation of
risks to human health and the environment, whether direct
or indirect, immediate or delayed, which the deliberate
release or the placing on the market of GMOs may pose
and carried out in accordance with Annex II.

Article 3

Exemptions

This Directive shall not apply to organisms obtained
1.
through the techniques of genetic modification listed in
Annex IB.

(1) OJ L 117, 8.5.1990, p. 1. Directive as amended by Directive

98/81/EC (OJ L 330, 5.12.1998, p. 13).

2.
This Directive shall not apply to the carriage of genet-
ically modified organisms by rail, road, inland waterway, sea
or air.

Article 4

General obligations

1. Member States, in accordance with the precautionary
principle, 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 the placing on
the market of GMOs. GMOs may only be deliberately released
or placed on the market in conformity with Part B or Part C
respectively.

Any person, before submitting a notification under Part B
2.
or Part C, shall carry out an environmental risk assessment.
The information which may be necessary to carry out the
environmental risk assessment is laid down in Annex III.
Member States and the Commission shall ensure that GMOs
which contain genes expressing resistance to antibiotics in use
for medical or veterinary treatment are taken into particular
consideration when carrying out an environmental risk assess-
ment, with a view to identifying and phasing out antibiotic
resistance markers in GMOs which may have adverse effects
on human health and the environment.

3. Member States shall designate the competent authority
or authorities responsible for carrying out the requirements
of this Directive. The competent authority shall examine
notifications under Parts B and C for compliance with the
requirements of this Directive and whether the assessment
provided for in paragraph 2 is appropriate.

4. Member States shall ensure that the competent authority
organises inspections and other control measures as appropri-
ate, to ensure compliance with this Directive. In the event of a
release of GMO(s) or placing on the market as or in products
for which no authorisation was given the Member State
concerned shall ensure that necessary measures are taken to
terminate the release or placing on the market, to initiate
remedial action if necessary, and to inform its public, the
Commission and other Member States.

5. Member States shall take measures to ensure, in line with
the requirements laid down in Annex IV, traceability, at all
stages of the placing on the market of GMOs authorised under
Part C.

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PART B

DELIBERATE RELEASE OF GMOS FOR ANY OTHER PURPOSE
THAN FOR PLACING ON THE MARKET

Article 5

Standard authorisation procedure

1.
Any person before undertaking a deliberate release of a
GMO or of a combination of GMOs, must submit a notification
to the competent authority of the Member State within whose
territory the release is to take place.

5.
The competent authority shall acknowledge the date of
receipt of the notification and, having considered, where
appropriate, any observations by other Member States made
in accordance with Article 10, shall 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 that notification is therefore rejected.

6.
For the purpose of calculating the 90-day period referred
to in paragraph 5, no account shall be taken of any periods of
time during which the competent authority:

2.

The notification referred to in paragraph 1 shall include:

(a)

is awaiting further information which it may have request-
ed from the notifier, or

(a) a technical dossier supplying the information specified in
Annex III necessary for carrying out the environmental
risk assessment of the deliberate release of a GMO or
combination of GMOs, in particular:

(i) general information including information on person-

nel and training,

(ii) information relating to the GMO(s),

(iii) information relating to the conditions of release and

the potential receiving environment,

(iv) information on the interactions between the GMO(s)

and the environment,

(v) a plan for monitoring in accordance with the relevant
parts of Annex III in order to identify effects of the
GMO(s) on human health or the environment,

(vi) information on control, remedial methods, waste treat-

ment and emergency response plans,

(vii)a summary of the dossier;

(b) the environmental risk assessment and the conclusions
together with any
required in Annex II, Section D,
bibliographic reference and indications of the methods
used.

3.
The notifier may refer to data or results from notifications
previously submitted by other notifiers, provided that the
information, data and results are non-confidential or these
notifiers have given their agreement in writing, or may submit
additional information he considers relevant.

4.
The competent authority may accept that releases of the
same GMO or of a combination of GMOs on the same site or
on different sites for the same purpose and within a defined
period may be notified in a single notification.

(b) is carrying out a public inquiry or consultation in accord-
ance with Article 8; this public inquiry or consultation shall
not prolong the 90-day period referred to in paragraph 5
by more than 30 days.

7.
The notifier may proceed with the release only when he
has received the written consent of the competent authority,
and in conformity with any conditions required in this consent.

8. Member States shall ensure that no material derived from
GMOs which are deliberately released in accordance with Part
B is placed on the market, unless in accordance with Part C.

Article 6

Differentiated procedures

If sufficient experience has been obtained of releases of
1.
certain GMOs in certain ecosystems and the GMOs concerned
meet the criteria set out in Annex V, a competent authority
may submit to the Commission a reasoned proposal for the
application of differentiated procedures to such types of
GMOs.

2.
Following its own initiative or at the latest 30 days
following the receipt of a competent authority’s proposal, the
Commission shall:

(a) forward the proposal to the competent authorities, which
may, within 60 days, present observations and at the same
time:

(b) make available the proposal to the public which may,

within 60 days, make comments; and

(c) consult the relevant Scientific Committee(s) which may,

within 60 days, give an opinion.

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3.
A decision shall be taken on each proposal in accordance
with the procedure laid down in Article 29(2). This decision
shall establish the minimum amount of technical information
from Annex III necessary for evaluating any foreseeable risks
from the release, in particular:

Article 7

Handling of modifications and new information

(a)

information relating to the GMO(s);

(b) information relating to the conditions of release and the

potential receiving environment;

(c)

information on the interactions between the GMO(s) and
the environment;

1.
In the event of any modification of, or unintended
change to, the deliberate release of a GMO or of a combination
of GMOs which could have consequences with regards to risks
for human health and the environment after the competent
authority has given its written consent, or if new information
has become available on such risks, either while the notification
is being examined by the competent authority of a Member
State or after that authority has given its written consent, the
notifier shall immediately:

(d) the environmental risk assessment.

(a) take the measures necessary to protect human health and

the environment;

4.
This decision shall be taken within 90 days of the date
of the Commission’s proposal or of receipt of the competent
authority’s proposal. This 90-day period shall not take into
account the period of time during which the Commission
is awaiting the observations of competent authorities, the
comments of the public or the opinion of Scientific Com-
mittees, as provided for in paragraph 2.

5.
The decision taken under paragraphs 3 and 4 shall
provide that the notifier may proceed with the release only
when he has received the written consent of the competent
authority. The notifier shall proceed with the release in
conformity with any conditions required in this consent.

(b) inform the competent authority in advance of any modifi-
cation or as soon as the unintended change is known or
the new information is available;

(c) revise the measures specified in the notification.

If

information becomes available to the competent
2.
authority referred to in paragraph 1 which could have
significant consequences with regard to risks for human health
and the environment or under the circumstances described in
paragraph 1, the competent authority shall evaluate such
information and may require the notifier to modify the
conditions of, suspend or terminate the deliberate release.

The decision taken under paragraphs 3 and 4 may provide
that releases of a GMO or of a combination of GMOs on the
same site or on different sites for the same purpose and within
a defined period may be notified in a single notification.

Article 8

Consultation of and information to the public

6. Without prejudice to paragraphs 1 to 5, Commission
Decision 94/730/EC of 4 November 1994 establishing simpli-
fied procedures concerning the deliberate release into the
environment of genetically modified plants pursuant to Article
6(5) of Council Directive 90/220/EEC (1) shall continue to
apply.

1. Member States shall, without prejudice to the provisions
of Articles 6 and 24, consult the public and, where appropriate,
groups on the proposed deliberate release. In doing so, Member
States shall
lay down arrangements for this consultation,
including a reasonable time period, in order to give the public
or groups the opportunity to express an opinion.

7. Where a Member State decides to make use or not of a
procedure established in a decision taken in accordance with
paragraphs 3 and 4 for releases of GMOs within its territory it
shall inform the Commission thereof.

(1) OJ L 292, 12.11.1994, p. 31.

2. Without prejudice to the provisions of Article 24:

— Member States shall make available to the public infor-
mation on all Part B releases of GMOs in their territory,

— the Commission shall make available to the public the
information contained in the system of exchange of
information pursuant to Article 10.

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Article 9

PART C

PLACING ON THE MARKET OF GMOS AS OR IN PRODUCTS

Reporting by notifiers on releases

After completion of a release, and, thereafter, at any intervals
laid down in the consent on the basis of the results of the
environmental risk assessment, 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, where
appropriate, particular reference to any kind of product that
the notifier intends to notify at a later stage. The format for
the presentation of this result shall be established in accordance
with the procedure laid down in Article 29(2).

Article 10

Exchange of information between competent authorities
and the Commission

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 under Article
5. The format of this summary shall be established and
modified if appropriate in accordance with the procedure laid
down in Article 29(2).

2.
The Commission shall, at the latest 30 days following
their receipt, forward these summaries to the other Member
States, which may, within 30 days, present observations
through the Commission or directly. At its request, a Member
State shall be permitted to receive a copy of the full notification
from the competent authority of the relevant Member State.

