# C_2022099EN.01006601.xml

| 1.3.2022 | EN | Official Journal of the European Union | C 99/66 |
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1.3.2022

EN

Official Journal of the European Union

C 99/66

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P9_TA(2021)0336

Genetically modified maize Bt 11 (SYN-BTØ11-1)

European Parliament resolution of 7 July 2021 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize Bt 11 (SYN-BTØ11-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D073424/01 — 2021/2761(RSP))

(2022/C 99/08)

The European Parliament,

| — | having regard to the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize Bt 11 (SYN-BTØ11-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D073424/01, |
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having regard to the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize Bt 11 (SYN-BTØ11-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D073424/01,

| — | having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 11(3) and 23(3) thereof, |
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having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 11(3) and 23(3) thereof,

| — | having regard to the vote of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003, on 17 May 2021, at which no opinion was delivered, |
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having regard to the vote of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003, on 17 May 2021, at which no opinion was delivered,

| — | having regard to Articles 11 and 13 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (2), |
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having regard to Articles 11 and 13 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (2),

| — | having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 25 November 2020, and published on 13 January 2021 (3), |
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having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 25 November 2020, and published on 13 January 2021 (3),

| — | having regard to its previous resolutions objecting to the authorisation of genetically modified organisms (‘GMOs’) (4), |
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having regard to its previous resolutions objecting to the authorisation of genetically modified organisms (‘GMOs’) (4),

| — | having regard to Rule 112(2) and (3) of its Rules of Procedure, |
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having regard to Rule 112(2) and (3) of its Rules of Procedure,

| — | having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety, |
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having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,

| A. | whereas, on 24 September 2018, Syngenta Crop Protection NV/SA, submitted to the Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of the authorisation for the placing on the market of products containing or consisting of genetically modified maize Bt11 (‘the GM maize’) for uses other than food and feed, with the exception of cultivation; |
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A.

whereas, on 24 September 2018, Syngenta Crop Protection NV/SA, submitted to the Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of the authorisation for the placing on the market of products containing or consisting of genetically modified maize Bt11 (‘the GM maize’) for uses other than food and feed, with the exception of cultivation;

| B. | whereas, on 25 November 2020, EFSA adopted a favourable opinion in relation to the renewal of the GM maize, which was published on 13 January 2021; whereas, on 28 January 2009, EFSA adopted a favourable opinion in relation to the initial authorisation of the GM maize which was published on 17 February 2009 (5); |
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B.

whereas, on 25 November 2020, EFSA adopted a favourable opinion in relation to the renewal of the GM maize, which was published on 13 January 2021; whereas, on 28 January 2009, EFSA adopted a favourable opinion in relation to the initial authorisation of the GM maize which was published on 17 February 2009 (5);

| C. | whereas the GM maize confers tolerance to herbicides containing glufosinate as well as producing an insecticidal protein, a ‘Bt toxin’, Cry1Ab which is toxic to certain lepidopteran pests (6); |
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C.

whereas the GM maize confers tolerance to herbicides containing glufosinate as well as producing an insecticidal protein, a ‘Bt toxin’, Cry1Ab which is toxic to certain lepidopteran pests (6);

Lack of assessment of herbicide residues, metabolites and cocktail effects

| D. | whereas a number of studies show that herbicide-tolerant GM crops result in a higher use of ‘complementary’ herbicides, in large part because of the emergence of herbicide-tolerant weeds (7); whereas, as a consequence, it has to be expected that the GM maize will be exposed to both higher and repeated doses of glufosinate, and that therefore a higher quantity of residues may be present in the harvest; |
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D.

whereas a number of studies show that herbicide-tolerant GM crops result in a higher use of ‘complementary’ herbicides, in large part because of the emergence of herbicide-tolerant weeds (7); whereas, as a consequence, it has to be expected that the GM maize will be exposed to both higher and repeated doses of glufosinate, and that therefore a higher quantity of residues may be present in the harvest;

| E. | whereas glufosinate is classified as toxic to reproduction 1B and therefore meets the ‘cut-off criteria’ set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council (8); whereas the approval of glufosinate for use in the Union expired on 31 July 2018 (9); |
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E.

