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implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances

The active substances, as set out in Part A of the Annex, shall be deemed to have been approved under Regulation (EC) No 1107/2009.

The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex to this Regulation. The basic substances approved under Regulation (EC) No 1107/2009 are as set out in Part C of the Annex to this Regulation. The low-risk active substances approved under Regulation (EC) No 1107/2009 are as set out in Part D of the Annex to this Regulation.

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Active substances deemed to have been approved under Regulation (EC) No 1107/2009

Number	Common name, identification numbers	IUPAC name	Purity (1)	Date of approval	Expiration of approval	Specific provisions
▼M6 —————
▼M4 —————
▼M18 —————
▼M13 —————
▼M5 —————
▼M8 —————
▼B
7	Metsulfuron methyl CAS No 74223-64-6	Methyl-2-(4-methoxy-6-methyl-1,3,5,-triazin-2-ylcarbamoylsulfamoyl)benzoate	960 g/kg	1 July 2001	31 December 2015	Only uses as herbicide may be authorised. In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States — must pay particular attention to the protection of groundwater; — must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 16 June 2000.
▼M3 —————
▼B
9	Triasulfuron CAS No 82097-50-5 CIPAC No 480	1-[2-(2-chloroethoxy)phenylsulfonyl]-3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea	940 g/kg	1 August 2001	31 December 2015	Only uses as herbicide may be authorised. In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States: — must pay particular attention to the protection of groundwater; — must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.
10	Esfenvalerate CAS No 66230-04-4 CIPAC No 481	(S)-α-Cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate	830 g/kg	1 August 2001	31 December 2015	Only uses as insecticide may be authorised. In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States: — must pay particular attention to the potential impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.
11	Bentazone CAS No 25057-89-0 CIPAC No 366	3-isopropyl-(1H)-2,1,3-benzothiadiazin-4-(3H)-one-2,2-dioxide	960 g/kg	1 August 2001	31 December 2015	Only uses as herbicide may be authorised. In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States must pay particular attention to the protection of groundwater. Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.
12	Lambda-cyhalothrin CAS No 91465-08-6 CIPAC No 463	A 1:1 mixture of: (S)-α-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate, and (R)-α-cyano-3-phenoxybenzyl (Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate	810 g/kg	1 January 2002	31 December 2015	Only uses as insecticide may be authorised. In their decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States: — must pay particular attention to operator safety; — must pay particular attention to the potential impact on aquatic organisms and non-target arthropods including bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — must pay particular attention to the residues in food and especially the acute effects thereof. Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000.
13	Fenhexamid CAS No 126833-17-8 CIPAC No 603	N-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexanecarboxamide	≥ 950 g/kg	1 June 2001	31 December 2015	Only uses as a fungicide may be authorized. In decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, Member States must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000.
14	Amitrole CAS No 61-82-5 CIPAC No 90	H-[1,2,4]-triazole-3-ylamine	900 g/kg	1 January 2002	31 December 2015	Only uses as herbicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amitrole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of operators; — must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses; — must pay particular attention to the protection of beneficial arthropods; — must pay particular attention to the protection of birds and wild mammals. Use of amitrole during the breeding season may only be authorised when an appropriate risk assessment has demonstrated that there is no unacceptable impact and when the conditions of authorisation include, where appropriate, risk mitigation measures.
15	Diquat CAS No 2764-72-9 (ion), 85-00-7 (dibromide) CIPAC No 55	9,10-Dihydro-8a,10a-diazoniaphenanthrene ion (dibromide)	950 g/kg	1 January 2002	31 December 2015	On the basis of currently available information, only uses as terrestrial herbicide and desiccant may be authorised. Uses in aquatic weed control shall not be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the Review report on diquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — must pay particular attention to operator safety as related to non-professional use and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
16	Pyridate CAS No 55512-33.9 CIPAC No 447	6-Chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate	900 g/kg	1 January 2002	31 December 2015	Only uses as herbicide may be authorized. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the Review report on Pyridate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of groundwater; — must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
17	Thiabendazole CAS No 148-79-8 CIPAC No 323	2-Thiazol-4-yl-1H-benzimidazole	985 g/kg	1 January 2002	31 December 2015	Only uses as fungicide may be authorised. Foliar spray applications shall not be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the Review report on thiabendazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of aquatic and sediment-dwelling organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Suitable risk mitigation measures (e.g. depuration with diatom earth or activated carbon) have to be implemented to protect surface waters from unacceptable levels of contamination via wastewater.
▼M136 —————
▼B
19	DPX KE 459 (flupyrsulfuron-methyl) CAS No 144740-54-5 CIPAC No 577	2-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-6-trifluromethylnicotinate monosodium salt	903 g/kg	1 July 2001	31 December 2015	Only uses as a herbicide may be authorised. In decision making according to the Uniform Principles Member States must pay particular attention to the protection of groundwater. Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001.
20	Acibenzolar-s-methyl CAS No 135158-54-2 CIPAC No 597	Benzo[1,2,3]thiadiazole-7-carbothioic acid S-methyl ester	970 g/kg	1 November 2001	31 December 2015	Only uses as a plant activator may be authorised. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001
▼M22
21	Cyclanilide CAS No 113136-77-9 CIPAC No 586	Not available	960 g/kg	1 November 2001	31 October 2011	Only uses as a plant growth regulator may be authorised. The maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active substance as manufactured should be 1 g/kg. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.
▼B
22	Ferric phosphate CAS No 10045-86-0 CIPAC No 629	Ferric phosphate	990 g/kg	1 November 2001	31 December 2015	Only uses as a molluscicide may be authorised. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.
23	Pymetrozine CAS No 123312-89-0 CIPAC No 593	(E)-6-methyl-4-[(pyridin-3-ylmetylene)amino]-4,5-dihydro-2H-[1,2,4]-triazin-3 one	950 g/kg	1 November 2001	31 December 2015	Only uses as an insecticide may be authorised. In decision making according to the Uniform Principles Member States must pay particular attention to the protection of aquatic organisms. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.
24	Pyraflufen-ethyl CAS No 129630-19-9 CIPAC No 605	Ethyl-2-chloro-5-(4-chloro-5-difluoromethoxy-1-mhypyrazol-3-yl)-4-fluorophenoxyacetate	956 g/kg	1 November 2001	31 December 2015	Only uses as a herbicide may be authorised. In decision making according to the Uniform Principles Member States must pay particular attention to the protection of algae and aquatic plants and should apply, where appropriate, risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.
25	Glyphosate CAS No 1071-83-6 CIPAC No 284	N-(phosphonomethyl)-glycin	950 g/kg	1 July 2002	31 December 2015	Only uses as herbicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on glyphosate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses.
26	Thifensulfuron-methyl CAS No 79277-27-3 CIPAC No 452	Methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoyl-sulfamoyl) thiophene-2-carboxylate	960 g/kg	1 July 2002	31 December 2015	Only uses as herbicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thifensulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of groundwater; — must pay particular attention to the impact on aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
27	2,4-D CAS No 94-75-7 CIPAC No 1	(2,4-dichlorophenoxy) acetic acid	960 g/kg	1 October 2002	31 December 2015	Only uses as herbicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-D, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 2 October 2001 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — must pay particular attention to the dermal absorption; — must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
28	Isoproturon CAS No 34123-59-6 CIPAC No 336	3-(4-isopropylphenyl)-1,1-dimethylurea	970 g/kg	1 January 2003	31 December 2015	Only uses as herbicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isoproturon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 7 December 2001 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions or at use rates higher than those described in the review report and must apply risk mitigation measures, where appropriate; — must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
29	Ethofumesate CAS No 26225-79-6 CICAP No 223	(±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-ylmethanesulfonate	960 g/kg	1 March 2003	28 February 2013	Only uses as herbicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethofumesate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States may pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and must apply risk mitigation measures, where appropriate.
30	Iprovalicarb CAS No 140923-17-7 CICAP No 620	{2-Methyl-1-[1-(4-methylphenyl)ethylcarbonyl] propyl}-carbamic acid isopropylester	950 g/kg (provisional specification)	1 July 2002	31 December 2015	Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iprovalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment: — 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 dossier should be compared and verified against this specification of the technical material; — Member States must pay particular attention to the protection of operators.
31	Prosulfuron CAS No 94125-34-5 CICAP No 579	1-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea	950 g/kg	1 Juli 2002	31 December 2015	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States: — must carefully consider the risk to aquatic plants if the active substance is applied adjacent to surface waters. Risk mitigation measures should be applied where appropriate; — must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate.
32	Sulfosulfuron CAS No 141776-32-1 CICAP No 601	1-(4,6-dimethoxypyrimidin-2-yl)-3-[2-ethanesulfonyl-imidazo[1,2-a]pyridine) sulfonyl]urea	980 g/kg	1 July 2002	31 December 2015	Only uses as a herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic plants and algae. Where appropriate, risk mitigation measures should be applied; — Member States must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.
▼M24
33	Cinidon-ethyl CAS No 142891-20-1 CIPAC No 598	(Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate	940 g/kg	1 October 2002	30 September 2012	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions, — should pay particular attention to the protection of aquatic organisms. Conditions of authorisation must include risk mitigation measures, where appropriate.
▼B
34	Cyhalofop butyl CAS No 122008-85-9 CIPAC No 596	Butyl-(R)-2-[4(4-cyano-2-fluorophenoxy) phenoxy]propionate	950 g/kg	1 October 2002	31 December 2015	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyhalofop butyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: — Member States must carefully consider the potential impact of aerial applications to non-target organisms and in particular to aquatic species. Conditions of authorisation must include restrictions or risk mitigation measures, where appropriate. — Member States must carefully consider the potential impact of terrestrial applications on aquatic organisms within paddy fields. Conditions of authorisation must include risk mitigation measures, where appropriate.
35	Famoxadone CAS No 131807-57-3 CIPAC No 594	3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione	960 g/kg	1 October 2002	31 December 2015	Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms; — Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — Member States should pay particular attention to the protection of operators.
36	Florasulam CAS No 145701-23-1 CIPAC No 616	2′, 6′, 8-Trifluoro-5-methoxy-[1,2,4]-triazolo [1,5-c] pyrimidine-2-sulphonanilide	970 g/kg	1 October 2002	31 December 2015	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on florasulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.
37	Metalaxyl-M CAS No 70630-17-0 CIPAC No 580	Methyl(R)-2-{[(2,6-dimethylphenyl)methoxy-acetyl] amino} propionate	910 g/kg	1 October 2002	31 December 2015	Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Metalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: — particular attention should be given to the potential for groundwater contamination by the active substance or its degradation products CGA 62826, and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate.
38	Picolinafen CAS No 137641-05-5 CIPAC No 639	4′-Fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide	970 g/kg	1 October 2002	31 December 2015	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on picolinafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.
39	Flumioxazine CAS No 103361-09-7 CICAP No 578	N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide	960 g/kg	1 January 2003	31 December 2015	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States: — must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate.
40	Deltamethrin CAS No 52918-63-5 CIPAC No 333	(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate	980 g/kg	1 November 2003	31 October 2013	Only uses as insecticide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures, — should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels, — must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.
41	Imazamox CAS No 114311-32-9 CIPAC No 619	(±)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-(methoxymethyl) nicotinic acid	950 g/kg	1 July 2003	30 June 2013	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazamox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate.
42	Oxasulfuron CAS No 144651-06-9 CIPAC No 626	Oxetan-3-yl 2[(4,6-dimethylpyrimidin-2-yl) carbamoyl-sulfamoyl] benzoate	930 g/kg	1 July 2003	30 June 2013	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxasulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied, where appropriate.
43	Ethoxysulfuron CAS No 126801-58-9 CIPAC No 591	3-(4,6-dimethoxypyrimidin-2-yl)-1-(2-ethoxyphenoxy-sulfonyl)urea	950 g/kg	1 July 2003	30 June 2013	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethoxysulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. Member States should pay particular attention to the protection of non-target aquatic plants and algae in drainage canals. Risk mitigation measures should be applied where appropriate.
44	Foramsulfuron CAS No 173159-57-4 CIPAC No 659	1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea	940 g/kg	1 July 2003	30 June 2013	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on foramsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied, where appropriate.
45	Oxadiargyl CAS No 39807-15-3 CIPAC No 604	5-tert-butyl-3-(2,4-dichloro-5-propargyloxyphenyl)-1,3,4 oxadiazol-2-(3H)-one	980 g/kg	1 July 2003	30 June 2013	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiargyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of algae and aquatic plants. Risk mitigation measures should be applied where appropriate.
46	Cyazofamid CAS No 120116-88-3 CIPAC No 653	4-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide	935 g/kg	1 July 2003	30 June 2013	Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyazofamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms; — Member States must pay particular attention to the degradation kinetics of the metabolite CTCA in soil, especially for Northern European regions. Risk mitigation measures or use restrictions should be applied where appropriate.
47	2,4-DB CAS No 94-82-6 CIPAC No 83	4-(2,4-dichlorophenoxy) butyric acid	940 g/kg	1 January 2004	31 December 2013	Only use as herbicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-DB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate.
48	Beta-cyfluthrin CAS No 68359-37-5 (unstated stereochemistry) CIPAC No 482	(1RS,3RS;1RS,3SR)-3- (2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylic acid (SR)-α-cyano- (4-fluoro-3-phenoxy-phenyl)methyl ester	965 g/kg	1 January 2004	31 December 2013	Only use as insecticide may be authorised Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops. For the implementation of the uniform principles, the conclusions of the review report on beta-cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures.
49	Cyfluthrin CAS No 68359-37-5 (unstated stereochemistry) CIPAC No 385	(RS),-α-cyano-4-fluoro-3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethycyclopropanecarboxylate	920 g/kg	1 January 2004	31 December 2013	Only use as insecticide may be authorised Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops. For the implementation of the uniform principles, the conclusions of the review report on cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures.
50	Iprodione CAS No 36734-19-7 CIPAC No 278	3-(3,5-dichlorophenyl)-Nisopropyl-2,4-dioxo-imidazolidine-1-carboximide	960 g/kg	1 January 2004	31 December 2013	Only uses as fungicide and nematicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iprodione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment, Member States: — should pay particular attention to the potential for groundwater contamination when the active substance is applied at high use rates (in particular use in turf) on acidic soils (pH below 6) under vulnerable climatic conditions, — must carefully consider the risk to aquatic invertebrates if the active substance is applied directly adjacent to surface waters. Risk mitigation measures should be applied, where appropriate.
51	Linuron CAS No 330-55-2 CIPAC No 76	3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea	900 g/kg	1 January 2004	31 December 2013	Only use as herbicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on linuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of wild mammals, non-target arthropods and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, — must pay particular attention to the protection of operators.
52	Maleic hydrazide CAS No 123-33-1 CIPAC No 310	6-hydroxy-2H-pyridazin-3-one	940 g/kg.	1 January 2004	31 December 2013	Only use as growth regulator may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on maleic hydrazide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, — must pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate.
53	Pendimethalin CAS No 40487-42-1 CIPAC No 357	N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene	900 g/kg	1 January 2004	31 December 2013	Only use as herbicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pendimethalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health 3 December 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of aquatic organisms and non-target terrestrial plants. Conditions of authorisation must include risk mitigation measures, where appropriate, — must pay particular attention to the possibility of short-range transport of the active substance in air.
54	Propineb CAS No 12071-83-9 (monomer), 9016-72-2 (homopolymer) CIPAC No 177	Polymeric zinc 1,2-propylenebis(dithiocarbamate)	The technical active substance should comply with the FAO specification	1 April 2004	31 March 2014	Only uses as fungicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propineb, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2003 shall be taken into account. In this overall assessment: — Member States should 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 should pay particular attention to the protection of small mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate — Member States should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels
55	Propyzamide CAS No 23950-58-5 CIPAC No 315	3,5-dichloro-N-(1,1-dimethyl-prop-2-ynyl)benzamide	920 g/kg	1 April 2004	31 March 2014	Only uses as herbicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propyzamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health 26 February 2003 shall be taken into account. In this overall assessment, Member States: — must pay particular attention to the protection of operators and must ensure that conditions of authorisation include risk mitigation measures, where appropriate — must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season. Conditions of authorisation should include risk mitigation measures, where appropriate
56	Mecoprop CAS No 7085-19-0 CIPAC No 51	(RS)-2-(4-chloro-o-tolyloxy)-propionic acid	930 g/kg	1 June 2004	31 May 2014	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for groundwater contamination, 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, — Member States should pay particular attention to the protection of non-target arthropods. Risk mitigation measures should be applied, where appropriate.
57	Mecoprop-P CAS No 16484-77-8 CIPAC No 475	(R)-2-(4-chloro-o-tolyloxy)-propionic acid	860 g/kg	1 June 2004	31 May 2014	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for groundwater contamination, 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.
58	Propiconazole CAS No 60207-90-1 CIPAC No 408	(±)-1-[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole	920 g/kg	1 June 2004	31 May 2014	Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States should pay particular attention to the protection of soil organisms for applications rates exceeding 625 g a.i./ha (e.g. uses in lawn). Conditions of authorisation should include risk mitigation measures (e.g. spotwise application scheme), where appropriate.
59	Trifloxystrobin CAS No 141517-21-7 CIPAC No 617	Methyl (E)-methoxyimino-{(E)-a-[1-a-(a,a,a-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate	960 g/kg	1 October 2003	30 September 2013	Only use as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on trifloxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied and/or monitoring programs may be initiated where appropriate.
60	Carfentrazone ethyl CAS No 128639-02.1 CIPAC No 587	Ethyl (RS)-2-chloro-3-[2-chloro-5-(4-difluoromethyl-4,5-dihydro-3-methyl-5oxo-1H 1,2,4-triazol-1-yl)-4-fluorophenyl]propionate	900 g/kg	1 October 2003	30 September 2013	Only use as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carfentrazone-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate.
61	Mesotrione CAS No 104206-8 CIPAC No 625	2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione	920 g/kg The manufacturing impurity 1-cyano-6-(methylsulfonyl)-7-nitro-9H-xanthen-9-one is considered to be of toxicological concern and must remain below 0,0002 % (w/w) in the technical product.	1 October 2003	30 September 2013	Only use as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mesotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account.
62	Fenamidone CAS No 161326-34-7 CIPAC No 650	(S)-5-methyl-2-methylthio-5-phenyl-3-phenylamino-3,5-dihydroimidazol-4-one	975 g/kg	1 October 2003	30 September 2013	Only use as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenamidone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of non-target arthropods, — should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate.
63	Isoxaflutole CAS No 141112-29-0 CIPAC No 575	5-cyclopropyl-4-(2-methylsulfonyl-4-trifluoromethylbenzoyl) isoxazole	950 g/kg	1 October 2003	30 September 2013	Only use as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isoxaflutole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures or monitoring programs should be applied where appropriate.
64	Flurtamone CAS No 96525-23-4	(RS)-5-methylamino-2-phenyl-4-(a,a,a-trifluoro-m-tolyl) furan-3 (2H)-one	960 g/kg	1 January 2004	31 December 2013	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flurtamone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of algae and other aquatic plants. Risk mitigation measures should be applied where appropriate.
65	Flufenacet CAS No 142459-58-3 CIPAC No 588	4′-fluoro-N-isopropyl-2-[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yloxy]acetanilide	950 g/kg	1 January 2004	31 December 2013	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flufenacet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of algae and aquatic plants, — should pay particular attention to the protection of operators. Risk mitigation measures should be applied where appropriate.
66	Iodosulfuron CAS No 185119-76-0 (parent) 144550-36-7 (iodosulfuron-methyl-sodium) CIPAC No 634 (parent) 634.501 (iodosulfuron-methyl-sodium)	4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-ureidosulfonyl]benzoate	910 g/kg	1 January 2004	31 December 2013	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iodosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential of iodosulfuron and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied where appropriate.
67	Dimethenamid-p CAS No 163515-14-8 CIPAC No 638	S-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy-1-methylethyl)-acetamide	890 g/kg (preliminary value based on a pilot plant)	1 January 2004	31 December 2013	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethenamid-p, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential of the metabolites of dimethenamid-p for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
68	Picoxystrobin CAS No 117428-22-5 CIPAC No 628	Methyl (E)-3-methoxy-2-{2-[6-(trifluoromethyl) -2- pyridyloxymethyl]phenyl} acrylate	950 g/kg (preliminary value based on a pilot plant)	1 January 2004	31 December 2013	Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on picoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of soil organisms, — should pay particular attention to the protection of aquatic ecosystems. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
69	Fosthiazate CAS No 98886-44-3 CIPAC No 585	(RS)-S-sec-butyl O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate	930 g/kg	1 January 2004	31 December 2013	Only uses as insecticide or nematicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosthiazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions; — should pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season; — should pay particular attention to the protection of non-target soil organisms. Risk mitigation measures should be applied where appropriate. In order to mitigate the potential risk to small birds, product authorisations must require that a very high level of incorporation of granules into soil is achieved. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
70	Silthiofam CAS No 175217-20-6 CIPAC No 635	N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide	950 g/kg	1 January 2004	31 December 2013	Only uses as fungicide may be authorised. Uses other than seed treatments are currently not adequately supported by data. To support authorisations for such uses, data and information to prove their acceptability for consumers, operators and the environment will have to be generated and submitted to the Member States. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on silthiofam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of operators. Risk mitigation measures must be applied, where appropriate.
71	Coniothyrium minitans Strain CON/M/91-08 (DSM 9660) CIPAC No 614	Not applicable	For details on purity and production control see Review Report	1 January 2004	31 December 2013	Only uses as fungicide may be authorised. When granting authorisations, the conclusions of the review report on Coniothyrium minitans, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the operator and worker safety and must ensure that the conditions of authorisation include appropriate protective measures.
72	Molinate CAS No 2212-67-1 CIPAC No 235	S-ethyl azepane-1-carbothioate; S-ethyl perhydroazepine-1-carbothioate; S-ethyl perhydroazepine-1-thiocarboxilate	950 g/kg	1 August 2004	31 July 2014	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on molinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for groundwater contamination, 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, — Member States should pay particular attention to the possibility of short-range transport of the active substance in air.
73	Thiram CAS No 137-26-8 CIPAC No 24	tetramethylthiuram disulfide; bis (dimethylthiocarbamoyl)-disulfide	960 g/kg	1 August 2004	►M43 30 April 2017 ◄	Only uses as fungicide or as repellent may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied, where appropriate, — Member States should pay particular attention to the protection of small mammals and birds when the substance is used as a seed treatment in spring uses. Risk mitigation measures should be applied, where appropriate.
74	Ziram CAS No 137-30-4 CIPAC No 31	Zinc bis (dimethyldithiocarbamate)	950 g/kg (FAO-specification) Arsenic: maximum 250 mg/kg Water: maximum 1,5 %	1 August 2004	►M43 30 April 2017 ◄	Only uses as fungicide or as repellent may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ziram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Risk mitigation measures should be applied, where appropriate, — Member States should observe the acute dietary exposure situation of consumers in view of future revisions of Maximum Residue Levels.
75	Mesosulfuron CAS No 400852-66-6 CIPAC No 441	2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-(methanesulfonamido)-p-toluic acid	930 g/kg	1 April 2004	31 March 2014	Only use as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mesosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of aquatic plants; — should pay particular attention to the potential of mesosulfuron and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate.
76	Propoxycarbazone CAS No 145026-81-9 CIPAC No 655	2-(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-yl) carboxamidosulfonylbenzoicacid-methylester	≥ 950 g/kg (expressed as propoxy-carbazone-sodium)	1 April 2004	31 March 2014	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propoxycarbazone, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential of propoxycarbazone and its metabolites for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants. Risk mitigation measures should be applied where appropriate.
77	Zoxamide CAS No 156052-68-5 CIPAC No 640	(RS)-3,5-Dichloro-N-(3-chloro-1-ethyl-1-methylacetonyl)-p-toluamide	950 g/kg	1 April 2004	31 March 2014	Only use as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on zoxamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken into account.
78	Chlorpropham CAS No 101-21-3 CIPAC No 43	Isopropyl 3-chlorophenylcarbamate	975 g/kg	1 February 2005	►M43 31 July 2017 ◄	Only uses as herbicide and sprout suppression may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorpropham, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, consumers and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate.
79	Benzoic acid CAS No 65-85-0 CIPAC No 622	benzoic acid	990 g/kg	1 June 2004	31 May 2014	Only uses as disinfectant may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benzoic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account.
80	Flazasulfuron CAS No 104040-78-0 CIPAC No 595	1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulphonyl)urea	940 g/kg	1 June 2004	31 May 2014	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flazasulfuron, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States — should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
81	Pyraclostrobin CAS No 175013-18-0 CIPAC No 657	methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate	975 g/kg The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product.	1 June 2004	31 May 2014	Only uses as fungicide or plant growth regulator may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of aquatic organisms, especially fish, — should pay particular attention to the protection of terrestrial arthropods and earthworms. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
82	Quinoxyfen CAS No 124495-18-7 CIPAC No 566	5, 7-dichloro-4 (ρ-fluorophenoxy) quinoline	970 g/kg	1 September 2004	►M43 30 April 2017 ◄	Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on quinoxyfen, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003, shall be taken into account. Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures must be applied and monitoring programmes must be initiated in vulnerable zones where appropriate.
83	Alpha-cypermethrin CAS No 67375-30-8 CIPAC No	Racemate comprising (S)-α- cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate and (R)-α- cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate (= cis-2 isomer pair of cypermethrin)	930 g/kg CIS-2	1 March 2005	►M43 31 July 2017 ◄	Only uses as insecticide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on alpha-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. — Member States must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures.
84	Benalaxyl CAS No 71626-11-4 CIPAC No 416	Methyl N-phenylacetyl–N-2, 6–xylyl–DL-alaninate	960 g/kg	1 March 2005	►M43 31 July 2017 ◄	Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benalaxyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the potential for groundwater contamination, 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.
