# C_2018346EN.01011701.xml

| 27.9.2018 | EN | Official Journal of the European Union | C 346/117 |
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27.9.2018

EN

Official Journal of the European Union

C 346/117

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P8_TA(2017)0395

Renewing the approval of the active substance glyphosate

European Parliament resolution of 24 October 2017 on the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (D053565-01 — 2017/2904(RSP))

(2018/C 346/16)

The European Parliament,

| — | having regard to the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (D053565-01), |
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having regard to the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (D053565-01),

| — | having regard to 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 (1), and in particular Article 20(1) thereof, |
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having regard to 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 (1), and in particular Article 20(1) thereof,

| — | 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 Article 7 of 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 (3), |
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having regard to Article 7 of 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 (3),

| — | having regard to the European Food Safety Authority (EFSA) conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate (4), |
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having regard to the European Food Safety Authority (EFSA) conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate (4),

| — | having regard to the Committee for Risk Assessment (RAC) opinion of the European Chemicals Agency (ECHA) proposing harmonised classification and labelling at EU level of glyphosate (5), |
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having regard to the Committee for Risk Assessment (RAC) opinion of the European Chemicals Agency (ECHA) proposing harmonised classification and labelling at EU level of glyphosate (5),

| — | having regard to its resolution of 13 April 2016 on the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (6), |
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—

having regard to its resolution of 13 April 2016 on the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (6),

| — | having regard to the European Citizens’ Initiative ‘Ban glyphosate and protect people and the environment from toxic pesticides’ (7), |
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having regard to the European Citizens’ Initiative ‘Ban glyphosate and protect people and the environment from toxic pesticides’ (7),

| — | 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,

| — | having regard to Rule 106(2) and (3) of its Rules of Procedure, |
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having regard to Rule 106(2) and (3) of its Rules of Procedure,

| A. | whereas the purpose of Regulation (EC) No 1107/2009 is ‘to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production’; whereas the provisions of Regulation (EC) No 1107/2009 are underpinned by the precautionary principle; |
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A.

whereas the purpose of Regulation (EC) No 1107/2009 is ‘to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production’; whereas the provisions of Regulation (EC) No 1107/2009 are underpinned by the precautionary principle;

| B. | whereas the systemic herbicide glyphosate currently has the highest global production volume of all herbicides; whereas 76 % of the use of glyphosate worldwide is in agriculture; whereas it is also widely used in forestry, urban and garden applications; whereas 72 % of the total volume of glyphosate applied globally from 1974 to 2014 has been sprayed in just the last 10 years; |
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B.

whereas the systemic herbicide glyphosate currently has the highest global production volume of all herbicides; whereas 76 % of the use of glyphosate worldwide is in agriculture; whereas it is also widely used in forestry, urban and garden applications; whereas 72 % of the total volume of glyphosate applied globally from 1974 to 2014 has been sprayed in just the last 10 years;

| C. | whereas the general population is exposed primarily through residence near sprayed areas, through home use, and through diet; whereas exposure to glyphosate is on the rise owing to the increase in the total volume of glyphosate used; whereas the impact of glyphosate and its most common co-formulants on human health must be regularly monitored; whereas glyphosate and/or its residues have been detected in water, soil, food and drinks and non-edible goods, as well as in the human body (e.g. in urine); |
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C.

whereas the general population is exposed primarily through residence near sprayed areas, through home use, and through diet; whereas exposure to glyphosate is on the rise owing to the increase in the total volume of glyphosate used; whereas the impact of glyphosate and its most common co-formulants on human health must be regularly monitored; whereas glyphosate and/or its residues have been detected in water, soil, food and drinks and non-edible goods, as well as in the human body (e.g. in urine);

| D. | whereas, in the 2014 European Union Report on Pesticide Residues in Food published on 26 October 2016, EFSA noted that Member States took a limited number of oilseed and soybean samples, even though these crops are likely to be treated with glyphosate and residues may therefore be expected; whereas, according to EFSA, no information on glyphosate residues in animal products is available; whereas EFSA considered the results to be statistically not very robust; |
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D.

