Commission Directive 2009/11/ECShow full title

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.
No	Common name, identification numbers	IUPAC name	Puritya	Entry into force	Expiration of inclusion	Specific provisions
‘276	Bensulfuron CAS No 83055-99-6 CIPAC No 502.201	α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluic acid (bensulfuron) methyl α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluate (bensulfuron-methyl)	≥ 975 g/kg	1 November 2009	31 October 2019	PART A Only uses as a herbicide PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on bensulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to the following: 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 the groundwater, where 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, information to further address the route and rate of degradation of bensulfuron-methyl under aerobic flooded soil conditions, information to address the relevance of metabolites for the consumer risk assessment. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.
277	Sodium 5-nitroguaiacolate CAS No 67233-85-6 CIPAC number not allocated	Sodium 2-methoxy-5-nitrophenolate	≥ 980 g/kg	1 November 2009	31 October 2019	PART A Only use 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 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 and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.
278	Sodium o-nitrophenolate CAS No 824-39-5 CIPAC number not allocated	Sodium 2-nitrophenolate; sodium o-nitrophenolate	≥ 980 g/kg The following impurities are of toxicological concern: Phenol Max content: 0,1 g/kg 2,4 dinitrophenol max content: 0,14 g/kg 2,6 dinitrophenol max content: 0,32 g/kg	1 November 2009	31 October 2019	PART A Only use 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 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 and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.
279	Sodium p-nitrophenolate CAS No 824-78-2 CIPAC number not allocated	Sodium 4-nitrophenolate; sodium p-nitrophenolate	≥ 998 g/kg The following impurities are of toxicological concern: Phenol max content: 0,1 g/kg 2,4 dinitrophenol max content: 0,07 g/kg 2,6 dinitrophenol max content: 0,09 g/kg	1 November 2009	31 October 2019	PART A Only use 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 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 and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.
280	Tebufenpyrad CAS No 119168-77-3 CIPAC No 725	N-(4-tert-butylbenzyl)-4-chloro-3-ethyl-1-methylpyrazole-5-carboxamide	≥ 980 g/kg	1 November 2009	31 October 2019	PART A Only uses as acaricide and insecticide may be authorised. PART B In assessing applications to authorise plant protection products containing tebufenpyrad in formulations other than water soluble bags 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 tebufenpyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 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 aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, the protection of insectivorous birds and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. The Member States concerned shall ensure that the notifier submits to the Commission: further information confirming that no relevant impurities are present, information to further address the risk to insectivorous birds. They shall ensure that the notifier provides such information to the Commission by 31 October 2011.’