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Commission Directive 2005/72/ECShow full title

Commission Directive 2005/72/EC of 21 October 2005 amending Council Directive 91/414/EEC to include chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram as active substances (Text with EEA relevance)

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ANNEXU.K.

The following entries 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
‘112

Chlorpyrifos

CAS No

2921-88-2

CIPAC No

221

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

≥ 970 g/kg

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

1 July 200630 June 2016

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

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

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

113

Chlorpyrifos-methyl

CAS No

5598-13-0

CIPAC No

486

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

≥ 960 g/kg

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

1 July 200630 June 2016

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

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

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

114

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 200630 June 2016

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 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 entry into force of this Directive.

115

Mancozeb

CAS No

8018-01-7 (formerly 8065-67-5)

CIPAC No

34

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

≥ 800 g/kg

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

1 July 200630 June 2016

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

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

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

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

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

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

116

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 200630 June 2016

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 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 entry into force of this Directive.’

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