whereas, in the 2014 European Union Report on Pesticide Residues in Food published on 26 October 2016, EFSA noted that Member States took a limited number of oilseed and soybean samples, even though these crops are likely to be treated with glyphosate and residues may therefore be expected; whereas, according to EFSA, no information on glyphosate residues in animal products is available; whereas EFSA considered the results to be statistically not very robust;

| E. | whereas EFSA recommended in 2015 that Member States should increase the number of analyses of glyphosate and related residues (e.g. trimethyl-sulfonium) in products for which the use of glyphosate has been approved and where measurable residues are expected; whereas, in particular, the number of samples of soybeans, maize and oilseed rape should be increased; whereas Member States are also encouraged to develop and/or implement existing analytical methods to control glyphosate-related metabolites and to share the results with EFSA; |
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E.

whereas EFSA recommended in 2015 that Member States should increase the number of analyses of glyphosate and related residues (e.g. trimethyl-sulfonium) in products for which the use of glyphosate has been approved and where measurable residues are expected; whereas, in particular, the number of samples of soybeans, maize and oilseed rape should be increased; whereas Member States are also encouraged to develop and/or implement existing analytical methods to control glyphosate-related metabolites and to share the results with EFSA;

| F. | whereas glyphosate is a non-selective herbicide which kills all herbage; whereas it acts by interfering with the so-called shikimate pathway, a pathway that is also present in algae, bacteria and fungi; whereas sub-lethal exposures of Escherichia coli and Salmonella enterica serovar Typhimurium to commercial formulations of glyphosate have been found to induce a changed response to antibiotics; |
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F.

whereas glyphosate is a non-selective herbicide which kills all herbage; whereas it acts by interfering with the so-called shikimate pathway, a pathway that is also present in algae, bacteria and fungi; whereas sub-lethal exposures of Escherichia coli and Salmonella enterica serovar Typhimurium to commercial formulations of glyphosate have been found to induce a changed response to antibiotics;

| G. | whereas, in accordance with Regulation (EC) No 1107/2009, an active substance may only be approved if it is not or is not to be classified as a carcinogen category 1A or 1B under Regulation (EC) No 1272/2008, unless the exposure of humans to the active substance concerned is negligible or there is a serious danger to plant health that cannot be contained by other available means; |
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G.

whereas, in accordance with Regulation (EC) No 1107/2009, an active substance may only be approved if it is not or is not to be classified as a carcinogen category 1A or 1B under Regulation (EC) No 1272/2008, unless the exposure of humans to the active substance concerned is negligible or there is a serious danger to plant health that cannot be contained by other available means;

| H. | whereas in March 2015 the International Agency for Research on Cancer (IARC) classified glyphosate as ‘probably carcinogenic to humans’ (Group 2A), on the basis of ‘limited evidence’ of cancer in humans (from cases of real-world exposure), ‘sufficient evidence’ of cancer in laboratory animals (from studies of ‘pure’ glyphosate), and ‘strong evidence’ of mechanistic information related to carcinogenicity (for genotoxicity and oxidative stress) for both ‘pure’ glyphosate and glyphosate formulations; whereas the criteria used by IARC for Group 2A are comparable to those for Category 1B in Regulation (EC) No 1272/2008; |
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H.

whereas in March 2015 the International Agency for Research on Cancer (IARC) classified glyphosate as ‘probably carcinogenic to humans’ (Group 2A), on the basis of ‘limited evidence’ of cancer in humans (from cases of real-world exposure), ‘sufficient evidence’ of cancer in laboratory animals (from studies of ‘pure’ glyphosate), and ‘strong evidence’ of mechanistic information related to carcinogenicity (for genotoxicity and oxidative stress) for both ‘pure’ glyphosate and glyphosate formulations; whereas the criteria used by IARC for Group 2A are comparable to those for Category 1B in Regulation (EC) No 1272/2008;

| I. | whereas in November 2015 EFSA finalised a peer review of glyphosate and concluded that ‘glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential according to Regulation (EC) No 1272/2008’; whereas in March 2017 the Risk Assessment Committee (RAC) of ECHA concluded by consensus that there is no evidence to link glyphosate to cancer in humans based on the available information, and that glyphosate should not be classified as a substance that causes genetic damage (mutagen) or disrupts reproduction; |
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I.

