Amended proposal for a European Parliament and Council Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms
Date: 1999-03-26
Institutions: European Commission
Subjects: EC Directive, environmental impact, environmental protection, genetically modified organism, public health

19.5.1999

EN

Official Journal of the European Communities

C 139/7

II

(Preparatory Acts)

COMMISSION

for a European Parliament and Council Directive amending Directive
Amended proposal
90/220/EEC on the deliberate release into the environment of genetically modified organisms (1)

(1999/C 139/10)

COM(1999) 139 final (cid:151) 98/0072(COD)

(Submitted by the Commission pursuant to Article 189a(2) of the EC Treaty on 25 March 1999)

(1) OJ C 139, 4.5.1998.

ORIGINAL PROPOSAL

AMENDED PROPOSAL

Recital 1

Whereas, under the Treaty, action by the Community relating
to the environment should be based on the principle that
preventive action should be taken;

Whereas, under the Treaty, action by the Community relating
to the environment should be based on the principle that
preventive action should be taken; whereas the precautionary
principle has been taken into account in the drafting of this
Directive;

Recital 4a (new)

Whereas means shall be sought of providing possibilities to
facilitate the control of GMOs or their retrieval in the event
of an acute risk;

Recital 5

Whereas the provisions of
the Directive concerning Part B
releases of products shall not apply to products under devel-
opment covered by Community legislation which provides for
a specific environmental risk assessment similar to that laid
down in this Directive;

Whereas the provisions of
the Directive concerning Part B
releases of products shall not apply to products under devel-
opment covered by Community legislation which provides for
a specific environmental risk assessment at least equivalent to
that laid down in this Directive;

Recital 5a (new)

Whereas the environmental risk assessment of this Directive
concerning Part C releases should be a point of reference for
products containing, or consisting of, GMOs covered by other
Community legislation which should therefore provide for a
specific environmental risk assessment at least equivalent to
that laid down in this Directive;

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Official Journal of the European Communities

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ORIGINAL PROPOSAL

AMENDED PROPOSAL

Recital 5b (new)

for the renewal of consent, all

Whereas,
the
original consent may be revised, including those such as moni-
toring or the fixed period of the consent;

the terms of

Recital 7

Whereas it is appropriate that the administrative procedure for
granting consents to the placing on the market of GMOs as or
in products should become more efficient and more trans-
parent and that consent should only be granted for a fixed
period;

Whereas it is appropriate that the administrative procedure for
granting consents to the placing on the market of GMOs as or
in products should become more efficient and more trans-
parent and that first-time consent should be granted for a
fixed period;

Recital 12

Whereas the Commission may consult any committee it has
created with a view to advising it on the ethical implications of
biotechnology on general matters which in the view of the
Commission may raise ethical concerns;

Whereas the Commission’s European Group on Ethics in
Science and New Technologies may be consulted with a view
to obtaining advice on ethical
issues of general nature
regarding the deliberate release of GMOs;

Article 2(1)

(cid:145)organism(cid:146) is any biological entity capable of replication

1.
or of transferring genetic material;

(cid:145)organism(cid:146) is any biological entity, with the exception of
transferring genetic

replication or of

1.
humans, capable of
material;

Article 2(3a) (new)

(3a)
(cid:145)unauthorised deliberate release(cid:146) means any deliberate
release of GMOs as or in products for which no authorisation
was given;

Article 2(3b) (new)

(cid:145)product(cid:146) means

(3b)
a preparation consisting of, or
containing, a GMO or a combination of GMOs, which is
placed on the market;

Article 2(5)

(cid:145)notification(cid:146) means
requisite

the presentation of documents
5.
containing
competent
information to the
authority of a Member State. The person making the presen-
tation shall be referred to as (cid:145)the notifier(cid:146);

the

(cid:145)notification(cid:146) means

5.
the presentation of documents
containing the requisite information to, and if appropriate,
the lodging of samples of the GMO or its genetic materials
with, the competent authorities of a Member State. The person
making the presentation shall be referred to as (cid:145)the notifier(cid:146);

Article 2(6)

(cid:145)environmental risk assessment(cid:146) means the evaluation of
6.
the direct and indirect
to human health and the
environment which the deliberate release of GMOs into the
environment may pose;

risks

6.
(cid:145)environmental risk assessment(cid:146) means the evaluation of
the direct, indirect, immediate or delayed risks to human health
and the environment which the deliberate release of GMOs into
the environment may pose;

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Official Journal of the European Communities

C 139/9

ORIGINAL PROPOSAL

AMENDED PROPOSAL

Article 2(6a) (new)

(6a)
(cid:145)use(cid:146) means the deliberate release of a product which
has been placed on the market. The persons carrying out this
use will be referred to as (cid:145)users(cid:146).

