# Official Journal L 153/2011

| | ISSN 1725-2555
  doi:10.3000/17252555.L_2011.153.eng |
| --- | --- |
| Official Journal
  of the European Union | L 153 |
| | |
| English edition | Legislation | Volume 5411 June 2011 |

ISSN 1725-2555

doi:10.3000/17252555.L_2011.153.eng

Official Journal

of the European Union

L 153

English edition

Legislation

Volume 5411 June 2011

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | 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 (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (
  1
  ) | 187 |
| | * | Commission Implementing Regulation (EU) No 542/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances to take into account Directive 2011/58/EU amending Council Directive 91/414/EEC to renew the inclusion of carbendazim as active substance (
  1
  ) | 189 |
| | | DECISIONS |
| | | 2011/328/EU |
| | * | Commission Implementing Decision of 1 June 2011 concerning the non-inclusion of flurprimidol in Annex I to Council Directive 91/414/EEC
  (notified under document C(2011) 3733)

   (
  1
  ) | 192 |
| | | 2011/329/EU |
| | * | Commission Implementing Decision of 1 June 2011 concerning the non-inclusion of dicloran in Annex I to Council Directive 91/414/EEC
  (notified under document C(2011) 3731)

   (
  1
  ) | 194 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

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 (
  1
  )

1

1

*

Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (
  1
  )

1

187

*

Commission Implementing Regulation (EU) No 542/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances to take into account Directive 2011/58/EU amending Council Directive 91/414/EEC to renew the inclusion of carbendazim as active substance (
  1
  )

1

189

DECISIONS

2011/328/EU

*

Commission Implementing Decision of 1 June 2011 concerning the non-inclusion of flurprimidol in Annex I to Council Directive 91/414/EEC
  (notified under document C(2011) 3733)

   (
  1
  )

(notified under document C(2011) 3733)

1

192

2011/329/EU

*

Commission Implementing Decision of 1 June 2011 concerning the non-inclusion of dicloran in Annex I to Council Directive 91/414/EEC
  (notified under document C(2011) 3731)

   (
  1
  )

(notified under document C(2011) 3731)

1

194

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

REGULATIONS

| 11.6.2011 | EN | Official Journal of the European Union | L 153/1 |
| --- | --- | --- | --- |

11.6.2011

EN

Official Journal of the European Union

L 153/1

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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. |
| --- | --- |

(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, |
| --- | --- |

(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, |
| --- | --- |

(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.

1

(2)  
  OJ L 230, 19.8.1991, p. 1.

2

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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; |
| --- | --- |

—

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. |
| --- | --- |

—

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, |

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, |
| --- | --- |

—

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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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, |
| --- | --- |

—

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 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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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. |
| --- | --- |

—

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 |
| --- | --- |

(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 |
| --- | --- |

(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 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 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. |
| --- | --- |

—

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 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 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 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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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. |
| --- | --- |

—

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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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 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 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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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; |
| --- | --- |

—

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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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 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 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. |
| --- | --- |

—

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. |
| --- | --- |

—

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. |
| --- | --- |

—

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. |
| --- | --- |

—

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. |
| --- | --- |

—

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, |
| --- | --- |

—

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, |
| --- | --- |

—

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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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. |
| --- | --- |

—

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. |
| --- | --- |

—

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. |
| --- | --- |

—

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, |
| --- | --- |

—

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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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 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. |
| --- | --- |

—

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

1 April 2004

31 March 2014

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 propineb, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2003 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 soils and/or extreme climatic conditions |
| --- | --- |

—

Member States should pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions

| — | Member States should pay particular attention to the protection of small mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate |
| --- | --- |

—

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

| — | Member States should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels |
| --- | --- |

—

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

55

Propyzamide

CAS No 23950-58-5

CIPAC No 315

3,5-dichloro-N-(1,1-dimethyl-prop-2-ynyl)benzamide

920  g/kg

1 April 2004

31 March 2014

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 propyzamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health 26 February 2003 shall be taken into account. In this overall assessment, Member States:

| — | must pay particular attention to the protection of operators and must ensure that conditions of authorisation include risk mitigation measures, where appropriate |
| --- | --- |

—

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

| — | must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season. Conditions of authorisation should include risk mitigation measures, where appropriate |
| --- | --- |

—

must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season. Conditions of authorisation should include risk mitigation measures, where appropriate

56

Mecoprop

CAS No 7085-19-0

CIPAC No 51

(RS)-2-(4-chloro-o-tolyloxy)-propionic acid

930  g/kg

1 June 2004

31 May 2014

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 mecoprop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 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 climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate, |
| --- | --- |

—

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 climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate,

| — | Member States should pay particular attention to the protection of non-target arthropods. Risk mitigation measures should be applied, where appropriate. |
| --- | --- |

—

Member States should pay particular attention to the protection of non-target arthropods. Risk mitigation measures should be applied, where appropriate.

57

Mecoprop-P

CAS No 16484-77-8

CIPAC No 475

(R)-2-(4-chloro-o-tolyloxy)-propionic acid

860  g/kg

1 June 2004

31 May 2014

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 mecoprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 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 climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| --- | --- |

—

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 climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

58

Propiconazole

CAS No 60207-90-1

CIPAC No 408

(±)-1-[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole

920  g/kg

1 June 2004

31 May 2014

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 propiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:

| — | Member States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, |
| --- | --- |

—

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

| — | Member States should pay particular attention to the protection of soil organisms for applications rates exceeding 625 g a.i./ha (e.g. uses in lawn). Conditions of authorisation should include risk mitigation measures (e.g. spotwise application scheme), where appropriate. |
| --- | --- |

—

Member States should pay particular attention to the protection of soil organisms for applications rates exceeding 625 g a.i./ha (e.g. uses in lawn). Conditions of authorisation should include risk mitigation measures (e.g. spotwise application scheme), where appropriate.

59

Trifloxystrobin

CAS No 141517-21-7

CIPAC No 617

Methyl (E)-methoxyimino-{(E)-a-[1-a-(a,a,a-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate

960  g/kg

1 October 2003

30 September 2013

Only use 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 trifloxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:

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

—

Member States should 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 and/or monitoring programs may be initiated where appropriate.

60

Carfentrazone ethyl

CAS No 128639-02.1

CIPAC No 587

Ethyl (RS)-2-chloro-3-[2-chloro-5-(4-difluoromethyl-4,5-dihydro-3-methyl-5oxo-1H 1,2,4-triazol-1-yl)-4-fluorophenyl]propionate

900  g/kg

1 October 2003

30 September 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 carfentrazone-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:

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

—

Member States should 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.

61

Mesotrione

CAS No 104206-8

CIPAC No 625

2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione

920 g/kg

The manufacturing impurity 1-cyano-6-(methylsulfonyl)-7-nitro-9H-xanthen-9-one is considered to be of toxicological concern and must remain below 0,0002 % (w/w) in the technical product.

1 October 2003

30 September 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 mesotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account.

62

Fenamidone

CAS No 161326-34-7

CIPAC No 650

(S)-5-methyl-2-methylthio-5-phenyl-3-phenylamino-3,5-dihydroimidazol-4-one

975  g/kg

1 October 2003

30 September 2013

Only use 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 fenamidone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States:

| — | should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, |
| --- | --- |

—

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

| — | should pay particular attention to the protection of non-target arthropods, |
| --- | --- |

—

should pay particular attention to the protection of non-target arthropods,

| — | should pay particular attention to the protection of aquatic organisms. |
| --- | --- |

—

should pay particular attention to the protection of aquatic organisms.

Risk mitigation measures should be applied where appropriate.

63

Isoxaflutole

CAS No 141112-29-0

CIPAC No 575

5-cyclopropyl-4-(2-methylsulfonyl-4-trifluoromethylbenzoyl) isoxazole

950  g/kg

1 October 2003

30 September 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 isoxaflutole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 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 climate conditions. Risk mitigation measures or monitoring programs 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 or monitoring programs should be applied where appropriate.

64

Flurtamone

CAS No 96525-23-4

(RS)-5-methylamino-2-phenyl-4-(a,a,a-trifluoro-m-tolyl) furan-3 (2H)-one

960  g/kg

1 January 2004

31 December 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 flurtamone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States:

| — | should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, |
| --- | --- |

—

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

| — | should pay particular attention to the protection of algae and other aquatic plants. |
| --- | --- |

—

should pay particular attention to the protection of algae and other aquatic plants.

Risk mitigation measures should be applied where appropriate.

65

Flufenacet

CAS No 142459-58-3

CIPAC No 588

4′-fluoro-N-isopropyl-2-[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yloxy]acetanilide

950  g/kg

1 January 2004

31 December 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 flufenacet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States:

| — | should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, |
| --- | --- |

—

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

| — | should pay particular attention to the protection of algae and aquatic plants, |
| --- | --- |

—

should pay particular attention to the protection of algae and aquatic plants,

| — | should pay particular attention to the protection of operators. |
| --- | --- |

—

should pay particular attention to the protection of operators.

Risk mitigation measures should be applied where appropriate.

66

Iodosulfuron

CAS No 185119-76-0 (parent)

144550-36-7 (iodosulfuron-methyl-sodium)

CIPAC No 634 (parent)

634.501 (iodosulfuron-methyl-sodium)

4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-ureidosulfonyl]benzoate

910  g/kg

1 January 2004

31 December 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 iodosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States:

| — | should pay particular attention to the potential of iodosulfuron and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, |
| --- | --- |

—

should pay particular attention to the potential of iodosulfuron and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

| — | should pay particular attention to the protection of aquatic plants. |
| --- | --- |

—

should pay particular attention to the protection of aquatic plants.

Risk mitigation measures should be applied where appropriate.

67

Dimethenamid-p

CAS No 163515-14-8

CIPAC No 638

S-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy-1-methylethyl)-acetamide

890 g/kg (preliminary value based on a pilot plant)

1 January 2004

31 December 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 dimethenamid-p, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States:

| — | should pay particular attention to the potential of the metabolites of dimethenamid-p for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, |
| --- | --- |

—

should pay particular attention to the potential of the metabolites of dimethenamid-p for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

| — | should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants. |
| --- | --- |

—

should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants.

Risk mitigation measures should be applied where appropriate.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

68

Picoxystrobin

CAS No 117428-22-5

CIPAC No 628

Methyl (E)-3-methoxy-2-{2-[6-(trifluoromethyl) -2- pyridyloxymethyl]phenyl} acrylate

950 g/kg (preliminary value based on a pilot plant)

1 January 2004

31 December 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 picoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States:

| — | should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, |
| --- | --- |

—

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

| — | should pay particular attention to the protection of soil organisms, |
| --- | --- |

—

should pay particular attention to the protection of soil organisms,

| — | should pay particular attention to the protection of aquatic ecosystems. |
| --- | --- |

—

should pay particular attention to the protection of aquatic ecosystems.

Risk mitigation measures should be applied where appropriate.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

69

Fosthiazate

CAS No 98886-44-3

CIPAC No 585

(RS)-S-sec-butyl O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate

930  g/kg

1 January 2004

31 December 2013

Only uses as insecticide or 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 fosthiazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States

| — | should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions; |
| --- | --- |

—

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

| — | should pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season; |
| --- | --- |

—

should pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season;

| — | should pay particular attention to the protection of non-target soil organisms. |
| --- | --- |

—

should pay particular attention to the protection of non-target soil organisms.

Risk mitigation measures should be applied where appropriate. In order to mitigate the potential risk to small birds, product authorisations must require that a very high level of incorporation of granules into soil is achieved.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

70

Silthiofam

CAS No 175217-20-6

CIPAC No 635

N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide

950  g/kg

1 January 2004

31 December 2013

Only uses as fungicide may be authorised.

Uses other than seed treatments are currently not adequately supported by data. To support authorisations for such uses, data and information to prove their acceptability for consumers, operators and the environment will have to be generated and submitted to the Member States.

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 silthiofam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of operators. Risk mitigation measures must be applied, where appropriate.

71

Coniothyrium minitans

Strain CON/M/91-08 (DSM 9660)

CIPAC No 614

Not applicable

For details on purity and production control see Review Report

1 January 2004

31 December 2013

Only uses as fungicide may be authorised.

When granting authorisations, the conclusions of the review report on Coniothyrium minitans, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account.

In this overall assessment:

| — | Member States must pay particular attention to the operator and worker safety and must ensure that the conditions of authorisation include appropriate protective measures. |
| --- | --- |

—

Member States must pay particular attention to the operator and worker safety and must ensure that the conditions of authorisation include appropriate protective measures.

72

Molinate

CAS No 2212-67-1

CIPAC No 235

| | S-ethyl azepane-1-carbothioate; |
| --- | --- |

S-ethyl azepane-1-carbothioate;

| | S-ethyl perhydroazepine-1-carbothioate; |
| --- | --- |

S-ethyl perhydroazepine-1-carbothioate;

| | S-ethyl perhydroazepine-1-thiocarboxilate |
| --- | --- |

S-ethyl perhydroazepine-1-thiocarboxilate

950  g/kg

1 August 2004

31 July 2014

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 molinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 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 climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate, |
| --- | --- |

—

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 climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate,

| — | Member States should pay particular attention to the possibility of short-range transport of the active substance in air. |
| --- | --- |

—

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

73

Thiram

CAS No 137-26-8

CIPAC No 24

| | tetramethylthiuram disulfide; |
| --- | --- |

tetramethylthiuram disulfide;

| | bis (dimethylthiocarbamoyl)-disulfide |
| --- | --- |

bis (dimethylthiocarbamoyl)-disulfide

960  g/kg

1 August 2004

31 July 2014

Only uses as fungicide or as repellent 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 thiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment:

| — | Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied, where appropriate, |
| --- | --- |

—

Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied, where appropriate,

| — | Member States should pay particular attention to the protection of small mammals and birds when the substance is used as a seed treatment in spring uses. Risk mitigation measures should be applied, where appropriate. |
| --- | --- |

—

Member States should pay particular attention to the protection of small mammals and birds when the substance is used as a seed treatment in spring uses. Risk mitigation measures should be applied, where appropriate.

74

Ziram

CAS No 137-30-4

CIPAC No 31

Zinc bis (dimethyldithiocarbamate)

950 g/kg (FAO-specification)

| | Arsenic: maximum 250 mg/kg |
| --- | --- |

Arsenic: maximum 250 mg/kg

| | Water: maximum 1,5 % |
| --- | --- |

Water: maximum 1,5 %

1 August 2004

31 July 2014

Only uses as fungicide or as repellent 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 ziram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment:

| — | Member States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Risk mitigation measures should be applied, where appropriate, |
| --- | --- |

—

Member States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Risk mitigation measures should be applied, where appropriate,

| — | Member States should observe the acute dietary exposure situation of consumers in view of future revisions of Maximum Residue Levels. |
| --- | --- |

—

Member States should observe the acute dietary exposure situation of consumers in view of future revisions of Maximum Residue Levels.

75

Mesosulfuron

CAS No 400852-66-6

CIPAC No 441

2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-(methanesulfonamido)-p-toluic acid

930  g/kg

1 April 2004

31 March 2014

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 mesosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account. In this overall assessment Member States:

| — | should pay particular attention to the protection of aquatic plants; |
| --- | --- |

—

should pay particular attention to the protection of aquatic plants;

| — | should pay particular attention to the potential of mesosulfuron and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions. |
| --- | --- |

—

should pay particular attention to the potential of mesosulfuron and its metabolites 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.

76

Propoxycarbazone

CAS No 145026-81-9

CIPAC No 655

2-(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-yl) carboxamidosulfonylbenzoicacid-methylester

≥ 950 g/kg (expressed as propoxy-carbazone-sodium)

1 April 2004

31 March 2014

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 propoxycarbazone, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account. In this overall assessment Member States:

| — | should pay particular attention to the potential of propoxycarbazone and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, |
| --- | --- |

—

should pay particular attention to the potential of propoxycarbazone and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

| — | should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants. |
| --- | --- |

—

should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants.

Risk mitigation measures should be applied where appropriate.

77

Zoxamide

CAS No 156052-68-5

CIPAC No 640

(RS)-3,5-Dichloro-N-(3-chloro-1-ethyl-1-methylacetonyl)-p-toluamide

950  g/kg

1 April 2004

31 March 2014

Only use 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 zoxamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account.

78

Chlorpropham

CAS No 101-21-3

CIPAC No 43

Isopropyl 3-chlorophenylcarbamate

975  g/kg

1 February 2005

31 January 2015

Only uses as herbicide and sprout suppression 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 chlorpropham, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, consumers and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate.

79

Benzoic acid

CAS No 65-85-0

CIPAC No 622

benzoic acid

990  g/kg

1 June 2004

31 May 2014

Only uses as disinfectant 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 benzoic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account.

80

Flazasulfuron

CAS No 104040-78-0

CIPAC No 595

1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulphonyl)urea

940  g/kg

1 June 2004

31 May 2014

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 flazasulfuron, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 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, |
| --- | --- |

—

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,

| — | should pay particular attention to the protection of aquatic plants. |
| --- | --- |

—

should pay particular attention to the protection of aquatic plants.

Risk mitigation measures should be applied where appropriate.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

81

Pyraclostrobin

CAS No 175013-18-0

CIPAC No 657

methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate

975 g/kg

The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product.

1 June 2004

31 May 2014

Only uses as fungicide or plant 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 pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States:

| — | should pay particular attention to the protection of aquatic organisms, especially fish, |
| --- | --- |

—

should pay particular attention to the protection of aquatic organisms, especially fish,

| — | should pay particular attention to the protection of terrestrial arthropods and earthworms. |
| --- | --- |

—

should pay particular attention to the protection of terrestrial arthropods and earthworms.

Risk mitigation measures should be applied where appropriate.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

82

Quinoxyfen

CAS No 124495-18-7

CIPAC No 566

5, 7-dichloro-4 (ρ-fluorophenoxy) quinoline

970  g/kg

1 September 2004

31 August 2014

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 quinoxyfen, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003, shall be taken into account.

Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures must be applied and monitoring programmes must be initiated in vulnerable zones where appropriate.

83

Alpha-cypermethrin

CAS No 67375-30-8

CIPAC No

Racemate comprising

| | (S)-α- cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate
  and |
| --- | --- |

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

and

| | (R)-α- cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate
  (= cis-2 isomer pair of cypermethrin) |
| --- | --- |

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

(= cis-2 isomer pair of cypermethrin)

930 g/kg CIS-2

1 March 2005

28 February 2015

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 alpha-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment:

| — | Member States 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. |
| --- | --- |

—

Member States 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.

| — | Member States must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures. |
| --- | --- |

—

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

84

Benalaxyl

CAS No 71626-11-4

CIPAC No 416

Methyl N-phenylacetyl–N-2, 6–xylyl–DL-alaninate

960  g/kg

1 March 2005

28 February 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 benalaxyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 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 climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

85

Bromoxynil

CAS No 1689-84-5

CIPAC No 87

3,5 dibromo – 4- hydroxybenzonitrile

970  g/kg

1 March 2005

28 February 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 bromoxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals, in particular if the substance is applied in winter, and of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

86

Desmedipham

CAS No 13684-56-5

CIPAC No 477

| | ethyl 3′-phenylcarbamoyloxycarbanilate |
| --- | --- |

ethyl 3′-phenylcarbamoyloxycarbanilate

| | ethyl 3-phenylcarbamoyloxyphenylcarbamate |
| --- | --- |

ethyl 3-phenylcarbamoyloxyphenylcarbamate

Min. 970 g/kg

1 March 2005

28 February 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 desmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms and earthworms. Risk mitigation measures should be applied if appropriate

87

Ioxynil

CAS No 13684-83-4

CIPAC No 86

4- hydroxy- 3,5- di-iodobenzonitrile

960  g/kg

1 March 2005

28 February 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 ioxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied in winter and to aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

88

Phenmedipham

CAS No 13684-63-4

CIPAC No 77

| | methyl 3-(3-methylcarbaniloyloxy)carbanilate; |
| --- | --- |

methyl 3-(3-methylcarbaniloyloxy)carbanilate;

| | 3-methoxycarbonylaminophenyl 3′-methylcarbanilate |
| --- | --- |

3-methoxycarbonylaminophenyl 3′-methylcarbanilate

Min. 970 g/kg

1 March 2005

28 February 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 phenmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

89

Pseudomonas chlororaphis

Strain: MA 342

CIPAC No 574

Not applicable

The amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the fermentate at the point of formulation of the product must not exceed the LOQ (2 mg/l).

1 October 2004

30 September 2014

Only uses as fungicide for seed dressing in closed seed dressing machinery may be authorised.

When granting authorisations, the conclusions of the review report on Pseudomonas chlororaphis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account.

In this overall assessment, Member States should pay particular attention to the safety of operators and workers. Risk mitigation measures should be applied where appropriate.

90

Mepanipyrim

CAS No 110235-47-7

CIPAC No 611

N-(4-methyl-6-prop-1-ynylpyrimidin-2-yl)aniline

960  g/kg

1 October 2004

30 September 2014

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 mepanipyrim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account.

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

91

Acetamiprid

CAS No 160430-64-8

CIPAC No Not yet allocated

(E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine

≥ 990 g/kg

1 January 2005

31 December 2014

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 Acetamiprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 June 2004 shall be taken into account.

In this overall assessment Member States

| — | should pay particular attention to worker exposure, |
| --- | --- |

—

should pay particular attention to worker exposure,

| — | should pay particular attention to the protection of aquatic organisms. |
| --- | --- |

—

should pay particular attention to the protection of aquatic organisms.

Risk mitigation measures should be applied where appropriate.

92

Thiacloprid

CAS No 111988-49-9

CIPAC No 631

(Z)-N-{3-[(6-Chloro-3-pyridinyl)methyl]-1,3-thiazolan-2-yliden}cyanamide

≥ 975 g/kg

1 January 2005

31 December 2014

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 Thiacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 June 2004 shall be taken into account.

In this overall assessment Member States:

| — | should pay particular attention to the protection of non-target arthropods, |
| --- | --- |

—

should pay particular attention to the protection of non-target arthropods,

| — | should pay particular attention to the protection of aquatic organisms, |
| --- | --- |

—

should pay particular attention to the protection of aquatic organisms,

| — | should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

—

should 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.

93

Ampelomyces quisqualis

Strain: AQ 10

Culture collection No CNCM I-807

CIPAC No

Not allocated

Not applicable

1 April 2005

31 March 2015

Only uses as fungicide may be authorised.

When granting authorisations, the conclusions of the review report on Ampelomyces quisqualis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

94

Imazosulfuron

CAS No 122548-33-8

CIPAC No 590

1-(2-chloroimidazo[1,2-α]pyridin-3-ylsul-phonyl)-3-(4,6-dimethoxypyrimidin-2-yl)urea

≥ 980 g/kg

1 April 2005

31 March 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 imazosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

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

95

Laminarin

CAS No 9008-22-4

CIPAC No 671

(1→3)-β-D-glucan

(according to IUPAC-IUB Joint Commission on Biochemical Nomenclature)

≥ 860 g/kg on dry matter

1 April 2005

31 March 2015

Only uses as elicitor of the crop's self-defence mechanisms 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 laminarin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

96

Methoxyfenozide

CAS No 161050-58-4

CIPAC No 656

N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide

≥ 970 g/kg

1 April 2005

31 March 2015

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 methoxyfenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of terrestrial and aquatic non-target arthropods.

Risk mitigation measures should be applied where appropriate.

97

S-metolachlor

CAS No 87392-12-9

(S-isomer)

178961-20-1 (R-isomer)

CIPAC No 607

Mixture of:

| | (aRS, 1 S)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (80-100 %)
  and: |
| --- | --- |

(aRS, 1 S)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (80-100 %)

and:

| | (aRS, 1 R)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (20-0 %) |
| --- | --- |

(aRS, 1 R)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (20-0 %)

≥ 960 g/kg

1 April 2005

31 March 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 s-metolachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.

In this overall assessment Member States:

| — | should pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites CGA 51202 and CGA 354743, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, |
| --- | --- |

—

should pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites CGA 51202 and CGA 354743, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

| — | should pay particular attention to the protection of aquatic plants. |
| --- | --- |

—

should pay particular attention to the protection of aquatic plants.

Risk mitigation measures should be applied where appropriate.

98

Gliocladium catenulatum

Strain: J1446

Culture collection No DSM 9212

CIPAC No

Not allocated

Not applicable

1 April 2005

31 March 2015

Only uses as fungicide may be authorised.

When granting authorisations, the conclusions of the review report on Gliocladium catenulatum, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account.

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

99

Etoxazole

CAS No 153233-91-1

CIPAC No 623

(RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro-1,3-oxazol-4-yl] phenetole

≥ 948 g/kg

1 June 2005

31 May 2015

Only uses as acaricide 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 etoxazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic organisms.

Risk mitigation measures should be applied where appropriate.

100

Tepraloxydim

CAS No 149979-41-9

CIPAC No 608

(EZ)-(RS)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one

≥ 920 g/kg

1 June 2005

31 May 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 tepraloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account.

In this overall assessment, Member States should pay particular attention to the protection of terrestrial non-target arthropods.

Risk mitigation measures should be applied where appropriate.

101

Chlorothalonil

CAS No 1897-45-6

CIPAC No 288

Tetrachloroisophthalonitrile

985 g/kg

| — | Hexachlorobenzene: not more than 0,04 g/kg |
| --- | --- |

—

Hexachlorobenzene: not more than 0,04 g/kg

| — | Decachlorobiphenyl: not more than 0,03 g/kg |
| --- | --- |

—

Decachlorobiphenyl: not more than 0,03 g/kg

1 March 2006

28 February 2016

PART A

Only uses as fungicide may be authorised.

PART B

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 chlorothalonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee onthe Food Chain and Animal Health on 15 February 2005 shall be taken into account.

In this overall assessment Members States must pay particular attention to the protection of:

| — | aquatic organisms, |
| --- | --- |

—

aquatic organisms,

| — | groundwater, in particular with regards to the active substance and its metabolites R417888 and R611965 (SDS46851), when the substance is applied in regions with vulnerable soil and/or climate conditions. |
| --- | --- |

—

groundwater, in particular with regards to the active substance and its metabolites R417888 and R611965 (SDS46851), when the substance is applied in regions with vulnerable soil and/or climate conditions.

Conditions of use should include risk mitigation measures, where appropriate.

102

Chlorotoluron (unstated stereochemistry)

CAS No 15545-48-9

CIPAC No 217

3-(3-chloro-p-tolyl)-1,1-dimethylurea

975  g/kg

1 March 2006

28 February 2016

PART A

Only uses as herbicide may be authorised

PART B

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 chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 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 climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate

103

Cypermethrin

CAS No 52315-07-8

CIPAC No 332

(RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate

(4 isomer pairs: cis-1, cis-2, trans-3, trans-4)

900  g/kg

1 March 2006

28 February 2016

PART A

Only uses as insecticide may be authorised

PART B

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 cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment:

| — | Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, |
| --- | --- |

—

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

| — | Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate |
| --- | --- |

—

Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate

104

Daminozide

CAS No 1596-84-5

CIPAC No 330

N-dimethylaminosuccinamic acid

990 g/kg

Impurities:

| — | N-nitrosodimethylamine: not more than 2,0 mg/kg |
| --- | --- |

—

N-nitrosodimethylamine: not more than 2,0 mg/kg

| — | 1,1-dimethylhydrazide: not more than 30 mg/kg |
| --- | --- |

—

1,1-dimethylhydrazide: not more than 30 mg/kg

1 March 2006

28 February 2016

PART A

Only uses as growth regulator in non-edible crops may be authorised

PART B

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 daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate

105

Thiophanate-methyl (unstated stereochemistry)

CAS No 23564-05-8

CIPAC No 262

Dimethyl 4,4′-(o-phenylene)bis(3-thioallophanate)

950  g/kg

1 March 2006

28 February 2016

PART A

Only uses as fungicide may be authorised

PART B

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 thiophanate-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of aquatic organisms, earthworms and other soil macro-organisms. Conditions of authorisation should include risk mitigation measures, where appropriate

106

Tribenuron

CAS No 106040-48-6 (tribenuron)

CIPAC No 546

2-[4-methoxy-6-methyl-1,3,5-triazin-2-yl(methyl)carbamoylsulfamoyl]benzoic acid

950 g/kg (expressed as tribenuron-methyl)

1 March 2006

28 February 2016

PART A

Only uses as herbicide may be authorised.

PART B

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 tribenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of non-target terrestrial plants, higher aquatic plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.

107

MCPA

CAS No 94-74-6

CIPAC No 2

4-chloro-o-tolyloxyacetic acid

≥ 930 g/kg

1 May 2006

30 April 2016

PART A

Only uses as herbicide may be authorised

PART B

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 MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account

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 climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate

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

108

MCPB

CAS No 94-81-5

CIPAC No 50

4-(4-chloro-o-tolyloxy)butyric acid

≥ 920 g/kg

1 May 2006

30 April 2016

PART A

Only uses as herbicide may be authorised

PART B

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 MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account

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 climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate

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

109

Bifenazate

CAS No 149877-41-8

CIPAC No 736

Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate

≥ 950 g/kg

1 December 2005

30 November 2015

PART A

Only uses as acaricide may be authorised.

PART B

In assessing applications to authorise plant protection products containing bifenazate for uses other than on ornamental plants in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.

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 bifenazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

110

Milbemectin

Milbemectin is a mixture of M.A3 and M.A4

CAS No

| | M.A3: 51596-10-2 |
| --- | --- |

M.A3: 51596-10-2

| | M.A4: 51596-11-3 |
| --- | --- |

M.A4: 51596-11-3

CIPAC No 660

| | M.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one |
| --- | --- |

M.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one

| | M.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one |
| --- | --- |

M.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one

≥ 950 g/kg

1 December 2005

30 November 2015

PART A

Only uses as acaricide or insecticide may be authorised.

PART B

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 milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

In this overall assessment Member States should pay particular attention to the protection of aquatic organisms.

Risk mitigation measures should be applied where appropriate.

111

Chlorpyrifos

CAS No 2921-88-2

CIPAC No 221

O,O-diethyl-O-3,5,6-trichloro-2-pyridyl phosphorothioate

≥ 970 g/kg

The impurity O,O,O,O-tetraethyl dithiopyrophosphate (Sulfotep) was considered of toxicological concern and a maximum level of 3 g/Kg is established.

1 July 2006

30 June 2016

PART A

Only uses as insecticide may be authorised.

PART B

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 chlorpyrifos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request chlorpyrifos has been included in this Annex provide such studies to the Commission within two years from the approval.