whereas glufosinate is classified as toxic to reproduction 1B and therefore meets the ‘cut-off criteria’ set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council (8); whereas the approval of glufosinate for use in the Union expired on 31 July 2018 (9);

| F. | whereas assessment of herbicide residues and their break-down products found on GM plants is considered outside the remit of the EFSA Panel on Genetically Modified Organisms (‘EFSA GMO Panel’) and is therefore not undertaken as part of the authorisation process for GMOs; whereas this is problematic since the way in which complementary herbicides are broken down by the GM plant concerned, and the composition and thus toxicity of the break-down products (‘metabolites’), can be driven by the genetic modification itself; |
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F.

whereas assessment of herbicide residues and their break-down products found on GM plants is considered outside the remit of the EFSA Panel on Genetically Modified Organisms (‘EFSA GMO Panel’) and is therefore not undertaken as part of the authorisation process for GMOs; whereas this is problematic since the way in which complementary herbicides are broken down by the GM plant concerned, and the composition and thus toxicity of the break-down products (‘metabolites’), can be driven by the genetic modification itself;

| G. | whereas, due to specific agricultural practices in the cultivation of herbicide-tolerant GM plants, there are specific patterns of applications, exposure, occurrence of specific metabolites and emergence of combinatorial effects that require special attention; whereas those were not considered by EFSA; |
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G.

whereas, due to specific agricultural practices in the cultivation of herbicide-tolerant GM plants, there are specific patterns of applications, exposure, occurrence of specific metabolites and emergence of combinatorial effects that require special attention; whereas those were not considered by EFSA;

Outstanding questions concerning Bt toxins

| H. | whereas toxicological tests for GM authorisations are carried out with isolated Bt toxins; whereas little significance can be attributed to toxicological tests conducted with proteins in isolation due to the fact that Bt toxins in GM crops, such as maize, cotton and soybeans, are inherently more toxic than isolated Bt toxins; whereas this is because protease inhibitors (PI), present in the plant tissue, can increase the toxicity of the Bt toxins by delaying their degradation; whereas this phenomena has been demonstrated in a number of scientific studies, including one conducted for Monsanto 30 years ago which showed that even the presence of extremely low levels of PI enhanced the toxicity of Bt toxins up to 20-fold (10); |
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H.

whereas toxicological tests for GM authorisations are carried out with isolated Bt toxins; whereas little significance can be attributed to toxicological tests conducted with proteins in isolation due to the fact that Bt toxins in GM crops, such as maize, cotton and soybeans, are inherently more toxic than isolated Bt toxins; whereas this is because protease inhibitors (PI), present in the plant tissue, can increase the toxicity of the Bt toxins by delaying their degradation; whereas this phenomena has been demonstrated in a number of scientific studies, including one conducted for Monsanto 30 years ago which showed that even the presence of extremely low levels of PI enhanced the toxicity of Bt toxins up to 20-fold (10);

| I. | whereas those effects are not taken into account in EFSA risk assessments, even though they are relevant for all Bt plants approved for import or cultivation in the Union; whereas risks, arising from this enhanced toxicity due to the interaction between PI and Bt toxins, to humans and animals consuming food and feed containing Bt toxins cannot be ruled out; |
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I.

whereas those effects are not taken into account in EFSA risk assessments, even though they are relevant for all Bt plants approved for import or cultivation in the Union; whereas risks, arising from this enhanced toxicity due to the interaction between PI and Bt toxins, to humans and animals consuming food and feed containing Bt toxins cannot be ruled out;

| J. | whereas a number of studies show that side effects have been observed that may affect the immune system following exposure to Bt toxins and that some Bt toxins may have adjuvant properties (11), meaning that they can increase the allergenicity of other proteins with which they come into contact; |
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J.

whereas a number of studies show that side effects have been observed that may affect the immune system following exposure to Bt toxins and that some Bt toxins may have adjuvant properties (11), meaning that they can increase the allergenicity of other proteins with which they come into contact;

| K. | whereas assessment of the potential interaction of herbicide residues and their metabolites with Bt toxins is considered outside the remit of the EFSA GMO Panel and is therefore not undertaken as part of the risk assessment; whereas this is problematic since residues from spraying with glufosinate are known to disturb the microbiome which, for example, may enhance immune reactions in combination with Bt toxins (12); |
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K.

whereas assessment of the potential interaction of herbicide residues and their metabolites with Bt toxins is considered outside the remit of the EFSA GMO Panel and is therefore not undertaken as part of the risk assessment; whereas this is problematic since residues from spraying with glufosinate are known to disturb the microbiome which, for example, may enhance immune reactions in combination with Bt toxins (12);

