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Document 32011R0540

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 Text with EEA relevance

OJ L 153, 11.6.2011, p. 1–186 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

This document has been published in a special edition(s) (HR)

Legal status of the document In force: This act has been changed. Current consolidated version: 01/11/2024

ELI: http://data.europa.eu/eli/reg_impl/2011/540/oj

11.6.2011   

EN

Official Journal of the European Union

L 153/1


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

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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 78(3) thereof,

After consulting the Standing Committee on the Food Chain and Animal Health,

Whereas:

(1)

In accordance with Regulation (EC) No 1107/2009 active substances included in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2) are to be deemed to have been approved under that Regulation.

(2)

It is therefore necessary for the implementation of Regulation (EC) No 1107/2009 to adopt a Regulation containing the list of active substances included in Annex I to Directive 91/414/EEC at the moment of the adoption of this Regulatation,

(3)

In this context it is to be borne in mind that, as a consequence of Article 83 of Regulation (EC) No 1107/2009 having repealed Directive 91/414/EEC, the Directives which included the active substances in Annex I to Directive 91/414/EEC have become obsolete to the extent that they amend that Directive. However, the autonomous provisions of these Directives continue to apply,

HAS ADOPTED THIS REGULATION:

Article 1

The active substances as set out in the Annex to this Regulation shall be deemed to have been approved under Regulation (EC) No 1107/2009.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply from 14 June 2011.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 25 May 2011.

For the Commission

The President

José Manuel BARROSO


(1)   OJ L 309, 24.11.2009, p. 1.

(2)   OJ L 230, 19.8.1991, p. 1.


ANNEX

ACTIVE SUBSTANCES APPROVED FOR USE IN PLANT PROTECTION PRODUCTS

General provisions applying to all substances listed in this Annex:

for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;

Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.

Number

Common name, identification numbers

IUPAC name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

1

Imazalil

CAS No 73790-28-0, 35554-44-0

CIPAC No 335

(+)-1-(β-allyloxy-2,4-dichlorophenylethyl)imidazole or (+)-allyl 1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether

975  g/kg

1 January 1999

31 December 2011

Only uses as fungicide may be authorized.

For the following uses the following particular conditions apply:

post-harvest fruit, vegetable and potato treatments may only be authorised when an appropriate decontamination system is available or a risk assessment has demonstrated to the authorizing Member State that the discharge of the treatment solution does not have an unacceptable risk to the environment and in particular to aquatic organisms,

post-harvest treatment of potatoes may only be authorised when a risk assessment has demonstrated to the authorizing Member State that the discharge of the processing waste from treated potatoes does not have an unacceptable risk to aquatic organisms,

outdoor foliar uses may only be authorised when a risk assessment has demonstrated to the authorizing Member State that the use has no unacceptable effects on human and animal health and the environment.

Date of Standing Committee on Plant Health at which the review report was finalised: 11 July 1997.

2

Azoxystrobin

CAS No 131860-33-8

CIPAC No 571

Methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy] phenyl}-3-methoxyacrylate

930 g/kg (Z isomer max. 25 g/kg)

1 July 1998

31 December 2011

Only uses as fungicide may be authorised.

In the decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, particular attention should be given to the impact on aquatic organisms. Authorisation conditions should include appropriate risk mitigation measures.

Date of Standing Committee on Plant Health at which the review report was finalised: 22 April 1998.

3

Kresoxim-Methyl

CAS No 143390-89-0

CIPAC No 568

Methyl (E)-2-methoxyimino-2-[2-(o-tolyloxymethyl) phenyl]acetate

910  g/kg

1 February 1999

31 December 2011

Only uses as fungicide may be authorised.

In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States shall pay particular attention to the protection of groundwater under vulnerable conditions.

Date of Standing Committee on Plant Health at which the review report was finalised: 16 October 1998.

4

Spiroxamine

CAS No 1181134-30-8

CIPAC No 572

(8-tert-Butyl-1,4-dioxa-spiro [4.5] decan-2-ylmethyl)-ethyl-propyl-amine

940 g/kg (diastereomers A and B combined)

1 September 1999

31 December 2011

Only uses as a fungicide may be authorised.

In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States:

must pay particular attention to operator safety and must ensure that the conditions of authorisation include appropriate protective measures,

must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

Date of Standing Committee on Plant Health at which the review report was finalised: 12 May 1999.

