Amendments on EP Report A5-0154/2003 (Recommendation for second reading of a draft regulation on transboundary movements of genetically modified organisms)

Brussels, 02 Jun 2003

Full text of Amendments 001 - 018 PIN archive of Amendments 001 - 018

28 May 2003 A5-0154/ 1-18

AMENDMENTS 1-18
tabled by the Committee on the Environment, Public Health and Consumer Policy

RECOMMENDATION FOR 2nd READING by Jonas Sjöstedt A5-0154/2003
Transboundary movement of GMOs

Council common position
(15546/1/2002 &emdash; C5-0081/2003 &emdash; 2002/0046(COD))

Council common position

Amendments by Parliament

Amendment 1
Recital 6

(6) Exports of GMOs intended for deliberate release into the environment should be notified to the Party or non-Party of import, allowing it to make an informed decision, based on a risk assessment carried out in a scientifically sound manner.
(6) Exports of GMOs should be notified to the Party or non-Party of import, allowing it to make an informed decision, based on a risk assessment carried out in a scientifically sound manner and taking into account the precautionary principle.

(Reflects Am. 3 at first reading, adopted on 24th September 2002)

Justification

The amendment reflects first reading amendment 3.

Amendment 2
Recital 8

(8) Exporters should await the express consent of the Party or non-Party of import before proceeding with the first transboundary movement of a GMO intended for deliberate release into the environment.
(8) Exporters should await the express consent of the Party or non-Party of import before proceeding with a transboundary movement of a GMO intended for deliberate release into the environment. This obligation should not apply where the Party or non-Party of import has given notice in writing that subsequent transboundary movements of the GMO will no longer require an approval.

(Reflects Am. 60 at first reading, adopted on 24th September 2002)

Justification

Recital 8 of the common position offers new text. The amendment reflects first reading amendment 60 which also deleted the word "first".

Amendment 3
Article 1

In accordance with the precautionary principle, and without prejudice to the provisions of Directive 2001/18/EC , the objectives of this Regulation are to establish a common system of notification and information for transboundary movements of genetically modified organisms (GMOs) and to ensure coherent implementation of the provisions of the Protocol on behalf of the Community in order to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of GMOs that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
In accordance with the precautionary principle, and without prejudice to the provisions of Directive 2001/18/EC , the objectives of this Regulation are to establish a common system of notification and information for transboundary movements of genetically modified organisms (GMOs) and to ensure coherent implementation of the provisions of the Protocol on behalf of the Community in order to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of GMOs that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and to ensure, in accordance with the Protocol, compliance with the regulatory framework of the importing country in relation to such GMOs.

(Reflects Am. 9 at first reading, adopted on 24th September 2002)

Justification

The amendment reflects first reading amendment 9. The Council rejected amendment 9 arguing that the concept of "facilitation" is "diffuse". The term "facilitate" is therefore replaced by "ensure".

Amendment 4
Article 2, paragraph 2

2. Pharmaceuticals for humans that are addressed by other relevant international agreements or organisations are excluded from the scope of this Regulation.
2. Pharmaceuticals for humans that are addressed by other relevant international agreements to which the Community or the relevant Member State is party or organisations of which the Community or the relevant Member State is a member are excluded from the scope of this Regulation.

Justification

Without the additional wording, which reflects Amendment 10 adopted in first reading, this paragraph would be open to abuse and would not be in line with Art. 5 of the Biosafety Protocol.

Amendment 5
Article 4

The exporter shall ensure notification, in writing, to the competent authority of the Party or non-Party of import prior to the first intentional transboundary movement of a GMO intended for deliberate release into the environment and destined for the use specified in accordance with Annex  I, point (i). The notification shall contain, as a minimum, the information specified in Annex  I. The exporter shall ensure the accuracy of the information contained in the notification.
The exporter shall ensure notification, in writing, to the competent authority of the Party or non-Party of import prior to the intentional transboundary movement of a GMO intended directly or indirectly for deliberate release into the environment and destined for the use specified in accordance with Annex  I, point (i). The notification shall contain, as a minimum, the information specified in Annex  I. The exporter shall ensure the accuracy of the information contained in the notification. If the Party or non-Party of import has, before or after the first transboundary movement of the GMO, given notice in writing that subsequent transboundary movements of the GMO will no longer require an approval, this Article shall not apply to such subsequent transboundary movements.