3.
The competent authorities shall inform the Commission
of
the final decisions taken in compliance with Article
including where relevant the reasons for rejecting a
5(5),
notification, and of the results of the releases received in
accordance with Article 9.

4.
For the releases of GMOs referred to in Article 6, once a
year Member States shall send a list of GMOs which have been
released on their territory and a list of notifications that were
rejected to the Commission, which shall forward them to the
competent authorities of the other Member States.

Article 11

Sectoral legislation

1.
Articles 12 to 23 shall not apply to any GMO as or in
products as far as they are authorised by Community legislation
which provides for a specific environmental risk assessment
carried out in accordance with the principles set out in Annex
II and on the basis of information specified in Annex III
without prejudice to additional requirements provided for
by the Community legislation mentioned above, and for
requirements as regards risk management, labelling, monitor-
ing as appropriate, information to the public and safeguard
clause at least equivalent to that laid down in this Directive.

2.
As far as Council Regulation (EEC) No 2309/93 is
concerned, Articles 12 to 23 of this Directive shall not apply
to any GMO as or in products as far as they are authorised by
that Regulation provided that a specific environmental risk
assessment is carried out in accordance with the principles set
out in Annex II to this Directive and on the basis of information
specified in Annex III to this Directive without prejudice to
additional requirements provided for in Regulation (EEC) No
2309/93.

3.
Procedures ensuring that the risk assessment, require-
ments regarding risk management, labelling, monitoring as
appropriate, information to the public and safeguard clause
are equivalent to those laid down in this Directive shall be
introduced, in a regulation of the European Parliament and of
the Council. Until that regulation enters into force any GMO
as or in products as far as they are authorised by other
Community legislation shall only be placed on the market
after having been accepted for placing on the market in
accordance with this Directive.

During evaluation of the requests for the placing on the
4.
market of the GMOs referred to in paragraph 1, the bodies
established by the Community under this Directive and by
Member States for the purpose of implementing this Directive
shall be consulted.

Article 12

Notification procedure

1.
Before a GMO or a combination of GMOs as or in
products is placed on the market, a notification shall be
submitted to the competent authority of the Member State
where such a GMO is to be placed on the market for the first
time. The competent authority shall acknowledge the date of
receipt of
the notification and immediately forward the
summary of the dossier referred to in paragraph 2(h) to the
competent authorities of the other Member States and the
Commission.

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The competent authority shall without delay examine whether
the notification is in accordance with paragraph 2 and shall, if
necessary, ask the notifier for additional information.

When the notification is in accordance with paragraph 2, and
at the latest when it sends its assessment report in accordance
with Article 13(2), the competent authority shall forward a
copy of the notification to the Commission which shall, within
30 days of its receipt, forward it to the competent authorities
of the other Member States.

2.

The notification shall contain:

(a) the information required in Annexes III and IV. This
information shall take into account the diversity of sites of
use of the GMO as or in a product and shall
include
information on data and results obtained from research
and developmental releases concerning the impact of the
release on human health and the environment;

(b) the environmental risk assessment and the conclusions

required in Annex II, section D;

(c) the conditions for the placing on the market of the
product, including specific conditions of use and handling;

(d) a proposed period for the consent which should not exceed

10 years;

(e) a plan for monitoring in accordance with Annex VII,
including a proposal for the time period of the monitoring
plan; this time period may be different from the proposed
period for the consent;

(f) a proposal for labelling which shall comply with the
requirements laid down in Annex IV. The labelling shall
clearly state that a GMO is present. The words ‘This
product contains genetically modified organisms’ shall
appear either on a label or in an accompanying document;

(g) a proposal for packaging which shall comprise the require-

ments laid down in Annex IV;

(h) a summary of the dossier. The format of the summary
shall be established in accordance with the procedure laid
down in Article 29(2).

3.
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 inside or outside the
Community.

The notifier may also refer to data or results from
4.
notifications previously submitted by other notifiers or submit
additional information he considers relevant, provided that the
information, data and results are non-confidential or these
notifiers have given their agreement in writing.

5.
In order for a GMO or combination of GMOs to be used
for a use different from that already specified in a notification,
a separate notification shall be submitted.

6.
If new information has become available with regard to
the risks of the GMO to human health or the environment,
before the written consent
the notifier shall
immediately take the measures necessary to protect human
health and the environment, and inform the competent
authority thereof. In addition, the notifier shall revise the
information and conditions specified in the notification.

is granted,

Article 13

Assessment report

On receipt and after acknowledgement of the notification
1.
in accordance with Article 12(2), the competent authority shall
examine it for compliance with this Directive.

2. Within 90 days after receipt of the notification the
competent authority shall:

— prepare an assessment report and send it to the notifier. A
subsequent withdrawal by the notifier shall be without
prejudice to any further submission of the notification to
another competent authority,

— in the case referred to in paragraph 3(a), send its report,
together with the information referred to in paragraph 4
and any other information on which it has based its report,
to the Commission which shall, within 30 days of its
receipt, forward it to the competent authorities of the
other Member States.

If on the basis of the results of any release notified under Part
B, or on other substantive, reasoned scientific grounds, a
notifier considers that the placing on the market and use of a
GMO as or in a product do not pose a risk to human health
and the environment, he may propose to the competent
authority not to provide part or all of the information required
in Annex IV, Section B.

In the case referred to paragraph 3(b) the competent authority
shall send its report, together with the information referred to
in paragraph 4 and any other information on which it has
based its report, to the Commission no earlier than 15 days
after sending the assessment report to the notifier and no later
than 105 days after receipt of the notification. The Commission
shall, within 30 days of its receipt, forward the report to the
competent authorities of the other Member States.

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3.

The assessment report shall indicate whether:

(a) the GMO(s) in question should be placed on the market

and under which conditions, or

(b) the GMO(s)
market.

in question should not be placed on the

The assessment reports shall be established in accordance with
the guidelines laid down in Annex VI.

For the purpose of calculating the 90-day period referred
4.
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 be taken into
account. The competent authority shall state the reasons in
any request for further information.

Article 14

Standard procedure

In the cases referred to in Article 13(3), a competent
1.
authority or the Commission may ask for further information,
make comments or present reasoned objections to the placing
on the market of the GMO(s) in question within a period of
60 days from the date of circulation of the assessment report.

Comments or reasoned objections and replies shall be for-
warded to the Commission which shall, immediately circulate
them to all competent authorities.

The competent authorities and the Commission may discuss
any outstanding issues with the aim of arriving at an agreement
within 105 days from the date of circulation of the assessment
report.

The consent shall be given for a maximum period of 10

4.
years.

Article 15

Criteria and information for specified GMOs

1.
A competent authority, or the Commission on its own
initiative, may make a proposal on criteria and information
requirements to be met
for the notification, by way of
derogation from Article 12 for placing on the market of
certain types of GMOs as or in products.

2.
These criteria and information requirements as well as
any appropriate requirements for a summary shall be adopted,
after consultation of the relevant scientific committee(s), in
accordance with the procedure laid down in Article 29(2). The
criteria and the information requirements shall be such as to
ensure a high level of safety to human health and the
environment and be based on the scientific evidence available
on such safety and on the experience gained with the release
of comparable GMOs.

The requirements set out in Article 12(2) shall be replaced by
those adopted above, and the procedure set out in Article
12(3), (4), (5) and (6) and Articles 13 and 14 shall apply.

Before the procedure laid down in Article 29(2) on a
3.
decision for criteria and information requirements referred to
in paragraph 1 is initiated, the Commission shall make the
proposal available to the public. The public may make
comments to the Commission within 60 days.

Article 16

Renewal of consent

Any periods of time during which further information from
the notifier is awaited shall not be taken into account for the
purpose of calculating the final 45-day period to arrive at an
agreement. Reasons shall be stated in any request for further
information.

1.
By way of derogation from Articles 12, 13 and 14, the
procedure set out in paragraphs 2 to 9 shall be applied to the
renewal of:

(a) consents granted under Part C, and

In the case referred to in Article 13(3)(b), if the competent
2.
authority which prepared the report decides that the GMO(s)
should not be placed on the market, the notification shall be
rejected. This decision shall state the reasons.

3.
If the competent authority which prepared the report
decides that the product may be placed on the market, in the
absence of any reasoned objection from a Member State or the
Commission within 60 days following the date of circulation
of the assessment report referred to in Article 13(3)(a) or if
outstanding issues are resolved within the 105-day period
referred to in paragraph 1, the competent authority which
prepared the report shall give consent in writing for placing
on the market, shall transmit it to the notifier and shall inform
the other Member States and the Commission thereof within
30 days.

(b) before

... (*) of

granted under Directive
90/220/EEC for placing on the market of GMOs as or in
products before ... (**)

consents

2.
At the latest nine months before the expiry of the
consent, for the consents referred to in paragraph 1(a), and
before ... (*), for the consents referred to in paragraph 1(b), the
notifier under this Article shall submit a notification, to the
competent authority which received the original notification,
which shall contain:

(a) a copy of the consent to the placing on the market of the

GMOs;

(*) Four years after the date referred to in Article 32.
(**) Date referred to in Article 32.