5

Azimsulfuron

CAS No 120162-55-2

CIPAC No 584

1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea

980  g/kg

1 October 1999

31 December 2011

Only uses as herbicide may be authorised.

Aerial applications may not be authorised.

In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States must pay particular attention to the impact on aquatic organisms and terrestrial non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures (e.g. in rice cultivation minimum holding periods for water prior to discharge).

Date of Standing Committee on Plant Health at which the review report was finalised: 2 July 1999.

6

Fluroxypyr

CAS No 69377-81-7

CIPAC No 431

4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid

950  g/kg

1 December 2000

31 December 2011

Only uses as herbicide may be authorised.

In their decision making according to the Uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 Member States:

shall take into account the additional information requested in point 7 of the Review Report,

must pay particular attention to the protection of groundwater,

must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

Member States shall inform the Commission if the requested additional trials and information as outlined in point 7 of the Review Report were not submitted by 1 December 2000.

Date of Standing Committee on Plant Health at which the review report was finalised: 30 November 1999.

7

Metsulfuron methyl

CAS No 74223-64-6

Methyl-2-(4-methoxy-6-methyl-1,3,5,-triazin-2-ylcarbamoylsulfamoyl)benzoate

960  g/kg

1 July 2001

31 December 2015

Only uses as herbicide may be authorised.

In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States

must pay particular attention to the protection of groundwater;

must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

Date of Standing Committee on Plant Health at which the review report was finalised: 16 June 2000.

8

Prohexadione Calcium

CAS No 127277-53-6

CIPAC No 567

Calcium 3,5-dioxo-4-propionylcyclohexanecarboxylate

890  g/kg

1 October 2000

31 December 2011

Only uses as plant growth regulator may be authorised.

Date of Standing Committee on Plant Health at which the review report was finalised: 16 June 2000.

9

Triasulfuron

CAS No 82097-50-5

CIPAC No 480

1-[2-(2-chloroethoxy)phenylsulfonyl]-3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea

940  g/kg

1 August 2001

31 December 2015

Only uses as herbicide may be authorised.

In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States:

must pay particular attention to the protection of groundwater;

must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.

10

Esfenvalerate

CAS No 66230-04-4

CIPAC No 481

(S)-α-Cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate

830  g/kg

1 August 2001

31 December 2015

Only uses as insecticide may be authorised.

In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States:

must pay particular attention to the potential impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.

11

Bentazone

CAS No 25057-89-0

CIPAC No 366

3-isopropyl-(1H)-2,1,3-benzothiadiazin-4-(3H)-one-2,2-dioxide

960  g/kg

1 August 2001

31 December 2015

Only uses as herbicide may be authorised.

In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States must pay particular attention to the protection of groundwater.

Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.

12

Lambda-cyhalothrin

CAS No 91465-08-6

CIPAC No 463

A 1:1 mixture of:

 

(S)-α-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate,

and

 

(R)-α-cyano-3-phenoxybenzyl (Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate

810  g/kg

1 January 2002

31 December 2015

Only uses as insecticide may be authorised.

In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States:

must pay particular attention to operator safety;

must pay particular attention to the potential impact on aquatic organisms and non-target arthropods including bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

must pay particular attention to the residues in food and especially the acute effects thereof.

Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000.

13

Fenhexamid

CAS No 126833-17-8

CIPAC No 603

N-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexanecarboxamide

≥ 950 g/kg

1 June 2001

31 December 2015

Only uses as a fungicide may be authorized.

In decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000.

14

Amitrole

CAS No 61-82-5

CIPAC No 90

H-[1,2,4]-triazole-3-ylamine

900  g/kg

1 January 2002

31 December 2015

Only uses as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amitrole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of operators;

must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses;

must pay particular attention to the protection of beneficial arthropods;

must pay particular attention to the protection of birds and wild mammals. Use of amitrole during the breeding season may only be authorised when an appropriate risk assessment has demonstrated that there is no unacceptable impact and when the conditions of authorisation include, where appropriate, risk mitigation measures.