(Partially reinstates Ams. 60 and 50 first reading, adopted on 24 September 2002)

Justification

Partial representation of first reading amendments 60 and 50. The second part is intended to clarify the procedures necessary as a result of the removal of the blanket qualification implied by the word removed in the first part of the amendment. Whilst it would plainly be absurd for every shipment of every GMO to require separate express consent, to apply this requirement only to first movements is too restrictive. To the extent the Biosafety Protocol allows this, the amendment also aims to accomodate the idea of amendment 50 .

Amendment 6
Article 5, paragraph 1

1. A failure by the Party of import to acknowledge receipt of a notification or to communicate its decision shall not imply its consent to an intentional transboundary movement. No first intentional transboundary movement may be made without express consent of the Party or, where appropriate, non-Party of import.
1. A failure by the Party of import to acknowledge receipt of a notification or to communicate its decision shall not imply its consent to an intentional transboundary movement. No first intentional transboundary movement may be made without prior written consent of the Party or, where appropriate, non-Party of import.

(Partially reflects Am 60 at first reading, adopted on 24th September 2002)

Justification

The amendment partially reflects first reading amendment 60.

Amendment 7
Article 5, paragraph 3

3. The exporter shall not proceed with the first intentional transboundary movement of a GMO intended for deliberate release unless the procedures determined by the Party of import in accordance with Articles 9 and 10 of the Protocol or, where appropriate, equivalent procedures required by a non-Party of import have been followed.
3. Without prejudice to the requirements laid down in paragraph 1, the exporter shall not proceed with the first intentional transboundary movement of a GMO intended for deliberate release unless the procedures determined by the Party of import in accordance with Articles 9 and 10 of the Protocol or, where appropriate, equivalent procedures required by a non-Party of import have been followed.

Justification

It is important to clarify that, even where the procedures determined by the Party of import in accordance with Articles 9 and 10 of the Protocol or equivalent procedures required by a non-Party of import have been followed, transboundary movement should not occur without that Party or non-Party's express consent. The words are added to avoid possible conflicts of interpretation between Article 5.1 (and various other references to "express consent") and Article 5.3. Without this, there remains a danger that national authorities, particularly in developing countries, might be persuaded, perhaps through external pressure, to adopt procedures which do not include a clear requirement for "express consent". This amendment reflects the spirit and intentions of first reading Amendment 60.

Amendment 8
Article 5, paragraph 4

4. Paragraphs 1, 2 and 3 shall not apply to cases of transboundary movements covered by simplified procedures or bilateral, regional and multilateral agreements or arrangements entered into in accordance with Article 13 and 14 of the Protocol.
4. Paragraphs 1, 2 and 3 shall not apply to cases of transboundary movements covered by simplified procedures, notified in accordance with Article 13 of the Protocol, or by bilateral, regional and multilateral agreements or arrangements entered into in accordance with Article 14 of the Protocol, provided these agreements and arrangements do not result in a lower level of protection than that provided by the Protocol and this Regulation.

Justification

The amendment proposes to amend a part of the text of the common position which was not included in the proposal submitted in first reading. The amendment shall clarify that bilateral, regional or multilateral agreements the Community enters into should not result in a lower level of protection than provided for by the Protocol and by this regulation.

Amendment 9
Article 6

The exporter shall for a period of a minimum of five years keep a record of the notification referred to in Article 4 and the acknowledgement of receipt and the decision of the Party or, where appropriate, non-Party of import and send a copy of these documents to the competent authority of the Member State from which the GMO is exported and to the Commission.
The exporter shall for a period of a minimum of five years keep a record of the notification referred to in Article 4 and the acknowledgement of receipt and the decision of the Party or, where appropriate, non-Party of import and send a copy of these documents to the competent authority of the Member State from which the GMO is exported and to the Commission. Without prejudice to Article 16, the Commission shall make available to the public the notification referred to in Article 4.