Bt crops: effects on non-target organisms and increased resistance

| L. | whereas, unlike the use of insecticides, where exposure is at the time of spraying and for a limited time afterwards, the use of Bt GM crops leads to continuous exposure of the target and non-target organisms to Bt toxins; |
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L.

whereas, unlike the use of insecticides, where exposure is at the time of spraying and for a limited time afterwards, the use of Bt GM crops leads to continuous exposure of the target and non-target organisms to Bt toxins;

| M. | whereas the assumption that Bt toxins exhibit a single target-specific mode-of-action can no longer be considered correct and effects on non-target organisms cannot be excluded (13) whereas an increasing number of non-target organisms are reported to be affected in many ways; whereas 39 peer-reviewed publications that report significant adverse effects of Bt toxins on many ‘out-of-range’ species are mentioned in a recent overview (14); whereas a range of non-target organisms in the Union could be exposed to Bt toxins via spillage, waste and manure resulting from the import of Bt crops; whereas no effects on non-target organisms were evaluated in the risk assessment; |
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M.

whereas the assumption that Bt toxins exhibit a single target-specific mode-of-action can no longer be considered correct and effects on non-target organisms cannot be excluded (13) whereas an increasing number of non-target organisms are reported to be affected in many ways; whereas 39 peer-reviewed publications that report significant adverse effects of Bt toxins on many ‘out-of-range’ species are mentioned in a recent overview (14); whereas a range of non-target organisms in the Union could be exposed to Bt toxins via spillage, waste and manure resulting from the import of Bt crops; whereas no effects on non-target organisms were evaluated in the risk assessment;

| N. | whereas the risk assessment did not consider the development of resistance in the target pests to Bt toxins, possibly resulting in the use of less environmentally safe pesticides or increased doses and the number of applications to the GM crop in the country of cultivation; whereas, the United States Environmental Protection Agency is planning to phase out many Bt corn hybrids, as well as some Bt cotton varieties, in the next three to five years, due to the growth in insect resistance to such crops (15); |
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N.

whereas the risk assessment did not consider the development of resistance in the target pests to Bt toxins, possibly resulting in the use of less environmentally safe pesticides or increased doses and the number of applications to the GM crop in the country of cultivation; whereas, the United States Environmental Protection Agency is planning to phase out many Bt corn hybrids, as well as some Bt cotton varieties, in the next three to five years, due to the growth in insect resistance to such crops (15);

| O. | whereas, while it has been claimed that the use of Bt crops leads to a decrease in the use of insecticides, a study undertaken in the United States (16), finds that ‘several analyses on the influence of Bt crops on pesticide-use patterns do not seem to have considered seed treatments and so may have overstated reductions in insecticide use (especially “area treated”) associated with Bt crops’; |
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O.

whereas, while it has been claimed that the use of Bt crops leads to a decrease in the use of insecticides, a study undertaken in the United States (16), finds that ‘several analyses on the influence of Bt crops on pesticide-use patterns do not seem to have considered seed treatments and so may have overstated reductions in insecticide use (especially “area treated”) associated with Bt crops’;

| P. | whereas the Union is party to the United Nations (UN) Convention on Biological Diversity (UN CBD), which makes it clear that both exporting and importing countries have international responsibilities regarding biological diversity; |
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P.

whereas the Union is party to the United Nations (UN) Convention on Biological Diversity (UN CBD), which makes it clear that both exporting and importing countries have international responsibilities regarding biological diversity;

Comments by Member State competent authorities

| Q. | whereas Member State competent authorities submitted many comments to EFSA during the three-month consultation period (17); whereas those comments include criticism over the literature search performed by the applicant, that the monitoring reports of the GM maize for the authorisation period have severe shortcomings and that data on glufosinate residue levels, including relevant metabolites, in plant material from the field studies would support the assessment of food, feed, and environmental safety; whereas one competent authority requested an assessment of what impacts the GM crop has on biodiversity in producing and exporting countries, including on how the import of this crop influences the selection of crops in the Union and also raised the ethical issue of whether a commodity whose cultivation will entail operators’ exposure to glufosinate which is toxic for reproduction and no longer authorised in the Union, should be authorised for import into the Union; |
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Q.