15

Diquat

CAS No 2764-72-9 (ion), 85-00-7 (dibromide)

CIPAC No 55

9,10-Dihydro-8a,10a-diazoniaphenanthrene ion (dibromide)

950  g/kg

1 January 2002

31 December 2015

On the basis of currently available information, only uses as terrestrial herbicide and desiccant may be authorised. Uses in aquatic weed control shall not be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the Review report on diquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

must pay particular attention to operator safety as related to non-professional use and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

16

Pyridate

CAS No 55512-33.9

CIPAC No 447

6-Chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate

900  g/kg

1 January 2002

31 December 2015

Only uses as herbicide may be authorized.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the Review report on Pyridate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of groundwater;

must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

17

Thiabendazole

CAS No 148-79-8

CIPAC No 323

2-Thiazol-4-yl-1H-benzimidazole

985  g/kg

1 January 2002

31 December 2015

Only uses as fungicide may be authorised. Foliar spray applications shall not be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the Review report on thiabendazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of aquatic and sediment-dwelling organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

Suitable risk mitigation measures (e.g. depuration with diatom earth or activated carbon) have to be implemented to protect surface waters from unacceptable levels of contamination via wastewater.

18

Paecilomyces fumosoroseus

Apopka strain 97, PFR 97 or CG 170, ATCC20874

Not applicable

The absence of secondary metabolites should be checked in each fermentation broth by HPLC

1 July 2001

31 December 2015

Only uses as an insecticide may be authorised.

Each fermentation broth should be checked by HPLC to ensure that no secondary metabolites are present.

Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001.

19

DPX KE 459 (flupyrsulfuron-methyl)

CAS No 144740-54-5

CIPAC No 577

2-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-6-trifluromethylnicotinate monosodium salt

903  g/kg

1 July 2001

31 December 2015

Only uses as a herbicide may be authorised.

In decision making according to the Uniform Principles Member States must pay particular attention to the protection of groundwater.

Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001.

20

Acibenzolar-s-methyl

CAS No 135158-54-2

CIPAC No 597

Benzo[1,2,3]thiadiazole-7-carbothioic acid S-methyl ester

970  g/kg

1 November 2001

31 December 2015

Only uses as a plant activator may be authorised.

Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001

21

Cyclanilide

CAS No 113136-77-9

CIPAC No 586

Not available

960  g/kg

1 November 2001

31 December 2015

Only uses as a plant growth regulator may be authorised.

The maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active substance as manufactured should be 1 g/kg.

Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

22

Ferric phosphate

CAS No 10045-86-0

CIPAC No 629

Ferric phosphate

990  g/kg

1 November 2001

31 December 2015

Only uses as a molluscicide may be authorised.

Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

23

Pymetrozine

CAS No 123312-89-0

CIPAC No 593

(E)-6-methyl-4-[(pyridin-3-ylmetylene)amino]-4,5-dihydro-2H-[1,2,4]-triazin-3 one

950  g/kg

1 November 2001

31 December 2015

Only uses as an insecticide may be authorised.

In decision making according to the Uniform Principles Member States must pay particular attention to the protection of aquatic organisms.

Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

24

Pyraflufen-ethyl

CAS No 129630-19-9

CIPAC No 605

Ethyl-2-chloro-5-(4-chloro-5-difluoromethoxy-1-mhypyrazol-3-yl)-4-fluorophenoxyacetate

956  g/kg

1 November 2001

31 December 2015

Only uses as a herbicide may be authorised.

In decision making according to the Uniform Principles Member States must pay particular attention to the protection of algae and aquatic plants and should apply, where appropriate, risk mitigation measures.

Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.

25

Glyphosate

CAS No 1071-83-6

CIPAC No 284

N-(phosphonomethyl)-glycin

950  g/kg

1 July 2002

31 December 2015

Only uses as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on glyphosate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses.

26

Thifensulfuron-methyl

CAS No 79277-27-3

CIPAC No 452

Methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoyl-sulfamoyl) thiophene-2-carboxylate

960  g/kg

1 July 2002

31 December 2015

Only uses as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thifensulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of groundwater;

must pay particular attention to the impact on aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

27

2,4-D

CAS No 94-75-7

CIPAC No 1

(2,4-dichlorophenoxy) acetic acid

960  g/kg

1 October 2002

31 December 2015

Only uses as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-D, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 2 October 2001 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

must pay particular attention to the dermal absorption;

must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

28

Isoproturon

CAS No 34123-59-6

CIPAC No 336

3-(4-isopropylphenyl)-1,1-dimethylurea

970  g/kg

1 January 2003

31 December 2015

Only uses as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isoproturon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 7 December 2001 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions or at use rates higher than those described in the review report and must apply risk mitigation measures, where appropriate;

must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

29

Ethofumesate

CAS No 26225-79-6

CICAP No 223

(±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-ylmethanesulfonate

960  g/kg

1 March 2003

28 February 2013

Only uses as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethofumesate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States may pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and must apply risk mitigation measures, where appropriate.