112

Chlorpyrifos-methyl

CAS No 5598-13-0

CIPAC No 486

O,O-dimethyl-O-3,5,6-trichloro-2-pyridyl phosphorothioate

≥ 960 g/kg

The impurities O,O,O,O-tetramethyl dithiopyrophosphate (Sulfotemp) and OOO-trimethyl-O-(3,5,6-trichloro-2-pyridinyl) diphosphorodithioate (Sulfotemp -ester) were considered of toxicological concern and a maximum level of 5 g/Kg is established for each impurity.

1 July 2006

30 June 2016

PART A

Only uses as insecticide may be authorised.

PART B

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 chlorpyrifos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals in case of outdoor uses. They shall ensure that the notifiers at whose request chlorpyrifos-methyl has been included in this Annex provide such studies to the Commission within two years from the approval.

113

Maneb

CAS No 12427-38-2

CIPAC No 61

manganese ethylenebis (dithiocarbamate) (polymeric )

≥ 860 g/kg

The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the maneb content.

1 July 2006

30 June 2016

PART A

Only uses as fungicide may be authorised.

PART B

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 maneb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.

Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity.

They shall ensure that the notifiers at whose request maneb has been included in this Annex provide such studies to the Commission within two years from the approval.

114

Mancozeb

CAS No 8018-01-7 (formerly 8065-67-5)

CIPAC No 34

Manganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc salt

≥ 800 g/kg

The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the mancozeb content.

1 July 2006

30 June 2016

PART A

Only uses as fungicide may be authorised.

PART B

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 mancozeb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.

Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity.

They shall ensure that the notifiers at whose request mancozeb has been included in this Annex provide such studies to the Commission within two years from the approval.

115

Metiram

CAS No 9006-42-2

CIPAC No 478

Zinc ammoniate ethylenebis(dithiocarbamate) — poly[ethylenebis(thiuramdisulfide)]

≥ 840 g/kg

The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the metiram content.

1 July 2006

30 June 2016

PART A

Only uses as fungicide may be authorised.

PART B

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 metiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

Member States must pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions.

Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers.

Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non target arthropods and must ensure that the conditions of authorisation include risk mitigation measures.

Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request metiram has been included in this Annex provide such studies to the Commission within two years from the approval.

116

Oxamyl

CAS No 23135-22-0

CIPAC No 342

N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide

970  g/kg

1 August 2006

31 July 2016

PART A

Only uses as nematicide and insecticide may be authorised.

PART B

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 oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account. In this overall assessment,

| — | Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations. |
| --- | --- |

—

Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations.

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

| — | Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. |
| --- | --- |

—

Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms. They shall ensure that the notifiers at whose request oxamyl has been included in this Annex provide such studies to the Commission within two years from the approval.

117

1-methylcyclopropene (an ISO Common Name will not be considered for this active substance)

CAS No 3100-04-7

CIPAC No not allocated

1-methylcyclopropene

≥ 960 g/kg

The manufacturing impurities 1-chloro-2-methylpropene and 3-chloro-2-methylpropene are of toxicological concern and each of them must not exceed 0,5 g/kg in the technical material.

1 April 2006

31 March 2016

PART A

Only uses as plant growth regulator for post harvest storage in sealable warehouse may be authorised.

PART B

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 1-methylcyclopropene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.

118

Forchlorfenuron

CAS No 68157-60-8

CIPAC No 633

1-(2-chloro-4-pyridinyl)-3-phenylurea

≥ 978 g/kg

1 April 2006

31 March 2016

PART A

Only uses as plant growth regulator may be authorised.

PART B

In assessing applications to authorise plant protection products containing forchlorfenuron for uses other than in kiwi plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.

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 forchlorfenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.

In this overall assessment Member States 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.

119

Indoxacarb

CAS No 173584-44-6

CIPAC No 612

methyl (S)-N-[7-chloro-2,3,4a,5-tetrahydro-4a-(methoxycarbonyl)indeno[1,2-e][1,3,4]oxadiazin-2-ylcarbonyl]-4′-(trifluoromethoxy)carbanilate

TC (Technical Material): ≥ 628 g/kg indoxacarb

1 April 2006

31 March 2016

PART A

Only uses as insecticide may be authorised.

PART B

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 indoxacarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.

In this overall assessment Member States must pay particular attention to the protection of aquatic organisms.

Conditions of use should include risk mitigation measures, where appropriate.

120

Warfarin

CAS No 81-81-2

CIPAC No 70

(RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin 3-(α-acetonyl-benzyl)-4-hydroxycoumarin

≥ 990 g/kg

1 October 2006

30 September 2013

PART A

Only uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in specially constructed hoppers, are authorised.

PART B

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 warfarin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005, shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, birds and non-target mammals.

Risk mitigation measures should be applied where appropriate.

121

Clothianidin

CAS No 210880-92-5

CIPAC No 738

(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine

≥ 960 g/kg

1 August 2006

31 July 2016

PART A

Only uses as insecticide may be authorised.

For the protection of non-target organisms, in particular honey bees, for use as seed treatment:

| — | the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised, |
| --- | --- |

—

the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised,

| — | adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission. |
| --- | --- |

—

adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission.

Member States shall ensure that:

| — | the label of the treated seed includes the indication that the seeds were treated with clothianidin and sets out the risk mitigation measures provided for in the authorisation, |
| --- | --- |

—

the label of the treated seed includes the indication that the seeds were treated with clothianidin and sets out the risk mitigation measures provided for in the authorisation,

| — | the conditions of the authorisation, in particular for spray applications, include, where appropriate, risk mitigation measures to protect honey bees, |
| --- | --- |

—

the conditions of the authorisation, in particular for spray applications, include, where appropriate, risk mitigation measures to protect honey bees,

| — | monitoring programmes are initiated to verify the real exposure of honey bees to clothianidin in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. |
| --- | --- |

—

monitoring programmes are initiated to verify the real exposure of honey bees to clothianidin in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.

PART B

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 clothianidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 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 climate conditions, |
| --- | --- |

—

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

| — | must pay particular attention to the risk to granivorous birds and mammals when the substance is used as a seed dressing. |
| --- | --- |

—

must pay particular attention to the risk to granivorous birds and mammals when the substance is used as a seed dressing.

Conditions of use shall include risk mitigation measures, where appropriate.

122

Pethoxamid

CAS No 106700-29-2

CIPAC No 655

2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide

≥ 940 g/kg

1 August 2006

31 July 2016

PART A

Only uses as herbicide may be authorised.

PART B

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 pethoxamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 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 climate conditions, |
| --- | --- |

—

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

| — | must pay particular attention to the protection of the aquatic environment, in particular higher aquatic plants. |
| --- | --- |

—

must pay particular attention to the protection of the aquatic environment, in particular higher aquatic plants.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

123

Clodinafop

CAS No 114420-56-3

CIPAC No 683

(R)-2-[4-(5-chloro-3-fluoro- 2 pyridyloxy)-phenoxy]-propionic acid

≥ 950 g/kg (expressed as clodinafop-propargyl)

1 February 2007

31 January 2017

PART A

Only uses as herbicide may be authorised.

PART B

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 clodinafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

124

Pirimicarb

CAS No 23103-98-2

CIPAC No 231

2-dimethylamino-5,6-dimethylpyrimidin-4-yl dimethylcarbamate

≥ 950 g/kg

1 February 2007

31 January 2017

PART A

Only uses as insecticide may be authorised.

PART B

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 pirimicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

Member States must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment.

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

The concerned Member States shall request the submission of further studies to confirm the long term risk assessment for birds and for potential groundwater contamination, in particular concerning metabolite R35140. They shall ensure that the notifiers at whose request pirimicarb has been included in this Annex provide such studies to the Commission within two years from the approval.

125

Rimsulfuron

CAS No 122931-48-0 (rimsulfuron)

CIPAC No 716

1-(4-6 dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl) urea

≥ 960 g/kg (expressed as rimsulfuron)

1 February 2007

31 January 2017

PART A

Only uses as herbicide may be authorised.

PART B

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 rimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

Member States must pay particular attention to the protection of non target plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.

126

Tolclofos-methyl

CAS No 57018-04-9

CIPAC No 479

| | O-2,6-dichloro-p-tolyl O,O-dimethyl phosphorothioate |
| --- | --- |

O-2,6-dichloro-p-tolyl O,O-dimethyl phosphorothioate

| | O-2,6-dichloro-4-methylphenyl O,O-dimethyl phosphorothioate |
| --- | --- |

O-2,6-dichloro-4-methylphenyl O,O-dimethyl phosphorothioate

≥ 960 g/kg

1 February 2007

31 January 2017

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing tolclofos-methyl for uses other than pre-planting tuber (seed) treatment in potato and soil treatment in lettuce within greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 tolclofos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.

127

Triticonazole

CAS No 131983-72-7

CIPAC No 652

(±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

≥ 950 g/kg

1 February 2007

31 January 2017

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing triticonazole for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 triticonazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States:

| — | must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate, |
| --- | --- |

—

must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate,

| — | must pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones, |
| --- | --- |

—

must pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones,

| — | must pay particular attention to the protection of granivorous birds (long term risk). |
| --- | --- |

—

must pay particular attention to the protection of granivorous birds (long term risk).

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

The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds. They shall ensure that the notifier at whose request triticonazole has been included in this Annex provide such studies to the Commission within two years from the approval.

128

Dimoxystrobin

CAS No 149961-52-4

CIPAC No 739

(E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide

≥ 980 g/kg

1 October 2006

30 September 2016

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing dimoxystrobin for indoor uses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 dimoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 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 a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions; |
| --- | --- |

—

must pay particular attention to the protection of groundwater, when the active substance is applied in a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions;

| — | must pay particular attention to the protection of aquatic organisms. |
| --- | --- |

—

must pay particular attention to the protection of aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of

| — | a refined risk assessment for birds and mammals considering the formulated active substance; |
| --- | --- |

—

a refined risk assessment for birds and mammals considering the formulated active substance;

| — | a comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage. |
| --- | --- |

—

a comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage.

They shall ensure that the notifiers at whose request dimoxystrobin has been included in this Annex provide such studies to the Commission within two years from the approval.

129

Clopyralid

CAS No 1702-17-6

CIPAC No 455

3,6-dichloropyridine-2-carboxylic acid

≥ 950 g/kg

1 May 2007

30 April 2017

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing clopyralid for uses other than spring applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 clopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of non target plants and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate. |
| --- | --- |

—

the protection of non target plants and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate.

The concerned Member States shall request the submission of further studies to confirm the results on animal metabolism. They shall ensure that the notifiers at whose request clopyralid has been included in this Annex provide such studies to the Commission within two years from the approval.

130

Cyprodinil

CAS No 121522-61-2

CIPAC No 511

(4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine

≥ 980 g/kg

1 May 2007

30 April 2017

PART A

Only uses as fungicide may be authorised.

PART B

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 cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States:

| — | must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | must pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones. |
| --- | --- |

—

must pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA 304075 in food of animal origin. They shall ensure that the notifiers at whose request cyprodinil has been included in this Annex provide such studies to the Commission within two years from the approval.

131

Fosetyl

CAS No 15845-66-6

CIPAC No 384

Ethyl hydrogen phosphonate

≥ 960 g/kg (expressed as fosetyl-Al)

1 May 2007

30 April 2017

PART A

Only uses as fungicide may be authorised.

PART B

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 fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States:

| — | must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods. |
| --- | --- |

—

must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods.

Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones.

The concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Annex provide such studies to the Commission within two years from the approval.

132

Trinexapac

CAS No 104273-73-6

CIPAC No 732

4-(cyclopropyl-hydroxymethylene)-3,5-dioxo- cyclohexanecarboxylic acid

≥ 940 g/kg (expressed as trinexapac-ethyl)

1 May 2007

30 April 2017

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 trinexapac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

In this overall assessment Member States:

| — | must pay particular attention to the protection of birds and mammals. |
| --- | --- |

—

must pay particular attention to the protection of birds and mammals.

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

133

Dichlorprop-P

CAS No 15165-67-0

CIPAC No 476

(R)-2-(2,4-dichlorophenoxy) propanoic acid

≥ 900 g/kg

1 June 2007

31 May 2017

PART A

Only uses as herbicide may be authorised.

PART B

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 dichlorprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.

In this overall assessment Member States:

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

—

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

The Member States concerned shall request the submission of further studies to confirm the results on animal metabolism and the risk assessment on acute and short-term exposure for birds and on acute exposure for herbivorous mammals.

They shall ensure that the notifiers at whose request dichlorprop-P has been included in this Annex provide such studies to the Commission within two years of the approval.

134

Metconazole

CAS No 125116-23-6 (unstated stereo-chemistry)

CIPAC No 706

(1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol

≥ 940 g/kg

(sum of cis-and trans-isomers)

1 June 2007

31 May 2017

PART A

Only uses as fungicide and plant growth regulator may be authorised.

PART B

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 metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.

In this overall assessment:

| — | Member States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate, |
| --- | --- |

—

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

| — | Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. |
| --- | --- |

—

Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.

135

Pyrimethanil

CAS No 53112-28-0

CIPAC No not allocated

N-(4,6-dimethylpyrimidin-2-yl) aniline

≥ 975 g/kg

(the manufacturing impurity cyanamide is considered to be of toxicological concern and must not exceed 0,5 g/kg in the technical material)

1 June 2007

31 May 2017

PART A

Only uses as fungicide may be authorised.

PART B

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 pyrimethanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 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, such as buffer zones, |
| --- | --- |

—

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

| — | must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. |
| --- | --- |

—

must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.

The Member States concerned shall request the submission of further studies to confirm the risk assessment to fish. They shall ensure that the notifiers at whose request pyrimethanil has been included in this Annex provide such studies to the Commission within two years from the approval.

136

Triclopyr

CAS No 055335-06-3

CIPAC No 376

3,5,6-trichloro-2-pyridyloxyacetic acid

≥ 960 g/kg

(as Triclopyr butoxyethyl ester)

1 June 2007

31 May 2017

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing triclopyr for uses other than spring applications in pasture and grassland, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.

In this overall assessment Member States:

| — | must pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate, |
| --- | --- |

—

must pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate,

| — | must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment,

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

—

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

The Member States concerned shall request the submission of further studies to confirm the acute and long-term risk assessment for birds and mammals and the risk to aquatic organisms from exposure to the metabolite 6-chloro-2-pyridinol. They shall ensure that the notifiers at whose request triclopyr has been included in this Annex provide such studies to the Commission within two years from the approval.

137

Metrafenone

CAS No 220899-03-6

CIPAC No 752

3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone

≥ 940 g/kg

1 February 2007

31 January 2017

PART A

Only uses as fungicide may be authorised.

PART B

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 metrafenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

138

Bacillus subtilis

(Cohn 1872)

Strain QST 713, identical with strain AQ 713

Culture collection No: NRRL B -21661

CIPAC No not allocated

Not applicable

1 February 2007

31 January 2017

PART A

Only uses as fungicide may be authorised.

PART B

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 Bacillus subtilis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

139

Spinosad

CAS No 131929-60-7 (Spinosyn A)

131929-63-0 (Spinosyn D)

CIPAC No 636

| | Spinosyn A:
  (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione |
| --- | --- |

Spinosyn A:

(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione

| | Spinosyn D:
  (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione |
| --- | --- |

Spinosyn D:

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione

Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D

≥ 850 g/kg

1 February 2007

31 January 2017

PART A

Only uses as insecticide may be authorised.

PART B

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 spinosad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

In this overall assessment Member States

| — | must pay particular attention to the protection of aquatic organisms; |
| --- | --- |

—

must pay particular attention to the protection of aquatic organisms;

| — | must pay particular attention to the risk to earthworms when the substance is used in glasshouses. |
| --- | --- |

—

must pay particular attention to the risk to earthworms when the substance is used in glasshouses.

Conditions of use shall include risk mitigation measures, where appropriate.

140

Thiamethoxam

CAS No 153719-23-4

CIPAC No 637

(E,Z)-3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine

≥ 980 g/kg

1 February 2007

31 January 2017

PART A

Only uses as insecticide may be authorised.

For the protection of non-target organisms, in particular honey bees, for use as seed treatment:

| — | the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised, |
| --- | --- |

—

the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised,

| — | adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission. |
| --- | --- |

—

adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission.

Member States shall ensure that:

| — | the label of the treated seed includes the indication that the seeds were treated with thiamethoxam and sets out the risk mitigation measures provided for in the authorisation, |
| --- | --- |

—

the label of the treated seed includes the indication that the seeds were treated with thiamethoxam and sets out the risk mitigation measures provided for in the authorisation,

| — | the conditions of the authorisation, in particular for spray applications, include, where appropriate, risk mitigation measures to protect honey bees, |
| --- | --- |

—

the conditions of the authorisation, in particular for spray applications, include, where appropriate, risk mitigation measures to protect honey bees,

| — | monitoring programmes are initiated to verify the real exposure of honey bees to thiamethoxam in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. |
| --- | --- |

—

monitoring programmes are initiated to verify the real exposure of honey bees to thiamethoxam in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.

PART B

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 thiamethoxam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

In this overall assessment Member States:

| — | must pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites NOA 459602, SYN 501406 and CGA 322704, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, |
| --- | --- |

—

must pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites NOA 459602, SYN 501406 and CGA 322704, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

| — | must pay particular attention to the protection of aquatic organisms, |
| --- | --- |

—

must pay particular attention to the protection of aquatic organisms,

| — | must pay particular attention to the long-term risk to small herbivorous animals if the substance is used for seed treatment. |
| --- | --- |

—

must pay particular attention to the long-term risk to small herbivorous animals if the substance is used for seed treatment.

Conditions of use shall include risk mitigation measures, where appropriate.

141

Fenamiphos

CAS No 22224-92-6

CIPAC No 692

(RS)-ethyl 4-methylthio-m-tolyl isopropyl-phosphoramidate

≥ 940 g/kg

1 August 2007

31 July 2017

PART A

Only uses as nematicide applied by drip irrigation in greenhouses with permanent structure may be authorised.

PART B

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 fenamiphos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

In this overall assessment:

| — | Member States must pay particular attention to the protection of aquatic organisms, soil non-target organisms and groundwater in vulnerable situations. |
| --- | --- |

—

Member States must pay particular attention to the protection of aquatic organisms, soil non-target organisms and groundwater in vulnerable situations.

Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate.

142

Ethephon

CAS No 16672-87-0

CIPAC No 373

2-chloroethyl-phosphonic acid

≥ 910 g/kg (technical material — TC)

The manufacturing impurities MEPHA (Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid) and 1,2-Dichloroethane are of toxicological concern and must not exceed respectively 20 g/kg and 0,5 g/kg in the technical material.

1 August 2007

31 July 2017

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

143

Flusilazole (2)

CAS No 85509-19-9

CIPAC No 435

Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane

925  g/kg

1 January 2007

30 June 2008 (2)

PART A

Only uses as fungicide on the following crops may be authorised:

| — | cereals other than rice (2), |
| --- | --- |

—

cereals other than rice (2),

| — | maize (2), |
| --- | --- |

—

maize (2),

| — | rape seed (2), |
| --- | --- |

—

rape seed (2),

| — | sugar beet (2), |
| --- | --- |

—

sugar beet (2),

at rates not exceeding 200 g active substance per hectare per application.

The following uses must not be authorised:

| — | air application, |
| --- | --- |

—

air application,

| — | knapsack and hand-held applications, neither by amateur nor by professional users, |
| --- | --- |

—

knapsack and hand-held applications, neither by amateur nor by professional users,

| — | home gardening. |
| --- | --- |

—

home gardening.

Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

| — | aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices, |
| --- | --- |

—

aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices,

| — | birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, |
| --- | --- |

—

birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,

| — | operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. |
| --- | --- |

—

operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

PART B

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 flusilazole, and in particular Appendices I and II thereof, shall be taken into account.

Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained.

Member States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request flusilazole has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines.

144

Carbendazim (unstated stereochemistry)

CAS No 10605-21-7

CIPAC No 263

Methyl benzimidazol-2-ylcarbamate

980  g/kg

1 January 2007

13 June 2011

PART A

Only uses as fungicide on the following crops may be authorised:

| — | cereals |
| --- | --- |

—

cereals

| — | rapeseed |
| --- | --- |

—

rapeseed

| — | sugar beet |
| --- | --- |

—

sugar beet

| — | maize |
| --- | --- |

—

maize

at rates not exceeding

| — | 0,25 kg active substance per hectare per application for cereals and rapeseed, |
| --- | --- |

—

0,25 kg active substance per hectare per application for cereals and rapeseed,

| — | 0,075 kg active substance per hectare per application for sugar beet, |
| --- | --- |

—

0,075 kg active substance per hectare per application for sugar beet,

| — | 0,1 kg active substance per hectare per application for maize. |
| --- | --- |

—

0,1 kg active substance per hectare per application for maize.

The following uses must not be authorised:

| — | air application, |
| --- | --- |

—

air application,

| — | knapsack and hand-held applications neither by amateur nor by professional users, |
| --- | --- |

—

knapsack and hand-held applications neither by amateur nor by professional users,

| — | home gardening. |
| --- | --- |

—

home gardening.

Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

| — | aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices, |
| --- | --- |

—

aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices,

| — | earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, rates of application, and, if necessary, the degree of concentration of the active substance, |
| --- | --- |

—

earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, rates of application, and, if necessary, the degree of concentration of the active substance,

| — | birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, |
| --- | --- |

—

birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species,

| — | operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. |
| --- | --- |

—

operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

PART B

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 carbendazim, and in particular Appendices I and II thereof, shall be taken into account.

Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of carbendazim can be obtained.

145

Captan

CAS No 133-06-02

CIPAC No 40

N-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide

≥ 910 g/kg

Impurities:

| | Perchloromethylmercaptan (R005406): not more than 5 g/kg |
| --- | --- |

Perchloromethylmercaptan (R005406): not more than 5 g/kg

| | Folpet: not more than 10 g/kg |
| --- | --- |

Folpet: not more than 10 g/kg

| | Carbon tetrachloride not more than 0,1 g/Kg |
| --- | --- |

Carbon tetrachloride not more than 0,1 g/Kg

1 October 2007

30 September 2017

PART A

Only uses as fungicide can be authorised.

PART B

In assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure; |
| --- | --- |

—

the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

| — | the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; |
| --- | --- |

—

the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

| — | the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate; |
| --- | --- |

—

the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate;

| — | the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures. |
| --- | --- |

—

the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the approval.

146

Folpet

CAS No 133-07-3

CIPAC No 75

N-(trichloromethylthio) phthalimide

≥ 940 g/kg

Impurities:

| | Perchloromethylmercaptan (R005406): not more than 3,5 g/kg |
| --- | --- |

Perchloromethylmercaptan (R005406): not more than 3,5 g/kg

| | Carbon tetrachloride not more than 4 g/kg |
| --- | --- |

Carbon tetrachloride not more than 4 g/kg

1 October 2007

30 September 2017

PART A

Only uses as fungicide can be authorised.

PART B

In assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; |
| --- | --- |

—

operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

| — | the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; |
| --- | --- |

—

the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

| — | the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures. |
| --- | --- |

—

the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the approval.

147

Formetanate

CAS No 23422-53-9

CIPAC No 697

3-dimethylaminomethyleneaminophenyl methylcarbamate

≥ 910 g/kg

1 October 2007

30 September 2017

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

In assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States:

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

—

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

| — | must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; |
| --- | --- |

—

must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

| — | must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. |
| --- | --- |

—

must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the approval.

148

Methiocarb

CAS No 2032-65-7

CIPAC No 165

4-methylthio-3,5-xylyl methylcarbamate

≥ 980 g/kg

1 October 2007

30 September 2017

PART A

Only uses as repellent in seed treatment, insecticide and molluscicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 methiocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States:

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

—

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

| — | must pay particular attention to the operator and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; |
| --- | --- |

—

must pay particular attention to the operator and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

| — | must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. |
| --- | --- |

—

must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops. They shall ensure that the notifier at whose request methiocarb has been included in this Annex provide such studies to the Commission within two years from the approval.

149

Dimethoate

CAS No 60-51-5

CIPAC No 59

O,O-Dimethyl-S-(N-methylcarbamoylmethyl) phosphorodithioate; 2-Dimethoxy-phosphinothioylthio-N-methylacetamide

≥ 950 g/kg

Impurities:

| — | omethoate: not more than 2 g/kg |
| --- | --- |

—

omethoate: not more than 2 g/kg

| — | isodimethoate: not more than 3 g/kg |
| --- | --- |

—

isodimethoate: not more than 3 g/kg

1 October 2007

30 September 2017

PART A

Only uses as insecticide may be authorised.

PART B

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 dimethoate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States:

| — | must pay particular attention to the protection of birds, mammals, aquatic organisms and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water; |
| --- | --- |

—

must pay particular attention to the protection of birds, mammals, aquatic organisms and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water;

| — | must pay particular attention to the dietary exposure of consumers; |
| --- | --- |

—

must pay particular attention to the dietary exposure of consumers;

| — | must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. |
| --- | --- |

—

must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops.

They shall ensure that the notifier at whose request dimethoate has been included in this Annex provides such studies to the Commission within two years from the approval.

150

Dimethomorph

CAS No 110488-70-5

CIPAC No 483

(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl]morpholine

≥ 965 g/kg

1 October 2007

30 September 2017

PART A

Only uses as fungicide may be authorised.

PART B

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 dimethomorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; |
| --- | --- |

—

the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

| — | to the protection of birds, mammals and aquatic organisms. |
| --- | --- |

—

to the protection of birds, mammals and aquatic organisms.

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

151

Glufosinate

CAS No 77182-82-2

CIPAC No 437.007

ammonium(DL)-homoalanin-4-yl(methyl)phosphinate

950  g/kg

1 October 2007

30 September 2017

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing glufosinate for uses other than in apple orchards, notably as regards the operator and consumer exposure, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 glufosinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to:

| — | the operators, workers and bystanders safety. Conditions of authorisation should include protective measures, where appropriate; |
| --- | --- |

—

the operators, workers and bystanders safety. Conditions of authorisation should include protective measures, where appropriate;

| — | the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

—

the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

| — | the protection of mammals, non-target arthropods and non-target plants. |
| --- | --- |

—

the protection of mammals, non-target arthropods and non-target plants.

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

The Member States concerned shall request the submission of further studies to confirm the risk assessment for mammals and non-target arthropods in apple orchards. They shall ensure that the notifier at whose request glufosinate has been included in this Annex provide such studies to the Commission within two years from the approval.

152

Metribuzin

CAS No 21087-64-9

CIPAC No 283

4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one

≥ 910 g/kg

1 October 2007

30 September 2017

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing metribuzin for uses other than in post-emergence selective herbicide in potatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 metribuzin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States:

| — | must pay particular attention to the protection of algae, aquatic plants, non-target plants outside the treated field and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. |
| --- | --- |

—

must pay particular attention to the protection of algae, aquatic plants, non-target plants outside the treated field and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

| — | must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. |
| --- | --- |

—

must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.

The Member States concerned shall request the submission of further data to confirm the risk assessment for groundwater. They shall ensure that the notifiers at whose request metribuzin has been included in this Annex provide such studies to the Commission within two years from the approval.

153

Phosmet

CAS No 732-11-6

CIPAC No 318

O,O-dimethyl S-phthalimidomethyl phosphorodithioate; N-(dimethoxyphosphinothioylthiomethyl)phatalimide

≥ 950 g/kg

Impurities:

| — | phosmet oxon: not more than 0,8 g/kg |
| --- | --- |

—

phosmet oxon: not more than 0,8 g/kg

| — | iso phosmet: not more than 0,4 g/kg |
| --- | --- |

—

iso phosmet: not more than 0,4 g/kg

1 October 2007

30 September 2017

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

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 phosmet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States:

| — | must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water, |
| --- | --- |

—

must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water,

| — | must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment. |
| --- | --- |

—

must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds (acute risk) and herbivorous mammals (long term risk). They shall ensure that the notifier at whose request phosmet has been included in this Annex provides such studies to the Commission within two years from the approval.

154

Propamocarb

CAS No 24579-73-5

CIPAC No 399

Propyl 3-(dimethylamino) propylcarbamate

≥ 920 g/kg

1 October 2007

30 September 2017

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing propamocarb for uses other than foliar applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, as regards worker exposure and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 propamocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operators and workers safety. Conditions of authorisation should include protective measures, where appropriate; |
| --- | --- |

—

the operators and workers safety. Conditions of authorisation should include protective measures, where appropriate;

| — | the transfer of soil residues for rotating or succeeding crops; |
| --- | --- |

—

the transfer of soil residues for rotating or succeeding crops;

| — | the protection of surface and groundwater in vulnerable zones; |
| --- | --- |

—

the protection of surface and groundwater in vulnerable zones;

| — | the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| --- | --- |

—

the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.

155

ethoprophos

CAS No 13194-48-4

CIPAC No 218

O-ethyl S,S-dipropyl phosphorodithioate

> 940 g/kg

1 October 2007

30 September 2017

PART A

Only uses as nematicide and insecticide in soil application can be authorised.

Authorisations should be limited to professional users.

PART B

In assessing applications to authorise plant protection products containing ethoprophos for uses other than potatoes not cultivated for human or animal consumption, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 ethoprophos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the residues and evaluate the dietary exposure of consumers in view of future revisions of Maximum Residue Levels, |
| --- | --- |

—

the residues and evaluate the dietary exposure of consumers in view of future revisions of Maximum Residue Levels,

| — | the operator safety. Authorised conditions of use must prescribe the application of adequate personal and respiratory protective equipment and other risk mitigation measures such as the use of closed transfer system for the distribution of the product, |
| --- | --- |

—

the operator safety. Authorised conditions of use must prescribe the application of adequate personal and respiratory protective equipment and other risk mitigation measures such as the use of closed transfer system for the distribution of the product,

| — | he protection of birds, mammals, aquatic organisms, surface and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures, such as buffer zones and the achievement of complete incorporation of granules in the soil. |
| --- | --- |

—

he protection of birds, mammals, aquatic organisms, surface and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures, such as buffer zones and the achievement of complete incorporation of granules in the soil.

The concerned Member States shall request the submission of further studies to confirm the short and long term risk assessment for birds and for earthworms eating mammals. They shall ensure that the notifiers at whose request ethoprophos has been included in this Annex provide such studies to the Commission within two years from the approval.

