BETA


2018/2569(RSP) Resolution on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603, and repealing Decision 2010/420/EU

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI PIETIKÄINEN Sirpa (icon: PPE PPE), BALAS Guillaume (icon: S&D S&D), MAZURONIS Valentinas (icon: ALDE ALDE), STAES Bart (icon: Verts/ALE Verts/ALE), EVI Eleonora (icon: EFDD EFDD)
Lead committee dossier:
Legal Basis:
RoP 112-p2

Events

2018/07/23
   EC - Commission response to text adopted in plenary
Documents
2018/03/01
   EP - Motion for a resolution
Documents
2018/03/01
   EP - Results of vote in Parliament
2018/03/01
   EP - Decision by Parliament
Details

The European Parliament adopted by 402 votes to 208, with 25 abstentions, a resolution objecting to the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603, and repealing Decision 2010/420/EU.

On 13 September 2013, Monsanto Europe S.A. submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified (GM) maize MON 87427 × MON 89034 × NK603 to the national competent authority of Belgium. It covers the placing on the market of products consisting of or containing genetically modified maize MON 87427 × MON 89034 × NK603 for uses other than food and feed as any other maize, with the exception of cultivation.

The application covered, for those uses, all three sub-combinations of GM maize MON 87427 × MON 89034 × NK603.

GM maize MON 87427 × MON 89034 × NK603 contains two genes for glyphosate resistance and produces Cry1A.105 and Cry2Ab2 proteins which confer resistance to specific lepidopteran pests.

Although the European Food Safety Authority (EFSA) adopted a favourable opinion to renew the authorisation, many critical comments were submitted by Member States in relation to the opinion during the three-month consultation period relating to:

the fact that the compositional analysis does not cover residues of the complementary herbicides nor its metabolites; that, due to concerns over studies showing an increase in the incidence of bladder stones in mice fed on MON 89034, a conclusion about the risks associated with the use of this GM organism (‘GMO’) in human or animal food cannot be drawn; that further information is required before the risk assessment can be finalised.

Other areas of concern include : (i) the lack of experimental data for MON 87427 × MON 89034 and MON 87427 × NK603 sub-combinations; (ii) the post-market environmental monitoring plan submitted by the applicant for the three-event stack maize does not include any provisions for the two sub-combinations MON 87427 × MON 89034 and MON 87427 × NK603.

Members also questioned the issue concerning the carcinogenicity of glyphosate . However, one of the key purposes of the stacked event is to increase the plant’s tolerance to glyphosate (both NK603 and MON 87427 express EPSPS enzymes which confer tolerance to glyphosate). In consequence, it has to be expected that the plant will be exposed to higher and also repeated dosages of glyphosate.

On the basis of these considerations, Parliament considered that the Commission’s implementing decision is not compatible with Union law which requires the provision of the basis for ensuring a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, while ensuring the effective functioning of the internal market.

As a result, Parliament asked the Commission to withdraw its draft implementing decision.

On a procedural level , Members recalled that since the entry into force of authorisation procedure for GMOs, authorisation decisions have been adopted by the Commission without the support of the Standing Committee on the Food Chain and Animal Health.

Moreover, the return of the dossier to the Commission for final decision , which is very much the exception for the procedure as a whole, has become the norm for decision-making on genetically modified food and feed authorisations. This practice has also been deplored by Commission President Juncker as not being democratic .

Parliament also called on the Commission to suspend any implementing decision regarding applications for authorisation of GMOs until the authorisation procedure has been revised in such a way so as to address the shortcomings of the current procedure, which has proven inadequate.

It also called on the legislators responsible to advance work on the Commission proposal amending Regulation (EU) No 182/2011 on comitology as a matter of urgency and to ensure that, inter alia , if no opinion is delivered by the Food Chain and Animal Health Standing Committee with respect to GMOs approvals, either for cultivation or for food and feed, the Commission will withdraw the proposal.

Parliament also called on the Commission to:

not to authorise any herbicide-tolerant genetically modified plants (HT GMP) without full assessment of the residues from spraying with the complementary herbicides and their commercial formulations as applied in the countries of cultivation; request much more detailed testing of health risks relating to stacked events such as genetically modified maize MON 87427 × MON 89034 × NK603; develop strategies for health risk assessment , toxicology and post-market monitoring that target the whole food and feed chain; fully integrate the risk assessment of the application of complementary herbicides and their residues into the risk assessment of HT GMP, regardless of whether the GM plant is for cultivation in the Union or for import for food and feed.