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(b) a report on the results of the monitoring which was carried
out according to Article 19. In the case of consents referred
to in paragraph 1(b) this report shall be submitted when
the monitoring was carried out;

(c) any other new information which has become available
with regard to the risks of the product to human health
and/or the environment; and,

(d) as appropriate, a proposal for amending or complementing
the conditions of
the
conditions concerning future monitoring and the time
limitation of the consent.

the original consent,

inter alia,

The competent authority shall acknowledge the date of receipt
of the notification and when the notification is in accordance
with this paragraph it shall without delay forward a copy of
the notification and its assessment report to the Commission,
which shall, within 30 days of their receipt, forward them to
the competent authorities of the other Member States. It shall
also send its assessment report to the notifier.

3.

The assessment report shall indicate whether:

(a) the GMO(s) should remain on the market and under which

conditions; or

(b) the GMO(s) should not remain on the market.

4.
The other competent authorities or the Commission may
ask for further information, make comments, or present
reasoned objections within a period of 60 days from the date
of circulation of the assessment report.

5.
All comments, reasoned objections and replies shall be
forwarded to the Commission which shall immediately circu-
late them to all competent authorities.

6.
In the case of paragraph 3(a) and in the absence of any
reasoned objection from a Member State or the Commission
within 60 days from the date of circulation of the assessment
report, the competent authority which prepared the report
shall transmit to the notifier the final decision in writing and
shall inform the other Member States and the Commission
thereof within 30 days. The validity of the consent may be
limited as appropriate.

The competent authorities and the Commission may
7.
discuss any outstanding issues with the aim of arriving at an
agreement within 75 days from the date of circulation of the
assessment report.

9.
Following a notification for the renewal of a consent in
accordance with paragraph 2, the notifier may continue to
place the GMOs on the market under the conditions specified
in that consent until a final decision has been taken on the
notification.

Article 17

Community procedure in case of objections

1.
In cases where an objection is raised and maintained by
a competent authority or the Commission in accordance with
Articles 14, 16 and 19 a decision shall be adopted and
published within 120 days in accordance with the procedure
laid down in Article 29(2). This decision shall contain the
same information as in Article 18(3).

For the purpose of calculating the 120-day period, any period
of time during which the Commission is awaiting further
information which it may have requested from the notifier or
is seeking the opinion of a scientific committee which has
been consulted in accordance with Article 27 shall not be
taken into account. The Commission shall state reasons in any
request for further information and inform the competent
authorities of its requests to the notifier. The period of time
during which the Commission is awaiting the opinion of the
scientific committee shall not exceed 90 days.

The period of time that the Council takes to act in accordance
with the procedure laid down in Article 29(2) shall not be
taken into account.

2. Where a favourable decision has been taken, the com-
petent authority which prepared the report shall give consent
in writing to the placing on the market or to the renewal of
the consent, shall transmit it to the notifier and shall inform
the other Member States and the Commission thereof within
30 days following the publication or notification of
the
decision.

Article 18

Consent

1. Without prejudice to requirements under other Com-
munity legislation, only if a written consent has been given for
the placing on the market of a GMO as or in a product may
that product 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 in these
conditions are strictly adhered to.

8.
If outstanding issues are resolved within the 75-day
period referred to in paragraph 7, the competent authority
which prepared the report shall transmit to the notifier its final
decision in writing and shall inform the other Member States
and the Commission thereof within 30 days. The validity of
the consent may be limited as appropriate.

The notifier may proceed with the placing on the market
2.
only when he has received the written consent of
the
competent authority in accordance with Articles 14, 16 and
17, and in conformity with any conditions required in that
consent.

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The written consent referred to in Articles 14, 16 and 17

3.
shall, in all cases, explicitly specify:

(a) the scope of the consent, including the identity of the
GMO(s) to be placed on the market as or in products, and
their unique identifier;

2.
If new information has become available, from the users
or other sources, with regards to the risks of the GMO(s) to
human health or the environment after the written consent,
the notifier shall immediately take the measures necessary to
protect human health and the environment, and inform the
competent authority thereof.

(b) the period of validity of the consent;

(c) the conditions for the placing on the market of the
product, including any specific condition of use, handling
and packaging of the GMO(s) as or in products, and
conditions for the protection of particular ecosystems/en-
vironments and/or geographical areas;

(d) that, without prejudice to Article 24, the notifier shall
make control samples available to the competent authority
on request;

(e) the labelling requirements, in compliance with the require-
ments laid down in Annex IV. The labelling shall clearly
state that a GMO is present. The words ‘This product
contains genetically modified organisms’ shall appear
either on a label or in a document accompanying the
product or other products containing the GMO(s);

(f) monitoring requirements in accordance with Annex VII,
including obligations to report to the Commission and
competent authorities, the time period of the monitoring
plan and, where appropriate, any obligations on any
person selling the product or any user of it.

In addition, the notifier shall revise the information and
conditions specified in the notification.

If

information becomes available to the competent
3.
authority which could have consequences for the risks of the
GMO(s) to the human health or the environment, or under the
circumstances described in paragraph 2, it shall immediately
forward the information to the Commission and the competent
authorities of the other Member States and may avail itself of
the provisions provided for in Articles 14(1) and 16(7) where
appropriate, when the information has become available
before the written consent.

When the information has become available after the consent
has been given, the competent authority shall, within 60 days
after receipt of the new information, forward its assessment
report indicating whether and how the conditions of the
consent should be amended or the consent should be termin-
ated to the Commission which shall, within 30 days of its
receipt, forward it to the competent authorities of the other
Member States.

4. Member States shall take all necessary measures to ensure
that the written consent and the decision referred to in
Article 17, where applicable, are made accessible to the public
and that the conditions specified in the written consent and
the decision, where applicable, are complied with.

Comments or reasoned objections to further placing on the
market of the GMO or on the proposal for amending the
conditions of the consent shall be forwarded, within 60 days
following the circulation of the assessment report, to the
immediately forward them to all
Commission which shall
competent authorities.

Article 19

Monitoring and handling of new information

The competent authorities and the Commission may discuss
any outstanding issues with the aim of arriving at an agreement
within 75 days from the date of circulation of the assessment
report.

1.
Following the placing on the market of a GMO as or in
a product, the notifier shall ensure that monitoring and
reporting on it are carried out according to the conditions
specified in the consent. The reports of this monitoring shall
be submitted to the Commission and the competent authorities
of the Member States. On the basis of these reports,
in
accordance with the consent and within the framework for the
the competent
monitoring plan specified in the consent,
authority which received the original notification may adapt
the monitoring plan after the first monitoring period.

In the absence of any reasoned objection from a Member State
or the Commission within 60 days following the date of
circulation of the new information or if outstanding issues are
resolved within 75 days,
the competent authority which
prepared the report shall amend the consent as proposed, shall
transmit the amended consent to the notifier and shall inform
the other Member States and the Commission thereof within
30 days.

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Article 20

Labelling

1. Member States shall take all necessary measures to ensure
that at all stages of the placing on the market, the labelling and
packaging of GMOs placed on the market as or in products
comply with the relevant requirements specified in the written
consent referred to in Articles 14(3), 16(5) and (8), 17(2) and
18(3).

2.
For products where adventitious or technically unavoid-
able traces of authorised GMOs cannot be excluded a minimum
threshold may be established below which these products
shall not have to be labelled according to the provision in
paragraph 1. The threshold levels shall be established accord-
ing to the product concerned, under the procedure laid down
in Article 29(2).

Article 21

Free circulation

Without prejudice to Article 22 Member States may not
prohibit, restrict or impede the placing on the market of
GMOs, as or in products, which comply with the requirements
of this Directive.

Article 22

Safeguard clause

1. Where a Member State, as a result of new or additional
information made available since the date of the consent and
affecting the environmental risk assessment or reassessment of
existing information on the basis of new or additional scientific
knowledge, has detailed grounds for considering that a GMO
as or in a product which has been properly notified and has
received written consent under this Directive constitutes a risk
to human health or the environment, that Member State may
provisionally restrict or prohibit the use and/or sale of that
GMO as or in a product on its territory.

The Member State shall ensure that in the event of a severe
risk, emergency measures, such as suspension or termination
of the placing on the market, shall be applied,
including
information to the public.

The Member State shall immediately inform the Commission
and the other Member States of actions taken under this Article
and give reasons for its decision, supplying its reassessment of
the environmental risk assessment, indicating whether and
how the conditions of the consent should be amended or the
consent should be terminated, and, where appropriate, the
new or additional information on which its decision is based.

2.
A decision shall be taken on the matter within 60 days
in accordance with the procedure laid down in Article 29(2).
For the purpose of calculating the 60-day period, any period
of time during which the Commission is awaiting further
information which it may have requested from the notifier or
is seeking the opinion of scientific committee(s) which have
been consulted shall not be taken into account. The period of
time during which the Commission is awaiting the opinion of
the scientific committee(s) consulted shall not exceed 60 days.