Article 4(3)

Member States shall ensure that
the competent authorities
organises inspections and other control measures as appro-
priate, to ensure compliance with this Directive.

Member States shall ensure that
the competent authorities
organises inspections and other control measures as appro-
priate, to ensure compliance with this Directive. In the event
of an unauthorised deliberate release of GMOs the Member
State concerned shall ensure that necessary measures are
taken to terminate the release, to initiate remedial action and
to inform other Member States,
the Commission and the
public.

Article 5

Articles 6 to 9 shall not apply to any products under devel-
opment covered by Community legislation which provides for
a specific environmental risk assessment similar to that laid
down in those Articles.

Articles 6 to 9 shall not apply to any products under devel-
opment covered by Community legislation which provides for
a specific environmental risk assessment at least equivalent to
that laid down in Annex II of this Directive.

Article 6b(2)

2.
The notification referred to in paragraph 1 shall include a
technical dossier supplying the information specified in Annex
III necessary for evaluating any foreseeable risks from the
in
deliberate release of a GMO or combination of GMOs,
particular:

2.
The notification referred to in paragraph 1 shall include a
technical dossier supplying the information specified in Annex
III necessary for evaluating any foreseeable risks from the
in
deliberate release of a GMO or combination of GMOs,
particular:

(a) general

information including information on personnel

(a) general

information including information on personnel

and training,

and training,

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

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

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

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

receiving environment,

receiving environment,

(d) information on the interactions between the GMO(s) and

(d) information on the interactions between the GMO(s) and

the environment,

the environment,

(e) information on monitoring, control, waste treatment and

emergency response plans,

(f) a statement evaluating the impacts and risks posed by the
GMO(s) to human health or the environment from the uses
envisaged.

(e) a detailed plan for monitoring in order to identify any
immediate or delayed effects of

relevant direct,
the GMOs on human health or the environment,

indirect,

(f)

information on control, remediation, waste treatment and
emergency response plans,

(g) a statement evaluating the impacts and risks posed by the
GMO(s) to human health or the environment from the uses
envisaged.

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Official Journal of the European Communities

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ORIGINAL PROPOSAL

AMENDED PROPOSAL

Article 6d(2)

If

2.
information becomes available subsequently to the
competent authority which could have significant conse-
the competent
quences for the risks posed by the release,
authority may require the notifier to modify the conditions
of, suspend or terminate the deliberate release.

If

2.
information becomes available subsequently to the
competent authority which could have significant conse-
the competent
quences for the risks posed by the release,
authority shall evaluate such information and may require
the notifier
suspend or
to modify the
terminate the deliberate release.

conditions of,

Article 7

Without prejudice to the provisions of Article 19, Member
States shall make available to the public information on Part
B releases of GMOs. To the extent feasible and appropriate,
inform and consult the public on any
Member States shall
the proposed deliberate release in an adequate,
aspect of
effective and timely manner. Any such public participation
procedure shall not exceed 90 days. The Commission shall
lay down, pursuant to Article 21, the manner in which this
public participation procedure shall take place before . . . [the
date foreseen for the transposition of the amending Directive].

Article 8

shall

the notifier

After completion of a release and, thereafter, at the intervals
laid down in the consent,
inform the
competent authority of the result of the release in respect of
any risk to human health or the environment, with particular
reference to any kind of product that the notifier may intend to
notify at a later stage. The summaries of the results of the
release,
including any data resulting from monitoring, shall
be made available to the Commission and the other Member
States.

