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7.2.

2001 EN Official Journal of the European Communities C 40/123

Wednesday 12 April 2000

European Parliament legislative resolution on the initiative of the Republic of Finland with a view
to adopting a Council Decision concerning arrangements for cooperation between financial intelli-
gence units of the Member States in respect of exchanging information (11636/1999 % C5-0330/
1999 % 1999/0824(CNS))

(Consultation procedure)

The European Parliament,

 having regard to the initiative of the Republic of Finland (11636/1999  1999/0824(CNS)) (1),

 having been consulted by the Council pursuant to Article 34(2) (c) of the EU Treaty (C5-0330/1999),

 having regard to Rule 67 and Rule 106 of its Rules of Procedure,

 having regard to the report of the Committee on Citizens’ Freedoms and Rights, Justice and Home
Affairs and the opinions of the Committee on Economic and Monetary Affairs and the Committee
on Legal Affairs and the Internal Market (A5-0102/2000),

1. Approves the initiative of the Republic of Finland as amended;

2. Calls on the Council to notify Parliament should it intend to depart from the text approved by Parlia-
ment;

3. Asks to be consulted again should the Council intend to modify the initiative of the Republic of
Finland substantially;

4. Instructs its President to forward its position to the Council, the Republic of Finland and the Com-
mission.

(1) OJ C 362, 16.12.1999, p. 6.

7. Deliberate release into the environment of GMOs ***II

A5-0083/2000

European Parliament legislative resolution on the Council common position for adopting a Euro-
pean Parliament and Council directive on the deliberate release into the environment of geneti-
cally modified organisms and repealing Council Directive 90/220/EEC (11216/1/1999 % C5-0012/
2000 % 1998/0072(COD))

(Codecision procedure: second reading)

The European Parliament,

 having regard to the Council common position (11216/1/1999  C5-0012/2000) (1),

 having regard to its position at first reading (2) on the Commission proposal to Parliament and the
Council (COM(1998) 85) (3),

 having regard to the Commission’s amended proposal (COM(1999) 139) (4),

 having regard to Article 251(2) of the EC Treaty,

(1) OJ C 64, 6.3.2000, p. 1.
(2) OJ C 150, 28.5.1999, p. 363.
(3) OJ C 139, 4.5.1998, p. 1.
(4) OJ C 139, 19.5.1999, p. 7.
C 40/124 Official Journal of the European Communities EN 7.2.2001

Wednesday 12 April 2000

 having regard to Rule 80 of its Rules of Procedure,

 having regard to the recommendation for second reading of the Committee on the Environment,
Public Health and Consumer Policy (A5-0083/2000),

1. Amends the common position as follows;

2. Instructs its President to forward its position to the Council and Commission.

COUNCIL AMENDMENTS
COMMON POSITION BY PARLIAMENT

(Amendment 1)
Recital 13

(13) The content of this Directive duly takes into account (13) The content of this Directive duly takes into account
international experience in this field and international trade international experience in this field and international trade
commitments; commitments and must respect the requirements of the
Cartagena Biosafety Protocol concluded in Montreal
in January 2000; where necessary the Commission will,
in the context of the ratification of the Protocol, submit
proposals for the amendment and clarification of this
Directive;

(Amendments 36 and 46)
Recital 16

(16) The provisions of this Directive should be without prejudice to (16) There may be a wide range of causes of damage to
national legislation in the field of liability; the environment, not only GMOs; EU-wide environment
liability rules should therefore be introduced to provide
wide-ranging regulation of possible cases of damage; the
Commission will, after discussion with the European Par-
liament and the Council, bring forward a proposal before
the end of 2001 which will include the impact of biotech-
nology on all areas of the European Union;

(Amendment 3)
Recital 19a (new)

(19a) Risk assessments should be made of the accumu-
lated long-term effects associated with granting consent
and releasing any new genetically modified organism; the
accumulated long-term effects should also form a compul-
sory part of the monitoring process;

(Amendment 4)
Recital 20a (new)

(20a) It is necessary to carry out independent, systematic
research into the risks involved; the necessary resources
should be secured for such research and the independent
researchers should be given access to all relevant material;
7.2.2001 EN Official Journal of the European Communities C 40/125