whereas in November 2015 EFSA finalised a peer review of glyphosate and concluded that ‘glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential according to Regulation (EC) No 1272/2008’; whereas in March 2017 the Risk Assessment Committee (RAC) of ECHA concluded by consensus that there is no evidence to link glyphosate to cancer in humans based on the available information, and that glyphosate should not be classified as a substance that causes genetic damage (mutagen) or disrupts reproduction;

| J. | whereas at a Joint Meeting on Pesticide Residues (JMPR) held by the Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO) in May 2016, the FAO Panel of Experts on Pesticide Residues in Food and the Environment, and the WHO Core Assessment Group on Pesticide Residues, concluded that ‘glyphosate is unlikely to be genotoxic at anticipated diary exposures’ and ‘is unlikely to pose a carcinogenic risk to humans from exposure through the diet’; |
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J.

whereas at a Joint Meeting on Pesticide Residues (JMPR) held by the Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO) in May 2016, the FAO Panel of Experts on Pesticide Residues in Food and the Environment, and the WHO Core Assessment Group on Pesticide Residues, concluded that ‘glyphosate is unlikely to be genotoxic at anticipated diary exposures’ and ‘is unlikely to pose a carcinogenic risk to humans from exposure through the diet’;

| K. | whereas in the context of litigation in the US brought by plaintiffs who claim to have developed non-Hodgkin’s lymphoma as a result of exposure to glyphosate, the court unsealed internal documents by Monsanto, the owner and producer of Roundup, a product whose active substance is glyphosate; whereas the released correspondence cast doubts on the credibility of some studies, both Monsanto-sponsored and presumably independent ones, which were among the evidence used by EFSA and ECHA for their evaluation of the safety of glyphosate; whereas in that respect, the transparency and public availability of scientific studies, as well as of the raw data on which these studies are based, are of the utmost importance; |
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K.

whereas in the context of litigation in the US brought by plaintiffs who claim to have developed non-Hodgkin’s lymphoma as a result of exposure to glyphosate, the court unsealed internal documents by Monsanto, the owner and producer of Roundup, a product whose active substance is glyphosate; whereas the released correspondence cast doubts on the credibility of some studies, both Monsanto-sponsored and presumably independent ones, which were among the evidence used by EFSA and ECHA for their evaluation of the safety of glyphosate; whereas in that respect, the transparency and public availability of scientific studies, as well as of the raw data on which these studies are based, are of the utmost importance;

| L. | whereas, apart from its conclusion on the carcinogenicity of glyphosate, ECHA concludes that glyphosate causes serious eye damage and is toxic to aquatic life, with long-lasting effects; |
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L.

whereas, apart from its conclusion on the carcinogenicity of glyphosate, ECHA concludes that glyphosate causes serious eye damage and is toxic to aquatic life, with long-lasting effects;

| M. | whereas, before an 18-month technical extension was granted for glyphosate on 29 June 2016, Parliament adopted a resolution on 13 April 2016 which called on the Commission to renew the approval of glyphosate for seven years, but also stressed that the Commission should not approve it for any non-professional uses, for its uses in or close to public parks, public playgrounds and public gardens, or for any agricultural uses where integrated pest management systems are sufficient for the necessary weed control; whereas the same resolution also called on the Commission to develop training and user authorisation for professionals, to provide better information on the use of glyphosate, and to place strict limits on the pre-harvest use of products containing the active substance glyphosate, in order to prevent incorrect use of this substance and to limit the potential risks associated with it; |
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M.