156

Pirimiphos-methyl

CAS No 29232-93-7

CIPAC No 239

| | O-2-diethylamino-6-methylpyrimidin-4-yl |
| --- | --- |

O-2-diethylamino-6-methylpyrimidin-4-yl

| | O,O-dimethylphosphorothioate |
| --- | --- |

O,O-dimethylphosphorothioate

> 880 g/kg

1 October 2007

30 September 2017

PART A

Only uses as insecticide for post harvest storage can be authorised.

Hand-held applications shall not be authorised.

PART B

In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure; |
| --- | --- |

—

the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure;

| — | the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. |
| --- | --- |

—

the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.

157

Fipronil

CAS No 120068-37-3

CIPAC No 581

(±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile

≥ 950 g/kg

1 October 2007

30 September 2017

PART A

Only uses as insecticide for use as seed treatment may be authorised.

For the protection of non-target organisms, in particular honey bees:

| — | the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised, |
| --- | --- |

—

the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised,

| — | adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission. |
| --- | --- |

—

adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission.

Member States shall ensure that:

| — | the label of the treated seed includes the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation, |
| --- | --- |

—

the label of the treated seed includes the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation,

| — | monitoring programmes are initiated to verify the real exposure of honey bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. |
| --- | --- |

—

monitoring programmes are initiated to verify the real exposure of honey bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.

PART B

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 fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to:

| — | the packaging of the marketed products to avoid the generation of photo-degradation products of concern, |
| --- | --- |

—

the packaging of the marketed products to avoid the generation of photo-degradation products of concern,

| — | the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, |
| --- | --- |

—

the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

| — | the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees. |
| --- | --- |

—

the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees.

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

The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds and mammals, and honey bees, especially bee brood. They shall ensure that the notifier at whose request fipronil has been included in this Annex provide such studies to the Commission within one year from the approval.

158

Beflubutamid

CAS No 113614-08-7

CIPAC No 662

(RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide

≥ 970 g/kg

1 December 2007

30 November 2017

PART A

Only uses as herbicide may be authorised.

PART B

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 beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.

In this overall assessment Member States:

| — | must pay particular attention to the risk to aquatic organisms. |
| --- | --- |

—

must pay particular attention to the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

159

Spodoptera exigua nuclear polyhedrosis virus

CIPAC No

Not allocated

Not applicable

1 December 2007

30 November 2017

PART A

Only uses as insecticide may be authorised.

PART B

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 Spodoptera exigua NPV, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.

160

Prosulfocarb

CAS No 52888-80-9

CIPAC No 539

S-benzyl dipropyl(thiocarbamat)

970  g/kg

1 November 2008

31 October 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone, |
| --- | --- |

—

the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone,

| — | the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone. |
| --- | --- |

—

the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone.

161

Fludioxonil

CAS No 131341-86-1

CIPAC No 522

4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile

950  g/kg

1 November 2008

31 October 2018

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted and:

| — | must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones, |
| --- | --- |

—

must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones,

| — | must pay particular attention to the protection of fish and aquatic invertebrates. |
| --- | --- |

—

must pay particular attention to the protection of fish and aquatic invertebrates.

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

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 fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.

162

Clomazone

CAS No 81777-89-1

CIPAC No 509

2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one

960  g/kg

1 November 2008

31 October 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones. |
| --- | --- |

—

the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones.

163

Benthiavalicarb

CAS No 413615-35-7

CIPAC No 744

[(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid

≥ 910 g/kg

The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:

| | 6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg |
| --- | --- |

6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg

| | bis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg |
| --- | --- |

bis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg

1 August 2008

31 July 2018

PART A

Only uses as fungicide may be authorised.

PART B

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 benthiavalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety, |
| --- | --- |

—

the operator safety,

| — | the protection of non-target arthropods. |
| --- | --- |

—

the protection of non-target arthropods.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

In assessing applications to authorise plant protection products containing benthiavalicarb for uses other than in glasshouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

164

Boscalid

CAS No 188425-85-6

CIPAC No 673

2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide

≥ 960 g/kg

1 August 2008

31 July 2018

PART A

Only uses as fungicide may be authorised.

PART B

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 boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention

| — | to the operator safety, |
| --- | --- |

—

to the operator safety,

| — | to the long term risk to birds and soil organisms, |
| --- | --- |

—

to the long term risk to birds and soil organisms,

| — | to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation. |
| --- | --- |

—

to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

165

Carvone

CAS No 99-49-0 (d/l mixture)

CIPAC No 602

5-isopropenyl-2-methylcyclohex-2-en-1-one

≥ 930 g/kg with a d/l ratio of at least 100:1

1 August 2008

31 July 2018

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 carvone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to the operator safety.

Conditions of use shall include risk mitigation measures, where appropriate.

166

Fluoxastrobin

CAS No 361377-29-9

CIPAC No 746

(E)-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime

≥ 940 g/kg

1 August 2008

31 July 2018

PART A

Only uses as fungicide may be authorised.

PART B

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 fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield, |
| --- | --- |

—

the operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield,

| — | the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, |
| --- | --- |

—

the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

| — | the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate, |
| --- | --- |

—

the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate,

| — | the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation. |
| --- | --- |

—

the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of:

| — | data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures, |
| --- | --- |

—

data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures,

| — | data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff. |
| --- | --- |

—

data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff.

They shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the approval.

167

Paecilomyces lilacinus (Thom)

Samson 1974 strain 251 (AGAL: No 89/030550)

CIPAC No 753

Not applicable

1 August 2008

31 July 2018

PART A

Only uses as nematicide may be authorised.

PART B

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 Paecilomyces lilacinus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers), |
| --- | --- |

—

the operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers),

| — | the protection of leaf dwelling non-target arthropods. |
| --- | --- |

—

the protection of leaf dwelling non-target arthropods.

Conditions of use shall include risk mitigation measures, where appropriate.

168

Prothioconazole

CAS No 178928-70-6

CIPAC No 745

(RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione

≥ 970 g/kg

The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material:

| — | Toluene: < 5 g/kg |
| --- | --- |

—

Toluene: < 5 g/kg

| — | Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD) |
| --- | --- |

—

Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD)

1 August 2008

31 July 2018

PART A

Only uses as fungicide may be authorised.

PART B

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 prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety in spray applications. Conditions of use shall include adequate protective measures, |
| --- | --- |

—

the operator safety in spray applications. Conditions of use shall include adequate protective measures,

| — | the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, |
| --- | --- |

—

the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

| — | the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate. |
| --- | --- |

—

the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate.

Conditions of use shall include risk mitigation measures, where appropriate.

The concerned Member States shall request the submission of:

| — | information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin, |
| --- | --- |

—

information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin,

| — | a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds, |
| --- | --- |

—

a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds,

| — | information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment. |
| --- | --- |

—

information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment.

They shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the approval.

169

Amidosulfuron

CAS No 120923-37-7

CIPAC No 515

| | 3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea
  or |
| --- | --- |

3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea

or

| | 1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea |
| --- | --- |

1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea

≥ 970 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions, |
| --- | --- |

—

the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions,

| — | the protection of aquatic plants. |
| --- | --- |

—

the protection of aquatic plants.

In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

170

Nicosulfuron

CAS No 111991-09-4

CIPAC No 709

| | 2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide
  or |
| --- | --- |

2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide

or

| | 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea |
| --- | --- |

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

≥ 910 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions, |
| --- | --- |

—

the potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions,

| — | the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones, |
| --- | --- |

—

the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones,

| — | the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone, |
| --- | --- |

—

the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone,

| — | the protection of groundwater and surface water under vulnerable soil and climatic conditions. |
| --- | --- |

—

the protection of groundwater and surface water under vulnerable soil and climatic conditions.

171

Clofentezine

CAS No 74115-24-5

CIPAC No 418

3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine

≥ 980 g/kg (dry material)

1 January 2009

31 December 2018

PART A

Only uses as acaricide may be authorised.

PART B

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 clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; |
| --- | --- |

—

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

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate; |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate;

| — | the potential for long range transport via air; |
| --- | --- |

—

the potential for long range transport via air;

| — | the risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| --- | --- |

—

the risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier presents to the Commission a monitoring programme to assess the potential for long-range atmospheric transport of clofentezine and the related environmental risks by 31 July 2011. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State and to the Commission by 31 July 2013.

The Member States concerned shall ensure that the notifier submits to the Commission confirmatory studies on clofentezine metabolites relating to their toxicological and environmental risk assessment by 30 June 2012.

172

Dicamba

CAS No 1918-00-9

CIPAC No 85

3,6-dichloro-2-methoxybenzoic acid

≥ 850 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

173

Difenoconazole

CAS No 119446-68-3

CIPAC No 687

3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether

≥ 940 g/kg

1 January 2009

31 December 2018

PART A

Only uses as fungicide may be authorised.

PART B

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 difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of aquatic organisms. |
| --- | --- |

—

the protection of aquatic organisms.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

174

Diflubenzuron

CAS No 35367-38-5

CIPAC No 339

1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl) urea

≥ 950 g/kg impurity: max. 0,03 g/kg 4-chloroaniline

1 January 2009

31 December 2018

PART A

Only uses as insecticide may be authorised.

PART B

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 diflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; |
| --- | --- |

—

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

| — | the protection of aquatic organisms; |
| --- | --- |

—

the protection of aquatic organisms;

| — | the protection of terrestrial organisms; |
| --- | --- |

—

the protection of terrestrial organisms;

| — | the protection of non-target arthropods including bees. |
| --- | --- |

—

the protection of non-target arthropods including bees.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further studies to address the potential toxicological relevance of the impurity and metabolite 4-chloroaniline (PCA) by 30 June 2011.

175

Imazaquin

CAS No 81335-37-7

CIPAC No 699

2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]quinoline-3-carboxylic acid

≥ 960 g/kg (racemic mixture)

1 January 2009

31 December 2018

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 imazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

176

Lenacil

CAS No 2164-08-1

CIPAC No 163

3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione

≥ 975 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies; |
| --- | --- |

—

the risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies;

| — | the protection of the groundwater, where the active substance is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate. |
| --- | --- |

—

the protection of the groundwater, where the active substance is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission confirmatory information on the identity and characterisation of soil metabolites Polar B and Polars and metabolites M1, M2 and M3 which occurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

If a decision on the classification of lenacil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) identifies the need for further information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3, Polar B and Polars, the Member States concerned shall request the submission of such information. They shall ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision.

177

Oxadiazon

CAS No 19666-30-9

CIPAC No 213

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

≥ 940 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 oxadiazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; |
| --- | --- |

—

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

| — | the potential for ground water contamination by the metabolite AE0608022 where the active substance is applied in situations for which prolonged anaerobic conditions may be expected to occur or in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate. |
| --- | --- |

—

the potential for ground water contamination by the metabolite AE0608022 where the active substance is applied in situations for which prolonged anaerobic conditions may be expected to occur or in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission:

| — | further studies to address the potential toxicological relevance of an impurity in the proposed technical specification; |
| --- | --- |

—

further studies to address the potential toxicological relevance of an impurity in the proposed technical specification;

| — | information to further clarify the occurrence of metabolite AE0608033 in primary crops and rotational crops; |
| --- | --- |

—

information to further clarify the occurrence of metabolite AE0608033 in primary crops and rotational crops;

| — | further trials on rotational crops (namely root crops and cereals) and a metabolism study on ruminants to confirm the consumer risk assessment; |
| --- | --- |

—

further trials on rotational crops (namely root crops and cereals) and a metabolism study on ruminants to confirm the consumer risk assessment;

| — | information to further address the risk to earthworm-eating birds and mammals, and the long-term risk to fish. |
| --- | --- |

—

information to further address the risk to earthworm-eating birds and mammals, and the long-term risk to fish.

They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

178

Picloram

CAS No 1918-02-1

CIPAC No 174

4-amino-3,5,6-trichloropyridine-2-carboxylic acid

≥ 920 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In the overall assessment Member States must pay particular attention to:

| — | the potential for ground water contamination where picloram is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate; |
| --- | --- |

—

the potential for ground water contamination where picloram is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate;

The Member States concerned shall ensure that the notifier submits to the Commission:

| — | further information to confirm that the monitoring analytical method applied in residue trials correctly quantifies the residues of picloram and its conjugates; |
| --- | --- |

—

further information to confirm that the monitoring analytical method applied in residue trials correctly quantifies the residues of picloram and its conjugates;

| — | a soil photolysis study to confirm the evaluation of picloram degradation. |
| --- | --- |

—

a soil photolysis study to confirm the evaluation of picloram degradation.

They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

179

Pyriproxyfen

CAS No 95737-68-1

CIPAC No 715

4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether

≥ 970 g/kg

1 January 2009

31 December 2018

PART A

Only uses as insecticide may be authorised.

PART B

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 pyriproxyfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In the overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate; |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate;

| — | the risk to aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate. |
| --- | --- |

—

the risk to aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information confirming the risk assessment in respect of two points, namely the risk posed to aquatic insects by pyriproxfen and the metabolite DPH-pyr and the risk posed by pyriproxfen to pollinators. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

180

Bifenox

CAS No 42576-02-3

CIPAC No 413

Methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate

≥ 970 g/kg impurities:

| | max. 3 g/kg 2,4-dichlorophenol |
| --- | --- |

max. 3 g/kg 2,4-dichlorophenol

| | max. 6 g/kg 2,4-dichloroanisole |
| --- | --- |

max. 6 g/kg 2,4-dichloroanisole

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 bifenox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

| — | the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops. |
| --- | --- |

—

the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops.

The Member States concerned shall request the submission of:

| — | information on residues of bifenox and its metabolite hydroxy bifenox acid in food of animal origin and on residues of bifenox in rotational crops, |
| --- | --- |

—

information on residues of bifenox and its metabolite hydroxy bifenox acid in food of animal origin and on residues of bifenox in rotational crops,

| — | information to further address the long-term risk to herbivorous mammals arising from the use of bifenox. |
| --- | --- |

—

information to further address the long-term risk to herbivorous mammals arising from the use of bifenox.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.

181

Diflufenican

CAS No 83164-33-4

CIPAC No 462

2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide

≥ 970 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, |
| --- | --- |

—

the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

| — | the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate. |
| --- | --- |

—

the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate.

182

Fenoxaprop-P

CAS No 113158-40-0

CIPAC No 484

(R)-2[4-[(6-chloro-2-benzoxazolyl)oxy]-phenoxy]-propanoic acid

≥ 920 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 fenoxaprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of non target plants, |
| --- | --- |

—

the protection of non target plants,

| — | the presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure, |
| --- | --- |

—

the presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure,

| — | the persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur. |
| --- | --- |

—

the persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur.

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

183

Fenpropidin

CAS No 67306-00-7

CIPAC No 520

(R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine

≥ 960 g/kg (racemate)

1 January 2009

31 December 2018

PART A

Only uses as fungicide may be authorised.

PART B

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 fenpropidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone. |
| --- | --- |

—

the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone.

The Member States concerned shall request the submission of:

| — | information to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin. |
| --- | --- |

—

information to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.

184

Quinoclamine

CAS No 2797-51-5

CIPAC No 648

2-amino-3-chloro-1,4-naphthoquinone

≥ 965 g/kg impurity:

dichlone (2,3-dichloro-1,4-naphthoquinone) max. 15 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing quinoclamine for uses other than ornamentals or nursery plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 quinoclamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of aquatic organisms, |
| --- | --- |

—

the protection of aquatic organisms,

| — | the protection of birds and small mammals. |
| --- | --- |

—

the protection of birds and small mammals.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

185

Chloridazon

CAS No 1698-60-8

CIPAC No 111

5-amino-4-chloro-2-phenylpyridazin-3(2H)-one

920 g/kg

The manufacturing impurity 4-amino-5-chloro-isomer is considered to be of toxicological concern and a maximum level of 60 g/kg is established.

1 January 2009

31 December 2018

PART A

Only uses as herbicide in application max. of 2,6 kg/ha only every third year on the same field may be authorised.

PART B

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 chloridazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 December 2007 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of aquatic organisms, |
| --- | --- |

—

the protection of aquatic organisms,

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination from metabolites B and B1 in vulnerable zones, where appropriate.

186

Tritosulfuron

CAS No 142469-14-5

CIPAC No 735

1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea

≥ 960 g/kg

The following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material:

2-Amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine: <0,2 g/kg

1 December 2008

30 November 2018

PART A

Only uses as herbicide may be authorised.

PART B

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 tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States 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, |
| --- | --- |

—

the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

| — | the protection of aquatic organisms, |
| --- | --- |

—

the protection of aquatic organisms,

| — | the protection of small mammals. |
| --- | --- |

—

the protection of small mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

187

Flutolanil

CAS No 66332-96-5

CIPAC No 524

α,α,α-trifluoro-3′-isopropoxy-o-toluanilide

≥ 975 g/kg

1 March 2009

28 February 2019

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 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. |
| --- | --- |

—

the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

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

188

Benfluralin

CAS No 1861-40-1

CIPAC No 285

N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine

≥ 960 g/kg

Impurities:

| — | ethyl-butyl-nitrosamine: max. 0,1 mg/kg |
| --- | --- |

—

ethyl-butyl-nitrosamine: max. 0,1 mg/kg

1 March 2009

28 February 2019

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 benfluralin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of the operators’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, |
| --- | --- |

—

the protection of the operators’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

| — | the residues in food of plant and animal origin and evaluate the dietary exposure of consumers, |
| --- | --- |

—

the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,

| — | the protection of birds, mammals, surface waters and aquatic organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. |
| --- | --- |

—

the protection of birds, mammals, surface waters and aquatic organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies on rotational crops metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Annex provide such studies to the Commission within two years from the approval.

189

Fluazinam

CAS No 79622-59-6

CIPAC No 521

3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine

≥ 960 g/kg

Impurities:

5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidine

| — | not more than 2 g/kg |
| --- | --- |

—

not more than 2 g/kg

1 March 2009

28 February 2019

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of the operators’ and workers’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, |
| --- | --- |

—

the protection of the operators’ and workers’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

| — | the residues in food of plant and animal origin and evaluate the dietary exposure of consumers, |
| --- | --- |

—

the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,

| — | the protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate. |
| --- | --- |

—

the protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Annex provide such studies to the Commission within two years from the approval.

190

Fuberidazole

CAS No 3878-19-1

CIPAC No 525

2-(2′-furyl)benzimidazole

≥ 970 g/kg

1 March 2009

28 February 2019

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 fuberidazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | long-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply. |
| --- | --- |

—

long-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply.

Conditions of use shall include adequate risk mitigation measures, where appropriate.

191

Mepiquat

CAS No 15302-91-7

CIPAC No 440

1,1-dimethylpiperidinium chloride (mepiquat chloride)

≥ 990 g/kg

1 March 2009

28 February 2019

PART A

Only uses as plant growth regulator may be authorised.

PART B

In assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

The Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers.

192

Diuron

CAS No 330-54-1

CIPAC No 100

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

≥ 930 g/kg

1 October 2008

30 September 2018

PART A

Only uses as herbicide at rates not exceeding 0,5 kg/ha (areic average) may be authorised.

PART B

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 diuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety; conditions of use shall prescribe the use of personal protective equipment, if appropriate, |
| --- | --- |

—

the operator safety; conditions of use shall prescribe the use of personal protective equipment, if appropriate,

| — | the protection of aquatic organisms and non-target plants. |
| --- | --- |

—

the protection of aquatic organisms and non-target plants.

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

193

Bacillus thuringiensis subsp. aizawai

STRAIN: ABTS-1857

Culture collection: No SD-1372,

STRAIN: GC-91

Culture collection: No NCTC 11821

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

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 Bacillus thuringiensis subsp.Aizawai ABTS-1857 (SANCO/1539/2008) and GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

194

Bacillus thuringiensis subsp. israeliensis (serotype H-14)

STRAIN: AM65-52

Culture collection: No ATCC-1276

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

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 Bacillus thuringiensis subsp. israeliensis (serotype H-14) AM65-52 (SANCO/1540/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

195

Bacillus thuringiensis subsp. kurstaki

| | STRAIN: ABTS 351
  Culture collection: No ATCC SD-1275 |
| --- | --- |

STRAIN: ABTS 351

Culture collection: No ATCC SD-1275

| | STRAIN: PB 54
  Culture collection: No CECT 7209 |
| --- | --- |

STRAIN: PB 54

Culture collection: No CECT 7209

| | STRAIN: SA 11
  Culture collection: No NRRL B-30790 |
| --- | --- |

STRAIN: SA 11

Culture collection: No NRRL B-30790

| | STRAIN: SA 12
  Culture collection: No NRRL B-30791 |
| --- | --- |

STRAIN: SA 12

Culture collection: No NRRL B-30791

| | STRAIN: EG 2348
  Culture collection: No NRRL B-18208 |
| --- | --- |

STRAIN: EG 2348

Culture collection: No NRRL B-18208

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

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 Bacillus thuringiensis subsp. kurstaki ABTS 351 (SANCO/1541/2008), PB 54 (SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

196

Bacillus thuringiensis subsp. Tenebrionis

STRAIN: NB 176 (TM 141)

Culture collection: No SD-5428

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

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 Bacillus thuringiensis subsp. tenebrionis NB 176 (SANCO/1545/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

197

Beauveria bassiana

| | STRAIN: ATCC 74040
  Culture collection: No ATCC 74040 |
| --- | --- |

STRAIN: ATCC 74040

Culture collection: No ATCC 74040

| | STRAIN: GHA
  Culture collection: No ATCC 74250 |
| --- | --- |

STRAIN: GHA

Culture collection: No ATCC 74250

Not applicable

Max level of beauvericin: 5 mg/kg

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

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 Beauveria bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

198

Cydia pomonella Granulovirus (CpGV)

Not applicable

Contaminating micro-organisms (Bacillus cereus) < 1 × 106 CFU/g

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

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 Cydia pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

199

Lecanicillium muscarium

(formerly Verticilium lecanii)

STRAIN: Ve 6

Culture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide may be authorised.

PART B

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 Lecanicillium muscarium (formerly Verticilium lecanii) Ve 6 (SANCO/1861/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

200

Metarhizium anisopliae var. anisopliae

(formerly Metarhizium anisopliae)

STRAIN: BIPESCO 5/F52

Culture collection: No M.a. 43; No 275-86 (acronyms V275 or KVL 275); No KVL 99-112 (Ma 275 or V 275); No DSM 3884; No ATCC 90448; No ARSEF 1095

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

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 Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) BIPESCO 5 and F52 (SANCO/1862/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

201

Phlebiopsis gigantea

| | STRAIN: VRA 1835
  Culture collection: No ATCC 90304 |
| --- | --- |

STRAIN: VRA 1835

Culture collection: No ATCC 90304

| | STRAIN: VRA 1984
  Culture collection: No DSM16201 |
| --- | --- |

STRAIN: VRA 1984

Culture collection: No DSM16201

| | STRAIN: VRA 1985
  Culture collection: No DSM 16202 |
| --- | --- |

STRAIN: VRA 1985

Culture collection: No DSM 16202

| | STRAIN: VRA 1986
  Culture collection: No DSM 16203 |
| --- | --- |

STRAIN: VRA 1986

Culture collection: No DSM 16203

| | STRAIN: FOC PG B20/5
  Culture collection: No IMI 390096 |
| --- | --- |

STRAIN: FOC PG B20/5

Culture collection: No IMI 390096

| | STRAIN: FOC PG SP log 6
  Culture collection: No IMI 390097 |
| --- | --- |

STRAIN: FOC PG SP log 6

Culture collection: No IMI 390097

| | STRAIN: FOC PG SP log 5
  Culture collection: No IMI 390098 |
| --- | --- |

STRAIN: FOC PG SP log 5

Culture collection: No IMI 390098

| | STRAIN: FOC PG BU 3
  Culture collection: No IMI 390099 |
| --- | --- |

STRAIN: FOC PG BU 3

Culture collection: No IMI 390099

| | STRAIN: FOC PG BU 4
  Culture collection: No IMI 390100 |
| --- | --- |

STRAIN: FOC PG BU 4

Culture collection: No IMI 390100

| | STRAIN: FOC PG 410.3
  Culture collection: No IMI 390101 |
| --- | --- |

STRAIN: FOC PG 410.3

Culture collection: No IMI 390101

| | STRAIN: FOC PG97/1062/116/1.1
  Culture collection: No IMI 390102 |
| --- | --- |

STRAIN: FOC PG97/1062/116/1.1

Culture collection: No IMI 390102

| | STRAIN: FOC PG B22/SP1287/3.1
  Culture collection: No IMI 390103 |
| --- | --- |

STRAIN: FOC PG B22/SP1287/3.1

Culture collection: No IMI 390103

| | STRAIN: FOC PG SH 1
  Culture collection: No IMI 390104 |
| --- | --- |

STRAIN: FOC PG SH 1

Culture collection: No IMI 390104

| | STRAIN: FOC PG B22/SP1190/3.2
  Culture collection: No IMI 390105 |
| --- | --- |

STRAIN: FOC PG B22/SP1190/3.2

Culture collection: No IMI 390105

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 Phlebiopsis gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

202

Pythium oligandrum

STRAINS: M1

Culture collection No ATCC 38472

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised

PART B

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 Pythium oligandrum M1 (SANCO/1864/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

203

Streptomyces K61 (formerly S. griseoviridis)

STRAIN: K61

Culture collection: No DSM 7206

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 Streptomyces (formerly Streptomyces griseoviridis) K61 (SANCO/1865/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

204

Trichoderma atroviride

(formerly T. harzianum)

| | STRAIN: IMI 206040
  Culture collection No IMI 206040, ATCC 20476; |
| --- | --- |

STRAIN: IMI 206040

Culture collection No IMI 206040, ATCC 20476;

| | STRAIN: T11
  Culture collection: No
  Spanish type culture collection CECT 20498, identical with IMI 352941 |
| --- | --- |

STRAIN: T11

Culture collection: No

Spanish type culture collection CECT 20498, identical with IMI 352941

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 reports on Trichoderma atroviride (formerly T. harzianum) IMI 206040 (SANCO/1866/2008) and T-11 (SANCO/1841/2008) respectively, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

205

Trichoderma polysporum

STRAIN: Trichoderma polysporum IMI 206039

Culture collection No IMI 206039, ATCC 20475

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 Trichoderma polysporum IMI 206039 (SANCO/1867/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

206

Trichoderma harzianum Rifai

| | STRAIN:
  Trichoderma harzianum T-22;
  Culture collection No ATCC 20847 |
| --- | --- |

STRAIN:

Trichoderma harzianum T-22;

Culture collection No ATCC 20847

| | STRAIN: Trichoderma harzianum ITEM 908;
  Culture collection No CBS 118749 |
| --- | --- |

STRAIN: Trichoderma harzianum ITEM 908;

Culture collection No CBS 118749

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 reports on Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908 (SANCO/1840/208) respectively and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

207

Trichoderma asperellum

(formerly T. harzianum)

| | STRAIN: ICC012
  Culture collection No CABI CC IMI 392716 |
| --- | --- |

STRAIN: ICC012

Culture collection No CABI CC IMI 392716

| | STRAIN: Trichoderma asperellum
  (formerly T. viride T25) T25
  Culture collection No CECT 20178 |
| --- | --- |

STRAIN: Trichoderma asperellum

(formerly T. viride T25) T25

Culture collection No CECT 20178

| | STRAIN: Trichoderma asperellum
  (formerly T. viride TV1) TV1
  Culture collection No MUCL 43093 |
| --- | --- |

STRAIN: Trichoderma asperellum

(formerly T. viride TV1) TV1

Culture collection No MUCL 43093

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 reports on Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008) and Trichoderma asperellum (formerly T. viride T25 and TV1) T25 and TV1 (SANCO/1868/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

208

Trichoderma gamsii (formerly T. viride)

STRAINS:

ICC080

Culture collection No IMI CC number 392151 CABI

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 Trichoderma viride (SANCO/1868/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

209

Verticillium albo-atrum

(formerly Verticillium dahliae)

STRAIN: Verticillium albo-atrum isolate WCS850

Culture collection No CBS 276.92

Not applicable

No relevant impurities

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 Verticillium albo-atrum (formerly Verticillium dahliae) WCS850 (SANCO/1870/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

210

| | Abamectin
  CAS No 71751-41-2 |
| --- | --- |

Abamectin

CAS No 71751-41-2

| | avermectin B1a
  CAS No 65195-55-3 |
| --- | --- |

avermectin B1a

CAS No 65195-55-3

| | Avermectin B1b
  CAS No 65195-56-4 |
| --- | --- |

Avermectin B1b

CAS No 65195-56-4

| | abamectin
  CIPAC No 495 |
| --- | --- |

abamectin

CIPAC No 495

| | AvermectinB1a
  (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside |
| --- | --- |

AvermectinB1a

(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside

| | AvermectinB1b
  (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside |
| --- | --- |

AvermectinB1b

(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside

≥ 850 g/kg

1 May 2009

30 April 2019

PART A

Only uses as insecticide, acaricide may be authorised.

PART B

In assessing applications to authorise plant protection products containing abamectin for uses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information are provided before such an authorisation is granted.

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 (abamectin), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the residues in food of plant origin and evaluate the dietary exposure of consumers, |
| --- | --- |

—

the residues in food of plant origin and evaluate the dietary exposure of consumers,

| — | the protection of bees, non-target arthropods, birds, mammals and aquatic organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, waiting periods, should be applied where appropriate. |
| --- | --- |

—

the protection of bees, non-target arthropods, birds, mammals and aquatic organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, waiting periods, should be applied where appropriate.

The Member States concerned shall request the submission of:

| — | further studies on the specification, |
| --- | --- |

—

further studies on the specification,

| — | information to further address the risk assessment for birds and mammals, |
| --- | --- |

—

information to further address the risk assessment for birds and mammals,

| — | information to address the risk to aquatic organisms with respect to the major soil metabolites, |
| --- | --- |

—

information to address the risk to aquatic organisms with respect to the major soil metabolites,

| — | information to address the risk to groundwater with respect to the metabolite U8. |
| --- | --- |

—

information to address the risk to groundwater with respect to the metabolite U8.

They shall ensure that the notifiers provide such studies to the Commission within two years from the approval.