85	Bromoxynil CAS No 1689-84-5 CIPAC No 87	3,5 dibromo – 4- hydroxybenzonitrile	970 g/kg	1 March 2005	►M43 31 July 2017 ◄	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bromoxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals, in particular if the substance is applied in winter, and of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.
86	Desmedipham CAS No 13684-56-5 CIPAC No 477	ethyl 3′-phenylcarbamoyloxycarbanilate ethyl 3-phenylcarbamoyloxyphenylcarbamate	Min. 970 g/kg	1 March 2005	►M43 31 July 2017 ◄	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on desmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms and earthworms. Risk mitigation measures should be applied if appropriate
87	Ioxynil CAS No 13684-83-4 CIPAC No 86	4- hydroxy- 3,5- di-iodobenzonitrile	960 g/kg	1 March 2005	28 February 2015	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ioxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied in winter and to aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.
88	Phenmedipham CAS No 13684-63-4 CIPAC No 77	methyl 3-(3-methylcarbaniloyloxy)carbanilate; 3-methoxycarbonylaminophenyl 3′-methylcarbanilate	Min. 970 g/kg	1 March 2005	►M43 31 July 2017 ◄	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phenmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.
89	Pseudomonas chlororaphis Strain: MA 342 CIPAC No 574	Not applicable	The amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the fermentate at the point of formulation of the product must not exceed the LOQ (2 mg/l).	1 October 2004	►M43 30 April 2017 ◄	Only uses as fungicide for seed dressing in closed seed dressing machinery may be authorised. When granting authorisations, the conclusions of the review report on Pseudomonas chlororaphis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account. In this overall assessment, Member States should pay particular attention to the safety of operators and workers. Risk mitigation measures should be applied where appropriate.
90	Mepanipyrim CAS No 110235-47-7 CIPAC No 611	N-(4-methyl-6-prop-1-ynylpyrimidin-2-yl)aniline	960 g/kg	1 October 2004	►M43 30 April 2017 ◄	Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mepanipyrim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate.
91	Acetamiprid CAS No 160430-64-8 CIPAC No Not yet allocated	(E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine	≥ 990 g/kg	1 January 2005	►M43 30 April 2017 ◄	Only uses as insecticide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Acetamiprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 June 2004 shall be taken into account. In this overall assessment Member States — should pay particular attention to worker exposure, — should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate.
92	Thiacloprid CAS No 111988-49-9 CIPAC No 631	(Z)-N-{3-[(6-Chloro-3-pyridinyl)methyl]-1,3-thiazolan-2-yliden}cyanamide	≥ 975 g/kg	1 January 2005	►M43 30 April 2017 ◄	Only uses as insecticide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Thiacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 June 2004 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of non-target arthropods, — should pay particular attention to the protection of aquatic organisms, — should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied where appropriate.
93	Ampelomyces quisqualis Strain: AQ 10 Culture collection No CNCM I-807 CIPAC No Not allocated	Not applicable		1 April 2005	►M43 31 July 2017 ◄	Only uses as fungicide may be authorised. When granting authorisations, the conclusions of the review report on Ampelomyces quisqualis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.
94	Imazosulfuron CAS No 122548-33-8 CIPAC No 590	1-(2-chloroimidazo[1,2-α]pyridin-3-ylsul-phonyl)-3-(4,6-dimethoxypyrimidin-2-yl)urea	≥ 980 g/kg	1 April 2005	►M43 31 July 2017 ◄	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic and terrestrial non-target plants. Risk mitigation measures should be applied where appropriate.
95	Laminarin CAS No 9008-22-4 CIPAC No 671	(1→3)-β-D-glucan (according to IUPAC-IUB Joint Commission on Biochemical Nomenclature)	≥ 860 g/kg on dry matter	1 April 2005	►M43 31 July 2017 ◄	Only uses as elicitor of the crop's self-defence mechanisms may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on laminarin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account.
96	Methoxyfenozide CAS No 161050-58-4 CIPAC No 656	N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide	≥ 970 g/kg	1 April 2005	►M43 31 July 2017 ◄	Only uses as insecticide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methoxyfenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of terrestrial and aquatic non-target arthropods. Risk mitigation measures should be applied where appropriate.
97	S-metolachlor CAS No 87392-12-9 (S-isomer) 178961-20-1 (R-isomer) CIPAC No 607	Mixture of: (aRS, 1 S)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (80-100 %) and: (aRS, 1 R)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (20-0 %)	≥ 960 g/kg	1 April 2005	►M43 31 July 2017 ◄	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on s-metolachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites CGA 51202 and CGA 354743, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied where appropriate.
98	Gliocladium catenulatum Strain: J1446 Culture collection No DSM 9212 CIPAC No Not allocated	Not applicable		1 April 2005	►M43 31 July 2017 ◄	Only uses as fungicide may be authorised. When granting authorisations, the conclusions of the review report on Gliocladium catenulatum, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account. In this overall assessment, Member States should pay particular attention to the protection of operators and workers. Risk mitigation measures should be applied where appropriate.
99	Etoxazole CAS No 153233-91-1 CIPAC No 623	(RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro-1,3-oxazol-4-yl] phenetole	≥ 948 g/kg	1 June 2005	►M43 31 July 2017 ◄	Only uses as acaricide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on etoxazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate.
100	Tepraloxydim CAS No 149979-41-9 CIPAC No 608	(EZ)-(RS)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one	≥ 920 g/kg	1 June 2005	►M134 31 May 2015 ◄	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tepraloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account. In this overall assessment, Member States should pay particular attention to the protection of terrestrial non-target arthropods. Risk mitigation measures should be applied where appropriate.
101	Chlorothalonil CAS No 1897-45-6 CIPAC No 288	Tetrachloroisophthalonitrile	985 g/kg — Hexachlorobenzene: not more than 0,04 g/kg — Decachlorobiphenyl: not more than 0,03 g/kg	1 March 2006	►M67 31 October 2017 ◄	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorothalonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee onthe Food Chain and Animal Health on 15 February 2005 shall be taken into account.In this overall assessment Members States must pay particular attention to the protection of: — aquatic organisms, — groundwater, in particular with regards to the active substance and its metabolites R417888 and R611965 (SDS46851), when the substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of use should include risk mitigation measures, where appropriate.
102	Chlorotoluron (unstated stereochemistry) CAS No 15545-48-9 CIPAC No 217	3-(3-chloro-p-tolyl)-1,1-dimethylurea	975 g/kg	1 March 2006	►M67 31 October 2017 ◄	PART AOnly uses as herbicide may be authorisedPART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate
103	Cypermethrin CAS No 52315-07-8 CIPAC No 332	(RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate (4 isomer pairs: cis-1, cis-2, trans-3, trans-4)	900 g/kg	1 March 2006	►M67 31 October 2017 ◄	PART AOnly uses as insecticide may be authorisedPART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate
104	Daminozide CAS No 1596-84-5 CIPAC No 330	N-dimethylaminosuccinamic acid	990 g/kg Impurities: — N-nitrosodimethylamine: not more than 2,0 mg/kg — 1,1-dimethylhydrazide: not more than 30 mg/kg	1 March 2006	►M67 31 October 2017 ◄	PART AOnly uses as growth regulator in non-edible crops may be authorisedPART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate
105	Thiophanate-methyl (unstated stereochemistry) CAS No 23564-05-8 CIPAC No 262	Dimethyl 4,4′-(o-phenylene)bis(3-thioallophanate)	950 g/kg	1 March 2006	►M67 31 October 2017 ◄	PART AOnly uses as fungicide may be authorisedPART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiophanate-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of aquatic organisms, earthworms and other soil macro-organisms. Conditions of authorisation should include risk mitigation measures, where appropriate
106	Tribenuron CAS No 106040-48-6 (tribenuron) CIPAC No 546	2-[4-methoxy-6-methyl-1,3,5-triazin-2-yl(methyl)carbamoylsulfamoyl]benzoic acid	950 g/kg (expressed as tribenuron-methyl)	1 March 2006	►M67 31 October 2017 ◄	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tribenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of non-target terrestrial plants, higher aquatic plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.
107	MCPA CAS No 94-74-6 CIPAC No 2	4-chloro-o-tolyloxyacetic acid	≥ 930 g/kg	1 May 2006	►M71 31 October 2017 ◄	PART AOnly uses as herbicide may be authorisedPART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into accountMember States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriateMember States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones
108	MCPB CAS No 94-81-5 CIPAC No 50	4-(4-chloro-o-tolyloxy)butyric acid	≥ 920 g/kg	1 May 2006	►M71 31 October 2017 ◄	PART AOnly uses as herbicide may be authorisedPART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into accountMember States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriateMember States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones
109	Bifenazate CAS No 149877-41-8 CIPAC No 736	Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate	≥ 950 g/kg	1 December 2005	►M43 31 July 2017 ◄	PART AOnly uses as acaricide may be authorised.PART BIn assessing applications to authorise plant protection products containing bifenazate for uses other than on ornamental plants in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenazate, 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.
110	Milbemectin Milbemectin is a mixture of M.A3 and M.A4 CAS No M.A3: 51596-10-2 M.A4: 51596-11-3 CIPAC No 660	M.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one M.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one	≥ 950 g/kg	1 December 2005	►M43 31 July 2017 ◄	PART AOnly uses as acaricide or insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on milbemectin, 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.In this overall assessment Member States should pay particular attention to the protection of aquatic organisms.Risk mitigation measures should be applied where appropriate.
111	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 2006	►M71 31 January 2018 ◄	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 approval.
112	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 2006	►M71 31 January 2018 ◄	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 approval.
113	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 2006	►M71 31 January 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 approval.
114	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 2006	►M71 31 January 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 approval.
115	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 2006	►M71 31 January 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 approval.
116	Oxamyl CAS No 23135-22-0 CIPAC No 342	N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide	970 g/kg	1 August 2006	►M86 31 January 2018 ◄	PART AOnly uses as nematicide and insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account. In this overall assessment, — Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate. — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms. They shall ensure that the notifiers at whose request oxamyl has been included in this Annex provide such studies to the Commission within two years from the approval.
117	1-methylcyclopropene (an ISO Common Name will not be considered for this active substance) CAS No 3100-04-7 CIPAC No not allocated	1-methylcyclopropene	≥ 960 g/kg The manufacturing impurities 1-chloro-2-methylpropene and 3-chloro-2-methylpropene are of toxicological concern and each of them must not exceed 0,5 g/kg in the technical material.	1 April 2006	►M67 31 October 2017 ◄	PART AOnly uses as plant growth regulator for post harvest storage in sealable warehouse may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1-methylcyclopropene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.
118	Forchlorfenuron CAS No 68157-60-8 CIPAC No 633	1-(2-chloro-4-pyridinyl)-3-phenylurea	≥ 978 g/kg	1 April 2006	►M67 31 October 2017 ◄	PART AOnly uses as plant growth regulator may be authorised.PART BIn assessing applications to authorise plant protection products containing forchlorfenuron for uses other than in kiwi plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on forchlorfenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.In this overall assessment Member States must pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.Risk mitigation measures should be applied where appropriate.
119	Indoxacarb CAS No 173584-44-6 CIPAC No 612	methyl (S)-N-[7-chloro-2,3,4a,5-tetrahydro-4a-(methoxycarbonyl)indeno[1,2-e][1,3,4]oxadiazin-2-ylcarbonyl]-4′-(trifluoromethoxy)carbanilate	TC (Technical Material): ≥ 628 g/kg indoxacarb	1 April 2006	►M67 31 October 2017 ◄	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on indoxacarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005 shall be taken into account.In this overall assessment Member States must pay particular attention to the protection of aquatic organisms.Conditions of use should include risk mitigation measures, where appropriate.
120	Warfarin CAS No 81-81-2 CIPAC No 70	(RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin 3-(α-acetonyl-benzyl)-4-hydroxycoumarin	≥ 990 g/kg	1 October 2006	30 September 2013	PART AOnly uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in specially constructed hoppers, are authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on warfarin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 September 2005, shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of operators, birds and non-target mammals.Risk mitigation measures should be applied where appropriate.
121	Clothianidin CAS No 210880-92-5 CIPAC No 738	(E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine	≥ 960 g/kg	1 August 2006	►M86 31 January 2018 ◄	►M65 PART AOnly professional uses as insecticide may be authorised.Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June:barley, millet, oats, rice, rye, sorghum, triticale, wheat.Foliar treatments shall not be authorised for the following cereals:barley, millet, oats, rice, rye, sorghum, triticale, wheat.Uses as seed treatment, soil treatment or foliar application shall not be authorised for the following crops with the exception of uses in greenhouses and with the exception of foliar treatments after flowering: Alfalfa (Medicago sativa) almonds (Prunus amygdalus; P. communis; Amygdalus communis) anise (Pimpinella anisum); badian or star anise (Illicium verum); caraway (Carum carvi); coriander (Coriandrum sativum); cumin (Cuminum cyminum); fennel (Foeniculum vulgare); juniper berries (Juniperus communis) apples (Malus pumila; M. sylvestris; M. communis; Pyrus malus) apricots (Prunus armeniaca) avocados (Persea americana) bananas (Musa sapientum; M. cavendishii; M. nana); beans (Phaseolus spp.) blackberry (Rubus fruticosus) blueberries, European blueberry, wild bilberry, whortleberry (Vaccinium myrtillus); American blueberry (V. corymbosum) broad beans, horse beans (Vicia faba var. major; var. equina; var. Minor) buckwheat (Fagopyrum esculentum) carobs, carob-tree, locust bean (Ceratonia siliqua) castor oil seed (Ricinus communis) cherries (Prunus avium) chestnuts (Castanea spp.) chick peas (Cicer arietinum) chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper (Pimenta officinalis) clovers (Trifolium spp.) coffee (Coffea spp. arabica, robusta, liberica) cotton (Gossypium spp.) cowpeas, black eyed peas (Vigna unguiculata) cranberries (Vaccinium macrocarpon); European cranberries (Vaccinum oxycoccus) cucumbers (Cucumis sativus) currants black (Ribes nigrum); red and white (R. rubrum) dates (Phoenix dactylifera) elderberries (Sambucus nigra) gooseberries (Ribes uva-crispa) grapefruit (C. paradisi) grapes (Vitis vinifera) groundnuts/peanuts (Arachis hypogea) hazelnut (Corylus avellana) hemp (Cannabis sativa) japanese rose (Rosa rugosa) kiwi fruit (Actinidia chinensis) leguminous: birdsfoot/trefoil (Lotus corniculatus); lespedeza (Lespedeza spp.); kudzu (Pueraria lobata); sesbania (Sesbania spp.); sainfoin, esparcette (Onobrychis sativa); sulla (Hedysarum coronarium) lemons and limes Lemon (Citrus limon); sour lime (C. aurantiifolia); sweet lime (C. limetta) lentils (Lens esculenta; Ervum lens) linseed (Linum usitatissimum) lupins (Lupinus spp.) maize/corn (Zea mays) melon seeds (Cucumis melo) mustard seeds: white mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra) okra (Abelmoschus esculentus); gombo (Hibiscus esculentus) olives (Olea europaea) oranges: sweet orange (Citrus sinensis); bitter orange (C. aurantium) peaches and nectarines (Prunus persica; Amygdalus persica; Persica laevis) pears (Pyrus communis) peas garden pea (Pisum sativum); field pea (P. arvense) peppermint (Mentha spp.: M. piperita) persimmons (Diospyros kaki: D. virginiana) pistachios (Pistacia vera) plums and sloes greengage, mirabelle, damson (Prunus domestica); sloe (P. spinosa) poppy seed (Papaver somniferum) pumpkins, squash, gourds and marrows (Cucurbita spp.) pyrethrum, (Chrysanthemum cinerariifolium) quinces (Cydonia oblonga; C. vulgaris; C. japonica) rapeseed (Brassica napus var. oleifera) raspberries (Rubus idaeus) safflower seed (Carthamus tinctorius) serradella/birds foot (Ornithopus sativus) sesame seed (Sesamum indicum) soybeans (Glycine soja) spices: bay leaves (Laurus nobilis); dill seed (Anethum graveolens); fenugreek seed (Trigonella foenumgraecum); saffron (Crocus sativus); thyme (Thymus vulgaris); turmeric (Curcuma longa) strawberries (Fragaria spp.) sunflower seed (Helianthus annuus) tangerine (Citrus tangerina); mandarin (Citrus reticulata); clementine (C. unshiu); turnips and turnip rapes (Brassica rapa var. rapifera and oleifera spp.) vetches Spring/common vetch (Vicia sativa) viper’s Grass (Scorzonera hispanica) walnuts (Jugland spp.: J. regia) watermelons (Citrullus vulgaris) ornamentals flowering in year of treatment. PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clothianidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 and the conclusions of the addendum of the review report on clothianidin as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — the risk to granivorous birds and mammals when the substance is used as a seed dressing. Member States shall ensure that: — the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised, — adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission, — the conditions of the authorisation include, where appropriate, risk mitigation measures to protect bees, — monitoring programmes are initiated to verify the real exposure of bees to clothianidin in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. Conditions of use shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards: (a) the risk to pollinators other than honey bees; (b) the risk to honey bees foraging in nectar or pollen in succeeding crops; (c) the potential uptake via roots to flowering weeds; (d) the risk to honey bees foraging on insect honey dew; (e) the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure; (f) the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure; (g) the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen. The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2014. ◄
122	Pethoxamid CAS No 106700-29-2 CIPAC No 655	2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide	≥ 940 g/kg	1 August 2006	►M86 31 January 2018 ◄	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pethoxamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.In this overall assessment Member States — must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — must pay particular attention to the protection of the aquatic environment, in particular higher aquatic plants. Conditions of use shall include risk mitigation measures, where appropriate.The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
123	Clodinafop CAS No 114420-56-3 CIPAC No 683	(R)-2-[4-(5-chloro-3-fluoro- 2 pyridyloxy)-phenoxy]-propionic acid	≥ 950 g/kg (expressed as clodinafop-propargyl)	1 February 2007	►M113 30 April 2018 ◄	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clodinafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.
124	Pirimicarb CAS No 23103-98-2 CIPAC No 231	2-dimethylamino-5,6-dimethylpyrimidin-4-yl dimethylcarbamate	≥ 950 g/kg	1 February 2007	►M113 30 April 2018 ◄	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.Member States must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment.Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones.The concerned Member States shall request the submission of further studies to confirm the long term risk assessment for birds and for potential groundwater contamination, in particular concerning metabolite R35140. They shall ensure that the notifiers at whose request pirimicarb has been included in this Annex provide such studies to the Commission within two years from the approval.
125	Rimsulfuron CAS No 122931-48-0 (rimsulfuron) CIPAC No 716	1-(4-6 dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl) urea	≥ 960 g/kg (expressed as rimsulfuron)	1 February 2007	►M113 30 April 2018 ◄	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on rimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.Member States must pay particular attention to the protection of non target plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.
126	Tolclofos-methyl CAS No 57018-04-9 CIPAC No 479	O-2,6-dichloro-p-tolyl O,O-dimethyl phosphorothioate O-2,6-dichloro-4-methylphenyl O,O-dimethyl phosphorothioate	≥ 960 g/kg	1 February 2007	►M113 30 April 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BIn assessing applications to authorise plant protection products containing tolclofos-methyl for uses other than pre-planting tuber (seed) treatment in potato and soil treatment in lettuce within greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tolclofos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.
127	Triticonazole CAS No 131983-72-7 CIPAC No 652	(±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol	≥ 950 g/kg	1 February 2007	►M113 30 April 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BIn assessing applications to authorise plant protection products containing triticonazole for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triticonazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate, — must pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones, — must pay particular attention to the protection of granivorous birds (long term risk). Conditions of authorisation should include risk mitigation measures, where appropriate.The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds. They shall ensure that the notifier at whose request triticonazole has been included in this Annex provide such studies to the Commission within two years from the approval.
128	Dimoxystrobin CAS No 149961-52-4 CIPAC No 739	(E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide	≥ 980 g/kg	1 October 2006	►M86 31 January 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BIn assessing applications to authorise plant protection products containing dimoxystrobin for indoor uses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.In this overall assessment Member States — must pay particular attention to the protection of groundwater, when the active substance is applied in a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions; — must pay particular attention to the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate.The concerned Member States shall request the submission of — a refined risk assessment for birds and mammals considering the formulated active substance; — a comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage. They shall ensure that the notifiers at whose request dimoxystrobin has been included in this Annex provide such studies to the Commission within two years from the approval.
129	Clopyralid CAS No 1702-17-6 CIPAC No 455	3,6-dichloropyridine-2-carboxylic acid	≥ 950 g/kg	1 May 2007	►M120 30 April 2018 ◄	PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing clopyralid for uses other than spring applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the protection of non target plants and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate. The concerned Member States shall request the submission of further studies to confirm the results on animal metabolism. They shall ensure that the notifiers at whose request clopyralid has been included in this Annex provide such studies to the Commission within two years from the approval.
130	Cyprodinil CAS No 121522-61-2 CIPAC No 511	(4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine	≥ 980 g/kg	1 May 2007	►M120 30 April 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.In this overall assessment Member States: — must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — must pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA 304075 in food of animal origin. They shall ensure that the notifiers at whose request cyprodinil has been included in this Annex provide such studies to the Commission within two years from the approval.
131	Fosetyl CAS No 15845-66-6 CIPAC No 384	Ethyl hydrogen phosphonate	≥ 960 g/kg (expressed as fosetyl-Al)	1 May 2007	►M120 30 April 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones.The concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Annex provide such studies to the Commission within two years from the approval.
132	Trinexapac CAS No 104273-73-6 CIPAC No 732	4-(cyclopropyl-hydroxymethylene)-3,5-dioxo- cyclohexanecarboxylic acid	≥ 940 g/kg (expressed as trinexapac-ethyl)	1 May 2007	►M120 30 April 2018 ◄	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on trinexapac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.In this overall assessment Member States: — must pay particular attention to the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate.
133	Dichlorprop-P CAS No 15165-67-0 CIPAC No 476	(R)-2-(2,4-dichlorophenoxy) propanoic acid	≥ 900 g/kg	1 June 2007	►M121 30 April 2018 ◄	►M89 PART AOnly uses as herbicide may be authorised.As regards cereals, only application in spring may be authorised, at rates not exceeding 800 g active substance per hectare per application.Use on grassland shall not be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dichlorprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants.Conditions of authorisation shall include risk mitigation measures, where appropriate. ◄
134	Metconazole CAS No 125116-23-6 (unstated stereo-chemistry) CIPAC No 706	(1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol	≥ 940 g/kg (sum of cis-and trans-isomers)	1 June 2007	►M121 30 April 2018 ◄	PART AOnly uses as fungicide and plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.
135	Pyrimethanil CAS No 53112-28-0 CIPAC No not allocated	N-(4,6-dimethylpyrimidin-2-yl) aniline	≥ 975 g/kg (the manufacturing impurity cyanamide is considered to be of toxicological concern and must not exceed 0,5 g/kg in the technical material)	1 June 2007	►M120 30 April 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyrimethanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.In this overall assessment Member States: — must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment to fish. They shall ensure that the notifiers at whose request pyrimethanil has been included in this Annex provide such studies to the Commission within two years from the approval.
136	Triclopyr CAS No 055335-06-3 CIPAC No 376	3,5,6-trichloro-2-pyridyloxyacetic acid	≥ 960 g/kg (as Triclopyr butoxyethyl ester)	1 June 2007	►M121 30 April 2018 ◄	►M137 PART AOnly uses as herbicide may be authorised. Only uses with a total application per year of maximum 480 g active substance per hectare shall be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014 shall be taken into account.In this overall assessment Member States: — shall pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated in vulnerable zones, where appropriate, — shall pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate. ◄
137	Metrafenone CAS No 220899-03-6 CIPAC No 752	3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone	≥ 940 g/kg	1 February 2007	►M113 30 April 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metrafenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
138	Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713 Culture collection No: NRRL B -21661 CIPAC No not allocated	Not applicable		1 February 2007	►M113 30 April 2018 ◄	►M154 PART AOnly uses as fungicide and bactericide may be authorised. ◄ PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus subtilis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.
139	Spinosad CAS No 131929-60-7 (Spinosyn A) 131929-63-0 (Spinosyn D) CIPAC No 636	Spinosyn A: (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione Spinosyn D: (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D	≥ 850 g/kg	1 February 2007	►M113 30 April 2018 ◄	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spinosad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.In this overall assessment Member States — must pay particular attention to the protection of aquatic organisms; — must pay particular attention to the risk to earthworms when the substance is used in glasshouses. Conditions of use shall include risk mitigation measures, where appropriate.