Likewise, the period of time the Council takes to act in
accordance with the procedure laid down in Article 29(2) shall
not be taken into account.

Article 23

Information to the public

1. Without prejudice to Article 24, upon receipt of a
notification in accordance with Article 12(1), the Commission
shall immediately make available to the public the summary
referred to in Article 12(2)(h). The Commission shall also
make available to the public assessment reports in the case
referred to in Article 13(3)(a). The public may make comments
to the Commission within 30 days. The Commission shall
immediately forward the comments to the competent auth-
orities.

2. Without prejudice to Article 24, for all GMOs which
have received written consent for the placing on the market or
whose placing on the market was rejected as or in products
under this Directive, the assessment reports carried out for
these GMOs and the opinion(s) of the scientific committees
consulted shall be made available to the public. For each
product, the GMO or GMOs contained therein and the use or
uses shall be clearly specified.

PART D

FINAL PROVISIONS

Article 24

Confidentiality

1.
The Commission and the competent authorities shall not
divulge to third parties any confidential information notified
or exchanged under this Directive and shall protect intellectual
property rights relating to the data received.

2.
The notifier may indicate the information in the notifi-
cation submitted under this Directive, the disclosure of which
might harm his competitive position, that should therefore be
treated as confidential. Verifiable justification must be given in
such cases.

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3.
The competent authority shall decide, after consultation
with the notifier, which information will be kept confidential
and shall inform the notifier of its decisions.

Article 27

Consultation of scientific committee(s)

4.
In no case may the following information when sub-
mitted according to Articles 5, 6, 7, 12, 16, 19 or 22 be kept
confidential:

— general description of the GMO or GMOs, name and
address of the notifier, purpose of the release, location of
release and intended uses,

— methods and plans for monitoring of the GMO or GMOs

and for emergency response,

— the environmental risk assessment.

In cases where an objection as regards the risk of GMOs
1.
to human health or to the environment
is raised by a
competent authority or the Commission and maintained in
accordance with Articles 14(1), 16(4), 19(3) or 22, or where
the assessment report referred to in Article 13 indicates that
the GMO should not be placed on the market, the relevant
scientific committee(s) shall be consulted by the Commission,
on its own initiative or at the request of a Member State, on
the objection.

2.
The relevant scientific committee(s) may also be con-
sulted by the Commission, on its own initiative or at the
request of a Member State on any matter under this Directive
that may have an adverse effect on human health and the
environment.

If,

5.
for whatever reasons, the notifier withdraws the
notification, the competent authorities and the Commission
must respect the confidentiality of the information supplied.

The administrative procedures laid down in this Directive

3.
shall not be affected by paragraph 2.

Article 25

Article 28

Consultation of Committee(s) on Ethics

Labelling of GMOs referred to in Article 2(4), second
subparagraph

1.
The GMOs to be made available for operations referred
to under Article 2(4), second subparagraph shall be subject to
adequate labelling requirements in accordance with the rel-
evant sections of Annex IV in order to provide for clear
information, on a label or in accompanying document, on the
presence of genetically modified organisms. To that effect the
words ‘This product contains genetically modified organisms’
shall appear either on a label or in an accompanying document.

2.
The conditions for the implementation of paragraph 1,
without duplicating or creating inconsistencies with existing
labelling provisions laid down in existing Community legis-
lation, shall be determined in accordance with the procedure
laid down in Article 29(2). In doing so, account should be
taken, as appropriate, of labelling provisions established by
Member States in accordance with Community legislation.

Article 26

Adaptation of Annexes to technical progress

Sections C and D of Annex II, Annexes III to VI, and section C
of Annex VII shall be adapted to technical progress in accord-
ance with the procedure laid down in Article 29(2).

1. Without prejudice to the competence of Member States
as regards ethical issues, the Commission, on its own initiative
or at the request of the European Parliament or the Council,
shall consult any committee it has created with a view to
obtaining its advice on the ethical implications of biotechno-
logy, such as the European Group on ethics in science and
new technologies, on ethical issues of a general nature.

This consultation may also take place at the request of a
Member State.

The administrative procedures provided for in this

2.
Directive shall not be affected by paragraph 1.

Article 29

Committee procedure

The Commission shall be assisted by a committee,

1.
hereinafter referred to as the ‘committee’.

2. Where reference is made to this paragraph, Articles 5
and 7 of Decision 1999/468/EC shall apply, having regard to
the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

3.

The committee shall adopt its own rules of procedure.

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Article 30

(d) socioeconomic implications of deliberate releases and

placing on the market of GMOs.

Exchange of information and reporting

1. Member States and the Commission shall meet regularly
and exchange information on the experience acquired with
regard to the prevention of risks related to the release and the
placing on the market of GMOs. This information exchange
shall also cover experience gained with the implementation of
Article 2(4), second subparagraph, environmental risk assess-
ment, monitoring and the issue of consultation and infor-
mation of the public.

7.
The Commission shall send to the European Parliament
and the Council, every year, a report on the ethical issues
referred to in Article 28(1); this report may be accompanied, if
appropriate, by a proposal with a view to amending this
Directive.

Article 31

Penalties

Where necessary, guidance on the
implementation of
Article 2(4), second subparagraph may be provided by the
committee established under Article 29(1).

Member States shall determine the penalties applicable to
breaches of the national provisions adopted pursuant to this
Directive. Those penalties shall be effective, proportionate and
dissuasive.

2.
The Commission shall establish one or several register(s)
for the purpose of recording the information on genetic
modifications in GMOs mentioned in point A.7 of Annex IV.
Without prejudice to Article 24 the register(s) shall include a
part which is accessible to the public. The detailed arrange-
ments for the operation of the register(s) shall be decided in
accordance with the procedure laid down in Article 29(2).

3.
Every three years. Member States shall send the Com-
mission a report on the measures taken to implement the
provisions of this Directive. This report shall include a brief
factual report on their experience with GMOs placed on the
market in or as products under this Directive.

Every three years,

4.
summary based on the reports referred to in paragraph 3.

the Commission shall publish a

The Commission shall send to the European Parliament
5.
and the Council, in 2003 and thereafter every three years, a
report on the experience of Member States with GMOs placed
on the market under this Directive.

6. When submitting this report in 2003 the Commission
shall at the same time submit a specific report on the operation
of Part B and Part C including an assessment of:

(a) all

its implications, particularly to take account of the
diversity of European ecosystems and the need to comp-
lement the regulatory framework in this field;

(b) the feasibility of various options to improve further the
consistency and efficiency of this framework, including a
centralised Community authorisation procedure and the
arrangements for the final decision-making by the Com-
mission;

(c) whether sufficient experience has accumulated on the
implementation of Part B differentiated procedures to
justify a provision on implicit consent in these procedures
and on Part C to justify the application of differentiated
procedures; and

Article 32

Transposition

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by ... (*). They shall forthwith inform the Commission
thereof.

When Member States adopt these measures they shall contain
a reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. The
methods of making such a reference shall be laid down by the
Member States.

2. Member States shall communicate to the Commission
the texts of the main provisions of domestic law which they
adopt in the field covered by this Directive.

Article 33

Pending notifications

1.
Notifications concerning placing on the market of GMOs
as or in products received pursuant to Directive 90/220/EEC
and in respect of which the procedures of that Directive have
not been completed by ... (*) shall be subject to the provisions
of this Directive.

By ... (**) notifiers shall have completed their notification

2.
in accordance with this Directive.

Article 34

Repeal

1.

Directive 90/220/EEC shall be repealed on ... (***).

(*) 18 months after the entry into force of this Directive.
(**) 21 months after the entry into force of this Directive.
(***) Date referred to in Article 32.

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2.
References made to the repealed Directive shall be
construed as being made to this Directive and should be read
in accordance with the correlation table in Annex VIII.

Article 36

This Directive is addressed to the Member States.

Article 35

Done at ...,

This Directive shall enter into force on the day of its publication
in the Official Journal of the European Communities.

For the European Parliament

For the Council

The President

The President

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ANNEX I A

TECHNIQUES REFERRED TO IN ARTICLE 2(2)

PART 1

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

1.

2.

3.

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

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

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

PART 2

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

1.

in-vitro fertilisation;

2. natural processes such as: conjugation, transduction, transformation;

3. polyploidy induction.

ANNEX I B

TECHNIQUES REFERRED TO IN ARTICLE 3

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

1. mutagenesis;

2.

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

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ANNEX II

PRINCIPLES FOR THE ENVIRONMENTAL RISK ASSESSMENT

This Annex describes in general terms the objective to be achieved, the elements to be considered and the general
principles and methodology to be followed to perform the environmental risk assessment (ERA) referred to in
Articles 4 and 12. It will be supplemented by guidance notes to be developed in accordance with the procedure laid
down in Article 29(2). These guidance notes shall be completed by ... (*).