(Partially reflects Am. 23 at first reading, adopted on 24th September 2002)

Justification

The amendment reflects first reading amendment 23 and takes into account the new Article 16 of the common position.

Amendment 10
Article 9, paragraph 1, subparagraph 1

1. The Commission on behalf of the Community or, where appropriate, the Member State which made the decision shall inform the BCH and other Parties through the BCH of any final decision regarding use, including placing on the market, within the Community or use within a Member State, of a GMO that may be subject to transboundary movements for direct use as food or feed or for processing. This information shall be sent to the BCH within fifteen days of the adoption of that decision.
1. The Commission on behalf of the Community shall inform the BCH and other Parties through the BCH of any final decision regarding use, including placing on the market, within the Community or use within a Member State, of a GMO that may be subject to transboundary movements for direct use as food or feed or for processing. This information shall be sent to the BCH within fifteen days of the adoption of that decision.

Justification

Article 9 paragraph 1 confuses responsibilities. While the Commission's proposal (see Art. 8.1) required the Commission to inform the BCH, the common position foresees two alternative information chains. Art. 9.1 does not define in which cases the Commission and in which cases the Member States shall inform BCH.

Amendment 11
Article 10, paragraph 2

2 If a developing country Party or non-Party of import or a Party or non-Party of import with an economy in transition has declared through the BCH that it will take a decision prior to an import of a specific GMO intended for direct use as food or feed, or for processing, in accordance with Article 11(6) of the Protocol, the exporter shall not proceed with the first export of such GMO unless the procedure provided for under that provision has been followed.
2. If a developing country Party or non-Party of import or a Party or non-Party of import with an economy in transition has declared through the BCH that it will take a decision prior to an import of a specific GMO intended for direct use as food or feed, or for processing, in accordance with Article 11(6) of the Protocol, the exporter shall not proceed with the first export of such GMO unless the procedure provided for under that provision has been followed. Where no decision is taken, Article 5 of this Regulation shall apply mutatis mutandis.

Justification

The amendment reflects the second sentence of amendment 29, adopted in 1st reading.

Amendment 12
Article 10, paragraph 3

3. Failure by the Party or non-Party of import to acknowledge receipt of a notification or to communicate its decision in accordance with paragraph 2 shall not imply its consent or refusal to the import of a GMO intended for direct use as food or feed, or for processing. No GMO that may be subject to transboundary movements for direct use as food or feed or for processing may be exported, unless it is authorised within the Community or the competent authority of a third country has expressly agreed to the import as required under Article 12 of Regulation (EC) No 178/2002 .

3. Failure by the Party or non-Party of import to acknowledge receipt of a notification or to communicate its decision in accordance with paragraph 2 shall not imply its consent or refusal to the import of a GMO intended for direct use as food or feed, or for processing. No GMO that may be subject to transboundary movements for direct use as food or feed or for processing may be exported, unless it is authorised within the Community.

Justification

By deleting this text this amendment places the proposed Regulation in conformity with the requirements of the Cartagena Protocol on Biosafety.

Amendment 13
Section 3a (new)

Section 3a

Food and feed produced from or with the aid of GMOs

Article 11a

Where a Party or non-Party of import requires, under its domestic regulatory framework, the notification of imports of food or feed produced from or with the aid of GMOs but not containing GMOs, the exporter shall comply with the laws and rules of the Party or non-Party of import in accordance with the Protocol.

(Partially reflects Am. 30 at first reading, adopted on 24th September 2002)

Justification

The amendment partially reflects first reading amendment 30. While the Council agreed to address in some more detail GMOs destined to be used for contained use operations (see Article 11), the common position does not address food and feed products produced from or with the aid of GMOs.

Amendment 14
Article 12, paragraph 2, subparagraph 2

Paragraph 1(b) shall not apply to products consisting of or containing mixtures of GMOs to be used only and directly as food or feed, or for processing. These products shall be subject to the traceability requirements of Directive 2001/18/EC and, when applicable, future Community legislation covering traceability, labelling and identification of such GMOs.
In the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed or for processing, the information referred to in paragraph 1(b) may be replaced by a declaration of use by the operator, accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the mixture.