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COUNCIL AMENDMENTS
COMMON POSITION BY PARLIAMENT

(Amendment 5)
Recital 26

(26) Concerning the environmental risk assessment for Part (26) Concerning the environmental risk assessment for Part
C, risk management, labelling, monitoring, information to the C, risk management, labelling, monitoring, information to the
public and safeguard clause, this Directive should be a point of public and safeguard clause, this Directive should be a point of
reference for GMOs as or in products authorised by other reference for GMOs as or in products authorised by other
Community legislation which should therefore provide for a Community legislation which should therefore provide for a
specific environmental risk assessment, to be carried out in specific environmental risk assessment, to be carried out in
accordance with the principles set out in Annex II and on the accordance with the principles set out in Annex II and on the
basis of information specified in Annex III without prejudice to basis of information specified in Annex III without prejudice to
additional requirements laid down by the Community legisla- additional requirements laid down by the Community legisla-
tion mentioned above, and for requirements as regards risk tion mentioned above, and for requirements as regards risk
management, labelling, monitoring as appropriate, information management, labelling, monitoring as appropriate, information
to the public and safeguard clause at least equivalent to that to the public and safeguard clause at least equivalent to that
laid down in this Directive; laid down in this Directive; the regulations to ensure that
risk assessment and the requirements concerning risk
management, labelling, monitoring as appropriate, infor-
mation to the public and safeguard clause are equivalent
to those laid down in this Directive should be implemen-
ted in cooperation with the relevant Commission services
and national authorities responsible for the implementa-
tion of this Directive;

(Amendment 6)
Recital 27a (new)

(27a) The long-term aim should be to create a centralised
procedure at Community level for the release of GMOs,
for example along the lines of the procedure used for the
licensing of medicinal products; the Commission should
conduct a study of the possibility of centralised monitor-
ing of the release of genetically modified organisms, for
instance by the European Environment Agency in Copen-
hagen or the proposed European Food Authority;

(Amendment 47)
Recital 59

(59) In order to increase the effective implementation of the (59) In order to increase the effective implementation of the
provisions adopted under this Directive it is appropriate to provisions adopted under this Directive it is appropriate to
provide for penalties to be applied by Member States; provide for penalties to be applied by Member States, includ-
ing penalties for the negligent release of GMOs;

(Amendment 8)
Recital 59a (new)

(59a) A study should be made annually of the likely
socio-economic costs and benefits of the proposed delib-
erate release/market authorisation, which also takes due
account of the interests of farmers and consumers;
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COUNCIL AMENDMENTS
COMMON POSITION BY PARLIAMENT

(Amendment 9)
Article 2(7a) (new)

(7a) ‘use’ means the deliberate release of a product
which has been placed on the market. The persons
carrying out this use will be referred to as ‘users’;

(Amendment 10)
Article 3(1a) (new)

1a. This Directive shall not apply to pharmaceutical
products for human use consisting of or containing a
GMO or a combination of GMOs, provided that the
Community legislation governing them provides for an
environmental risk assessment equivalent to that set out
in Annexes II and III.

(Amendments 48 and 52)
Article 4(2)

2. Any person, before submitting a notification under Part B 2. Any person, before submitting a notification under Part B
or Part C, shall carry out an environmental risk assessment. or Part C, shall carry out an environmental risk assessment.
The information which may be necessary to carry out the The information which may be necessary to carry out the
environmental risk assessment is laid down in Annex III. Mem- environmental risk assessment is laid down in Annex III. Mem-
ber States and the Commission shall ensure that GMOs which ber States and the Commission shall ensure that GMOs which
contain genes expressing resistance to antibiotics in use for contain genes expressing resistance to antibiotics in use for
medical or veterinary treatment are taken into particular con- medical or veterinary treatment are taken into particular con-
sideration when carrying out an environmental risk assessment, sideration when carrying out an environmental risk assessment,
with a view to identifying and phasing out antibiotic resistance in order to identify and phase out by 2005 antibiotic resis-
markers in GMOs which may have adverse effects on human tance markers in GMOs which may have adverse effects on
health and the environment. human health and the environment.

(Amendments 38 and 49)
Article 4(2a) (new)

2a. When consent is given for a deliberate release,
Member States and the Commission shall ensure that
every form of effect on the environment caused by gene
transfer to other organisms is accurately assessed. As the
degree of environmental impact varies according to the
nature of the organism introduced, a separate assessment
shall be made in each individual case.

(Amendment 16)
Article 5(6)

6. For the purpose of calculating the 90-day period referred 6. For the purpose of calculating the 90-day period referred
to in paragraph 5, no account shall be taken of any periods of to in paragraph 5, no account shall be taken of any periods of
time during which the competent authority: time during which the competent authority is awaiting further
information which it may have requested from the notifier.
A public inquiry or consultation in accordance with Article 8
shall not prolong the 90-day period referred to in paragraph 5.
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COUNCIL AMENDMENTS
COMMON POSITION BY PARLIAMENT

(a) is awaiting further information which it may have
requested from the notifier, or

(b) is carrying out a public inquiry or consultation in accor-
dance 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.