140	Thiamethoxam CAS No 153719-23-4 CIPAC No 637	(E,Z)-3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine	≥ 980 g/kg	1 February 2007	►M113 30 April 2018 ◄	►M65 PART AOnly professional uses as insecticide may be authorised.Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June:barley, millet, oats, rice, rye, sorghum, triticale, wheat.Foliar treatments shall not be authorised for the following cereals:barley, millet, oats, rice, rye, sorghum, triticale, wheat.Uses as seed treatment, soil treatment or foliar application shall not be authorised for the following crops with the exception of uses in greenhouses and with the exception of foliar treatment after flowering: Alfalfa (Medicago sativa) almonds (Prunus amygdalus; P. communis; Amygdalus communis) anise (Pimpinella anisum); badian or star anise (Illicium verum); caraway (Carum carvi); coriander (Coriandrum sativum); cumin (Cuminum cyminum); fennel (Foeniculum vulgare); juniper berries (Juniperus communis) apples (Malus pumila; M. sylvestris; M. communis; Pyrus malus) apricots (Prunus armeniaca) avocados (Persea americana) bananas (Musa sapientum; M. cavendishii; M. nana) beans (Phaseolus spp.) blackberry (Rubus fruticosus) blueberries, European blueberry, wild bilberry, whortleberry (Vaccinium myrtillus); American blueberry (V. corymbosum) broad beans, horse beans (Vicia faba var. major; var. equina; var. Minor) buckwheat (Fagopyrum esculentum) carobs, carob-tree, locust bean (Ceratonia siliqua) castor oil seed (Ricinus communis) cherries (Prunus avium) chestnuts (Castanea spp.) chick peas (Cicer arietinum) chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper (Pimenta officinalis) clovers (Trifolium spp.) coffee (Coffea spp. arabica, robusta, liberica) cotton (Gossypium spp.) cowpeas, black eyed peas (Vigna unguiculata) cranberries (Vaccinium macrocarpon); European cranberries (Vaccinum oxycoccus) cucumbers (Cucumis sativus) currants black (Ribes nigrum); red and white (R. rubrum) dates (Phoenix dactylifera) elderberries (Sambucus nigra) gooseberries (Ribes uva-crispa) grapefruit (C. paradisi) grapes (Vitis vinifera) groundnuts/peanuts (Arachis hypogea) hazelnut (Corylus avellana) hemp (Cannabis sativa) japanese rose (Rosa rugosa) kiwi fruit (Actinidia chinensis) leguminous: birdsfoot/trefoil (Lotus corniculatus); lespedeza (Lespedeza spp.); kudzu (Pueraria lobata); sesbania (Sesbania spp.); sainfoin, esparcette (Onobrychis sativa); sulla (Hedysarum coronarium) lemons and limes Lemon (Citrus limon); sour lime (C. aurantiifolia); sweet lime (C. limetta) lentils (Lens esculenta; Ervum lens) linseed (Linum usitatissimum) lupins (Lupinus spp.) maize/corn (Zea mays) melon seeds (Cucumis melo) mustard seeds: white mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra) okra (Abelmoschus esculentus); gombo (Hibiscus esculentus) olives (Olea europaea) oranges: sweet orange (Citrus sinensis); bitter orange (C. aurantium) peaches and nectarines (Prunus persica; Amygdalus persica; Persica laevis) pears (Pyrus communis) peas garden pea (Pisum sativum); field pea (P. arvense) peppermint (Mentha spp.: M. piperita) persimmons (Diospyros kaki: D. virginiana) pistachios (Pistacia vera) plums and sloes greengage, mirabelle, damson (Prunus domestica); sloe (P. spinosa) poppy seed (Papaver somniferum) pumpkins, squash, gourds and marrows (Cucurbita spp.) pyrethrum, (Chrysanthemum cinerariifolium) quinces (Cydonia oblonga; C. vulgaris; C. japonica) rapeseed (Brassica napus var. oleifera) raspberries (Rubus idaeus) safflower seed (Carthamus tinctorius) serradella/birds foot(Ornithopus sativus) sesame seed (Sesamum indicum) soybeans (Glycine soja) spices: bay leaves (Laurus nobilis); dill seed (Anethum graveolens); fenugreek seed (Trigonella foenumgraecum); saffron (Crocus sativus); thyme (Thymus vulgaris); turmeric (Curcuma longa) strawberries (Fragaria spp.) sunflower seed (Helianthus annuus) tangerine (Citrus tangerina); mandarin (Citrus reticulata) clementine (C. unshiu); turnips andturnip rapes (Brassica rapa var. rapifera and oleifera spp.) vetches Spring/common vetch (Vicia sativa) viper’s Grass (Scorzonera hispanica) walnuts (Jugland spp.: J. regia) watermelons (Citrullus vulgaris) ornamentals flowering in year of treatment. PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiamethoxam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 and the conclusions of the addendum of the review report on thiamethoxam as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the potential for groundwater contamination, particularly of the active substance and its metabolites NOA 459602, SYN 501406 and CGA 322704, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic organisms, — the long-term risk to small herbivorous animals if the substance is used for seed treatment. Member States shall ensure that: — the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised, — adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission, — the conditions of the authorisation include, where appropriate, risk mitigation measures to protect bees, — monitoring programmes are initiated to verify the real exposure of bees to thiamethoxam in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. Conditions of use shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards: (a) the risk to pollinators other than honey bees; (b) the risk to honey bees foraging in nectar or pollen in succeeding crops; (c) the potential uptake via roots to flowering weeds; (d) the risk to honey bees foraging on insect honey dew; (e) the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure; (f) the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure; (g) the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen. The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2014. ◄
141	Fenamiphos CAS No 22224-92-6 CIPAC No 692	(RS)-ethyl 4-methylthio-m-tolyl isopropyl-phosphoramidate	≥ 940 g/kg	1 August 2007	►M140 31 July 2018 ◄	PART AOnly uses as nematicide applied by drip irrigation in greenhouses with permanent structure may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenamiphos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, soil non-target organisms and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate.
142	Ethephon CAS No 16672-87-0 CIPAC No 373	2-chloroethyl-phosphonic acid	≥ 910 g/kg (technical material — TC) The manufacturing impurities MEPHA (Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid) and 1,2-Dichloroethane are of toxicological concern and must not exceed respectively 20 g/kg and 0,5 g/kg in the technical material.	1 August 2007	►M140 31 July 2018 ◄	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.
143	Flusilazole (2) CAS No 85509-19-9 CIPAC No 435	Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane	925 g/kg	1 January 2007	30 June 2008 (2)	PART AOnly uses as fungicide on the following crops may be authorised: — cereals other than rice (2), — maize (2), — rape seed (2), — sugar beet (2), at rates not exceeding 200 g active substance per hectare per application.The following uses must not be authorised: — air application, — knapsack and hand-held applications, neither by amateur nor by professional users, — home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of: — aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices, — birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, — operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flusilazole, and in particular Appendices I and II thereof, shall be taken into account.Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained.Member States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shallensure that the notifier at whose request flusilazole has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines.
▼M2
144	Carbendazim CAS No 10605-21-7 CIPAC No 263	Methyl benzimidazol-2-ylcarbamate	≥ 980 g/kg Relevant impurities 2-amino-3-hydroxyphenazine (AHP): not more than 0,0005 g/kg 2,3-diaminophenazine (DAP): not more than 0,003 g/kg	1 June 2011	30 November 2014	PART AOnly uses as fungicide on the following crops may be authorised: — cereals — rape seed — sugar and fodder beet — maize at rates not exceeding — 0,25 kg active substance per hectare per application for cereals and rape seed; — 0,075 kg active substance per hectare per application for sugar and fodder beet — 0,1 kg active substance per hectare per application for maize. The following uses must not be authorised: — air application; — knapsack and handheld applications neither by amateur nor by professional users; — home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of: — aquatic organisms. Appropriate drift mitigation measures must be applied to minimise the exposure of surface water bodies. This should include keeping a distance between treated areas and surface water bodies alone or in combination with the use of drift-reducing techniques or devices; — earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, and, if necessary, the degree of concentration of the active substance; — birds (long term risk). Depending on the results of the risk assessment for specific uses, targeted mitigation measures to minimise the exposure may become necessary; — operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carbendazim, and in particular Appendices I and II thereof, shall be taken into account.The Member States concerned shall request that the applicant provides the following to the Commission: — by 1 December 2011 at the latest, information as regards the toxicological and ecotoxicological relevance of the impurity AEF037197; — by 1 June 2012 at the latest, the examination of the studies included in the list in the draft re-assessment report of 16 July 2009 (Volume 1, Level 4 ‘Further information’, pp. 155 – 157); — by 1 June 2013 at the latest, information on the fate and behaviour (route of aerobic degradation in soil) and the long term risk to birds.
▼B
145	Captan CAS No 133-06-02 CIPAC No 40	N-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide	≥ 910 g/kg Impurities: Perchloromethylmercaptan (R005406): not more than 5 g/kg Folpet: not more than 10 g/kg Carbon tetrachloride not more than 0,1 g/Kg	1 October 2007	►M139 31 July 2018 ◄	PART AOnly uses as fungicide can be authorised.PART BIn assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 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; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; — the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate; — the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures. The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the approval.
146	Folpet CAS No 133-07-3 CIPAC No 75	N-(trichloromethylthio) phthalimide	≥ 940 g/kg Impurities: Perchloromethylmercaptan (R005406): not more than 3,5 g/kg Carbon tetrachloride not more than 4 g/kg	1 October 2007	►M139 31 July 2018 ◄	PART AOnly uses as fungicide can be authorised.PART BIn assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.In this overall assessment Member States must pay particular attention to: — operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; — the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the approval.
147	Formetanate CAS No 23422-53-9 CIPAC No 697	3-dimethylaminomethyleneaminophenyl methylcarbamate	≥ 910 g/kg	1 October 2007	►M139 31 July 2018 ◄	PART AOnly uses as insecticide and acaricide may be authorised.PART BIn assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the approval.
148	Methiocarb CAS No 2032-65-7 CIPAC No 165	4-methylthio-3,5-xylyl methylcarbamate	≥ 980 g/kg	1 October 2007	►M139 31 July 2018 ◄	►M107 PART AOnly uses as repellent in seed treatment and insecticide may be authorised.PART BIn assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methiocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the protection of birds, mammals and non-target arthropods, ensuring that the conditions of authorisation include risk mitigation measures, where appropriate; — the operator and bystander safety, ensuring that the conditions of use prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers. ◄
149	Dimethoate CAS No 60-51-5 CIPAC No 59	O,O-Dimethyl-S-(N-methylcarbamoylmethyl) phosphorodithioate; 2-Dimethoxy-phosphinothioylthio-N-methylacetamide	≥ 950 g/kg Impurities: — omethoate: not more than 2 g/kg — isodimethoate: not more than 3 g/kg	1 October 2007	►M139 31 July 2018 ◄	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethoate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water; — must pay particular attention to the dietary exposure of consumers; — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops.They shall ensure that the notifier at whose request dimethoate has been included in this Annex provides such studies to the Commission within two years from the approval.
150	Dimethomorph CAS No 110488-70-5 CIPAC No 483	(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl]morpholine	≥ 965 g/kg	1 October 2007	►M139 31 July 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethomorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 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; — to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.
151	Glufosinate CAS No 77182-82-2 CIPAC No 437.007	ammonium(DL)-homoalanin-4-yl(methyl)phosphinate	950 g/kg	1 October 2007	►M139 31 July 2018 ◄	►M57 PART AOnly uses as herbicide for band or spot application may be authorised at rates not exceeding 750 g active substance/ha (treated surface) per application and maximum two applications per year.PART BIn assessing applications to authorise plant protection products containing glufosinate, notably as regards the operator and consumer exposure, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on glufosinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the operator, worker and bystander safety; conditions of authorisation shall include protective measures, where appropriate; (b) the potential for groundwater contamination, where the active substance is applied in regions with vulnerable soil or climatic conditions; (c) the protection of mammals, non-target arthropods and non-target plants. Conditions of authorisation shall include the application of drift reducing nozzles and spray shields and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate. ◄
152	Metribuzin CAS No 21087-64-9 CIPAC No 283	4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one	≥ 910 g/kg	1 October 2007	►M139 31 July 2018 ◄	PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing metribuzin for uses other than in post-emergence selective herbicide in potatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metribuzin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.In this overall assessment Member States: — must pay particular attention to the protection of algae, aquatic plants, non-target plants outside the treated field and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further data to confirm the risk assessment for groundwater. They shall ensure that the notifiers at whose request metribuzin has been included in this Annex provide such studies to the Commission within two years from the approval.
153	Phosmet CAS No 732-11-6 CIPAC No 318	O,O-dimethyl S-phthalimidomethyl phosphorodithioate; N-(dimethoxyphosphinothioylthiomethyl)phatalimide	≥ 950 g/kg Impurities: — phosmet oxon: not more than 0,8 g/kg — iso phosmet: not more than 0,4 g/kg	1 October 2007	►M139 31 July 2018 ◄	PART AOnly uses as insecticide and acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phosmet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water, — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds (acute risk) and herbivorous mammals (long term risk). They shall ensure that the notifier at whose request phosmet has been included in this Annex provides such studies to the Commission within two years from the approval.
154	Propamocarb CAS No 24579-73-5 CIPAC No 399	Propyl 3-(dimethylamino) propylcarbamate	≥ 920 g/kg	1 October 2007	►M139 31 July 2018 ◄	PART AOnly uses as fungicide may be authorised.PART BIn assessing applications to authorise plant protection products containing propamocarb for uses other than foliar applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, as regards worker exposure and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propamocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Conditions of authorisation should include protective measures, where appropriate; — the transfer of soil residues for rotating or succeeding crops; — the protection of surface and groundwater in vulnerable zones; — the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.
155	ethoprophos CAS No 13194-48-4 CIPAC No 218	O-ethyl S,S-dipropyl phosphorodithioate	> 940 g/kg	1 October 2007	►M139 31 July 2018 ◄	►M93 PART AOnly uses as nematicide and insecticide in soil application may be authorised. Only one application per season may be authorised, at a rate not exceeding 6 kg active substance/ha.Authorisations shall be limited to professional users.PART BIn assessing applications to authorise plant protection products containing ethoprophos for uses other than potatoes not cultivated for human or animal consumption, Member States shall pay particular attention to the criteria in Article 29(1) of Regulation (EC) No 1107/2009 and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethoprophos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007, shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the dietary exposure of consumers; (b) the operator safety, ensuring that the conditions of use prescribe the application of adequate personal and respiratory protective equipment and other risk mitigation measures such as the use of a closed transfer system for the distribution of the product; (c) the protection of birds, mammals, aquatic organisms, surface and groundwater under vulnerable conditions. Conditions of authorisation shall include risk mitigation measures, such as buffer zones and the achievement of complete incorporation of granules in the soil. ◄
156	Pirimiphos-methyl CAS No 29232-93-7 CIPAC No 239	O-2-diethylamino-6-methylpyrimidin-4-yl O,O-dimethylphosphorothioate	> 880 g/kg	1 October 2007	►M139 31 July 2018 ◄	PART AOnly uses as insecticide for post harvest storage can be authorised.Hand-held applications shall not be authorised.PART BIn assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.
157	Fipronil CAS No 120068-37-3 CIPAC No 581	(±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile	≥ 950 g/kg	1 October 2007	►M139 31 July 2018 ◄	►M73 PART AOnly uses as insecticide for use as seed treatment may be authorised. Uses shall only be authorised for seeds intended to be sown in greenhouses and seeds of leek, onions, shallots and the group of Brassica vegetables intended to be sown in fields and harvested before flowering.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 and the conclusions of the addendum of the review report on fipronil as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the packaging of the marketed products to avoid the generation of photodegradation products of concern; (b) the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (c) the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees. Member States shall also ensure that: (a) the seed coating shall only be performed in professional seed treatment facilities; those facilities shall apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised; (b) adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission; (c) the label of the treated seeds shall include the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation; (d) monitoring programmes shall be initiated to verify the real exposure of bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. Conditions of use shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards: (a) the risk to pollinators other than honey bees; (b) the acute and long-term risk to colony survival and development, and the risk to bee brood from plant and soil metabolites, except the soil photolysis metabolites; (c) the potential exposure to dust drift emitted during the drilling procedure and the acute and long-term risk to colony survival and development, and the risk to bee brood for situations where bees forage on vegetation exposed to dust drift; (d) the acute and long-term risk to colony survival and development, and the risk to bee brood from foraging on insect honeydew; (e) the potential exposure to guttation fluid and the acute and long-term risk to colony survival and development, and the risk to bee brood; (f) the potential exposure to residues in nectar and pollen, honeydew and guttation fluid of succeeding crops or weeds occurring in fields, including the persistent soil metabolites (RPA 200766, MB 46136 and MB 45950). The notifier shall submit that information to the Commission, the Member States and the Authority by 30 March 2015. ◄
158	Beflubutamid CAS No 113614-08-7 CIPAC No 662	(RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide	≥ 970 g/kg	1 December 2007	►M139 31 July 2018 ◄	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.In this overall assessment Member States: — must pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate.
159	Spodoptera exigua nuclear polyhedrosis virus CIPAC No Not allocated	Not applicable		1 December 2007	30 November 2017	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Spodoptera exigua NPV, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account.
160	Prosulfocarb CAS No 52888-80-9 CIPAC No 539	S-benzyl dipropyl(thiocarbamat)	970 g/kg	1 November 2008	31 October 2018	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 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 and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone.
161	Fludioxonil CAS No 131341-86-1 CIPAC No 522	4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile	950 g/kg	1 November 2008	31 October 2018	PART AOnly uses as fungicide may be authorised.PART BIn assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted and: — must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones, — must pay particular attention to the protection of fish and aquatic invertebrates. Conditions of authorisation should include risk mitigation measures, where appropriate.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.
162	Clomazone CAS No 81777-89-1 CIPAC No 509	2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one	960 g/kg	1 November 2008	31 October 2018	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 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 non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones.
163	Benthiavalicarb CAS No 413615-35-7 CIPAC No 744	[(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid	≥ 910 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: 6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg bis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg	1 August 2008	31 July 2018	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benthiavalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the operator safety, — the protection of non-target arthropods. Conditions of use shall include adequate risk mitigation measures, where appropriate.In assessing applications to authorise plant protection products containing benthiavalicarb for uses other than in glasshouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
164	Boscalid CAS No 188425-85-6 CIPAC No 673	2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide	≥ 960 g/kg	1 August 2008	31 July 2018	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.In this overall assessment Member States must pay particular attention — to the operator safety, — to the long term risk to birds and soil organisms, — to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include adequate risk mitigation measures, where appropriate.
165	Carvone CAS No 99-49-0 (d/l mixture) CIPAC No 602	5-isopropenyl-2-methylcyclohex-2-en-1-one	≥ 930 g/kg with a d/l ratio of at least 100:1	1 August 2008	31 July 2018	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carvone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to the operator safety.Conditions of use shall include risk mitigation measures, where appropriate.
166	Fluoxastrobin CAS No 361377-29-9 CIPAC No 746	(E)-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime	≥ 940 g/kg	1 August 2008	31 July 2018	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield, — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate, — the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include risk mitigation measures, where appropriate.The concerned Member States shall request the submission of: — data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures, — data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff. They shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the approval.
167	Paecilomyces lilacinus (Thom) Samson 1974 strain 251 (AGAL: No 89/030550) CIPAC No 753	Not applicable		1 August 2008	31 July 2018	PART AOnly uses as nematicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Paecilomyces lilacinus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers), — the protection of leaf dwelling non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate.
168	Prothioconazole CAS No 178928-70-6 CIPAC No 745	(RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione	≥ 970 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: — Toluene: < 5 g/kg — Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD)	1 August 2008	31 July 2018	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the operator safety in spray applications. Conditions of use shall include adequate protective measures, — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate. Conditions of use shall include risk mitigation measures, where appropriate.The concerned Member States shall request the submission of: — information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin, — a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds, — information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment. They shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the approval.
169	Amidosulfuron CAS No 120923-37-7 CIPAC No 515	3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea or 1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea	≥ 970 g/kg	1 January 2009	31 December 2018	PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.
170	Nicosulfuron CAS No 111991-09-4 CIPAC No 709	2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide or 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea	≥ 910 g/kg	1 January 2009	31 December 2018	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions, — the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone, — the protection of groundwater and surface water under vulnerable soil and climatic conditions.
171	Clofentezine CAS No 74115-24-5 CIPAC No 418	3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine	≥ 980 g/kg (dry material)	1 January 2009	31 December 2018	PART AOnly uses as acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 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, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate; — the potential for long range transport via air; — the risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier presents to the Commission a monitoring programme to assess the potential for long-range atmospheric transport of clofentezine and the related environmental risks by 31 July 2011. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State and to the Commission by 31 July 2013.The Member States concerned shall ensure that the notifier submits to the Commission confirmatory studies on clofentezine metabolites relating to their toxicological and environmental risk assessment by 30 June 2012.
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172	Dicamba CAS No 1918-00-9 CIPAC No 85	3,6-dichloro-2-methoxybenzoic acid	≥ 850 g/kg	1 January 2009	31 December 2018	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of non-target plants.Conditions of use shall include adequate risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards: (a) the identification and quantification of a group of soil transformation products formed in a soil incubation study; (b) the potential for long range transport through the atmosphere. The notifier shall submit this information to the Member States, the Commission and the Authority by 30 November 2013.
173	Difenoconazole CAS No 119446-68-3 CIPAC No 687	3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether	≥ 940g/kg Toluene maximum content: 5 g/kg	1 January 2009	31 December 2018	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.Conditions of use shall include adequate risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards: (a) further data on the specification of the technical material; (b) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin; (c) the potential for endocrine disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 (16); (d) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012, the information set out in points (b) and (c) by 30 November 2013 and the information set out in point (d) within 2 years from the adoption of specific guidance.
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174	Diflubenzuron CAS No 35367-38-5 CIPAC No 339	1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl) urea	≥ 950 g/kg impurity: max. 0,03 g/kg 4-chloroaniline	1 January 2009	31 December 2018	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as finalised inthe Standing Committee on the Food Chain and Animal Health on 11 May 2010 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, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; — the protection of aquatic organisms; — the protection of terrestrial organisms; — the protection of non-target arthropods including bees. Conditions of use shall include adequate risk mitigation measures, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further studies to address the potential toxicological relevance of the impurity and metabolite 4-chloroaniline (PCA) by 30 June 2011.
▼M23
175	Imazaquin CAS No 81335-37-7 CIPAC No 699	2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]quinoline-3-carboxylic acid	≥ 960 g/kg (racemic mixture)	1 January 2009	31 December 2018	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into accountThe notifier shall submit confirmatory information as regards: (a) further data on the specification of the technical material; (b) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012 and the information set out in point (b) within 2 years from the adoption of specific guidance.
▼B
176	Lenacil CAS No 2164-08-1 CIPAC No 163	3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione	≥ 975 g/kg	1 January 2009	31 December 2018	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies; — the protection of the groundwater, where the active substance is applied in regions with vulnerable soil 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 IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission confirmatory information on the identity and characterisation of soil metabolites Polar B and Polars and metabolites M1, M2 and M3 whichoccurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.If a decision on the classification of lenacil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) identifies the need for further information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3, Polar B and Polars, the Member States concerned shall request the submission of such information. They shall ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision.
177	Oxadiazon CAS No 19666-30-9 CIPAC No 213	5-tert-butyl-3-(2,4-dichloro-5-isopropoxyphenyl)-1,3,4-oxadiazol-2(3H)-one	≥ 940 g/kg	1 January 2009	31 December 2018	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 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, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; — the potential for ground water contamination by the metabolite AE0608022 where the active substance is applied in situations for which prolonged anaerobic conditions may be expected to occur or in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission: — further studies to address the potential toxicological relevance of an impurity in the proposed technical specification; — information to further clarify the occurrence of metabolite AE0608033 in primary crops and rotational crops; — further trials on rotational crops (namely root crops and cereals) and a metabolism study on ruminants to confirm the consumer risk assessment; — information to further address the risk to earthworm-eating birds and mammals, and the long-term risk to fish. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.
178	Picloram CAS No 1918-02-1 CIPAC No 174	4-amino-3,5,6-trichloropyridine-2-carboxylic acid	≥ 920 g/kg	1 January 2009	31 December 2018	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.In the overall assessment Member States must pay particular attention to: — the potential for ground water contamination where picloram is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate; The Member States concerned shall ensure that the notifier submits to the Commission: — further information to confirm that the monitoring analytical method applied in residue trials correctly quantifies the residues of picloram and its conjugates; — a soil photolysis study to confirm the evaluation of picloram degradation. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.
179	Pyriproxyfen CAS No 95737-68-1 CIPAC No 715	4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether	≥ 970 g/kg	1 January 2009	31 December 2018	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyriproxyfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.In the 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 aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information confirming the risk assessment in respect of two points, namely the risk posed to aquatic insects by pyriproxfen and the metabolite DPH-pyr and the risk posed by pyriproxfen to pollinators. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.
180	Bifenox CAS No 42576-02-3 CIPAC No 413	Methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate	≥ 970 g/kg impurities: max. 3 g/kg 2,4-dichlorophenol max. 6 g/kg 2,4-dichloroanisole	1 January 2009	31 December 2018	►M85 PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; (b) the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops; (c) the environmental conditions leading to the potential formation of nitrofen. Member States shall impose restrictions as regards the conditions of use, where appropriate in view of point (c). ◄
181	Diflufenican CAS No 83164-33-4 CIPAC No 462	2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide	≥ 970 g/kg	1 January 2009	31 December 2018	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate.
182	Fenoxaprop-P CAS No 113158-40-0 CIPAC No 484	(R)-2[4-[(6-chloro-2-benzoxazolyl)oxy]-phenoxy]-propanoic acid	≥ 920 g/kg	1 January 2009	31 December 2018	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenoxaprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 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 non target plants, — the presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure, — the persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur. Conditions of authorisation should include risk mitigation measures, where appropriate.
183	Fenpropidin CAS No 67306-00-7 CIPAC No 520	(R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine	≥ 960 g/kg (racemate)	1 January 2009	31 December 2018	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpropidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 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 the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone. The Member States concerned shall request the submission of: — information to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin. They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.
184	Quinoclamine CAS No 2797-51-5 CIPAC No 648	2-amino-3-chloro-1,4-naphthoquinone	≥ 965 g/kg impurity: dichlone (2,3-dichloro-1,4-naphthoquinone) max. 15 g/kg	1 January 2009	31 December 2018	PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing quinoclamine for uses other than ornamentals or nursery plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on quinoclamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms, — the protection of birds and small mammals. Conditions of use shall include adequate risk mitigation measures, where appropriate.
185	Chloridazon CAS No 1698-60-8 CIPAC No 111	5-amino-4-chloro-2-phenylpyridazin-3(2H)-one	920 g/kg The manufacturing impurity 4-amino-5-chloro-isomer is considered to be of toxicological concern and a maximum level of 60 g/kg is established.	1 January 2009	31 December 2018	PART AOnly uses as herbicide in application max. of 2,6 kg/ha only every third year on the same field may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chloridazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 December 2007 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 should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination from metabolites B and B1 in vulnerable zones, where appropriate.
