# C_2021474EN.01006601.xml

| 24.11.2021 | EN | Official Journal of the European Union | C 474/66 |
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24.11.2021

EN

Official Journal of the European Union

C 474/66

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P9_TA(2021)0080

Genetically modified cotton GHB614 × T304-40 × GHB119

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 (D070621/02 — 2021/2553(RSP))

(2021/C 474/06)

The European Parliament,

| — | having regard to 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 (D070621/02, |
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having regard to 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 (D070621/02,

| — | 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 7(3) and 19(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 7(3) and 19(3) thereof,

| — | having regard to Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (2), |
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having regard to Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (2),

| — | 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 11 January 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 11 January 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 (3), |
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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 (3),

| — | having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 21 June 2018, and published on 25 July 2018 (4) |
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having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 21 June 2018, and published on 25 July 2018 (4)

| — | having regard to its previous resolutions objecting to the authorisation of genetically modified organisms (‘GMOs’) (5), |
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having regard to its previous resolutions objecting to the authorisation of genetically modified organisms (‘GMOs’) (5),

| — | 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 30 September 2014, Bayer CropScience AG (‘the applicant’) submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119 (‘the GM cotton’) in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003; whereas the application also covered the placing on the market of products containing or consisting of the GM cotton for uses other than food and feed, with the exception of cultivation; |
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A.

whereas, on 30 September 2014, Bayer CropScience AG (‘the applicant’) submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified cotton GHB614 × T304-40 × GHB119 (‘the GM cotton’) in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003; whereas the application also covered the placing on the market of products containing or consisting of the GM cotton for uses other than food and feed, with the exception of cultivation;

| B. | whereas, on 21 June 2018, EFSA adopted a favourable opinion, which was published on 25 July 2018; |
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B.

whereas, on 21 June 2018, EFSA adopted a favourable opinion, which was published on 25 July 2018;

| C. | whereas the GM cotton is derived from crossing three genetically modified (‘GM’) cotton events, and confers tolerance to herbicides containing glufosinate and glyphosate (the ‘complementary herbicides’) as well as producing two insecticidal proteins (‘Bt’ or ‘Cry’ toxins): Cry1Ab and Cry2Ae, which are toxic to certain lepidopteran larvae feeding on cotton (6); |
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C.

whereas the GM cotton is derived from crossing three genetically modified (‘GM’) cotton events, and confers tolerance to herbicides containing glufosinate and glyphosate (the ‘complementary herbicides’) as well as producing two insecticidal proteins (‘Bt’ or ‘Cry’ toxins): Cry1Ab and Cry2Ae, which are toxic to certain lepidopteran larvae feeding on cotton (6);

| D. | whereas while the human consumption of cottonseed oil may be relatively limited in Europe, it can be found in a wide variety of food products, including dressings, mayonnaise, fine bakery wares, chocolate spreads and chips; whereas cotton is fed to animals mainly in the form of cottonseed cake/meal or as full fat cottonseeds (7); whereas cotton is also consumed in the form of cotton flour by humans; |
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D.

whereas while the human consumption of cottonseed oil may be relatively limited in Europe, it can be found in a wide variety of food products, including dressings, mayonnaise, fine bakery wares, chocolate spreads and chips; whereas cotton is fed to animals mainly in the form of cottonseed cake/meal or as full fat cottonseeds (7); whereas cotton is also consumed in the form of cotton flour by humans;

| E. | whereas Regulation (EC) No 1829/2003 states 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 United Nations (UN) Sustainable Development Goals (‘SDGs’), the Paris Climate Agreement and the UN Convention on Biological Diversity (‘UN CBD’); |
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E.

whereas Regulation (EC) No 1829/2003 states 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 United Nations (UN) Sustainable Development Goals (‘SDGs’), the Paris Climate Agreement and the UN Convention on Biological Diversity (‘UN CBD’);

| F. | whereas Implementing Regulation (EU) No 503/2013 requires an assessment of whether the expected agricultural practices influence the outcome of the studied endpoints; whereas, according to that Implementing Regulation, this is especially relevant for herbicide resistant plants; whereas, furthermore, the different sites selected for the field trials shall reflect the different meteorological and agronomic conditions under which the crop is to be grown; |
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F.

