# C_2021385EN.01014801.xml

| 22.9.2021 | EN | Official Journal of the European Union | C 385/148 |
| --- | --- | --- | --- |

22.9.2021

EN

Official Journal of the European Union

C 385/148

---

P9_TA(2020)0238

Objection to an implementing act: Maximum residue levels for several substances including flonicamid, haloxyfop and mandestrobin

European Parliament resolution of 17 September 2020 on the draft Commission regulation amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cycloxydim, flonicamid, haloxyfop, mandestrobin, mepiquat, Metschnikowia fructicola strain NRRL Y-27328 and prohexadione in or on certain products (D063880/06 — 2020/2734(RPS))

(2021/C 385/17)

The European Parliament,

| — | having regard to the draft Commission regulation amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cycloxydim, flonicamid, haloxyfop, mandestrobin, mepiquat, Metschnikowia fructicola strain NRRL Y-27328 and prohexadione in or on certain products (D063880/06, |
| --- | --- |

—

having regard to the draft Commission regulation amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cycloxydim, flonicamid, haloxyfop, mandestrobin, mepiquat, Metschnikowia fructicola strain NRRL Y-27328 and prohexadione in or on certain products (D063880/06,

| — | having regard to 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 (1), and in particular Article 5(1) and Article 14(1)(a) thereof, |
| --- | --- |

—

having regard to 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 (1), and in particular Article 5(1) and Article 14(1)(a) thereof,

| — | having regard to the opinion delivered on 17-18 February 2020 by the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

—

having regard to the opinion delivered on 17-18 February 2020 by the Standing Committee on Plants, Animals, Food and Feed,

| — | having regard to Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (2), |
| --- | --- |

—

having regard to Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (2),

| — | having regard to the reasoned opinion adopted by the European Food Safety Authority (EFSA) on 27 May 2019, and published on 2 August 2019 (3), |
| --- | --- |

—

having regard to the reasoned opinion adopted by the European Food Safety Authority (EFSA) on 27 May 2019, and published on 2 August 2019 (3),

| — | having regard to the conclusion adopted by EFSA on 18 December 2009, and published on 7 May 2010 (4), |
| --- | --- |

—

having regard to the conclusion adopted by EFSA on 18 December 2009, and published on 7 May 2010 (4),

| — | having regard to the reasoned opinion adopted by EFSA on 18 October 2018, and published on 2 November 2018 (5), |
| --- | --- |

—

having regard to the reasoned opinion adopted by EFSA on 18 October 2018, and published on 2 November 2018 (5),

| — | having regard to Article 5a(3)(b) and Article 5a(5) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6), |
| --- | --- |

—

having regard to Article 5a(3)(b) and Article 5a(5) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6),

| — | having regard to Rule 112(2) and (3), and (4)(c) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 112(2) and (3), and (4)(c) of its Rules of Procedure,

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

—

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

| A. | whereas flonicamid is a selective insecticide used on, inter alia, potatoes, wheat, apples, pears, peaches and peppers; |
| --- | --- |

A.

whereas flonicamid is a selective insecticide used on, inter alia, potatoes, wheat, apples, pears, peaches and peppers;

| B. | whereas the approval period of flonicamid as an active substance has been extended by Commission Implementing Regulation (EU) 2017/2069 (7); |
| --- | --- |

B.

whereas the approval period of flonicamid as an active substance has been extended by Commission Implementing Regulation (EU) 2017/2069 (7);

| C. | whereas in the opinion of 5 June 2013 (8) of the Committee for Risk Assessment of the European Chemicals Agency (‘ECHA’), which proposed harmonised classification and labelling of flonicamid, the Danish Member State Competent Authority observes ‘clear effects on visceral malformations occurring at non-maternally toxic levels in the rabbit’; |
| --- | --- |

C.

whereas in the opinion of 5 June 2013 (8) of the Committee for Risk Assessment of the European Chemicals Agency (‘ECHA’), which proposed harmonised classification and labelling of flonicamid, the Danish Member State Competent Authority observes ‘clear effects on visceral malformations occurring at non-maternally toxic levels in the rabbit’;

| D. | whereas flonicamid is under scrutiny in the United States for potentially posing a higher risk to pollinators than previously understood, since new studies submitted by the flonicamid manufacturer ISK Biosciences show that flonicamid exposes bees to up to 51 times the amount of flonicamid that would cause them substantial harm (9); |
| --- | --- |

D.

whereas flonicamid is under scrutiny in the United States for potentially posing a higher risk to pollinators than previously understood, since new studies submitted by the flonicamid manufacturer ISK Biosciences show that flonicamid exposes bees to up to 51 times the amount of flonicamid that would cause them substantial harm (9);

| E. | whereas haloxyfop-P is a herbicide used on, inter alia, carrots, fodder legumes, rapeseed, soyabean and sugarbeet; |
| --- | --- |

E.

whereas haloxyfop-P is a herbicide used on, inter alia, carrots, fodder legumes, rapeseed, soyabean and sugarbeet;

| F. | whereas haloxyfop-P is harmful if swallowed and is harmful to aquatic life with long-lasting effects based on the ECHA classification; whereas haloxyfop-P has shown effects of hepatotoxicity, nephrotoxicity and oxidative stress in rats following exposure to haloxyfop-P-methyl (10); |
| --- | --- |