211

Epoxiconazole

CAS No 135319-73-2 (formerly 106325-08-0)

CIPAC No 609

(2RS, 3SR)-1-[3-(2-chlorophenyl)-2,3-epoxy-2-(4-fluorophenyl)propyl]-1H-1.2,4-triazole

≥ 920 g/kg

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 epoxiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

| — | the dietary exposure of consumers to the epoxiconazole (triazole) metabolites, |
| --- | --- |

—

the dietary exposure of consumers to the epoxiconazole (triazole) metabolites,

| — | the potential for long-range transport via air, |
| --- | --- |

—

the potential for long-range transport via air,

| — | the risk to aquatic organisms, birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| --- | --- |

—

the risk to aquatic organisms, birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further studies addressing the potential endocrine disrupting properties of epoxiconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

The Member States concerned shall ensure that the notifier presents to the Commission not later than 30 June 2009 a monitoring programme to assess the long-range atmospheric transport of epoxiconazole and related environmental risks. The results of this monitoring shall be submitted as a monitoring report to the Commission by 31 December 2011 at the latest.

The concerned Member States shall ensure that the notifier submits within two years from the approval, at the latest, information on residues of epoxiconazole metabolites in primary crops, rotational crops and products of animal origin and information to further address the long-term risk to herbivorous birds and mammals.

212

Fenpropimorph

CAS No 67564-91-4

CIPAC No 427

(RS)-cis-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine

≥ 930 g/kg

1 May 2009

30 April 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 fenpropimorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, such as restrictions of the daily work rate, |
| --- | --- |

—

the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, such as restrictions of the daily work rate,

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

| — | the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles. |
| --- | --- |

—

the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles.

The Member States concerned shall request the submission of further studies to confirm the mobility in soil of the metabolite BF-421-7. They shall ensure that the notifiers at whose request fenpropimorph has been included in this Annex provide such studies to the Commission within two years from the approval.

213

Fenpyroximate

CAS No 134098-61-6

CIPAC No 695

tert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate

> 960 g/kg

1 May 2009

30 April 2019

PART A

Only uses as acaricide may be authorised.

The following uses must not be authorised:

| — | applications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications. |
| --- | --- |

—

applications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications.

PART B

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 fenpyroximate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. |
| --- | --- |

—

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

The Member States concerned shall request the submission of information to further address:

| — | the risk to aquatic organisms from metabolites containing the benzyl moiety, |
| --- | --- |

—

the risk to aquatic organisms from metabolites containing the benzyl moiety,

| — | the risk of biomagnification in aquatic food chains. |
| --- | --- |

—

the risk of biomagnification in aquatic food chains.

They shall ensure that the notifiers at whose request fenpyroximate has been included in this Annex provide such information to the Commission within two years from the approval.

214

Tralkoxydim

CAS No 87820-88-0

CIPAC No 544

(RS)-2-[(EZ)-1-(ethoxyimino)propyl]-3-hydroxy-5-mesitylcyclohex-2-en-1-one

≥ 960 g/kg

1 May 2009

30 April 2019

PART A

Only uses as herbicide may be authorised.

PART B

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 tralkoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of the groundwater, in particular from the soil metabolite R173642 when the active substance is applied in regions with vulnerable soil and/or climatic conditions, |
| --- | --- |

—

the protection of the groundwater, in particular from the soil metabolite R173642 when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

| — | the protection of herbivorous mammals. |
| --- | --- |

—

the protection of herbivorous mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of:

| — | information to further address the long-term risk to herbivorous mammals arising from the use of tralkoxydim. |
| --- | --- |

—

information to further address the long-term risk to herbivorous mammals arising from the use of tralkoxydim.

They shall ensure that the notifiers at whose request tralkoxydim has been included in this Annex provide such information to the Commission within two years from the approval.

215

Aclonifen

CAS No 74070-46-5

CIPAC No 498

2-chloro-6-nitro-3-phenoxyaniline

≥ 970 g/kg

The impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established.

1 August 2009

31 July 2019

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, |
| --- | --- |

—

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

| — | the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, |
| --- | --- |

—

the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

| — | the residues in rotational crops and evaluate the dietary exposure of consumers, |
| --- | --- |

—

the residues in rotational crops and evaluate the dietary exposure of consumers,

| — | the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. |
| --- | --- |

—

the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.

216

Imidacloprid

CAS No 138261-41-3

CIPAC No 582

(E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine

≥ 970 g/kg

1 August 2009

31 July 2019

PART A

Only uses as insecticide may be authorised.

For the protection of non-target organisms, in particular honey bees and birds, for use as seed treatment:

| — | the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage and transport can be minimised, |
| --- | --- |

—

the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage and transport can be minimised,

| — | adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission. |
| --- | --- |

—

adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission.

Member States shall ensure that:

| — | the label of treated seed includes the indication that the seeds were treated with imidacloprid and sets out the risk mitigation measures provided for in the authorisation, |
| --- | --- |

—

the label of treated seed includes the indication that the seeds were treated with imidacloprid and sets out the risk mitigation measures provided for in the authorisation,

| — | the conditions of the authorisation, in particular for spray applications, include, where appropriate, risk mitigation measures to protect honey bees, |
| --- | --- |

—

the conditions of the authorisation, in particular for spray applications, include, where appropriate, risk mitigation measures to protect honey bees,

| — | monitoring programmes are initiated to verify the real exposure of honey bees to imidacloprid in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. |
| --- | --- |

—

monitoring programmes are initiated to verify the real exposure of honey bees to imidacloprid in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.

PART B

In assessing applications to authorise plant protection products containing imidacloprid for uses other than tomatoes in glasshouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the impact on aquatic organisms, non-target arthropods, earthworms, other soil macroorganisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. |
| --- | --- |

—

the impact on aquatic organisms, non-target arthropods, earthworms, other soil macroorganisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

The Member States concerned shall request the submission of:

| — | information to further address the risk assessment for operators and workers, |
| --- | --- |

—

information to further address the risk assessment for operators and workers,

| — | information to further address the risk to birds and mammals. |
| --- | --- |

—

information to further address the risk to birds and mammals.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.

217

Metazachlor

CAS No 67129-08-2

CIPAC No 411

2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide

≥ 940 g/kg

The manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,05 % is established.

1 August 2009

31 July 2019

PART A

Only uses as herbicide may be authorised; application max. of 1,0 kg/ha only every third year on the same field.

PART B

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 metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of aquatic organisms, |
| --- | --- |

—

the protection of aquatic organisms,

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate.

If metazachlor is classified under Regularion (EC) No 1272/2008 as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer.

They shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision.

218

Acetic acid

CAS No 64-19-7

CIPAC No not allocated

Acetic acid

≥ 980 g/kg

1 September 2009

31 August 2019

PART A

Only uses as herbicide may be authorised.

PART B

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 acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

219

Aluminium ammonium sulphate

CAS No 7784-26-1

CIPAC No not allocated

Aluminium ammonium sulphate

≥ 960 g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 aluminium ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

220

Aluminium silicate

CAS No 1332-58-7

CIPAC No not allocated

Not available

Chemical name: Kaolin

≥ 999,8 g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 aluminium silicate (SANCO/2603/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

221

Ammonium acetate

CAS No 631-61-8

CIPAC No not allocated

Ammonium acetate

≥ 970 g/kg

Relevant impurity: Heavy metals as Pb maximum 10 ppm

1 September 2009

31 August 2019

PART A

Only uses as attractant may be authorised.

PART B

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 ammonium acetate (SANCO/2986/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

222

Blood meal

CAS No not allocated

CIPAC No not allocated

Not available

≥ 990 g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1069/2009.

PART B

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 blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

223

Calcium carbide

CAS No 75-20-7

CIPAC No not allocated

| | Calcium carbide |
| --- | --- |

Calcium carbide

| | Calcium acetylide |
| --- | --- |

Calcium acetylide

≥ 765 g/kg

Containing 0,08-0,52 g/kg Calcium Phosphide

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

224

Calcium carbonate

CAS No 471-34-1

CIPAC No not allocated

Calcium carbonate

≥ 995 g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

225

Carbon dioxide

CAS No 124-38-9

Carbon dioxide

≥ 99,9 %

1 September 2009

31 August 2019

PART A

Only uses as fumigant may be authorised.

PART B

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 carbon dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

226

Denathonium benzoate

CAS No 3734-33-6

CIPAC No not allocated

Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate

≥ 995 g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

227

Ethylene

CAS No 74-85-1

CIPAC No not allocated

Ethene

≥ 99 %

1 September 2009

31 August 2019

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 ethylene (SANCO/2608/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

228

Extract from tea tree

CAS No Tee Tree Oil 68647-73-4

Main components:

| | terpinen-4-ol 562-74-3 |
| --- | --- |

terpinen-4-ol 562-74-3

| | γ-terpinene 99-85-4 |
| --- | --- |

γ-terpinene 99-85-4

| | α-terpinene 99-86-5 |
| --- | --- |

α-terpinene 99-86-5

| | 1,8-cineol 470-82-6 |
| --- | --- |

1,8-cineol 470-82-6

CIPAC No not allocated

Tee Tree Oil is a complex mixture of chemical substances.

Main components:

| | terpinen-4-ol ≥ 300 g/kg |
| --- | --- |

terpinen-4-ol ≥ 300 g/kg

| | γ-terpinene ≥ 100 g/kg |
| --- | --- |

γ-terpinene ≥ 100 g/kg

| | α-terpinene ≥ 50 g/kg |
| --- | --- |

α-terpinene ≥ 50 g/kg

| | 1,8-cineol trace |
| --- | --- |

1,8-cineol trace

1 September 2009

31 August 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 extract from tea tree (SANCO/2609/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

229

Fat destilation residues

CAS No not allocated

CIPAC No not allocated

Not available

≥ 40 % of cleaved fatty acids

Relevant impurity: Ni maximum 200 mg/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised. Fat destilation residues of animal origin must be in compliance with Regulation (EC) No 1069/2009.

PART B

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 fat destilation residues (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

230

Fatty acids C7 to C20

CAS No 112-05-0 (Pelargonic Acid)

| | 67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts) |
| --- | --- |

67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts)

| | 124-07-2 (Caprylic Acid) |
| --- | --- |

124-07-2 (Caprylic Acid)

| | 334-48-5 (Capric Acid) |
| --- | --- |

334-48-5 (Capric Acid)

| | 143-07-7 (Lauric Acid) |
| --- | --- |

143-07-7 (Lauric Acid)

| | 112-80-1 (Oleic Acid) |
| --- | --- |

112-80-1 (Oleic Acid)

| | 85566-26-3 (Fatty acids C8-C10 Me esters) |
| --- | --- |

85566-26-3 (Fatty acids C8-C10 Me esters)

| | 111-11-5 (Methyl octanoate) |
| --- | --- |

111-11-5 (Methyl octanoate)

| | 110-42-9 (Methyl decanoate) |
| --- | --- |

110-42-9 (Methyl decanoate)

CIPAC No not allocated

| | Nonanoic acid |
| --- | --- |

Nonanoic acid

| | Caprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case) |
| --- | --- |

Caprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case)

| | Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case) |
| --- | --- |

Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case)

| | Fatty acids, C7-C10, Me esters |
| --- | --- |

Fatty acids, C7-C10, Me esters

| | ≥ 889 g/kg (Pelargonic Acid) |
| --- | --- |

≥ 889 g/kg (Pelargonic Acid)

| | ≥ 838 g/kg fatty acids |
| --- | --- |

≥ 838 g/kg fatty acids

| | ≥ 99 % fatty acid methyl esters |
| --- | --- |

≥ 99 % fatty acid methyl esters

1 September 2009

31 August 2019

PART A

Only uses as insecticide, acaricide, and herbicide and plant growth regulator may be authorised.

PART B

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 fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

231

Garlic extract

CAS No 8008-99-9

CIPAC No not allocated

Food grade garlic juice concentrate

≥ 99,9 %

1 September 2009

31 August 2019

PART A

Only uses as repellent, insecticide and nematicide may be authorised.

PART B

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 garlic extract (SANCO/2612/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

232

Gibberellic acid

CAS No 77-06-5

CIPAC No 307

| | (3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acid |
| --- | --- |

(3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acid

| | Alt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid |
| --- | --- |

Alt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid

≥ 850 g/kg

1 September 2009

31 August 2019

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 gibberellic acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

233

Gibberellins

| | CAS No GA4: 468-44-0 |
| --- | --- |

CAS No GA4: 468-44-0

| | GA7: 510-75-8 |
| --- | --- |

GA7: 510-75-8

| | GA4A7 mixture: 8030-53-3 |
| --- | --- |

GA4A7 mixture: 8030-53-3

CIPAC No not allocated

| | GA4:
  (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acid |
| --- | --- |

GA4:

(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acid

| | GA7:
  (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid |
| --- | --- |

GA7:

(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid

Review report (SANCO/2614/2008).

1 September 2009

31 August 2019

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 gibberellins (SANCO/2614/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

234

Hydrolysed proteins

CAS No not allocated

CIPAC No not allocated

Not available

Review report (SANCO/2615/2008)

1 September 2009

31 August 2019

PART A

Only uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009.

PART B

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 hydrolysed proteins (SANCO/2615/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

235

Iron sulphate

| | Iron(II)sulphate anhydrous: CAS No 7720-78-7 |
| --- | --- |

Iron(II)sulphate anhydrous: CAS No 7720-78-7

| | Iron(II)sulphate monohydrate: CAS No 17375-41-6 |
| --- | --- |

Iron(II)sulphate monohydrate: CAS No 17375-41-6

| | Iron(II)sulphate heptahydrate: CAS No 7782-63-0 |
| --- | --- |

Iron(II)sulphate heptahydrate: CAS No 7782-63-0

CIPAC No not allocated

Iron (II) sulfate

| | Iron(II)sulphate anhydrous ≥ 367,5 g/kg |
| --- | --- |

Iron(II)sulphate anhydrous ≥ 367,5 g/kg

| | Iron(II)sulphate monohydrate ≥ 300 g/kg |
| --- | --- |

Iron(II)sulphate monohydrate ≥ 300 g/kg

| | Iron(II)sulphate heptahydrate ≥ 180 g/kg |
| --- | --- |

Iron(II)sulphate heptahydrate ≥ 180 g/kg

1 September 2009

31 August 2019

PART A

Only uses as herbicide may be authorised.

PART B

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 iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

236

Kieselgur (Diatomaceous earth)

CAS No 61790-53-2

CIPAC No 647

Kieselgur (diatomaceous earth)

920 ± 20 g SiO2/kg DE

Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)

1 September 2009

31 August 2019

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

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 kieselgur (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

237

Limestone

CAS No 1317-65-3

CIPAC No not allocated

not available

≥ 980 g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

238

Methyl nonyl ketone

CAS No 112-12-9

CIPAC No not allocated

Undecan-2-one

≥ 975 g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 methylnonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

239

Pepper

CAS No not allocated

CIPAC No not allocated

Black pepper — Piper nigrum

It is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 %

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

240

Plant oils/citronella oil

CAS No 8000-29-1

CIPAC No not allocated

Citronella Oil is a complex mixture of chemical substances.

The main components are:

| | Citronellal (3,7-dimethyl-6-octenal). |
| --- | --- |

Citronellal (3,7-dimethyl-6-octenal).

| | Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol). |
| --- | --- |

Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).

| | Citronellol (3,7-dimethyl-6-octan-2-ol). |
| --- | --- |

Citronellol (3,7-dimethyl-6-octan-2-ol).

| | Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate). |
| --- | --- |

Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate).

Relevant impurities methyl eugenol and methyl-isoeugenol maximum 0,1 %.

1 September 2009

31 August 2019

PART A

Only uses as herbicide may be authorised.

PART B

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 citronella oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

241

Plant oils/clove oil

CAS No 94961-50-2 (clove oil)

97-53-0 (Eugenol — main component)

CIPAC No not allocated

Clove Oil is a complex mixture of chemical substances.

The main component is eugenol.

≥ 800 g/kg

1 September 2009

31 August 2019

PART A

Only uses as fungicide and bactericide may be authorised.

PART B

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 clove oil (SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

242

Plant oils/rape seed oil

CAS No 8002-13-9

CIPAC No not allocated

Rape seed oil

Rape seed oil is a complex mixture of fatty acids

1 September 2009

31 August 2019

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

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 rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

243

Plant oils/spear mint oil

CAS No 8008-79-5

CIPAC No not allocated

Spearmint oil

≥ 550 g/kg as L-Carvone

1 September 2009

31 August 2019

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

244

Potassium hydrogen carbonate

CAS No 298-14-6

CIPAC No not allocated

Potassium hydrogen carbonate

≥ 99,5 %

1 September 2009

31 August 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

245

Putrescin (1,4-Diaminobutane)

CAS No 110-60-1

CIPAC No not allocated

Butane-1,4-diamine

≥ 990 g/kg

1 September 2009

31 August 2019

PART A

Only uses as attractant may be authorised.

PART B

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 putrescin (SANCO/2626/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

246

Pyrethrins

CAS No (A) and (B):

Pyrethrins: 8003-34-7

| | Extract A: extractives of Chrysanthemum cinerariaefolium: 89997-63-7 | pyrethrin 1: CAS 121-21-1 |
| --- | --- | --- |

Extract A: extractives of Chrysanthemum cinerariaefolium: 89997-63-7

pyrethrin 1: CAS 121-21-1

| | pyrethrin 2: CAS 121-29-9 |
| --- | --- |

pyrethrin 2: CAS 121-29-9

| | cinerin 1: CAS 25402-06-6 |
| --- | --- |

cinerin 1: CAS 25402-06-6

| | cinerin 2: CAS 121-20-0 |
| --- | --- |

cinerin 2: CAS 121-20-0

| | jasmolin 1: CAS 4466-14-2 |
| --- | --- |

jasmolin 1: CAS 4466-14-2

| | jasmolin 2: CAS 1172-63-0 |
| --- | --- |

jasmolin 2: CAS 1172-63-0

| | Extract B: pyrethrin 1: CAS 121-21-1 | pyrethrin 2: CAS 121-29-9 |
| --- | --- | --- |

Extract B: pyrethrin 1: CAS 121-21-1

pyrethrin 2: CAS 121-29-9

| | cinerin 1: CAS 25402-06-6 |
| --- | --- |

cinerin 1: CAS 25402-06-6

| | cinerin 2: CAS 121-20-0 |
| --- | --- |

cinerin 2: CAS 121-20-0

| | jasmolin 1: CAS 4466-14-2 |
| --- | --- |

jasmolin 1: CAS 4466-14-2

| | jasmolin 2: CAS 1172-63-0 |
| --- | --- |

jasmolin 2: CAS 1172-63-0

CIPAC No 32

Pyrethrins are a complex mixture of chemical substances.

| | Extract A: ≥ 500 g/kg Pyrethrins |
| --- | --- |

Extract A: ≥ 500 g/kg Pyrethrins

| | Extract B: ≥ 480 g/kg Pyrethrins |
| --- | --- |

Extract B: ≥ 480 g/kg Pyrethrins

1 September 2009

31 August 2019

PART A

Only uses as insecticide may be authorised.

PART B

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 pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

247

Quartz sand

CAS No 14808-60-7

CIPAC No not allocated

Quarz, Quartz, Siliciumdioxid, Silica, Silicon dioxide, SiO2

≥ 915 g/kg

Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 quartz sand (SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

248

Repellents by smell of animal or plant origin/fish oil

CAS No 100085-40-3

CIPAC No not allocated

Fish Oil

≥ 99 %

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1069/2009

PART B

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 fish oil (SANCO/2629/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

249

Repellents by smell of animal or plant origin/sheep fat

CAS No 98999-15-6

CIPAC No not allocated

Sheep Fat

Pure sheep fat containing a maximum of 0,18 % w/w/water.

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1069/2009

PART B

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 sheep fat (SANCO/2630/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

250

Repellents by smell of animal or plant origin/tall oil crude

CAS No 8002-26-4

CIPAC No not allocated

Tall Oil Crude

Tall oil crude is a complex mixture of tall rosin and fatty acids

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 tall oil crude (SANCO/2631/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

251

Repellents by smell of animal or plant origin/tall oil pitch

CAS No 8016-81-7

CIPAC No not allocated

Tall Oil Pitch

Complex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids.

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 tall oil pitch (SANCO/2632/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

252

Sea-algae extract (formerly sea algae extract and sea weeds)

CAS No not allocated

CIPAC No not allocated

See algae extract

See algae extract is a complex mixture. Main components as markers: mannitol, fucoidans and alginates. Review report SANCO/2634/2008

1 September 2009

31 August 2019

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 sea algae extract (SANCO/2634/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

253

Sodium aluminium silicate

CAS No 1344-00-9

CIPAC No not allocated

Sodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O

1 000  g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

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 sodium aluminium silicate (SANCO/2635/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

254

Sodium Hypochlorite

CAS No 7681-52-9

CIPAC No not allocated

Sodium Hypochlorite

10 % (w/w) expressed as chlorine

1 September 2009

31 August 2019

PART A

Only uses as disinfectant may be authorised.

PART B

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 sodium hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

255

Straight Chain Lepidopteran Pheromones

Acetate group:

Review report (SANCO/2633/2008)

1 September 2009

31 August 2019

PART A

Only uses as attractants may be authorised.

PART B

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 straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

(E)-5-decen-1-yl acetate

CAS No 38421-90-8

CIPAC No not allocated

(E)-5-decen-1-yl acetate

(E)-8-dodecen-1-yl acetate

CAS No 38363-29-0

CIPAC No

not allocated

(E)-8-dodecen-1-yl acetate

(E/Z)-8-dodecen-1-yl acetate

CAS No not available

CIPAC No not avaiable

(E/Z)-8-dodecen-1-yl acetate as individual isomers

(Z)-8-dodecen-1-yl acetate

CAS No 28079-04-1

CIPAC No not allocated

(Z)-8-dodecen-1-yl acetate

(Z)-9-dodecen-1-yl acetate

CAS No 16974-11-1

CIPAC No 422

(Z)-9-dodecen-1-yl acetate

(E,Z)-7,9-dodecadien-1-yl acetate

CAS No 54364-62-4

CIPAC No not allocated

(E,Z)-7,9-dodecadien-1-yl acetate

(E)-11-tetradecen-1-yl acetate

CAS No 33189-72-9

CIPAC No not allocated

(E)-11-tetradecen-1-yl acetate

(Z)-9-tetradecen-1-yl acetate

CAS No 16725-53-4

CIPAC No not allocated

(Z)-9-tetradecen-1-yl acetate

(Z)-11-tetradecen-1-yl acetate

CAS No 20711-10-8

CIPAC No not allocated

(Z)-11-tetradecen-1-yl acetate

(Z, E)-9, 12-tetradecadien-1-yl acetate

CAS No 31654-77-0

CIPAC No not allocated

(Z, E)-9, 12-tetradecadien-1-yl acetate

Z-11-hexadecen-1-yl acetate

CAS No 34010-21-4

CIPAC No not allocated

Z-11-hexadecen-1-yl acetate

(Z, E)-7, 11-hexadecadien-1-yl acetate

CAS No 51606-94-4

CIPAC No not allocated

Z, E)-7, 11-hexadecadien-1-yl acetate

(E, Z)-2, 13-octadecadien-1-yl acetate.

CAS No 86252-65-5

CIPAC No not allocated

(E, Z)-2, 13-octadecadien-1-yl acetate.

Alcohol group:

Alcohol group:

(E)-5-decen-1-ol

CAS No 56578-18-8

CIPAC No not allocated

(E)-5-decen-1-ol

(Z)-8-dodecen-1-ol

CAS No 40642-40-8

CIPAC No not allocated

(Z)-8-dodecen-1-ol

(E,E)-8,10-dodecadien-1-ol

CAS No 33956-49-9

CIPAC No not allocated

(E,E)-8,10-dodecadien-1-ol

tetradecan-1-ol

CAS No 112-72-1

CIPAC No not allocated

tetradecan-1-ol

(Z)-11-hexadecen-1-ol

CAS No 56683-54-6

CIPAC No not allocated

(Z)-11-hexadecen-1-ol

Aldehyde group:

Aldehyde group:

(Z)-7-tetradecenal

CAS No 65128-96-3

CIPAC No not allocated

(Z)-7-tetradecenal

(Z)-9-hexadecenal

CAS No 56219-04-6

CIPAC No not allocated

(Z)-9-hexadecenal

(Z)-11-hexadecenal

CAS No 53939-28-9

CIPAC No not allocated

(Z)-11-hexadecenal

(Z)-13-octadecenal

CAS No 58594-45-9

CIPAC No not allocated

(Z)-13-octadecenal

Blends acetates:

Blends acetates:

| (i) | (Z)-8-dodecen-1-yl acetate
  CAS No 28079-04-1
  CIPAC No not allocated
  and |
| --- | --- |

(i)

(Z)-8-dodecen-1-yl acetate

CAS No 28079-04-1

CIPAC No not allocated

and

| (i) | (Z)-8-dodecen-1-yl acetate
  and |
| --- | --- |

(i)

(Z)-8-dodecen-1-yl acetate

and

| (ii) | Dodecyl acetate
  CAS No 112-66-3
  CIPAC No not allocated; |
| --- | --- |

(ii)

Dodecyl acetate

CAS No 112-66-3

CIPAC No not allocated;

| (ii) | Dodecyl acetate; |
| --- | --- |

(ii)

Dodecyl acetate;

| (i) | (Z)-9-dodecen-1-yl acetate
  CAS No 16974-11-1
  CIPAC No 422
  and |
| --- | --- |

(i)

(Z)-9-dodecen-1-yl acetate

CAS No 16974-11-1

CIPAC No 422

and

| (i) | (Z)-9-dodecen-1-yl acetate
  and |
| --- | --- |

(i)

(Z)-9-dodecen-1-yl acetate

and

| (ii) | Dodecyl acetate
  CAS No 112-66-3
  CIPAC No 422; |
| --- | --- |

(ii)

Dodecyl acetate

CAS No 112-66-3

CIPAC No 422;

| (ii) | Dodecyl acetate; |
| --- | --- |

(ii)

Dodecyl acetate;

| (i) | (E,Z)-7,9-dodecadien-1-yl acetate
  CAS No 55774-32-8
  CIPAC No not allocated
  and |
| --- | --- |

(i)

(E,Z)-7,9-dodecadien-1-yl acetate

CAS No 55774-32-8

CIPAC No not allocated

and

| (i) | (E,Z)-7,9-dodecadien-1-yl acetate,
  and |
| --- | --- |

(i)

(E,Z)-7,9-dodecadien-1-yl acetate,

and

| (ii) | (E,E)-7,9-dodecadien-1-yl acetate
  CAS No 54364-63-5
  CIPAC No not allocated; |
| --- | --- |

(ii)

(E,E)-7,9-dodecadien-1-yl acetate

CAS No 54364-63-5

CIPAC No not allocated;

| (ii) | (E,E)-7,9-dodecadien-1-yl acetate; |
| --- | --- |

(ii)

(E,E)-7,9-dodecadien-1-yl acetate;

| (i) | (Z,Z)-7,11-hexadecadien-1-yl acetate
  and |
| --- | --- |

(i)

(Z,Z)-7,11-hexadecadien-1-yl acetate

and

| (i) | (Z,Z)-7,11-hexadecadien-1-yl acetate
  and |
| --- | --- |

(i)

(Z,Z)-7,11-hexadecadien-1-yl acetate

and

| (ii) | (Z,E)-7,11-hexadecadien-1-yl acetate
  CAS No i) & ii) 53042-79-8
  CAS No i) 52207-99-5
  CAS No ii) 51606-94-4
  CIPAC No not allocated; |
| --- | --- |

(ii)

(Z,E)-7,11-hexadecadien-1-yl acetate

CAS No i) & ii) 53042-79-8

CAS No i) 52207-99-5

CAS No ii) 51606-94-4

CIPAC No not allocated;

| (ii) | (Z,E)-7,11-hexadecadien-1-yl acetate; |
| --- | --- |

(ii)

(Z,E)-7,11-hexadecadien-1-yl acetate;

Blends aldehydes:

Blends aldehydes:

| (i) | (Z)-9-hexadecenal
  CAS No 56219-04-6
  CIPAC No not allocated
  and |
| --- | --- |

(i)

(Z)-9-hexadecenal

CAS No 56219-04-6

CIPAC No not allocated

and

| (i) | (Z)-9-hexadecenal
  and |
| --- | --- |

(i)

(Z)-9-hexadecenal

and

| (ii) | (Z)-11-hexadecenal
  CAS No 53939-28-9
  CIPAC: not allocated
  and |
| --- | --- |

(ii)

(Z)-11-hexadecenal

CAS No 53939-28-9

CIPAC: not allocated

and

| (ii) | (Z)-11-hexadecenal
  and |
| --- | --- |

(ii)

(Z)-11-hexadecenal

and

| (iii) | (Z)-13-octadecenal
  CAS No 58594-45-9
  CIPAC No not allocated; |
| --- | --- |

(iii)

(Z)-13-octadecenal

CAS No 58594-45-9

CIPAC No not allocated;

| (iii) | (Z)-13-octadecenal; |
| --- | --- |

(iii)

(Z)-13-octadecenal;

Blends mixtures:

Blends mixtures:

| (i) | (E)-5-decen-1-yl acetate
  CAS No 38421-90-8
  CIPAC No not allocated
  and |
| --- | --- |

(i)

(E)-5-decen-1-yl acetate

CAS No 38421-90-8

CIPAC No not allocated

and

| (i) | (E)-5-decen-1-yl acetate and |
| --- | --- |

(i)

(E)-5-decen-1-yl acetate and

| (ii) | (E)-5-decen-1-ol
  CAS No 56578-18-8
  CIPAC No not allocated; |
| --- | --- |

(ii)

(E)-5-decen-1-ol

CAS No 56578-18-8

CIPAC No not allocated;

| (ii) | (E)-5-decen-1-ol; |
| --- | --- |

(ii)

(E)-5-decen-1-ol;

| (i) | (E/Z)-8-dodecen-1-yl acetate
  CAS No as individual isomers
  CIPAC No not allocated;
  and |
| --- | --- |

(i)

(E/Z)-8-dodecen-1-yl acetate

CAS No as individual isomers

CIPAC No not allocated;

and

| (i) | (E/Z)-8-dodecen-1-yl acetate
  and |
| --- | --- |

(i)

(E/Z)-8-dodecen-1-yl acetate

and

| (i) | (E)-8-dodecen-1-yl acetate
  CAS No (E) 38363-29-0
  CIPAC No not allocated
  and |
| --- | --- |

(i)

(E)-8-dodecen-1-yl acetate

CAS No (E) 38363-29-0

CIPAC No not allocated

and

| (i) | (E)-8-dodecen-1-yl acetate
  and |
| --- | --- |

(i)

(E)-8-dodecen-1-yl acetate

and

| (i) | (Z)-8-dodecen-1-yl acetate
  CAS No (Z) 28079-04-1
  CIPAC No not allocated
  and |
| --- | --- |

(i)

(Z)-8-dodecen-1-yl acetate

CAS No (Z) 28079-04-1

CIPAC No not allocated

and

| (i) | (Z)-8-dodecen-1-yl acetate
  and |
| --- | --- |

(i)

(Z)-8-dodecen-1-yl acetate

and

| (ii) | (Z)-8-dodecen-1-ol
  CAS No ii) 40642-40-8
  CIPAC No not allocated; |
| --- | --- |

(ii)

(Z)-8-dodecen-1-ol

CAS No ii) 40642-40-8

CIPAC No not allocated;

| (ii) | (Z)-8-dodecen-1-ol; |
| --- | --- |

(ii)

(Z)-8-dodecen-1-ol;

| (i) | (Z)-11-hexadecenal
  CAS No 53939-28-9
  CIPAC No not allocated
  and |
| --- | --- |

(i)

(Z)-11-hexadecenal

CAS No 53939-28-9

CIPAC No not allocated

and

| (i) | (Z)-11-hexadecenal
  and |
| --- | --- |

(i)

(Z)-11-hexadecenal

and

| (ii) | (Z)-11-hexadecen-1-yl acetate
  CAS No 34010-21-4
  CIPAC No not allocated |
| --- | --- |

(ii)

(Z)-11-hexadecen-1-yl acetate

CAS No 34010-21-4

CIPAC No not allocated

| (ii) | (Z)-11-hexadecen-1-yl acetate |
| --- | --- |

(ii)

(Z)-11-hexadecen-1-yl acetate

256

Trimethylamine hydrochloride

CAS No 593-81-7

CIPAC No not allocated

Trimethylamine hydrochloride

≥ 988 g/kg

1 September 2009

31 August 2019

PART A

Only uses as attractant may be authorised.

