BETA


2021/2706(RSP) Resolution on Commission Implementing Regulation (EU) 2021/745 of 6 May 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, beflubutamid, benthiavalicarb, bifenazate, boscalid, calcium carbonate, captan, carbon dioxide, cymoxanil, dimethomorph, ethephon, extract from tea tree, famoxadone, fat distillation residues, fatty acids C7 to C20, flumioxazine, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, gibberellins, heptamaloxyloglucan, hydrolysed proteins, iron sulphate, metazachlor, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, plant oils/rape seed oil, potassium hydrogen carbonate, propamocarb, prothioconazole, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, S-metolachlor, Straight Chain Lepidopteran Pheromones, tebuconazole and urea

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI ARENA Maria (icon: S&D S&D), METZ Tilly (icon: Verts/ALE Verts/ALE), HAZEKAMP Anja (icon: GUE/NGL GUE/NGL)
Lead committee dossier:

Events

2021/09/23
   EC - Commission response to text adopted in plenary
Documents
2021/06/10
   EP - End of procedure in Parliament
2021/06/09
   EP - Results of vote in Parliament
2021/06/09
   EP - Decision by Parliament
Details

The European Parliament adopted by 434 votes to 230, with 27 abstentions, a resolution objecting to Commission Implementing Regulation (EU) 2021/745 of 6 May 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances.

Flumioxazine was included in Annex I to Council Directive 91/414/EEC on 1 January 2003 by Commission Directive 2002/81/EC and was deemed to be approved by Regulation (EC) No 1107/2009.

A procedure to renew the approval of flumioxazine under Commission Implementing Regulation (EU) No 844/2012(8) has been ongoing since 2010. The approval period for the active substance flumioxazine has already been extended by five years and subsequently by one year every year since 2015 and now again by one year by Implementing Regulation (EU) 2021/745 which extends the approval period until 30 June 2022.

Members recalled that in the 18 years since its approval as an active substance, flumioxazine has been identified and classified as toxic for reproduction category 1B and as a probable endocrine disruptor . The European Food Safety Authority (EFSA) concluded already in 2014, and subsequently in 2017 and 2018, that there were critical areas of concern as flumioxazine is classified under reproductive toxicity category 1B and also that the potential endocrine disruption of flumioxazine was an issue that could not be finalised and a critical area of concern.

EFSA published in September 2020 its updated peer review of the pesticide risk assessment of the active substance flumioxazine, in which it was not able to rule out endocrine-disrupting properties as several data gaps were identified, also on other safety aspects, leading to critical areas of concern.

More specifically, EFSA also identified data gaps in the area of residues and consumer safety, EFSA was not able to finalise the ground water exposure assessment due to data gaps, and the assessment of the endocrine-disrupting properties of flumioxazine for humans and non-target organisms could not be finalised due to the incomplete data sets.

Parliament has already opposed two previous extensions of the approval period for flumioxazine in its resolutions of 10 October 2019 and 10 July 2020 . The Commission has not responded convincingly to these resolutions and has not satisfactorily demonstrated that it would not exceed its implementing powers by granting a further extension.

In the light of these considerations, Parliament considered that the implementing regulation (EU) 2021/745 is not in line with EU law in that it does not respect the precautionary principle, strongly criticising the considerable delay in the process of renewing the authorisation and identifying endocrine disruptors.

Members considered to extend the approval period for flumioxazine again 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.

The Commission is invited to:

- repeal its Implementing Regulation (EU) 2021/745 and submit a new draft to the Commission that takes into account the scientific evidence on the harmful properties of all substances concerned, in particular flumioxazine;

- present a proposal for the non-renewal of the approval of flumioxazine at the next meeting of the Standing Committee on Plants, Animals, Food and Feed;

- communicate to Parliament the specific circumstances and reasons why the assessments are being delayed;

- submit 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;

- withdraw the approvals for substances, if proof or reasonable doubt exists that they will not meet the safety criteria laid down in Regulation (EC) No 1107/2009.