30

Iprovalicarb

CAS No 140923-17-7

CICAP No 620

{2-Methyl-1-[1-(4-methylphenyl)ethylcarbonyl] propyl}-carbamic acid isopropylester

950 g/kg (provisional specification)

1 July 2002

31 December 2015

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iprovalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment:

the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossier should be compared and verified against this specification of the technical material;

Member States must pay particular attention to the protection of operators.

31

Prosulfuron

CAS No 94125-34-5

CICAP No 579

1-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea

950  g/kg

1 Juli 2002

31 December 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States:

must carefully consider the risk to aquatic plants if the active substance is applied adjacent to surface waters. Risk mitigation measures should be applied where appropriate;

must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate.

32

Sulfosulfuron

CAS No 141776-32-1

CICAP No 601

1-(4,6-dimethoxypyrimidin-2-yl)-3-[2-ethanesulfonyl-imidazo[1,2-a]pyridine) sulfonyl]urea

980  g/kg

1 July 2002

31 December 2015

Only uses as a herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment:

Member States must pay particular attention to the protection of aquatic plants and algae. Where appropriate, risk mitigation measures should be applied;

Member States must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

33

Cinidon-ethyl

CAS No 142891-20-1

CIPAC No 598

(Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate

940  g/kg

1 October 2002

31 December 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:

should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions;

should pay particular attention to the protection of aquatic organisms.

Conditions of authorisation must include risk mitigation measures, where appropriate.

34

Cyhalofop butyl

CAS No 122008-85-9

CIPAC No 596

Butyl-(R)-2-[4(4-cyano-2-fluorophenoxy) phenoxy]propionate

950  g/kg

1 October 2002

31 December 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyhalofop butyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:

Member States must carefully consider the potential impact of aerial applications to non-target organisms and in particular to aquatic species. Conditions of authorisation must include restrictions or risk mitigation measures, where appropriate.

Member States must carefully consider the potential impact of terrestrial applications on aquatic organisms within paddy fields. Conditions of authorisation must include risk mitigation measures, where appropriate.

35

Famoxadone

CAS No 131807-57-3

CIPAC No 594

3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione

960  g/kg

1 October 2002

31 December 2015

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:

Member States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms;

Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;

Member States should pay particular attention to the protection of operators.

36

Florasulam

CAS No 145701-23-1

CIPAC No 616

2′, 6′, 8-Trifluoro-5-methoxy-[1,2,4]-triazolo [1,5-c] pyrimidine-2-sulphonanilide

970  g/kg

1 October 2002

31 December 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on florasulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:

should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.

37

Metalaxyl-M

CAS No 70630-17-0

CIPAC No 580

Methyl(R)-2-{[(2,6-dimethylphenyl)methoxy-acetyl] amino} propionate

910  g/kg

1 October 2002

31 December 2015

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Metalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:

particular attention should be given to the potential for groundwater contamination by the active substance or its degradation products CGA 62826, and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate.

38

Picolinafen

CAS No 137641-05-5

CIPAC No 639

4′-Fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide

970  g/kg

1 October 2002

31 December 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on picolinafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

39

Flumioxazine

CAS No 103361-09-7

CICAP No 578

N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide

960  g/kg

1 January 2003

31 December 2015

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States:

must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate.

40

Deltamethrin

CAS No 52918-63-5

CIPAC No 333

(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate

980  g/kg

1 November 2003

31 October 2013

Only uses as insecticide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures,

should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels,

must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.

41

Imazamox

CAS No 114311-32-9

CIPAC No 619

(±)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-(methoxymethyl) nicotinic acid

950  g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazamox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

In this overall assessment Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate.

42

Oxasulfuron

CAS No 144651-06-9

CIPAC No 626

Oxetan-3-yl 2[(4,6-dimethylpyrimidin-2-yl) carbamoyl-sulfamoyl] benzoate

930  g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxasulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions.