whereas Implementing Regulation (EU) No 503/2013 requires an assessment of whether the expected agricultural practices influence the outcome of the studied endpoints; whereas, according to that Implementing Regulation, this is especially relevant for herbicide resistant plants; whereas, furthermore, the different sites selected for the field trials shall reflect the different meteorological and agronomic conditions under which the crop is to be grown;

Lack of data on gene expression and plant composition

| G. | whereas, field trials for the compositional and agronomic assessment of the GM cotton were conducted in the United States at only eight sites, but not in other relevant cotton producing areas; whereas only data from one year, 2012, were used to produce data on the relevant meteorological conditions under which the plants may be grown; |
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G.

whereas, field trials for the compositional and agronomic assessment of the GM cotton were conducted in the United States at only eight sites, but not in other relevant cotton producing areas; whereas only data from one year, 2012, were used to produce data on the relevant meteorological conditions under which the plants may be grown;

| H. | whereas, glufosinate and glyphosate were not used in the high doses that may be expected in the context of increasing weed resistance; |
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H.

whereas, glufosinate and glyphosate were not used in the high doses that may be expected in the context of increasing weed resistance;

| I. | whereas EFSA failed to request further studies, e.g. field trials lasting for more than one season and from sites in other cotton producing regions; whereas, furthermore, no data were generated representing more extreme environmental conditions, such as those caused by climate change, even though it has been shown that environmental factors can impact the expression of Bt toxins (8); |
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I.

whereas EFSA failed to request further studies, e.g. field trials lasting for more than one season and from sites in other cotton producing regions; whereas, furthermore, no data were generated representing more extreme environmental conditions, such as those caused by climate change, even though it has been shown that environmental factors can impact the expression of Bt toxins (8);

Lack of assessment of the complementary herbicides

| J. | 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 (9); whereas, as a consequence, it has to be expected that the GM cotton will be exposed to both higher and repeated doses of glufosinate and glyphosate, and that therefore a higher quantity of residues may be present in the harvest; |
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J.

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 (9); whereas, as a consequence, it has to be expected that the GM cotton will be exposed to both higher and repeated doses of glufosinate and glyphosate, and that therefore a higher quantity of residues may be present in the harvest;

| K. | whereas questions concerning the carcinogenicity of glyphosate remain; whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic and the European Chemicals Agency concluded in March 2017 that no classification was warranted; whereas, on the contrary, in 2015, the International Agency for Research on Cancer, the specialised cancer agency of the World Health Organization, classified glyphosate as a probable carcinogen for humans; |
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K.

whereas questions concerning the carcinogenicity of glyphosate remain; whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic and the European Chemicals Agency concluded in March 2017 that no classification was warranted; whereas, on the contrary, in 2015, the International Agency for Research on Cancer, the specialised cancer agency of the World Health Organization, classified glyphosate as a probable carcinogen for humans;

| L. | whereas, according to EFSA, toxicological data allowing a consumer risk assessment to be performed for several break-down products of glyphosate relevant for GM glyphosate-tolerant crops are missing (10); |
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L.

whereas, according to EFSA, toxicological data allowing a consumer risk assessment to be performed for several break-down products of glyphosate relevant for GM glyphosate-tolerant crops are missing (10);

| M. | 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 (11); whereas the approval of glufosinate for use in the Union expired on 31 July 2018 (12); whereas the GM cotton has been made doubly tolerant to glufosinate, allowing even higher doses to be used on the plants; |
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M.

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 (11); whereas the approval of glufosinate for use in the Union expired on 31 July 2018 (12); whereas the GM cotton has been made doubly tolerant to glufosinate, allowing even higher doses to be used on the plants;

| N. | whereas studies show that glyphosate and glufosinate can severely impact the microbiome (13), and consequently the long term toxicity (mixed toxicity) of whole food and feed of the Bt toxins on the intestinal gut from spraying with glyphosate and glufosinate should first be assessed before any conclusion can be reached on health impacts and food safety; |
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N.

whereas studies show that glyphosate and glufosinate can severely impact the microbiome (13), and consequently the long term toxicity (mixed toxicity) of whole food and feed of the Bt toxins on the intestinal gut from spraying with glyphosate and glufosinate should first be assessed before any conclusion can be reached on health impacts and food safety;

| O. | 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 impacted by the genetic modification itself (14); |
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O.