Article 9(2)

The Commission shall

2.
these
summaries to the other Member States, which may, within
30 days, present observations through the Commission or
directly.

immediately

forward

immediately

The Commission shall

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

forward

Article 10

Articles 11 to 18 shall not apply to any products covered by
Community legislation which provides for a specific environ-
mental risk assessment similar
laid down in this
Directive.

to that

Articles 11 to 18 shall not apply to any products covered by
Community legislation which provides for a specific environ-
mental risk assessment at least equivalent to that laid down in
Annex II of this Directive.

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Official Journal of the European Communities

C 139/11

ORIGINAL PROPOSAL

AMENDED PROPOSAL

Article 12(3)

3.
The assessment report shall indicate whether the GMO(s)
in question should be placed on the market and under which
conditions, if any, or whether additional assessment is required.

3.

The assessment report shall indicate

(i) whether the GMO(s) in question should be placed on the

market and under what conditions, if any,

(ii) whether the GMO(s) in question shall not be placed on the

market or

(iii) whether additional assessment is required.

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

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

Article 12(3a) (new)

In the case referred to in paragraph 3(ii), the competent
(3a)
inform the notifier that the release does not
authority shall
fulfil the conditions of this Directive and that it is therefore
rejected at the same time as it forwards its assessment report to
the Commission.

Article 13c(4)

4.
In the absence of any reasoned objection from a Member
State or the Commission within 30 days following the date of
submission referred to in paragraph 3, the competent authority
that received the original notification shall give its consent in
writing for the renewal of the original consent and shall inform
the other Member States and the Commission thereof. The
consent shall be granted for a fixed period of seven years.

4.
In the absence of any reasoned objection from a Member
State or the Commission within 30 days following the date of
submission referred to in paragraph 3, the competent authority
that received the original notification shall give its consent in
writing for the renewal of the original consent and shall inform
the other Member States and the Commission thereof. The
period of validity of the consent may be limited as appropriate.

Article 13d(1)

In cases where an objection is raised and maintained in
1.
accordance with Article 13(2), 13b(5) or 13c(3), or an
additional assessment is required in accordance with Article
12(3),
take a decision within three
months
in accordance with the procedure laid down in
Article 21.

the Commission shall

In cases where an objection is raised and maintained in
1.
accordance with Article 13(2), 13b(5) or 13c(3), or an
additional assessment is required in accordance with Article
12(3),
take a decision within three
months
in accordance with the procedure laid down in
Article 21.

the Commission shall

For the purpose of calculating the three month period, any
time during which the Commission is awaiting
period of
further information which it may have requested from the
notifier or is seeking the opinion of a Scientific Committee
which has been consulted shall not be taken into account.

For the purpose of calculating the three month period, any
time during which the Commission is awaiting
period of
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 20a(1)
shall not be taken into account.

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ORIGINAL PROPOSAL

AMENDED PROPOSAL

Article 13e(3)

3.
Consent to the placing on the market of GMOs in or as a
product shall be granted for a fixed period of seven years. The
notifier may proceed with the placing on the market only
when he has received the written consent of the competent
authority in accordance with Articles 13, 13b, 13c and 13d,
and in conformity with any conditions, including reference to
particular ecosystems/environments, required in that consent.

3. Without prejudice to Article 13c(4), consent
to the
placing on the market of GMOs in or as a product shall be
granted for a fixed period of seven years. The notifier may
proceed with the placing on the market only when he has
received the written consent of the competent authority in
accordance with Articles 13, 13b, 13c and 13d, and in
conformity with any conditions,
to
particular ecosystems/environments, required in that consent.

including reference

Article 13e(5)

If the competent authority receives additional information
immediately inform the
the other

5.
pursuant
Commission and the competent authorities of
Member States.

to paragraph 4,

it shall

If the competent authority receives additional information
5.
pursuant
to paragraph 4, or otherwise, which could have
significant consequences for the risks posed by the release,
the competent authority shall evaluate such information, and
it shall immediately inform the Commission and the competent
authorities of the other Member States of the action taken.

Article 16(1)

received written consent under

1. Where a Member State, as a result of new information or
reassessment of existing information, has detailed grounds for
considering that a product which has been properly notified
this Directive
and has
constitutes a risk to human health or the environment, that
Member State may provisionally restrict or prohibit the use
and/or sale of that product on its territory. It shall immediately
inform the Commission and the other Member States of such
action and give reasons for its decision.

