Number

Common name, identification numbers

IUPAC name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

▼M6 —————

▼M4 —————

▼M18 —————

▼M13 —————

▼M5 —————

▼M8 —————

▼M169 —————

▼M3 —————

▼M181 —————

▼M162 —————

▼M253 —————

▼M170 —————

▼M155 —————

▼M182 —————

▼M280 —————

▼M148 —————

▼M198 —————

▼M136 —————

▼M233 —————

▼M175 —————

▼M22

21

Cyclanilide

CAS No 113136-77-9

CIPAC No 586

Not available

960  g/kg

1 November 2001

31 October 2011

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.

▼M152 —————

▼M279 —————

▼M173 —————

▼M244 —————

▼M191 —————

▼M161 —————

▼M183 —————

▼M193 —————

▼M171 —————

▼M205 —————

▼M150 —————

▼M24

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

30 September 2012

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:

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

▼M215 —————

▼B

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

►M328  30 June 2021 ◄

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:

▼M159 —————

▼M324 —————

▼M190 —————

▼B

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

►M328  30 June 2021 ◄

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:

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

►M341  31 October 2021 ◄

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:

▼M239 —————

▼M265 —————

▼B

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.

▼M323 —————

▼B

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

►M328  31 July 2021 ◄

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:

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

▼M232 —————

▼M329 —————

▼B

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:

▼M243 —————

▼M201 —————

▼M234 —————

▼M227 —————

▼M251 —————

▼M260 —————

▼B

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:

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

►M348  31 January 2022 ◄

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:

▼M282 —————

▼M267 —————

▼M268 —————

▼M214 —————

▼M266 —————

▼M305 —————

▼M287 —————

▼B

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

►M341  31 October 2021 ◄

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:

Risk mitigation measures should be applied where appropriate.

▼M207 —————

▼M311 —————

▼M231 —————

▼B

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

►M341  31 October 2021 ◄

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

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.

▼M259 —————

▼M222 —————

▼B

72

Molinate

CAS No 2212-67-1

CIPAC No 235

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:

▼M278 —————

▼B

74

Ziram

CAS No 137-30-4

CIPAC No 31

Zinc bis (dimethyldithiocarbamate)

950 g/kg (FAO-specification)

1 August 2004

►M322  30 April 2021 ◄

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:

▼M216 —————

▼M228 —————

▼M258 —————

▼M306 —————

▼M226 —————

▼M218 —————

▼B

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

►M348  31 January 2022 ◄

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:

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.

▼M284 —————

▼M317 —————

▼M338 —————

▼M337 —————

▼M309 —————

▼B

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

Min. 970 g/kg

1 March 2005

►M328  31 July 2021 ◄

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

►M322  30 April 2021 ◄

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

►M322  30 April 2021 ◄

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.

▼M247 —————

▼M321 —————

▼M269 —————

▼B

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

►M43  31. July 2017 ◄

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.

▼M246 —————

▼M293 —————

▼B

97

S-metolachlor

CAS No 87392-12-9

(S-isomer)

178961-20-1 (R-isomer)

CIPAC No 607

Mixture of:

≥ 960 g/kg

1 April 2005

►M328  31 July 2021 ◄

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:

Risk mitigation measures should be applied where appropriate.

▼M292 —————

▼M347 —————

▼B

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

►M134  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.

▼M301 —————

▼B

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

►M341  31 October 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 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

►M341  31 October 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 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:

104

Daminozide

CAS No 1596-84-5

CIPAC No 330

N-dimethylaminosuccinamic acid

990 g/kg

Impurities:

1 March 2006

►M341  31 October 2021 ◄

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

▼M340 —————

▼M283 —————

▼B

107

MCPA

CAS No 94-74-6

CIPAC No 2

4-chloro-o-tolyloxyacetic acid

≥ 930 g/kg

1 May 2006

►M341  31 October 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 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

►M341  31 October 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 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

►M328  31 July 2021 ◄

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

CIPAC No 660

≥ 950 g/kg

1 December 2005

►M328  31 July 2021 ◄

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.

▼M320 —————

▼M319 —————

▼B

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

►M197  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 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.

▼M344 —————

▼B

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

►M348  31 January 2022 ◄

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

►M348  31 January 2022 ◄

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,

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 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.

▼M307 —————

▼M255 —————

▼B

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

►M341  31 October 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 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

►M245  31 January 2019 ◄

PART A

Only uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.

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 and the conclusions of the revised addendum of the review report on clothianidin as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.

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

Member States shall ensure that 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.

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

▼M272 —————

▼B

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

►M322  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 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

►M322  30 April 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 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

►M322  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 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.