whereas Member State competent authorities submitted many comments to EFSA during the three-month consultation period (17); whereas those comments include criticism over the literature search performed by the applicant, that the monitoring reports of the GM maize for the authorisation period have severe shortcomings and that data on glufosinate residue levels, including relevant metabolites, in plant material from the field studies would support the assessment of food, feed, and environmental safety; whereas one competent authority requested an assessment of what impacts the GM crop has on biodiversity in producing and exporting countries, including on how the import of this crop influences the selection of crops in the Union and also raised the ethical issue of whether a commodity whose cultivation will entail operators’ exposure to glufosinate which is toxic for reproduction and no longer authorised in the Union, should be authorised for import into the Union;

Upholding the Union’s international obligations

| R. | whereas Regulation (EC) No 1829/2003 provides that GM food or feed must not have adverse effects on human health, animal health or the environment, and requires the Commission to take into account any relevant provisions of Union law and other legitimate factors relevant to the matter under consideration when drafting its decision; whereas such legitimate factors should include the Union’s obligations under the UN Sustainable Development Goals (‘SDGs’), the Paris Climate Agreement and the UN CBD; |
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R.

whereas Regulation (EC) No 1829/2003 provides that GM food or feed must not have adverse effects on human health, animal health or the environment, and requires the Commission to take into account any relevant provisions of Union law and other legitimate factors relevant to the matter under consideration when drafting its decision; whereas such legitimate factors should include the Union’s obligations under the UN Sustainable Development Goals (‘SDGs’), the Paris Climate Agreement and the UN CBD;

| S. | whereas a 2017 report by the UN’s Special Rapporteur on the right to food found that, particularly in developing countries, hazardous pesticides have catastrophic impacts on health (18); whereas UN SDG Target 3.9 aims by 2030 to substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination (19); whereas authorising the import of the GM maize would increase demand for this crop treated with a herbicide that is toxic to reproduction and that is no longer authorised for use in the Union, thereby increasing the exposure of workers in third countries; whereas the risk of increased worker exposure is of particular concern in relation to herbicide-tolerant GM crops, given the higher volumes of herbicides used; |
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S.

whereas a 2017 report by the UN’s Special Rapporteur on the right to food found that, particularly in developing countries, hazardous pesticides have catastrophic impacts on health (18); whereas UN SDG Target 3.9 aims by 2030 to substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination (19); whereas authorising the import of the GM maize would increase demand for this crop treated with a herbicide that is toxic to reproduction and that is no longer authorised for use in the Union, thereby increasing the exposure of workers in third countries; whereas the risk of increased worker exposure is of particular concern in relation to herbicide-tolerant GM crops, given the higher volumes of herbicides used;

Undemocratic decision-making

| T. | whereas the vote on 17 May 2021 of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003 delivered no opinion, meaning that the authorisation was not supported by a qualified majority of Member States; |
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T.

whereas the vote on 17 May 2021 of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003 delivered no opinion, meaning that the authorisation was not supported by a qualified majority of Member States;

| U. | whereas the Commission recognises that the fact that GMO authorisation decisions continue to be adopted by the Commission without a qualified majority of Member States in favour, which is very much the exception for product authorisations as a whole but has become the norm for decision-making on GM food and feed authorisations, is problematic; |
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U.

whereas the Commission recognises that the fact that GMO authorisation decisions continue to be adopted by the Commission without a qualified majority of Member States in favour, which is very much the exception for product authorisations as a whole but has become the norm for decision-making on GM food and feed authorisations, is problematic;

| V. | whereas, in its eighth term, the European Parliament adopted a total of 36 resolutions objecting to the placing on the market of GMOs for food and feed (33 resolutions) and to the cultivation of GMOs in the Union (three resolutions); whereas, in its ninth term, the European Parliament has already adopted 18 objections to placing GMOs on the market; whereas there was not a qualified majority of Member States in favour of authorising any of those GMOs; whereas the reasons for Member States not supporting authorisations include lack of respect for the precautionary principle in the authorisation process and scientific concerns relating to the risk assessment; |
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V.

