# C_2018307EN.01006701.xml

| 30.8.2018 | EN | Official Journal of the European Union | C 307/67 |
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30.8.2018

EN

Official Journal of the European Union

C 307/67

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P8_TA(2017)0214

Genetically modified cotton GHB119

European Parliament resolution of 17 May 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D050182 — 2017/2675(RSP))

(2018/C 307/07)

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 GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D050182), |
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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 GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D050182),

| — | 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), 9(2), 19(3) and 21(2) 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), 9(2), 19(3) and 21(2) 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 27 March 2017, where 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 27 March 2017, where 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 21 September 2016, and published on 21 October 2016 (3); |
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having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 21 September 2016, and published on 21 October 2016 (3);

| — | having regard to the proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (COM(2017)0085, COD(2017)0035), |
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having regard to the proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (COM(2017)0085, COD(2017)0035),

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

| — | 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 on 25 March 2011, Bayer submitted an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from GHB119 cotton to the competent authority of the Netherlands; whereas that application also covered the placing on the market of genetically modified cotton GHB119 in products consisting of it or containing it for uses other than food and feed as any other cotton, with the exception of cultivation; |
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A.

whereas on 25 March 2011, Bayer submitted an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from GHB119 cotton to the competent authority of the Netherlands; whereas that application also covered the placing on the market of genetically modified cotton GHB119 in products consisting of it or containing it for uses other than food and feed as any other cotton, with the exception of cultivation;

| B. | whereas on 21 September 2016, the European Food Safety Authority (EFSA) adopted a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003, which was published on 21 October 2016; |
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B.

whereas on 21 September 2016, the European Food Safety Authority (EFSA) adopted a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003, which was published on 21 October 2016;

| C. | whereas the unique identifier BCS-GHØØ5-8 assigned to GHB119 cotton, as described in the application, expresses the PAT protein which confers tolerance to glufosinate ammonium-based herbicides and Cry2Ae protein which confers resistance to certain lepidopteran pests; whereas an authorisation for import of this cotton into the Union would undoubtedly lead to an increase in its cultivation in other parts of the world, with a corresponding increase in the use of glufosinate ammonium-based herbicides; |
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C.

whereas the unique identifier BCS-GHØØ5-8 assigned to GHB119 cotton, as described in the application, expresses the PAT protein which confers tolerance to glufosinate ammonium-based herbicides and Cry2Ae protein which confers resistance to certain lepidopteran pests; whereas an authorisation for import of this cotton into the Union would undoubtedly lead to an increase in its cultivation in other parts of the world, with a corresponding increase in the use of glufosinate ammonium-based herbicides;

| D. | whereas glufosinate is classified as toxic to reproduction and thus falls under the exclusion criteria set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council (5); whereas the approval of glufosinate expires on 31 July 2018; |
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D.

whereas glufosinate is classified as toxic to reproduction and thus falls under the exclusion criteria set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council (5); whereas the approval of glufosinate expires on 31 July 2018;

| E. | whereas independent research raises concerns about major gaps in the comparative assessment, e.g. the fact that, although statistically significant differences in the composition were found for many compounds, no further investigation was deemed necessary; concerns about serious gaps as regards the toxicology assessment, e.g. the fact that only one mode of action of Bt toxins was considered, that no investigations into combinatorial effects have been conducted and that no assessment of pesticide residues has been conducted; and concerns about an inconclusive assessment of the possible impact on the immune system (6); |
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E.

whereas independent research raises concerns about major gaps in the comparative assessment, e.g. the fact that, although statistically significant differences in the composition were found for many compounds, no further investigation was deemed necessary; concerns about serious gaps as regards the toxicology assessment, e.g. the fact that only one mode of action of Bt toxins was considered, that no investigations into combinatorial effects have been conducted and that no assessment of pesticide residues has been conducted; and concerns about an inconclusive assessment of the possible impact on the immune system (6);

| F. | whereas many critical comments were submitted by Member States during the three-month consultation period; whereas those comments refer to, inter alia: missing data as regards identification and quantification of the herbicide and metabolite residues in the GM plants and seeds used for food/feed, shortcomings in the environmental risk assessment and environmental monitoring plan relating, inter alia, to differing views on whether wild relatives have been reported in Europe, or missing data as regards the germination power of the imported seed, as well as the fact that no unintended effects were taken into consideration; whereas some of the comments further criticised the very poor data base in general and, more specifically, the fact that only a very limited number of studies had been taken into consideration and that, for example, no appropriate toxicity test with plant material from GHB119 cotton, as well as no appropriate studies on the effect of the GM cotton on human and animal health, had been carried out, and that the nutritional study submitted was not considered to be admissible (7); |
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F.