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 impacted by the genetic modification itself (14);

Outstanding questions concerning Bt toxins

| P. | whereas Cry1Ab and Cry2Ae proteins produced in Escherichia coli (E. coli) and B. thuringiensis respectively were used to conduct the safety studies, rather than proteins produced by the GM plant itself (15), meaning that the assessment of toxic effects is based on the assumed equivalence of Bt toxins produced artificially in bacteria with the plant produced Bt toxins; whereas, however, in order to adequately take into account synergistic effects, assessments should not solely be based on tests with transgenic Bt toxins produced in microbial systems; |
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P.

whereas Cry1Ab and Cry2Ae proteins produced in Escherichia coli (E. coli) and B. thuringiensis respectively were used to conduct the safety studies, rather than proteins produced by the GM plant itself (15), meaning that the assessment of toxic effects is based on the assumed equivalence of Bt toxins produced artificially in bacteria with the plant produced Bt toxins; whereas, however, in order to adequately take into account synergistic effects, assessments should not solely be based on tests with transgenic Bt toxins produced in microbial systems;

| Q. | whereas, furthermore, 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 (16); |
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Q.

whereas, furthermore, 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 (16);

| R. | whereas those effects have never been 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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R.

whereas those effects have never been 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;

| S. | 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 (17), meaning that they can increase the allergenicity of other proteins with which they come into contact; |
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S.

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 (17), meaning that they can increase the allergenicity of other proteins with which they come into contact;

| T. | 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 glyphosate and glufosinate are known to disturb the microbiome which, for example, may enhance immune reactions in combination with Bt toxins (18); |
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T.

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 glyphosate and glufosinate are known to disturb the microbiome which, for example, may enhance immune reactions in combination with Bt toxins (18);

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

| U. | 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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U.

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;

| V. | 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 (19); 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 (20); |
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V.

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 (19); 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 (20);

| W. | 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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W.

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;

| X. | 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 (21); |
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X.

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 (21);

| Y. | whereas, while it has been claimed that the use of Bt crops leads to a decrease in the use of insecticides, a recently published United States study (22), 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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Y.

whereas, while it has been claimed that the use of Bt crops leads to a decrease in the use of insecticides, a recently published United States study (22), 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’;

| Z. | whereas the Union is party to the UN CBD, which makes it clear that both exporting and importing countries have international responsibilities regarding biological diversity; |
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Z.

whereas the Union is party to the UN CBD, which makes it clear that both exporting and importing countries have international responsibilities regarding biological diversity;

Member State competent authority comments

| AA. | whereas Member States submitted many critical comments to EFSA during the three-month consultation period (23); whereas those critical comments include that data and data analyses provided on phenotypic evaluation, composition and toxicity is insufficient, that the compositional analysis did not take into account residues nor metabolites of the complementary herbicides, and that the applicant’s proposal for an environmental monitoring plan does not meet the objectives defined in Annex VII of Directive 2001/18/EC of the European Parliament and of the Council (24) and that it does not relate the monitoring activities to relevant protection goals; whereas one Member State competent authority rejected the proposal to place the GM cotton on the market on the basis that the previous evaluations for the three single events were insufficient to ensure a high protection of human health; |
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AA.

whereas Member States submitted many critical comments to EFSA during the three-month consultation period (23); whereas those critical comments include that data and data analyses provided on phenotypic evaluation, composition and toxicity is insufficient, that the compositional analysis did not take into account residues nor metabolites of the complementary herbicides, and that the applicant’s proposal for an environmental monitoring plan does not meet the objectives defined in Annex VII of Directive 2001/18/EC of the European Parliament and of the Council (24) and that it does not relate the monitoring activities to relevant protection goals; whereas one Member State competent authority rejected the proposal to place the GM cotton on the market on the basis that the previous evaluations for the three single events were insufficient to ensure a high protection of human health;

Upholding the Union’s international obligations

| AB. | 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 (25); 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 (26); whereas authorising the import of the GM cotton 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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AB.

