# C_2021474EN.01006201.xml

| 24.11.2021 | EN | Official Journal of the European Union | C 474/62 |
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24.11.2021

EN

Official Journal of the European Union

C 474/62

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P9_TA(2021)0079

Active substances, including dimoxystrobin

European Parliament resolution of 11 March 2021 on Commission Implementing Regulation (EU) 2021/52 of 22 January 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (2021/2552(RSP))

(2021/C 474/05)

The European Parliament,

| — | having regard to Commission Implementing Regulation (EU) 2021/52 of 22 January 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (1), |
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having regard to Commission Implementing Regulation (EU) 2021/52 of 22 January 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (1),

| — | 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 (2), and in particular the first paragraph of Article 17 and Article 21 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 (2), and in particular the first paragraph of Article 17 and Article 21 thereof,

| — | having regard to the opinion delivered on 10 December 2020 by the Standing Committee on Plants, Animals, Food and Feed, |
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having regard to the opinion delivered on 10 December 2020 by the Standing Committee on Plants, Animals, Food and Feed,

| — | having regard to Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (3), |
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having regard to Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (3),

| — | 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 (4), |
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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 (4),

| — | having regard to its resolution of 13 September 2018 on the implementation of the Plant Protection Products Regulation (EC) No 1107/2009 (5), |
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having regard to its resolution of 13 September 2018 on the implementation of the Plant Protection Products Regulation (EC) No 1107/2009 (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 dimoxystrobin was included in Annex I to Council Directive 91/414/EEC (6) on 1 October 2006 by Commission Directive 2006/75/EC (7) and has been deemed to be approved under Regulation (EC) No 1107/2009; |
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A.

whereas dimoxystrobin was included in Annex I to Council Directive 91/414/EEC (6) on 1 October 2006 by Commission Directive 2006/75/EC (7) and has been deemed to be approved under Regulation (EC) No 1107/2009;

| B. | whereas a procedure to renew the approval of dimoxystrobin under Commission Implementing Regulation (EU) No 844/2012 (8) has been ongoing since 2013; |
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B.

whereas a procedure to renew the approval of dimoxystrobin under Commission Implementing Regulation (EU) No 844/2012 (8) has been ongoing since 2013;

| C. | whereas the approval period of the active substance dimoxystrobin, which was originally due to end on 30 September 2016, was already extended by 16 months by Commission Implementing Regulation (EU) No 1136/2013 (9), and subsequently by further periods of one year by Commission Implementing Regulations (EU) 2018/84 (10), (EU) 2018/1796 (11) and (EU) 2019/2094 (12), and has now again been extended by one year by Implementing Regulation (EU) 2021/52, which extends the approval period to 31 January 2022; |
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C.

whereas the approval period of the active substance dimoxystrobin, which was originally due to end on 30 September 2016, was already extended by 16 months by Commission Implementing Regulation (EU) No 1136/2013 (9), and subsequently by further periods of one year by Commission Implementing Regulations (EU) 2018/84 (10), (EU) 2018/1796 (11) and (EU) 2019/2094 (12), and has now again been extended by one year by Implementing Regulation (EU) 2021/52, which extends the approval period to 31 January 2022;

| D. | whereas the Commission has failed in Implementing Regulation (EU) 2021/52 to explain the reasons for the extensions other than by stating: ‘Due to the fact that the assessment of those substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal’; |
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D.

whereas the Commission has failed in Implementing Regulation (EU) 2021/52 to explain the reasons for the extensions other than by stating: ‘Due to the fact that the assessment of those substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal’;

| E. | whereas Regulation (EC) No 1107/2009 aims to ensure a high level of protection of both human and animal health and the environment, and at the same time to safeguard the competitiveness of Union agriculture; whereas particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children; |
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E.

whereas Regulation (EC) No 1107/2009 aims to ensure a high level of protection of both human and animal health and the environment, and at the same time to safeguard the competitiveness of Union agriculture; whereas particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children;

| F. | whereas the precautionary principle should apply, and Regulation (EC) No 1107/2009 provides that substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and that they are not expected to have any harmful effect on human or animal health or any unacceptable effects on the environment; |
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F.

whereas the precautionary principle should apply, and Regulation (EC) No 1107/2009 provides that substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and that they are not expected to have any harmful effect on human or animal health or any unacceptable effects on the environment;

| G. | whereas Regulation (EC) No 1107/2009 provides that in the interest of safety the approval period for active substances should be limited in time; whereas the approval period should be proportionate to the possible risks inherent in the use of such substances, but, in the case of the active substances that are subject to Implementing Regulation (EU) 2021/52, it is clear that no such proportionality exists; |
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G.