Documents
2021/06/08
   EP - Motion for a resolution
Documents
2021/04/28
   EP - ARENA Maria (S&D) appointed as rapporteur in ENVI
2021/04/28
   EP - METZ Tilly (Verts/ALE) appointed as rapporteur in ENVI
2021/04/28
   EP - HAZEKAMP Anja (GUE/NGL) appointed as rapporteur in ENVI

Documents

Votes

Objection au titre de l'article 112, paragraphes 2 et 3, du règlement intérieur: substances actives, dont la flumioxazine - Objection pursuant to Rule 112(2) and (3): Active substances, including flumioxazine - B9-0312/2021 - Proposition de résolution #

2021/06/09 Outcome: +: 434, -: 230, 0: 27
FR IT ES EL BE SK PT MT CY LU AT FI IE DK HR LV SI EE RO CZ DE LT NL BG SE HU PL
Total
78
75
59
21
21
14
21
6
6
6
18
13
13
14
12
8
8
5
33
20
93
11
29
17
20
21
49
icon: S&D S&D
143

Greece S&D

2

Cyprus S&D

2

Luxembourg S&D

For (1)

1

Finland S&D

1

Latvia S&D

2

Slovenia S&D

2

Estonia S&D

For (1)

1

Czechia S&D

For (1)

1

Lithuania S&D

2
icon: Verts/ALE Verts/ALE
70

Spain Verts/ALE

3

Belgium Verts/ALE

3

Portugal Verts/ALE

1

Luxembourg Verts/ALE

For (1)

1

Austria Verts/ALE

2

Finland Verts/ALE

3

Ireland Verts/ALE

2

Denmark Verts/ALE

2

Latvia Verts/ALE

1

Czechia Verts/ALE

2

Lithuania Verts/ALE

2

Netherlands Verts/ALE

3

Sweden Verts/ALE

3

Poland Verts/ALE

For (1)

1
icon: ID ID
69
3

Finland ID

2

Denmark ID

For (1)

1

Czechia ID

For (1)

Against (1)

2

Netherlands ID

1
icon: Renew Renew
98

Italy Renew

2

Belgium Renew

Against (1)

4

Luxembourg Renew

2

Austria Renew

For (1)

1

Finland Renew

3

Ireland Renew

2

Croatia Renew

Against (1)

1

Latvia Renew

For (1)

1

Slovenia Renew

2

Estonia Renew

3

Lithuania Renew

1

Bulgaria Renew

3

Sweden Renew

3

Hungary Renew

2
icon: The Left The Left
39

Belgium The Left

For (1)

1

Cyprus The Left

2

Finland The Left

For (1)

1

Denmark The Left

1

Czechia The Left

1

Netherlands The Left

For (1)

1

Sweden The Left

For (1)

1
icon: NI NI
38

Slovakia NI

For (1)

Against (1)

2

Germany NI

Against (1)

3

Lithuania NI

1

Netherlands NI

1
icon: ECR ECR
59

Greece ECR

1

Slovakia ECR

Abstain (1)

1

Croatia ECR

Against (1)

1

Latvia ECR

2

Romania ECR

Abstain (1)

1

Lithuania ECR

Against (1)

1

Netherlands ECR

4

Bulgaria ECR

2
3
icon: PPE PPE
175

Malta PPE

2
2

Luxembourg PPE

2

Finland PPE

3

Denmark PPE

Against (1)

1

Latvia PPE

2

Slovenia PPE

4

Estonia PPE

Against (1)

1

Hungary PPE

Against (1)

1

History

(these mark the time of scraping, not the official date of the change)