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 (25); 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 (26); whereas authorising the import of the GM cotton 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

| AC. | whereas the vote on 11 January 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; whereas 13 Member States (representing 35,52 % of the Union population) voted against authorisation, whilst only 10 Member States (representing 27,49 %) voted in favour; whereas 4 Member States (representing 37 %) abstained; |
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AC.

whereas the vote on 11 January 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; whereas 13 Member States (representing 35,52 % of the Union population) voted against authorisation, whilst only 10 Member States (representing 27,49 %) voted in favour; whereas 4 Member States (representing 37 %) abstained;

| AD. | 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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AD.

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;

| AE. | 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 16 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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AE.

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 16 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;

| AF. | 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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AF.

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;

| AG. | 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 (27); |
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AG.

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 (27);

| 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 (28), 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 (29); 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 finally accept 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 make sure that data from field trials or greenhouses cover a sufficiently broad range of agronomic and environmental conditions to assess the impact of all stress factors which have to be expected during cultivation on gene expression and plant composition; |
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10.

| 11. | Calls on EFSA to make sure that the data from field trials or greenhouses cover a sufficiently broad range of different varieties to assess the impact of various genetic backgrounds on gene expression and plant composition; |
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11.

| 12. | 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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12.

| 13. | 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; |
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13.

| 14. | 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 (30), 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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14.

| 15. | 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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15.

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

(2)  OJ L 157, 8.6.2013, p. 1.

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

(4)  Scientific Opinion of the EFSA Panel on Genetically Modified Organisms on assessment of genetically modified cotton GHB614× T304-40 × GHB119 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014-122), EFSA Journal 2018; 16(7):5349, https://efsa.onlinelibrary. wiley.com/doi/full/10.2903/j.efsa.2018.5349

,

(5)  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).

(6)  EFSA opinion, p. 10.

(7)  EFSA opinion, p. 22.

(8)  See, for example, Adamczyk, J.J. Jr., Meredith, W. R. Jr., ‘Genetic basis for variability of Cry1Ac expression among commercial transgenic Bacillus thuringiensis (Bt) cotton cultivars in the United States’, Journal of Cotton Science, 2004, 8(1), pp. 433-440, https://pubag.nal.usda.gov/catalog/10670

and Trtikova, M., Wikmark, O.G., Zemp, N., Widmer, A., Hilbeck, A., ‘Transgene expression and Bt protein content in transgenic Bt maize (MON810) under optimal and stressful environmental conditions’, Plos ONE, 2015:10(4), e0123011, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123011

(9)  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

(10)  EFSA conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate, EFSA journal 2015; 13(11):4302, p. 3, https://www.efsa.europa.eu/en/efsajournal/pub/4302

(11)  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).

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

(13)  See, for example, https://www.sciencedirect.com/science/article/abs/pii/S0304389420301400?via%3Dihub

(14)  This is indeed the case for glyphosate, as stated in the reasoned opinion of EFSA ‘Review of the existing maximum residue levels for glyphosate according to Article 12 of Regulation (EC) No 396/2005’, EFSA Journal 2018; 16(5):5263, p. 12, https://www.efsa.europa.eu/fr/efsajournal/pub/5263

(15)  Scientific Opinion of the EFSA Panel on Genetically Modified Organisms on application EFSA-GMO-NL-2011-97 for the placing on the market of insect-resistant and herbicide-tolerant genetically modified cotton T304-40 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience AG, EFSA Journal 2013; 11(6):3251, https://www.efsa.europa.eu/en/efsajournal/pub/3251, and Scientific opinion of the EFSA Panel on Genetically Modified Organisms on application (EFSA-GMO-NL-2011-96) for the placing on the market of genetically modified insect-resistant and herbicide-tolerant cotton GHB119, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience AG, EFSA Journal 2016; 14(10):4586, https://www.efsa.europa.eu/en/efsajournal/pub/4586, p. 14.

(16)  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

(17)  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, http://onlinelibrary.wiley.com/doi/10.1002/jat.3252/full

(18)  Parenti, M.D., Santoro, A., Del Rio, A., Franceschi, C., ‘Literature review in support of adjuvanticity/immuno-genicity 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

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

(20)  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

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

(22)  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

(23)  Member States comments, accessible via the EFSA register of questions (Reference: EFSA-Q-2014-00721): https://www.efsa.europa.eu/en/register-of-questions

(24)  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

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

(26)  https://www.un.org/sustainabledevelopment/health/

(27)  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)).

(28)  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).

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

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

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