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

— ‘direct effects’ refers to primary effects on human health or the environment which are a result of the GMO itself

and which do not occur through a causal chain of events,

— ‘indirect effects’ refers to effects on human health or the environment occurring through a causal chain of events,
through mechanisms such as interaction with other organisms, transfer of genetic material, or changes in use or
management. Observations of indirect effects are likely to be delayed,

— ‘immediate effects’ refers to effects on human health or the environment which are observed during the period

of the release of the GMO. Immediate effects may be direct or indirect,

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

A. OBJECTIVE

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

B. GENERAL PRINCIPLES

In accordance with the precautionary principle, the following general principles should be followed when
performing the ERA:

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

— the ERA should be carried out in a scientifically sound and transparent manner based on available scientific

and technical data,

— the ERA should be carried out on a case by case basis, meaning that the required information may vary
depending on the type of the GMO’s concerned, their intended use and the potential receiving environment,
taking into account, inter alia, GMOs already in the environment,

— if new information on the GMO and its effects on human health or the environment becomes available, the

ERA may need to be re-addressed in order to:

— determine whether the risk has changed,

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

(*) Date referred to in Article 32.

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C. METHODOLOGY

C.1. Characteristics of GMOs and releases

Depending on the case the ERA has to take into account the relevant technical and scientific details regarding
characteristics of:

— the recipient or parental organism(s),

— the genetic modification(s), be it inclusion or deletion of genetic material, and relevant information on the

vector and the donor,

— the GMO,

— the intended release or use including its scale,

— the potential receiving environment, and

— the interaction between these.

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

C.2. Steps in the ERA

In drawing conclusions for the ERA referred to in Articles 4, 5, 6 and 12 the following points should be
addressed:

1.

Identification of characteristics which may cause adverse effects:

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

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

— disease to humans including allergenic or toxic effects (see e.g. points II.A.11 and II.C.2(i) in Annex IIIA,

and B.7 in Annex IIIB),

— disease to animals and plants including toxic, and where appropriate, allergenic effects (see e.g. points

II.A.11 and II.C.2(i) in Annex IIIA, and B.7 and D.8 in Annex IIIB),

— effects on the dynamics of populations of species in the receiving environment and the genetic diversity

of each of these populations (see e.g. points IV.B.8, 9 and 12 in Annex IIIA),

— altered susceptibility to pathogens facilitating the dissemination of infectious diseases and/or creating

new reservoirs or vectors,

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

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— effects on biogeochemistry (biogeochemical cycles), particularly carbon and nitrogen recycling through
changes in soil decomposition of organic material (see e.g. points II.A.11(f) and IV.B.15 in Annex IIIA,
and D.11 in Annex IIIB).

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

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

— the transfer of the inserted genetic material to other organisms, or the same organism whether genetically

modified or not,

— phenotypic and genetic instability,

— interactions with other organisms,

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

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

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

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

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

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

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

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

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

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

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

D. CONCLUSIONS ON THE POTENTIAL ENVIRONMENTAL IMPACT FROM THE RELEASE OR THE PLACING

ON THE MARKET OF GMOS

On the basis of an ERA carried out in accordance with the principles and methodology outlined in sections B
and C, information on the points listed in sections D.1 or D.2 should be included, as appropriate, in notifications
with a view to assisting in drawing conclusions on the potential environmental impact from the release or the
placing on the market of GMOs:

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

1. Likelihood of the GMO to become persistent and invasive in natural habitats under the conditions of the

proposed release(s).

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2. Any selective advantage or disadvantage conferred to the GMO and the likelihood of this becoming realised

under the conditions of the proposed release(s).

3. Potential for gene transfer to other species under conditions of the proposed release of the GMO and any

selective advantage or disadvantage conferred to those species.

4. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the

GMO and target organisms (if applicable)

5. Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the
including impact on population levels of competitors, prey, hosts,

GMO with non-target organisms,
symbionts, predators, parasites and pathogens.

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

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

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

9. Possible immediate and/or delayed, direct and indirect environmental impacts of the specific techniques used

for the management of the GMO where these are different from those used for non-GMOs.

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

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

habitats or more invasive in natural habitats.

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

3. Potential for gene transfer to the same or other sexually compatible plant species under conditions of

planting the GMHP and any selective advantage or disadvantage conferred to those plant species

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

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

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

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

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

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

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ANNEX III

INFORMATION REQUIRED IN THE NOTIFICATION

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

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

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

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

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

Annex IIIA applies to releases of all types of genetically modified organisms other than higher plants. Annex IIIB
applies to release of genetically modified higher plants.

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

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ANNEX III A

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

I. GENERAL INFORMATION

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

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

C. Title of the project

II.

INFORMATION RELATING TO THE GMO

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

1. scientific name;

2. taxonomy;

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

4. phenotypic and genetic markers;

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

6. description of identification and detection techniques;

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

8. description of the geographic distribution and of the natural habitat of the organism including

information on natural predators, preys, parasites and competitors, symbionts and hosts;

9. organisms with which transfer of genetic material is known to occur under natural conditions;

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

11. pathological, ecological and physiological traits:

(a) classification of hazard according to existing Community rules concerning the protection of human

health and/or the environment;

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

(c)

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

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

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

prophylaxis and therapy;

(f)

involvement in environmental process: primary production, nutrient turnover, decomposition of
organic matter, respiration, etc.

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12. Nature of indigenous vectors:

(a)

sequence;

(b)

frequency of mobilisation;

(c)

specificity;

(d) presence of genes which confer resistance.

13. History of previous genetic modifications.

B. Characteristics of the vector:

1. nature and source of the vector;

2.

3.

4.

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

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

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

C. Characteristics of the modified organism:

1.

Information relating to the genetic modification:

(a) methods used for the modification;

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

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

(d) purity of the insert from any unknown sequence and information on the degree to which the

inserted sequence is limited to the DNA required to perform the intended function;

(e) methods and criteria used for selection;

(f)

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

2.

Information on the final GMO:

(a) description of genetic trait(s) or phenotypic characteristics and in particular any new traits and

characteristics which may be expressed or no longer expressed;

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

of the modified organism;

(c)

stability of the organism in terms of genetic traits;

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

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

(f) description of identification and detection techniques including techniques for the identification and

detection of the inserted sequence and vector;

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

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

(i)

considerations for human health and animal health, as well as plant health:

(i)

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

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

organism regarding pathogenicity;

(iii) capacity for colonisation;

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

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

— communicability,

— infective dose,

— host range, possibility of alteration,

— possibility of survival outside of human host,

— presence of vectors or means of dissemination,

— biological stability,

— antibiotic-resistance patterns,

— allergenicity,

— availability of appropriate therapies.

(v) other product hazards.

III.

INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT

A.

Information on the release:

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

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

releases;

3. preparation of the site previous to the release;

4. size of the site;

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

6. quantities of GMOs to be released;

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

8. worker protection measures taken during the release;

9. post-release treatment of the site;

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

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

different ecosystems.

B.

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

1. geographical location and grid reference of the site(s) (in case of notifications under Part C the site(s) of

release will be the foreseen areas of use of the product);

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

3. proximity to significant biotopes, protected areas, or drinking water supplies;

4.

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

5. geographical, geological and pedological characteristics;

6.

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

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

8.

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

9.

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

IV.

INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GMOS AND THE ENVIRONMENT

A. Characteristics affecting survival, multiplication and dissemination:

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

2. known or predicted environmental conditions which may affect survival, multiplication and dissemi-

nation (wind, water, soil, temperature, pH, etc.);

3.

sensitivity to specific agents.

B.

Interactions with the environment:

1. predicted habitat of the GMOs;

2. studies of the behaviour and characteristics of the GMOs and their ecological impact carried out in

simulated natural environments, such as microcosms, growth rooms, greenhouses;

3. genetic transfer capability:

(a) 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/of undesirable traits in

the modified organism;

5. measures employed to ensure and to verify genetic stability. Description of genetic traits which may

prevent or minimise dispersal of genetic material; methods to verify genetic stability;

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6. routes of biological dispersal, known or potential modes of interaction with the disseminating agent,

including inhalation, ingestion, surface contact, burrowing, etc.;

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

8. potential for excessive population increase in the environment;

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

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

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

if applicable;

12. identification and description of non-target organisms which may be adversely affected by the release of

the GMO, and the anticipated mechanisms of any identified adverse interaction;

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

14. known or predicted interactions with non-target organisms in the environment, including competitors,

preys, hosts, symbionts, predators, parasites and pathogens;

15. known or predicted involvement in biogeochemical processes;

16. other potential interactions with the environment.

V.

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

A. Monitoring techniques:

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

2.

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

3.

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

4. duration and frequency of the monitoring.

B. Control of the release:

1. methods and procedures to avoid and/or minimise the spread of the GMOs beyond the site of release or

the designated area for use;

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

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

C. Waste treatment:

1.

type of waste generated;

2.

expected amount of waste;

3. description of treatment envisaged.

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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, soils, etc. that were exposed during or after the

spread;

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

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

effect.