whereas, in its eighth term, the European Parliament adopted a total of 36 resolutions objecting to the placing on the market of GMOs for food and feed (33 resolutions) and to the cultivation of GMOs in the Union (three resolutions); whereas, in its ninth term, the European Parliament has already adopted 18 objections to placing GMOs on the market; whereas there was not a qualified majority of Member States in favour of authorising any of those GMOs; whereas the reasons for Member States not supporting authorisations include lack of respect for the precautionary principle in the authorisation process and scientific concerns relating to the risk assessment;

| W. | whereas despite its own acknowledgement of the democratic shortcomings, the lack of support from Member States and the objections of Parliament, the Commission continues to authorise GMOs; |
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W.

whereas despite its own acknowledgement of the democratic shortcomings, the lack of support from Member States and the objections of Parliament, the Commission continues to authorise GMOs;

| X. | whereas no change of law is required for the Commission to be able not to authorise GMOs when there is no qualified majority of Member States in favour in the Appeal Committee (20); |
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X.

whereas no change of law is required for the Commission to be able not to authorise GMOs when there is no qualified majority of Member States in favour in the Appeal Committee (20);

| 1. | Considers that the draft Commission implementing decision exceeds the implementing powers provided for in Regulation (EC) No 1829/2003; |
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1.

| 2. | Considers that the draft Commission implementing decision is not consistent with Union law, in that it is not compatible with the aim of Regulation (EC) No 1829/2003, which is, in accordance with the general principles laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council (21), to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, and environmental and consumer interests, in relation to GM food and feed, while ensuring the effective functioning of the internal market; |
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2.

| 3. | Calls on the Commission to withdraw its draft implementing decision; |
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3.

| 4. | Welcomes the fact that the Commission finally recognised, in a letter of 11 September 2020 to Members, the need to take sustainability into account when it comes to authorisation decisions on GMOs (22); expresses its deep disappointment, however, that, since then the Commission has continued to authorise GMOs for import into the Union, despite ongoing objections by Parliament and a majority of Member States voting against; |
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4.

| 5. | Calls on the Commission to move forward with the utmost urgency concerning the development of sustainability criteria, with full involvement of Parliament; calls on the Commission to provide information on how this process will be undertaken and in what timeframe; |
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5.

| 6. | Reiterates its call on the Commission not to authorise herbicide-tolerant GM crops until the health risks associated with the residues have been comprehensively investigated on a case-by-case basis, which requires a full assessment of the residues from spraying such GM crops with complementary herbicides, an assessment of the herbicide break-down products and any combinatorial effects, including with the GM plant itself; |
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6.

| 7. | Reiterates its call on the Commission not to authorise the import for food or feed uses of any GM plant which has been made tolerant to a herbicide-active substance that is not authorised for use in the Union; |
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7.

| 8. | Calls on EFSA to investigate the substantial differences between native Bt toxins and those expressed by synthetic transgenes in GM crop plants, and to widen its risk assessment in order to fully take into account all interactions and combinatorial effects between Bt-toxins, GM plants and their constituents, residues from spraying with the complementary herbicides, the environment as well as impacts on health and food safety; |
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8.

| 9. | Calls on EFSA to no longer accept toxicity studies based on isolated proteins which are likely to be different in structure and biological effects compared to those produced by the plant itself, and to require that all tests are carried out with tissue from the GM plant; |
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9.

| 10. | Calls on EFSA to request data on the impact of the consumption of food and feed derived from GM plants on the intestinal microbiome; |
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10.

| 11. | Urges the Commission, again, to take into account the Union’s obligations under international agreements, such as the Paris Climate Agreement, the UN CBD and the UN SDGs; reiterates its call for draft implementing acts to be accompanied by an explanatory memorandum explaining how they uphold the principle of ‘do no harm’ (23); |
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11.

| 12. | Highlights that the amendments adopted by the European Parliament on 17 December 2020 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011 (24), which were adopted in Parliament as a basis for negotiations with the Council, state that the Commission shall not authorise GMOs when there is not a qualified majority of Member States in favour; insists that the Commission respect this position and calls on the Council to proceed with its work and adopt a general approach on this file as a matter of urgency; |
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12.

| 13. | Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States. |
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13.

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(1)  OJ L 268, 18.10.2003, p. 1.

(2)  OJ L 55, 28.2.2011, p. 13.