186	Tritosulfuron CAS No 142469-14-5 CIPAC No 735	1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea	≥ 960 g/kg The following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material: 2-Amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine: <0,2 g/kg	1 December 2008	30 November 2018	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic organisms, — the protection of small mammals. Conditions of use shall include risk mitigation measures, where appropriate.
187	Flutolanil CAS No 66332-96-5 CIPAC No 524	α,α,α-trifluoro-3′-isopropoxy-o-toluanilide	≥ 975 g/kg	1 March 2009	28 February 2019	PART AOnly uses as fungicide may be authorised.PART BIn assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the protection of 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.
188	Benfluralin CAS No 1861-40-1 CIPAC No 285	N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine	≥ 960 g/kg Impurities: — ethyl-butyl-nitrosamine: max. 0,1 mg/kg	1 March 2009	28 February 2019	PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report onbenfluralin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — 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 food of plant and animal origin and evaluate the dietary exposure of consumers, — the protection of birds, mammals, surface waters and aquatic organisms. In relauion to these identified risks, sisk 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 metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Annex provide such studies to the Commission within two years from the approval.
189	Fluazinam CAS No 79622-59-6 CIPAC No 521	3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine	≥ 960 g/kg Impurities: 5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidine — not more than 2 g/kg	1 March 2009	28 February 2019	PART AOnly uses as fungicide may be authorised.PART BIn assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to: — 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 residues in food of plant and animal origin and evaluate the dietary exposure of consumers, — the protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Annex provide such studies to the Commission within two years from the approval.
190	Fuberidazole CAS No 3878-19-1 CIPAC No 525	2-(2′-furyl)benzimidazole	≥ 970 g/kg	1 March 2009	28 February 2019	PART AOnly uses as fungicide may be authorised.PART BIn assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fuberidazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 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, — long-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply. Conditions of use shall include adequate risk mitigation measures, where appropriate.
191	Mepiquat CAS No 15302-91-7 CIPAC No 440	1,1-dimethylpiperidinium chloride (mepiquat chloride)	≥ 990 g/kg	1 March 2009	28 February 2019	PART AOnly uses as plant growth regulator may be authorised.PART BIn assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.The Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers.
192	Diuron CAS No 330-54-1 CIPAC No 100	3-(3,4-dichlorophenyl)-1,1-dimethylurea	≥ 930 g/kg	1 October 2008	30 September 2018	PART AOnly uses as herbicide at rates not exceeding 0,5 kg/ha (areic average) may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diuron, 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; conditions of use shall prescribe the use of personal protective equipment, if appropriate, — the protection of aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate.
193	Bacillus thuringiensis subsp. aizawai STRAIN: ABTS-1857 Culture collection: No SD-1372, STRAIN: GC-91 Culture collection: No NCTC 11821	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp.Aizawai ABTS-1857 (SANCO/1539/2008) and GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
194	Bacillus thuringiensis subsp. israeliensis (serotype H-14) STRAIN: AM65-52 Culture collection: No ATCC-1276	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp. israeliensis (serotype H-14) AM65-52(SANCO/1540/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
195	Bacillus thuringiensis subsp. kurstaki STRAIN: ABTS 351 Culture collection: No ATCC SD-1275 STRAIN: PB 54 Culture collection: No CECT 7209 STRAIN: SA 11 Culture collection: No NRRL B-30790 STRAIN: SA 12 Culture collection: No NRRL B-30791 STRAIN: EG 2348 Culture collection: No NRRL B-18208	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki ABTS 351 (SANCO/1541/2008), PB 54 (SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
196	Bacillus thuringiensis subsp. Tenebrionis STRAIN: NB 176 (TM 141) Culture collection: No SD-5428	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp. tenebrionis NB 176 (SANCO/1545/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
197	Beauveria bassiana STRAIN: ATCC 74040 Culture collection: No ATCC 74040 STRAIN: GHA Culture collection: No ATCC 74250	Not applicable	Max level of beauvericin: 5 mg/kg	1 May 2009	30 April 2019	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
198	Cydia pomonella Granulovirus (CpGV)	Not applicable	►M122 Minimum concentration: 1 × 1013 OB/l (occlusion bodies/l) and Contaminating microorganisms (Bacillus cereus) in the formulated product < 1 × 107 CFU/g ◄	1 May 2009	30 April 2019	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Cydia pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
199	Lecanicillium muscarium (formerly Verticilium lecanii) STRAIN: Ve 6 Culture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Lecanicillium muscarium (formerly Verticilium lecanii) Ve 6 (SANCO/1861/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
200	Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) STRAIN: BIPESCO 5/F52 Culture collection: No M.a. 43; No 275-86 (acronyms V275 or KVL 275); No KVL 99-112 (Ma 275 or V 275); No DSM 3884; No ATCC 90448; No ARSEF 1095	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as insecticide and acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) BIPESCO 5 and F52 (SANCO/1862/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
201	Phlebiopsis gigantea STRAIN: VRA 1835 Culture collection: No ATCC 90304 STRAIN: VRA 1984 Culture collection: No DSM16201 STRAIN: VRA 1985 Culture collection: No DSM 16202 STRAIN: VRA 1986 Culture collection: No DSM 16203 STRAIN: FOC PG B20/5 Culture collection: No IMI 390096 STRAIN: FOC PG SP log 6 Culture collection: No IMI 390097 STRAIN: FOC PG SP log 5 Culture collection: No IMI 390098 STRAIN: FOC PG BU 3 Culture collection: No IMI 390099 STRAIN: FOC PG BU 4 Culture collection: No IMI 390100 STRAIN: FOC PG 410.3 Culture collection: No IMI 390101 STRAIN: FOC PG97/1062/116/1.1 Culture collection: No IMI 390102 STRAIN: FOC PG B22/SP1287/3.1 Culture collection: No IMI 390103 STRAIN: FOC PG SH 1 Culture collection: No IMI 390104 STRAIN: FOC PG B22/SP1190/3.2 Culture collection: No IMI 390105	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Phlebiopsis gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
202	Pythium oligandrum STRAINS: M1 Culture collection No ATCC 38472	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as fungicide may be authorisedPART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pythium oligandrum M1 (SANCO/1864/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
203	Streptomyces K61 (formerly S. griseoviridis) STRAIN: K61 Culture collection: No DSM 7206	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Streptomyces (formerly Streptomyces griseoviridis) K61 (SANCO/1865/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
204	Trichoderma atroviride (formerly T. harzianum) STRAIN: IMI 206040 Culture collection No IMI 206040, ATCC 20476; STRAIN: T11 Culture collection: No Spanish type culture collection CECT 20498, identical with IMI 352941	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on Trichoderma atroviride (formerly T. harzianum) IMI 206040 (SANCO/1866/2008) and T-11 (SANCO/1841/2008) respectively, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
205	Trichoderma polysporum STRAIN: Trichoderma polysporum IMI 206039 Culture collection No IMI 206039, ATCC 20475	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma polysporum IMI 206039 (SANCO/1867/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
206	Trichoderma harzianum Rifai STRAIN: Trichoderma harzianum T-22; Culture collection No ATCC 20847 STRAIN: Trichoderma harzianum ITEM 908; Culture collection No CBS 118749	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908 (SANCO/1840/208) respectively and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
207	Trichoderma asperellum (formerly T. harzianum) STRAIN: ICC012 Culture collection No CABI CC IMI 392716 STRAIN: Trichoderma asperellum (formerly T. viride T25) T25 Culture collection No CECT 20178 STRAIN: Trichoderma asperellum (formerly T. viride TV1) TV1 Culture collection No MUCL 43093	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review reports on Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008) and Trichoderma asperellum (formerly T. viride T25 and TV1) T25 and TV1 (SANCO/1868/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
208	Trichoderma gamsii (formerly T. viride) STRAINS: ICC080 Culture collection No IMI CC number 392151 CABI	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma viride (SANCO/1868/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
209	Verticillium albo-atrum (formerly Verticillium dahliae) STRAIN: Verticillium albo-atrum isolate WCS850 Culture collection No CBS 276.92	Not applicable	No relevant impurities	1 May 2009	30 April 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Verticillium albo-atrum (formerly Verticillium dahliae) WCS850 (SANCO/1870/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
210	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 AOnly uses as insecticide, acaricide may be authorised.PART BIn 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(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information are provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 approval.
211	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 AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 approval, 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.
212	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 AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 approval.
213	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 AOnly 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 BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 approval.
214	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 AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 approval.
215	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 2009	31 July 2019	PART AOnly uses as herbicide may be authorised.PART BIn 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(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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, which 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 approval.
216	Imidacloprid CAS No 138261-41-3 CIPAC No 582	(E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine	≥ 970 g/kg	1 August 2009	31 July 2019	►M65 PART AOnly professional uses as insecticide may be authorised.Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June:barley, millet, oats, rice, rye, sorghum, triticale, wheat.Foliar treatments shall not be authorised for the following cereals:barley, millet, oats, rice, rye, sorghum, triticale, wheat.Uses as seed treatment, soil treatment or foliar application shall not be authorised for the following crops with the exception of uses in greenhouses and with the exception of foliar treatment after flowering: Alfalfa (Medicago sativa) almonds (Prunus amygdalus; P. communis; Amygdalus communis) anise (Pimpinella anisum); badian or star anise (Illicium verum); caraway (Carum carvi); coriander (Coriandrum sativum); cumin (Cuminum cyminum); fennel (Foeniculum vulgare); juniper berries (Juniperus communis) apples (Malus pumila; M. sylvestris; M. communis; Pyrus malus) apricots (Prunus armeniaca) avocados (Persea americana) bananas (Musa sapientum; M. cavendishii; M. nana) beans (Phaseolus spp.) blackberry (Rubus fruticosus) blueberries, European blueberry, wild bilberry, whortleberry (Vaccinium myrtillus); American blueberry (V. corymbosum) broad beans, horse beans (Vicia faba var. major; var. equina; var. Minor) buckwheat (Fagopyrum esculentum) carobs, carob-tree, locust bean (Ceratonia siliqua) castor oil seed (Ricinus communis) cherries (Prunus avium) chestnuts (Castanea spp.) chick peas (Cicer arietinum) chillies (Capsicum frutescens; C. annuum); allspice, Jamaica pepper (Pimenta officinalis) clovers (Trifolium spp.) coffee (Coffea spp. arabica, robusta, liberica) cotton (Gossypium spp.) cowpeas, black eyed peas (Vigna unguiculata) cranberries (Vaccinium macrocarpon); European cranberries (Vaccinum oxycoccus) cucumbers (Cucumis sativus) currants black (Ribes nigrum); red and white (R. rubrum) dates (Phoenix dactylifera) elderberries (Sambucus nigra) gooseberries (Ribes uva-crispa) grapefruit (C. paradisi) grapes (Vitis vinifera) groundnuts/peanuts (Arachis hypogea) hazelnut (Corylus avellana) hemp (Cannabis sativa) japanese rose (Rosa rugosa) kiwi fruit (Actinidia chinensis) leguminous: birdsfoot/trefoil (Lotus corniculatus); lespedeza (Lespedeza spp.); kudzu (Pueraria lobata); sesbania (Sesbania spp.); sainfoin, esparcette (Onobrychis sativa); sulla (Hedysarum coronarium) lemons and limes Lemon (Citrus limon); sour lime (C. aurantiifolia); sweet lime (C. limetta) lentils (Lens esculenta; Ervum lens) linseed (Linum usitatissimum) lupins (Lupinus spp.) maize/corn (Zea mays) melon seeds (Cucumis melo) mustard seeds: white mustard (Brassica alba; B. hirta; Sinapis alba); black mustard (Brassica nigra; Sinapis nigra) okra (Abelmoschus esculentus); gombo (Hibiscus esculentus) olives (Olea europaea) oranges: sweet orange (Citrus sinensis); bitter orange (C. aurantium) peaches and nectarines (Prunus persica; Amygdalus persica; Persica laevis) pears (Pyrus communis) peas garden pea (Pisum sativum); field pea (P. arvense) peppermint (Mentha spp.: M. piperita) persimmons (Diospyros kaki: D. virginiana) pistachios (Pistacia vera) plums and sloes greengage, mirabelle, damson (Prunus domestica); sloe (P. spinosa) poppy seed (Papaver somniferum) pumpkins, squash, gourds and marrows (Cucurbita spp.) pyrethrum, (Chrysanthemum cinerariifolium) quinces (Cydonia oblonga; C. vulgaris; C. japonica) rapeseed (Brassica napus var. oleifera) raspberries (Rubus idaeus) safflower seed (Carthamus tinctorius) serradella/birds foot (Ornithopus sativus) sesame seed (Sesamum indicum) soybeans (Glycine soja) spices: bay leaves (Laurus nobilis); dill seed (Anethum graveolens); fenugreek seed (Trigonella foenumgraecum); saffron (Crocus sativus); thyme (Thymus vulgaris); turmeric (Curcuma longa) strawberries (Fragaria spp.) sunflower seed (Helianthus annuus) tangerine (Citrus tangerina); mandarin (Citrus reticulata) clementine (C. unshiu); turnips andturnip rapes (Brassica rapa var. rapifera and oleifera spp.) vetches Spring/common vetch (Vicia sativa) viper’s Grass (Scorzonera hispanica) walnuts (Jugland spp.: J. regia) watermelons (Citrullus vulgaris) ornamentals flowering in year of treatment. PART BIn assessing applications to authorise plant protection products containing imidacloprid, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 and the conclusions of the addendum of the review report on imidacloprid as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 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. Member States shall ensure that: — the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised, — adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission, — the conditions of the authorisation, include, where appropriate, risk mitigation measures to protect bees, — monitoring programmes are initiated to verify the real exposure of bees to imidacloprid in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. Conditions of use shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards: (a) the risk to pollinators other than honey bees; (b) the risk to honey bees foraging in nectar or pollen in succeeding crops; (c) the potential uptake via roots to flowering weeds; (d) the risk to honey bees foraging on insect honey dew; (e) the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure; (f) the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure; (g) the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen. The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2014. ◄
217	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 0,05 % is established.	1 August 2009	31 July 2019	►M28 PART AOnly uses as herbicide may be authorised. Applications shall be limited to a total dose of not more than 1,0 kg metazachlor/ha in a three-year period on the same field. ◄ PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 Regularion (EC) No 1272/2008 as ‘suspected of causing cancer’, 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.
▼M74
218	Acetic acid CAS No 64-19-7 CIPAC 838	acetic acid	≥ 980 g/kg	1 September 2009	31 August 2019	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators, the protection of groundwater and the protection of aquatic organisms.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards: — the acute and long-term risk to birds and mammals, — the risk to honeybees, — the risk to non-target arthropods. The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2015.
▼M36
219	Aluminium ammonium sulphate CAS No 7784-26-1 (dodecahydrate), 7784-25-0 (anhydrous) CIPAC No 840	Aluminium ammonium sulphate	≥ 960 g/kg (expressed as dodecahydrate) ≥ 502 g/kg (anhydrous)	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards: (a) the impact on the environment of the transformation/dissociation products of aluminium ammonium sulphate; (b) the risk to non-target terrestrial organisms other than vertebrates and aquatic organisms. This information shall be submitted to the Member States, the Commission and the Authority by 1 January 2016.
▼M32
220	Aluminium silicate CAS No 1332-58-7 CIPAC No 841	Not available Chemical name: Aluminium silicate	≥ 999,8 g/kg	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium silicate (SANCO/2603/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to the operator safety; conditions of use shall include the application of adequate personal and respiratory protective equipment, where appropriate.Conditions of use shall include, where appropriate, risk mitigation measures.The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards: (a) the specification of the technical material, as commercially manufactured, supported by appropriate analytical data; (b) the relevance of the test material used in the toxicity dossier in view of the specification of the technical material. The Member States concerned shall ensure that the applicant submits such information to the Commission by 1 May 2013.
▼B
221	Ammonium acetate CAS No 631-61-8 CIPAC No not allocated	Ammonium acetate	≥ 970 g/kg Relevant impurity: Heavy metals as Pb maximum 10 ppm	1 September 2009	31 August 2019	PART AOnly uses as attractant may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ammonium acetate (SANCO/2986/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M31
222	Blood meal CAS No: 90989-74-5 CIPAC No: 909	Not available	≥ 990 g/Kg	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1069/2009 (17) and Regulation (EU) No 142/2011 (18).PART BIn assessing applications to authorise plant protection products containing blood meal for uses other than with direct application localised on individual plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013.
223	Calcium carbide CAS No: 75-20-7 CIPAC No: 910	Calcium acetylide	≥ 765 g/kg Containing 0,08 – 0,9 g/kg Calcium Phosphide	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
224	Calcium carbonate CAS No: 471-34-1 CIPAC No: 843	Calcium carbonate	≥ 995 g/kg	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards: — further data on the specification of the technical material, — analytical methods for the determination of calcium carbonate in the representative formulation and of the impurities in the technical material. These information shall be submitted to the Member States, the Commission and the Authority by 1 March 2013.
▼M66
225	carbon dioxide CAS No: 124-38-9 CIPAC No: 844	carbon dioxide	≥ 99,9 % Relevant impurities: phosphane max. 0,3 ppm v/v benzene max. 0,02 ppm v/v carbon monoxide max. 10 ppm v/v methanol max. 10 ppm v/v hydrogen cyanide max. 0,5 ppm v/v	1 September 2009	31 August 2019	PART AOnly uses as a fumigant may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carbon dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M37
226	Denathonium benzoate CAS No 3734-33-6 CIPAC No 845	Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate	≥ 975g/kg	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BIn assessing applications to authorise plant protection products containing denathonium benzoate for uses other than brushing with automatic rolling equipment in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.In this overall assessment Member States must pay particular attention to the protection of the operators. Authorised conditions of use must prescribe the application of adequate personal protective equipment.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M49
227	Ethylene CAS No 74-85-1 CIPAC No 839	Ethylene	≥ 90 % Relevant impurity: ethylene oxide, max content 1 mg/kg	1 September 2009	31 August 2019	PART AOnly indoor uses as plant growth regulator by professional users may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethylene (SANCO/2608/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the compliance of ethylene with the required specifications, irrespective of the form in which it is supplied to the user; (b) the protection of operators, workers and bystanders. Conditions of authorisation shall include, where appropriate, risk mitigation measures.
▼M106
228	Extract from tea tree CAS No Tea Tree Oil 68647-73-4 Main components: terpinen-4-ol 562-74-3 γ-terpinene 99-85-4 α-terpinene 99-86-5 1,8-cineole 470-82-6 CIPAC No 914	Tea Tree Oil is a complex mixture of chemical substances.	Main components: terpinen-4-ol ≥ 300 g/kg γ-terpinene ≥ 100 g/kg α-terpinene ≥ 50 g/kg 1,8-cineole ≥ 1 g/kg Relevant impurity: Methyl eugenol: maximum 1 g/kg of the technical material	1 September 2009	31 August 2019	PART AOnly uses as fungicide in greenhouse may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on extract from tea tree (SANCO/2609/2008 final) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of surface water and aquatic organisms; — the protection of honey bees, non-target arthropods, earthworms and non-target micro- and macro-organisms. Conditions of use shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards: (a) the plant metabolism and consumer exposure; (b) the toxicity of the compounds that constitute the extract and the relevance of possible impurities other than methyl eugenol; (c) the groundwater exposure for the less strongly absorbed components that constitute the extract and for potential soil transformation products; (d) the effects on biological methods of sewage treatment. The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016 at latest.
▼M36
229	Fat distillation residues CAS No: not allocated CIPAC No 915	Not available	≥ 40 % of cleaved fatty acids Relevant impurity: Ni maximum 200 mg/kg	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised. Fat distillation residues of animal origin must be in compliance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council and Commission Regulation (EU) No 142/2011 (OJ L 54, 26.2.2011, p. 1).PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on fat distillation residues (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.
▼B
230	Fatty acids C7 to C20 CAS No 112-05-0 (Pelargonic Acid) 67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts) 124-07-2 (Caprylic Acid) 334-48-5 (Capric Acid) 143-07-7 (Lauric Acid) 112-80-1 (Oleic Acid) 85566-26-3 (Fatty acids C8-C10 Me esters) 111-11-5 (Methyl octanoate) 110-42-9 (Methyl decanoate) CIPAC No not allocated	Nonanoic acid Caprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case) Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case) Fatty acids, C7-C10, Me esters	≥ 889 g/kg (Pelargonic Acid) ≥ 838 g/kg fatty acids ≥ 99 % fatty acid methyl esters	1 September 2009	31 August 2019	PART AOnly uses as insecticide, acaricide, and herbicide and plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
231	Garlic extract CAS No 8008-99-9 CIPAC No not allocated	Food grade garlic juice concentrate	≥ 99,9 %	1 September 2009	31 August 2019	PART AOnly uses as repellent, insecticide and nematicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on garlic extract (SANCO/2612/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
232	Gibberellic acid CAS No 77-06-5 CIPAC No 307	(3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acid Alt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid	≥ 850 g/kg	1 September 2009	31 August 2019	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on gibberellic acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
233	Gibberellins CAS No GA4: 468-44-0 GA7: 510-75-8 GA4A7 mixture: 8030-53-3 CIPAC No not allocated	GA4: (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acid GA7: (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid	Review report (SANCO/2614/2008).	1 September 2009	31 August 2019	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on gibberellins (SANCO/2614/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M32
234	Hydrolysed proteins CAS No not allocated CIPAC No 901	Not available	Review report (SANCO/2615/2008)	1 September 2009	31 August 2019	PART AOnly uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009 (17) and Commission Regulation (EU) No 142/2011 (18).PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on hydrolysed proteins (SANCO/2615/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to the operator and worker safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate.Conditions of use shall include, where appropriate, risk mitigation measures.The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards: (a) the specifications of the technical material, as commercially manufactured, supported by appropriate analytical data; (b) the risk to aquatic organisms. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 1 May 2013, the information set out in point (b) by 1 November 2013.
▼M38
235	Iron sulphate: Iron(II)sulfate anhydrous: CAS No 7720-78-7 Iron(II)sulfate monohydrate: CAS No 17375-41-6 Iron(II)sulfate heptahydrate: CAS No 7782-63-0 CIPAC No 837	Iron(II)sulphate or iron(2+) sulfate	Iron(II)sulfate anhydrous: ≥ 350 g/kg total iron. Relevant impurities: arsenic, 18 mg/kg cadmium, 1,8 mg/kg chromium, 90 mg/kg lead, 36 mg/kg mercury, 1,8 mg/kg expressed on the basis of the anhydrous variant	1 September 2009	31 August 2019	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the risk for operator; — the risk to children/residents playing on treated turf; — the risk to surface waters and to aquatic organisms. Conditions of use shall include, where appropriate, risk mitigation measures and the application of adequate personal protective equipment. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers.The Member States concerned shall ensure that the notifier submits to the Commission such information by 1 May 2013.
▼M84
236	Kieselgur (diatomaceous earth) CAS No 61790-53-2 CIPAC No 647	Kieselgur (no IUPAC name) Diatomaceous earth Amorphous silicon dioxide Silica Diatomite	The product consists of 100 % diatomaceous earth. Maximum 0,1 % of particles of crystalline silica with diameter below 50 μm	1 September 2009	31 August 2019	PART AOnly indoor uses as insecticide and acaricide by professional users may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on kieselgur (diatomaceous earth) (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the safety of operators and workers. Conditions of use shall include the application of adequate personal and respiratory protective equipment. Where necessary, conditions of use shall prohibit the presence of workers after application of the product concerned for a period appropriate in view of the risks caused by that product.The Member States concerned shall ensure that the notifiers submit, by 25 November 2015, to the Commission, the Member States and the Authority information concerning the inhalation toxicity to confirm the occupational limits of kieselgur (diatomaceous earth).
▼M31
237	Limestone CAS No: 1317-65-3 CIPAC No: 852	Calcium carbonate	≥ 980 g/kg	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M37
238	Methyl nonyl ketone CAS No 112-12-9 CIPAC No 846	Undecan-2-one	►M118 ≥ 985 g/kg ◄	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methyl nonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. Contact with food and feedcrops shall be avoided.The notifier shall submit confirmatory information as regards: (a) the specification of the material tested in the mammalian toxicology and ecotoxicology studies; (b) the specification with suporting batch data and validated methods of analysis; (c) an appropriate assessment of the fate and behaviour of methyl nonyl ketone and potential transformation products in the environment; (d) the risk to aquatic and to soil living organisms. The notifier shall submit to the Commission, the Member States and the Authority the information set out in points (a) and (b) by 30 April 2013 and the information set out in points (c) and (d) by 31 December 2015.
▼M31
239	Pepper dust extraction residue (PDER) CAS No: not allocated CIPAC No: not allocated	Steam distilled and solvent extracted Black pepper – Piper nigrum	It is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 %	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BIn assessing applications to authorise plant protection products containing pepper dust extraction residue (PDER) for uses other than in home garden area, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measuresThe notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013.
▼M115
240	Plant oils/citronella oil CAS No 8000-29-1 CIPAC No 905	Citronella Oil is a complex mixture of chemical substances. The main components are: Citronellal (3,7-dimethyl-6-octenal). Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol). Citronellol (3,7-dimethyl-6-octan-2-ol). Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate).	The sum of the following impurities must not exceed 0,1 % of technical material: methyl eugenol and methyl-isoeugenol.	1 September 2009	31 August 2019	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on citronella oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.In this overall assessment Member States shall pay particular attention to: — the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; — the protection of groundwater, when the substance is applied in regions with vulnerable soil; — the risk to non-target organisms. The notifier shall submit confirmatory information as regards: (a) the technical specification; (b) data comparing natural background exposure situations of plant oils/citronella oil and methyl eugenol and methyl isoeugenol in relation to exposure from the use of plant oils/citronella oil as a plant protection product. This data shall cover human exposure as well as exposure of non-target organisms; (c) the groundwater exposure assessment for potential metabolites of plant oils/citronella oil, in particular for methyl eugenol and methyl isoeugenol. The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016.