PART B

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 trimethylamine hydrochloride (SANCO/2636/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

257

Urea

CAS No 57-13-6

CIPAC No 8352

Urea

≥ 98 % w/w

1 September 2009

31 August 2019

PART A

Only uses as attractant and fungicide may be authorised.

PART B

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 urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

258

Z-13-hexadecen-11-yn-1-yl acetate

CAS No 78617-58-0

CIPAC: not allocated

Z-13-hexadecen-11-yn-1-yl acetate

≥ 75 %

1 September 2009

31 August 2019

PART A

Only uses as attractant may be authorised.

PART B

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 Z-13-hexadecen-11-yn-1-yl acetate (SANCO/2649/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

259

Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate

CAS No 135459-81-3

CIPAC: not allocated

Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate

≥ 90 %

1 September 2009

31 August 2019

PART A

Only uses as attractant may be authorised.

PART B

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 Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate (SANCO/2650/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

260

Aluminium phosphide

CAS No 20859-73-8

CIPAC No 227

Aluminium phosphide

≥ 830 g/kg

1 September 2009

31 August 2019

PART A

Only uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use aluminium phosphide containing products may be authorised.

As rodenticide, talpicide and leporicide only outdoor uses may be authorised.

Authorisations should be limited to professional users.

PART B

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 aluminium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of consumers and ensure that the spent ready-to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied; |
| --- | --- |

—

the protection of consumers and ensure that the spent ready-to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

| — | the protection of operators and workers during fumigation for indoor uses; |
| --- | --- |

—

the protection of operators and workers during fumigation for indoor uses;

| — | the protection of workers at re-entry (after fumigation period) for indoor uses; |
| --- | --- |

—

the protection of workers at re-entry (after fumigation period) for indoor uses;

| — | the protection of bystanders against leaking of gas for indoor uses; |
| --- | --- |

—

the protection of bystanders against leaking of gas for indoor uses;

| — | the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; |
| --- | --- |

—

the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

| — | the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. |
| --- | --- |

—

the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

261

Calcium phosphide

CAS No 1305-99-3

CIPAC No 505

Calcium phosphide

≥ 160 g/kg

1 September 2009

31 August 2019

PART A

Only outdoor uses as rodenticide and talpicide in the form of ready-to-use calcium phosphide containing products may be authorised.

Authorisations should be limited to professional users.

PART B

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 calcium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

| — | the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; |
| --- | --- |

—

the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

| — | the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. |
| --- | --- |

—

the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

262

Magnesium phosphide

CAS No 12057-74-8

CIPAC No 228

Magnesium phosphide

≥ 880 g/kg

1 September 2009

31 August 2019

PART A

Only uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use magnesium phosphide containing products may be authorised.

As rodenticide, talpicide and leporicide only outdoor uses may be authorised.

Authorisations should be limited to professional users.

PART B

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 magnesium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of consumers and ensure that the spent ready-to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied; |
| --- | --- |

—

the protection of consumers and ensure that the spent ready-to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

| — | the protection of operators and workers during fumigation for indoor uses; |
| --- | --- |

—

the protection of operators and workers during fumigation for indoor uses;

| — | the protection of workers at re-entry (after fumigation period) for indoor uses; |
| --- | --- |

—

the protection of workers at re-entry (after fumigation period) for indoor uses;

| — | the protection of bystanders against leaking of gas for indoor uses; |
| --- | --- |

—

the protection of bystanders against leaking of gas for indoor uses;

| — | the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; |
| --- | --- |

—

the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

| — | the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. |
| --- | --- |

—

the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

263

Cymoxanil

CAS No 57966-95-7

CIPAC No 419

1-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea

≥ 970 g/kg

1 September 2009

31 August 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 cymoxanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

—

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

| — | the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. |
| --- | --- |

—

the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

264

Dodemorph

CAS No 1593-77-7

CIPAC No 300

cis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine

≥ 950 g/kg

1 September 2009

31 August 2019

PART A

Only uses as fungicide on ornamentals in glasshouse may be authorised.

PART B

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 dodemorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions; |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions;

| — | conditions of authorisation should include risk mitigation measures, where appropriate. |
| --- | --- |

—

conditions of authorisation should include risk mitigation measures, where appropriate.

265

2,5-Dichlorobenzoic acid methylester

CAS No 2905-69-3

CIPAC No 686

methyl-2,5-dichlorobenzoate

≥ 995 g/kg

1 September 2009

31 August 2019

PART A

Only indoor uses as plant growth regulator and fungicide for grafting of grapevines may be authorised.

PART B

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 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

266

Metamitron

CAS No 41394-05-2

CIPAC No 381

4-amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one

≥ 960 g/kg

1 September 2009

31 August 2019

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate; |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate;

| — | the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

—

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

| — | the risk to birds and mammals, and non-target terrestrial plants. |
| --- | --- |

—

the risk to birds and mammals, and non-target terrestrial plants.

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

The Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.

267

Sulcotrione

CAS No 99105-77-8

CIPAC No 723

2-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione

≥ 950 g/kg

Impurities:

| — | hydrogen cyanide: not more than 80 mg/kg |
| --- | --- |

—

hydrogen cyanide: not more than 80 mg/kg

| — | toluene: not more than 4 g/kg |
| --- | --- |

—

toluene: not more than 4 g/kg

1 September 2009

31 August 2019

PART A

Only uses as herbicide may be authorised.

PART B

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 sulcotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;

| — | the risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-target arthropods. |
| --- | --- |

—

the risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-target arthropods.

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

The Member States concerned shall request the submission of further information on the degradation in soil and water of the cyclohexadione moiety and the long-term risk to insectivorous birds. They shall ensure that the notifier at whose request sulcotrione has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.

268

Tebuconazole

CAS No 107534-96-3

CIPAC No 494

(RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-pentan-3-ol

≥ 905 g/kg

1 September 2009

31 August 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

| — | the dietary exposure of consumers to the tebuconazole (triazole) metabolites; |
| --- | --- |

—

the dietary exposure of consumers to the tebuconazole (triazole) metabolites;

| — | the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. |
| --- | --- |

—

the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

| — | the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. |
| --- | --- |

—

the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

The Member States concerned shall request the submission of further information to confirm the risk assessment for birds and mammals. They shall ensure that the notifier at whose request tebuconazole has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.

The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

269

Triadimenol

CAS No 55219-65-3

CIPAC No 398

(1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

≥ 920 g/kg

isomer A (1RS,2SR), isomer B (1RS,2RS)

| | Diastereomer A, RS + SR, range: 70 to 85 % |
| --- | --- |

Diastereomer A, RS + SR, range: 70 to 85 %

| | Diastereomer B, RR + SS, range: 15 to 30 % |
| --- | --- |

Diastereomer B, RR + SS, range: 15 to 30 %

1 September 2009

31 August 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure; |
| --- | --- |

—

the presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure;

| — | the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate. |
| --- | --- |

—

the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission:

| — | further information on the specification; |
| --- | --- |

—

further information on the specification;

| — | information to further address the risk assessment for birds and mammals. |
| --- | --- |

—

information to further address the risk assessment for birds and mammals.

| — | information to further address the risk of endocrine disrupting effects on fish. |
| --- | --- |

—

information to further address the risk of endocrine disrupting effects on fish.

They shall ensure that the notifier at whose request triadimenol has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.

The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

270

Methomyl

CAS No 16752-77-50

CIPAC No 264

S-methyl (EZ)-N-(methylcarbamoyloxy)thioacetimidate

≥ 980 g/kg

1 September 2009

31 August 2019

PART A

Only uses as insecticide on vegetables may be authorised at rates not exceeding 0,25 kg active substance per hectare per application and for a maximum of 2 applications per season.

Authorisations shall be limited to professional users.

PART B

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 methomyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 June 2009 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the operator safety: conditions of use shall prescribe the use of adequate personal protective equipment. Special attention shall be paid to the exposure of operators using knapsacks or other hand-held application equipment, |
| --- | --- |

—

the operator safety: conditions of use shall prescribe the use of adequate personal protective equipment. Special attention shall be paid to the exposure of operators using knapsacks or other hand-held application equipment,

| — | the protection of birds, |
| --- | --- |

—

the protection of birds,

| — | the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles, |
| --- | --- |

—

the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles,

| — | the protection of non-target arthropods, in particular bees: risk mitigation measures to avoid all contact with bees shall be applied. |
| --- | --- |

—

the protection of non-target arthropods, in particular bees: risk mitigation measures to avoid all contact with bees shall be applied.

Member States shall ensure that methomyl-based formulations contain effective repelling and/or emetic agents.

Where appropriate, conditions of authorisation shall include further risk mitigation measures.

271

Bensulfuron

CAS No 83055-99-6

CIPAC No 502.201

| | α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluic acid (bensulfuron) |
| --- | --- |

α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluic acid (bensulfuron)

| | methyl α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluate (bensulfuron-methyl) |
| --- | --- |

methyl α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluate (bensulfuron-methyl)

≥ 975 g/kg

1 November 2009

31 October 2019

PART A

Only uses as a herbicide may be authorised.

PART B

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 bensulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 December 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to the following:

| — | the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, |
| --- | --- |

—

the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,

| — | the protection of the groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

—

the protection of the groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions.

The Member States concerned shall ensure that the notifier submits to the Commission:

| — | further studies on the specification, |
| --- | --- |

—

further studies on the specification,

| — | information to further address the route and rate of degradation of bensulfuron-methyl under aerobic flooded soil conditions, |
| --- | --- |

—

information to further address the route and rate of degradation of bensulfuron-methyl under aerobic flooded soil conditions,

| — | information to address the relevance of metabolites for the consumer risk assessment. |
| --- | --- |

—

information to address the relevance of metabolites for the consumer risk assessment.

They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

272

Sodium 5-nitroguaiacolate

CAS No 67233-85-6

CIPAC number not allocated

Sodium 2-methoxy-5-nitrophenolate

≥ 980 g/kg

1 November 2009

31 October 2019

PART A

Only use as plant growth regulator may be authorised.

PART B

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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, |
| --- | --- |

—

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

| — | the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, |
| --- | --- |

—

the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

273

Sodium o-nitrophenolate

CAS No 824-39-5

CIPAC number not allocated

Sodium 2-nitrophenolate; sodium o-nitrophenolate

≥ 980 g/kg

The following impurities are of toxicological concern:

| | Phenol |
| --- | --- |

Phenol

| | Max content: 0,1 g/kg |
| --- | --- |

Max content: 0,1 g/kg

| | 2,4 dinitrophenol |
| --- | --- |

2,4 dinitrophenol

| | max content: 0,14 g/kg |
| --- | --- |

max content: 0,14 g/kg

| | 2,6 dinitrophenol |
| --- | --- |

2,6 dinitrophenol

| | max content: 0,32 g/kg |
| --- | --- |

max content: 0,32 g/kg

1 November 2009

31 October 2019

PART A

Only use as plant growth regulator may be authorised.

PART B

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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, |
| --- | --- |

—

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

| — | the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, |
| --- | --- |

—

the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

274

Sodium p-nitrophenolate

CAS No 824-78-2

CIPAC number not allocated

Sodium 4-nitrophenolate; sodium p-nitrophenolate

≥ 998 g/kg

The following impurities are of toxicological concern:

| | Phenol |
| --- | --- |

Phenol

| | max content: 0,1 g/kg |
| --- | --- |

max content: 0,1 g/kg

| | 2,4 dinitrophenol |
| --- | --- |

2,4 dinitrophenol

| | max content: 0,07 g/kg |
| --- | --- |

max content: 0,07 g/kg

| | 2,6 dinitrophenol |
| --- | --- |

2,6 dinitrophenol

| | max content: 0,09 g/kg |
| --- | --- |

max content: 0,09 g/kg

1 November 2009

31 October 2019

PART A

Only use as plant growth regulator may be authorised.

PART B

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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, |
| --- | --- |

—

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

| — | the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, |
| --- | --- |

—

the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

275

Tebufenpyrad

CAS No 119168-77-3

CIPAC No 725

N-(4-tert-butylbenzyl)-4-chloro-3-ethyl-1-methylpyrazole-5-carboxamide

≥ 980 g/kg

1 November 2009

31 October 2019

PART A

Only uses as acaricide and insecticide may be authorised.

PART B

In assessing applications to authorise plant protection products containing tebufenpyrad in formulations other than water soluble bags Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 tebufenpyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, |
| --- | --- |

—

the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,

| — | the protection of insectivorous birds and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. |
| --- | --- |

—

the protection of insectivorous birds and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

The Member States concerned shall ensure that the notifier submits to the Commission:

| — | further information confirming that no relevant impurities are present, |
| --- | --- |

—

further information confirming that no relevant impurities are present,

| — | information to further address the risk to insectivorous birds. |
| --- | --- |

—

information to further address the risk to insectivorous birds.

They shall ensure that the notifier provides such information to the Commission by 31 October 2011.

276

Chlormequat

| | CAS No 7003-89-6 (chlormequat) |
| --- | --- |

CAS No 7003-89-6 (chlormequat)

| | CAS No 999-81-5 (chlormequat chloride) |
| --- | --- |

CAS No 999-81-5 (chlormequat chloride)

| | CIPAC No 143 (chlormequat) |
| --- | --- |

CIPAC No 143 (chlormequat)

| | CIPAC No 143.302 (chlormequat chloride) |
| --- | --- |

CIPAC No 143.302 (chlormequat chloride)

| | 2-chloroethyltrimethylammonium (chlormequat) |
| --- | --- |

2-chloroethyltrimethylammonium (chlormequat)

| | 2-chloroethyltrimethylammonium chloride
  (chlormequat chloride) |
| --- | --- |

2-chloroethyltrimethylammonium chloride

(chlormequat chloride)

≥ 636 g/kg

Impurities

| | 1,2-dichloroethane: max 0,1 g/kg (on the dry chlormequat chloride content) |
| --- | --- |

1,2-dichloroethane: max 0,1 g/kg (on the dry chlormequat chloride content)

| | Chloroethene (vinylchloride): max 0,0005 g/kg (on the dry chlormequat chloride content) |
| --- | --- |

Chloroethene (vinylchloride): max 0,0005 g/kg (on the dry chlormequat chloride content)

1 December 2009

30 November 2019

PART A

Only uses as plant growth regulator on cereals and non edible crops may be authorised.

PART B

In assessing applications to authorise plant protection products containing chlormequat for uses other than in rye and triticale, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 chlormequat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

| — | the protection of birds and mammals. |
| --- | --- |

—

the protection of birds and mammals.

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

The Member States concerned shall request the submission of further information on the fate and behaviour (adsorption studies to be performed at 20 °C, recalculation of the predicted concentrations in groundwater, surface water and sediment), the monitoring methods for determination of the substance in animal products and water, and the risk to aquatic organisms, birds and mammals. They shall ensure that the notifier at whose request chlormequat has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.

277

Copper compounds:

1 December 2009

30 November 2016

PART A

Only uses as bactericide and fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing copper for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 copper compounds, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, |
| --- | --- |

—

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

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

| — | the protection of water and non-target organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate, |
| --- | --- |

—

the protection of water and non-target organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate,

| — | the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects. |
| --- | --- |

—

the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects.

The concerned Member States shall request the submission of information to further address:

| — | the risk from inhalation, |
| --- | --- |

—

the risk from inhalation,

| — | the risk assessment for non-target organisms and for soil and water. |
| --- | --- |

—

the risk assessment for non-target organisms and for soil and water.

They shall ensure that the notifier at whose request copper compounds have been included in this Annex provides such information to the Commission by 30 November 2011 at the latest.

Member States shall initiate monitoring programmes in vulnerable areas where the contamination of the soil compartment by copper is of concern, in order to set, where appropriate, limitations such as maximum application rates.

Copper hydroxide

CAS No 20427-59-2

CIPAC No 44.305

Copper (II) hydroxide

≥ 573 g/kg

Copper oxychloride

CAS No 1332-65-6 or 1332-40-7

CIPAC No 44.602

Dicopper chloride trihydroxide

≥ 550 g/kg

Copper oxide

CAS No 1317-39-1

CIPAC No 44.603

Copper oxide

≥ 820 g/kg

Bordeaux mixture

CAS No 8011-63-0

CIPAC No 44.604

Not allocated

≥ 245 g/kg

Tribasic copper sulphate

CAS No 12527-76-3

CIPAC No 44.306

Not allocated

≥ 490 g/kg

The following impurities are of toxicological concern and must not exceed the levels below:

| | Lead max 0,0005 g/kg of copper content. |
| --- | --- |

Lead max 0,0005 g/kg of copper content.

| | Cadmium max 0,0001 g/kg of copper content. |
| --- | --- |

Cadmium max 0,0001 g/kg of copper content.

| | Arsenic max 0,0001 g/kg of copper content. |
| --- | --- |

Arsenic max 0,0001 g/kg of copper content.

278

Propaquizafop

CAS No 111479-05-1

CIPAC No 173

2-isopropylidenamino-oxyethyl (R)-2-[4-(6-chloro-quinoxalin-2-yloxy)phenoxy]propionate

≥ 920 g/kg

Toluene maximum content 5 g/kg

1 December 2009

30 November 2019

PART A

Only uses as herbicide may be authorised.

PART B

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 propaquizafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, |
| --- | --- |

—

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

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, |
| --- | --- |

—

the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,

| — | the protection of non-target arthropods and ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. |
| --- | --- |

—

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

The Member States concerned shall ensure that the notifier submits to the Commission:

| — | further information on the relevant impurity Ro 41-5259, |
| --- | --- |

—

further information on the relevant impurity Ro 41-5259,

| — | information to further address the risk to aquatic organisms and to non-target arthropods. |
| --- | --- |

—

information to further address the risk to aquatic organisms and to non-target arthropods.

They shall ensure that the notifier provides such information to the Commission by 30 November 2011.

279

Quizalofop-P:

1 December 2009

30 November 2019

PART A

Only uses as herbicide may be authorised.

PART B

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 quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, |
| --- | --- |

—

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

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. |
| --- | --- |

—

the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

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

The Member States concerned shall ensure that the notifier submits to the Commission further information on the risk to non-target arthropods.

They shall ensure that the notifier provides such information to the Commission by 30 November 2011.

Quizalofop-P-ethyl

CAS No 100646-51-3

CIPAC No 641.202

ethyl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate

≥ 950 g/kg

Quizalofop-P-tefuryl

CAS No 119738-06-6

CIPAC No 641.226

(RS)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate

≥ 795 g/kg

280

Teflubenzuron

CAS No 83121-18-0

CIPAC No 450

1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea

≥ 970 g/kg

1 December 2009

30 November 2019

PART A

Only uses as insecticide in glasshouses (on artificial substrate or closed hydroponic systems) may be authorised.

PART B

In assessing applications to authorise plant protection products containing teflubenzuron for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 teflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator and workers safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate, |
| --- | --- |

—

the operator and workers safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate,

| — | the protection of aquatic organisms. Releases from glasshouse application must be minimised and, in any case, should not have the potential to reach in significant levels water bodies in the vicinity, |
| --- | --- |

—

the protection of aquatic organisms. Releases from glasshouse application must be minimised and, in any case, should not have the potential to reach in significant levels water bodies in the vicinity,

| — | the protection of bees which should be prevented from accessing the glasshouse, |
| --- | --- |

—

the protection of bees which should be prevented from accessing the glasshouse,

| — | the protection of pollinator colonies purposely placed in the glasshouse, |
| --- | --- |

—

the protection of pollinator colonies purposely placed in the glasshouse,

| — | the safe disposal of condensation water, drain water and substrate in order to preclude risks to non-target organisms and contamination of surface water and groundwater. |
| --- | --- |

—

the safe disposal of condensation water, drain water and substrate in order to preclude risks to non-target organisms and contamination of surface water and groundwater.

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

281

Zeta-cypermethrin

CAS No 52315-07-8

CIPAC No 733

Mixture of the stereoisomers (S)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2 dimethylcyclopropanecarboxylate where the ratio of the (S);(1RS,3RS) isomeric pair to the (S);(1RS,3SR) isomeric pair lies in the ratio range 45-55 to 55-45 respectively

≥ 850 g/kg

Impurities:

| | toluene: max 2 g/kg |
| --- | --- |

toluene: max 2 g/kg

| | tars: max 12,5 g/kg |
| --- | --- |

tars: max 12,5 g/kg

1 December 2009

30 November 2019

PART A

Only uses as insecticide may be authorised.

PART B

In assessing applications to authorise plant protection products containing zeta-cypermethrin for uses other than in cereals, notably as regards the exposure of consumers to mPBAldehyde, a degradation product that may be formed during processing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 zeta-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate,

| — | the protection of birds, aquatic organisms, bees, non-target arthropods and non-target soil macro-organisms. |
| --- | --- |

—

the protection of birds, aquatic organisms, bees, non-target arthropods and non-target soil macro-organisms.

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

The Member States concerned shall request the submission of further information on the fate and behaviour (aerobic degradation in soil), the long-term risk to birds, aquatic organisms and non-target arthropods. They shall ensure that the notifier at whose request zeta-cypermethrin has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.

282

Chlorsulfuron

CAS No 64902-72-3

CIPAC No 391

1-(2-chlorophenylsulfonyl)-3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea

≥ 950 g/kg

Impurities:

| | 2-Chlorobenzenesulfonamide (IN-A4097) not more than 5 g/kg and |
| --- | --- |

2-Chlorobenzenesulfonamide (IN-A4097) not more than 5 g/kg and

| | 4-methoxy-6-methyl-1,3,5-triazin-2-amine (IN-A4098) not more than 6 g/kg |
| --- | --- |

4-methoxy-6-methyl-1,3,5-triazin-2-amine (IN-A4098) not more than 6 g/kg

1 January 2010

31 December 2019

PART A

Only uses as herbicide may be authorised.

PART B

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 chlorsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, |
| --- | --- |

—

the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

The Member States concerned shall:

| — | ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010. |
| --- | --- |

—

ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.

If chlorsulfuron is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN-A4097, IN-A4098, IN-JJ998, IN-B5528 and IN-V7160 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.

283

Cyromazine

CAS No 66215-27-8

CIPAC No 420

N-cyclopropyl-1,3,5-triazine-2,4,6-triamine

≥ 950 g/kg

1 January 2010

31 December 2019

PART A

Only uses as insecticide in greenhouses may be authorised.

PART B

In assessing applications to authorise plant protection products containing cyromazine for uses other than in tomatoes, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 cyromazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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, |
| --- | --- |

—

the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

| — | the protection of aquatic organisms, |
| --- | --- |

—

the protection of aquatic organisms,

| — | the protection of pollinators. |
| --- | --- |

—

the protection of pollinators.

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

The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite NOA 435343 and on the risk to aquatic organisms. They shall ensure that the notifier at whose request cyromazine has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest.

284

Dimethachlor

CAS No 50563-36-5

CIPAC No 688

2-chloro-N-(2-methoxyethyl)acet-2′,6′-xylidide

≥ 950 g/kg

Impurity 2,6-dimethylaniline: Not more than 0,5 g/kg

1 January 2010

31 December 2019

PART A

Only uses as herbicide in application max. of 1,0 kg/ha only every third year on the same field may be authorised.

PART B

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 dimethachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, |
| --- | --- |

—

the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 in vulnerable zones, where appropriate.

The Member States concerned shall:

| — | ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010. |
| --- | --- |

—

ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.

If dimethachlor is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.

285

Etofenprox

CAS No 80844-07-1

CIPAC No 471

| | 2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl |
| --- | --- |

2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl

| | ether |
| --- | --- |

ether

≥ 980 g/kg

1 January 2010

31 December 2019

PART A

Only uses as insecticide may be authorised.

PART B

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 etofenprox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, |
| --- | --- |

—

the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,

| — | the protection of bees and non-target arthropods; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate. |
| --- | --- |

—

the protection of bees and non-target arthropods; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate.

The Member States concerned shall:

| — | ensure that the notifier submits to the Commission further information on the risk to aquatic organisms including the risk to sediment dwellers and biomagnification, |
| --- | --- |

—

ensure that the notifier submits to the Commission further information on the risk to aquatic organisms including the risk to sediment dwellers and biomagnification,

| — | the submission of further studies on the endocrine disruption potential in aquatic organisms (fish full life cycle study). |
| --- | --- |

—

the submission of further studies on the endocrine disruption potential in aquatic organisms (fish full life cycle study).

They shall ensure that the notifiers provide such studies to the Commission by 31 December 2011.

286

Lufenuron

CAS No 103055-07-8

CIPAC No 704

(RS)-1-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoro-propoxy)-phenyl]-3-(2,6-difluorobenzoyl)-urea

≥ 970 g/kg

1 January 2010

31 December 2019

PART A

Only indoor uses or use in outdoor bait stations as insecticide may be authorised.

PART B

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 lufenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the high persistency in the environment and the high risk for bioaccumulation and shall ensure that the use of lufenuron has no adverse long-term effects on non-target organisms, |
| --- | --- |

—

the high persistency in the environment and the high risk for bioaccumulation and shall ensure that the use of lufenuron has no adverse long-term effects on non-target organisms,

| — | the protection of birds, mammals, soil non-target organisms, bees, non-target arthropods, surface waters and aquatic organisms in vulnerable situations. |
| --- | --- |

—

the protection of birds, mammals, soil non-target organisms, bees, non-target arthropods, surface waters and aquatic organisms in vulnerable situations.

The Member States concerned shall:

| — | ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010. |
| --- | --- |

—

ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.

287

Penconazole

CAS No 66246-88-6

CIPAC No 446

(RS) 1-[2-(2,4-dichloro-phenyl)-pentyl]-1H-[1,2,4] triazole

≥ 950 g/kg

1 January 2010

31 December 2019

PART A

Only uses as fungicides may be authorised.

PART B

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 penconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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. |
| --- | --- |

—

the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

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

The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite CGA179944 in acidic soils. They shall ensure that the notifier at whose request penconazole has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest.

288

Tri-allate

CAS No 2303-17-5

CIPAC No 97

S-2,3,3-trichloroallyl di-isopropyl

(thiocarbamate)

≥ 940 g/kg

NDIPA (Nitroso-diisopropylamine)

max. 0,02 mg/kg

1 January 2010

31 December 2019

PART A

Only uses as herbicide may be authorised.

PART B

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 tri-allate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | the dietary exposure of consumers to residues of tri-allate in treated crops as well as in succeeding rotational crops and in products of animal origin |
| --- | --- |

—

the dietary exposure of consumers to residues of tri-allate in treated crops as well as in succeeding rotational crops and in products of animal origin

| — | the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, |
| --- | --- |

—

the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,

| — | the potential for ground water contamination by the degradation products TCPSA 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. |
| --- | --- |

—

the potential for ground water contamination by the degradation products TCPSA 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.

The Member States concerned shall ensure that the notifier submits to the Commission:

| — | further information to assess the primary plant metabolism, |
| --- | --- |

—

further information to assess the primary plant metabolism,

| — | further information on the fate and behaviour of the soil metabolite diisopropylamine, |
| --- | --- |

—

further information on the fate and behaviour of the soil metabolite diisopropylamine,

| — | further information on the potential for biomagnification in aquatic food chains, |
| --- | --- |

—

further information on the potential for biomagnification in aquatic food chains,

| — | information to further address the risk to fish-eating mammals and the long-term risk to earthworms. |
| --- | --- |

—

information to further address the risk to fish-eating mammals and the long-term risk to earthworms.

They shall ensure that the notifier provides such information to the Commission by 31 December 2011.

289

Triflusulfuron

CAS No 126535-15-7

CIPAC No 731

2-[4-dimethylamino-6-(2,2,2-trifluoroethoxy)-1,3,5-triazin-2-ylcarbamoylsulfamoyl]-m-toluic acid

≥ 960 g/kg

N,N-dimethyl-6-(2,2,2-trifluoroethoxy)-1,3,5-triazine-2,4-diamine

Max. 6 g/kg

1 January 2010

31 December 2019

PART A

Only uses as a herbicide in application on sugar and fodder beet at max 60 g/ha only every third year on the same field may be authorised. Foliage of treated crops may not be fed to livestock.

PART B

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 triflusulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the dietary exposure of consumers to residues of metabolites IN-M7222 and IN-E7710 in succeeding rotational crops and in products of animal origin, |
| --- | --- |

—

the dietary exposure of consumers to residues of metabolites IN-M7222 and IN-E7710 in succeeding rotational crops and in products of animal origin,

| — | the protection of aquatic organisms and aquatic plants from the risk arising from triflusulfuron and the metabolite IN-66036 and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, |
| --- | --- |

—

the protection of aquatic organisms and aquatic plants from the risk arising from triflusulfuron and the metabolite IN-66036 and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,

| — | the potential for ground water contamination by the degradation products IN-M7222 and IN-W6725 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. |
| --- | --- |

—

the potential for ground water contamination by the degradation products IN-M7222 and IN-W6725 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.