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ANNEX III B

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

A. GENERAL INFORMATION

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

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

3. Title of the project.

B.

INFORMATION RELATING TO (A) THE RECIPIENT OR (B) (WHERE APPROPRIATE) PARENTAL PLANTS

1. Complete name:

(a)

family name;

(b) genus;

(c)

species;

(d) subspecies;

(e) cultivar/breeding line;

(f)

common name.

2.

(a)

Information concerning reproduction:

(i) mode(s) of reproduction;

(ii) specific factors affecting reproduction, if any;

(iii) generation time.

(b) Sexual compatibility with other cultivated or wild plant species, including the distribution in Europe of

the compatible species.

3. Survivability:

(a) ability to form structures for survival or dormancy;

(b) specific factors affecting survivability, if any.

4. Dissemination:

(a) ways and extent (e.g. an estimation of how viable pollen and/or seeds decline(s) with distance) of

dissemination;

(b) specific factors affecting dissemination, if any.

5. Geographical distribution of the plant.

6.

In the case of plant species not normally grown in the Member State(s), description of the natural habitat of
the plant, including information on natural predators, parasites, competitors and symbionts.

7. Other potential interactions, relevant to the GMO, of the plant with organisms in the ecosystem where it is
usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

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C.

INFORMATION RELATING TO THE GENETIC MODIFICATION

1. Description of the methods used for the genetic modification.

2. Nature and source of the vector used.

3. Size, source (name) of donor organism(s) and intended function of each constituent fragment of the region

intended for insertion.

D.

INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT

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

2. Information on the sequences actually inserted/deleted:

(a) size and structure of the insert and methods used for its characterisation, including information on any
parts of the vector introduced in the GMHP or any carrier or foreign DNA remaining in the GMHP;

(b)

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

(c) copy number of the insert;

(d)

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

3. Information on the expression of the insert:

(a)

information on the developmental expression of the insert during the lifecycle of the plant and methods
used for its characterisation;

(b) parts of the plant where the insert is expressed (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 and phenotypic stability of the GMHP.

6. Any change to the ability of the GMHP to transfer genetic material to other organisms.

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

modification.

8. Information on the safety of the GMHP to animal health, particularity regarding any toxic, allergenic or
other harmful effects arising from the genetic modification, where the GMHP is intended to be used in
animal feedstuffs.

9. Mechanism of interaction between the genetically modified plant and target organisms (if applicable).

10. Potential changes in the interactions of the GMHP with non-target organisms resulting from the genetic

modification.

11. Potential interactions with the abiotic environment.

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12. Description of detection and identification techniques for the genetically modified plant.

13. Information about previous releases of the genetically modified plant, if applicable.

E.

INFORMATION RELATING TO THE SITE OF RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT
TO ARTICLES 5 AND 6)

1. Location and size of the release site(s).

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

3. Presence of sexually compatible wild relatives or cultivated plant species.

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

F.

INFORMATION RELATING TO THE RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO
ARTICLES 5 AND 6)

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 m2).

G.

INFORMATION ON CONTROL, MONITORING, POST-RELEASE AND WASTE TREATMENT PLANS (ONLY
FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 5 AND 6)

1. Any precautions taken:

(a) distance(s) from sexually compatible plant species, both wild relatives and crops

(b) any measures to minimise/prevent dispersal of any reproductive organ of the GMHP (e.g. pollen, seeds,

tuber).

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.

6. Methods and procedures to protect the site.

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ANNEX IV

ADDITIONAL INFORMATION

This Annex describes in general terms the additional information to be provided in the case of notification for
placing on the market and information for labelling requirements regarding GMOs as or in product to be placed on
the market, and GMO exempted under Article 2(4), second subparagraph. It will be supplemented by guidance notes,
as regards, inter alia, the description of how the product is intended to be used, to be developed in accordance with
the procedure laid down in Article 29(2). The labelling of exempted organisms as required by Article 25 shall be met
by providing appropriate recommendations for, and restrictions on, use:

A. The following information shall be provided in the notification for placing on the market of GMOs as or in

product in addition to that of Annex III:

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

2. name and full address of the person established in the Community who is responsible for the placing on the

market, whether it be the manufacturer, the importer or the distributor;

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

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

5. description of the geographical area(s) and types of environment where the product is intended to be used

within the Community, including where possible, estimated scale of use in each area;

6.

7.

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

information on the genetic modification for the purposes of placing on one or several registers modifications
in organisms, which can be used for the detection and identification of particular GMO products to facilitate
post-marketing control and inspection. This information should include where appropriate the lodging of
samples of the GMO or its genetic material, with the competent authority and details of nucleotide sequences
or other type of information which is necessary to identify the GMO product and its progeny, e.g. the
methodology for detecting and identifying the GMO product, including experimental data demonstrating
the specificity of the methodology. Information that cannot be placed, for confidentiality reasons, in the
publicly accessible part of the register should be identified;

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

B. The following information shall be provided in the notification, when relevant, in addition to that of point A, in

accordance with Article 12 of this Directive:

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

2.

specific instructions or recommendations for storage and handling;

3.

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

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

what purposes;

5. proposed packaging;

6.

estimated production in and/or imports to the Community;

7. proposed additional labelling. This may include, at least in summarised form, the information referred to in

points A.4, A.5, B.1, B.2, B.3 and B.4.

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ANNEX V

CRITERIA FOR THE APPLICATION OF DIFFERENTIATED PROCEDURES (ARTICLE 6)

The criteria referred to in Article 6(1) are set out below.

1. The taxonomic status and the biology (e. g. mode of reproduction and pollination, ability to cross with related

species, pathogenecity) of the non-modified (recipient) organism shall be well-known.

2. There shall be sufficient knowledge about the safety for human health and the environment of the parental,

where appropriate, and recipient organisms in the environment of the release.

3.

4.

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

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

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

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ANNEX VI

GUIDELINES FOR THE ASSESSMENT REPORTS

The assessment report provided for by Articles 12, 16, 18 and 19 should include in particular the following:

1.

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

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

3. Assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating

any risks to human health and the environment.

4.

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

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

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ANNEX VII

MONITORING PLAN

This Annex describes in general terms the objective to be achieved and the general principles to be followed to design
the monitoring plan referred to in Articles 12(2), 18(3) and 19. It will be supplemented by guidance notes to be
developed in accordance with the procedure laid down in Article 29(2).

These guidance notes shall be completed by ... (*).

A. OBJECTIVE

The objective of a monitoring plan is to:

— confirm that any assumption regarding the occurrence and impact of potential adverse effects of the GMO

or its use in the ERA are correct, and

— identify the occurrence of adverse effects of the GMO or its use on human health or the environment which

were not anticipated in the ERA.

B. GENERAL PRINCIPLES

Monitoring, as referred to in Articles 12, 18 and 19, takes place after the consent to the placing of a GMO on
the market.

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

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

C. DESIGN OF THE MONITORING PLAN

The design of the monitoring plan should:

1. be detailed on a case basis by case taking into account the ERA;

2.

3.

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

incorporate general surveillance for unanticipated adverse effects and, if necessary, (case-) specific monitoring
focusing on adverse effects identified in the ERA;

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

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

(*) Date referred to in Article 32.

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4.

5.

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

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

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

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ANNEX VIII

CORRELATION TABLE

Directive 90/220/EEC

This Directive

Article 1(1)
Article 1(2)
Article 2
Article 3
Article 4
Article 5

Article 6(1) to (4)

}

Article 6(5)
Article 6(6)
Article 7
Article 8
Article 9
Article 10(2)
Article 11
Article 12(1) to (3) and (5)
—
—
—
—
Article 13(5) and (6)
Article 12(4)
Article 14
Article 15
Article 16
—
Article 19
—
Article 20
—
—
Article 21
Article 22
Article 18(2)
Article 18(3)
—
Article 23
—
—
—
Article 24
Annex IA
Annex IB
—
Annex II
—
Annex III
—
—
—

Article 1
Article 3(2)
Article 2
Article 3(1)
Article 4
Article 5

Article 6
Article 7
Article 8
Article 9
Article 10
Article 11
Article 12
Article 13
Article 14
Article 15
Article 16
Article 17
Article 18(1) and (4)
Article 19(3)
Article 20
Article 21
Article 22
Article 23
Article 24
Article 25
Article 26
Article 27
Article 28
Article 29
Article 30(1)(3) and (4)
Article 30(5)
Article 30(6)
Article 31
Article 32
Article 33
Article 34
Article 35
Article 36
Annex IA
Annex IB
Annex II
Annex IIIA
Annex IIIB
Annex IV
Annex V
Annex VI
Annex VII

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STATEMENT OF THE COUNCIL’S REASONS

I.

INTRODUCTION

1. On 24 February 1998 the Commission submitted to the Council a proposal for a directive based
on Article 100a (Article 95 of the Amsterdam Treaty) of the EC Treaty and amending Directive
90/220/EEC.