whereas many critical comments were submitted by Member States during the three-month consultation period; whereas those comments refer to, inter alia: missing data as regards identification and quantification of the herbicide and metabolite residues in the GM plants and seeds used for food/feed, shortcomings in the environmental risk assessment and environmental monitoring plan relating, inter alia, to differing views on whether wild relatives have been reported in Europe, or missing data as regards the germination power of the imported seed, as well as the fact that no unintended effects were taken into consideration; whereas some of the comments further criticised the very poor data base in general and, more specifically, the fact that only a very limited number of studies had been taken into consideration and that, for example, no appropriate toxicity test with plant material from GHB119 cotton, as well as no appropriate studies on the effect of the GM cotton on human and animal health, had been carried out, and that the nutritional study submitted was not considered to be admissible (7);

| G. | whereas, in spite of all the abovementioned concerns, EFSA did not consider any post-market monitoring of food/feed derived from cotton GHB119 to be necessary; |
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G.

whereas, in spite of all the abovementioned concerns, EFSA did not consider any post-market monitoring of food/feed derived from cotton GHB119 to be necessary;

| H. | whereas no opinion was delivered at 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 27 March 2017; whereas 15 Member States voted against, while only 11 Member States representing just 38,69 % of the Union population voted in favour, with 2 Member States abstaining; |
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H.

whereas no opinion was delivered at 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 27 March 2017; whereas 15 Member States voted against, while only 11 Member States representing just 38,69 % of the Union population voted in favour, with 2 Member States abstaining;

| I. | whereas, both in the explanatory memorandum of its legislative proposal presented on 22 April 2015 amending Regulation (EC) No 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed on their territory (COM(2015)0177) and in the explanatory memorandum of the legislative proposal presented on 14 February 2017 amending Regulation (EU) No 182/2011, the Commission deplored the fact that, since the entry into force of Regulation (EC) No 1829/2003, authorisation decisions have been adopted by the Commission without the support of the Member States’ committee opinion and that returning the dossier to the Commission for final decision, which is very much the exception for the procedure as a whole, has become the norm for decision-making on genetically modified food and feed authorisations; whereas that practice has, on several occasions, been deplored by Commission President Juncker as not being democratic (8); |
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I.

whereas, both in the explanatory memorandum of its legislative proposal presented on 22 April 2015 amending Regulation (EC) No 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed on their territory (COM(2015)0177) and in the explanatory memorandum of the legislative proposal presented on 14 February 2017 amending Regulation (EU) No 182/2011, the Commission deplored the fact that, since the entry into force of Regulation (EC) No 1829/2003, authorisation decisions have been adopted by the Commission without the support of the Member States’ committee opinion and that returning the dossier to the Commission for final decision, which is very much the exception for the procedure as a whole, has become the norm for decision-making on genetically modified food and feed authorisations; whereas that practice has, on several occasions, been deplored by Commission President Juncker as not being democratic (8);

| J. | whereas Parliament rejected the legislative proposal of 22 April 2015 amending Regulation (EC) No 1829/2003 on 28 October 2015 at first reading (9) and called on the Commission to withdraw it and submit a new one; |
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J.

whereas Parliament rejected the legislative proposal of 22 April 2015 amending Regulation (EC) No 1829/2003 on 28 October 2015 at first reading (9) and called on the Commission to withdraw it and submit a new one;

| K. | whereas Recital 14 of Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers clearly states that: ‘When considering the adoption of other draft implementing acts concerning particularly sensitive sectors, notably taxation, consumer health, food safety and protection of the environment, the Commission, in order to find a balanced solution, will, as far as possible, act in such a way as to avoid going against any predominant position which might emerge within the appeal committee against the appropriateness of an implementing act’; |
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K.

whereas Recital 14 of Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers clearly states that: ‘When considering the adoption of other draft implementing acts concerning particularly sensitive sectors, notably taxation, consumer health, food safety and protection of the environment, the Commission, in order to find a balanced solution, will, as far as possible, act in such a way as to avoid going against any predominant position which might emerge within the appeal committee against the appropriateness of an implementing act’;

| 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 (10), to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, the environment and consumer interests in relation to genetically modified food and feed, whilst 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. | Calls on the Commission to suspend any implementing decision regarding applications for authorisation of genetically modified organisms until the authorisation procedure has been revised in such a way as to address the shortcomings of the current procedure, which has proven inadequate; |
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4.

| 5. | 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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5.