F.

whereas haloxyfop-P is harmful if swallowed and is harmful to aquatic life with long-lasting effects based on the ECHA classification; whereas haloxyfop-P has shown effects of hepatotoxicity, nephrotoxicity and oxidative stress in rats following exposure to haloxyfop-P-methyl (10);

| G. | whereas the manufacture, distribution and use of haloxyfop-P is banned in France for all agricultural and non-agricultural purposes since 4 September 2007 (11); whereas haloxyfop-P had been banned for four years throughout the Union under Commission Regulation (EC) No 1376/2007 (12); |
| --- | --- |

G.

whereas the manufacture, distribution and use of haloxyfop-P is banned in France for all agricultural and non-agricultural purposes since 4 September 2007 (11); whereas haloxyfop-P had been banned for four years throughout the Union under Commission Regulation (EC) No 1376/2007 (12);

| H. | whereas haloxyfop-P has been approved as an active substance in Commission Implementing Regulation (EU) No 540/2011 (13), with a very restricted use (14) and strict requirements for Member States with regard to groundwater protection, the protection of aquatic organisms and the safety of operators; |
| --- | --- |

H.

whereas haloxyfop-P has been approved as an active substance in Commission Implementing Regulation (EU) No 540/2011 (13), with a very restricted use (14) and strict requirements for Member States with regard to groundwater protection, the protection of aquatic organisms and the safety of operators;

| I. | whereas, in Commission Implementing Regulation (EU) 2015/2233 (15), the Commission concluded as regards the use of haloxyfop-P as an active substance that ‘further confirmatory information required has not fully been provided and that an unacceptable risk for groundwater cannot be excluded except by imposing further restrictions’; |
| --- | --- |

I.

whereas, in Commission Implementing Regulation (EU) 2015/2233 (15), the Commission concluded as regards the use of haloxyfop-P as an active substance that ‘further confirmatory information required has not fully been provided and that an unacceptable risk for groundwater cannot be excluded except by imposing further restrictions’;

| J. | whereas, in Implementing Regulation (EU) 2015/2233, the Commission also concluded that it was ‘appropriate to amend the conditions of use of this active substance, in particular by setting limits to the rates and frequency of its application’; |
| --- | --- |

J.

whereas, in Implementing Regulation (EU) 2015/2233, the Commission also concluded that it was ‘appropriate to amend the conditions of use of this active substance, in particular by setting limits to the rates and frequency of its application’;

| K. | whereas the Commission decided on 30 April 2018 to extend the approval period of haloxyfop-P as an active substance until 31 December 2023 (16); |
| --- | --- |

K.

whereas the Commission decided on 30 April 2018 to extend the approval period of haloxyfop-P as an active substance until 31 December 2023 (16);

| L. | whereas Article 191(2) of the Treaty on the Functioning of the European Union (TFEU) sets out the precautionary principle as one of the fundamental principles of the Union; |
| --- | --- |

L.

whereas Article 191(2) of the Treaty on the Functioning of the European Union (TFEU) sets out the precautionary principle as one of the fundamental principles of the Union;

| M. | whereas Article 168(1) TFEU states that ‘a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities’; |
| --- | --- |

M.

whereas Article 168(1) TFEU states that ‘a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities’;

| N. | whereas Directive 2009/128/EC aims to achieve a sustainable use of pesticides in the Union by reducing the risks and impacts of pesticide use on human and animal health and the environment and by promoting the use of integrated pest management and of alternative approaches or techniques, such as non-chemical alternatives to pesticides; |
| --- | --- |

N.

whereas Directive 2009/128/EC aims to achieve a sustainable use of pesticides in the Union by reducing the risks and impacts of pesticide use on human and animal health and the environment and by promoting the use of integrated pest management and of alternative approaches or techniques, such as non-chemical alternatives to pesticides;

| O. | whereas when setting maximum residue levels (MRLs), cumulative and synergistic effects need to be taken into account, and it is of the utmost importance to develop urgently appropriate methods for this assessment; |
| --- | --- |

O.

whereas when setting maximum residue levels (MRLs), cumulative and synergistic effects need to be taken into account, and it is of the utmost importance to develop urgently appropriate methods for this assessment;

| P. | whereas the MRL increases for haloxyfop-P on linseeds and for mandestrobin on strawberries and grapes are based on requests for normative alignment from third countries; |
| --- | --- |

P.

whereas the MRL increases for haloxyfop-P on linseeds and for mandestrobin on strawberries and grapes are based on requests for normative alignment from third countries;

| Q. | whereas the applicants claim that the authorised use of haloxyfop-P and mandestrobin on such crops in Australia and Canada lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops; |
| --- | --- |

Q.

whereas the applicants claim that the authorised use of haloxyfop-P and mandestrobin on such crops in Australia and Canada lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops;

| 1. | Opposes adoption of the draft Commission regulation; |
| --- | --- |

1.