Justification

The amendment proposes to amend a part of the text of the common position which was not included in the proposal submitted in first reading. The proposed new text is identical with Article 4 (3) of the common position adopted by the Council with a view to the adoption of the Regulation on traceability of GMOs and feed and food produced from GMOs (15798/02). To avoid any confusion, it would certainly be wise to quote the relevant provision here rather than to refer to the corresponding regulation.

Amendment 15
Article 16, paragraph 1

1. The Commission and the Member States shall not divulge to third parties any confidential in formation received or exchanged under this Regulation.
1. The Commission and the Member States shall not divulge to third parties any confidential information received or exchanged under this Regulation. However, they shall make available information received in accordance with Article 6 provided this information is not confidential.

Justification

The amendment clarifies the fact that the Commission and the Member States are the addressees of Amendment 24, adopted in the first reading and should also be the addressees of the new Art. 16, proposed by the Commission.

Amendment 16
Article 16, paragraph 3

3. The Party or, where appropriate, the non-Party of import shall, after consultation with the exporter, decide which information will be kept confidential and shall inform the exporter of its decisions.
Deleted

Justification

The Community cannot regulate parties of import. Art. 16 addresses the Commission and the Member States

Amendment 17
Article 16, paragraph 4, point (a)

(a) name and address of the exporter,
(a) name and address of the exporter and importer,

Justification

Whilst confidentiality is of great importance for the protection of intellectual property rights, this aspect must be balanced against the public's right to be informed. This restores an amendment from first reading which in the Rapporteur's view relates to information which the confidentiality of which is unnecessary to the defence of intellectual property rights and should therefore be in the public domain.

Amendment 18
Article 16, paragraph 4, point (c)

(c) a summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and
(c) a summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, including an indication of the purpose for which the release is intended and the location of the intended release and taking also into account risks to human health, and

Justification

See justification Am. 16.

PE 331.5/ 8
EN

PE 331.5/ 9
EN Full text of Amendments 019 - 026 PIN archive of Amendments 019 - 026

28 May 2003 A5-0154/ 19

AMENDMENT 19
tabled by Jonas Sjöstedt, on behalf of the GUE/NGL Group, Renate Sommer, on behalf of the PPE-DE Group, Torben Lund, on behalf of the PSE Group, Dirk Sterckx, on behalf of the ELDR Group, Jillian Evans, on behalf of the Verts/ALE Group, and Johannes Blokland, on behalf of the EDD Group

RECOMMENDATION FOR SECOND READING
by Jonas Sjöstedt A5-0154/2003
Transboundary movement of GMOs

Council common position
(15546/1/2002 &emdash; C5-0081/2003 &emdash; 2002/0046(COD))

Council common position

Amendments by Parliament

Amendment 19
Recital 5a (new)

(5a) Recognising the need to respect the Party or non-Party of import's regulatory biosafety framework consistent with the Protocol.

Justification

This is the first of eight amendments negotiated with the Presidency of the Council. This amendment replaces amendment 3 adopted in committee. Instead of amending the Council Common Position Chapter 1, Article 1 this recital is added.

Or. en AMENDMENT 20
tabled by Jonas Sjöstedt, on behalf of the GUE/NGL Group, Renate Sommer, on behalf of the PPE-DE Group, Torben Lund, on behalf of the PSE Group, Dirk Sterckx, on behalf of the ELDR Group, Jillian Evans, on behalf of the Verts/ALE Group, and Johannes Blokland, on behalf of the EDD Group

RECOMMENDATION FOR SECOND READING
by Jonas Sjöstedt A5-0154/2003
Transboundary movement of GMOs

Council common position
(15546/1/2002 &emdash; C5-0081/2003 &emdash; 2002/0046(COD))

Council common position

Amendments by Parliament

Amendment 20
Recital 5b (new)

(5b) Pharmaceuticals for humans that are addressed by other international agreements, to which the Community or the relevant Member State is party, or organisations, of which the Community or the relevant Member State is a member, should be excluded from the scope of this Regulation.

Justification

This is the second of eight amendments negotiated with the Presidency of the Council. This amendment replaces amendment 4 adopted in committee. Instead of amending the Council Common Position Chapter 1, Article 2(2) this recital is added.