Documents
2018/03/01
   EP - End of procedure in Parliament
2018/01/29
   EP - PIETIKÄINEN Sirpa (PPE) appointed as rapporteur in ENVI
2018/01/29
   EP - BALAS Guillaume (S&D) appointed as rapporteur in ENVI
2018/01/29
   EP - MAZURONIS Valentinas (ALDE) appointed as rapporteur in ENVI
2018/01/29
   EP - STAES Bart (Verts/ALE) appointed as rapporteur in ENVI
2018/01/29
   EP - EVI Eleonora (EFDD) appointed as rapporteur in ENVI

Documents

Votes

B8-0124/2018 - Résolution 01/03/2018 12:18:39.000 #

2018/03/01 Outcome: +: 402, -: 208, 0: 25
IT FR HU DE EL AT PT PL GB CY SE MT LV BG DK SK LU SI ES NL RO LT BE IE EE HR FI CZ
Total
45
60
16
84
19
17
19
48
58
6
18
6
7
15
13
11
5
7
49
22
28
10
20
8
4
9
13
17
icon: S&D S&D
162

Cyprus S&D

2

Malta S&D

3

Latvia S&D

1

Luxembourg S&D

For (1)

1

Netherlands S&D

3

Estonia S&D

For (1)

1
icon: Verts/ALE Verts/ALE
46

Italy Verts/ALE

For (1)

1

Hungary Verts/ALE

For (1)

1

Austria Verts/ALE

2

United Kingdom Verts/ALE

5

Latvia Verts/ALE

1

Denmark Verts/ALE

For (1)

1

Luxembourg Verts/ALE

For (1)

1

Slovenia Verts/ALE

For (1)

1

Spain Verts/ALE

3

Netherlands Verts/ALE

2

Lithuania Verts/ALE

For (1)

1

Belgium Verts/ALE

2

Estonia Verts/ALE

For (1)

1

Croatia Verts/ALE

For (1)

1

Finland Verts/ALE

For (1)

1
icon: GUE/NGL GUE/NGL
44

United Kingdom GUE/NGL

1

Cyprus GUE/NGL

2

Sweden GUE/NGL

For (1)

1

Denmark GUE/NGL

For (1)

1

Netherlands GUE/NGL

3

Ireland GUE/NGL

3

Finland GUE/NGL

For (1)

1

Czechia GUE/NGL

2
icon: ENF ENF
27

Italy ENF

2
2

United Kingdom ENF

Abstain (1)

1

Netherlands ENF

3

Romania ENF

1
icon: EFDD EFDD
34

Germany EFDD

Abstain (1)

1

Poland EFDD

1

Sweden EFDD

2
icon: NI NI
15

France NI

For (1)

Against (1)

2

Hungary NI

2

Germany NI

2

United Kingdom NI

Against (1)

1

Denmark NI

1
icon: ECR ECR
58

Italy ECR

Against (1)

1

Germany ECR

For (1)

4

Greece ECR

For (1)

1

Cyprus ECR

1

Latvia ECR

For (1)

1

Bulgaria ECR

2

Slovakia ECR

Against (1)

2

Netherlands ECR

For (1)

1

Romania ECR

Against (1)

1

Lithuania ECR

1

Croatia ECR

Against (1)

1

Finland ECR

Against (1)

2

Czechia ECR

2
icon: ALDE ALDE
58

Germany ALDE

For (1)

3

Austria ALDE

Against (1)

1

Portugal ALDE

1

United Kingdom ALDE

Against (1)

1

Sweden ALDE

2

Latvia ALDE

1

Bulgaria ALDE

For (1)

4

Denmark ALDE

3

Slovenia ALDE

Against (1)

1

Romania ALDE

Against (1)

3

Lithuania ALDE

Against (1)

Abstain (1)

3

Ireland ALDE

For (1)

1

Estonia ALDE

Against (1)

1

Croatia ALDE

For (1)

Against (1)

2
icon: PPE PPE
190

United Kingdom PPE

2

Cyprus PPE

1

Latvia PPE

Against (1)

3

Denmark PPE

Against (1)

1

Luxembourg PPE

3

Belgium PPE

4

Estonia PPE

Against (1)

1

Finland PPE

3

History

(these mark the time of scraping, not the official date of the change)

