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Commission Directive 2008/125/EC (repealed)Show full title

Commission Directive 2008/125/EC of 19 December 2008 amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances (Text with EEA relevance) (repealed)

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ANNEX

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

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
‘266

Aluminium phosphide

CAS No 20859-73-8

CIPAC No 227

Aluminium phosphide≥ 830 g/kg1 September 200931 August 2019

PART A

Only uses as insecticide and rodenticide in the form of ready-to-use aluminium phosphide containing products may be authorised.

As rodenticide only outdoor uses may be authorised.

Authorisations should be limited to professional users.

PART B

For the implementation of the uniform principles of Annex VI, 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 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 workers at re-entry (after fumigation period) 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 aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

267

Calcium phosphide

CAS No 1305-99-3

CIPAC No 505

Calcium phosphide≥ 160 g/kg1 September 200931 August 2019

PART A

Only outdoor uses as rodenticide 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 of Annex VI, 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 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.

268

Magnesium phosphide

CAS No 12057-74-8

CIPAC No 228

Magnesium phosphide≥ 880 g/kg1 September 200931 August 2019

PART A

Only uses as insecticide and rodenticide in the form of ready-to-use magnesium phosphide containing products may be authorised.

As rodenticide only outdoor uses may be authorised.

Authorisations should be limited to professional users.

PART B

For the implementation of the uniform principles of Annex VI, 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 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 workers at re-entry (after fumigation period) 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 aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

269

Cymoxanil

CAS No 57966-95-7

CIPAC No 419

1-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea≥ 970 g/kg1 September 200931 August 2019

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 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 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.

270

Dodemorph

CAS No 1593-77-7

CIPAC No 300

cis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine≥ 950 g/kg1 September 200931 August 2019

PART A

Only uses as fungicide on ornamentals in glasshouse may be authorised.

PART B

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

271

2,5-Dichlorobenzoic acid methylester

CAS No 2905-69-3

CIPAC No 686

methyl-2,5-dichlorobenzoate≥ 995 g/kg1 September 200931 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 of Annex VI, 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.

272

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/kg1 September 200931 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(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 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 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.

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.

273

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

  • toluene: not more than 4 g/kg

1 September 200931 August 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 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 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.

274

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/kg1 September 200931 August 2019

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 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 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 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.

275

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 B, RR + SS, range: 15 to 30 %

1 September 200931 August 2019

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 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 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 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;

  • information to further address the risk assessment for birds and mammals.

  • 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.’

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