Annex

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

Further details on identity and specification of active substance are provided in the review report.
No	Common name, identification numbers	IUPAC name	Purityf1	Entry into force	Expiration of inclusion	Specific provisions
‘216	Abamectin CAS No 71751-41-2 avermectin B1a CAS No 65195-55-3 Avermectin B1b CAS No 65195-56-4 abamectin CIPAC No 495	AvermectinB1a (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside AvermectinB1b (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside	≥ 850 g/kg	1 May 2009	30 April 2019	PART A Only uses as insecticide, acaricide. PART B In assessing applications to authorise plant protection products containing abamectin for uses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information are provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on (abamectin), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 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 residues in food of plant origin and evaluate the dietary exposure of consumers, the protection of bees, non-target arthropods, birds, mammals and aquatic organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, waiting periods, should be applied where appropriate. The Member States concerned shall request the submission of: further studies on the specification, information to further address the risk assessment for birds and mammals, information to address the risk to aquatic organisms with respect to the major soil metabolites, information to address the risk to groundwater with respect to the metabolite U8. They shall ensure that the notifiers provide such studies to the Commission within two years from the entry into force of this Directive.
217	Epoxiconazole CAS No 135319-73-2 (formerly 106325-08-0) CIPAC No 609	(2RS, 3SR)-1-[3-(2-chlorophenyl)-2,3-epoxy-2-(4-fluorophenyl)propyl]-1H-1.2,4-triazole	≥ 920 g/kg	1 May 2009	30 April 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 epoxiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 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 dietary exposure of consumers to the epoxiconazole (triazole) metabolites, the potential for long-range transport via air, the risk to aquatic organisms, birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further studies addressing the potential endocrine disrupting properties of epoxiconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. The Member States concerned shall ensure that the notifier presents to the Commission not later than 30 June 2009 a monitoring programme to assess the long-range atmospheric transport of epoxiconazole and related environmental risks. The results of this monitoring shall be submitted as a monitoring report to the Commission by 31 December 2011 at the latest. The concerned Member States shall ensure that the notifier submits within two years from the entry into force of this Directive, at the latest, information on residues of epoxiconazole metabolites in primary crops, rotational crops and products of animal origin and information to further address the long-term risk to herbivorous birds and mammals.
218	Fenpropimorph CAS No 67564-91-4 CIPAC No 427	(RS)-cis-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine	≥ 930 g/kg	1 May 2009	30 April 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 fenpropimorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: 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, such as restrictions of the daily work rate, 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. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles. The Member States concerned shall request the submission of further studies to confirm the mobility in soil of the metabolite BF-421-7. They shall ensure that the notifiers at whose request fenpropimorph has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.
219	Fenpyroximate CAS No 134098-61-6 CIPAC No 695	tert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate	> 960 g/kg	1 May 2009	30 April 2019	PART A Only uses as acaricide may be authorised. The following uses must not be authorised: applications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenpyroximate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 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 and non-target arthropods 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 to aquatic organisms from metabolites containing the benzyl moiety, the risk of biomagnification in aquatic food chains. They shall ensure that the notifiers at whose request fenpyroximate has been included in this Annex provide such information to the Commission within two years from the entry into force of this Directive.
220	Tralkoxydim CAS No 87820-88-0 CIPAC No 544	(RS)-2-[(EZ)-1-(ethoxyimino)propyl]-3-hydroxy-5-mesitylcyclohex-2-en-1-one	≥ 960 g/kg	1 May 2009	30 April 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 tralkoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: the protection of the groundwater, in particular from the soil metabolite R173642 when the active substance is applied in regions with vulnerable soil and/or climatic conditions, the protection of herbivorous mammals. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of: information to further address the long-term risk to herbivorous mammals arising from the use of tralkoxydim. They shall ensure that the notifiers at whose request tralkoxydim has been included in this Annex provide such information to the Commission within two years from the entry into force of this Directive.’