whereas, before an 18-month technical extension was granted for glyphosate on 29 June 2016, Parliament adopted a resolution on 13 April 2016 which called on the Commission to renew the approval of glyphosate for seven years, but also stressed that the Commission should not approve it for any non-professional uses, for its uses in or close to public parks, public playgrounds and public gardens, or for any agricultural uses where integrated pest management systems are sufficient for the necessary weed control; whereas the same resolution also called on the Commission to develop training and user authorisation for professionals, to provide better information on the use of glyphosate, and to place strict limits on the pre-harvest use of products containing the active substance glyphosate, in order to prevent incorrect use of this substance and to limit the potential risks associated with it;

| N. | whereas Parliament’s resolution of 13 April 2016 also called on the Commission and on EFSA to disclose immediately all the scientific evidence that has been the basis for the positive classification of glyphosate and the proposed re-authorisation, given the overriding public interest in disclosure; whereas this has not been done to date; |
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N.

whereas Parliament’s resolution of 13 April 2016 also called on the Commission and on EFSA to disclose immediately all the scientific evidence that has been the basis for the positive classification of glyphosate and the proposed re-authorisation, given the overriding public interest in disclosure; whereas this has not been done to date;

| O. | whereas the European Citizens’ Initiative (ECI), referred to in recital 13 of the draft implementing measure, which gathered more than a million signatures of European citizens within less than a year, not only refers specifically to glyphosate in one of its three aims, but also explicitly calls to ‘ban glyphosate and protect people and the environment from toxic pesticides’ in its title; whereas the Commission received this submission on 6 October 2017 and is required to reply by 8 January 2018; |
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O.

whereas the European Citizens’ Initiative (ECI), referred to in recital 13 of the draft implementing measure, which gathered more than a million signatures of European citizens within less than a year, not only refers specifically to glyphosate in one of its three aims, but also explicitly calls to ‘ban glyphosate and protect people and the environment from toxic pesticides’ in its title; whereas the Commission received this submission on 6 October 2017 and is required to reply by 8 January 2018;

| P. | whereas, in accordance with Article 13 of Regulation (EC) No 1107/2009, any decision for the approval of an active substance need to be based on the review report by EFSA, other factors legitimate to the matter under consideration and the precautionary principle; |
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P.

whereas, in accordance with Article 13 of Regulation (EC) No 1107/2009, any decision for the approval of an active substance need to be based on the review report by EFSA, other factors legitimate to the matter under consideration and the precautionary principle;

| Q. | whereas the draft Commission implementing regulation, based on a scientific evaluation conducted by the German Federal Institute for Risk Assessment (BfR), EFSA and ECHA proposes authorising glyphosate until 15 December 2027, i.e. for 10 years; whereas it would apply from 16 December 2017; |
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Q.

whereas the draft Commission implementing regulation, based on a scientific evaluation conducted by the German Federal Institute for Risk Assessment (BfR), EFSA and ECHA proposes authorising glyphosate until 15 December 2027, i.e. for 10 years; whereas it would apply from 16 December 2017;

| R. | whereas the specific provisions outlined in Annex I of the draft implementing regulation renewing the approval of the active substance glyphosate are not binding at Union level, but pass the responsibility on to the Member States; |
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R.

whereas the specific provisions outlined in Annex I of the draft implementing regulation renewing the approval of the active substance glyphosate are not binding at Union level, but pass the responsibility on to the Member States;

| S. | whereas, in its resolution of 15 February 2017 on low-risk pesticides of biological origin (8), Parliament stressed the need to revise Regulation (EC) No 1107/2009 in order to foster the development, authorisation and placing on the Union market of low-risk pesticides of biological origin, and called on the Commission to submit, before the end of 2018, a specific legislative proposal amending Regulation (EC) No 1107/2009, outside of the general revision in connection with the REFIT initiative, with a view to establishing a fast-track evaluation, authorisation and registration process for low-risk pesticides of biological origin; |
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S.