▼M100
241	Plant oils/clove oil CAS No 84961-50-2 (clove oil) 97-53-0 (Eugenol — main component) CIPAC No 906	Clove Oil is a complex mixture of chemical substances. The main component is eugenol.	≥ 800 g/kg Relevant impurity: methyl eugenol maximum 0,1 % of the technical material	1 September 2009	31 August 2019	PART AOnly indoor uses as post-harvest fungicide and bactericide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clove oil (SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate.The notifier shall submit confirmatory information as regards (a) the technical specification; (b) data comparing natural background exposure situations of plant oils/clove oil, eugenol and methyl eugenol in relation to exposure from the use of plant oils/clove oil as a plant protection product. This data shall cover human exposure. The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016.
▼M87
242	Plant oils/rape seed oil CAS No: 8002-13-9 CIPAC No: not allocated	Rape seed oil	Rape seed oil is a complex mixture of fatty acids Relevant impurity: Maximum 2 % of erucic acid	1 September 2009	31 August 2019	PART AOnly uses as insecticide and acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M37
243	Plant oils/spear mint oil CAS No 8008-79-5 CIPAC No 908	Spearmint oil	≥ 550 g/kg as (R)-Carvone	1 September 2009	31 August 2019	PART AOnly uses as plant growth regulator for postharvest treatment of potatoes may be authorised.Member States shall ensure that authorisations provide that hot fogging is performed exclusively in professional storage facilities and that the best available techniques are applied to exclude the release into the environment of the product (fogging mist) during storage, transport, waste disposal and application.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on plant oils/spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M39
244	Potassium hydrogen carbonate CAS No 298-14-6 CIPAC No 853	Potassium hydrogen carbonate	≥ 99,5 % Impurities: Pb max. 10 mg/kg As max. 3 mg/kg	1 September 2009	31 August 2019	PART AOnly uses as fungicide and insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to honeybees. Conditions of use shall include, where appropriate, risk mitigation measures.
▼M32
245	1,4-diaminobutane (putrescine) CAS No 110-60-1 CIPAC No 854	Butane-1,4-diamine	≥ 990 g/kg	1 September 2009	31 August 2019	PART AOnly uses as attractant may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1,4-diaminobutane (putrescine) (SANCO/2626/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M75
246	Pyrethrins: 8003-34-7 CIPAC No 32 Extract A: extractives of Chrysanthemum cinerariaefolium: 89997- 63-7 Pyrethrin 1: CAS 121- 21-1 Pyrethrin 2: CAS 121- 29-9 Cinerin 1: CAS 25402- 06-6 Cinerin 2: CAS 121- 20-0 Jasmolin 1: CAS 4466- 14-2 Jasmolin 2: CAS 1172- 63-0 Extract B: Pyrethrin 1: CAS 121-21-1 Pyrethrin 2: CAS 121- 29-9 Cinerin 1: CAS 25402- 06-6 Cinerin 2: CAS 121- 20-0 Jasmolin 1: CAS 4466- 14-2 Jasmolin 2: CAS 1172- 63-0	Pyrethrins are a complex mixture of chemical substances.	Extract A: ≥ 500 g/kg Pyrethrins Extract B: ≥ 480 g/kg Pyrethrins	1 September 2009	31 August 2019	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the risk to operators and workers; (b) the risk to non-target organisms. Conditions of use shall, where appropriate, include the application of adequate personal protective equipment and other risk mitigation measures.The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured including information on any relevant impurities and its equivalence with the specifications of the test material used in the toxicity studies; (2) the risk from inhalation; (3) the residue definition; (4) the representativeness of the major component ‘pyrethrin 1’ as regards the fate and behaviour in soil and water. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) by 31 March 2014 and the information set out in points (2), (3) and (4) by 31 December 2015.
▼M31
247	Quartz sand CAS No: 14808-60-7, 7637-86-9 CIPAC No: 855	Quartz, Silicon dioxide	≥ 915 g/kg Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BIn assessing applications to authorise plant protection products containing quartz sand for uses other than on trees in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M36
248	Fish oil CAS No 100085-40-3 CIPAC No 918	Fish oil	≥ 99 % Relevant impurity: Dioxine max. 6 pg/kg for animal feed Hg max. 0,5 mg/kg feed derived from fish and other sea food processing Cd max. 2 mg/kg feed of animal origin except in feed for domestic pets Pb max. 10 mg/kg PCBs max. 5 mg/kg	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fish oil (SANCO/2629/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.
▼B
249	Repellents by smell of animal or plant origin/sheep fat CAS No 98999-15-6 CIPAC No not allocated	Sheep Fat	Pure sheep fat containing a maximum of 0,18 % w/w/water.	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1069/2009PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sheep fat (SANCO/2630/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M38
250	Repellents by smell of animal or plant origin/tall oil crude: CAS No 8002-26-4 CIPAC No 911	Not available	The qualitative parameters below comprise the specification of repellents by smell of animal or plant origin/tall oil crude: acid number: min. 125 mgKOH/g water content: max. 2 % rosin acid content: min. 35 % (proposed) ash content: max. 0,2 % pH: approx. min. 5,5 unsaponifiables: max. 12 % free mineral acids: max. 0,02 %	1 September 2009	31 August 2019	PART AOnly uses as repellent applied by glove or brush may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on repellents by smell of animal or plant origin/tall oil crude (SANCO/2631/2008) and in particular Appendices I and II thereof,as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.In assessing applications to authorise plant protection products containing Repellents by smell of animal or plant origin/tall oil crude for uses other than as a repellent in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorisation is granted.In this overall assessment Member States shall pay particular attention to: — the protection of operator, worker and bystander; — the risk to non target species. Conditions of use shall include, where appropriate, risk mitigation measures.The Member States concerned shall request the submission of confirmatory information as regards: (a) the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers; (b) the toxicological profile of repellents by smell of animal or plant origin/tall oil crude. The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014.
251	Repellents by smell of animal or plant origin/tall oil pitch: CAS No 8016-81-7 CIPAC No 912	Not available	Complex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids.	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on repellents by smell of animal or plant origin/tall oil pitch (SANCO/2632/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.In assessing applications to authorise plant protection products containing repellents by smell of animal or plant origin/tall oil pitch for uses other than as a repellent in forestry applied by glove or brush, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorization is granted.In this overall assessment Member States shall pay particular attention to: — the protection of operator, worker and bystander; — the risk to non target species. Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards: (a) the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers; (b) the toxicological profile of repellents by smell of animal or plant origin/tall oil pitch. The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014.
▼B
252	Sea-algae extract (formerly sea algae extract and sea weeds) CAS No not allocated CIPAC No not allocated	See algae extract	See algae extract is a complex mixture. Main components as markers: mannitol, fucoidans and alginates. Review report SANCO/2634/2008	1 September 2009	31 August 2019	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sea algae extract (SANCO/2634/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
253	Sodium aluminium silicate CAS No 1344-00-9 CIPAC No not allocated	Sodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O	1 000 g/kg	1 September 2009	31 August 2019	PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium aluminium silicate (SANCO/2635/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M51
254	Sodium hypochlorite CAS No: 7681-52-9 CIPAC: 848	Sodium hypochlorite	Sodium hypochlorite: 105 g/kg-126 g/kg (122 g/L-151 g/L) technical concentrate 10-12 % (w/w) expressed as chlorine	1 September 2009	31 August 2019	PART AOnly indoor uses as disinfectant may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the risk to operator and workers; (b) the exposure of soil to sodium hypochlorite and its reaction products through spreading of treated compost on organic land shall be avoided. Conditions of use shall include risk mitigation measures, where appropriate.
▼M127
255	Straight Chain Lepidopteran Pheromones	Review report (SANCO/2633/2008)	Review report (SANCO/2633/2008)	1 September 2009	31 August 2019	PART AOnly uses as attractants may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards: (1) the genotoxic profile of aldehyde group compounds; (2) exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones. The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 31 December 2015 and the information set out in point (2) by 31 December 2016.
▼B
256	Trimethylamine hydrochloride CAS No 593-81-7 CIPAC No not allocated	Trimethylamine hydrochloride	≥ 988 g/kg	1 September 2009	31 August 2019	PART AOnly uses as attractant may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on trimethylamine hydrochloride (SANCO/2636/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
▼M36
257	Urea CAS No 57-13-6 CIPAC No 913	Urea	≥ 98 % w/w	1 September 2009	31 August 2019	PART AOnly uses as attractant and fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards: (a) the analysis method for urea and for the impurity biuret; (b) the risk for operators, workers and bystanders. The information set out in point (a) and in point (b) shall be submitted to the Member States, the Commission and the Authority respectively by 1 May 2013 and 1 January 2016.
▼M141
258	Z-13-hexadecen-11-yn-1-yl acetate CAS No 78617-58-0 CIPAC: 974	Z-13-hexadecen-11-yn-1-yl acetate	≥ 75 %	1 September 2009	31 August 2019	PART AOnly uses as attractant may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Z-13-hexadecen-11-yn-1-yl acetate (SANCO/2649/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured including information on any relevant impurities; (2) exposure risk assessment for operators, workers and bystanders; (3) environmental fate and behaviour of the substance; (4) exposure risk assessment for non-target organisms. The notifier shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2015 and the information set out in points (2), (3) and (4) by 31 December 2016.
▼M138
259	Z,Z,Z,Z-7,13,16,19- docosatetraen-1-yl isobutyrate CAS No 135459-81-3 CIPAC: 973	Z,Z,Z,Z-7,13,16,19- docosatetraen-1-yl isobutyrate	≥ 90 %	1 September 2009	31 August 2019	PART AOnly uses as attractant may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Z,Z,Z,Z-7,13,16,19- docosatetraen-1-yl isobutyrate (SANCO/2650/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured, including information on any relevant impurities; (2) exposure risk assessment for operators, workers and bystanders; (3) environmental fate and behaviour of the substance; (4) exposure risk assessment for non-target organisms. The notifier shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2015 and the information set out in points (2), (3) and (4) by 31 December 2016.
▼B
260	Aluminium phosphide CAS No 20859-73-8 CIPAC No 227	Aluminium phosphide	≥ 830 g/kg	1 September 2009	31 August 2019	PART AOnly uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use aluminium phosphide containing products may be authorised.As rodenticide, talpicide and leporicide only outdoor uses may be authorised.Authorisations should be limited to professional users.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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.
261	Calcium phosphide CAS No 1305-99-3 CIPAC No 505	Calcium phosphide	≥ 160 g/kg	1 September 2009	31 August 2019	PART AOnly outdoor uses as rodenticide and talpicide in the form of ready-to-use calcium phosphide containing products may be authorised.Authorisations should be limited to professional users.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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.
262	Magnesium phosphide CAS No 12057-74-8 CIPAC No 228	Magnesium phosphide	≥ 880 g/kg	1 September 2009	31 August 2019	PART AOnly uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use magnesium phosphide containing products may be authorised.As rodenticide, talpicide and leporicide only outdoor uses may be authorised.Authorisations should be limited to professional users.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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.
263	Cymoxanil CAS No 57966-95-7 CIPAC No 419	1-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea	≥ 970 g/kg	1 September 2009	31 August 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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.
264	Dodemorph CAS No 1593-77-7 CIPAC No 300	cis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine	≥ 950 g/kg	1 September 2009	31 August 2019	PART AOnly uses as fungicide on ornamentals in glasshouse may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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.
265	2,5-Dichlorobenzoic acid methylester CAS No 2905-69-3 CIPAC No 686	methyl-2,5-dichlorobenzoate	≥ 995 g/kg	1 September 2009	31 August 2019	PART AOnly indoor uses as plant growth regulator and fungicide for grafting of grapevines may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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.
266	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/kg	1 September 2009	31 August 2019	PART AOnly uses as herbicide may be authorised.PART BIn 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(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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.
267	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 2009	31 August 2019	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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.
268	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/kg	1 September 2009	31 August 2019	►M128 PART AOnly uses as fungicide and plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole; — 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 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. ◄
269	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 2009	31 August 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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 2008 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.
270	Methomyl CAS No 16752-77-50 CIPAC No 264	S-methyl (EZ)-N-(methylcarbamoyloxy)thioacetimidate	≥ 980 g/kg	1 September 2009	31 August 2019	PART AOnly uses as insecticide on vegetables may be authorised at rates not exceeding 0,25 kg active substance per hectare per application and for a maximum of 2 applications per season.Authorisations shall be limited to professional users.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methomyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 June 2009 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the operator safety: conditions of use shall prescribe the use of adequate personal protective equipment. Special attention shall be paid to the exposure of operators using knapsacks or other hand-held application equipment, — the protection of birds, — the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles, — the protection of non-target arthropods, in particular bees: risk mitigation measures to avoid all contact with bees shall be applied. Member States shall ensure that methomyl-based formulations contain effective repelling and/or emetic agents.Where appropriate, conditions of authorisation shall include further risk mitigation measures.
271	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 AOnly uses as a herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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.
272	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 AOnly use as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodiump-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, which 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.
273	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 AOnly use as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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, which 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.
274	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 AOnly use as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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, which 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.
275	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 AOnly uses as acaricide and insecticide may be authorised.PART BIn 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(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, 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.
276	Chlormequat CAS No 7003-89-6 (chlormequat) CAS No 999-81-5 (chlormequat chloride) CIPAC No 143 (chlormequat) CIPAC No 143.302 (chlormequat chloride)	2-chloroethyltrimethylammonium (chlormequat) 2-chloroethyltrimethylammonium chloride (chlormequat chloride)	≥ 636 g/kg Impurities 1,2-dichloroethane: max 0,1 g/kg (on the dry chlormequat chloride content) Chloroethene (vinylchloride): max 0,0005 g/kg (on the dry chlormequat chloride content)	1 December 2009	30 November 2019	PART AOnly uses as plant growth regulator on cereals and non edible crops may be authorised.PART BIn assessing applications to authorise plant protection products containing chlormequat for uses other than in rye and triticale, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlormequat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 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 birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the fate and behaviour (adsorption studies to be performed at 20 °C, recalculation of the predicted concentrations in groundwater, surface water and sediment), the monitoring methods for determination of the substance in animal products and water, and the risk to aquatic organisms, birds and mammals. They shall ensure that the notifier at whose request chlormequat has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.
▼M135
277	Copper compounds:			1 December 2009	31 January 2018	PART AOnly uses as bactericide and fungicide may be authorised.PART BIn assessing applications to authorise plant protection products containing copper for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on copper compounds, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009, shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured which 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 operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, — the protection of water and non-target organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate, — the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects and do not cause any unacceptable effect on the environment taking into account background levels of copper at the application site. The notifiers shall present to the Commission, the Authority and the Member States a monitoring programme for vulnerable areas where the contamination of the soil and water (including sediments) by copper is a concern or may become one.That monitoring programme shall be submitted by 31 July 2015. The interim results of such monitoring programme shall be submitted as interim report to the Rapporteur Member State, the Commission and the Authority by 31 December 2016. Final results shall be submitted by 31 December 2017.
	Copper hydroxide CAS No 20427-59-2 CIPAC No 44.305	Copper (II) hydroxide	≥ 573 g/kg
	Copper oxychloride CAS No 1332-65-6 or 1332-40-7 CIPAC No 44.602	Dicopper chloride trihydroxide	≥ 550 g/kg
	Copper oxide CAS No 1317-39-1 CIPAC No 44.603	Copper oxide	≥ 820 g/kg
	Bordeaux mixture CAS No 8011-63-0 CIPAC No 44.604	Not allocated	≥ 245 g/kg
	Tribasic copper sulphate CAS No 12527-76-3 CIPAC No 44.306	Not allocated	≥ 490 g/kg The following impurities are of toxicological concern and must not exceed the levels below (expressed in g/g): Lead max 0,0005 g/g of copper content; Cadmium max 0,0001 g/g of copper content; Arsenic max 0,0001 g/g of copper content.
▼B
278	Propaquizafop CAS No 111479-05-1 CIPAC No 173	2-isopropylidenamino-oxyethyl (R)-2-[4-(6-chloro-quinoxalin-2-yloxy)phenoxy]propionate	≥ 920 g/kg Toluene maximum content 5 g/kg	1 December 2009	30 November 2019	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propaquizafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 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 which 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 operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, — the protection of non-target arthropods and 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 on the relevant impurity Ro 41-5259, — information to further address the risk to aquatic organisms and to non-target arthropods. They shall ensure that the notifier provides such information to the Commission by 30 November 2011.
279	Quizalofop-P:			1 December 2009	30 November 2019	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 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 which 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 operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information on the risk to non-target arthropods.They shall ensure that the notifier provides such information to the Commission by 30 November 2011.
	Quizalofop-P-ethyl CAS No 100646-51-3 CIPAC No 641.202	ethyl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate	≥ 950 g/kg
	Quizalofop-P-tefuryl CAS No 119738-06-6 CIPAC No 641.226	(RS)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate	≥ 795 g/kg
280	Teflubenzuron CAS No 83121-18-0 CIPAC No 450	1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea	≥ 970 g/kg	1 December 2009	30 November 2019	PART AOnly uses as insecticide in glasshouses (on artificial substrate or closed hydroponic systems) may be authorised.PART BIn assessing applications to authorise plant protection products containing teflubenzuron for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on teflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the operator and workers safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate, — the protection of aquatic organisms. Releases from glasshouse application must be minimised and, in any case, should not have the potential to reach in significant levels water bodies in the vicinity, — the protection of bees which should be prevented from accessing the glasshouse, — the protection of pollinator colonies purposely placed in the glasshouse, — the safe disposal of condensation water, drain water and substrate in order to preclude risks to non-target organisms and contamination of surface water and groundwater. Conditions of authorisation shall include risk mitigation measures, where appropriate.
281	Zeta-cypermethrin CAS No 52315-07-8 CIPAC No 733	Mixture of the stereoisomers (S)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2 dimethylcyclopropanecarboxylate where the ratio of the (S);(1RS,3RS) isomeric pair to the (S);(1RS,3SR) isomeric pair lies in the ratio range 45-55 to 55-45 respectively	≥ 850 g/kg Impurities: toluene: max 2 g/kg tars: max 12,5 g/kg	1 December 2009	30 November 2019	PART AOnly uses as insecticide may be authorised.PART BIn assessing applications to authorise plant protection products containing zeta-cypermethrin for uses other than in cereals, notably as regards the exposure of consumers to mPBAldehyde, a degradation product that may be formed during processing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on zeta-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 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 protection of birds, aquatic organisms, bees, non-target arthropods and non-target soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the fate and behaviour (aerobic degradation in soil), the long-term risk to birds, aquatic organisms and non-target arthropods. They shall ensure that the notifier at whose request zeta-cypermethrin has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.
282	Chlorsulfuron CAS No 64902-72-3 CIPAC No 391	1-(2-chlorophenylsulfonyl)-3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea	≥ 950 g/kg Impurities: 2-Chlorobenzenesulfonamide (IN-A4097) not more than 5 g/kg and 4-methoxy-6-methyl-1,3,5-triazin-2-amine (IN-A4098) not more than 6 g/kg	1 January 2010	31 December 2019	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, when 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 by 1 January 2010. If chlorsulfuron is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN-A4097, IN-A4098, IN-JJ998, IN-B5528 and IN-V7160 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.
283	Cyromazine CAS No 66215-27-8 CIPAC No 420	N-cyclopropyl-1,3,5-triazine-2,4,6-triamine	≥ 950 g/kg	1 January 2010	31 December 2019	PART AOnly uses as insecticide in greenhouses may be authorised.PART BIn assessing applications to authorise plant protection products containing cyromazine for uses other than in tomatoes, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyromazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic organisms, — the protection of pollinators. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite NOA 435343 and on the risk to aquatic organisms. They shall ensure that the notifier at whose request cyromazine has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest.
284	Dimethachlor CAS No 50563-36-5 CIPAC No 688	2-chloro-N-(2-methoxyethyl)acet-2′,6′-xylidide	≥ 950 g/kg Impurity 2,6-dimethylaniline: Not more than 0,5 g/kg	1 January 2010	31 December 2019	PART AOnly uses as herbicide in application max. of 1,0 kg/ha only every third year on the same field may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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 and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — 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 metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 in vulnerable zones, where appropriate.The Member States concerned shall: — ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010. If dimethachlor is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.
285	Etofenprox CAS No 80844-07-1 CIPAC No 471	2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl ether	≥ 980 g/kg	1 January 2010	31 December 2019	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on etofenprox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of bees and non-target arthropods; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate. The Member States concerned shall: — ensure that the notifier submits to the Commission further information on the risk to aquatic organisms including the risk to sediment dwellers and biomagnification, — the submission of further studies on the endocrine disruption potential in aquatic organisms (fish full life cycle study). They shall ensure that the notifiers provide such studies to the Commission by 31 December 2011.
286	Lufenuron CAS No 103055-07-8 CIPAC No 704	(RS)-1-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoro-propoxy)-phenyl]-3-(2,6-difluorobenzoyl)-urea	≥ 970 g/kg	1 January 2010	31 December 2019	PART AOnly indoor uses or use in outdoor bait stations as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on lufenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the high persistency in the environment and the high risk for bioaccumulation and shall ensure that the use of lufenuron has no adverse long-term effects on non-target organisms, — the protection of birds, mammals, soil non-target organisms, bees, non-target arthropods, surface waters and aquatic organisms in vulnerable situations. The Member States concerned shall: — ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.
287	Penconazole CAS No 66246-88-6 CIPAC No 446	(RS) 1-[2-(2,4-dichloro-phenyl)-pentyl]-1H-[1,2,4] triazole	≥ 950 g/kg	1 January 2010	31 December 2019	PART AOnly uses as fungicides may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite CGA179944 in acidic soils. They shall ensure that the notifier at whose request penconazole has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest.
288	Tri-allate CAS No 2303-17-5 CIPAC No 97	S-2,3,3-trichloroallyl di-isopropyl (thiocarbamate)	≥ 940 g/kg NDIPA (Nitroso-diisopropylamine) max. 0,02 mg/kg	1 January 2010	31 December 2019	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tri-allate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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 dietary exposure of consumers to residues of tri-allate in treated crops as well as in succeeding rotational crops and in products of animal origin — the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, — the potential for ground water contamination by the degradation products TCPSA when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission: — further information to assess the primary plant metabolism, — further information on the fate and behaviour of the soil metabolite diisopropylamine, — further information on the potential for biomagnification in aquatic food chains, — information to further address the risk to fish-eating mammals and the long-term risk to earthworms. They shall ensure that the notifier provides such information to the Commission by 31 December 2011.
289	Triflusulfuron CAS No 126535-15-7 CIPAC No 731	2-[4-dimethylamino-6-(2,2,2-trifluoroethoxy)-1,3,5-triazin-2-ylcarbamoylsulfamoyl]-m-toluic acid	►M29 ≥ 960 g/kg ◄	1 January 2010	31 December 2019	►M29 PART AOnly uses as a herbicide may be authorised. ◄ PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triflusulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the dietary exposure of consumers to residues of metabolites IN-M7222 and IN-E7710 in succeeding rotational crops and in products of animal origin, — the protection of aquatic organisms and aquatic plants from the risk arising from triflusulfuron and the metabolite IN-66036 and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, — the potential for ground water contamination by the degradation products IN-M7222 and IN-W6725 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate. If triflusulfuron is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN-M7222, IN-D8526 and IN-E7710 with respect to cancer. They shall ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.
290	Difenacoum CAS No 56073-07-5 CIPAC No 514	3-[(1RS,3RS;1RS,3SR)-3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl]-4-hydroxycoumarin	≥ 905 g/kg	1 January 2010	30 December 2019	PART AOnly uses as rodenticide in the form of pre-prepared baits placed in specially constructed, tamper resistant and secured bait boxes are authorised.The nominal concentration of the active substance in the products shall not exceed 50 mg/kg.Authorisations shall be limited to professional users.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on difenacoum, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of birds and non-target mammals from primary and secondary poisoning. Risk mitigation measures shall be applied where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information on methods for the determination of residues of difenacoum in body fluids.They shall ensure that the notifier provides such information to the Commission by 30 November 2011.The Member States concerned shall ensure that the notifier submits to the Commission further information on the specification of the active substance as manufactured.They shall ensure that the notifier provides such information to the Commission by 31 December 2009.
▼M48 —————
▼B
292	sulphur CAS No 7704-34-9 CIPAC No 18	sulphur	≥ 990 g/kg	1 January 2010	31 December 2019	PART AOnly uses as fungicide and acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submit to the Commission further information to confirm the risk assessment for birds, mammals, sediment dwelling organisms and non-target arthropods. They shall ensure that the notifier at whose request sulphur has been included in this Annex provide such data to the Commission at latest by 30 June 2011.
293	Tetraconazole CAS No 112281-77-3 CIPAC No 726	(RS)-2-(2,4-dichlorophenyl)-3-(1H-1.2,4-triazol-1-yl)-propyl-1.1,2,2-tetrafluoroethyl ether	≥ 950 g/kg (racemic mixture) Impurity toluene: not more than 13 g/kg	1 January 2010	31 December 2019	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tetraconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to: — the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. The Member States concerned shall request: — the submission of further information on a refined consumer risk assessment, — further information on the specification regarding ecotoxicology, — further information on the fate and behaviour of potential metabolites in all relevant compartments, — the refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods, — further information on the potential for endocrine disrupting effects to birds, mammals and fish. They shall ensure that the notifier provides such information to the Commission by 31 December 2011.
294	Paraffin oils CAS No 64742-46-7 CAS No 72623-86-0 CAS No 97862-82-3 CIPAC No n.a.	paraffin oil	European Pharmacopoeia 6.0	1 January 2010	31 December 2019	PART AOnly uses as insecticide and acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, and in particular Appendices I and II thereto shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The Member States concerned shall request: — the submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6.0. They shall ensure that the notifiers provides such information to the Commission by 30 June 2010.