docs/1
date
2021-09-23T00:00:00
docs
url: /oeil/spdoc.do?i=56640&j=0&l=en title: SP(2021)531
type
Commission response to text adopted in plenary
body
EC
docs/1
date
2021-06-09T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0285_EN.html title: T9-0285/2021
type
Text adopted by Parliament, single reading
body
EP
events/0
date
2021-06-09T00:00:00
type
Decision by Parliament
body
EP
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0285_EN.html title: T9-0285/2021
events/0
date
2021-06-09T00:00:00
type
Results of vote in Parliament
body
EP
docs
url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=56640&l=en title: Results of vote in Parliament
events/1
date
2021-06-09T00:00:00
type
Decision by Parliament
body
EP
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0285_EN.html title: T9-0285/2021
events/1/summary
  • The European Parliament adopted by 434 votes to 230, with 27 abstentions, a resolution objecting to Commission Implementing Regulation (EU) 2021/745 of 6 May 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances.
  • Flumioxazine was included in Annex I to Council Directive 91/414/EEC on 1 January 2003 by Commission Directive 2002/81/EC and was deemed to be approved by Regulation (EC) No 1107/2009.
  • A procedure to renew the approval of flumioxazine under Commission Implementing Regulation (EU) No 844/2012(8) has been ongoing since 2010. The approval period for the active substance flumioxazine has already been extended by five years and subsequently by one year every year since 2015 and now again by one year by Implementing Regulation (EU) 2021/745 which extends the approval period until 30 June 2022.
  • Members recalled that in the 18 years since its approval as an active substance, flumioxazine has been identified and classified as toxic for reproduction category 1B and as a probable endocrine disruptor . The European Food Safety Authority (EFSA) concluded already in 2014, and subsequently in 2017 and 2018, that there were critical areas of concern as flumioxazine is classified under reproductive toxicity category 1B and also that the potential endocrine disruption of flumioxazine was an issue that could not be finalised and a critical area of concern.
  • EFSA published in September 2020 its updated peer review of the pesticide risk assessment of the active substance flumioxazine, in which it was not able to rule out endocrine-disrupting properties as several data gaps were identified, also on other safety aspects, leading to critical areas of concern.
  • More specifically, EFSA also identified data gaps in the area of residues and consumer safety, EFSA was not able to finalise the ground water exposure assessment due to data gaps, and the assessment of the endocrine-disrupting properties of flumioxazine for humans and non-target organisms could not be finalised due to the incomplete data sets.
  • Parliament has already opposed two previous extensions of the approval period for flumioxazine in its resolutions of 10 October 2019 and 10 July 2020 . The Commission has not responded convincingly to these resolutions and has not satisfactorily demonstrated that it would not exceed its implementing powers by granting a further extension.
  • In the light of these considerations, Parliament considered that the implementing regulation (EU) 2021/745 is not in line with EU law in that it does not respect the precautionary principle, strongly criticising the considerable delay in the process of renewing the authorisation and identifying endocrine disruptors.
  • Members considered to extend the approval period for flumioxazine again 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.
  • The Commission is invited to:
  • - repeal its Implementing Regulation (EU) 2021/745 and submit a new draft to the Commission that takes into account the scientific evidence on the harmful properties of all substances concerned, in particular flumioxazine;
  • - present a proposal for the non-renewal of the approval of flumioxazine at the next meeting of the Standing Committee on Plants, Animals, Food and Feed;
  • - communicate to Parliament the specific circumstances and reasons why the assessments are being delayed;
  • - submit 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;
  • - withdraw the approvals for substances, if proof or reasonable doubt exists that they will not meet the safety criteria laid down in Regulation (EC) No 1107/2009.
docs/1
date
2021-06-09T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0285_EN.html title: T9-0285/2021
type
Text adopted by Parliament, single reading
body
EP
events
  • date: 2021-06-09T00:00:00 type: Decision by Parliament body: EP docs: url: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0285_EN.html title: T9-0285/2021
  • date: 2021-06-10T00:00:00 type: End of procedure in Parliament body: EP
procedure/stage_reached
Old
Awaiting plenary debate/vote
New
Procedure completed
forecasts
  • date: 2021-06-09T00:00:00 title: Vote in plenary scheduled
procedure/title
Old
Objection to Commission Implementing Regulation (EU) amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of several active substances, including flumioxazine
New
Resolution on Commission Implementing Regulation (EU) 2021/745 of 6 May 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, beflubutamid, benthiavalicarb, bifenazate, boscalid, calcium carbonate, captan, carbon dioxide, cymoxanil, dimethomorph, ethephon, extract from tea tree, famoxadone, fat distillation residues, fatty acids C7 to C20, flumioxazine, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, gibberellins, heptamaloxyloglucan, hydrolysed proteins, iron sulphate, metazachlor, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, plant oils/rape seed oil, potassium hydrogen carbonate, propamocarb, prothioconazole, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, S-metolachlor, Straight Chain Lepidopteran Pheromones, tebuconazole and urea
docs
  • date: 2021-06-08T00:00:00 docs: url: https://www.europarl.europa.eu/doceo/document/B-9-2021-0312_EN.html title: B9-0312/2021 type: Motion for a resolution body: EP