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  • date: 2018-03-01T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2018-0052 type: Decision by Parliament, 1st reading/single reading title: T8-0052/2018 body: EP type: Decision by Parliament, 1st reading/single reading
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  • date: 2018-03-01T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=MOTION&reference=B8-2018-0124&language=EN title: B8-0124/2018 type: Motion for a resolution body: EP
  • date: 2018-07-23T00:00:00 docs: url: /oeil/spdoc.do?i=30819&j=0&l=en title: SP(2018)292 type: Commission response to text adopted in plenary
events
  • date: 2018-03-01T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=30819&l=en title: Results of vote in Parliament
  • date: 2018-03-01T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2018-0052 title: T8-0052/2018 summary: The European Parliament adopted by 402 votes to 208, with 25 abstentions, a resolution objecting to the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603, and repealing Decision 2010/420/EU. On 13 September 2013, Monsanto Europe S.A. submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified (GM) maize MON 87427 × MON 89034 × NK603 to the national competent authority of Belgium. It covers the placing on the market of products consisting of or containing genetically modified maize MON 87427 × MON 89034 × NK603 for uses other than food and feed as any other maize, with the exception of cultivation. The application covered, for those uses, all three sub-combinations of GM maize MON 87427 × MON 89034 × NK603. GM maize MON 87427 × MON 89034 × NK603 contains two genes for glyphosate resistance and produces Cry1A.105 and Cry2Ab2 proteins which confer resistance to specific lepidopteran pests. Although the European Food Safety Authority (EFSA) adopted a favourable opinion to renew the authorisation, many critical comments were submitted by Member States in relation to the opinion during the three-month consultation period relating to: the fact that the compositional analysis does not cover residues of the complementary herbicides nor its metabolites; that, due to concerns over studies showing an increase in the incidence of bladder stones in mice fed on MON 89034, a conclusion about the risks associated with the use of this GM organism (‘GMO’) in human or animal food cannot be drawn; that further information is required before the risk assessment can be finalised. Other areas of concern include : (i) the lack of experimental data for MON 87427 × MON 89034 and MON 87427 × NK603 sub-combinations; (ii) the post-market environmental monitoring plan submitted by the applicant for the three-event stack maize does not include any provisions for the two sub-combinations MON 87427 × MON 89034 and MON 87427 × NK603. Members also questioned the issue concerning the carcinogenicity of glyphosate . However, one of the key purposes of the stacked event is to increase the plant’s tolerance to glyphosate (both NK603 and MON 87427 express EPSPS enzymes which confer tolerance to glyphosate). In consequence, it has to be expected that the plant will be exposed to higher and also repeated dosages of glyphosate. On the basis of these considerations, Parliament considered that the Commission’s implementing decision is not compatible with Union law which requires the provision of the basis for ensuring a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, while ensuring the effective functioning of the internal market. As a result, Parliament asked the Commission to withdraw its draft implementing decision. On a procedural level , Members recalled that since the entry into force of authorisation procedure for GMOs, authorisation decisions have been adopted by the Commission without the support of the Standing Committee on the Food Chain and Animal Health. Moreover, the return of the dossier to the Commission for final decision , which is very much the exception for the procedure as a whole, has become the norm for decision-making on genetically modified food and feed authorisations. This practice has also been deplored by Commission President Juncker as not being democratic . Parliament also called on the Commission to suspend any implementing decision regarding applications for authorisation of GMOs until the authorisation procedure has been revised in such a way so as to address the shortcomings of the current procedure, which has proven inadequate. It also called on the legislators responsible to advance work on the Commission proposal amending Regulation (EU) No 182/2011 on comitology as a matter of urgency and to ensure that, inter alia , if no opinion is delivered by the Food Chain and Animal Health Standing Committee with respect to GMOs approvals, either for cultivation or for food and feed, the Commission will withdraw the proposal. Parliament also called on the Commission to: not to authorise any herbicide-tolerant genetically modified plants (HT GMP) without full assessment of the residues from spraying with the complementary herbicides and their commercial formulations as applied in the countries of cultivation; request much more detailed testing of health risks relating to stacked events such as genetically modified maize MON 87427 × MON 89034 × NK603; develop strategies for health risk assessment , toxicology and post-market monitoring that target the whole food and feed chain; fully integrate the risk assessment of the application of complementary herbicides and their residues into the risk assessment of HT GMP, regardless of whether the GM plant is for cultivation in the Union or for import for food and feed.
  • date: 2018-03-01T00:00:00 type: End of procedure in Parliament body: EP
links
other
    procedure/dossier_of_the_committee
    Old
    ENVI/8/12161
    New
    • ENVI/8/12161
    procedure/legal_basis/0
    Rules of Procedure EP 112-p2
    procedure/legal_basis/0
    Rules of Procedure of the European Parliament EP 106-p2
    procedure/subject
    Old
    • 3.10.09.06 Agro-genetics, GMOs
    New
    3.10.09.06
    Agro-genetics, GMOs
    procedure/title
    Old
    Authorisation of genetically modified maize MON 87427 x MON 89034 x NK603
    New
    Resolution on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603, and repealing Decision 2010/420/EU
    activities/0/docs/0/text
    • The European Parliament adopted by 402 votes to 208, with 25 abstentions, a resolution objecting to the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603, and repealing Decision 2010/420/EU.