295	Paraffin oil CAS No 8042-47-5 CIPAC No n.a.	paraffin oil	European Pharmacopoeia. 6,0	1 January 2010	31 December 2019	PART AOnly uses as insecticide and acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on paraffin oil 8042-47-5, and in particular Appendices I and II thereof, shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The Member States concerned shall request: The submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6,0 They shall ensure that the notifier provides such information to the Commission by 30 June 2010.
296	Cyflufenamid CAS No 180409-60-3 CIPAC No 759	(Z)-N-[α-(cyclopropylmethoxyimino) – 2,3-difluoro-6-(trifluoromethyl)benzyl]-2-phenylacetamide	> 980 g/kg	1 April 2010	31 March 2020	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyflufenamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 October 2009 shall be taken into account.In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of authorisation shall include risk mitigation measures, where appropriate.
297	Fluopicolide CAS No 239110-15-7 CIPAC No 787	2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide	≥ 970 g/kg The impurity toluene must not exceed 3 g/kg in the technical material.	1 June 2010	31 May 2020	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.In this overall assessment, Member States must pay particular attention to: — the protection of aquatic organisms, — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — to the risk to operators during application, — the potential for long range transport via air. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest.
298	Heptamaloxyloglucan CAS No 870721-81-6 CIPAC No Not available	Full IUPAC name in footnote (1) Xyl p: xylopyranosyl Glc p: glucopyranosyl Fuc p: fucopyranosyl Gal p: galactopyranosyl Glc-ol: glucitol	≥ 780 g/kg The impurity Patulin must not exceed 50 μg/kg in the technical material.	1 June 2010	31 May 2020	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on heptamaloxyloglucan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.
299	2-phenylphenol (including its salts such as the sodium salt) CAS No 90-43-7 CIPAC No 246	biphenyl-2-ol	≥ 998 g/kg	1 January 2010	31 December 2019	PART AOnly uses as a post-harvest fungicide for indoor use may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2-phenylphenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009, as amended in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.In this overall assessment Member States must pay particular attention: — to the protection of operators and workers and ensure that conditions of use prescribe the application of adequate personal protective equipment, — to put in place appropriate waste management practices to handle the waste solution remaining after application, including the cleaning water of the drenching and other application systems. Member States permitting the release of wastewater into the sewage system, shall ensure that a local risk assessment is carried out. The Member States concerned shall ensure that the notifier submits to the Commission: — further information on the potential for skin depigmentation for workers and consumers due to possible exposure to the metabolite 2-phenylhydroquinone (PHQ) on citrus peel, — further information to confirm that the analytical method applied in residue trials correctly quantifies the residues of 2-phenylphenol, PHQ and their conjugates. They shall ensure that the notifier provides such information to the Commission by 31 December 2011.Furthermore, the Member States concerned shall ensure that the notifier submits to the Commission further information to confirm the residue levels occurring as a result of application techniques other than those in drench chambers.They shall ensure that the notifier provides such information to the Commission by 31 December 2012.
300	Malathion CAS No 121-75-5 CIPAC No 12	diethyl (dimethoxyphosphinothioylthio)succinate or S-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioate racemate	≥ 950 g/kg Impurities: Isomalathion: not more than 2 g/kg	1 May 2010	30 April 2020	PART AOnly uses as insecticide may be authorised. Authorisations shall be limited to professional users.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on malathion, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment; — the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones; — the protection of insectivorous birds and honey bees: conditions of authorisation shall include risk mitigation measures, where appropriate. As regards bees, the necessary indications shall be provided on the labelling and the accompanying instructions as to avoid exposure. Member States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport.Where appropriate, conditions of authorisation shall include further risk mitigation measures.The Member States concerned shall ensure that the notifier presents to the Commission: — information confirming the consumer risk assessment and the acute and long-term risk assessment for insectivorous birds; — information on the quantification of the different potency of malaoxon and malathion.
301	Penoxsulam CAS No 219714-96-2 CIPAC No 758	3-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-α,α,α-trifluorotoluene-2-sulfonamide	> 980 g/kg The impurity Bis-CHYMP 2-chloro-4-[2-(2-chloro-5-methoxy-4-pyrimidinyl)hydrazino]-5-methoxypyrimidine must not exceed 0,1 g/kg in the technical material	1 August 2010	31 July 2020	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penoxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.In this overall assessment, Member States must pay particular attention to: — the protection of aquatic organisms, — the dietary exposure of consumers to residues of the metabolite BSCTA in succeeding rotational crops, — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information to address the off-field risk to higher aquatic plants. They shall ensure that the notifier provides such information to the Commission by 31 July 2012.The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
302	Proquinazid CAS No 189278-12-4 CIPAC No 764	6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one	> 950 g/kg	1 August 2010	31 July 2020	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on proquinazid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.In this overall assessment, Member States must pay particular attention: — to the long-term risk to earthworm-eating birds for uses in grapevine, — to the risk to aquatic organisms, — the dietary exposure of consumers to proquinazid residues in products of animal origin and in succeeding rotational crops, — to the operator safety. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
303	Spirodiclofen CAS No 148477-71-8 CIPAC No 737	3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate	> 965 g/kg The following impurities must not exceed a certain amount in the technical material: 3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4.5]dec-3-en-2-one (BAJ-2740 enol): ≤ 6 g/kg N,N-dimethylacetamide: ≤ 4 g/kg	1 August 2010	31 July 2020	PART AOnly uses as acaricide or insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spirodiclofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.In this overall assessment, Member States must pay particular attention: — to the long-term risk to aquatic organisms, — to the operator safety, — to the risk to bee brood. Conditions of authorisation shall include risk mitigation measures, where appropriate.
304	Metalaxyl CAS No 57837-19-1 CIPAC No 365	Methyl N-(methoxyacetyl)-N-(2,6-xylyl)-DL-alaninate	950 g/kg The impurity 2,6-dimethylaniline was considered of toxicological concern and a maximum level of 1 g/kg is established.	1 July 2010	30 June 2020	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account.Member States must pay particular attention to the potential contamination of groundwater by the active substance or its degradation products CGA 62826 and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied where appropriate.
305	Flonicamid (IKI-220) CAS No 158062-67-0 CIPAC No 763	N-cyanomethyl-4-(trifluoromethyl)nicotinamide	≥ 960 g/kg The impurity toluene must not exceed 3 g/kg in the technical material.	1 September 2010	31 August 2020	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flonicamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010, shall be taken into account.In this overall assessment, Member States must pay particular attention to: — the risk to operators and re-entry workers, — the risk to bees. Conditions of authorisation shall include risk mitigation measures where appropriate.The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
306	Triflumizole CAS No 99387-89-0 CIPAC No 730	(E)-4-chloro-α,α,α-trifluoro-N-(1-imidazol-1-yl-2-propoxyethylidene)-o-toluidine	≥ 980 g/kg Impurities: Toluene: not more than 1 g/kg	1 July 2010	30 June 2020	PART AOnly uses as fungicide in greenhouses on artificial substrates may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triflumizole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment, — the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, as appropriate, risk mitigation measures.
307	Sulfuryl fluoride CAS No 002699-79-8 CIPAC No 757	Sulfuryl fluoride	> 994 g/kg	1 November 2010	31 October 2020	PART AOnly uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures — which are empty; or — where conditions of use ensure that consumer exposure is acceptable; may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfuryl fluoride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.In this overall assessment, Member States must pay particular attention to: — the risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that such products do not enter the food and feed chain, — the risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration. Measures are required to ensure that they wear self containing breathing apparatus or other appropriate personal protective equipment, — the risk to bystanders by applying an appropriate exclusion zone around the fumigated structure. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information and in particular, confirmatory data on: — the mill processing conditions necessary to ensure that residues of fluoride ion in flour, bran and grain do not exceed the natural background levels, — tropospheric concentrations of sulfuryl fluoride. Measured concentrations should be updated regularly. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air), — estimates of sulfuryl fluoride atmospheric lifetime based on worst case scenario, with respect to the global warming potential (GWP). They shall ensure that the notifier provides such information to the Commission by 31 August 2012.
308	FEN 560 (also called fenugreek or fenugreek seed powder) CAS No None CIPAC No None The active substance is prepared from the seed powder of Trigonella foenum-graecum L. (fenugreek).	Not applicable	100 % fenugreek seed powder without any additive and no extraction; the seed being of human food grade quality.	1 November 2010	31 October 2020	PART AOnly uses as elicitor of the crop's self-defence mechanisms may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on FEN 560 (fenugreek seed powder), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.In this overall assessment, Member States must pay particular attention to the risk to operators, workers and bystanders.Conditions of authorisation shall include risk mitigation measures where appropriate.
309	Haloxyfop-P CAS No Acid: 95977-29-0 Ester: 72619-32-0 CIPAC No Acid: 526 Ester: 526.201	Acid: (R)-2-[4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy]propanoic acid Ester: Methyl (R)-2-{}{4-[3-chloro-5-(trifluoromethyl)-2-pyridyloxy]phenoxy}}propionate	≥ 940 g/kg (Haloxyfop-P-methyl ester)	1 January 2011	31 December 2020	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on haloxyfop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — operator safety: conditions of use shall prescribe the use of adequate personal protective equipment; — protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones; — consumer safety as regards the occurrence in groundwater of metabolites DE-535 pyridinol and DE-535 pyridinone. The Member States concerned shall ensure that the applicant presents to the Commission, by 31 December 2012 at the latest, information confirming the groundwater exposure assessment as regards the active substance and its soil metabolites DE-535 phenol, DE-535 pyridinol and DE-535 pyridinone.
310	Napropamide CAS No 15299-99-7	(RS)-N,N-diethyl-2-(1-naphthyloxy)propionamide	≥ 930 g/kg (Racemic mixture) Relevant impurity Toluene: not more than 1,4 g/kg	1 January 2011	31 December 2020	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on napropamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.In this overall assessment Member States shall pay particular attention to: — operator safety: conditions of use shall prescribe the use of adequate personal protective equipment, where necessary, — protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones, — consumer safety as regards the occurrence in groundwater of the metabolite 2-(1-naphthyloxy)propionic acid, hereinafter ‘NOPA’. The Member States concerned shall ensure that the applicant presents to the Commission, by 31 December 2012 at the latest, information confirming the surface water exposure assessment as regards the photolysis metabolites and the metabolite NOPA and information for the risk assessment of aquatic plants.
311	Quinmerac CAS No 90717-03-6 CIPAC No 563	7-chloro-3-methylquinoline-8-carboxylic acid	≥ 980 g/kg	1 May 2011	30 April 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the dietary exposure of consumers to residues of quinmerac (and its metabolites) in succeeding rotational crops — the risk to aquatic organisms and the long term risk for earthworms. Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of information as regards: — the potential of plant metabolism to result in an opening of the quinoline ring; — residues in rotational crops and the long term risk for earthworms due to the metabolite BH 518-5. They shall ensure that the applicant provides such confirmatory data and information to the Commission by 30 April 2013.
312	Metosulam CAS No 139528-85-1 CIPAC No 707	2′,6′-dichloro-5,7-dimethoxy-3′-methyl[1,2,4]triazolo [1,5-a]pyrimidine-2-sulfonanilide	≥ 980 g/kg	1 May 2011	30 April 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metosulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms; — the risk to non-target plants in the off-field area. Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the applicant submits to the Commission, by 30 October 2011, further information on the specification of the active substance as manufactured.The Member States concerned shall ensure that the applicant submits to the Commission, by 30 April 2013, confirmatory information as regards: — potential pH dependence of soil adsorption, groundwater leaching and surface water exposure for metabolites M01 and M02; — potential genotoxicity of one impurity.
313	Pyridaben CAS No 96489-71-3 CIPAC No 583	2-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyrididazin-3(2H)-one	>980 g/kg	1 May 2011	30 April 2021	PART AOnly uses as insecticide and acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyridaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.In this overall assessment Member States shall 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 aquatic organisms and mammals, — the risk to non target arthropods including honeybees. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify the real exposure of honeybees to pyridaben in areas extensively used by such bees for foraging or by beekeepers, where and as appropriate.The Member States concerned shall request the submission of confirmatory information as regards: — the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3, — the potential long term risk for mammals, — the assessment of fat soluble residues. They shall ensure that the applicant provides such confirmatory information to the Commission by 30 April 2013.
314	Zinc phosphide CAS No 1314-84-7 CIPAC No 69	Trizinc diphosphide	≥ 800 g/kg	1 May 2011	30 April 2021	PART AOnly uses as rodenticide in the form of ready-to-use baits placed in bait stations or target locations may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on zinc 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 2010 shall be taken into account.In this overall assessment Member States should pay particular attention to: — the protection of non target organisms. Risk mitigation measures should be applied as appropriate in particular to avoid the spread of baits where only part of the content has been consumed.
315	Fenbuconazole CAS No 114369-43-6 CIPAC No 694	(R,S) 4-(4-chlorophenyl)-2-phenyl-2-(1H-1,2,4-triazol-1-ylmethyl)butyronitrile	≥ 965 g/kg	1 May 2011	30 April 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenbuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.In this overall assessment Member States shall 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 residues of triazole derivative metabolites (TDMs), — the risk to aquatic organisms and mammals. Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory data on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin.They shall ensure that the applicant provides such studies to the Commission by 30 April 2013.The Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of fenbuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
316	Cycloxydim CAS No 101205-02-1 CIPAC No 510	(5RS)-2-[(EZ)-1-(ethoxyimino)butyl]-3-hydroxy-5-[(3RS)-thian-3-yl]cyclohex-2-en-1-one	≥ 940 g/kg	1 June 2011	31 May 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cycloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information concerning the methods for analysis of residues of cycloxydim in plant and animal products.The Member States concerned shall ensure that the applicant submits such methods of analysis to the Commission by 31 May 2013.
317	6-Benzyladenine CAS No 1214-39-7 CIPAC No 829	N6-benzyladenine	≥ 973 g/kg	1 June 2011	31 May 2021	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 6-benzyladenine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate.
318	Bromuconazole CAS No 116255-48-2 CIPAC No 680	1-[(2RS,4RS:2RS,4SR)-4-bromo-2-(2,4-dichlorophenyl)tetrahydrofurfuryl]-1H-1,2,4-triazole	≥ 960 g/kg	1 February 2011	31 January 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bromuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment, Member States shall pay particular attention to: — operator's safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones. The Member States concerned shall ensure that the applicant presents to the Commission: — further information on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; — information to further address the long term risk to herbivorous mammals. They shall ensure that the applicant at whose request bromuconazole has been included in this Annex provides such confirmatory information to the Commission by 31 January 2013 at the latest.The Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of bromuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
319	Myclobutanil CAS No 88671-89-0 CIPAC No 442	RS)-2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile	≥ 925 g/kg The impurity 1-methylpyrrolidin-2-one shall not exceed 1 g/kg in the technical material	1 June 2011	31 May 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on myclobutanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information on the residues of myclobutanil and its metabolites in following growing seasons and information confirming that the available residue data cover all compounds of the residue definition.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 January 2013.
320	Buprofezin CAS No 953030-84-7 CIPAC No 681	(Z)-2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one	≥ 985 g/kg	1 February 2011	31 January 2021	PART AOnly uses as insecticide and acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on buprofezin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the operators’ and workers’ safety and ensure that conditions of use impose adequate personal protective equipment where appropriate; — the dietary exposure of consumers to the buprofezin (aniline) metabolites in processed food; — the application of an appropriate waiting period for rotational crops in greenhouses; — the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards the processing and conversion factors for consumer risk assessment.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 January 2013.
321	Triflumuron CAS No 64628-44-0 CIPAC No: 548	1-(2-chlorobenzoyl)-3-[4-trifluoromethoxyphenyl]urea	≥ 955 g/kg Impurities: — N,N′-bis-[4-(trifluoromethoxy)phenyl]urea: not more than 1 g/kg — 4-trifluoro-methoxyaniline: not more than 5 g/kg	1 April 2011	31 March 2021	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triflumuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment, Member States shall pay particular attention to: — the protection of the aquatic environment; — the protection of honey bees. Conditions of authorisation shall include risk mitigation measures, where appropriate. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards the long-term risk to birds, the risk to aquatic invertebrates and the risk to bee brood development.The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 March 2013.
322	Hymexazol CAS No 10004-44-1 CIPAC No 528	5-methylisoxazol-3-ol (or 5-methyl-1,2-oxazol-3-ol)	≥985 g/kg	1 June 2011	31 May 2021	PART AOnly uses as fungicide for seed pelleting of sugar beets in professional seed treatment facilities may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on hymexazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the operators and workers safety. Conditions of authorisation shall include protective measures, where appropriate, — the risk to granivorous birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards the nature of residues in root crops and the risk for granivorous birds and mammals.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
323	Dodine CAS No 2439-10-3 CIPAC No 101	1-dodecylguanidinium acetate	≥ 950 g/kg	1 June 2011	31 May 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dodine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the potential long-term risk to birds and mammals; — the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures; — the risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures; — the monitoring of residue levels in pome fruit. The Member States concerned shall request the submission of confirmatory information as regards: — long-term risk assessment for birds and mammals, — risk assessment in natural surface water systems where major metabolites have potentially formed. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
324	Diethofencarb CAS No 87130-20-9 CIPAC No 513	isopropyl 3,4-diethoxycarbanilate	≥ 970 g/kg Impurities: Toluene: not more than 1 g/kg	1 June 2011	31 May 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diethofencarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and non-target arthropods and shall ensure that conditions of use include the application of adequate risk mitigation measures.The Member States concerned shall request the submission of confirmatory information as regards: — the potential uptake of the metabolite 6-NO2-DFC in succeeding crops; — the risk assessment for non-target arthropod species. The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.
325	Etridiazole CAS No 2593-15-9 CIPAC No 518	ethyl-3-trichloromethyl-1,2,4-thiadiazol-5-yl ether	≥ 970 g/kg	1 June 2011	31 May 2021	PART AOnly uses as fungicide in non-soil bound systems in greenhouse may be authorised.PART BIn assessing applications to authorise plant protection products containing etridiazole for uses other than on ornamental plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorization is granted.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on etridiazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall: — pay particular attention to the risk to operators and workers and ensure that conditions of use include the application of appropriate risk mitigation measures; — ensure that appropriate waste management practices are applied as regards waste water from irrigation of non-soil bound growing systems; Member States permitting the release of waste water into the sewage system or into natural water bodies, shall ensure that an appropriate risk assessment is carried out; — pay particular attention to the risk to aquatic organisms and ensure that conditions of use include the application of appropriate risk mitigation measures. The Member States concerned shall request the submission of confirmatory information as regards: 1. the specification of the technical material, as commercially manufactured, by appropriate analytical data; 2. the relevance of the impurities; 3. the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the ecotoxicity dossiers; 4. the relevance of the plant metabolites 5-hydroxy-ethoxyetridiazole acid and 3-hydroxymethyletridiazole; 5. indirect exposure of groundwater and soil-dwelling organisms to etridiazole and to its soil metabolites dichloro-etridiazole and etridiazole acid; 6. long-range and short-range transport through the atmosphere of etridiazole acid. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1), (2) and (3) by 30 November 2011 and the information set out in points (4), (5) and (6) by 31 May 2013.
326	Indolylbutyric acid CAS No 133-32-4 CIPAC No 830	4-(1H-indol-3-yl)butyric acid	≥ 994 g/kg	1 June 2011	31 May 2021	PART AOnly uses as plant growth regulator in ornamentals may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on indolylbutyric acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the operators and workers safety. Conditions of authorisation shall include the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure.The Member States concerned shall request the submission of further information to confirm: — the absence of clastogenicity potential of indolylbutyric acid; — the vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study; — the natural background concentration of indolylbutyric acid in the soil. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
327	Oryzalin CAS No 19044-88-3 CIPAC No 537	3,5-dinitro-N4,N4-dipropylsulfanilamide	≥ 960 g/kg N-nitrosodipropylamine: ≤ 0,1 mg/kg Toluene: ≤ 4 g/kg	1 June 2011	31 May 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oryzalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the operator safety and ensure that conditions of use include the application of adequate personal protective equipment; — the protection of aquatic organisms and non target plants; — the protection of groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to herbivorous birds and mammals; — the risk to bees, in the flowering season. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolites OR13 (4) and OR15 (5) in vulnerable zones, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities which for confidentiality reasons are referred to as impurities 2, 6, 7, 9, 10, 11, 12; (2) the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material; (3) the risk assessment for aquatic organisms; (4) the relevance of the metabolites OR13 and OR15, and the corresponding groundwater risk assessment, if oryzalin is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013. The information set out in point (4) shall be submitted within six month of notification of a decision classifying oryzalin.
328	Tau-fluvalinate CAS No 102851-06-9 CIPAC No 786	(RS)-α-cyano-3-phenoxybenzyl N-(2-chloro- α,α α- trifluoro-p-tolyl)-D-valinate (Isomer ratio 1:1)	≥ 920 g/kg (1:1 ratio of R-α-cyano and S-α-cyano isomers) Impurities: Toluene: not more than 5 g/kg	1 June 2011	31 May 2021	PART AOnly uses as insecticide and acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tau-fluvalinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the risk to aquatic organisms and ensure that conditions of use prescribe the application of adequate risk mitigation measures; — the risk to non-target arthropods and ensure that conditions of use prescribe the application of adequate risk mitigation measures; — the test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material commercially manufactured. The Member States concerned shall request the submission of confirmatory information as regards: — the risk of bioaccumulation/biomagnification in the aquatic environment; — the risk to non-target arthropods; The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.The Member States concerned shall ensure that the applicant submits confirmatory information, two years after the adoption of specific guidance, as regards: — the possible impact on the environment of the potential enantio-selective degradation in environmental matrices.
▼M27
329	Clethodim CAS No 99129-21-2 CIPAC No 508	(5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyloxyimino]propyl}-5-[(2RS)-2-(ethylthio)propyl]-3-hydroxycyclohex-2-en-1-one	≥ 930 g/kg Impurities: toluene max. 4 g/kg	1 June 2011	31 May 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clethodim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 December 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection to aquatic organisms, birds and mammals, and shall ensure that conditions of use include the application of adequate risk mitigation measures.The Member States concerned shall request the submission of confirmatory information, on the basis of most recent scientific knowledge, as regards: — the soil and groundwater exposure assessments, — the residue definition for risk assessment. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
▼B
330	Bupirimate CAS No 41483-43-6 CIPAC No 261	5-butyl-2-ethylamino-6-methylpyrimidine-4-yl dimethylsulfamate	≥ 945 g/kg Impurities: Ethirimol: max. 2 g/kg Toluene: max. 3 g/kg	1 June 2011	31 May 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bupirimate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, — 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 mitigations, where appropriate, — the in-field risk to non-target arthropods. The Member States concerned shall request the submission of confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured, by appropriate analytical data; including information on the relevance of the impurities, (2) the equivalence between the specifications of the technical material; as commercially manufactured, and those of the test material used in the toxicity dossiers, (3) the kinetic parameters, the soil degradation and the adsorption and desorption parameter for the major soil metabolite DE-B (6). The Member States concerned shall ensure that the applicant submits such confirmatory data and information to the Commission set out in point (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013.
▼M112 —————
▼B
332	Fenoxycarb CAS No 79127-80-3 CIPAC No: 425	Ethyl 2-(4-phenoxyphenoxy)ethyl carbamate	≥ 970 g/kg Impurities: Toluene: max. 1 g/kg	1 June 2011	31 May 2021	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenoxycarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, — the risk to bees and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of information confirming the risk assessment for non-target arthropods and for bee brood.The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.
333	1-decanol CAS No 112-30-1 CIPAC No 831	Decan-1-ol	≥ 960 g/kg	1 June 2011	31 May 2021	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1-decanol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the risk to consumers from residues in case of use on food or feed crops; — the risk for operator and ensure that conditions of use prescribe the application of adequate 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 aquatic organisms; — the risk to non-target arthropods and bees that may be exposed to the active substance by visiting flowering weeds present in the crop at time of application. Risk mitigation measures shall be applied, where appropriate.The Member States concerned shall request the submission of confirmatory information, as regards the risk to aquatic organisms and of information confirming the groundwater, surface water and sediment exposure assessments.The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
334	Isoxaben CAS No 82558-50-7 CIPAC No 701	N-[3-(1-ethyl-1-methylpropyl)-1,2-oxazol-5-yl]-2,6-dimethoxybenzamide	≥ 910 g/kg Toluene: ≤ 3 g/kg	1 June 2011	31 May 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isoxaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, the risk to non-target terrestrial plants and the potential leaching of metabolites to groundwater.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards: (a) the specification of the technical material, as commercially manufactured, (b) the relevance of the impurities; (c) the residues in rotational crops; (d) the potential risk to aquatic organisms. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a) and (b) by 30 November 2011 and the information set out in points (c) and (d) by 31 May 2013.
335	Fluometuron CAS No: 2164-17-2 CIPAC No: 159	1,1-dimethyl-3-(α,α,α -trifluoro-m-tolyl)urea	≥ 940 g/kg	1 June 2011	31 May 2021	PART AOnly uses as herbicide on cotton may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluometuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall: — pay particular attention to the protection of the operators and workers and ensure that conditions of use include the application of adequate personal protective equipment; — pay particular attention to the protection of the groundwater where the active substance is applied in regions with vulnerable soil and/or climatic conditions; they shall ensure that conditions of authorisation include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential leaching of fluometuron and soil metabolites desmethyl-fluometuron and trifluoromethylaniline in vulnerable areas, where appropriate; — pay particular attention to the risk to non-target soil macro-organisms others than earthworms and non-target plants, and ensure that conditions of authorisation include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the applicants submit to the Commission confirmatory information as regards: (a) the toxicological properties of the plant metabolite trifluoroacetic acid; (b) the analytical methods for the monitoring of fluometuron in air; (c) the analytical methods for the monitoring of the soil metabolite trifluoromethylaniline in soil and water; (d) the relevance for ground water of the soil metabolites desmethyl-fluometuron and trifluoromethylaniline, if fluometuron is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’. The Member States concerned shall ensure that the applicants submit to the Commission the information set out in points (a), (b) and (c) by 31 March 2013 and the information set out in point (d) within six months from the notification of the decision classifying fluometuron.