(3)  Scientific Opinion of the EFSA Panel on Genetically Modified Organisms on assessment of genetically modified maize Bt11 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO RX-016), EFSA Journal 2021; 19(1):6347, https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.6347

(4)  In its eighth term, Parliament adopted 36 resolutions objecting to the authorisation of GMOs. Furthermore, in its ninth term Parliament has adopted the following resolutions:

| — | European Parliament resolution of 10 October 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MZHG0JG (SYN-ØØØJG-2), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0028). |
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European Parliament resolution of 10 October 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MZHG0JG (SYN-ØØØJG-2), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0028).

| — | European Parliament resolution of 10 October 2019 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0029). |
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European Parliament resolution of 10 October 2019 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0029).

| — | European Parliament resolution of 10 October 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS-40278-9 and genetically modified maize combining two, three or four of the single events MON 89034, 1507, MON 88017, 59122 and DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0030). |
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European Parliament resolution of 10 October 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS-40278-9 and genetically modified maize combining two, three or four of the single events MON 89034, 1507, MON 88017, 59122 and DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0030).

| — | European Parliament resolution of 14 November 2019 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified cotton LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0054). |
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European Parliament resolution of 14 November 2019 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified cotton LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0054).

| — | European Parliament resolution of 14 November 2019 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0055). |
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European Parliament resolution of 14 November 2019 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 89788 (MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0055).

| — | European Parliament resolution of 14 November 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and sub-combinations MON 89034 × NK603 × DAS-40278-9, 1507 × NK603 × DAS-40278-9 and NK603 × DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0056). |
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European Parliament resolution of 14 November 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and sub-combinations MON 89034 × NK603 × DAS-40278-9, 1507 × NK603 × DAS-40278-9 and NK603 × DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0056).

| — | European Parliament resolution of 14 November 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and genetically modified maize combining two, three, four or five of the single events Bt11, MIR162, MIR604, 1507, 5307 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0057). |
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European Parliament resolution of 14 November 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and genetically modified maize combining two, three, four or five of the single events Bt11, MIR162, MIR604, 1507, 5307 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2019)0057).

| — | European Parliament resolution of 14 May 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87708 × MON 89788 × A5547-127, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0069). |
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European Parliament resolution of 14 May 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87708 × MON 89788 × A5547-127, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0069).

| — | European Parliament resolution of 11 November 2020 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 × MIR162 × NK603 and genetically modified maize combining two or three of the single events MON 87427, MON 89034, MIR162 and NK603, and repealing Commission Implementing Decision (EU) 2018/1111 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0291). |
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European Parliament resolution of 11 November 2020 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 × MIR162 × NK603 and genetically modified maize combining two or three of the single events MON 87427, MON 89034, MIR162 and NK603, and repealing Commission Implementing Decision (EU) 2018/1111 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0291).

| — | European Parliament resolution of 11 November 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean SYHT0H2 (SYN-ØØØH2-5), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0292). |
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European Parliament resolution of 11 November 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean SYHT0H2 (SYN-ØØØH2-5), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0292).

| — | European Parliament resolution of 11 November 2020 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 87460 × MON 89034 × MIR162 × NK603 and genetically modified maize combining two, three or four of the single events MON 87427, MON 87460, MON 89034, MIR162 and NK603, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0293). |
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European Parliament resolution of 11 November 2020 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 87460 × MON 89034 × MIR162 × NK603 and genetically modified maize combining two, three or four of the single events MON 87427, MON 87460, MON 89034, MIR162 and NK603, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0293).

| — | European Parliament resolution of 17 December 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0365). |
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European Parliament resolution of 17 December 2020 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0365).

| — | European Parliament resolution of 17 December 2020 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 × MIR162 × MON 87411 and genetically modified maize combining two or three of the single events MON 87427, MON 89034, MIR162 and MON 87411 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0366). |
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European Parliament resolution of 17 December 2020 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 × MIR162 × MON 87411 and genetically modified maize combining two or three of the single events MON 87427, MON 89034, MIR162 and MON 87411 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0366).

| — | European Parliament resolution of 17 December 2020 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0367). |
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European Parliament resolution of 17 December 2020 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0367).

| — | European Parliament resolution of 17 December 2020 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 88017 (MON-88Ø17-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0368). |
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European Parliament resolution of 17 December 2020 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 88017 (MON-88Ø17-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0368).

| — | European Parliament resolution of 17 December 2020 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 (MON-89Ø34-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0369). |
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European Parliament resolution of 17 December 2020 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 (MON-89Ø34-3) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2020)0369).

| — | European Parliament resolution of 11 March 2021 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2021)0080). |
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European Parliament resolution of 11 March 2021 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2021)0080).

| — | European Parliament resolution of 11 March 2021 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MZIR098 (SYN-ØØØ98-3), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2021)0081). |
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European Parliament resolution of 11 March 2021 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MZIR098 (SYN-ØØØ98-3), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P9_TA(2021)0081).