whereas, in its resolution of 15 February 2017 on low-risk pesticides of biological origin (8), Parliament stressed the need to revise Regulation (EC) No 1107/2009 in order to foster the development, authorisation and placing on the Union market of low-risk pesticides of biological origin, and called on the Commission to submit, before the end of 2018, a specific legislative proposal amending Regulation (EC) No 1107/2009, outside of the general revision in connection with the REFIT initiative, with a view to establishing a fast-track evaluation, authorisation and registration process for low-risk pesticides of biological origin;

| T. | whereas a Commission communication on the future of the common agriculture policy (CAP) has been announced for publication before the end of 2017 and the budget proposals for May 2018; |
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T.

whereas a Commission communication on the future of the common agriculture policy (CAP) has been announced for publication before the end of 2017 and the budget proposals for May 2018;

| 1. | Considers that the Commission’s draft implementing regulation fails to ensure a high level of protection of both human and animal health and the environment, fails to apply the precautionary principle, and exceeds the implementing powers provided for in Regulation (EC) No 1107/2009; |
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1.

| 2. | Calls on the Commission to withdraw the draft implementing regulation and submit a new draft implementing regulation in line with the requirements laid down by Regulation (EC) No 1107/2009, i.e. including not only EFSA’s opinion, but also other legitimate factors and the precautionary principle; |
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2.

| 3. | Calls on the Commission and the Member States neither to approve any non-professional uses of glyphosate, nor to approve any uses of glyphosate in or close to public parks, public playgrounds or public gardens after 15 December 2017; |
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3.

| 4. | Calls on the Commission and the Member States in particular not to approve any agricultural uses of glyphosate after 15 December 2017 where integrated pest management systems are sufficient for the necessary weed control; |
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4.

| 5. | Calls on the Commission and the Member States not to approve the use of glyphosate for pre-harvest desiccation with effect from 16 December 2017; |
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5.

| 6. | Calls on the Commission to adopt necessary measures to phase out the active substance glyphosate in the European Union no later than 15 December 2022, ensuring that no use of glyphosate is authorised after that date, which includes any possible extension period or period referred to in Article 32 of Regulation (EC) No 1107/2009; |
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6.

| 7. | Welcomes the proposed exclusion of POE-tallowamine from use in plant protection products containing glyphosate; calls on the Commission and the Member States to accelerate their work on the list of co-formulants not accepted for inclusion in plant protection products; |
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7.

| 8. | Calls on the Commission and the Member States to ensure that the scientific evaluation of pesticides for EU regulatory approval is based only on published peer-reviewed and independent studies commissioned by competent public authorities; considers that the REFIT procedure of Regulation (EC) No 1107/2009 can potentially be used for that purpose; considers, furthermore, that EFSA and ECHA should be granted sufficient resources in order increase their capacity, to enable the commissioning of independent scientific studies and to further ensure that the highest scientific standards are upheld and the health and safety of EU citizens protected; |
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8.

| 9. | Calls on the Commission and the Member States to ensure sufficient testing and monitoring of glyphosate residues in feed, food and drinks produced in, as well as imported into, the Union, in order to address the current data gap pointed out by EFSA; |
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9.

| 10. | Calls on the Commission and the Member States to finance research and innovation with regard to sustainable and cost-efficient solutions for pest-management products to ensure a high level of protection of human and animal health and the environment; |
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10.

| 11. | Calls on the Commission and the Member States to propose adequate transitional measures for the agricultural sector and to publish a guidance document outlining all possible safer, low-risk alternatives to help the agricultural sector during the phase-out period of the active substance glyphosate and all of the resources already available to the agricultural sector in the context of the current CAP; |
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11.

| 12. | Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States. |
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12.

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(1)  OJ L 309, 24.11.2009, p. 1.

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

(3)  OJ L 31, 1.2.2002, p. 1.

(4)  http://www.efsa.europa.eu/en/efsajournal/pub/4302

(5)  https://echa.europa.eu/documents/10162/2d3a87cc-5ca1-31d6-8967-9f124f1ab7ae

(6)  Texts adopted, P8_TA(2016)0119.

(7)  ECI(2017)000002.

(8)  Texts adopted, P8_TA(2017)0042.

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