If triflusulfuron is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN-M7222, IN-D8526 and IN-E7710 with respect to cancer. They shall ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.

290

Difenacoum

CAS No 56073-07-5

CIPAC No 514

3-[(1RS,3RS;1RS,3SR)-3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl]-4-hydroxycoumarin

≥ 905 g/kg

1 January 2010

30 December 2019

PART A

Only uses as rodenticide in the form of pre-prepared baits placed in specially constructed, tamper resistant and secured bait boxes are authorised.

The nominal concentration of the active substance in the products shall not exceed 50 mg/kg.

Authorisations shall be limited to professional users.

PART B

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 difenacoum, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of birds and non-target mammals from primary and secondary poisoning. Risk mitigation measures shall be applied where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information on methods for the determination of residues of difenacoum in body fluids.

They shall ensure that the notifier provides such information to the Commission by 30 November 2011.

The Member States concerned shall ensure that the notifier submits to the Commission further information on the specification of the active substance as manufactured.

They shall ensure that the notifier provides such information to the Commission by 31 December 2009.

291

Didecyldimethylammonium chloride

CAS: not allocated

CIPAC: not allocated

Didecyldimethylammonium chloride is a mixture of alkyl-quaternary ammonium salts with typical alkyl chain lengths of C8, C10 and C12, with more than 90 % of C10

≥ 70 % (Technical concentrate)

1 January 2010

31 December 2019

PART A

Only indoor uses for ornamental plants as bactericide, fungicide, herbicide and algaecide may be authorised.

PART B

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 didecyldimethylammonium chloride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of the operator and worker safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, |
| --- | --- |

—

the protection of the operator and worker safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

| — | the protection of aquatic organisms. |
| --- | --- |

—

the protection of aquatic organisms.

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

The Member States concerned shall ensure that the notifier submits to the Commission further information on the specification of the active substance as manufactured by 1 January 2010 and on the risk to aquatic organisms by 31 December 2011.

292

sulphur

CAS No 7704-34-9

CIPAC No 18

sulphur

≥ 990 g/kg

1 January 2010

31 December 2019

PART A

Only uses as fungicide and acaricide may be authorised.

PART B

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 sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| --- | --- |

—

the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submit to the Commission further information to confirm the risk assessment for birds, mammals, sediment dwelling organisms and non-target arthropods. They shall ensure that the notifier at whose request sulphur has been included in this Annex provide such data to the Commission at latest by 30 June 2011.

293

Tetraconazole

CAS No 112281-77-3

CIPAC No 726

(RS)-2-(2,4-dichlorophenyl)-3-(1H-1.2,4-triazol-1-yl)-propyl-1.1,2,2-tetrafluoroethyl ether

≥ 950 g/kg (racemic mixture)

Impurity toluene: not more than 13 g/kg

1 January 2010

31 December 2019

PART A

Only uses as fungicide may be authorised.

PART B

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 tetraconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, |
| --- | --- |

—

the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

The Member States concerned shall request:

| — | the submission of further information on a refined consumer risk assessment, |
| --- | --- |

—

the submission of further information on a refined consumer risk assessment,

| — | further information on the specification regarding ecotoxicology, |
| --- | --- |

—

further information on the specification regarding ecotoxicology,

| — | further information on the fate and behaviour of potential metabolites in all relevant compartments, |
| --- | --- |

—

further information on the fate and behaviour of potential metabolites in all relevant compartments,

| — | the refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods, |
| --- | --- |

—

the refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods,

| — | further information on the potential for endocrine disrupting effects to birds, mammals and fish. |
| --- | --- |

—

further information on the potential for endocrine disrupting effects to birds, mammals and fish.

They shall ensure that the notifier provides such information to the Commission by 31 December 2011.

294

Paraffin oils

| | CAS No 64742-46-7 |
| --- | --- |

CAS No 64742-46-7

| | CAS No 72623-86-0 |
| --- | --- |

CAS No 72623-86-0

| | CAS No 97862-82-3 |
| --- | --- |

CAS No 97862-82-3

CIPAC No n.a.

paraffin oil

European Pharmacopoeia 6.0

1 January 2010

31 December 2019

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, and in particular Appendices I and II thereto shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

The Member States concerned shall request:

| — | the submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6.0. |
| --- | --- |

—

the submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6.0.

They shall ensure that the notifiers provides such information to the Commission by 30 June 2010.

295

Paraffin oil

CAS No 8042-47-5

CIPAC No n.a.

paraffin oil

European Pharmacopoeia. 6,0

1 January 2010

31 December 2019

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

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 paraffin oil 8042-47-5, and in particular Appendices I and II thereof, shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.

The Member States concerned shall request:

| | The submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6,0 |
| --- | --- |

The submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6,0

| | They shall ensure that the notifier provides such information to the Commission by 30 June 2010. |
| --- | --- |

They shall ensure that the notifier provides such information to the Commission by 30 June 2010.

296

Cyflufenamid

CAS No 180409-60-3

CIPAC No 759

(Z)-N-[α-(cyclopropylmethoxyimino) – 2,3-difluoro-6-(trifluoromethyl)benzyl]-2-phenylacetamide

> 980 g/kg

1 April 2010

31 March 2020

PART A

Only uses as fungicide may be authorised.

PART B

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 cyflufenamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 October 2009 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.

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

297

Fluopicolide

CAS No

239110-15-7

CIPAC No 787

2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide

≥ 970 g/kg

The impurity toluene must not exceed 3 g/kg in the technical material.

1 June 2010

31 May 2020

PART A

Only uses as fungicide may be authorised.

PART B

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 fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.

In this overall assessment, Member States must pay particular attention to:

| — | the protection of aquatic organisms, |
| --- | --- |

—

the protection of aquatic organisms,

| — | the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions, |
| --- | --- |

—

the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

| — | to the risk to operators during application, |
| --- | --- |

—

to the risk to operators during application,

| — | the potential for long range transport via air. |
| --- | --- |

—

the potential for long range transport via air.

Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest.

298

Heptamaloxyloglucan

CAS No

870721-81-6

CIPAC No

Not available

Full IUPAC name in footnote (1)

| | Xyl p: xylopyranosyl |
| --- | --- |

Xyl p: xylopyranosyl

| | Glc p: glucopyranosyl |
| --- | --- |

Glc p: glucopyranosyl

| | Fuc p: fucopyranosyl |
| --- | --- |

Fuc p: fucopyranosyl

| | Gal p: galactopyranosyl |
| --- | --- |

Gal p: galactopyranosyl

| | Glc-ol: glucitol |
| --- | --- |

Glc-ol: glucitol

≥ 780 g/kg

The impurity Patulin must not exceed 50 μg/kg in the technical material.

1 June 2010

31 May 2020

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 heptamaloxyloglucan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.

299

2-phenylphenol (including its salts such as the sodium salt)

CAS No 90-43-7

CIPAC No 246

biphenyl-2-ol

≥ 998 g/kg

1 January 2010

31 December 2019

PART A

Only uses as a post-harvest fungicide for indoor use may be authorised.

PART B

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-phenylphenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009, as amended in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.

In this overall assessment Member States must pay particular attention:

| — | to the protection of operators and workers and ensure that conditions of use prescribe the application of adequate personal protective equipment, |
| --- | --- |

—

to the protection of operators and workers and ensure that conditions of use prescribe the application of adequate personal protective equipment,

| — | to put in place appropriate waste management practices to handle the waste solution remaining after application, including the cleaning water of the drenching and other application systems. Member States permitting the release of wastewater into the sewage system, shall ensure that a local risk assessment is carried out. |
| --- | --- |

—

to put in place appropriate waste management practices to handle the waste solution remaining after application, including the cleaning water of the drenching and other application systems. Member States permitting the release of wastewater into the sewage system, shall ensure that a local risk assessment is carried out.

The Member States concerned shall ensure that the notifier submits to the Commission:

| — | further information on the potential for skin depigmentation for workers and consumers due to possible exposure to the metabolite 2-phenylhydroquinone (PHQ) on citrus peel, |
| --- | --- |

—

further information on the potential for skin depigmentation for workers and consumers due to possible exposure to the metabolite 2-phenylhydroquinone (PHQ) on citrus peel,

| — | further information to confirm that the analytical method applied in residue trials correctly quantifies the residues of 2-phenylphenol, PHQ and their conjugates. |
| --- | --- |

—

further information to confirm that the analytical method applied in residue trials correctly quantifies the residues of 2-phenylphenol, PHQ and their conjugates.

They shall ensure that the notifier provides such information to the Commission by 31 December 2011.

Furthermore, the Member States concerned shall ensure that the notifier submits to the Commission further information to confirm the residue levels occurring as a result of application techniques other than those in drench chambers.

They shall ensure that the notifier provides such information to the Commission by 31 December 2012.

300

Malathion

CAS No 121-75-5

CIPAC No 12

| | diethyl (dimethoxyphosphinothioylthio)succinate
  or |
| --- | --- |

diethyl (dimethoxyphosphinothioylthio)succinate

or

| | S-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioate
  racemate |
| --- | --- |

S-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioate

racemate

≥ 950 g/kg

Impurities:

Isomalathion: not more than 2 g/kg

1 May 2010

30 April 2020

PART A

Only uses as insecticide may be authorised. Authorisations shall be limited to professional users.

PART B

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 malathion, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment; |
| --- | --- |

—

the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment;

| — | the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones; |
| --- | --- |

—

the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones;

| — | the protection of insectivorous birds and honey bees: conditions of authorisation shall include risk mitigation measures, where appropriate. As regards bees, the necessary indications shall be provided on the labelling and the accompanying instructions as to avoid exposure. |
| --- | --- |

—

the protection of insectivorous birds and honey bees: conditions of authorisation shall include risk mitigation measures, where appropriate. As regards bees, the necessary indications shall be provided on the labelling and the accompanying instructions as to avoid exposure.

Member States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport.

Where appropriate, conditions of authorisation shall include further risk mitigation measures.

The Member States concerned shall ensure that the notifier presents to the Commission:

| — | information confirming the consumer risk assessment and the acute and long-term risk assessment for insectivorous birds; |
| --- | --- |

—

information confirming the consumer risk assessment and the acute and long-term risk assessment for insectivorous birds;

| — | information on the quantification of the different potency of malaoxon and malathion. |
| --- | --- |

—

information on the quantification of the different potency of malaoxon and malathion.

301

Penoxsulam

CAS No 219714-96-2

CIPAC No 758

3-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-α,α,α-trifluorotoluene-2-sulfonamide

> 980 g/kg

The impurity

Bis-CHYMP

2-chloro-4-[2-(2-chloro-5-methoxy-4-pyrimidinyl)hydrazino]-5-methoxypyrimidine must not exceed 0,1 g/kg in the technical material

1 August 2010

31 July 2020

PART A

Only uses as herbicide may be authorised.

PART B

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 penoxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.

In this overall assessment, Member States must pay particular attention to:

| — | the protection of aquatic organisms, |
| --- | --- |

—

the protection of aquatic organisms,

| — | the dietary exposure of consumers to residues of the metabolite BSCTA in succeeding rotational crops, |
| --- | --- |

—

the dietary exposure of consumers to residues of the metabolite BSCTA in succeeding rotational crops,

| — | the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

—

the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

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

The Member States concerned shall ensure that the notifier submits to the Commission further information to address the off-field risk to higher aquatic plants. They shall ensure that the notifier provides such information to the Commission by 31 July 2012.

The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

302

Proquinazid

CAS No 189278-12-4

CIPAC No 764

6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one

> 950 g/kg

1 August 2010

31 July 2020

PART A

Only uses as fungicide may be authorised.

PART B

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 proquinazid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.

In this overall assessment, Member States must pay particular attention:

| — | to the long-term risk to earthworm-eating birds for uses in grapevine, |
| --- | --- |

—

to the long-term risk to earthworm-eating birds for uses in grapevine,

| — | to the risk to aquatic organisms, |
| --- | --- |

—

to the risk to aquatic organisms,

| — | the dietary exposure of consumers to proquinazid residues in products of animal origin and in succeeding rotational crops, |
| --- | --- |

—

the dietary exposure of consumers to proquinazid residues in products of animal origin and in succeeding rotational crops,

| — | to the operator safety. |
| --- | --- |

—

to the operator safety.

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

The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

303

Spirodiclofen

CAS No 148477-71-8

CIPAC No 737

3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate

> 965 g/kg

The following impurities must not exceed a certain amount in the technical material:

| | 3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4.5]dec-3-en-2-one (BAJ-2740 enol): ≤ 6 g/kg |
| --- | --- |

3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4.5]dec-3-en-2-one (BAJ-2740 enol): ≤ 6 g/kg

| | N,N-dimethylacetamide: ≤ 4 g/kg |
| --- | --- |

N,N-dimethylacetamide: ≤ 4 g/kg

1 August 2010

31 July 2020

PART A

Only uses as acaricide or insecticide may be authorised.

PART B

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 spirodiclofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.

In this overall assessment, Member States must pay particular attention:

| — | to the long-term risk to aquatic organisms, |
| --- | --- |

—

to the long-term risk to aquatic organisms,

| — | to the operator safety, |
| --- | --- |

—

to the operator safety,

| — | to the risk to bee brood. |
| --- | --- |

—

to the risk to bee brood.

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

304

Metalaxyl

CAS No 57837-19-1

CIPAC No 365

Methyl N-(methoxyacetyl)-N-(2,6-xylyl)-DL-alaninate

950 g/kg

The impurity 2,6-dimethylaniline was considered of toxicological concern and a maximum level of 1 g/kg is established.

1 July 2010

30 June 2020

PART A

Only uses as fungicide may be authorised.

PART B

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, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account.

Member States must pay particular attention to the potential contamination of groundwater 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.

305

Flonicamid (IKI-220)

CAS No 158062-67-0

CIPAC No 763

N-cyanomethyl-4-(trifluoromethyl)nicotinamide

≥ 960 g/kg

The impurity toluene must not exceed 3 g/kg in the technical material.

1 September 2010

31 August 2020

PART A

Only uses as insecticide may be authorised.

PART B

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 flonicamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010, shall be taken into account.

In this overall assessment, Member States must pay particular attention to:

| — | the risk to operators and re-entry workers, |
| --- | --- |

—

the risk to operators and re-entry workers,

| — | the risk to bees. |
| --- | --- |

—

the risk to bees.

Conditions of authorisation shall include risk mitigation measures where appropriate.

The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

306

Triflumizole

CAS No 99387-89-0

CIPAC No 730

(E)-4-chloro-α,α,α-trifluoro-N-(1-imidazol-1-yl-2-propoxyethylidene)-o-toluidine

≥ 980 g/kg

Impurities:

Toluene: not more than 1 g/kg

1 July 2010

30 June 2020

PART A

Only uses as fungicide in greenhouses on artificial substrates may be authorised.

PART B

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 triflumizole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment, |
| --- | --- |

—

the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment,

| — | the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, as appropriate, risk mitigation measures. |
| --- | --- |

—

the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, as appropriate, risk mitigation measures.

307

Sulfuryl fluoride

CAS No 002699-79-8

CIPAC No 757

Sulfuryl fluoride

> 994 g/kg

1 November 2010

31 October 2020

PART A

Only uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures

| — | which are empty; or |
| --- | --- |

—

which are empty; or

| — | where conditions of use ensure that consumer exposure is acceptable; |
| --- | --- |

—

where conditions of use ensure that consumer exposure is acceptable;

may be authorised.

PART B

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 sulfuryl fluoride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment, Member States must pay particular attention to:

| — | the risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that such products do not enter the food and feed chain, |
| --- | --- |

—

the risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that such products do not enter the food and feed chain,

| — | the risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration. Measures are required to ensure that they wear self containing breathing apparatus or other appropriate personal protective equipment, |
| --- | --- |

—

the risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration. Measures are required to ensure that they wear self containing breathing apparatus or other appropriate personal protective equipment,

| — | the risk to bystanders by applying an appropriate exclusion zone around the fumigated structure. |
| --- | --- |

—

the risk to bystanders by applying an appropriate exclusion zone around the fumigated structure.

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

The Member States concerned shall ensure that the notifier submits to the Commission further information and in particular, confirmatory data on:

| — | the mill processing conditions necessary to ensure that residues of fluoride ion in flour, bran and grain do not exceed the natural background levels, |
| --- | --- |

—

the mill processing conditions necessary to ensure that residues of fluoride ion in flour, bran and grain do not exceed the natural background levels,

| — | tropospheric concentrations of sulfuryl fluoride. Measured concentrations should be updated regularly. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air), |
| --- | --- |

—

tropospheric concentrations of sulfuryl fluoride. Measured concentrations should be updated regularly. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air),

| — | estimates of sulfuryl fluoride atmospheric lifetime based on worst case scenario, with respect to the global warming potential (GWP). |
| --- | --- |

—

estimates of sulfuryl fluoride atmospheric lifetime based on worst case scenario, with respect to the global warming potential (GWP).

They shall ensure that the notifier provides such information to the Commission by 31 August 2012.

308

FEN 560 (also called fenugreek or fenugreek seed powder)

CAS No

None

CIPAC No

None

The active substance is prepared from the seed powder of Trigonella foenum-graecum L. (fenugreek).

Not applicable

100 % fenugreek seed powder without any additive and no extraction; the seed being of human food grade quality.

1 November 2010

31 October 2020

PART A

Only uses as elicitor of the crop's self-defence mechanisms may be authorised.

PART B

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 FEN 560 (fenugreek seed powder), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.

In this overall assessment, Member States must pay particular attention to the risk to operators, workers and bystanders.

Conditions of authorisation shall include risk mitigation measures where appropriate.

309

Haloxyfop-P

CAS No Acid: 95977-29-0

Ester: 72619-32-0

CIPAC No Acid: 526

Ester: 526.201

| | Acid: (R)-2-[4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy]propanoic acid |
| --- | --- |

Acid: (R)-2-[4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy]propanoic acid

| | Ester: Methyl (R)-2-{}{4-[3-chloro-5-(trifluoromethyl)-2-pyridyloxy]phenoxy}}propionate |
| --- | --- |

Ester: Methyl (R)-2-{}{4-[3-chloro-5-(trifluoromethyl)-2-pyridyloxy]phenoxy}}propionate

≥ 940 g/kg

(Haloxyfop-P-methyl ester)

1 January 2011

31 December 2020

PART A

Only uses as herbicide may be authorised.

PART B

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 haloxyfop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | operator safety: conditions of use shall prescribe the use of adequate personal protective equipment; |
| --- | --- |

—

operator safety: conditions of use shall prescribe the use of adequate personal protective equipment;

| — | protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones; |
| --- | --- |

—

protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones;

| — | consumer safety as regards the occurrence in groundwater of metabolites DE-535 pyridinol and DE-535 pyridinone. |
| --- | --- |

—

consumer safety as regards the occurrence in groundwater of metabolites DE-535 pyridinol and DE-535 pyridinone.

The Member States concerned shall ensure that the applicant presents to the Commission, by 31 December 2012 at the latest, information confirming the groundwater exposure assessment as regards the active substance and its soil metabolites DE-535 phenol, DE-535 pyridinol and DE-535 pyridinone.

310

Napropamide

CAS No 15299-99-7

(RS)-N,N-diethyl-2-(1-naphthyloxy)propionamide

≥ 930 g/kg

(Racemic mixture)

Relevant impurity

Toluene: not more than 1,4 g/kg

1 January 2011

31 December 2020

PART A

Only uses as herbicide may be authorised.

PART B

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 napropamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | operator safety: conditions of use shall prescribe the use of adequate personal protective equipment, where necessary, |
| --- | --- |

—

operator safety: conditions of use shall prescribe the use of adequate personal protective equipment, where necessary,

| — | protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones, |
| --- | --- |

—

protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones,

| — | consumer safety as regards the occurrence in groundwater of the metabolite 2-(1-naphthyloxy)propionic acid, hereinafter ‘NOPA’. |
| --- | --- |

—

consumer safety as regards the occurrence in groundwater of the metabolite 2-(1-naphthyloxy)propionic acid, hereinafter ‘NOPA’.

The Member States concerned shall ensure that the applicant presents to the Commission, by 31 December 2012 at the latest, information confirming the surface water exposure assessment as regards the photolysis metabolites and the metabolite NOPA and information for the risk assessment of aquatic plants.

311

Quinmerac

CAS No 90717-03-6

CIPAC No 563

7-chloro-3-methylquinoline-8-carboxylic acid

≥ 980 g/kg

1 May 2011

30 April 2021

PART A

Only uses as herbicide may be authorised.

PART B

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 quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

—

the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

| — | the dietary exposure of consumers to residues of quinmerac (and its metabolites) in succeeding rotational crops |
| --- | --- |

—

the dietary exposure of consumers to residues of quinmerac (and its metabolites) in succeeding rotational crops

| — | the risk to aquatic organisms and the long term risk for earthworms. |
| --- | --- |

—

the risk to aquatic organisms and the long term risk for earthworms.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of information as regards:

| — | the potential of plant metabolism to result in an opening of the quinoline ring; |
| --- | --- |

—

the potential of plant metabolism to result in an opening of the quinoline ring;

| — | residues in rotational crops and the long term risk for earthworms due to the metabolite BH 518-5. |
| --- | --- |

—

residues in rotational crops and the long term risk for earthworms due to the metabolite BH 518-5.

They shall ensure that the applicant provides such confirmatory data and information to the Commission by 30 April 2013.

312

Metosulam

CAS No 139528-85-1

CIPAC No 707

| | 2′,6′-dichloro-5,7-dimethoxy-3′-methyl[1,2,4]triazolo |
| --- | --- |

2′,6′-dichloro-5,7-dimethoxy-3′-methyl[1,2,4]triazolo

| | [1,5-a]pyrimidine-2-sulfonanilide |
| --- | --- |

[1,5-a]pyrimidine-2-sulfonanilide

≥ 980 g/kg

1 May 2011

30 April 2021

PART A

Only uses as herbicide may be authorised.

PART B

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 metosulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

—

the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

| — | the risk to aquatic organisms; |
| --- | --- |

—

the risk to aquatic organisms;

| — | the risk to non-target plants in the off-field area. |
| --- | --- |

—

the risk to non-target plants in the off-field area.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the applicant submits to the Commission, by 30 October 2011, further information on the specification of the active substance as manufactured.

The Member States concerned shall ensure that the applicant submits to the Commission, by 30 April 2013, confirmatory information as regards:

| — | potential pH dependence of soil adsorption, groundwater leaching and surface water exposure for metabolites M01 and M02; |
| --- | --- |

—

potential pH dependence of soil adsorption, groundwater leaching and surface water exposure for metabolites M01 and M02;

| — | potential genotoxicity of one impurity. |
| --- | --- |

—

potential genotoxicity of one impurity.

313

Pyridaben

CAS No 96489-71-3

CIPAC No 583

2-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyrididazin-3(2H)-one

>980 g/kg

1 May 2011

30 April 2021

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

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 pyridaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

| — | the risk to aquatic organisms and mammals, |
| --- | --- |

—

the risk to aquatic organisms and mammals,

| — | the risk to non target arthropods including honeybees. |
| --- | --- |

—

the risk to non target arthropods including honeybees.

Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify the real exposure of honeybees to pyridaben in areas extensively used by such bees for foraging or by beekeepers, where and as appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

| — | the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3, |
| --- | --- |

—

the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3,

| — | the potential long term risk for mammals, |
| --- | --- |

—

the potential long term risk for mammals,

| — | the assessment of fat soluble residues. |
| --- | --- |

—

the assessment of fat soluble residues.

They shall ensure that the applicant provides such confirmatory information to the Commission by 30 April 2013.

314

Zinc phosphide

CAS No 1314-84-7

CIPAC No 69

Trizinc diphosphide

≥ 800 g/kg

1 May 2011

30 April 2021

PART A

Only uses as rodenticide in the form of ready-to-use baits placed in bait stations or target locations may be authorised.

PART B

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 zinc phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In this overall assessment Member States should pay particular attention to:

| — | the protection of non target organisms. Risk mitigation measures should be applied as appropriate in particular to avoid the spread of baits where only part of the content has been consumed. |
| --- | --- |

—

the protection of non target organisms. Risk mitigation measures should be applied as appropriate in particular to avoid the spread of baits where only part of the content has been consumed.

315

Fenbuconazole

CAS No 114369-43-6

CIPAC No 694

(R,S) 4-(4-chlorophenyl)-2-phenyl-2-(1H-1,2,4-triazol-1-ylmethyl)butyronitrile

≥ 965 g/kg

1 May 2011

30 April 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 fenbuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, |
| --- | --- |

—

the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

| — | the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs), |
| --- | --- |

—

the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs),

| — | the risk to aquatic organisms and mammals. |
| --- | --- |

—

the risk to aquatic organisms and mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory data on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin.

They shall ensure that the applicant provides such studies to the Commission by 30 April 2013.

The Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of fenbuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

316

Cycloxydim

CAS No 101205-02-1

CIPAC No 510

(5RS)-2-[(EZ)-1-(ethoxyimino)butyl]-3-hydroxy-5-[(3RS)-thian-3-yl]cyclohex-2-en-1-one

≥ 940 g/kg

1 June 2011

31 May 2021

PART A

Only uses as herbicide may be authorised.

PART B

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 cycloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to non-target plants.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of further information concerning the methods for analysis of residues of cycloxydim in plant and animal products.

The Member States concerned shall ensure that the applicant submits such methods of analysis to the Commission by 31 May 2013.

317

6-Benzyladenine

CAS No 1214-39-7

CIPAC No 829

N6-benzyladenine

≥ 973 g/kg

1 June 2011

31 May 2021

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 6-benzyladenine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate.

318

Bromuconazole

CAS No 116255-48-2

CIPAC No 680

1-[(2RS,4RS:2RS,4SR)-4-bromo-2-(2,4-dichlorophenyl)tetrahydrofurfuryl]-1H-1,2,4-triazole

≥ 960 g/kg

1 February 2011

31 January 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 bromuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

In this overall assessment, Member States shall pay particular attention to:

| — | operator's safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; |
| --- | --- |

—

operator's safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;

| — | protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones. |
| --- | --- |

—

protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones.

The Member States concerned shall ensure that the applicant presents to the Commission:

| — | further information on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; |
| --- | --- |

—

further information on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

| — | information to further address the long term risk to herbivorous mammals. |
| --- | --- |

—

information to further address the long term risk to herbivorous mammals.

They shall ensure that the applicant at whose request bromuconazole has been included in this Annex provides such confirmatory information to the Commission by 31 January 2013 at the latest.

The Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of bromuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

319

Myclobutanil

CAS No 88671-89-0

CIPAC No 442

RS)-2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile

≥ 925 g/kg

The impurity 1-methylpyrrolidin-2-one shall not exceed 1 g/kg in the technical material

1 June 2011

31 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 myclobutanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information on the residues of myclobutanil and its metabolites in following growing seasons and information confirming that the available residue data cover all compounds of the residue definition.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 January 2013.

320

Buprofezin

CAS No 953030-84-7

CIPAC No 681

(Z)-2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one

≥ 985 g/kg

1 February 2011

31 January 2021

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

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 buprofezin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the operators’ and workers’ safety and ensure that conditions of use impose adequate personal protective equipment where appropriate; |
| --- | --- |

—

the operators’ and workers’ safety and ensure that conditions of use impose adequate personal protective equipment where appropriate;

| — | the dietary exposure of consumers to the buprofezin (aniline) metabolites in processed food; |
| --- | --- |

—

the dietary exposure of consumers to the buprofezin (aniline) metabolites in processed food;

| — | the application of an appropriate waiting period for rotational crops in greenhouses; |
| --- | --- |

—

the application of an appropriate waiting period for rotational crops in greenhouses;

| — | the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures, where appropriate. |
| --- | --- |

—

the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards the processing and conversion factors for consumer risk assessment.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 January 2013.

321

Triflumuron

CAS No 64628-44-0

CIPAC No: 548

1-(2-chlorobenzoyl)-3-[4-trifluoromethoxyphenyl]urea

≥ 955 g/kg

Impurities:

| — | N,N′-bis-[4-(trifluoromethoxy)phenyl]urea: not more than 1 g/kg |
| --- | --- |

—

N,N′-bis-[4-(trifluoromethoxy)phenyl]urea: not more than 1 g/kg

| — | 4-trifluoro-methoxyaniline: not more than 5 g/kg |
| --- | --- |

—

4-trifluoro-methoxyaniline: not more than 5 g/kg

1 April 2011

31 March 2021

PART A

Only uses as insecticide may be authorised.

PART B

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 triflumuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment, Member States shall pay particular attention to:

| — | the protection of the aquatic environment; |
| --- | --- |

—

the protection of the aquatic environment;

| — | the protection of honey bees. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| --- | --- |

—

the protection of honey bees. Conditions of authorisation shall include risk mitigation measures, where appropriate.

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

The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards the long-term risk to birds, the risk to aquatic invertebrates and the risk to bee brood development.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 March 2013.

322

Hymexazol

CAS No 10004-44-1

CIPAC No 528

5-methylisoxazol-3-ol (or 5-methyl-1,2-oxazol-3-ol)

≥985 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide for seed pelleting of sugar beets in professional seed treatment facilities may be authorised.

PART B

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 hymexazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the operators and workers safety. Conditions of authorisation shall include protective measures, where appropriate, |
| --- | --- |

—

the operators and workers safety. Conditions of authorisation shall include protective measures, where appropriate,

| — | the risk to granivorous birds and mammals. |
| --- | --- |

—

the risk to granivorous birds and mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards the nature of residues in root crops and the risk for granivorous birds and mammals.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

323

Dodine

CAS No 2439-10-3

CIPAC No 101

1-dodecylguanidinium acetate

≥ 950 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 dodine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the potential long-term risk to birds and mammals; |
| --- | --- |

—

the potential long-term risk to birds and mammals;

| — | the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures; |
| --- | --- |

—

the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures;

| — | the risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures; |
| --- | --- |

—

the risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures;

| — | the monitoring of residue levels in pome fruit. |
| --- | --- |

—

the monitoring of residue levels in pome fruit.

The Member States concerned shall request the submission of confirmatory information as regards:

| — | long-term risk assessment for birds and mammals, |
| --- | --- |

—

long-term risk assessment for birds and mammals,

| — | risk assessment in natural surface water systems where major metabolites have potentially formed. |
| --- | --- |

—

risk assessment in natural surface water systems where major metabolites have potentially formed.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

324

Diethofencarb

CAS No 87130-20-9

CIPAC No 513

isopropyl 3,4-diethoxycarbanilate

≥ 970 g/kg

Impurities:

Toluene: not more than 1 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 diethofencarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and non-target arthropods and shall ensure that conditions of use include the application of adequate risk mitigation measures.