2. The European Parliament and the Economic and Social Committee delivered their opinions on

11 February 1999 and 9 September 1998 respectively.

3. Following the European Parliament’s opinion, the Commission submitted its amended proposal

to the Council on 29 March 1999.

4. On 9 December 1999 the Council adopted its common position in accordance with Article 251

of the Treaty.

II. OBJECTIVE

The proposal seeks to revise Directive 90/220/EEC in the light of the experience gained and the
evaluation of scientific knowledge so as to ensure the setting up of a suitable regulatory framework
to cover the potential environmental and health risks of the release of genetically modified organisms
(GMOs) in the environment. The revision would also take account of the need to avoid imposing
over-long procedures or excessive administrative formalities on the sector in question.

III. ANALYSIS OF THE COMMON POSITION

In line with the objective described in point II, the Council’s common position has adopted, verbatim,
partially or in substance, 38 of the 39 European Parliament amendments included by the Commission
in its amended proposal, together with a large number of amendments that the Commission did not
include.

A. AMENDMENT NOT TAKEN UP BY THE COUNCIL

Amendment 16 which sought to define the term ‘use’ was not accepted in so far as this term was
used in its ordinary sense in the common position.

B. CHANGES MADE BY THE COUNCIL TO THE AMENDED PROPOSAL

Given that most of the provisions of Directive 90/220/EEC,
including its Annexes, had been
substantially amended by the common position, it was thought preferable, for reasons of clarity and
transparency vis-à-vis both the general public and the national administrations, to recast that Directive
and to put forward a consolidated directive. Annex VIII to the common position shows by way of
illustration the correspondence between the provisions of the old and the new Directive.

Apart from the incorporation of most of the recitals of Directive 90/220/EEC, and the structural
changes inherent in this presentation in consolidated form, the Council’s main changes are described
in points 1 to 6 below (unless otherwise indicated, the references in italics are to the common
position).

Generally speaking, the procedural time limits in the proposal have been extended so that further
information can be supplied and the information itself can be processed more effectively. In most
cases information is communicated via the Commission and no longer from a competent authority
to the Commission and the other competent authorities.

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1. Scope

Although the scope envisaged by the Council and the scope proposed by the Commission are very
similar, it was thought necessary:

— to make a clearer distinction between activities regulated by Part B of the Directive (first indent of

Article 1) and those covered by Part C (second indent);

— to regroup the exceptions (Article 1(2) and Article 3 of the proposal) in a single Article (Article 3);

— to ensure consistency between this Directive and Directive 90/219/EEC on the contained use of

micro-organisms as amended by Directive 98/81/EC: hence the amendment of Article 2(3);

— to clarify the definition of ‘placing on the market’ (Article 2(4)) to ensure that it did not apply to
the supplying of GMOs for activities regulated under Directive 90/219/EEC or subject to similar
containment measures, or for research and development activities covered by Part B of Directive
90/220/EEC. The definition thus takes account of Amendment 13.

In the interests of transparency, all GMOs supplied in this way will be appropriately labelled
(Article 25). It is also specified that placing on the market is not confined to the supply of GMOs
in return for payment;

— for the reference to the exception of ‘human beings’ to be included in the definition of GMO
(Article 2(2)) rather than in the definition of organism, where it seemed somewhat illogical.

In view of the questions of interpretation that could arise in practice, provision is made (second
subparagraph of Article 30(1)) to enable the regulatory committee (Article 29) set up by the Directive to
provide guidance on the implementation of these definitions.

2. General obligations

The Council has accepted (Article 4(1)) the reference to the precautionary principle suggested by the
European Parliament in Amendment 17 and it has sought to give operational effect to the substance
of Amendment 90 concerning genes conferring resistance to antibiotics (see also Annex II point C.2).
The Council has also included (Article 4(5)) the obligation to ensure the traceability of GMOs
(Amendment 92), with a stipulation that it must be ensured at all stages in the placing of GMOs on
the market (see also Article 30(2) and Annex IV).

Regarding Amendments 19 and 21 on GMO exports, the Council intends, at a later stage in the
revision of the Directive, to consider the implications for exports of the outcome of the negotiations
on the protocol on biosafety.

3. Deliberate release of GMOs for any purpose other than placing them on the market

(Part B)

The Council has accepted Amendment 22, taking the view that there was no need to exempt products
under development from the requirements of this part. It also thought the distinction between two
categories (I and II) of deliberate release as proposed by the Commission complicated the procedures
without any gain in terms of health and environmental protection. Likewise, and in line with
Amendment 28, the introduction of a third procedure (Article 6c of the proposal) for releases effected
in several Member States seemed to add nothing to a notification submitted simultaneously to those
Member States under the standard procedure (Article 5). Articles 5, 6 and 6c of the proposal have
thus been deleted.

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Essentially, Article 5 reproduces Article 6b of the proposal, specifying among other things that
(paragraph 2(b)) the environmental risk assessment is to be included in the notification and that
(paragraph 4) several releases may be covered by the same notification, and, in the line with the
principle of Amendment 27, placing a time limit on public inquiries and consultations (paragraph
6(b)).

With regard to the differentiated procedures, Article 6 combines Article 6a of the proposal and
Article 6(5) of Directive 90/220/EEC and reinforces (more information on the genetic modification
(paragraph 4), deletion of the criterion based on similarity to other releases (Part B of Annex V to the
proposal)) the criteria of Annex V for the application of these procedures. Also, it will be necessary for
the public and the relevant scientific committees to be consulted on any proposals for drawing up
differentiated procedures (paragraph 2) before the committee set up by Article 29 takes a decision on
them. Paragraph 5 stipulates that these procedures must provide that releases may only be made once
the competent authority has given its written consent. Decision 94/730/EC, which established such a
procedure under Directive 90/220/EEC, will be replaced by a decision based on Article 6 and will have
a similar content.

Since each Member State remains free to choose whether or not to use these procedures, it will have
to inform the Commission of its intentions in this regard (paragraph 7).

Article 8 (1) underlines that it is compulsory (and no longer simply a matter of what is possible) for
the public to be consulted, while it is left to the Member States (and no longer to a committee) to lay
down the arrangements for such consultation.

4. Placing on the market of GMOs (Part C)

Article 11 (sectoral legislation) has reinforced (paragraph 1) the conditions under which Part C does
not apply to GMOs authorised by other Community legislation by imposing a requirement of
equivalence not only as regards the environmental risk assessment but also as regards risk
management, labelling, monitoring, information to the public and the safeguard clause. As regards
medicinal products (paragraph 2), however, it was thought sufficient to restrict this condition to the
environmental risk assessment in view of the specific nature of the authorisation and monitoring
procedures laid down for such products in Regulation (EEC) No 2309/93. Procedures to ensure
equivalence will have to be laid down in a regulation of the European Parliament and the Council
(paragraph 3).

The Council considered that, in the light of the available experience, there was no justification for
introducing the simplified procedure in Article 13b of the proposal at the risk of undermining the
protection of human health and the environment. That Article has therefore been deleted. However,
in Article 15 the possibility of introducing different information requirements from those laid down
in the notification procedure (Article 12(2)) has been accepted on the understanding that the rest of
the standard procedure, in particular Articles 13 and 14, will apply.

As to the period of validity of consents, the Council has followed the approach advocated by the
European Parliament in several of its amendments, namely that a time limit should be imposed only
in the case of the original consent and that it should be considerably longer than the one proposed
by the Commission (seven years). By analogy with the limits laid down in other acts of Community
legislation, the Council decided on 10 years. Likewise, in the case of labelling the Council supports
the Parliament’s position in favour of clear and unambiguous labelling and has used the wording ‘This
product contains genetically modified organisms’ in Articles 12(2), 18(3) and 25(1).

(1) The Commission did not propose any amendment to Article 7 or Article 8 of Directive 90/220/EEC. These
Articles were, however, the subject of European Parliament Amendments 32 and 33, which were incorporated
into the amended proposal and the common position.

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Also, as regards the standard procedure (Articles 12 to 14):

— the competent authority must first ensure that the notification is in accordance with the
requirements concerning the information to be sent to the Commission (Article 12(1)); the sending
of such information must in any case occur not later than the submission of the assessment
report;

— the notification must propose a period not exceeding 10 years (paragraph 2(d));

— paragraph 6 reproduces paragraph 4 of Article 13e in so far as that paragraph also concerns

information available before written consent is granted;

— in Article 13 (assessment report) the common position clarifies (paragraph 2, first indent) the
consequences of the notifier’s withdrawal of his notification and stipulates (paragraph 2, second
subparagraph) that the procedure does not stop at this stage even if the competent authority that
prepared the report has issued a negative opinion as to placing on the market. In that case, a
GMO cannot be placed on the market if the competent authority confirms its original negative
opinion (Article 14(2));

— in Article 13(3) the Council took the view that only two options had to be considered (whether a
GMO was to be placed on the market or not) and that it was not necessary to keep the ‘additional
assessment requirement’ option, in view of, among other things, the provisions that already
require, at several stages in the procedures, consultation with the notifier and with other
competent authorities;

— Recitals 34 and 36 clarify the consequences that rejection of a notification has for any subsequent
submission or decision concerning the same GMO. Recital 35 explains what is meant by ‘reaching
an agreement’ at the end of the mediation period provided for, inter alia, in Article 14(1);

— the consent is valid for a maximum of 10 years.