(Amendment 17)
Article 5(6), 2nd paragraph (new)

If the competent authority requests further information it
must give its reasons for so doing.

(Amendment 19)
Article 7(2)

2. If information becomes available to the competent auth- 2. If information becomes available to the competent auth-
ority referred to in paragraph 1 which could have significant ority referred to in paragraph 1 which could have significant
consequences with regard to risks for human health and the consequences with regard to risks for human health and the
environment or under the circumstances described in para- environment or under the circumstances described in para-
graph 1, the competent authority shall evaluate such informa- graph 1, the competent authority shall evaluate such informa-
tion and may require the notifier to modify the conditions of, tion, inform the general public and may require the notifier
suspend or terminate the deliberate release. to modify the conditions of, suspend or terminate the deliber-
ate release.

(Amendment 20)
Article 11(2)

2. As far as Council Regulation (EEC) No 2309/93 is con- 2. As far as Council Regulation (EEC) No 2309/93 is con-
cerned, Articles 12 to 23 of this Directive shall not apply to cerned, Articles 12 to 23 of this Directive shall not apply to
any GMO as or in products as far as they are authorised by any GMO as or in products as far as they are authorised by
that Regulation provided that a specific environmental risk that Regulation provided that a specific environmental risk
assessment is carried out in accordance with the principles set assessment is carried out in accordance with the principles set
out in Annex II to this Directive and on the basis of out in Annex II to this Directive and on the basis of informa-
information specified in Annex III to this Directive without pre- tion specified in Annex III to this Directive and subject to re-
judice to additional requirements provided for in Regulation (EEC) quirements as regards risk management, labelling, moni-
No 2309/93. toring as appropriate, information to the public and
safeguard clause at least equivalent to those laid down in
this Directive.

(Amendment 21)
Article 11(3)

3. Procedures ensuring that the risk assessment, require- 3. Procedures ensuring that the risk assessment, require-
ments regarding risk management, labelling, monitoring as ments regarding risk management, labelling, monitoring as
appropriate, information to the public and safeguard clause appropriate, information to the public and safeguard clause
are equivalent to those laid down in this Directive shall be are equivalent to those laid down in this Directive shall be
introduced, in a Regulation of the European Parliament and of introduced, in a Regulation of the European Parliament and of
the Council. Until that Regulation enters into force any GMO the Council pursuant to Article 95 of the Treaty. As
as or in products as far as they are authorised by other regards the other provisions of this Directive, the Regula-
Community legislation shall only be placed on the market tion shall refer to the relevant Articles of this Directive.
after having been accepted for placing on the market in accor- Until the Regulation enters into force any GMO as or in pro-
dance with this Directive. ducts as far as they are authorised by other Community legisla-
tion shall only be placed on the market after having been
accepted for placing on the market in accordance with this
Directive.
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COUNCIL AMENDMENTS
COMMON POSITION BY PARLIAMENT

(Amendment 22)
Article 12(2) (d)

(d) a proposed period for the consent which should not (d) a proposed period for the consent which should not
exceed 10 years; exceed 10 years commencing after the first registration
of the final product;

(Amendment 23)
Article 14(4)

4. The consent shall be given for a maximum period of 4. The consent shall be given for a maximum period of 10
10 years. years, commencing after the first registration of the final
product.

(Amendment 24)
Article 15(3)

3. Before the procedure laid down in Article 29(2) on a 3. Before the procedure laid down in Article 29(2) on a
decision for criteria and information requirements referred to decision for criteria and information requirements referred to
in paragraph 1 is initiated, the Commission shall make the pro- in paragraph 1 is initiated, the Commission shall make the pro-
posal available to the public. The public may make comments posal available to the public. The public may make comments
to the Commission within 60 days. to the Commission within 60 days. Any such comments shall
be forwarded, together with a reasoned response, to the
Committee set up pursuant to Article 29.

(Amendment 25)
Article 15(3a) (new)

3a. If sufficient experience has been obtained from mar-
keting certain GMOs in certain ecosystems and the GMOs
concerned meet the criteria set out in Annex V, a compe-
tent authority may submit to the Commission a reasoned
proposal for the application of differentiated procedures
to such types of GMO. A decision shall be taken in accor-
dance with the procedures laid down in Article 6(2), (3)
and (4).