| 2. | Considers that the draft Commission regulation is not compatible with the aim and content of Regulation (EC) No 396/2005; |
| --- | --- |

2.

| 3. | Considers that the Union and the Commission should respect the principle of environmental responsibility, and should not encourage the use in third countries of products that some Member States ban on their territory and of which the Union is trying to restrain the use; |
| --- | --- |

3.

| 4. | Considers that free trade rules should never lead to a lowering of the Union’s protective standards; |
| --- | --- |

4.

| 5. | Acknowledges that EFSA is working on methods to assess cumulative risks, but also notes that the problem of the assessment of cumulative effects of pesticides and residues has been known for decades; therefore requests EFSA and the Commission to address the problem as a matter of absolute urgency; |
| --- | --- |

5.

| 6. | Notes that under the draft regulation, the MRLs for flonicamid would increase from 0,03 to 0,5 mg/kg for strawberries, from 0,03 to 1 mg/kg for blackberries and raspberries, from 0,03 to 0,7 mg/kg for other small fruits and berries, from 0,03 to 0,3 mg/kg for other root and tuber vegetables generally, but from 0,03 to 0,6 mg/kg for radishes, from 0,03 to 0,07 mg/kg for lettuces and salad plants, and from 0,03 to 0,8 mg/kg for pulses; |
| --- | --- |

6.

| 7. | Suggests that the MRL for flonicamid should remain at 0,03 mg/kg; |
| --- | --- |

7.

| 8. | Notes that under the draft regulation, the MRL for haloxyfop-P would increase from 0,01 to 0,05 mg/kg for linseeds; |
| --- | --- |

8.

| 9. | Suggests that the MRL for haloxyfop-P should remain at 0,01 mg/kg; |
| --- | --- |

9.

| 10. | Notes that under the draft regulation, the MRLs for mandestrobin would increase from 0,01 to 5 mg/kg for grapes, and from 0,01 to 3 mg/kg for strawberries; |
| --- | --- |

10.

| 11. | Suggests that the MRL for mandestrobin should remain at 0,01 mg/kg; |
| --- | --- |

11.

| 12. | Calls on the Commission to withdraw the draft regulation and submit a new one to the committee; |
| --- | --- |

12.

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

13.

---

(1)  OJ L 70, 16.3.2005, p. 1.

(2)  OJ L 309, 24.11.2009, p. 71.

(3)  EFSA reasoned opinion on modification of the existing maximum residue levels for flonicamid in strawberries and other berries, EFSA Journal 2019; 17(7):5745, https://www.efsa.europa.eu/en/efsajournal/pub/5745

(4)  EFSA conclusion on the peer review of the pesticide risk assessment of the active substance flonicamid, EFSA Journal 2010; 8(5):1445, https://www.efsa.europa.eu/en/efsajournal/pub/1445

(5)  EFSA reasoned opinion on setting of import tolerances for haloxyfop-P in linseed and rapeseed, EFSA Journal 2018; 16(11):5470, https://www.efsa.europa.eu/en/efsajournal/pub/5470

(6)  OJ L 184, 17.7.1999, p. 23.

(7)  Commission Implementing Regulation (EU) 2017/2069 of 13 November 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances flonicamid (IKI-220), metalaxyl, penoxsulam and proquinazid (OJ L 295, 14.11.2017, p. 51).

(8)  Opinion of 5 June 2013 of the Committee for Risk Assessment proposing harmonised classification and labelling at EU level of flonicamid, https://echa.europa.eu/documents/10162/0916c5b3-fa52-9cdf-4603-2cc40356ed95

(9)  https://oag.ca.gov/news/press-releases/attorney-general-becerra-warns-against-expanded-use-pesticide-found-harm-bees

(10)  Olayinka, E.T, and Ore, A., ‘Hepatotoxicity, Nephrotoxicity and Oxidative Stress in Rat Testis Following Exposure to Haloxyfop-p-methyl Ester, an Aryloxyphenoxypropionate Herbicide’, Toxics., December 2015, 3(4), pp. 373–389, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5606644/

(11)  https://www.legifrance.gouv.fr/affichTexte.do;jsessionid=235653D01B24A4B694A6C342E7323D6F.tplgfr38s_1?cidTexte=JORFTEXT000000464899&dateTexte=&oldAction=rechJO&categorieLien=id&idJO=JORFCONT000000005119

(12)  Commission Regulation (EC) No 1376/2007 of 23 November 2007 amending Annex I to Regulation (EC) No 304/2003 of the European Parliament and of the Council concerning the export and import of dangerous chemicals (OJ L 307, 24.11.2007, p. 14).

(13)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

(14)  Only uses as herbicide may be authorised at rates not exceeding 0,052 kg active substance per hectare per application, and only one application may be authorised every 3 years.

(15)  Commission Implementing Regulation (EU) 2015/2233 of 2 December 2015 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance haloxyfop-P (OJ L 317, 3.12.2015, p. 26).

(16)  Commission Implementing Regulation (EU) 2018/670 of 30 April 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bromuconazole, buprofezin, haloxyfop-P and napropamide (OJ L 113, 3.5.2018, p. 1).

---