(5)  Opinion of the EFSA Panel on Genetically Modified Organisms on application reference EFSA-GMO-RX-Bt11 for renewal of the authorisation of existing products produced from insect-resistant genetically modified maize Bt11, under Regulation (EC) No 1829/2003 from Syngenta, EFSA Journal 2009; 7(2):977, https://www.efsa.europa.eu/ en/efsajournal/pub/977

(6)  EFSA 2009 opinion, p. 2.

(7)  See, for example, Bonny, S., ‘Genetically Modified Herbicide-Tolerant Crops, Weeds, and Herbicides: Overview and Impact’, Environmental Management, January 2016; 57(1), pp. 31-48, https://www.ncbi.nlm.nih.gov/pubmed/26296738 and Benbrook, C.M., ‘Impacts of genetically engineered crops on pesticide use in the U.S. — the first sixteen years’, Environmental Sciences Europe; 28 September 2012, Vol. 24(1), https:// enveurope.springeropen.com/articles/10.1186/2190-4715-24-24

(8)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

(9)  https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=as.details&as_id=79

(10)  MacIntosh, S.C., Kishore, G.M., Perlak, F.J., Marrone, P.G., Stone, T.B., Sims, S.R., Fuchs, R.L., ‘Potentiation of Bacillus thuringiensis insecticidal activity by serine protease inhibitors’, Journal of Agricultural and Food Chemistry, 38, pp. 1145-1152, https://pubs. acs.org/doi/abs/10.1021/jf00094a051

(11)  For a review, see Rubio-Infante, N., Moreno-Fierros, L., ‘An overview of the safety and biological effects of Bacillus thuringiensis Cry toxins in mammals’, Journal of Applied Toxicology, May 2016, 36(5), pp. 630 648, https://onlinelibrary.wiley.com/ doi/full/10.1002/jat.3252

(12)  Parenti, M.D., Santoro, A., Del Rio, A., Franceschi, C., ‘Literature review in support of adjuvanticity/immunogenicity assessment of proteins’, EFSA Supporting Publications, January 2019, 16(1): 1551, https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/ sp.efsa.2019.EN-1551

(13)  See, for example, Hilbeck, A., Otto, M., ‘Specificity and combinatorial effects of Bacillus thuringiensis Cry toxins in the context of GMO environmental risk assessment’, Frontiers in Environmental Science 2015, 3:71, https://doi.org/10.3389/fenvs.2015.00071

(14)  Hilbeck, A., Defarge, N., Lebrecht, T., Bøhn, T., ‘Insecticidal Bt crops. EFSA’s risk assessment approach for GM Bt plants fails by design’, RAGES 2020, p. 4, https://www.testbiotech.org/sites/default/files/RAGES_report-Insecticidal %20Bt%20plants.pdf

(15)  https://www.dtnpf.com/agriculture/web/ag/crops/article/2020/09/29/epa-proposes-phasing-dozens-bt-corn

(16)  Douglas, M.R., Tooker, J.F., ‘Large-Scale Deployment of Seed Treatments Has Driven Rapid Increase in Use of Neonicotinoid Insecticides and Preemptive Pest Management in U.S. Field Crops’, Environmental Science and Technology 2015, 49, 8, pp. 5088-5097, https://pubs.acs.org/doi/10.1021/es506141g

(17)  State comments on the GM maize can be accessed via EFSA’s register of questions: http://registerofquestions.efsa.europa.eu/roqFrontend/login?

(18)  https://www.ohchr.org/EN/Issues/Food/Pages/Pesticides.aspx

(19)  https://sdgs.un.org/2030agenda

(20)  The Commission ‘may’ and not ‘shall’, go ahead with authorisation if there is no qualified majority of Member States in favour at the Appeal Committee, according to Regulation (EU) No 182/2011 (Article 6(3)).

(21)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

(22)  https://tillymetz.lu/wp-content/uploads/2020/09/Co-signed-letter-MEP-Metz.pdf

(23)  Texts adopted, P9_TA(2020)0005, paragraph 102.

(24)  Texts adopted, P9_TA(2020)0364.

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