      On 13 September 2013, Monsanto Europe S.A. submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified (GM) maize MON 87427 × MON 89034 × NK603 to the national competent authority of Belgium. It covers the placing on the market of products consisting of or containing genetically modified maize MON 87427 × MON 89034 × NK603 for uses other than food and feed as any other maize, with the exception of cultivation.

      The application covered, for those uses, all three sub-combinations of GM maize MON 87427 × MON 89034 × NK603.

      GM maize MON 87427 × MON 89034 × NK603 contains two genes for glyphosate resistance and produces Cry1A.105 and Cry2Ab2 proteins which confer resistance to specific lepidopteran pests.

      Although the European Food Safety Authority (EFSA) adopted a favourable opinion to renew the authorisation, many critical comments were submitted by Member States in relation to the opinion during the three-month consultation period relating to:

      • the fact that the compositional analysis does not cover residues of the complementary herbicides nor its metabolites;
      • that, due to concerns over studies showing an increase in the incidence of bladder stones in mice fed on MON 89034, a conclusion about the risks associated with the use of this GM organism (‘GMO’) in human or animal food cannot be drawn;
      • that further information is required before the risk assessment can be finalised.

      Other areas of concern include: (i) the lack of experimental data for MON 87427 × MON 89034 and MON 87427 × NK603 sub-combinations; (ii) the post-market environmental monitoring plan submitted by the applicant for the three-event stack maize does not include any provisions for the two sub-combinations MON 87427 × MON 89034 and MON 87427 × NK603.

      Members also questioned the issue concerning the carcinogenicity of glyphosate. However, one of the key purposes of the stacked event is to increase the plant’s tolerance to glyphosate (both NK603 and MON 87427 express EPSPS enzymes which confer tolerance to glyphosate). In consequence, it has to be expected that the plant will be exposed to higher and also repeated dosages of glyphosate.

      On the basis of these considerations, Parliament considered that the Commission’s implementing decision is not compatible with Union law which requires the provision of the basis for ensuring a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, while ensuring the effective functioning of the internal market.

      As a result, Parliament asked the Commission to withdraw its draft implementing decision.

      On a procedural level, Members recalled that since the entry into force of authorisation procedure for GMOs, authorisation decisions have been adopted by the Commission without the support of the Standing Committee on the Food Chain and Animal Health.

      Moreover, the return of the dossier to the Commission for final decision, which is very much the exception for the procedure as a whole, has become the norm for decision-making on genetically modified food and feed authorisations. This practice has also been deplored by Commission President Juncker as not being democratic.

      Parliament also called on the Commission to suspend any implementing decision regarding applications for authorisation of GMOs until the authorisation procedure has been revised in such a way so as to address the shortcomings of the current procedure, which has proven inadequate.

      It also called on the legislators responsible to advance work on the Commission proposal amending Regulation (EU) No 182/2011 on comitology as a matter of urgency and to ensure that, inter alia, if no opinion is delivered by the Food Chain and Animal Health Standing Committee with respect to GMOs approvals, either for cultivation or for food and feed, the Commission will withdraw the proposal.

      Parliament also called on the Commission to:

      • not to authorise any herbicide-tolerant genetically modified plants (HT GMP) without full assessment of the residues from spraying with the complementary herbicides and their commercial formulations as applied in the countries of cultivation;
      • request much more detailed testing of health risks relating to stacked events such as genetically modified maize MON 87427 × MON 89034 × NK603;
      • develop strategies for health risk assessment, toxicology and post-market monitoring that target the whole food and feed chain;
      • fully integrate the risk assessment of the application of complementary herbicides and their residues into the risk assessment of HT GMP, regardless of whether the GM plant is for cultivation in the Union or for import for food and feed.
    activities/0/docs
    • url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2018-0052 type: Decision by Parliament, 1st reading/single reading title: T8-0052/2018
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    committees
    • body: EP responsible: True committee: ENVI date: 2018-01-29T00:00:00 2018-01-29T00:00:00 2018-01-29T00:00:00 2018-01-29T00:00:00 2018-01-29T00:00:00 2018-01-29T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: EPP name: PIETIKÄINEN Sirpa group: S&D name: BALAS Guillaume group: ALDE name: MAZURONIS Valentinas group: GUE/NGL name: BOYLAN Lynn group: Verts/ALE name: STAES Bart group: EFD name: EVI Eleonora
    links
    other
      procedure
      dossier_of_the_committee
      ENVI/8/12161
      reference
      2018/2569(RSP)
      title
      Authorisation of genetically modified maize MON 87427 x MON 89034 x NK603
      legal_basis
      Rules of Procedure of the European Parliament EP 106-p2
      stage_reached
      Awaiting Parliament 1st reading / single reading / budget 1st stage
      subtype
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      RSP - Resolutions on topical subjects
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      3.10.09.06 Agro-genetics, GMOs