The Member States concerned shall request the submission of confirmatory information as regards:

| — | the potential uptake of the metabolite 6-NO2-DFC in succeeding crops; |
| --- | --- |

—

the potential uptake of the metabolite 6-NO2-DFC in succeeding crops;

| — | the risk assessment for non-target arthropod species. |
| --- | --- |

—

the risk assessment for non-target arthropod species.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.

325

Etridiazole

CAS No 2593-15-9

CIPAC No 518

ethyl-3-trichloromethyl-1,2,4-thiadiazol-5-yl ether

≥ 970 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide in non-soil bound systems in greenhouse may be authorised.

PART B

In assessing applications to authorise plant protection products containing etridiazole for uses other than on ornamental plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorization is granted.

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 etridiazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall:

| — | pay particular attention to the risk to operators and workers and ensure that conditions of use include the application of appropriate risk mitigation measures; |
| --- | --- |

—

pay particular attention to the risk to operators and workers and ensure that conditions of use include the application of appropriate risk mitigation measures;

| — | ensure that appropriate waste management practices are applied as regards waste water from irrigation of non-soil bound growing systems; Member States permitting the release of waste water into the sewage system or into natural water bodies, shall ensure that an appropriate risk assessment is carried out; |
| --- | --- |

—

ensure that appropriate waste management practices are applied as regards waste water from irrigation of non-soil bound growing systems; Member States permitting the release of waste water into the sewage system or into natural water bodies, shall ensure that an appropriate risk assessment is carried out;

| — | pay particular attention to the risk to aquatic organisms and ensure that conditions of use include the application of appropriate risk mitigation measures. |
| --- | --- |

—

pay particular attention to the risk to aquatic organisms and ensure that conditions of use include the application of appropriate risk mitigation measures.

The Member States concerned shall request the submission of confirmatory information as regards:

| 1. | the specification of the technical material, as commercially manufactured, by appropriate analytical data; |
| --- | --- |

1.

the specification of the technical material, as commercially manufactured, by appropriate analytical data;

| 2. | the relevance of the impurities; |
| --- | --- |

2.

the relevance of the impurities;

| 3. | the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the ecotoxicity dossiers; |
| --- | --- |

3.

the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the ecotoxicity dossiers;

| 4. | the relevance of the plant metabolites 5-hydroxy-ethoxyetridiazole acid and 3-hydroxymethyletridiazole; |
| --- | --- |

4.

the relevance of the plant metabolites 5-hydroxy-ethoxyetridiazole acid and 3-hydroxymethyletridiazole;

| 5. | indirect exposure of groundwater and soil-dwelling organisms to etridiazole and to its soil metabolites dichloro-etridiazole and etridiazole acid; |
| --- | --- |

5.

indirect exposure of groundwater and soil-dwelling organisms to etridiazole and to its soil metabolites dichloro-etridiazole and etridiazole acid;

| 6. | long-range and short-range transport through the atmosphere of etridiazole acid. |
| --- | --- |

6.

long-range and short-range transport through the atmosphere of etridiazole acid.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1), (2) and (3) by 30 November 2011 and the information set out in points (4), (5) and (6) by 31 May 2013.

326

Indolylbutyric acid

CAS No 133-32-4

CIPAC No 830

4-(1H-indol-3-yl)butyric acid

≥ 994 g/kg

1 June 2011

31 May 2021

PART A

Only uses as plant growth regulator in ornamentals may be authorised.

PART B

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 indolylbutyric acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the operators and workers safety. Conditions of authorisation shall include the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure.

The Member States concerned shall request the submission of further information to confirm:

| — | the absence of clastogenicity potential of indolylbutyric acid; |
| --- | --- |

—

the absence of clastogenicity potential of indolylbutyric acid;

| — | the vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study; |
| --- | --- |

—

the vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study;

| — | the natural background concentration of indolylbutyric acid in the soil. |
| --- | --- |

—

the natural background concentration of indolylbutyric acid in the soil.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

327

Oryzalin

CAS No 19044-88-3

CIPAC No 537

3,5-dinitro-N4,N4-dipropylsulfanilamide

≥ 960 g/kg

N-nitrosodipropylamine:

| | ≤ 0,1 mg/kg |
| --- | --- |

≤ 0,1 mg/kg

| | Toluene: ≤ 4 g/kg |
| --- | --- |

Toluene: ≤ 4 g/kg

1 June 2011

31 May 2021

PART A

Only uses as herbicide may be authorised.

PART B

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 oryzalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the operator safety and ensure that conditions of use include the application of adequate personal protective equipment; |
| --- | --- |

—

the operator safety and ensure that conditions of use include the application of adequate personal protective equipment;

| — | the protection of aquatic organisms and non target plants; |
| --- | --- |

—

the protection of aquatic organisms and non target plants;

| — | the protection of groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

—

the protection of groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions;

| — | the risk to herbivorous birds and mammals; |
| --- | --- |

—

the risk to herbivorous birds and mammals;

| — | the risk to bees, in the flowering season. |
| --- | --- |

—

the risk to bees, in the flowering season.

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

The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolites OR13 (4) and OR15 (5) in vulnerable zones, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards:

| (1) | the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities which for confidentiality reasons are referred to as impurities 2, 6, 7, 9, 10, 11, 12; |
| --- | --- |

(1)

the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities which for confidentiality reasons are referred to as impurities 2, 6, 7, 9, 10, 11, 12;

| (2) | the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material; |
| --- | --- |

(2)

the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material;

| (3) | the risk assessment for aquatic organisms; |
| --- | --- |

(3)

the risk assessment for aquatic organisms;

| (4) | the relevance of the metabolites OR13 and OR15, and the corresponding groundwater risk assessment, if oryzalin is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’. |
| --- | --- |

(4)

the relevance of the metabolites OR13 and OR15, and the corresponding groundwater risk assessment, if oryzalin is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013. The information set out in point (4) shall be submitted within six month of notification of a decision classifying oryzalin.

328

Tau-fluvalinate

CAS No 102851-06-9

CIPAC No 786

(RS)-α-cyano-3-phenoxybenzyl N-(2-chloro- α,α α- trifluoro-p-tolyl)-D-valinate

(Isomer ratio 1:1)

≥ 920 g/kg

(1:1 ratio of R-α-cyano and S-α-cyano isomers)

Impurities:

Toluene: not more than 5 g/kg

1 June 2011

31 May 2021

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

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 tau-fluvalinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the risk to aquatic organisms and ensure that conditions of use prescribe the application of adequate risk mitigation measures; |
| --- | --- |

—

the risk to aquatic organisms and ensure that conditions of use prescribe the application of adequate risk mitigation measures;

| — | the risk to non-target arthropods and ensure that conditions of use prescribe the application of adequate risk mitigation measures; |
| --- | --- |

—

the risk to non-target arthropods and ensure that conditions of use prescribe the application of adequate risk mitigation measures;

| — | the test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material commercially manufactured. |
| --- | --- |

—

the test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material commercially manufactured.

The Member States concerned shall request the submission of confirmatory information as regards:

| — | the risk of bioaccumulation/biomagnification in the aquatic environment; |
| --- | --- |

—

the risk of bioaccumulation/biomagnification in the aquatic environment;

| — | the risk to non-target arthropods; |
| --- | --- |

—

the risk to non-target arthropods;

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

The Member States concerned shall ensure that the applicant submits confirmatory information, two years after the adoption of specific guidance, as regards:

| — | the possible impact on the environment of the potential enantio-selective degradation in environmental matrices. |
| --- | --- |

—

the possible impact on the environment of the potential enantio-selective degradation in environmental matrices.

329

Clethodim

CAS No 99129-21-2

CIPAC No 508

(5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyloxyimino]propyl}-5-[(2RS)-2-(ethylthio)propyl]-3-hydroxycyclohex-2-en-1-one

≥ 930 g/kg

Impurities:

toluene max. 4 g/kg

1 June 2011

31 May 2021

PART A

Only uses as herbicide on sugar beet may be authorised.

PART B

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 clethodim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection to aquatic organisms, birds and mammals, and shall ensure that conditions of use include the application of adequate risk mitigation measures.

The Member States concerned shall request the submission of confirmatory information, on the basis of most recent scientific knowledge, as regards:

| — | the soil and groundwater exposure assessments, |
| --- | --- |

—

the soil and groundwater exposure assessments,

| — | the residue definition for risk assessment. |
| --- | --- |

—

the residue definition for risk assessment.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

330

Bupirimate

CAS No 41483-43-6

CIPAC No 261

5-butyl-2-ethylamino-6-methylpyrimidine-4-yl dimethylsulfamate

≥ 945 g/kg

Impurities:

| | Ethirimol: max. 2 g/kg |
| --- | --- |

Ethirimol: max. 2 g/kg

| | Toluene: max. 3 g/kg |
| --- | --- |

Toluene: max. 3 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 bupirimate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, |
| --- | --- |

—

the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate,

| — | the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigations, where appropriate, |
| --- | --- |

—

the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigations, where appropriate,

| — | the in-field risk to non-target arthropods. |
| --- | --- |

—

the in-field risk to non-target arthropods.

The Member States concerned shall request the submission of confirmatory information as regards:

| (1) | the specification of the technical material, as commercially manufactured, by appropriate analytical data; including information on the relevance of the impurities, |
| --- | --- |

(1)

the specification of the technical material, as commercially manufactured, by appropriate analytical data; including information on the relevance of the impurities,

| (2) | the equivalence between the specifications of the technical material; as commercially manufactured, and those of the test material used in the toxicity dossiers, |
| --- | --- |

(2)

the equivalence between the specifications of the technical material; as commercially manufactured, and those of the test material used in the toxicity dossiers,

| (3) | the kinetic parameters, the soil degradation and the adsorption and desorption parameter for the major soil metabolite DE-B (6). |
| --- | --- |

(3)

the kinetic parameters, the soil degradation and the adsorption and desorption parameter for the major soil metabolite DE-B (6).

The Member States concerned shall ensure that the applicant submits such confirmatory data and information to the Commission set out in point (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013.

331

Fenbutatin oxide

CAS No 13356-08-6

CIPAC No 359

bis[tris(2-methyl-2-phenylpropyl)-tin]oxide

≥ 970 g/kg

Impurities:

bis[hydroxybis(2-methyl-2-phenylpropyl)tin]oxide (SD 31723): not more than 3 g/kg

1 June 2011

31 May 2021

PART A

Only uses as acaricide in greenhouses may be authorised.

PART B

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 fenbutatin oxide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the technical specification of the impurity content, |
| --- | --- |

—

the technical specification of the impurity content,

| — | the residue levels in small tomato varieties (cherry tomatoes), |
| --- | --- |

—

the residue levels in small tomato varieties (cherry tomatoes),

| — | the operator safety. Conditions of use shall prescribe the application of adequate personal protective equipment, where appropriate; |
| --- | --- |

—

the operator safety. Conditions of use shall prescribe the application of adequate personal protective equipment, where appropriate;

| — | the risk to aquatic organisms. |
| --- | --- |

—

the risk to aquatic organisms.

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

The Member States concerned shall request the submission of information confirming the results of the risk assessment, on the basis of most recent scientific knowledge, as regards the impurity SD 31723. That information shall concern the following points:

| — | genotoxicological potential; |
| --- | --- |

—

genotoxicological potential;

| — | ecotoxicological relevance; |
| --- | --- |

—

ecotoxicological relevance;

| — | spectra, storage stability and methods of analysis in the formulation. |
| --- | --- |

—

spectra, storage stability and methods of analysis in the formulation.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

332

Fenoxycarb

CAS No 79127-80-3

CIPAC No: 425

Ethyl 2-(4-phenoxyphenoxy)ethyl carbamate

≥ 970 g/kg

Impurities:

Toluene: max. 1 g/kg

1 June 2011

31 May 2021

PART A

Only uses as insecticide may be authorised.

PART B

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 fenoxycarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, |
| --- | --- |

—

the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate,

| — | the risk to bees and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| --- | --- |

—

the risk to bees and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of information confirming the risk assessment for non-target arthropods and for bee brood.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.

333

1-decanol

CAS No 112-30-1

CIPAC No 831

Decan-1-ol

≥ 960 g/kg

1 June 2011

31 May 2021

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 1-decanol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the risk to consumers from residues in case of use on food or feed crops; |
| --- | --- |

—

the risk to consumers from residues in case of use on food or feed crops;

| — | the risk for operator and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; |
| --- | --- |

—

the risk for operator and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;

| — | the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

—

the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

| — | the risk to aquatic organisms; |
| --- | --- |

—

the risk to aquatic organisms;

| — | the risk to non-target arthropods and bees that may be exposed to the active substance by visiting flowering weeds present in the crop at time of application. |
| --- | --- |

—

the risk to non-target arthropods and bees that may be exposed to the active substance by visiting flowering weeds present in the crop at time of application.

Risk mitigation measures shall be applied, where appropriate.

The Member States concerned shall request the submission of confirmatory information, as regards the risk to aquatic organisms and of information confirming the groundwater, surface water and sediment exposure assessments.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

334

Isoxaben

CAS No 82558-50-7

CIPAC No 701

N-[3-(1-ethyl-1-methylpropyl)-1,2-oxazol-5-yl]-2,6-dimethoxybenzamide

≥ 910 g/kg

Toluene: ≤ 3 g/kg

1 June 2011

31 May 2021

PART A

Only uses as herbicide may be authorised.

PART B

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 isoxaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, the risk to non-target terrestrial plants and the potential leaching of metabolites to groundwater.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

| (a) | the specification of the technical material, as commercially manufactured, |
| --- | --- |

(a)

the specification of the technical material, as commercially manufactured,

| (b) | the relevance of the impurities; |
| --- | --- |

(b)

the relevance of the impurities;

| (c) | the residues in rotational crops; |
| --- | --- |

(c)

the residues in rotational crops;

| (d) | the potential risk to aquatic organisms. |
| --- | --- |

(d)

the potential risk to aquatic organisms.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a) and (b) by 30 November 2011 and the information set out in points (c) and (d) by 31 May 2013.

335

Fluometuron

CAS No: 2164-17-2

CIPAC No: 159

1,1-dimethyl-3-(α,α,α -trifluoro-m-tolyl)urea

≥ 940 g/kg

1 June 2011

31 May 2021

PART A

Only uses as herbicide on cotton may be authorised.

PART B

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 fluometuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall:

| — | pay particular attention to the protection of the operators and workers and ensure that conditions of use include the application of adequate personal protective equipment; |
| --- | --- |

—

pay particular attention to the protection of the operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;

| — | pay particular attention to the protection of the groundwater where the active substance is applied in regions with vulnerable soil and/or climatic conditions; they shall ensure that conditions of authorisation include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential leaching of fluometuron and soil metabolites desmethyl-fluometuron and trifluoromethylaniline in vulnerable areas, where appropriate; |
| --- | --- |

—

pay particular attention to the protection of the groundwater where the active substance is applied in regions with vulnerable soil and/or climatic conditions; they shall ensure that conditions of authorisation include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential leaching of fluometuron and soil metabolites desmethyl-fluometuron and trifluoromethylaniline in vulnerable areas, where appropriate;

| — | pay particular attention to the risk to non-target soil macro-organisms others than earthworms and non-target plants, and ensure that conditions of authorisation include risk mitigation measures, where appropriate. |
| --- | --- |

—

pay particular attention to the risk to non-target soil macro-organisms others than earthworms and non-target plants, and ensure that conditions of authorisation include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the applicants submit to the Commission confirmatory information as regards:

| (a) | the toxicological properties of the plant metabolite trifluoroacetic acid; |
| --- | --- |

(a)

the toxicological properties of the plant metabolite trifluoroacetic acid;

| (b) | the analytical methods for the monitoring of fluometuron in air; |
| --- | --- |

(b)

the analytical methods for the monitoring of fluometuron in air;

| (c) | the analytical methods for the monitoring of the soil metabolite trifluoromethylaniline in soil and water; |
| --- | --- |

(c)

the analytical methods for the monitoring of the soil metabolite trifluoromethylaniline in soil and water;

| (d) | the relevance for ground water of the soil metabolites desmethyl-fluometuron and trifluoromethylaniline, if fluometuron is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’. |
| --- | --- |

(d)

the relevance for ground water of the soil metabolites desmethyl-fluometuron and trifluoromethylaniline, if fluometuron is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’.

The Member States concerned shall ensure that the applicants submit to the Commission the information set out in points (a), (b) and (c) by 31 March 2013 and the information set out in point (d) within six months from the notification of the decision classifying fluometuron.

336

Carbetamide

CAS No 16118-49-3

CIPAC No 95

(R)-1-(Ethylcarbamoyl)ethyl carbanilate

≥ 950 g/kg

1 June 2011

31 May 2021

PART A

Only uses as herbicide may be authorised.

PART B

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 carbetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| (a) | the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

(a)

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

| (b) | the risk to non-target plants; |
| --- | --- |

(b)

the risk to non-target plants;

| (c) | the risk to aquatic organisms. |
| --- | --- |

(c)

the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

337

Carboxin

CAS No 5234-68-4

CIPAC No 273

5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide

≥ 970 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide for seed treatment may be authorised.

Member States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.

PART B

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 carboxin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the risk to operators; |
| --- | --- |

—

the risk to operators;

| — | the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

—

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

| — | the risk to birds and mammals. |
| --- | --- |

—

the risk to birds and mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

| (a) | the specification of the technical material, as commercially manufactured, -including appropriate analytical data-; |
| --- | --- |

(a)

the specification of the technical material, as commercially manufactured, -including appropriate analytical data-;

| (b) | the relevance of the impurities; |
| --- | --- |

(b)

the relevance of the impurities;

| (c) | comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material; |
| --- | --- |

(c)

comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;

| (d) | analytical methods for the monitoring of the metabolite M6 (7) in soil, groundwater and surface water and for the monitoring of metabolite M9 (8) in groundwater; |
| --- | --- |

(d)

analytical methods for the monitoring of the metabolite M6 (7) in soil, groundwater and surface water and for the monitoring of metabolite M9 (8) in groundwater;

| (e) | additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 (9) and P/V-55 (10), |
| --- | --- |

(e)

additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 (9) and P/V-55 (10),

| (f) | rotational crop metabolism, |
| --- | --- |

(f)

rotational crop metabolism,

| (g) | the long-term risk to granivorous birds, granivorous mammals and herbivorous mammals; |
| --- | --- |

(g)

the long-term risk to granivorous birds, granivorous mammals and herbivorous mammals;

| (h) | the relevance for ground water of the soil metabolites P/V-54 (11), P/V-55 (12) and M9 (13) if carboxin is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’. |
| --- | --- |

(h)

the relevance for ground water of the soil metabolites P/V-54 (11), P/V-55 (12) and M9 (13) if carboxin is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a), (b) and (c) by 30 November 2011, the information set out in points (d), (e), (f) and (g) by 31 May 2013 and the information set out in point (h) six months after the notification of decision classifying carboxin.

338

Cyproconazole

CAS No 94361-06-5

CIPAC No 600

(2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

≥ 940 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 cyproconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs); |
| --- | --- |

—

the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);

| — | the risk to aquatic organisms. |
| --- | --- |

—

the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

| (a) | the toxicological relevance of the impurities in the technical specification; |
| --- | --- |

(a)

the toxicological relevance of the impurities in the technical specification;

| (b) | analytical methods for the monitoring of cyproconazole in soil, body fluids and tissues; |
| --- | --- |

(b)

analytical methods for the monitoring of cyproconazole in soil, body fluids and tissues;

| (c) | residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; |
| --- | --- |

(c)

residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

| (d) | the long term risk to herbivorous mammals; |
| --- | --- |

(d)

the long term risk to herbivorous mammals;

| (e) | the possible environmental impact of the preferential degradation and/or conversion of the mixture of isomers. |
| --- | --- |

(e)

the possible environmental impact of the preferential degradation and/or conversion of the mixture of isomers.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 30 November 2011, the information set out in points (b), (c) and (d) by 31 May 2013 and the information set out in point (e) two years after the adoption of specific guidance.

339

Dazomet

CAS No 533-74-4

CIPAC No 146

| | 3,5-dimethyl-1,3,5-thiadiazinane-2-thione
  or |
| --- | --- |

3,5-dimethyl-1,3,5-thiadiazinane-2-thione

or

| | tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione |
| --- | --- |

tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione

≥ 950 g/kg

1 June 2011

31 May 2021

PART A

Only uses as nematicide, fungicide, herbicide and insecticide may be authorised. Only application as soil fumigant may be authorised. Use shall be limited to one application every third year.

PART B

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 dazomet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the risk to operators, workers and bystanders; |
| --- | --- |

—

the risk to operators, workers and bystanders;

| — | the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

—

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

| — | the risk to aquatic organisms. |
| --- | --- |

—

the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

| (a) | the potential groundwater contamination by methyl isothiocyanate; |
| --- | --- |

(a)

the potential groundwater contamination by methyl isothiocyanate;

| (b) | the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks; |
| --- | --- |

(b)

the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks;

| (c) | the acute risk to insectivorous birds; |
| --- | --- |

(c)

the acute risk to insectivorous birds;

| (d) | the long term risk to birds and mammals. |
| --- | --- |

(d)

the long term risk to birds and mammals.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013.

340

Metaldehyde

CAS No 108-62-3 (tetramer)

9002-91-9 (homopolymer)

CIPAC No 62

r-2, c-4, c-6, c-8-tetramethyl-1,3,5,7- tetroxocane

≥ 985 g/kg

acetaldehyde max. 1,5 g/kg

1 June 2011

31 May 2021

PART A

Only uses as molluscicide may be authorised.

PART B

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 metaldehyde, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the risk to operators and workers; |
| --- | --- |

—

the risk to operators and workers;

| — | the dietary exposure situation of consumers in view of future revisions of maximum residue levels; |
| --- | --- |

—

the dietary exposure situation of consumers in view of future revisions of maximum residue levels;

| — | the acute risk and long term risk to birds and mammals. |
| --- | --- |

—

the acute risk and long term risk to birds and mammals.

Member States shall ensure that authorisations shall contain an effective dog repellent agent.

Conditions of use shall include risk mitigation measures, where appropriate.

341

Sintofen

CAS No 130561-48-7

CIPAC No 717

1-(4-chlorophenyl)-1,4-dihydro-5-(2-methoxyethoxy)-4-oxocinnoline-3-carboxylic acid

≥ 980 g/kg

Impurities:

| | 2-methoxyethanol, not more than 0,25 g/kg |
| --- | --- |

2-methoxyethanol, not more than 0,25 g/kg

| | N,N-dimethylformamide, not more than 1,5 g/kg |
| --- | --- |

N,N-dimethylformamide, not more than 1,5 g/kg

1 June 2011

31 May 2021

PART A

Only uses as a plant growth regulator on wheat for hybrid seed production not intended for human consumption may be authorised.

PART B

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 sintofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate risk mitigation measures. They shall ensure that wheat treated with sintofen does not enter the food and feed chain.

The Member States concerned shall request the submission of confirmatory information as regards:

| (1) | the specification of the technical material, as commercially manufactured, supported by appropriate analytical data; |
| --- | --- |

(1)

the specification of the technical material, as commercially manufactured, supported by appropriate analytical data;

| (2) | the relevance of the impurities present in the technical specifications, except of the impurities 2-methoxyethanol and N,N-dimethylformamide; |
| --- | --- |

(2)

the relevance of the impurities present in the technical specifications, except of the impurities 2-methoxyethanol and N,N-dimethylformamide;

| (3) | the relevance of the test material used in the toxicity and ecotoxicity dossiers in view of the specification of the technical material; |
| --- | --- |

(3)

the relevance of the test material used in the toxicity and ecotoxicity dossiers in view of the specification of the technical material;

| (4) | the metabolic profile of sintofen in rotational crops. |
| --- | --- |

(4)

the metabolic profile of sintofen in rotational crops.

The Member States concerned shall ensure that the applicant submits to the Commission: the information set out in points (1) (2) and (3) by 30 November 2011 and the information set out in point (4) by 31 May 2013.

342

Fenazaquin

CAS No 120928-09-8

CIPAC No 693

4-tert-butylphenethyl quinazolin-4-yl ether

≥ 975 g/kg

1 June 2011

31 May 2021

PART A

Only uses as acaricide on ornamentals in greenhouses may be authorised.

PART B

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 fenazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall:

| — | pay particular attention to the protection of aquatic organisms; |
| --- | --- |

—

pay particular attention to the protection of aquatic organisms;

| — | pay particular attention to the risk to operators and ensure that conditions of use include the application of adequate personal protective equipment; |
| --- | --- |

—

pay particular attention to the risk to operators and ensure that conditions of use include the application of adequate personal protective equipment;

| — | pay particular attention to the protection of bees and ensure that conditions of use include risk mitigation measures, where appropriate; |
| --- | --- |

—

pay particular attention to the protection of bees and ensure that conditions of use include risk mitigation measures, where appropriate;

| — | provide for conditions of use which ensure that there are no residues of fenazaquin in crops for human and animal consumption. |
| --- | --- |

—

provide for conditions of use which ensure that there are no residues of fenazaquin in crops for human and animal consumption.

343

Azadirachtin

CAS No 11141-17-6 (azadirachtin A)

CIPAC No 627 (azadirachtin A)

Azadirachtin A:

dimethyl (2aR,3S,4S,4aR,5S,7aS,8S,10R,10aS,10bR)-10-acetoxy-3,5-dihydroxy-4-[(1aR,2S,3aS,6aS,7S,7aS)-6a-hydroxy-7a-methyl-3a,6a,7,7a-tetrahydro-2,7-methanofuro[2,3-b]oxireno[e]oxepin-1a(2H)-yl]-4-methyl-8-{[(2E)-2-methylbut-2-enoyl]oxy}octahydro-1H-naphtho[1,8a-c:4,5-b′c′]difuran-5,10a(8H)-dicarboxylate.

Expressed as azadirachtin A:

≥ 111 g/kg

Sum of the aflatoxins B1, B2, G1, G2 must not exceeding 300 μg/kg of the azadirachtin A content.

1 June 2011

31 May 2021

PART A

Only uses as insecticide may be authorised.

PART B

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 azadirachtin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; |
| --- | --- |

—

the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

| — | the protection of non target arthropods and aquatic organisms. Risk mitigation measures shall be applied where appropriate. |
| --- | --- |

—

the protection of non target arthropods and aquatic organisms. Risk mitigation measures shall be applied where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

| — | the relationship between azadirachtin A and the rest of the active components in the neem seeds extract with respect to amount, biological activity and persistence, in order to confirm the lead active compound approach with regard to azadirachtin A and to confirm specification of the technical material, residue definition and groundwater risk assessment. |
| --- | --- |

—

the relationship between azadirachtin A and the rest of the active components in the neem seeds extract with respect to amount, biological activity and persistence, in order to confirm the lead active compound approach with regard to azadirachtin A and to confirm specification of the technical material, residue definition and groundwater risk assessment.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 December 2013.

344

Diclofop

| | CAS No 40843-25-2 (parent) |
| --- | --- |

CAS No 40843-25-2 (parent)

| | CAS No 257-141-8 (diclofop-methyl) |
| --- | --- |

CAS No 257-141-8 (diclofop-methyl)

| | CIPAC No 358 (parent) |
| --- | --- |

CIPAC No 358 (parent)

| | CIPAC No 358.201 (diclofop-methyl) |
| --- | --- |

CIPAC No 358.201 (diclofop-methyl)

| | Diclofop
  (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionic acid |
| --- | --- |

Diclofop

(RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionic acid

| | Diclofop-methyl
  methyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate |
| --- | --- |

Diclofop-methyl

methyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate

≥ 980 g/kg (expressed as diclofop-methyl)

1 June 2011

31 May 2021

PART A

Only uses as herbicide may be authorised.

PART B

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 diclofop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall:

| — | pay particular attention to the operators and workers safety and include as a condition for authorisation the application of adequate personal protective equipment; |
| --- | --- |

—

pay particular attention to the operators and workers safety and include as a condition for authorisation the application of adequate personal protective equipment;

| — | pay particular attention to the risk to aquatic organisms and non target plants and require risk mitigation measures to be applied. |
| --- | --- |

—

pay particular attention to the risk to aquatic organisms and non target plants and require risk mitigation measures to be applied.

The Member States concerned shall request the submission of confirmatory information as regards:

| (a) | a metabolism study on cereals; |
| --- | --- |

(a)

a metabolism study on cereals;

| (b) | an update of the risk assessment concerning the possible environmental impact of the preferential degradation/conversion of the isomers. |
| --- | --- |

(b)

an update of the risk assessment concerning the possible environmental impact of the preferential degradation/conversion of the isomers.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 31 May 2013 and the information set out in point (b) at latest two years after the adoption of a specific guidance document on evaluation of isomers mixtures.

345

Lime sulphur

CAS No 1344 - 81 - 6

CIPAC No 17

Calcium polysulfide

≥ 290 g/Kg.

1 June 2011

31 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 lime sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | operator safety and shall ensure that the conditions of authorisation include appropriate protective measures; |
| --- | --- |

—

operator safety and shall ensure that the conditions of authorisation include appropriate protective measures;

| — | to the protection of aquatic organisms and non target arthropods and shall ensure that the conditions of use include risk mitigation measures as appropriate. |
| --- | --- |

—

to the protection of aquatic organisms and non target arthropods and shall ensure that the conditions of use include risk mitigation measures as appropriate.

346

Aluminium sulfate

CAS No 10043-01-3

CIPAC not available

Aluminium sulfate

970  g/kg

1 June 2011

31 May 2021

PART A

Only indoor uses as post-harvest bactericide for ornamental plants may be authorised.

PART B

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 aluminium sulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

The Member States concerned shall request the submission of confirmatory information as regards the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 30 November 2011.

347

Bromadiolone

CAS No 28772-56-7

CIPAC No 371

3-[(1RS,3RS;1RS,3SR)-3-(4′-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxycoumarin

≥ 970 g/kg

1 June 2011

31 May 2021

PART A

Only uses as rodenticide in the form of pre-prepared baits placed into the rodent tunnels may be authorised.

The nominal concentration of the active substance in the plant protection products shall not exceed 50 mg/kg.

Authorisations shall be granted for uses by professional users only.