Or. en AMENDMENT 21
tabled by Jonas Sjöstedt, on behalf of the GUE/NGL Group, Renate Sommer, on behalf of the PPE-DE Group, Torben Lund, on behalf of the PSE Group, Dirk Sterckx, on behalf of the ELDR Group, Jillian Evans, on behalf of the Verts/ALE Group, and Johannes Blokland, on behalf of the EDD Group

RECOMMENDATION FOR SECOND READING
by Jonas Sjöstedt A5-0154/2003
Transboundary movement of GMOs

Council common position
(15546/1/2002 &emdash; C5-0081/2003 &emdash; 2002/0046(COD))

Council common position

Amendments by Parliament

Amendment 21
Recital 8

(8) Exporters should await the express consent of the Party or non-Party of import before proceeding with the first transboundary movement of a GMO intended for deliberate release into the environment.
(8) Exporters should await the prior written, express consent of the Party or non-Party of import before proceeding with the first transboundary movement of a GMO intended for deliberate release into the environment.

Justification

This is the third of eight amendments negotiated with the Presidency of the Council. See justification for amendment 4. This amendment is necessary in order to bring the recital in line with the text agreed for Chapter II, Article 5 (1).

Or. en AMENDMENT 22
tabled by Jonas Sjöstedt, on behalf of the GUE/NGL Group, Renate Sommer, on behalf of the PPE-DE Group, Torben Lund, on behalf of the PSE Group, Dirk Sterckx, on behalf of the ELDR Group, Jillian Evans, on behalf of the Verts/ALE Group, and Johannes Blokland, on behalf of the EDD Group

RECOMMENDATION FOR SECOND READING
by Jonas Sjöstedt A5-0154/2003
Transboundary movement of GMOs

Council common position
(15546/1/2002 &emdash; C5-0081/2003 &emdash; 2002/0046(COD))

Council common position

Amendments by Parliament

Amendment 22
Article 5, paragraph 1

1. A failure by the Party of import to acknowledge receipt of a notification or to communicate its decision shall not imply its consent to an intentional transboundary movement. No first intentional transboundary movement may be made without express consent of the Party or, where appropriate, non-Party of import.
1. A failure by the Party of import to acknowledge receipt of a notification or to communicate its decision shall not imply its consent to an intentional transboundary movement. No first intentional transboundary movement may be made without prior written, express consent of the Party or, where appropriate, non-Party of import.

Justification

This is the fourth of eight amendments negotiated with the Presidency of the Council. This amendment replaces amendment 6 adopted in committee where the word "express" was replaced by"prior written".

Or. en AMENDMENT 23
tabled by Jonas Sjöstedt, on behalf of the GUE/NGL Group, Renate Sommer, on behalf of the PPE-DE Group, Torben Lund, on behalf of the PSE Group, Dirk Sterckx, on behalf of the ELDR Group, Jillian Evans, on behalf of the Verts/ALE Group, and Johannes Blokland, on behalf of the EDD Group

RECOMMENDATION FOR SECOND READING
by Jonas Sjöstedt A5-0154/2003
Transboundary movement of GMOs

Council common position
(15546/1/2002 &emdash; C5-0081/2003 &emdash; 2002/0046(COD))

Council common position

Amendments by Parliament

Amendment 23
Article 5, paragraph 3

3. The exporter shall not proceed with the first intentional transboundary movement of a GMO intended for deliberate release unless the procedures determined by the Party of import in accordance with Articles 9 and 10 of the Protocol or, where appropriate, equivalent procedures required by a non-Party of import have been followed.
3. Without prejudice to the requirements laid out in paragraph 1, the exporter shall not proceed with the first intentional transboundary movement of a GMO intended for deliberate release unless the procedures determined by the Party of import in accordance with Articles 9 and 10 of the Protocol or, where appropriate, equivalent procedures required by a non-Party of import have been followed.