336	Carbetamide CAS No 16118-49-3 CIPAC No 95	(R)-1-(Ethylcarbamoyl)ethyl carbanilate	≥ 950 g/kg	1 June 2011	31 May 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carbetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (b) the risk to non-target plants; (c) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate.
337	Carboxin CAS No 5234-68-4 CIPAC No 273	5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide	≥ 970 g/kg	1 June 2011	31 May 2021	PART AOnly uses as fungicide for seed treatment may be authorised.Member States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carboxin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the risk to operators; — 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. Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards: (a) the specification of the technical material, as commercially manufactured, -including appropriate analytical data-; (b) the relevance of the impurities; (c) comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material; (d) analytical methods for the monitoring of the metabolite M6 (7) in soil, groundwater and surface water and for the monitoring of metabolite M9 (8) in groundwater; (e) additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 (9) and P/V-55 (10), (f) rotational crop metabolism, (g) the long-term risk to granivorous birds, granivorous mammals and herbivorous mammals; (h) the relevance for ground water of the soil metabolites P/V-54 (11), P/V-55 (12) and M9 (13) if carboxin is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a), (b) and (c) by 30 November 2011, the information set out in points (d), (e), (f) and (g) by 31 May 2013 and the information set out in point (h) six months after the notification of decision classifying carboxin.
338	Cyproconazole CAS No 94361-06-5 CIPAC No 600	(2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol	≥ 940 g/kg	1 June 2011	31 May 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyproconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs); — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards: (a) the toxicological relevance of the impurities in the technical specification; (b) analytical methods for the monitoring of cyproconazole in soil, body fluids and tissues; (c) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; (d) the long term risk to herbivorous mammals; (e) the possible environmental impact of the preferential degradation and/or conversion of the mixture of isomers. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 30 November 2011, the information set out in points (b), (c) and (d) by 31 May 2013 and the information set out in point (e) two years after the adoption of specific guidance.
339	Dazomet CAS No 533-74-4 CIPAC No 146	3,5-dimethyl-1,3,5-thiadiazinane-2-thione or tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione	≥ 950 g/kg	1 June 2011	31 May 2021	PART AOnly uses as nematicide, fungicide, herbicide and insecticide may be authorised. Only application as soil fumigant may be authorised. Use shall be limited to one application every third year.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dazomet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the risk to operators, workers and bystanders; — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards: (a) the potential groundwater contamination by methyl isothiocyanate; (b) the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks; (c) the acute risk to insectivorous birds; (d) the long term risk to birds and mammals. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013.
340	Metaldehyde CAS No 108-62-3 (tetramer) 9002-91-9 (homopolymer) CIPAC No 62	r-2, c-4, c-6, c-8-tetramethyl-1,3,5,7- tetroxocane	≥ 985 g/kg acetaldehyde max. 1,5 g/kg	1 June 2011	31 May 2021	PART AOnly uses as molluscicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metaldehyde, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the risk to operators and workers; — the dietary exposure situation of consumers in view of future revisions of maximum residue levels; — the acute risk and long term risk to birds and mammals. Member States shall ensure that authorisations shall contain an effective dog repellent agent.Conditions of use shall include risk mitigation measures, where appropriate.
341	Sintofen CAS No 130561-48-7 CIPAC No 717	1-(4-chlorophenyl)-1,4-dihydro-5-(2-methoxyethoxy)-4-oxocinnoline-3-carboxylic acid	≥ 980 g/kg Impurities: 2-methoxyethanol, not more than 0,25 g/kg N,N-dimethylformamide, not more than 1,5 g/kg	1 June 2011	31 May 2021	PART AOnly uses as a plant growth regulator on wheat for hybrid seed production not intended for human consumption may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sintofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate risk mitigation measures. They shall ensure that wheat treated with sintofen does not enter the food and feed chain.The Member States concerned shall request the submission of confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured, supported by appropriate analytical data; (2) the relevance of the impurities present in the technical specifications, except of the impurities 2-methoxyethanol and N,N-dimethylformamide; (3) the relevance of the test material used in the toxicity and ecotoxicity dossiers in view of the specification of the technical material; (4) the metabolic profile of sintofen in rotational crops. The Member States concerned shall ensure that the applicant submits to the Commission: the information set out in points (1) (2) and (3) by 30 November 2011 and the information set out in point (4) by 31 May 2013.
342	Fenazaquin CAS No 120928-09-8 CIPAC No 693	4-tert-butylphenethyl quinazolin-4-yl ether	≥ 975 g/kg	1 June 2011	31 May 2021	PART AOnly uses as acaricide on ornamentals in greenhouses may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenazaquin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall: — pay particular attention to the protection of aquatic organisms; — pay particular attention to the risk to operators and ensure that conditions of use include the application of adequate personal protective equipment; — pay particular attention to the protection of bees and ensure that conditions of use include risk mitigation measures, where appropriate; — provide for conditions of use which ensure that there are no residues of fenazaquin in crops for human and animal consumption.
343	Azadirachtin CAS No 11141-17-6 (azadirachtin A) CIPAC No 627 (azadirachtin A)	Azadirachtin A: dimethyl (2aR,3S,4S,4aR,5S,7aS,8S,10R,10aS,10bR)-10-acetoxy-3,5-dihydroxy-4-[(1aR,2S,3aS,6aS,7S,7aS)-6a-hydroxy-7a-methyl-3a,6a,7,7a-tetrahydro-2,7-methanofuro[2,3-b]oxireno[e]oxepin-1a(2H)-yl]-4-methyl-8-{[(2E)-2-methylbut-2-enoyl]oxy}octahydro-1H-naphtho[1,8a-c:4,5-b′c′]difuran-5,10a(8H)-dicarboxylate.	Expressed as azadirachtin A: ≥ 111 g/kg Sum of the aflatoxins B1, B2, G1, G2 must not exceeding 300 μg/kg of the azadirachtin A content.	1 June 2011	31 May 2021	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azadirachtin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; — the protection of non target arthropods and aquatic organisms. Risk mitigation measures shall be applied where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: — the relationship between azadirachtin A and the rest of the active components in the neem seeds extract with respect to amount, biological activity and persistence, in order to confirm the lead active compound approach with regard to azadirachtin A and to confirm specification of the technical material, residue definition and groundwater risk assessment. The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 December 2013.
344	Diclofop CAS No 40843-25-2 (parent) CAS No 257-141-8 (diclofop-methyl) CIPAC No 358 (parent) CIPAC No 358.201 (diclofop-methyl)	Diclofop (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionic acid Diclofop-methyl methyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate	≥ 980 g/kg (expressed as diclofop-methyl)	1 June 2011	31 May 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diclofop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall: — pay particular attention to the operators and workers safety and include as a condition for authorisation the application of adequate personal protective equipment; — pay particular attention to the risk to aquatic organisms and non target plants and require risk mitigation measures to be applied. The Member States concerned shall request the submission of confirmatory information as regards: (a) a metabolism study on cereals; (b) an update of the risk assessment concerning the possible environmental impact of the preferential degradation/conversion of the isomers. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 31 May 2013 and the information set out in point (b) at latest two years after the adoption of a specific guidance document on evaluation of isomers mixtures.
345	Lime sulphur CAS No 1344 - 81 - 6 CIPAC No 17	Calcium polysulfide	≥ 290 g/Kg.	1 June 2011	31 May 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on lime sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — operator safety and shall ensure that the conditions of authorisation include appropriate protective measures; — to the protection of aquatic organisms and non target arthropods and shall ensure that the conditions of use include risk mitigation measures as appropriate.
346	Aluminium sulfate CAS No 10043-01-3 CIPAC not available	Aluminium sulfate	970 g/kg	1 June 2011	31 May 2021	PART AOnly indoor uses as post-harvest bactericide for ornamental plants may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium sulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.The Member States concerned shall request the submission of confirmatory information as regards the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data.The Member States concerned shall ensure that the applicant submits such information to the Commission by 30 November 2011.
347	Bromadiolone CAS No 28772-56-7 CIPAC No 371	3-[(1RS,3RS;1RS,3SR)-3-(4′-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxycoumarin	≥ 970 g/kg	1 June 2011	31 May 2021	PART AOnly uses as rodenticide in the form of pre-prepared baits placed into the rodent tunnels may be authorised.The nominal concentration of the active substance in the plant protection products shall not exceed 50 mg/kg.Authorisations shall be granted for uses by professional users only.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bromadiolone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall: — pay particular attention to the risk to professional operators and ensure that conditions of use include the application of adequate personal protective equipment where appropriate; — pay particular attention to the risk to birds and non-target mammals from primary and secondary poisoning. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards: (a) the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data; (b) the relevance of the impurities; (c) the determination of bromadiolone in water with a limit of quantification of 0,01 μg/l; (d) the effectiveness of proposed mitigation measures to reduce risk to birds and non-target mammals; (e) the groundwater exposure assessment in respect of metabolites. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 30 November 2011 and the information set out in points (d) and (e) by 31 May 2013.
348	Paclobutrazol CAS No 76738-62-0 CIPAC No 445	(2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol	≥ 930 g/kg	1 June 2011	31 May 2021	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on paclobutrazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic plants and ensure that conditions of use include the risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured; (2) the analytical methods in soil and surface water for the metabolite NOA457654; (3) the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; (4) the potential endocrine disrupting properties of paclobutrazol; (5) the potential adverse effects of breakdown products of the different optical structures of paclobutrazol and its metabolite CGA 149907 on the environmental compartments soil, water and air. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011, the information set out in points (3) by 31 May 2013, the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption and the information set out in point (5) within two years after the adoption of specific guidance.
349	Pencycuron CAS No 66063-05-6 CIPAC No 402	1-(4-chlorobenzyl)-1-cyclopentyl-3-phenylurea	≥ 980 g/kg	1 June 2011	31 May 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pencycuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of large omnivorous mammals.Conditions of use shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards: (1) the fate and behaviour in soil of the chlorophenyl and cyclopentyl portions of pencycuron; (2) the fate and behaviour in natural surface water and sediment systems of the chlorophenyl and phenyl portions of pencycuron; (3) the long-term risk to large omnivorous mammals. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1), (2) and (3) by 31 May 2013.
350	Tebufenozide CAS No 112410-23-8 CIPAC No 724	N-tert-butyl-N′-(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide	≥ 970 g/kg Relevant impurity t-butyl hydrazine < 0,001 g/kg	1 June 2011	31 May 2021	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tebufenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall: — pay particular attention to the safety of operators and workers after re-entry and ensure that conditions of authorisation prescribe appropriate protective equipment; — pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — pay particular attention to the protection of aquatic organism and ensure that conditions of use prescribe adequate mitigation measures; — pay particular attention to the risk to Lepidoptera non-target insects. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information, as regards: (1) the relevance of metabolites RH-6595, RH-2651, M2; (2) the degradation of tebufenozide in anaerobic soils and soils of alkaline pH. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 31 May 2013.
351	Dithianon CAS No 3347-22-6 CIPAC No 153	5,10-dihydro-5,10-dioxonaphtho[2,3-b]-1,4-dithiine-2,3-dicarbonitrile	≥ 930 g/kg	1 June 2011	31 May 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dithianon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall: — pay particular attention to the protection of aquatic organisms; conditions of use shall include risk mitigation measures, where appropriate, — pay particular attention to the operator safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate, — pay particular attention to the long-term risks to birds; conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: — the storage stability and the nature of residues in processed products, — the aquatic and groundwater exposure assessment for phthalic acid, — the risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol. The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.
352	Hexythiazox CAS No 78587-05-0 CIPAC No 439	(4RS,5RS)-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide	≥ 976 g/kg (1:1 mixture of (4R, 5R) and (4S, 5S))	1 June 2011	31 May 2021	PART AOnly uses as acaricide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on hexythiazox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate; — the operators and workers safety. Conditions of use shall include protective measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (a) the toxicological relevance of the metabolite PT-1-3 (14); (b) the potential occurrence of the metabolite PT-1-3 in processed commodities; (c) the potential adverse effects of hexythiazox on bee brood; (d) the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) two years after the adoption of specific guidance.
353	Flutriafol CAS No 76674-21-0 CIPAC No 436	(RS)-2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol	≥ 920 g/kg (racemate) Relevant impurities: dimethyl sulphate: max content 0,1 g/kg dimethylformamide: max content 1 g/kg methanol: max content 1 g/kg	1 June 2011	31 May 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flutriafol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.In this overall assessment Member States shall: — pay particular attention to the protection of the workers’ safety and ensure that conditions of use include the application of adequate personal protective equipment; — pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — pay particular attention to the long-term risk to insectivorous birds. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards: (a) the relevance of the impurities present in the technical specifications; (b) the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; (c) the long-term risk to insectivorous birds. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 30 November 2011, the information set out in points (b) and (c) by 31 May 2013.
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354	Flurochloridone CAS No 61213-25-0 CIPAC No 430	(3RS,4RS;3RS,4SR)-3-chloro-4-chloromethyl-1-(α,α,α-trifluoro-m-tolyl)-2-pyrrolidone	≥ 940 g/kg. Relevant impurities: Toluene: max 8 g/kg	1 June 2011	31 May 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flurochloridone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 February 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: 1. the risk for non-target plants and aquatic organisms; 2. 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, where appropriate.The Member States concerned shall ensure that the applicant submits to the Commission further confirmatory information as regards: 1. the relevance of impurities other than toluene; 2. the compliance of ecotoxicological test material with the technical specifications; 3. the relevance of the groundwater metabolite R42819 (15); 4. the potential endocrine disrupting properties of flurochloridone. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 1 December 2011, the information set out in point (3) by 31 May 2013 and the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption.
(1) Further details on identity and specification of active substances are provided in their review reports. (2) Suspended by order of the General Court of 19 July 2007 in case T-31/07 R, Du Pont de Nemours (France) SAS and others v Commission, [2007] ECR II-2767. (3) OJ L 353, 31.12.2008, p. 1. (4) 2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide. (5) 2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide. (6) De-ethyl-bupirimate. (7) 2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate. (8) (2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide. (9) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide. (10) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide. (11) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide. (12) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide. (13) (2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide. (14) (4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one. (15) R42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one. (16) 1-[2-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-1H-[1,2,4]triazol-yl]-ethanol. (17) OJ L 300, 14.11.2009, p. 1. (18) OJ L 54, 26.2.2011, p. 1.

Number	Common Name, Identification Numbers	IUPAC Name	Purity (1)	Date of approval	Expiration of approval	Specific provisions
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1	Bispyribac CAS No 125401-75-4 CIPAC No 748	2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid	≥ 930 g/kg (referred to as bispyribac-sodium)	1 August 2011	31 July 2021	PART AOnly uses as herbicide in rice may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bispyribac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment, Member States shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of authorisation shall include risk mitigation measures where appropriate.The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03 (2), M04 (3) and M10 (4).They shall ensure that the applicant provides such information to the Commission by 31 July 2013.
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2	Profoxydim CAS No 139001-49-3 CIPAC No 621	2 - [(1 E/Z) - [(2 R S) – 2 - (4 – chlorophenoxy) propoxyimino] butyl] – 3 – hydroxy – 5 - [(3 R S; 3 S R) – tetrahydro – 2 H – thiopyran – 3 – yl] cyclohex – 2 - enone	≥ 940 g/kg	1 August 2011	31 July 2021	PART AOnly uses as herbicide in rice may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on profoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment, Member States shall pay particular attention to: — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the long-term risk to non-target organisms. Conditions of authorisation shall include risk mitigation measures where appropriate.
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3	Azimsulfuron CAS No 120162-55-2 CIPAC No 584	1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea	≥ 980 g/kg maximum level of the impurity phenol 2 g/kg	1 January 2012	31 December 2021	PART AOnly uses as herbicide may be authorised.Aerial applications may not be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (1) the protection of non-target plants; (2) the potential for groundwater contamination, when the active substance is applied in vulnerable scenarios and/or climatic conditions; (3) the protection of aquatic organisms. Member States shall ensure that the conditions of authorisation include risk mitigation measures, where appropriate (e.g. buffer zones, in rice cultivation minimum holding periods for water prior to discharge).The notifier shall submit confirmatory information as regards: (a) the risk assessment on aquatic organisms; (b) the identification of the degradation products in the aqueous photolysis of the substance. The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
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4	Azoxystrobin CAS No 131860-33-8 CIPAC No 571	methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate	≥ 930 g/kg Toluene maximum content 2 g/kg Z-isomer maximum content 25 g/kg	1 January 2012	31 December 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (1) the fact that 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; (2) the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (3) the protection of aquatic organisms. The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms.The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
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5	Imazalil CAS No 35554-44-0 73790-28-0 (replaced) CIPAC No 335	(RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazole or allyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether	≥ 950 g/kg	1 January 2012	31 December 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazalil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall: (1) pay particular attention to the fact that 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; (2) pay particular attention to the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels; (3) 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; (4) ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out; (5) pay particular attention to risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards: (a) route of degradation of imazalil in soil and surface water systems; (b) environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible; (c) a hydrolysis study to investigate the nature of residues in processed commodities. The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
▼M3
6	Prohexadione CAS No 127277-53-6 (prohexadione-calcium) CIPAC No 567 (prohexadione) No 567.020 (prohexadione-calcium)	3,5-dioxo-4-propionylcyclohexanecarboxylic acid	≥ 890 g/kg (expressed as prohexadione-calcium)	1 January 2012	31 December 2021	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prohexadione and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
▼M13
7	Spiroxamine CAS No 1181134-30-8 CIPAC No 572	8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine (ISO)	≥ 940 g/kg (diastereomers A and B combined)	1 January 2012	31 December 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spiroxamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (1) the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment; (2) the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (3) the risk to aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards: (a) the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment; (b) the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities; (c) the groundwater exposure assessment for metabolite M03 (7); (d) the risk to aquatic organisms. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by two years after the adoption of specific guidance and the information set out in points (b), (c) and (d) by 31 December 2013.
▼M18
8	Kresoxim-methyl CAS No 143 390-89-0 CIPAC No 568	methyl (E)-methoxyimino[a-(o-tolyloxy)-o-tolyl]acetate	≥ 910 g/kg Methanol: max. 5 g/kg Methyl chloride: max. 1 g/kg Toluene: max. 1 g/kg	1 January 2012	31 December 2021	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on kresoxim-methyl and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.Member States shall pay particular attention to the protection of groundwater under vulnerable conditions; the conditions of authorisation shall include, where appropriate, risk mitigation measures.The applicant shall submit confirmatory information as regards:Groundwater exposure risk assessment, and in particular: — on the lysimeter study to support the statement that the two unidentified peaks observed do not correspond to metabolites individually exceeding the trigger value of 0,1 μg/L, — on the recovery of metabolite BF 490-5 in order to confirm its absence in the lysimeter leachate at levels exceeding 0,1 μg/L, — on a groundwater exposure risk assessment for the late application in apples, pears and grapes. The applicant shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
▼M8
9	Fluroxypyr CAS No 69377-81-7 CIPAC No 431	4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid	≥ 950 g/kg (fluroxypyr-meptyl)	1 January 2012	31 December 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluroxypyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall: (1) pay particular attention to the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil and/or with vulnerable climatic conditions; (2) pay particular attention to the risk to aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards: (a) the relevance of the impurities present in the technical specifications; (b) the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material; (c) the toxicological relevance of the metabolites fluroxypyr pyridinol and fluroxypyr methoxypyridine; (d) the residue analytical methods for plants; (e) the fate of fluroxypyr esters in animal matrices; (f) the long-term risk for earthworms and soil organisms. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) and (b) by 1 July 2012 and the information set out in points (c), (d), (e) and (f) by 31 December 2013.
▼M15
10	Tefluthrin CAS No: 79538-32-2 CIPAC No: 451	2,3,5,6-tetrafluoro-4-methylbenzyl (1RS, 3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate Tefluthrin is a 1:1 mixture of Z-(1R, 3R) and Z-(1S, 3S) enantiomers.	≥ 920 g/kg Hexachlorobenzene: not more than 1 mg/kg	1 January 2012	31 December 2021	PART AOnly uses as insecticide may be authorised.The seed coating shall only be performed in professional seed treatment facilities. These facilities shall apply the best available techniques in order to exclude the release of dust clouds during storage, transport and application.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tefluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: — the operators and workers safety and include among the authorised conditions of use the application of adequate personal protective equipment as well as respiratory protective equipment, — the risk to birds and mammals. Risk mitigation measures should be applied to grant a high degree of incorporation in soil and avoidance of spillage, — ensure that the label of treated seed includes the indication that the seeds were treated with tefluthrin and sets out the risk mitigation measures provided for in the authorisation. The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured; (2) a validated analytical method for water; (3) the possible environmental impact of the preferential degradation/conversion of the isomers and an estimation of the relative toxicity and risk assessment for the workers. The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2012, the information set out in point (2) by 31 December 2012, and the information set out in point (3) 2 years after the adoption of a specific guidance document on evaluation of isomers mixture.
▼M14
11	Oxyfluorfen CAS No 42874-03-3 CIPAC No 538	2-chloro-α,α,α-trifluoro-p-tolyl 3-ethoxy-4-nitrophenyl ether	≥ 970 g/kg Impurities: N,N-dimethylnitrosamine: not more than 50 μg/kg	1 January 2012	31 December 2021	PART AOnly uses as herbicide for banded applications close to ground from autumn to early spring may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxyfluorfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.In this overall assessment Member States shall: (a) pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; (b) pay particular attention to the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants. Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured including information on the relevance of the impurities; (2) the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies; (3) the potential risk to aquatic organisms for the active substance and for the metabolites RH-45469 (8), MW 306 (9), MW 347 (10), MW 274 (11) and for the unidentified metabolite Deg 27; (4) the potential risk from bioaccumulation and biomagnification in the aquatic food chain, including sediment dwellers; (5) exposure data for banded application adequate for use as drift mitigation values. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3) to (5) by 31 December 2013.
▼M10
12	1-naphthylacetamide CAS No 86-86-2 CIPAC No 282	2-(1-naphthyl)acetamide	≥ 980 g/kg	1 January 2012	31 December 2021	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1-naphthylacetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.In this overall assessment Member States: (a) shall pay particular attention to the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (c) shall pay particular attention to the risk to aquatic organisms; (d) shall pay particular attention to the risk to non-target plants; (e) shall pay particular attention to the risk to birds. Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards: (1) the risk to non-target plants; (2) the long-term risk to birds. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
▼M11
13	1-naphthylacetic acid CAS No 86-87-3 CIPAC No 313	1-naphthylacetic acid	≥ 980 g/kg	1 January 2012	31 December 2021	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1-naphthylacetic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States: (a) shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) shall pay particular attention to the dietary exposure situation of consumers in view of future revisions of maximum residue levels; (c) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (d) shall pay particular attention to the risk to aquatic organisms; (e) shall pay particular attention to the risk to birds. Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards: (1) the route and rate of degradation in soil including an assessment of the potential for photolysis; (2) the long-term risk to birds. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
▼M16
14	Fluquinconazole CAS No 136426-54-5 CIPAC No 474	3-(2,4-dichlorophenyl)-6-fluoro-2-(1H-1,2,4-triazol-1-yl)quinazolin-4(3H)-one	≥ 955 g/kg	1 January 2012	31 December 2021	PART AOnly uses as fungicide may be authorisedPART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluquinconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States: (a) shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs); (c) shall pay particular attention to the risk to birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards: (1) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; (2) the contribution of the potential residues of the metabolite dione in rotational crops to the overall consumer exposure; (3) the acute risk to insectivorous mammals; (4) the long-term risk to insectivorous and herbivorous birds and mammals; (5) the risk to earthworm-eating mammals; (6) the endocrine disruption potential in aquatic organisms (fish full life cycle study). The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
▼M12
15	Fluazifop P CAS No 83066-88-0 (fluazifop-P) CIPAC No 467 (fluazifop-P)	(R)-2-{4-[5-(trifluoromethyl)-2-pyridyloxy]phenoxy}propionic acid (fluazifop-P)	≥ 900 g/kg in fluazifop P-butyl The following impurity 2-chloro-5-(trifluoromethyl)pyridine must not exceed 1,5 g/kg in the material as manufactured.	1 January 2012	31 December 2021	►M53 PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluazifop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013, shall be taken into account.In this overall assessment Member States shall: — pay particular attention to consumer safety as regards the occurrence in groundwater of the metabolite compound X (5); — pay particular attention to operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; — pay particular attention to the protection of surface water and groundwater in vulnerable zones; — pay particular attention to the risk for non-target plants. Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured, including information on the relevance of the impurity R154719; (2) the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies; (3) the potential long-term risk to herbivorous mammals; (4) the fate and behaviour in the environment of the metabolite compounds X (5) and IV (6); (5) the potential risk to fish and aquatic invertebrates for the metabolite compound IV (6). The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3), (4) and (5) by 31 December 2013. ◄
▼M19
16	Terbuthylazine CAS No 5915-41-3 CIPAC No 234	N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine	≥ 950 g/kg Impurities: Propazine not more than 10 g/kg Atrazine not more than 1 g/kg Simazine not more than 30 g/kg	1 January 2012	31 December 2021	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (b) the risk to mammals and earthworms. Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities; (2) the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies; (3) groundwater exposure assessment for the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6; (4) the relevance of the metabolites MT1 (N-tert-butyl-6-chloro-1,3,5-triazine-2,4-diamine), MT 13 (4-(tert-butylamino)-6-(ethylamino)-1,3,5-triazin-2-ol or 6-hydroxy-N2-ethyl-N4-tert-butyl-1,3,5-triazine-2,4-diamine), MT14 (4-amino-6-(tert-butylamino)-1,3,5-triazin-2-ol or N-tert-butyl-6-hydroxy-1,3,5-triazine-2,4-diamine), and of the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6 with respect to cancer, if terbuthylazine is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012, the information set out in point (3) by 30 June 2013 and the information set out in point (4) within six months from the notification of the classification decision concerning that substance.