PART B

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 bromadiolone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall:

| — | pay particular attention to the risk to professional operators and ensure that conditions of use include the application of adequate personal protective equipment where appropriate; |
| --- | --- |

—

pay particular attention to the risk to professional operators and ensure that conditions of use include the application of adequate personal protective equipment where appropriate;

| — | pay particular attention to the risk to birds and non-target mammals from primary and secondary poisoning. |
| --- | --- |

—

pay particular attention to the risk to birds and non-target mammals from primary and secondary poisoning.

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

The Member States concerned shall request the submission of confirmatory information as regards:

| (a) | the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data; |
| --- | --- |

(a)

the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data;

| (b) | the relevance of the impurities; |
| --- | --- |

(b)

the relevance of the impurities;

| (c) | the determination of bromadiolone in water with a limit of quantification of 0,01 μg/l; |
| --- | --- |

(c)

the determination of bromadiolone in water with a limit of quantification of 0,01 μg/l;

| (d) | the effectiveness of proposed mitigation measures to reduce risk to birds and non-target mammals; |
| --- | --- |

(d)

the effectiveness of proposed mitigation measures to reduce risk to birds and non-target mammals;

| (e) | the groundwater exposure assessment in respect of metabolites. |
| --- | --- |

(e)

the groundwater exposure assessment in respect of metabolites.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 30 November 2011 and the information set out in points (d) and (e) by 31 May 2013.

348

Paclobutrazol

CAS No 76738-62-0

CIPAC No 445

(2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol

≥ 930 g/kg

1 June 2011

31 May 2021

PART A

Only uses as plant growth regulator may be authorised.

PART B

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 paclobutrazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to aquatic plants and ensure that conditions of use include the risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

| (1) | the specification of the technical material, as commercially manufactured; |
| --- | --- |

(1)

the specification of the technical material, as commercially manufactured;

| (2) | the analytical methods in soil and surface water for the metabolite NOA457654; |
| --- | --- |

(2)

the analytical methods in soil and surface water for the metabolite NOA457654;

| (3) | the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; |
| --- | --- |

(3)

the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

| (4) | the potential endocrine disrupting properties of paclobutrazol; |
| --- | --- |

(4)

the potential endocrine disrupting properties of paclobutrazol;

| (5) | the potential adverse effects of breakdown products of the different optical structures of paclobutrazol and its metabolite CGA 149907 on the environmental compartments soil, water and air. |
| --- | --- |

(5)

the potential adverse effects of breakdown products of the different optical structures of paclobutrazol and its metabolite CGA 149907 on the environmental compartments soil, water and air.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011, the information set out in points (3) by 31 May 2013, the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption and the information set out in point (5) within two years after the adoption of specific guidance.

349

Pencycuron

CAS No 66063-05-6

CIPAC No 402

1-(4-chlorobenzyl)-1-cyclopentyl-3-phenylurea

≥ 980 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 pencycuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of large omnivorous mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

| (1) | the fate and behaviour in soil of the chlorophenyl and cyclopentyl portions of pencycuron; |
| --- | --- |

(1)

the fate and behaviour in soil of the chlorophenyl and cyclopentyl portions of pencycuron;

| (2) | the fate and behaviour in natural surface water and sediment systems of the chlorophenyl and phenyl portions of pencycuron; |
| --- | --- |

(2)

the fate and behaviour in natural surface water and sediment systems of the chlorophenyl and phenyl portions of pencycuron;

| (3) | the long-term risk to large omnivorous mammals. |
| --- | --- |

(3)

the long-term risk to large omnivorous mammals.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1), (2) and (3) by 31 May 2013.

350

Tebufenozide

CAS No 112410-23-8

CIPAC No 724

N-tert-butyl-N′-(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide

≥ 970 g/kg

Relevant impurity

t-butyl hydrazine < 0,001 g/kg

1 June 2011

31 May 2021

PART A

Only uses as insecticide may be authorised.

PART B

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 tebufenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall:

| — | pay particular attention to the safety of operators and workers after re-entry and ensure that conditions of authorisation prescribe appropriate protective equipment; |
| --- | --- |

—

pay particular attention to the safety of operators and workers after re-entry and ensure that conditions of authorisation prescribe appropriate protective equipment;

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

—

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

| — | pay particular attention to the protection of aquatic organism and ensure that conditions of use prescribe adequate mitigation measures; |
| --- | --- |

—

pay particular attention to the protection of aquatic organism and ensure that conditions of use prescribe adequate mitigation measures;

| — | pay particular attention to the risk to Lepidoptera non-target insects. |
| --- | --- |

—

pay particular attention to the risk to Lepidoptera non-target insects.

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

The Member States concerned shall request the submission of confirmatory information, as regards:

| (1) | the relevance of metabolites RH-6595, RH-2651, M2; |
| --- | --- |

(1)

the relevance of metabolites RH-6595, RH-2651, M2;

| (2) | the degradation of tebufenozide in anaerobic soils and soils of alkaline pH. |
| --- | --- |

(2)

the degradation of tebufenozide in anaerobic soils and soils of alkaline pH.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 31 May 2013.

351

Dithianon

CAS No 3347-22-6

CIPAC No 153

5,10-dihydro-5,10-dioxonaphtho[2,3-b]-1,4-dithiine-2,3-dicarbonitrile

≥ 930 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 dithianon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall:

| — | pay particular attention to the protection of aquatic organisms; conditions of use shall include risk mitigation measures, where appropriate, |
| --- | --- |

—

pay particular attention to the protection of aquatic organisms; conditions of use shall include risk mitigation measures, where appropriate,

| — | pay particular attention to the operator safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate, |
| --- | --- |

—

pay particular attention to the operator safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate,

| — | pay particular attention to the long-term risks to birds; conditions of use shall include risk mitigation measures, where appropriate. |
| --- | --- |

—

pay particular attention to the long-term risks to birds; conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

| — | the storage stability and the nature of residues in processed products, |
| --- | --- |

—

the storage stability and the nature of residues in processed products,

| — | the aquatic and groundwater exposure assessment for phthalic acid, |
| --- | --- |

—

the aquatic and groundwater exposure assessment for phthalic acid,

| — | the risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol. |
| --- | --- |

—

the risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.

352

Hexythiazox

CAS No 78587-05-0

CIPAC No 439

(4RS,5RS)-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide

≥ 976 g/kg

(1:1 mixture of (4R, 5R) and (4S, 5S))

1 June 2011

31 May 2021

PART A

Only uses as acaricide may be authorised.

PART B

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 hexythiazox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate; |
| --- | --- |

—

the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate;

| — | the operators and workers safety. Conditions of use shall include protective measures, where appropriate. |
| --- | --- |

—

the operators and workers safety. Conditions of use shall include protective measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

| (a) | the toxicological relevance of the metabolite PT-1-3 (14); |
| --- | --- |

(a)

the toxicological relevance of the metabolite PT-1-3 (14);

| (b) | the potential occurrence of the metabolite PT-1-3 in processed commodities; |
| --- | --- |

(b)

the potential occurrence of the metabolite PT-1-3 in processed commodities;

| (c) | the potential adverse effects of hexythiazox on bee brood; |
| --- | --- |

(c)

the potential adverse effects of hexythiazox on bee brood;

| (d) | the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment. |
| --- | --- |

(d)

the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) two years after the adoption of specific guidance.

353

Flutriafol

CAS No 76674-21-0

CIPAC No 436

(RS)-2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol

≥ 920 g/kg

(racemate)

Relevant impurities:

| | dimethyl sulphate: max content 0,1 g/kg |
| --- | --- |

dimethyl sulphate: max content 0,1 g/kg

| | dimethylformamide: max content 1 g/kg |
| --- | --- |

dimethylformamide: max content 1 g/kg

| | methanol: max content 1 g/kg |
| --- | --- |

methanol: max content 1 g/kg

1 June 2011

31 May 2021

PART A

Only uses as fungicide may be authorised.

PART B

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 flutriafol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall:

| — | pay particular attention to the protection of the workers’ safety and ensure that conditions of use include the application of adequate personal protective equipment; |
| --- | --- |

—

pay particular attention to the protection of the workers’ safety and ensure that conditions of use include the application of adequate personal protective equipment;

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

—

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

| — | pay particular attention to the long-term risk to insectivorous birds. |
| --- | --- |

—

pay particular attention to the long-term risk to insectivorous birds.

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

The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:

| (a) | the relevance of the impurities present in the technical specifications; |
| --- | --- |

(a)

the relevance of the impurities present in the technical specifications;

| (b) | the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; |
| --- | --- |

(b)

the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

| (c) | the long-term risk to insectivorous birds. |
| --- | --- |

(c)

the long-term risk to insectivorous birds.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 30 November 2011, the information set out in points (b) and (c) by 31 May 2013.

---

(1)  Further details on identity and specification of active substances are provided in their review reports.

(2)  Suspended by order of the General Court of 19 July 2007 in case T-31/07 R, Du Pont de Nemours (France) SAS and others v Commission, [2007] ECR II-2767.

(3)  
  OJ L 353, 31.12.2008, p. 1.

(4)  2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide.

(5)  2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide.

(6)  De-ethyl-bupirimate.

(7)  2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.

(8)  (2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.

(9)  2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.

(10)  2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.

(11)  2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.

(12)  2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.

(13)  (2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.

(14)  (4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.

---

| 11.6.2011 | EN | Official Journal of the European Union | L 153/187 |
| --- | --- | --- | --- |

11.6.2011

EN

Official Journal of the European Union

L 153/187

---

COMMISSION IMPLEMENTING REGULATION (EU) No 541/2011

of 1 June 2011

amending Implementing Regulation (EU) No 540/2011 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(2) thereof,

Whereas:

| (1) | It is appropriate to list active substances deemed to be approved under Regulation (EC) No 1107/2009 and active substances approved under that Regulation in separate Parts of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2). |
| --- | --- |

(1)

It is appropriate to list active substances deemed to be approved under Regulation (EC) No 1107/2009 and active substances approved under that Regulation in separate Parts of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2).

| (2) | Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(2)

Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (3) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EU) No 540/2011 is amended as follows:

| (1) | Article 1 is replaced by the following:

  ‘Article 1
  The active substances, as set out in Part A of the Annex, shall be deemed to have been approved under Regulation (EC) No 1107/2009.
  The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex.’ |
| --- | --- |

(1)

Article 1 is replaced by the following:

‘Article 1

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

The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex.’

| (2) | The Annex to Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation. |
| --- | --- |

(2)

The Annex to Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

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, 1 June 2011.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  See page 1 of this Official Journal.

2

---

ANNEX

The Annex to Regulation (EU) No 540/2011 is amended as follows:

| (1) | In the title of the Annex the words ‘ACTIVE SUBSTANCES APPROVED FOR USE IN PLANT PROTECTION PRODUCTS’ are replaced by the following:

  ‘PART A

  Active substances deemed to have been approved under Regulation (EC) No 1107/2009
  ’ |
| --- | --- |

(1)

In the title of the Annex the words ‘ACTIVE SUBSTANCES APPROVED FOR USE IN PLANT PROTECTION PRODUCTS’ are replaced by the following:

‘PART A

Active substances deemed to have been approved under Regulation (EC) No 1107/2009
  ’

| (2) | The words ‘General provisions applying to all substances listed in this Annex:’ are replaced by ‘General provisions applying to all substances listed in this Part:’ |
| --- | --- |

(2)

The words ‘General provisions applying to all substances listed in this Annex:’ are replaced by ‘General provisions applying to all substances listed in this Part:’

| (3) | The following Part B is added:

  ‘PART B

  Active substances approved under Regulation (EC) No 1107/2009

  General provisions applying to all substances listed in this Part:






  — | 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; |
| --- | --- | --- |

(3)

The following Part B is added:

‘PART B

Active substances approved under Regulation (EC) No 1107/2009

General provisions applying to all substances listed in this Part:

—

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. |
| --- | --- |

—

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 |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | | | |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (*1)

Date of approval

Expiration of approval

Specific provisions

---

(*1)  Further details on identity and specification of active substance are provided in the review report.’

---

| 11.6.2011 | EN | Official Journal of the European Union | L 153/189 |
| --- | --- | --- | --- |

11.6.2011

EN

Official Journal of the European Union

L 153/189

---

COMMISSION IMPLEMENTING REGULATION (EU) No 542/2011

of 1 June 2011

amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances to take into account Directive 2011/58/EU amending Council Directive 91/414/EEC to renew the inclusion of carbendazim as active substance

(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) | Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) contains the list of active substances included in Annex I to Council Directive 91/414/EEC (3). |
| --- | --- |

(1)

Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) contains the list of active substances included in Annex I to Council Directive 91/414/EEC (3).

| (2) | Annex I to Directive 91/414/EEC has been amended by Commission Directive 2011/58/EU (4). |
| --- | --- |

(2)

Annex I to Directive 91/414/EEC has been amended by Commission Directive 2011/58/EU (4).

| (3) | Regulation (EU) No 540/2011 should therefore be amended accordingly, |
| --- | --- |

(3)

Regulation (EU) No 540/2011 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

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, 1 June 2011.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  See page 1 of this Official Journal.

2

(3)  
  OJ L 230, 19.8.1991, p. 1.

3

(4)  
  OJ L 122, 11.5.2011, p. 71.

4

---

ANNEX

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 144 is replaced by the following:

| Number | Common Name, identification numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘144 | Carbendazim
  CAS No 10605-21-7
  CIPAC No 263 | Methyl benzimidazol-2-ylcarbamate | ≥ 980 g/kg
  Relevant impurities | 2-amino-3-hydroxyphenazine (AHP): not more than 0,0005 g/kg |

Number

Common Name, identification numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘144

Carbendazim

CAS No 10605-21-7

CIPAC No 263

Methyl benzimidazol-2-ylcarbamate

≥ 980 g/kg

Relevant impurities

2-amino-3-hydroxyphenazine (AHP): not more than 0,0005 g/kg

| | 2,3-diaminophenazine (DAP): not more than 0,003 g/kg |
| --- | --- |

2,3-diaminophenazine (DAP): not more than 0,003 g/kg

1 June 2011

30 November 2014

PART A

Only uses as fungicide on the following crops may be authorised:

| — | cereals |
| --- | --- |

—

cereals

| — | rape seed |
| --- | --- |

—

rape seed

| — | sugar and fodder beet |
| --- | --- |

—

sugar and fodder beet

| — | maize |
| --- | --- |

—

maize

at rates not exceeding

| — | 0,25 kg active substance per hectare per application for cereals and rape seed; |
| --- | --- |

—

0,25 kg active substance per hectare per application for cereals and rape seed;

| — | 0,075 kg active substance per hectare per application for sugar and fodder beet |
| --- | --- |

—

0,075 kg active substance per hectare per application for sugar and fodder beet

| — | 0,1 kg active substance per hectare per application for maize. |
| --- | --- |

—

0,1 kg active substance per hectare per application for maize.

The following uses must not be authorised:

| — | air application; |
| --- | --- |

—

air application;

| — | knapsack and handheld applications neither by amateur nor by professional users; |
| --- | --- |

—

knapsack and handheld applications neither by amateur nor by professional users;

| — | home gardening. |
| --- | --- |

—

home gardening.

Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

| — | aquatic organisms. Appropriate drift mitigation measures must be applied to minimise the exposure of surface water bodies. This should include keeping a distance between treated areas and surface water bodies alone or in combination with the use of drift-reducing techniques or devices; |
| --- | --- |

—

aquatic organisms. Appropriate drift mitigation measures must be applied to minimise the exposure of surface water bodies. This should include keeping a distance between treated areas and surface water bodies alone or in combination with the use of drift-reducing techniques or devices;

| — | earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, and, if necessary, the degree of concentration of the active substance; |
| --- | --- |

—

earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, and, if necessary, the degree of concentration of the active substance;

| — | birds (long term risk). Depending on the results of the risk assessment for specific uses, targeted mitigation measures to minimise the exposure may become necessary; |
| --- | --- |

—

birds (long term risk). Depending on the results of the risk assessment for specific uses, targeted mitigation measures to minimise the exposure may become necessary;

| — | operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. |
| --- | --- |

—

operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

PART B

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 carbendazim, and in particular Appendices I and II thereof, shall be taken into account.

The Member States concerned shall request that the applicant provides the following to the Commission:

| — | by 1 December 2011 at the latest, information as regards the toxicological and ecotoxicological relevance of the impurity AEF037197; |
| --- | --- |

—

by 1 December 2011 at the latest, information as regards the toxicological and ecotoxicological relevance of the impurity AEF037197;

| — | by 1 June 2012 at the latest, the examination of the studies included in the list in the draft re-assessment report of 16 July 2009 (Volume 1, Level 4 “Further information”, pp. 155 – 157); |
| --- | --- |

—

by 1 June 2012 at the latest, the examination of the studies included in the list in the draft re-assessment report of 16 July 2009 (Volume 1, Level 4 “Further information”, pp. 155 – 157);

| — | by 1 June 2013 at the latest, information on the fate and behaviour (route of aerobic degradation in soil) and the long term risk to birds.’ |
| --- | --- |

—

by 1 June 2013 at the latest, information on the fate and behaviour (route of aerobic degradation in soil) and the long term risk to birds.’

---

(1)  Further details on identity and specification of active substance are provided in the review report.

1

---

DECISIONS

| 11.6.2011 | EN | Official Journal of the European Union | L 153/192 |
| --- | --- | --- | --- |

11.6.2011

EN

Official Journal of the European Union

L 153/192

---

COMMISSION IMPLEMENTING DECISION

of 1 June 2011

concerning the non-inclusion of flurprimidol in Annex I to Council Directive 91/414/EEC

(notified under document C(2011) 3733)

(Text with EEA relevance)

(2011/328/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,

Whereas:

| (1) | Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included flurprimidol. |
| --- | --- |

(1)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included flurprimidol.

| (2) | In accordance with Article 11f of Regulation (EC) No 1490/2002 and Article 12(1)(a) and Article 12(2)(b) of that Regulation, Commission Decision 2009/28/EC of 13 January 2009 concerning the non-inclusion of flurprimidol in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (4) was adopted. |
| --- | --- |

(2)

In accordance with Article 11f of Regulation (EC) No 1490/2002 and Article 12(1)(a) and Article 12(2)(b) of that Regulation, Commission Decision 2009/28/EC of 13 January 2009 concerning the non-inclusion of flurprimidol in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (4) was adopted.

| (3) | The original notifier (hereinafter ‘the applicant’) submitted a new application pursuant to Article 6(2) of Directive 91/414/EEC requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5). |
| --- | --- |

(3)

The original notifier (hereinafter ‘the applicant’) submitted a new application pursuant to Article 6(2) of Directive 91/414/EEC requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

| (4) | The application was submitted to Finland, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2009/28/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008. |
| --- | --- |

(4)

The application was submitted to Finland, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2009/28/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

| (5) | Finland evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 10 March 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on flurprimidol to the Commission on 16 December 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and the Animal Health and finalised on 5 May 2011 in the format of the Commission review report for flurprimidol. |
| --- | --- |

(5)

Finland evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 10 March 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on flurprimidol to the Commission on 16 December 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and the Animal Health and finalised on 5 May 2011 in the format of the Commission review report for flurprimidol.

| (6) | The additional report by the rapporteur Member State and the conclusion by the Authority concentrate on the concerns that lead to the non-inclusion. Those concerns were the risk to operators and workers in all evaluated scenarios and conditions of use, because the exposure was greater than 100 % of the acceptable operator exposure level (AOEL), and the lack of data on the impurity profile of batches used in toxicological studies. |
| --- | --- |

(6)

The additional report by the rapporteur Member State and the conclusion by the Authority concentrate on the concerns that lead to the non-inclusion. Those concerns were the risk to operators and workers in all evaluated scenarios and conditions of use, because the exposure was greater than 100 % of the acceptable operator exposure level (AOEL), and the lack of data on the impurity profile of batches used in toxicological studies.

| (7) | Additional information was submitted by the applicant, in particular as regards new calculations for the operator and worker exposure risk assessment. Furthermore, in order to reduce the risk to the environment, the applicant has limited its support to uses restricted to high technology glasshouse production systems with irrigation/excess water management systems that guarantee no release of contaminated water to the environment. |
| --- | --- |

(7)

Additional information was submitted by the applicant, in particular as regards new calculations for the operator and worker exposure risk assessment. Furthermore, in order to reduce the risk to the environment, the applicant has limited its support to uses restricted to high technology glasshouse production systems with irrigation/excess water management systems that guarantee no release of contaminated water to the environment.

| (8) | However, the additional information provided by the applicant did not permit to eliminate all of the specific concerns arising in respect of flurprimidol. |
| --- | --- |

(8)

However, the additional information provided by the applicant did not permit to eliminate all of the specific concerns arising in respect of flurprimidol.

| (9) | In particular, based on the information available and calculated on the basis of the uses supported by the applicant, estimated worker exposure still exceeds the AOEL, irrespective of the use of personal protective equipment. The environmental data package was not sufficient to perform an environmental risk assessment for realistic scenarios and conditions of use. The described greenhouse uses, for which exposure would be acceptable, do not reflect normal greenhouse practice and therefore cannot be considered to be representative. |
| --- | --- |

(9)

In particular, based on the information available and calculated on the basis of the uses supported by the applicant, estimated worker exposure still exceeds the AOEL, irrespective of the use of personal protective equipment. The environmental data package was not sufficient to perform an environmental risk assessment for realistic scenarios and conditions of use. The described greenhouse uses, for which exposure would be acceptable, do not reflect normal greenhouse practice and therefore cannot be considered to be representative.

| (10) | The Commission invited the applicant to submit its comments on the conclusion by the Authority. Furthermore, in accordance with Article 21(1) to Regulation (EC) No 33/2008, the Commission invited the applicant to submit comments on the draft review report. The applicant submitted its comments, which have been carefully examined. |
| --- | --- |

(10)

The Commission invited the applicant to submit its comments on the conclusion by the Authority. Furthermore, in accordance with Article 21(1) to Regulation (EC) No 33/2008, the Commission invited the applicant to submit comments on the draft review report. The applicant submitted its comments, which have been carefully examined.

| (11) | However, despite the arguments put forward by the applicant, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted and evaluated during the expert meetings of the Authority have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing flurprimidol satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. |
| --- | --- |

(11)

However, despite the arguments put forward by the applicant, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted and evaluated during the expert meetings of the Authority have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing flurprimidol satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

| (12) | Flurprimidol should therefore not be included in Annex I to Directive 91/414/EEC. |
| --- | --- |

(12)

Flurprimidol should therefore not be included in Annex I to Directive 91/414/EEC.

| (13) | Decision 2009/28/EC should be repealed. |
| --- | --- |

(13)

Decision 2009/28/EC should be repealed.

| (14) | This Decision does not prejudice the submission of a further application for flurprimidol pursuant to Article 6(2) of Directive 91/414/EEC and Chapter II of Regulation (EC) No 33/2008. |
| --- | --- |

(14)

This Decision does not prejudice the submission of a further application for flurprimidol pursuant to Article 6(2) of Directive 91/414/EEC and Chapter II of Regulation (EC) No 33/2008.

| (15) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(15)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Flurprimidol shall not be included as active substance in Annex I to Directive 91/414/EEC.

Article 2

Decision 2009/28/EC is repealed.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 1 June 2011.

For the Commission

John DALLI

Member of the Commission

---

(1)  
  OJ L 230, 19.8.1991, p. 1.

1

(2)  
  OJ L 55, 29.2.2000, p. 25.

2

(3)  
  OJ L 224, 21.8.2002, p. 23.

3

(4)  
  OJ L 10, 15.1.2009, p. 25.

4

(5)  
  OJ L 15, 18.1.2008, p. 5.

5

(6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance flurprimidol. EFSA Journal 2011;9(1):1962. [60 pp.] doi:10.2903/j.efsa.2011.1962. Available online: ww.efsa.europa.eu/efsajournal.htm.

6

EFSA Journal

---

| 11.6.2011 | EN | Official Journal of the European Union | L 153/194 |
| --- | --- | --- | --- |

11.6.2011

EN

Official Journal of the European Union

L 153/194

---

COMMISSION IMPLEMENTING DECISION

of 1 June 2011

concerning the non-inclusion of dicloran in Annex I to Council Directive 91/414/EEC

(notified under document C(2011) 3731)

(Text with EEA relevance)

(2011/329/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,

Whereas:

| (1) | Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included dicloran. |
| --- | --- |

(1)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included dicloran.

| (2) | In accordance with Article 11f of Regulation (EC) No 1490/2002 and Article 12(1)(a) and Article 12(2)(b) of that Regulation, Commission Decision 2008/744/EC of 18 September 2008 concerning the non-inclusion of dicloran in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (4) was adopted. |
| --- | --- |

(2)

In accordance with Article 11f of Regulation (EC) No 1490/2002 and Article 12(1)(a) and Article 12(2)(b) of that Regulation, Commission Decision 2008/744/EC of 18 September 2008 concerning the non-inclusion of dicloran in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (4) was adopted.

| (3) | The original notifier (hereinafter ‘the applicant’) submitted a new application pursuant to Article 6(2) of Directive 91/414/EEC requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5). |
| --- | --- |

(3)

The original notifier (hereinafter ‘the applicant’) submitted a new application pursuant to Article 6(2) of Directive 91/414/EEC requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

| (4) | The application was submitted to Spain, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/744/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008. |
| --- | --- |

(4)

The application was submitted to Spain, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/744/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

| (5) | Spain evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 6 October 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on dicloran to the Commission on 21 July 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and the Animal Health and finalised on 5 May 2011 in the format of the Commission review report for dicloran. |
| --- | --- |

(5)

Spain evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 6 October 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on dicloran to the Commission on 21 July 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and the Animal Health and finalised on 5 May 2011 in the format of the Commission review report for dicloran.

| (6) | The additional report by the rapporteur Member State and the conclusion by the Authority concentrate on the concerns that lead to the non-inclusion; in particular, there was a concern with regard to worker exposure. More concerns were identified in the review report for dicloran. |
| --- | --- |

(6)

The additional report by the rapporteur Member State and the conclusion by the Authority concentrate on the concerns that lead to the non-inclusion; in particular, there was a concern with regard to worker exposure. More concerns were identified in the review report for dicloran.

| (7) | Additional information was submitted by the applicant, in particular as regards the specification of the technical material, the equivalence of the test materials used in the toxicity studies and the technical material; as commercially manufactured, the mammalian toxicity, the operator and worker exposure and the degradation pathways. |
| --- | --- |

(7)

Additional information was submitted by the applicant, in particular as regards the specification of the technical material, the equivalence of the test materials used in the toxicity studies and the technical material; as commercially manufactured, the mammalian toxicity, the operator and worker exposure and the degradation pathways.

| (8) | However, the additional information provided by the applicant did not permit to eliminate all of the specific concerns arising in respect of dicloran. |
| --- | --- |

(8)

However, the additional information provided by the applicant did not permit to eliminate all of the specific concerns arising in respect of dicloran.

| (9) | In particular, there were the following concerns. It was not demonstrated that the specification of the technical material, as commercially manufactured, is equivalent with those of the test materials used in the toxicological and ecotoxicological studies. The data available were insufficient to conclude on the toxicological relevance of two impurities present in the technical material, for confidentiality reasons referred to as impurities 3 and 4. Harmful effects on human health were identified. In particular, worker exposure was found to exceed 100 % of the acceptable operator exposure level (AOEL). The consumer risk assessment could not be finalised due to unknown amounts of residues in succeeding crops. Information on risks to aquatic organisms from unidentified degradation products of the aqueous photolysis and to non target soil macro-organisms was not sufficient. |
| --- | --- |

(9)

In particular, there were the following concerns. It was not demonstrated that the specification of the technical material, as commercially manufactured, is equivalent with those of the test materials used in the toxicological and ecotoxicological studies. The data available were insufficient to conclude on the toxicological relevance of two impurities present in the technical material, for confidentiality reasons referred to as impurities 3 and 4. Harmful effects on human health were identified. In particular, worker exposure was found to exceed 100 % of the acceptable operator exposure level (AOEL). The consumer risk assessment could not be finalised due to unknown amounts of residues in succeeding crops. Information on risks to aquatic organisms from unidentified degradation products of the aqueous photolysis and to non target soil macro-organisms was not sufficient.

| (10) | The Commission invited the applicant to submit its comments on the conclusion by the Authority. Furthermore, in accordance with Article 21(1) to Regulation (EC) No 33/2008, the Commission invited the applicant to submit comments on the draft review report. The applicant submitted its comments, which have been carefully examined. |
| --- | --- |

(10)

The Commission invited the applicant to submit its comments on the conclusion by the Authority. Furthermore, in accordance with Article 21(1) to Regulation (EC) No 33/2008, the Commission invited the applicant to submit comments on the draft review report. The applicant submitted its comments, which have been carefully examined.

| (11) | However, despite the arguments put forward by the applicant, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted and evaluated during the expert meetings of the Authority have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing dicloran satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. |
| --- | --- |

(11)

However, despite the arguments put forward by the applicant, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted and evaluated during the expert meetings of the Authority have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing dicloran satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

| (12) | Dicloran should therefore not be included in Annex I to Directive 91/414/EEC. |
| --- | --- |

(12)

Dicloran should therefore not be included in Annex I to Directive 91/414/EEC.

| (13) | In the interest of clarity, Decision 2008/744/EC should be repealed. |
| --- | --- |

(13)

In the interest of clarity, Decision 2008/744/EC should be repealed.

| (14) | This Decision does not prejudice the submission of a further application for dicloran pursuant to Article 6(2) of Directive 91/414/EEC and Chapter II of Regulation (EC) No 33/2008. |
| --- | --- |

(14)

This Decision does not prejudice the submission of a further application for dicloran pursuant to Article 6(2) of Directive 91/414/EEC and Chapter II of Regulation (EC) No 33/2008.

| (15) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(15)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Dicloran shall not be included as active substance in Annex I to Directive 91/414/EEC.

Article 2

Decision 2008/744/EC is repealed.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 1 June 2011.

For the Commission

John DALLI

Member of the Commission

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(1)  
  OJ L 230, 19.8.1991, p. 1.

1

(2)  
  OJ L 55, 29.2.2000, p. 25.

2

(3)  
  OJ L 224, 21.8.2002, p. 23.

3

(4)  
  OJ L 251, 19.9.2008, p. 43.

4

(5)  
  OJ L 15, 18.1.2008, p. 5.

5

(6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance dicloran. EFSA Journal 2010;8(8):1698. [110 pp.]. doi:10.2903/j.efsa.2010.1698. Available online: www.efsa.europa.eu/efsajournal.

6

EFSA Journal

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