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

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

(3)  Available at: https://www.efsa.europa.eu/en/efsajournal/pub/4586

(4)

| — | Resolution of 16 January 2014 on the proposal for a Council decision concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests (OJ C 482, 23.12.2016, p. 110), |
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Resolution of 16 January 2014 on the proposal for a Council decision concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests (OJ C 482, 23.12.2016, p. 110),

| — | Resolution of 16 December 2015 on Commission Implementing Decision (EU) 2015/2279 of 4 December 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603 × T25 (P8_TA(2015)0456), |
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Resolution of 16 December 2015 on Commission Implementing Decision (EU) 2015/2279 of 4 December 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603 × T25 (P8_TA(2015)0456),

| — | Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788 (P8_TA(2016)0040), |
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Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788 (P8_TA(2016)0040),

| — | Resolution of 3 February 2016 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 (P8_TA(2016)0039), |
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Resolution of 3 February 2016 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 (P8_TA(2016)0039),

| — | Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) (P8_TA(2016)0038), |
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Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) (P8_TA(2016)0038),

| — | Resolution of 8 June 2016 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 × GA21, and genetically modified maizes combining two or three of those events (P8_TA(2016)0271), |
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Resolution of 8 June 2016 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 × GA21, and genetically modified maizes combining two or three of those events (P8_TA(2016)0271),

| — | Resolution of 8 June 2016 on the draft Commission implementing decision as regards the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) (P8_TA(2016)0272), |
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Resolution of 8 June 2016 on the draft Commission implementing decision as regards the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) (P8_TA(2016)0272),

| — | Resolution of 6 October 2016 on the draft Commission implementing decision renewing the authorisation for the placing on the market for cultivation of genetically modified maize MON 810 seeds (P8_TA(2016)0388), |
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Resolution of 6 October 2016 on the draft Commission implementing decision renewing the authorisation for the placing on the market for cultivation of genetically modified maize MON 810 seeds (P8_TA(2016)0388),

| — | Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of genetically modified maize MON 810 products (P8_TA(2016)0389), |
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Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of genetically modified maize MON 810 products (P8_TA(2016)0389),

| — | Resolution of 6 October 2016 on the draft Commission implementing decision concerning the placing on the market for cultivation of genetically modified maize Bt11 seeds (P8_TA(2016)0386), |
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Resolution of 6 October 2016 on the draft Commission implementing decision concerning the placing on the market for cultivation of genetically modified maize Bt11 seeds (P8_TA(2016)0386),

| — | Resolution of 6 October 2016 on the draft Commission implementing decision concerning the placing on the market for cultivation of genetically modified maize 1507 seeds (P8_TA(2016)0387), |
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Resolution of 6 October 2016 on the draft Commission implementing decision concerning the placing on the market for cultivation of genetically modified maize 1507 seeds (P8_TA(2016)0387),

| — | Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (P8_TA(2016)0390), |
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Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (P8_TA(2016)0390),

| — | Resolution of 5 April 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21, and genetically modified maizes combining two, three or four of the events Bt11, 59122, MIR604, 1507 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (P8_TA(2017)0123). |
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Resolution of 5 April 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21, and genetically modified maizes combining two, three or four of the events Bt11, 59122, MIR604, 1507 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (P8_TA(2017)0123).

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

(6)  Bauer-Panskus/Then: Testbiotech comment on the Scientific Opinion on application (EFSA-GMO-NL-2011-96) for the placing on the market of genetically modified insect-resistant and herbicide-tolerant cotton GHB119 from Bayer CropScience AG, available at: https://www.testbiotech.org/node/1860.

(7)  http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2011-00311

(8)  e.g. in the Opening Statement at the European Parliament plenary session included in the political guidelines for the next European Commission (Strasbourg, 15 July 2014) or in the State of the Union Address 2016 (Strasbourg, 14 September 2016).

(9)  Texts adopted, P8_TA(2015)0379.

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

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