Risk mitigation measures should be applied, where appropriate.

43

Ethoxysulfuron

CAS No 126801-58-9

CIPAC No 591

3-(4,6-dimethoxypyrimidin-2-yl)-1-(2-ethoxyphenoxy-sulfonyl)urea

950  g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethoxysulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

Member States should pay particular attention to the protection of non-target aquatic plants and algae in drainage canals. Risk mitigation measures should be applied where appropriate.

44

Foramsulfuron

CAS No 173159-57-4

CIPAC No 659

1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea

940  g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on foramsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied, where appropriate.

45

Oxadiargyl

CAS No 39807-15-3

CIPAC No 604

5-tert-butyl-3-(2,4-dichloro-5-propargyloxyphenyl)-1,3,4 oxadiazol-2-(3H)-one

980  g/kg

1 July 2003

30 June 2013

Only uses as herbicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiargyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of algae and aquatic plants. Risk mitigation measures should be applied where appropriate.

46

Cyazofamid

CAS No 120116-88-3

CIPAC No 653

4-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide

935  g/kg

1 July 2003

30 June 2013

Only uses as fungicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyazofamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment:

Member States must pay particular attention to the protection of aquatic organisms;

Member States must pay particular attention to the degradation kinetics of the metabolite CTCA in soil, especially for Northern European regions.

Risk mitigation measures or use restrictions should be applied where appropriate.

47

2,4-DB

CAS No 94-82-6

CIPAC No 83

4-(2,4-dichlorophenoxy) butyric acid

940  g/kg

1 January 2004

31 December 2013

Only use as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-DB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate.

48

Beta-cyfluthrin

CAS No 68359-37-5 (unstated stereochemistry)

CIPAC No 482

(1RS,3RS;1RS,3SR)-3- (2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylic acid (SR)-α-cyano- (4-fluoro-3-phenoxy-phenyl)methyl ester

965  g/kg

1 January 2004

31 December 2013

Only use as insecticide may be authorised

Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops.

For the implementation of the uniform principles, the conclusions of the review report on beta-cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment:

Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures.

49

Cyfluthrin

CAS No 68359-37-5 (unstated stereochemistry)

CIPAC No 385

(RS),-α-cyano-4-fluoro-3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethycyclopropanecarboxylate

920  g/kg

1 January 2004

31 December 2013

Only use as insecticide may be authorised

Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops.

For the implementation of the uniform principles, the conclusions of the review report on cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment:

Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures.

50

Iprodione

CAS No 36734-19-7

CIPAC No 278

3-(3,5-dichlorophenyl)-Nisopropyl-2,4-dioxo-imidazolidine-1-carboximide

960  g/kg

1 January 2004

31 December 2013

Only uses as fungicide and nematicide may be authorised.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iprodione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment, Member States:

should pay particular attention to the potential for groundwater contamination when the active substance is applied at high use rates (in particular use in turf) on acidic soils (pH below 6) under vulnerable climatic conditions,

must carefully consider the risk to aquatic invertebrates if the active substance is applied directly adjacent to surface waters. Risk mitigation measures should be applied, where appropriate.

51

Linuron

CAS No 330-55-2

CIPAC No 76

3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea

900  g/kg

1 January 2004

31 December 2013

Only use as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on linuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of wild mammals, non-target arthropods and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate,

must pay particular attention to the protection of operators.

52

Maleic hydrazide

CAS No 123-33-1

CIPAC No 310

6-hydroxy-2H-pyridazin-3-one

940  g/kg.

1 January 2004

31 December 2013

Only use as growth regulator may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on maleic hydrazide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate,

must pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate.

53

Pendimethalin

CAS No 40487-42-1

CIPAC No 357

N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene

900  g/kg

1 January 2004

31 December 2013

Only use as herbicide may be authorised

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pendimethalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health 3 December 2002 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the protection of aquatic organisms and non-target terrestrial plants. Conditions of authorisation must include risk mitigation measures, where appropriate,

must pay particular attention to the possibility of short-range transport of the active substance in air.

54

Propineb

CAS No 12071-83-9 (monomer), 9016-72-2 (homopolymer)

CIPAC No 177

Polymeric zinc 1,2-propylenebis(dithiocarbamate)

The technical active substance should comply with the FAO specification