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Commission Directive 2008/44/ECShow full title

Commission Directive 2008/44/EC of 4 April 2008 amending Council Directive 91/414/EEC to include benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole as active substances (Text with EEA relevance)

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ANNEX

In Annex I to Directive 91/414/EEC, the following rows are added at the end of the table:

a

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

NoCommon name, identification numbersIUPAC namePurityaEntry into forceExpiration of inclusionSpecific provisions
‘169

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

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

1 August 200831 July 2018

Part A

Only uses as fungicide may be authorised.

Part B

For the implementation of the uniform principles of Annex VI, 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 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(1)(b), 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 13(5) on the specification of the technical material as commercially manufactured.

170

Boscalid

CAS No 188425-85-6

CIPAC No 673

2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide≥ 960 g/kg1 August 200831 July 2018

Part A

Only uses as fungicide may be authorised.

Part B

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

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

171

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 100:11 August 200831 July 2018

Part A

Only uses as plant growth regulator may be authorised.

Part B

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

172

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/kg1 August 200831 July 2018

Part A

Only uses as fungicide may be authorised.

Part B

For the implementation of the uniform principles of Annex VI, 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 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 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 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 entry into force of the Directive of inclusion.

173

Paecilomyces lilacinus (Thom)

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

CIPAC No 753

Not applicable1 August 200831 July 2018

Part A

Only uses as nematicide may be authorised.

Part B

For the implementation of the uniform principles of Annex VI, 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 protection of leaf dwelling non-target arthropods.

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

174

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

  • 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 200831 July 2018

Part A

Only uses as fungicide may be authorised.

Part B

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

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,

  • 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.

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 entry into force of the Directive of inclusion.’

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