(Amendment 26)
Article 16(6)

6. In the case of paragraph 3(a) and in the absence of any 6. In the case of paragraph 3(a) and in the absence of any
reasoned objection from a Member State or the Commission reasoned objection from a Member State or the Commission
within 60 days from the date of circulation of the assessment within 60 days from the date of circulation of the assessment
report, the competent authority which prepared the report report, the competent authority which prepared the report
shall transmit to the notifier the final decision in writing and shall transmit to the notifier the final decision in writing and
shall inform the other Member States and the Commission shall inform the other Member States and the Commission
thereof within 30 days. The validity of the consent may be thereof within 30 days. The validity of the consent shall not
limited as appropriate. exceed 10 years and may be limited as appropriate for spe-
cific reasons.

(Amendment 27)
Article 17(1), 3rd subparagraph

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

(Amendment 28)
Article 18a (new)

Article 18a

Export

1. In connection with the export of GMOs and/or pro-
ducts containing GMOs to non-Member States, the expor-
ter or importer must obtain

% consent to the import from the country of destination
and

% export authorisation from the authority of the compe-
tent Member State.

2. The country of destination must give its consent to
the import before the authority of the competent Member
State can issue its authorisation.

3. The Commission shall bring forward a legislative
proposal for implementing in detail the Cartagena Proto-
col on Biosafety within six months of signature.

(Amendment 39)
Article 19(3a) (new)

3a. To facilitate monitoring, the location of GMOs
grown shall be recorded in public registers.

(Amendment 31)
Article 22(2), 2nd subparagraph

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

(Amendment 32)
Article 28(1), 3rd subparagraph (new)

The Commission shall take the necessary measures to
ensure that such consultations are conducted under clear
rules of openness and transparency with full public access.

(Amendment 34)
Annex II, introduction, 3rd paragraph (new)

A general principle for environmental risk assessment
shall also be an assessment/analysis of the ‘accumulated
long-term effects’. ‘Accumulated long-term effects’ refers
to the accumulated effects of all consents on natural
flora, other crops, soil fertility, soil degradation of organic
material, the food chain, biological diversity, human
health, and resistance problems in relation to antibiotics.
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COUNCIL AMENDMENTS
COMMON POSITION BY PARLIAMENT

(Amendment 35)
Annex IV(A)(8)

8. proposed labelling on a label or in an accompanying docu- 8. proposed labelling on a label or in an accompanying docu-
ment. This must include, at least in summarised form, a com- ment. This must include, at least in summarised form, a com-
mercial name of the product, the name of the GMO and the mercial name of the product, a statement that ‘this product
information referred to in point 2, the labelling should indicate contains or consists of GMOs’, the name of the GMO and
how to access the information in the publicly accessible part of the information referred to in point 2, the labelling should
the register. indicate how to access the information in the publicly accessi-
ble part of the register.

8. Identification, registration and labelling of beef ***I

A5-0088/2000

Proposal for a European Parliament and Council regulation establishing a system for the identifica-
tion and registration of bovine animals and regarding the labelling of beef and beef products and
repealing Council Regulation (EC) No 820/97 (COM(1999) 487 % C5-0240/1999 % 1999/
0204(COD))

The proposal was amended as follows:

TEXT PROPOSED AMENDMENTS
BY THE COMMISSION (1) BY PARLAIMENT

(Amendment 1)
Recital 1

(1) Article 19 of Council Regulation (EC) No 820/97 estab- (1) Article 19 of Council Regulation (EC) No 820/97 estab-
lishing a system for the identification and registration of bovine lishing a system for the identification and registration of bovine
animals and regarding the labelling of beef and beef products, animals and regarding the labelling of beef and beef products,
lays down that a compulsory beef labelling system shall be lays down that a compulsory beef labelling system shall be
introduced, which shall be obligatory in all Member States, introduced, which shall be obligatory in all Member States,
from 1 January 2001 onwards. On the basis of a Commission from 1 September 2000 onwards. On the basis of a Commi-
proposal, the same Article also states that the general rules for ssion proposal, the same Article also states that the general
that compulsory system shall be decided before that date. rules for that compulsory system shall be decided before that
date.

(Amendment 2)
Recital 1a (new)

(1a) Council Regulation (EC) No 2772/1999 of 21 Decem-
ber 1999 providing for the general rules for a compulsory
beef labelling system (1) specifies that such general rules
are to be applicable only on a provisional basis, for a max-
imum period of eight months, i.e. from 1 January to
31 August 2000.

(1) OJ L 334, 28.12.1999, p. 1.

(1) OJ C 376 E, 28.12.1999, p. 42.