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Commission Directive 2008/116/ECShow full title

Commission Directive 2008/116/EC of 15 December 2008 amending Council Directive 91/414/EEC to include aclonifen, imidacloprid and metazachlor as active substances (Text with EEA relevance)

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ANNEXU.K.+E.U.

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
‘221

Aclonifen

CAS No 74070-46-5

CIPAC No 498

2-chloro-6-nitro-3-phenoxyaniline

≥ 970 g/kg

The impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established.

1 August 200931 July 2019

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, 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 aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.

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

  • the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

  • the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

  • the residues in rotational crops and evaluate the dietary exposure of consumers,

  • the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of this Directive.

222

Imidacloprid

CAS No 138261-41-3

CIPAC No 582

(E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine≥ 970 g/kg1 August 200931 July 2019

PART A

Only uses as insecticide may be authorised.

For the protection of non-target organisms, in particular honey bees and birds, for use as seed treatment:

  • the seed coating shall only be performed in professional seed treatment facilities. These facilities must apply the best available techniques in order to ensure that the release of dust clouds during storage, transport and application can be excluded,

  • adequate application equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust clouds emission. Member States shall ensure that the label of treated seed includes the indication that the seeds were treated with imidacloprid and sets out the risk mitigation measures provided for in the authorisation.

PART B

In assessing applications to authorise plant protection products containing imidacloprid for uses other than tomatoes 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.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 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 impact on aquatic organisms, non-target arthropods, earthworms, other soil macroorganisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures,

  • the protection of honey bees, in particular for spray applications and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

The Member States concerned shall request the submission of:

  • information to further address the risk assessment for operators and workers,

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

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of this Directive.

223

Metazachlor

CAS No 67129-08-2

CIPAC No 411

2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide

≥ 940 g/kg

The manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,01 % is established.

1 August 200931 July 2019

PART A

Only uses as herbicide may be authorised; application max. of 1,0 kg/ha only every third year on the same field.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 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,

  • the protection of aquatic organisms,

  • 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 the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate.

If metazachlor is classified under Directive 67/548/EEC as “limited evidence of a cancerogenic effect”, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer.

They shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision.’

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