1. Where a Member State, as a result of additional
information or
reassessment of existing information, has
detailed grounds for considering that a product which has
received written consent
been properly notified and has
under this Directive constitutes a risk to human health or
the
that Member State may provisionally
restrict or prohibit the use and/or sale of that product on its
territory.

environment,

In the event of an acute risk, the deliberate release shall be
terminated immediately and, as far as possible, the GMOs shall
be recovered. In addition, the public shall be informed of the
risk posed by the GMOs.

The Member State shall immediately inform the Commission
and the other Member States of such action and give reasons
for its decision.

Article 20a

The relevant Scientific Committee(s) shall be consulted by the
Commission on any matter which is likely to have an effect on
human health and/or the environment before the decision
procedure referred to in Articles 13d(1) or 16(2) is initiated.

1.
The relevant Scientific Committee(s) shall be consulted by
the Commission on any matter which is likely to have an effect
on human health and/or the environment before the decision
procedure referred to in Articles 13d(1) or 16(2) is initiated.
The Commission may require the adoption of an opinion by
the Scientific Committee(s) within a specified time period.

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ORIGINAL PROPOSAL

AMENDED PROPOSAL

The Commission, on its own initiative or at the request of
2.
the Council or
its
European Group on Ethics in Science and New Technologies
with a view to advising it on ethical issues of general nature
regarding the release of GMOs.

the European Parliament, may consult

ANNEX II (A) (1)

1.

Elements which may be considered as potentially harmful effects:

1.

Elements which may be considered as potentially harmful effects:

(cid:151) pathogenicity to humans, animals or plants,

(cid:151) pathogenicity to humans, animals, plants or microorganisms,

(cid:151) compromising of prophylactic or therapeutic treatments,

(cid:151) compromising of prophylactic or therapeutic treatments,

(cid:151) effects

on

population

dynamics within

the

receiving

(cid:151) effects

on

population

dynamics within

the

receiving

environment,

environment,

(cid:151) effects on geochemistry,

(cid:151) effects on geochemistry,

(cid:151) the uncontrolled spread of the GMO(s) in the environment and

(cid:151) the uncontrolled spread of the GMO(s) in the environment and

invasion of unrelated ecosystems,

invasion of unrelated ecosystems,

(cid:151) effects resulting from the transfer of

the inserted genectic

(cid:151) effects resulting from the transfer of

the inserted genetic

material to other organisms,

material to other organisms,

(cid:151) phenotypic and genetic instability.

(cid:151) phenotypic and genetic instability.

ANNEX II (B) (5)

5. Application of management strategies for risks from the deliberate

5. Application of management strategies for risks from the deliberate

release of GMO(s)

release of GMO(s)

If for any release the estimated risk for any identified hazard is not
an acceptable level, the GMO(s) or the conditions of the release
should be modified to reduce the risk.

If for any release the estimated risk for any identified hazard is not
an acceptable level, the GMO(s) or the conditions of the release
shall be modified in such a way as to reduce the risk to an
acceptable level.

ANNEX IIIB (G) (4)

4. Description of monitoring plans and techniques.

4. Description of monitoring plans and techniques and their duration

and frequency.

ANNEX IV (A) (5)

5.

information relating to the introduced genetic modification which
could be of relevance to the establishment of a possible register of
modifications introduced in organisms (species). This may include
nucleotide sequences or other
information which is
relevant to the inclusion in such a register.

type of

5.

information relating to the introduced genetic modification which
is of relevance for the detection and identification of the GMO(s)
to facilitate post-marketing control and inspection. This may
include nucleotide sequences or other
information
which is relevant to the inclusion in a register regarding the
control of GMOs released for placing on the market.

type of

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ORIGINAL PROPOSAL

AMENDED PROPOSAL

ANNEX IV (B) (6) (new)

6.

description of procedures which facilitate the retrieval of
GMOs in the event of an acute risk.

the

ANNEX VI (5)

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 or whether an additional assessment is required on
certain aspects. The aspects which require additional assessment
should be specified.

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 GMO(s) in question shall not be placed
on the market or whether an additional assessment is required on
certain aspects. The aspects which require additional assessment
should be specified. In the case that it has been concluded that the
GMO(s)
the
competent authority shall give reasons for its decision.

in question shall not be placed on the market,