Article 16 (renewal of consent) incorporates Articles 13c (consents granted under the new Directive)
and 22b (consents granted under Directive 90/220/EEC) and makes the following stipulations:

— for ‘new’ consents (paragraph 2) a period of nine months before their expiry should be sufficient
for the renewal procedure. For ‘old’ consents granted without time limits, a longer period than
the seven years proposed by the Commission could create discrimination in favour of the ‘old’
consents; a shorter period is therefore necessary (four years);

— paragraph 2(d) also requires information on the conditions to be applied for future monitoring

and the period of validity of the future consent;

— the renewal procedure (paragraphs 3 to 8) has been based on the one involved in the standard
procedure (in particular as regards the assessment report) although the competent authority that
drew up the report will not be able to block the consent with a negative report.

The procedure in case of objections (Article 17) will also apply in connection with the monitoring and
handling of new information (Article 19). Like the Parliament
the Council
considered that the time required by the scientific committee for drawing up its opinion must not
hold up the procedure indefinitely, and it has set a limit of 90 days for this purpose.

(Amendment 44),

For reasons of clarity it is better for Article 13e to be split into an Article 18 (consent) and an Article
19 (monitoring and handling of new information).

Article 18 incorporates paragraphs 1, 3 and 6 of Article 13e, detailing (paragraph 3) the points that
must in all cases be specified in the consent (scope, period of validity, conditions for placing on the
market, labelling and monitoring arrangements, etc.) and stipulating that the consent and the decision
(when Article 17 is applied) are to be made accessible to the public.

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Article 19 takes paragraphs 2, 4 (concerning what is applicable after consent is given) and 5 from the
proposal and specifies (paragraph 1) the conditions under which the monitoring plan can be adjusted.
Paragraph 3 sets out a complete procedure for deciding (in the spirit of Amendment 89) whether a
consent should be amended or terminated; this procedure follows mutatis mutandis the one involved
in the renewal procedure (Article 16(3) to (8)).

Article 20 (labelling) states (paragraph 1) that the labelling and packaging requirements must apply at
all stages of the placing on the market. To take account of the fact that some products contain GMOs
only accidentally or because it is technically unavoidable, paragraph 2 provides that, below a certain
threshold (to be determined for the product concerned), such products will not have to be labelled in
accordance with paragraph 1.

In Article 21 (free circulation) the Council considered that the text would be more coherent if it were
specified that this Article applied without prejudice to the safeguard clause (Article 22).

Article 22(1) makes clear that new and additional information is information received by the Member
State after consent was given and that existing information is to be reassessed on the basis of new or
additional knowledge. It was not considered appropriate to confine the list of emergency measures to
the two measures (terminating the placing on the market, recovering (sic) the GMO) envisaged by the
Commission. Paragraph 1, third subparagraph, and paragraph 2 specify the information to be supplied
by the Member State concerned (revised version of the assessment report, amendments to the consent,
etc.) and the method for calculating the procedural time limits, which the Council wanted to reduce
to 60 days.

Paragraph 1 of Article 23 (information to the public) takes over Article 17(1) of the proposal by
requiring assessment reports (where favourable to placing on the market) to be supplied to the public
for its comments. Recital 44 indicates what should be done with the public’s comments. Article 17(3)
is already covered by Article 8(2) and has therefore not been incorporated.

5. Final provisions (Part D)

Article 24 takes over Article 19 of
the proposal, extending the application of paragraph 4
(non-confidential information) to Article 19 (new information) and Article 22, and adds to this
information the intended uses and, explicitly, the environmental risk assessment.

As already indicated in the fourth indent of point 1 above, the Council inserted Article 25 to provide
for the labelling of GMOs supplied in connection with the operations referred to in Article 2(4). Article
25(2) specifies the conditions under which such labelling will be done.

Regarding the adaptation of Annexes to technical progress (Article 26), the Council took the view that
the introduction, the objective and the general principles of Annexes II (risk assessment) and VII
(monitoring plan) play a vital role in the implementation of the Directive and should therefore be
adapted by means of a full procedure (Parliament/Council).

For reasons of clarity, Article 20a of the proposal has been split into an Article 27 (scientific
committee) and an Article 28 (committee on ethics). Article 27(1) makes it compulsory for a scientific
committee also to be consulted when Article 16 (renewal) and Article 19 (new information) are
applied, and it allows for the possibility of doing this (paragraph 2), including at the request of a
Member State, with regard to more general questions. In line with a number of recitals (9, 55, 56 and
58) that acknowledge the importance of the ethical aspects and of the possibility of consulting the
relevant committees, Article 28 makes it compulsory to consult such committees on matters of a
general nature at the request of the European Parliament, the Council and the Commission and it
allows for the possibility of doing this at the request of a Member State. Although there is no explicit
time limit on these consultations, as was envisaged by the European Parliament (Amendment 54),
they must not be allowed to affect the Directive’s administrative procedures.

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Article 30 incorporates Articles 18 and 22 (1) of the proposal and supplements them as regards:

— the exchange of information between the Member States and the Commission on the experience

acquired (paragraph 1) by including within it the implementation of Article 2(4);

— the collection of information on genetic modifications (paragraph 2): in the spirit of Amendment
92 and in conjunction with Annex IV, one or more registers, partly accessible to the public, will
be established to store this information;

— the assessments to be made by the Commission (paragraph 6) in the context of a report on the
operation of Parts B and C, to be submitted in 2003. These will cover, inter alia, the feasibility of a
centralised Community authorisation procedure (see Amendment 96 in this connection) and the
arrangements for the final decision-making by the Commission, the possible justification for
implicit consent in the case of Part B (see Amendment 24) and a differentiated procedure in Part
C (see second paragraph of point 3 above), and the socioeconomic implications (Amendment 61)
of releases and placing on the market of GMOs;

— (paragraph 7) a report on the ethical issues referred to in Article 28.

In Article 31 (penalties) the Council did not accept the provision on notification of penalties because
it duplicated Article 32(2) (transposition).

The Council considered that the new rules established by the Directive should be implemented as
soon as possible. Accordingly, Article 32 limits the transposition period to 18 months (this period
was not specified in the proposal) and Article 33 provides that notifications submitted under Directive
90/220/EEC for which the procedures are not yet completed by the date of transposition will be
subject to the provisions of the Directive under consideration.

To avoid any legal hiatus, the date on which Directive 90/220/EEC is to be repealed has been set at
the end of the Directive’s transposition period (Article 34(1)).

6. Annexes

Apart from an updating and clarification of the wording where appropriate in the light of scientific
and technical developments since the proposal was drafted, the adjustments necessitated by the
changes made to the enacting terms of the Directive and a clarification of the structure (objectives,
general principles, operational provisions) of Annexes II and VII, the main amendments are as follows:

— in Annex II definitions have been inserted for ‘direct effects’, ‘indirect effects’, ‘immediate effects’
and ‘delayed effects’ and clarification has been given of the link (Section A) between risk assessment
and risk management. The link between the precautionary principle and the general principles for
assessment has been underlined (Section B) and the general principles themselves have been
clarified (scientific basis of the assessment, case-by-case assessment, revision in the light of new
information, etc.).

Section C (methodology): point C.1 incorporates point A2 of the proposal; point C.2 incorporates
points B and A1 (in illustration of the negative effects referred to in point C2.1); this section adds,
inter alia, allergenic effects and the reference to genes conferring resistance to antibiotics).

(1) The Commission proposal does not contain any amendment of Article 22.

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Points D.1 and D.2 are based on, and provide a clarification of, point IV.C of Annex IIIA and
point H of Annex IIIB, the aim being to clarify the detailed conclusions to be drawn at the end of
the assessment;

— the insertion of Annex III indicates the directions in which this Annex may have to be adapted in
the future, and additional information is required particularly as regards human health and the
health of animals and plants (see, for example, Part IIIB, point D.8);

— Annex IV (point A.2) requires the name and full address of the person responsible for the placing
on the market, whatever his function (importer, distributor, etc.), and of the supplier of control
samples (point A.3). It includes the supply of samples (point A.7, Amendment 92)
in the
information to be provided and specifies the details that must appear on the label, including how
to access information in the part of the register that is accessible to the public;

— Annex V (see third paragraph of point 3 above);

— Annex VI.5 stipulates that the conclusions of the assessment report must deal with the use

proposed, risk management and the monitoring plan proposed;

— Annex VII distinguishes (point A) between confirmation of any assumptions made during the risk
assessment and the identification of adverse effects that were not anticipated in the assessment,
and it sets out (point C) the principles underlying the design of the monitoring plan (case-by-case
formulation, differentiation between general monitoring and case-specific, communication of
information on adverse effects to the competent authority and the notifier, etc.)