▼M310 —————

▼B

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

►M322  30 April 2021 ◄

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:

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

►M348  31 January 2022 ◄

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

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

The concerned Member States shall request the submission of

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

►M322  30 April 2021 ◄

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 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

►M322  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 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:

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

►M322  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 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:

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

►M322  30 April 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 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:

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

►M322  30 April 2021 ◄

►M89  
PART A
Only uses as herbicide may be authorised.
As regards cereals, only application in spring may be authorised, at rates not exceeding 800 g active substance per hectare per application.
Use on grassland shall not 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 shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants.
Conditions of authorisation shall include risk mitigation measures, where appropriate.  ◄

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

►M322  30 April 2021 ◄

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:

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

►M322  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 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:

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

►M322  30 April 2021 ◄

PART A

Only uses as herbicide may be authorised. Only uses with a total application per year of maximum 480 g active substance per hectare shall 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 triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014 shall be taken into account.

In this overall assessment Member States:

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

►M322  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 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

►M322  30 April 2021 ◄

►M158  
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 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

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

≥ 850 g/kg

1 February 2007

►M322  30 April 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 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

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

►M252  30 April 2019 ◄

PART A

Only uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.

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 and the conclusions of the revised addendum of the review report on thiamethoxam as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.

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

Member States shall ensure that 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.

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

▼M335 —————

▼B

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

►M328  31 July 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 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:

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

The following uses must not be authorised:

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

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.

▼M2

144

Carbendazim

CAS No 10605-21-7

CIPAC No 263

Methyl benzimidazol-2-ylcarbamate

≥ 980 g/kg

Relevant impurities

1 June 2011

30 November 2014

PART A

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

at rates not exceeding

The following uses must not be authorised:

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

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:

▼B

145

Captan

CAS No 133-06-02

CIPAC No 40

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

≥ 910 g/kg

Impurities:

1 October 2007

►M328  31 July 2021 ◄

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 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:

1 October 2007

►M328  31 July 2021 ◄

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:

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

►M328  31 July 2021 ◄

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:

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.

▼M315 —————

▼M308 —————

▼B

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

►M328  31 July 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 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:

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

►M139  31. July 2018 ◄

►M57  
PART A
Only uses as herbicide for band or spot application may be authorised at rates not exceeding 750 g active substance/ha (treated surface) per application and maximum two applications per year.
PART B
In assessing applications to authorise plant protection products containing glufosinate, 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 shall pay particular attention to:
(a)  the operator, worker and bystander safety; conditions of authorisation shall include protective measures, where appropriate;
(b)  the potential for groundwater contamination, where the active substance is applied in regions with vulnerable soil or climatic conditions;
(c)  the protection of mammals, non-target arthropods and non-target plants.
Conditions of authorisation shall include the application of drift reducing nozzles and spray shields and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate.  ◄

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

►M328  31 July 2021 ◄

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:

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:

1 October 2007

►M328  31 July 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 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:

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

►M328  31 July 2021 ◄

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:

▼M298 —————

▼B

156

Pirimiphos-methyl

CAS No 29232-93-7

CIPAC No 239

> 880 g/kg

1 October 2007

►M328  31 July 2021 ◄

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:

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

►M197  30 September 2017 ◄

►M73  
PART A
Only uses as insecticide for use as seed treatment may be authorised. Uses shall only be authorised for seeds intended to be sown in greenhouses and seeds of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.
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 15 March 2007 and the conclusions of the addendum of the review report on fipronil as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
(a)  the packaging of the marketed products to avoid the generation of photodegradation products of concern;
(b)  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;
(c)  the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees.
Member States shall also ensure that:
(a)  the seed coating shall only be performed in professional seed treatment facilities; those facilities shall 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;
(b)  adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission;
(c)  the label of the treated seeds shall include the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation;
(d)  monitoring programmes shall be initiated to verify the real exposure of bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate.
Conditions of use shall include risk mitigation measures, where appropriate.
The notifier shall submit confirmatory information as regards:
(a)  the risk to pollinators other than honey bees;
(b)  the acute and long-term risk to colony survival and development, and the risk to bee brood from plant and soil metabolites, except the soil photolysis metabolites;
(c)  the potential exposure to dust drift emitted during the drilling procedure and the acute and long-term risk to colony survival and development, and the risk to bee brood for situations where bees forage on vegetation exposed to dust drift;
(d)  the acute and long-term risk to colony survival and development, and the risk to bee brood from foraging on insect honeydew;
(e)  the potential exposure to guttation fluid and the acute and long-term risk to colony survival and development, and the risk to bee brood;
(f)  the potential exposure to residues in nectar and pollen, honeydew and guttation fluid of succeeding crops or weeds occurring in fields, including the persistent soil metabolites (RPA 200766, MB 46136 and MB 45950).
The notifier shall submit that information to the Commission, the Member States and the Authority by 30 March 2015.  ◄

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

►M328  31 July 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 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: