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Commission Directive 2009/77/ECShow full title

Commission Directive 2009/77/EC of 1 July 2009 amending Council Directive 91/414/EEC to include chlorsulfuron, cyromazine, dimethachlor, etofenprox, lufenuron, penconazole, tri-allate and triflusulfuron as active substances (Text with EEA relevance)

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ANNEX

The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

a

Further details on identity and specification of active substance are provided in the review report.

NoCommon Name, Identification NumbersIUPAC NamePurityaEntry into forceExpiration of inclusionSpecific provisions
‘287

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

4-methoxy-6-methyl-1,3,5-triazin-2-amine (IN-A4098) not more than 6 g/kg

1 January 201031 December 2019

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, 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 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.

If chlorsulfuron is classified as carcinogenic category 3 in accordance with point 4.2.1 of Annex VI to Directive 67/548/EEC, 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.

288

Cyromazine

CAS No 66215-27-8

CIPAC No 420

N-cyclopropyl-1,3,5-triazine-2,4,6-triamine≥ 950 g/kg1 January 201031 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(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles of Annex VI, 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 aquatic organisms,

  • 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.

289

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 201031 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 of Annex VI, 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 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.

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.

If dimethachlor is classified as carcinogenic category 3 in accordance with point 4.2.1 of Annex VI to Directive 67/548/EEC, 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.

290

Etofenprox

CAS No 80844-07-1

CIPAC No 471

2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl

ether

≥ 980 g/kg1 January 201031 December 2019

PART A

Only uses as insecticide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, 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 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 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,

  • 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.

291

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/kg1 January 201031 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 of Annex VI, 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 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.

292

Penconazole

CAS No 66246-88-6

CIPAC No 446

(RS) 1-[2-(2,4-dichloro-phenyl)-pentyl]-1H-[1,2,4] triazole≥ 950 g/kg1 January 201031 December 2019

PART A

Only uses as fungicide in greenhouses may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, 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.

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 U1. 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.

293

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 201031 December 2019

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, 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 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 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 on the fate and behaviour of the soil metabolite diisopropylamine,

  • 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.

They shall ensure that the notifier provides such information to the Commission by 31 December 2011.

294

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 201031 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 of Annex VI, 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 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.

If triflusulfuron is classified as carcinogenic category 3 in accordance with point 4.2.1 of Annex VI to Directive 67/548/EEC, 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.’

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