whereas Regulation (EC) No 1107/2009 provides that in the interest of safety the approval period for active substances should be limited in time; whereas the approval period should be proportionate to the possible risks inherent in the use of such substances, but, in the case of the active substances that are subject to Implementing Regulation (EU) 2021/52, it is clear that no such proportionality exists;

| H. | whereas the Commission and Member States have the possibility and responsibility to act in accordance with the precautionary principle when the risk of harmful effects on health has been identified but scientific uncertainty persists, by adopting provisional risk management measures that are necessary to ensure a high level of protection of human health; |
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H.

whereas the Commission and Member States have the possibility and responsibility to act in accordance with the precautionary principle when the risk of harmful effects on health has been identified but scientific uncertainty persists, by adopting provisional risk management measures that are necessary to ensure a high level of protection of human health;

| I. | whereas, more specifically, Article 21 of Regulation (EC) No 1107/2009 provides that the Commission may review the approval of an active substance at any time, especially where, in the light of new scientific and technical knowledge, it considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4 of that Regulation, and whereas this review may lead to the withdrawal or amendment of the approval of the substance; |
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I.

whereas, more specifically, Article 21 of Regulation (EC) No 1107/2009 provides that the Commission may review the approval of an active substance at any time, especially where, in the light of new scientific and technical knowledge, it considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4 of that Regulation, and whereas this review may lead to the withdrawal or amendment of the approval of the substance;

Endocrine-disrupting properties

| J. | whereas, in 2015, dimoxystrobin was placed on the ‘list of candidates for substitution’ by Implementing Regulation (EU) 2015/408 because the Acute Reference Dose (ARfD) for that active substance is significantly lower than that of the majority of the approved active substances within its group of substances, and because it is to be considered as having endocrine-disrupting properties that may cause adverse effects in humans; |
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J.

whereas, in 2015, dimoxystrobin was placed on the ‘list of candidates for substitution’ by Implementing Regulation (EU) 2015/408 because the Acute Reference Dose (ARfD) for that active substance is significantly lower than that of the majority of the approved active substances within its group of substances, and because it is to be considered as having endocrine-disrupting properties that may cause adverse effects in humans;

| K. | whereas, according to point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, an active substance cannot be approved when it is considered to have endocrine-disrupting properties that may cause adverse effects in humans, unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005 of the European Parliament and of the Council (13); |
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K.

whereas, according to point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, an active substance cannot be approved when it is considered to have endocrine-disrupting properties that may cause adverse effects in humans, unless the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005 of the European Parliament and of the Council (13);

| L. | whereas it is unacceptable that a substance which is known to meet the cut-off criteria for active substances that are mutagenic, carcinogenic and/or toxic for reproduction, or that have endocrine-disrupting properties, which are established to protect human health and the environment, continues to be allowed for use in the Union, thereby putting human health and the environment at risk; |
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L.

whereas it is unacceptable that a substance which is known to meet the cut-off criteria for active substances that are mutagenic, carcinogenic and/or toxic for reproduction, or that have endocrine-disrupting properties, which are established to protect human health and the environment, continues to be allowed for use in the Union, thereby putting human health and the environment at risk;

| M. | whereas applicants can take advantage of the automatic system built into Commission working methods, which immediately extends the approval periods of active substances if the risk reassessment has not been finalised, by deliberately prolonging the reassessment process by providing incomplete data and asking for more derogations and special conditions, which leads to unacceptable risks for human health and the environment since, during this time, exposure to the hazardous substance continues; |
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M.

whereas applicants can take advantage of the automatic system built into Commission working methods, which immediately extends the approval periods of active substances if the risk reassessment has not been finalised, by deliberately prolonging the reassessment process by providing incomplete data and asking for more derogations and special conditions, which leads to unacceptable risks for human health and the environment since, during this time, exposure to the hazardous substance continues;

| N. | whereas in its resolution of 13 September 2018 on the implementation of the Plant Products Regulation (EC) No 1107/2009, Parliament called on the Commission and Member States ‘to ensure that the procedural extension of the approval period for the duration of the procedure, pursuant to Article 17 of the Regulation, will not be used for active substances that are mutagenic, carcinogenic, toxic for reproduction and therefore in category 1A or 1B, or active substances that have endocrine disrupting characteristics and are damaging to humans or animals, as is currently the case for substances such as flumioxazine, thiacloprid, chlorotoluron and dimoxystrobin’; |
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N.

whereas in its resolution of 13 September 2018 on the implementation of the Plant Products Regulation (EC) No 1107/2009, Parliament called on the Commission and Member States ‘to ensure that the procedural extension of the approval period for the duration of the procedure, pursuant to Article 17 of the Regulation, will not be used for active substances that are mutagenic, carcinogenic, toxic for reproduction and therefore in category 1A or 1B, or active substances that have endocrine disrupting characteristics and are damaging to humans or animals, as is currently the case for substances such as flumioxazine, thiacloprid, chlorotoluron and dimoxystrobin’;

| O. | whereas Parliament has already objected to the previous extension of the approval period of dimoxystrobin in its resolution of 18 December 2019 (14), and the Commission has failed to give a convincing response to that resolution and has also failed to properly demonstrate that another extension would not exceed its implementing powers; |
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O.

whereas Parliament has already objected to the previous extension of the approval period of dimoxystrobin in its resolution of 18 December 2019 (14), and the Commission has failed to give a convincing response to that resolution and has also failed to properly demonstrate that another extension would not exceed its implementing powers;

| P. | whereas following the previous extension in 2019 of the approval periods of 10 active substances, including dimoxystrobin, under Implementing Regulation (EU) 2019/2094, the approval of only one of those substances has not been renewed, while under Implementing Regulation (EU) 2021/52, the approval periods of the remaining nine substances have been extended again, many of them for the third or fourth time and two of them for as much as the sixth time; |
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P.

whereas following the previous extension in 2019 of the approval periods of 10 active substances, including dimoxystrobin, under Implementing Regulation (EU) 2019/2094, the approval of only one of those substances has not been renewed, while under Implementing Regulation (EU) 2021/52, the approval periods of the remaining nine substances have been extended again, many of them for the third or fourth time and two of them for as much as the sixth time;

| 1. | Considers that Implementing Regulation (EU) 2021/52 exceeds the implementing powers provided for in Regulation (EC) No 1107/2009; |
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1.

| 2. | Considers that Implementing Regulation (EU) 2021/52 does not respect the precautionary principle; |
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2.

| 3. | Considers that the decision to extend the approval period of dimoxystrobin is not in line with the safety criteria laid down in Regulation (EC) No 1107/2009, and is based neither on evidence that that substance can be used safely, nor on a proven urgent need for that substance in food production in the Union; |
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3.

| 4. | Calls on the Commission to repeal Implementing Regulation (EU) 2021/52 and to submit a new draft to the committee, which takes into account the scientific evidence on the harmful properties of all the substances concerned, especially those of dimoxystrobin; |
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4.

| 5. | Calls on the Commission to present a proposal for non-renewal of dimoxystrobin in the next meeting of the Standing Committee on Plants, Animals, Food and Feed; |
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5.

| 6. | Calls on the Commission to communicate to Parliament the specific reasons why the assessment of the substances has been delayed for reasons beyond the control of the applicants, which specific endpoints are still under assessment, and why that assessment requires so much time to be conducted; |
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6.

| 7. | Reiterates its call on the Commission to present draft implementing regulations to extend the approval periods only of substances for which the current state of science is not expected to lead to a Commission proposal for non-renewal of the approval of the active substance concerned; |
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7.

| 8. | Reiterates its call on the Commission to withdraw the approvals for substances, if proof or reasonable doubts exist that they will not meet the safety criteria laid down in Regulation (EC) No 1107/2009; |
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8.

| 9. | Reiterates its call on the Member States to ensure the proper and timely reassessment of the approvals of the active substances for which they are the reporting Member States, and to ensure that the current delays are solved effectively as soon as possible; |
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9.

| 10. | 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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10.

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(1)  OJ L 23, 25.1.2021, p. 13.

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

(3)  OJ L 67, 12.3.2015, p. 18.

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

(5)  OJ C 433, 23.12.2019, p. 183.

(6)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(7)  Commission Directive 2006/75/EC of 11 September 2006 amending Council Directive 91/414/EEC to include dimoxystrobin as active substance (OJ L 248, 12.9.2006, p. 3).

(8)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

(9)  Commission Implementing Regulation (EU) No 1136/2013 of 12 November 2013 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances clothianidin, dimoxystrobin, oxamyl and pethoxamid (OJ L 302, 13.11.2013, p. 34).

(10)  Commission Implementing Regulation (EU) 2018/84 of 19 January 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and zoxamide (OJ L 16, 20.1.2018, p. 8).

(11)  Commission Implementing Regulation (EU) 2018/1796 of 20 November 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos-methyl, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop-p, fenpropidin, lenacil, mancozeb, mecoprop-p, metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin, pyriproxyfen and tritosulfuron (OJ L 294, 21.11.2018, p. 15).

(12)  Commission Implementing Regulation (EU) 2019/2094 of 29 November 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mancozeb, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (OJ L 317, 9.12.2019, p. 102).

(13)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

(14)  European Parliament resolution of 18 December 2019 on the draft Commission implementing regulation amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mancozeb, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (Texts adopted, P9_TA(2019)0099).

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