Justification

This is the fifth of eight amendments negotiated with the Presidency of the Council. This amendment is identical to amendment 7 adopted in committe . It is important to clarify that, even where the procedures determined by the Party of import in accordance with Articles 9 and 10 of the Protocol, or equivalent procedures required by a non-Party of import have been followed, transboundary movement should not take place without that Party or non-Party's express consent. The words are added to avoid possible conflicts of interpretation between Article 5.1 and article 5.3.

Or. en AMENDMENT 24
tabled by Jonas Sjöstedt, on behalf of the GUE/NGL Group, Renate Sommer, on behalf of the PPE-DE Group, Torben Lund, on behalf of the PSE Group, Dirk Sterckx, on behalf of the ELDR Group, Jillian Evans, on behalf of the Verts/ALE Group, and Johannes Blokland, on behalf of the EDD Group

RECOMMENDATION FOR SECOND READING
by Jonas Sjöstedt A5-0154/2003
Transboundary movement of GMOs

Council common position
(15546/1/2002 &emdash; C5-0081/2003 &emdash; 2002/0046(COD))

Council common position

Amendments by Parliament

Amendment 24
Article 6

The exporter shall for a period of a minimum of five years keep a record of the notification referred to in Article 4 and the acknowledgement of receipt and the decision of the Party or, where appropriate, non-Party of import and send a copy of these documents to the competent authority of the Member State from which the GMO is exported and to the Commission.
The exporter shall for a period of a minimum of five years keep a record of the notification referred to in Article 4 and the acknowledgement of receipt and the decision of the Party or, where appropriate, non-Party of import and send a copy of these documents to the competent authority of the Member State from which the GMO is exported and to the Commission. Without prejudice to Article 16, the Commission shall make these documents available to the public in accordance with the Community rules on access to environ mental information.

Justification

This is the sixth of eight amendments negotiated with the Presidency of the Council.This amendment replaces amendment 9 adopted in committee. The wording has been slightly changed. The amendment partially reflects amendment 23 adopted in first reading on 24th of September 2002 and takes into account the new Article 16 of the Council Common Position.

Or. en AMENDMENT 25
tabled by Jonas Sjöstedt, on behalf of the GUE/NGL Group, Renate Sommer, on behalf of the PPE-DE Group, Torben Lund, on behalf of the PSE Group, Dirk Sterckx, on behalf of the ELDR Group, Jillian Evans, on behalf of the Verts/ALE Group, and Johannes Blokland, on behalf of the EDD Group

RECOMMENDATION FOR SECOND READING
by Jonas Sjöstedt A5-0154/2003
Transboundary movement of GMOs

Council common position
(15546/1/2002 &emdash; C5-0081/2003 &emdash; 2002/0046(COD))

Council common position

Amendments by Parliament

Amendment 25
Article 16, paragraph 3

3. The Party or, where appropriate, the non-Party of Import shall, after consultation with the exporter, decide which information will be kept confidential and shall inform the exporter of its decisions.
Deleted

Justification

This is the seventh of eight amendments negotiated with the Presidency of the Council. This amendment is identical to amendment 16 adopted in committee. The Community cannot regulate parties of import. Article 16 addresses the Commission and the Member States.

Or. en AMENDMENT 26
tabled by Jonas Sjöstedt, on behalf of the GUE/NGL Group, Renate Sommer, on behalf of the PPE-DE Group, Torben Lund, on behalf of the PSE Group, Dirk Sterckx, on behalf of the ELDR Group, Jillian Evans, on behalf of the Verts/ALE Group, and Johannes Blokland, on behalf of the EDD Group

RECOMMENDATION FOR SECOND READING
by Jonas Sjöstedt A5-0154/2003
Transboundary movement of GMOs

Council common position
(15546/1/2002 &emdash; C5-0081/2003 &emdash; 2002/0046(COD))

Council common position

Amendments by Parliament

Amendment 26
Article 16, paragraph 4, point (a)

(a) name and address of the exporter
(a) name and address of the exporter and importer,

Justification

This is the last of eight amendments negotiated with the Presidency of the Council. This amendment is identical to amendment 17 adopted in committee. This restores an amendment from first reading which in the Rapporteur's view relates to information which the confidentiality of which is unnecessary to the defence of intellectual property rights and should therefore be in the public domain.

Or. en

Report A5-0154/2003