▼M17
17	Triazoxide CAS No 72459-58-6 CIPAC No 729	7-chloro-3-imidazol-1-yl-1,2,4-benzotriazine 1-oxide	≥ 970 g/kg Impurities: toluene: not more than 3 g/kg	1 October 2011	30 September 2021	PART AOnly uses as fungicide for use as seed treatment may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triazoxide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.In this overall assessment Member States: (a) shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) shall pay particular attention to the risk to granivorous birds and shall ensure that conditions of authorisation include risk mitigation measures. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the long-term risk to granivorous mammals by 30 September 2013.
▼M21
18	8-hydroxyquinoline CAS No 148-24-3 (8-hydroxyquinoline) CIPAC No 677 (8-hydroxyquinoline)	8-quinolinol	≥ 990 g/kg	1 January 2012	31 December 2021	PART AOnly uses as fungicide and bactericide in greenhouses may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 8-hydroxyquinoline, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate.The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards: (1) the method of analysis for air; (2) a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
▼M20
19	Acrinathrin CAS No 101007-06-1 CIPAC No 678	(S)-α-cyano-3-phenoxybenzyl (Z)-(1R,3S)-2,2-dimethyl-3-[2-(2,2,2-trifluoro-1-trifluoromethylethoxycarbonyl)vinyl]cyclopropanecarboxylate or (S)-α-cyano-3-phenoxybenzyl (Z)-(1R)-cis-2,2-dimethyl-3-[2-(2,2,2-trifluoro-1-trifluoromethylethoxycarbonyl)vinyl]cyclopropanecarboxylate	≥ 970 g/kg Impurities: 1,3-dicyclohexylurea: not more than 2 g/kg	1 January 2012	31 December 2021	PART AOnly uses as insecticide and acaricide may be authorised at rates not exceeding 22,5 g/ha per application.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acrinathrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.In this overall assessment Member States: (a) shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) shall pay particular attention to the risk to aquatic organisms, in particular fish, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate; (c) shall pay particular attention to the risk to non-target arthropods and bees and shall ensure that conditions of authorisation include risk mitigation measures. The applicant shall submit confirmatory information as regards: (1) the potential risk to groundwater from the metabolite 3-PBAld (12); (2) the chronic risk to fish; (3) the risk assessment for non-target arthropods; (4) the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points 1, 2 and 3 by 31 December 2013 and the information set out in point 4 2 years after the adoption of specific guidance.
▼M25
20	Prochloraz CAS No 67747-09-5 CIPAC No 407	N-propyl-N-[2-(2,4,6-trichlorophenoxy)ethyl]imidazole-1-carboxamide	≥ 970 g/kg Impurities: Sum of dioxins and furans (WHO-PCDD/T TEQ) (13): not more than 0,01 mg/kg	1 January 2012	31 December 2021	PART AOnly uses as fungicide may be authorised. In the case of outdoor uses, rates shall not exceed 450 g/ha per application.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prochloraz, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011, shall be taken into account.In this overall assessment Member States: (a) shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) shall pay particular attention to the risk to aquatic organisms, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate; (c) shall pay particular attention to the long-term risk to mammals and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate. The applicants shall submit confirmatory information as regards: (1) comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material; (2) the environmental risk assessment for the metal complexes of prochloraz; (3) the potential endocrine disrupting properties of prochloraz on birds. The notifier shall submit to the Commission, the Member States and the Authority the information set out in points 1 and 2 by 31 December 2013 and the information set out in point 3 within 2 years after the adoption of the pertinent OECD test guidelines on endocrine disruption.
▼M72 —————
▼M30
22	Metam CAS No 144-54-7 CIPAC No 20	Methyldithiocarbamic acid	≥ 965 g/kg Expressed as metam-sodium on a dry weight basis ≥ 990 g/kg Expressed as metam-potassium on a dry weight basis Relevant impurities: methylisothiocyanate (MITC) — max. 12 g/kg on dry weight basis (metam-sodium), — max. 0,42 g/kg on dry weight basis (metam-potassium). N,N’-dimethylthiourea (DMTU) — max. 23 g/kg on a dry weight basis (metam-sodium), — max. 6 g/kg on a dry weight basis (metam-potassium).	1 July 2012	30 June 2022	PART AOnly uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field.The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed.The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications.Authorisations shall be limited to professional users.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account.In this overall assessment Member States: (a) shall pay particular attention to the protection of operators and shall ensure that the conditions of use include risk mitigation measures such as application of adequate personal protective equipment and a limitation in the daily work rate; (b) shall pay particular attention to the protection of workers and shall ensure that the conditions of use include risk mitigation measures, such as use of adequate personal protective equipment, re-entry period and limitation in the daily work rate; (c) shall pay particular attention to the protection of bystanders and residents and shall ensure that the conditions of use include risk mitigation measures, such as an appropriate buffer zone during and until 24 hours after the application from the perimeter of the application area to any occupied residences and areas used by the general public with obligation to use warning signs and ground markers; (d) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and shall ensure that the conditions of use include risk mitigation measures, such as appropriate buffer zone; (e) shall pay particular attention to the risk to non-target organisms and shall ensure that conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information on methyl isothiocyanate as regards: (1) the assessment of the long-range atmospheric transport potential and related environmental risks; (2) the potential groundwater contamination. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014.
▼M33
23	Bifenthrin CAS No 82657-04-3 CIPAC No 415	2-methylbiphenyl-3-ylmethyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate or 2-methylbiphenyl-3-ylmethyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate	≥ 930 g/kg Impurities: Toluene: not more than 5 g/kg	1 August 2012	31 July 2019	PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the persistency in the environment; (b) the risk for bioaccumulation and biomagnification; (c) the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; (d) the risk to aquatic organisms, in particular fish and invertebrates, non-target arthropods and bees, ensuring that conditions of authorisation include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the residual toxicity for non-target arthropods and the potential for recolonisation; (2) the fate and behaviour of soil metabolite 4'-OH bifenthrin; (3) the degradation in soil of the isomers which constitute bifenthrin, 4'-OH bifenthrin and TFP acid. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points 1, 2 and 3 by 31 July 2014.The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential for bioaccumulation and biomagnification in the aquatic and terrestrial environment by 31 July 2013. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 31 July 2015.
▼M34
24	Fluxapyroxad CAS No 907204-31-3 CIPAC No 828	3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide	≥ 950 g/kg The impurity toluene must not exceed 1 g/kg in the technical material	1 January 2013	31 December 2022	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluxapyroxad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to groundwater, if the active substance is applied under vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
▼M35
25	Fenpyrazamine CAS No 473798-59-3 CIPAC No 832	S-allyl 5-amino-2,3-dihydro-2-isopropyl-3-oxo-4-(o-tolyl)pyrazole-1-carbothioate	≥ 940 g/kg	1 January 2013	31 December 2022	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpyrazamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
▼M40
26	Adoxophyes orana granulovirus Culture collection No DSM BV-0001 CIPAC No 782	Not applicable	No relevant impurities	1 February 2013	31 January 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Adoxophyes orana granulovirus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account.
▼M41
27	Isopyrazam CAS No 881685-58-1 (syn-isomer: 683777-13-1/anti-isomer: 683777-14-2) CIPAC No 963	A mixture of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide (syn-isomer – 50:50 mix of two enantiomers) and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide (anti-isomer– 50:50 mix of two enantiomers) In a range of 78:15 % to 100:0 % syn to anti.	≥ 920 g/kg In a range of 78:15 % to 100:0 % syn- to anti-isomers	1 April 2013	31 March 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isopyrazam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to aquatic organisms; (b) the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices; (c) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, like the exclusion of no cultivation/minimum cultivation practices, and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate. The applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater. ►M145 The applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017. ◄
▼M42
28	Phosphane CAS No 7803-51-2 CIPAC No 127	Phosphane	≥ 994 g/kg The relevant impurity arsane must not exceed 0,023 g/kg in the technical material	1 April 2013	31 March 2023	Authorisations shall be limited to professional users. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phosphane, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators in and around the treated premises during the treatment as well as during and after the aeration; — the protection of workers in and around the treated premises during the treatment as well as during and after the aeration; — the protection of bystanders around the treated premises during the treatment as well as during and after the aeration. Conditions of use shall include risk mitigation measures, like permanent monitoring of the phosphane concentration by automatic devices, the use of personal protection equipment and setting-up an area around the treated premise where bystanders are denied, where appropriate.
▼M45
29	Trichoderma asperellum (strain T34) CECT number: 20417	Not applicable	1 × 1010 cfu/g	1 June 2013	31 May 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma asperellum (strain T34), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Trichoderma asperellum (strain T34) is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures where appropriate.
▼M44
30	Zucchini Yellow Mosaic Virus — weak strain ATCC accession number: PV-593	Not applicable	≥ 0,05 mg/l	1 June 2013	31 May 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Zucchini Yellow Mosaic Virus — weak strain, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to non-target plants, if the crop plants are co-infected with another virus which can be transmitted by aphids. Conditions of use shall include risk mitigation measures, where appropriate.
▼M47
31	Cyflumetofen CAS No 400882-07-7 CIPAC No 721	2-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate	≥ 975 g/kg (racemic)	1 June 2013	31 May 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyflumetofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers; — the protection of groundwater, when the substance is applied in regions with vulnerable soils and/or climatic conditions; — the protection of drinking water; — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, like the use of personal protection equipment, where appropriate. The applicant shall submit confirmatory information as regards: (a) the possible mutagenic potential of the metabolite B3 (2-(trifluoromethyl) benzamide), by excluding an in vivo relevance of observed in vitro effects by an appropriate test protocol (in vivo Comet assay); (b) additional information to establish an ARfD for metabolite B3; (c) further ecotoxicological studies and assessments for aquatic vertebrates that cover their full life-cycle. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 May 2015.
▼M46
32	Trichoderma atroviride strain I-1237 CNCM number: I-1237	Not applicable	cfu/g ( spores/g)	1 June 2013	31 May 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride strain I-1237, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Trichoderma atroviride strain I-1237 is to be considered a potential sensitiser. Conditions of use shall include risk mitigation measures where appropriate.
▼M52
33	Ametoctradin CAS No 865318-97-4 CIPAC No 818	5-ethyl-6-octyl [1,2,4]triazolo[1,5-a] pyrimidin-7-amine	≥ 980 g/kg ►C2 The impurities amitrole and o-xylene are of toxicological relevance and shall not exceed 50 mg/kg and 2 g/kg respectively in the technical material. ◄	1 August 2013	31 July 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ametoctradin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the leakage of metabolite M650F04 (14) to groundwater under vulnerable conditions. Conditions of use shall include risk mitigation measures, where appropriate.
▼M50
34	Mandipropamid CAS No 374726-62-2 CIPAC No 783	(RS)-2-(4-chlorophenyl)-N-[3-methoxy-4-(prop-2-ynyloxy)phenethyl]-2-(prop-2-ynyloxy)acetamide	≥ 930 g/kg The impurity N-{2-[4-(2-chloro-allyloxy)-3-methoxy-phenyl]-ethyl}-2-(4-chloro-phenyl)-2-prop-2-ynyloxy-acetamide is of toxicological relevance and shall not exceed 0,1 g/kg in the technical material.	1 August 2013	31 July 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mandipropamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential for preferential enantiomeric transformation or racemisation of mandipropamid at the soil surface as a result of soil photolysis. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 July 2015.
▼M56
35	Halosulfuron-methyl CAS No 100785-20-1 CIPAC No 785.201	methyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate	≥ 980 g/kg	1 October 2013	30 September 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on halosulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk of leakage to groundwater of the metabolite ‘halosulfuron’ rearrangement (HSR) (15) under vulnerable conditions. This metabolite is considered toxicologically relevant based on the available information for halosulfuron, — the risk to non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and the test material used in the toxicological and ecotoxicological studies; (b) information on the toxicological relevance of the impurities present in the technical specification as commercially manufactured; (c) data to clarify the potential genotoxic properties of chlorosulfonamide acid (16). The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.
▼M58
36	Bacillus firmus I-1582 Collection number: CNCMI-1582	Not applicable	Minimum concentration: 7,1 × 1010 CFU/g	1 October 2013	30 September 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus firmus I-1582, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus firmus I-158 2 is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures, where appropriate.
▼M62
37	Candida oleophila strain O Collection number: MUCL40654	Not applicable	Nominal content: 3 × 1010 CFU/g dried product Range: 6 × 109 – 1 × 1011 CFU/g dried product	1 October 2013	30 September 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Candida oleophila strain O, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
▼M60
38	Helicoverpa armigera nucleopolyhedrovirus DSMZ number: BV-0003	Not applicable	Minimum concentration: 1,44 × 1013 OB/l (occlusion bodies/l)	1 June 2013	31 May 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Helicoverpa armigera nucleopolyhedrovirus, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.
▼M64
39	Paecilomyces fumosoroseus strain FE 9901 Collection number: USDA-ARS collection of Entomopathogenic Fungal Cultures U.S. Plant Soil and Nutrition laboratory. New York. Accession No ARSEF 4490	Not applicable	Minimum 1,0 × 109 CFU/g Maximum 3,0 × 109 CFU/g	1 October 2013	30 September 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Paecilomyces fumosoroseus strain FE 9901, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Paecilomyces fumosoroseus strain FE 9901 is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures, where appropriate.
▼M61
40	Potassium phosphonates (no ISO name) CAS No 13977-65-6 for potassium hydrogen phosphonate 13492-26-7 for dipotassium phosphonate Mixture: none CIPAC No 756 (for potassium phosphonates)	Potassium hydrogen phosphonate, Dipotassium phosphonate	31,6 to 32,6 % phosphonate ions (sum of hydrogen phosphonate and phosphonate ions) 17,8 to 20,0 % potassium ≥ 990 g/kg on dry weight basis	1 October 2013	30 September 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on potassium phosphonates, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to birds and mammals, — the risk of eutrophication of surface water, if the substance is applied in regions or under conditions favouring a quick oxidation of the active substance in surface water. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the long-term risk to insectivorous birds. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.
▼M63
41	Spiromesifen CAS No 283594-90-1 CIPAC No 747	3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrate	≥ 965 g/kg (racemic) The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material.	1 October 2013	30 September 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spiromesifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the long-term risk to aquatic invertebrates, — the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible, — the protection of workers and operators. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.
▼M59
42	Spodoptera littoralis nucleopolyhedrovirus DSMZ number: BV-0005	Not applicable	Maximum concentration: 1 × 1012 OB/l (occlusion bodies/l)	1 June 2013	31 May 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Spodoptera littoralis nucleopolyhedrovirus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
▼M54
43	Bixafen CAS No 581809-46-3 CIPAC No 819	N-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide	≥ 950 g/kg	1 October 2013	30 September 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bixafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the residues of bixafen and of its metabolites in rotational crops; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (c) the risk to aquatic organisms; (d) the risk to soil and sediment-dwelling organisms. Conditions of use shall include risk mitigation measures, where appropriate.
▼M55
44	Maltodextrin CAS No 9050-36-6 CIPAC No 801	None allocated	≥ 910 g/kg	1 October 2013	30 September 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on maltodextrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the potential increased growth of fungi and possible presence of mycotoxins on the surface of treated fruits; (b) the potential risk to honeybees and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate.
▼M68
45	Eugenol CAS No 97-53-0 CIPAC No 967	4-allyl-2-methoxyphenol	≥ 990 g/kg Relevant impurity: methyl eugenol maximum 0,1 % of the technical material	1 December 2013	30 November 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on eugenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate, — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions, — the risk to aquatic organisms, — the risk to insectivorous birds. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the storage stability (2 years) at ambient temperature on the formulated product; (b) data comparing natural background exposure situations of eugenol and methyl eugenol in relation to exposure from the use of eugenol as a plant protection product. This data shall cover human exposure as well as exposure of birds and aquatic organisms; (c) the groundwater exposure assessment for potential metabolites of eugenol, in particular for methyl eugenol. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.
▼M70
46	Geraniol CAS No 106-24-1 CIPAC No 968	(E) 3,7-dimethyl-2,6-octadien-1-ol	≥ 980 g/kg	1 December 2013	30 November 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on geraniol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to — the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms; — the risk to birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) data comparing natural background exposure situations of geraniol in relation to exposure from the use of geraniol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms; (b) the groundwater exposure. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.
▼M69
47	Thymol CAS No 89-83-8 CIPAC No 969	5-methyl-2-propan-2-yl-phenol	≥ 990 g/kg	1 December 2013	30 November 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thymol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to — the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms; — the risk to birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) data comparing natural background exposure situations of thymol in relation to exposure from the use of thymol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms; (b) the long-term and reproductive toxicity, in a form of a full report (in English) of the Combined Test of Repeated Oral-Administration Toxicity and Reproductive Toxicity of Thymol; (c) the groundwater exposure. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.
▼M77
48	Sedaxane CAS No 874967-67-6 (trans isomer: 599197-38-3/cis isomer: 599194-51-1) CIPAC No 833	mixture of 2 cis-isomers 2′-[(1RS,2RS)-1,1′-bicycloprop-2-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxanilide and 2 trans-isomers 2′-[(1RS,2SR)-1,1′-bicycloprop-2-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxanilide	≥ 960 g/kg Sedaxane (range 820-890 g/kg for the 2 trans-isomers 50:50 mixture of enantiomers and range 100-150 g/kg for the 2 cis-isomers 50:50 mixture of enantiomers)	1 February 2014	31 January 2024	PART AOnly uses for seed treatment may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sedaxane, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (b) the long-term risk to birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolite CSCD465008 in vulnerable zones, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards the relevance of the metabolite CSCD465008, and the corresponding groundwater risk assessment, if sedaxane is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’.The notifier shall submit to the Commission, the Member States and the Authority the relevant information within six months from the application date of the Regulation classifying sedaxane.
▼M79
49	Emamectin CAS No emamectin: 119791-41-2 (formerly 137335-79-6) and 123997-28-4 emamectin benzoate: 155569-91-8 (formerly 137512-74-4 and 179607-18-2) emamectin B1a benzoate: 138511-97-4 emamectin B1b benzoate: 138511-98-5 CIPAC No emamectin: 791 emamectin benzoate: 791.412	Emamectin B1a: (10E,14E,16E)-(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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside Emamectin B1b: (10E,14E,16E)-(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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside Emamectin B1a benzoate: (10E,14E,16E)-(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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside benzoate Emamectin B1b benzoate: (10E,14E,16E)-(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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside benzoate	≥ 950 g/kg as emamectin benzoate anhydrous (a mixture of min. 920 g/kg emamectin B1a benzoate and max. 50 g/kg emamectin B1b benzoate)	1 May 2014	30 April 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on emamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to non-target invertebrates; — the protection of workers and operators. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the risk of enantio-selective metabolisation or degradation. The applicant shall submit to the Commission, Member States and the Authority the relevant information two years after adoption of the pertinent guidance document on evaluation of isomer mixtures.
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50	Pseudomonas sp. strain DSMZ 13134 Collection number: DSMZ 13134	Not applicable	Minimum concentration: 3×1014 cfu/kg	1 February 2014	31 January 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pseudomonas sp. strain DSMZ 13134, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pseudomonas sp. strain DSMZ 13134 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit information to confirm the absence of an acute intratracheal and intraperitoneal toxicity/infectivity/pathogenicity potential. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.
▼M76
51	Fluopyram CAS No 658066-35-4 CIPAC No 807	N-{2-[3-chloro-5-(trifluoromethyl)-2-pyridyl]ethyl}-α,α,α-trifluoro-o-toluamide	≥ 960 g/kg	1 February 2014	31 January 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluopyram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to birds and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the long-term risk to insectivorous birds; (2) the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals. The applicant shall submit to the Commission, Member States and the Authority the information set out in point 1 by 1 February 2016 and the information set out in point 2 within two years after adoption of the corresponding OECD test guidelines on endocrine disruption.
▼M78
52	Aureobasidium pullulans (strains DSM 14940 and DSM 14941) Collection number: German Collection of Microorganisms and cell Cultures (DSMZ) with the accession numbers DSM 14940 and DSM 14941	Not applicable	Minimum 5,0 × 109 CFU/g for each strain; Maximum 5,0 × 1010 CFU/g for each strain	1 February 2014	31 January 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Aureobasidium pullulans (strains DSM 14940 and DSM 14941), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Aureobasidium pullulans (strains DSM 14940 and DSM 14941) is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.
▼M82
53	Pyriofenone: CAS No 688046-61-9 CIPAC No 827	(5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone	≥ 965 g/kg	1 February 2014	31 January 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyriofenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) the identity of two impurities to fully support the provisional specification; (b) the toxicological relevance of the impurities present in the proposed technical specification except for the one impurity for which an acute oral study and an Ames test were provided. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.
▼M81
54	Disodium phosphonate CAS No 13708-85-5 CIPAC No 808	disodium phosphonate	281-337 g/kg (TK) ≥ 917 g/kg (TC)	1 February 2014	31 January 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on disodium phosphonate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to eutrophication of surface water. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) the chronic risk to fish; (b) the long term risk to earthworms and soil macro-organisms. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.
▼M83
55	Penflufen CAS No 494793-67-8 CIPAC No 826	2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide	≥ 950 g/kg 1:1 (R:S) ratio of enantiomers	1 February 2014	31 January 2024	PART AOnly uses to treat seed potato tubers before or during planting, may be authorised, limited to one application every third year on the same field.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the protection of operators; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards: (1) the long term risk to birds; (2) the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 as ‘carcinogen category 2’. The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 September 2015 and the information set out in point (2) within six months from the notification of the classification decision concerning that substance.The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
▼M88
56	Orange oil CAS No 8028-48-6 (Orange extract) 5989-27-5 (D-limonene) CIPAC No 902	(R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene	≥ 945 g/kg (of D-limonene) The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E)	1 May 2014	30 April 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the metabolite fate of orange oil and the route and rate of degradation in soil and on the validation of endpoints used in the ecotoxicological risk assessment. The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016.
▼M94
57	Penthiopyrad CAS No 183675-82-3 CIPAC No 824	(RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)pyrazole-4-carboxamide	≥ 980 g/kg (50:50 racemic mixture)	1 May 2014	30 April 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penthiopyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to aquatic and soil organisms; (c) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (d) the level of residues in rotational crops following consecutive application of the active substance over several years. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-relevance of metabolite M11 (3-methyl-1-{3-[(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid) for groundwater with the exception of evidence related to the risk of carcinogenicity, which is dependent on the classificationof the parent and specified separately at (3) below; (2) the toxicological profile and the reference values of the metabolite PAM; (3) the relevance of the metabolites M11 (3-methyl-1-{3-[(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid), DM-PCA (3-trifluoromethyl-1H-pyrazole-4- carboxylic acid), PAM (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxamide) and PCA (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxylic acid) and their risk to contaminate groundwater, if penthiopyrad is classified under Regulation (EC) No 1272/2008 as carcinogenic cat. 2. The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) and (2) by 30 April 2016 and the information set out in point (3) within six months from the notification of the classification decision concerning penthiopyrad.
▼M90
58	Benalaxyl-M CAS No 98243-83-5 CIPAC No 766	Methyl N-(phenylacetyl)-N-(2,6-xylyl)-D-alaninate	≥ 950 g/kg	1 May 2014	30 April 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of workers at re-entry, — the risk to groundwater from the metabolites BM-M2 (N-(malonyl)-N-(2,6-xylyl)-DL-alanine) and BM-M3 (N-(malonyl)-N-(2,6-xylyl)-D-alanine), when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate.
▼M95
59	Tembotrione CAS No 335104-84-2 CIPAC No 790	2-{2-chloro-4-mesyl-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl}cyclohexane-1,3-dione	≥ 945 g/kg The following relevant impurities must not exceed a certain threshold in the technical material: Toluene: ≤ 10 g/kg HCN: ≤ 1 g/kg	1 May 2014	30 April 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tembotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate.
▼M92
60	Spirotetramat CAS No 203313-25-1 CIPAC No 795	cis-4-(ethoxycarbonyloxy)-8-methoxy-3-(2,5-xylyl)-1-azaspiro[4.5]dec-3-en-2-one	≥ 970 g/kg	1 May 2014	30 April 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spirotetramat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to insectivorous birds. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential for endocrine disruptor effects in birds and fish to the Commission, the Member States and the Authority within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
▼M91
61	Pyroxsulam CAS No 422556-08-9 CIPAC No 793	N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-(trifluoromethyl)pyridine-3-sulfonamide	≥ 965 g/kg	1 May 2014	30 April 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyroxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to groundwater, when the active substance is applied in regions with vulnerable soil or climatic conditions; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the toxicological relevance of impurity number 3 (as referred to in the review report); (2) the acute toxicity of the metabolite PSA; (3) the toxicological relevance of metabolite 6-Cl-7-OH-XDE-742. The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016.
▼M97
62	Chlorantraniliprole CAS No 500008-45-7 CIPAC No 794	3-bromo-4'-chloro-1-(3-chloro-2-pyridyl)-2'-methyl-6'-(methylcarbamoyl) pyrazole-5-carboxanilide	≥ 950 g/kg The following relevant impurities must not exceed a certain threshold in the technical material: Acetonitrile: ≤ 3 g/kg 3-picoline: ≤ 3 g/kg Methanesulfonic acid: ≤ 2 g/kg	1 May 2014	30 April 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorantraniliprole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and to soil macroorganisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the risk to groundwater from the active substance and its metabolites IN-EQW78 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one), IN-ECD73 (2,6-dichloro-4-methyl-11H-pyrido[2,1-b]quinazolin-11-one), IN-F6L99 (3-bromo-N-methyl-1H-pyrazole-5-carboxamide), IN-GAZ70 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-8-methylquinazolin-4(1H)-one) and IN-F9N04 (3-bromo-N-(2-carbamoyl-4-chloro-6-methylphenyl)-1-(3-chloropyridin-2-yl)-1H-pyrazole-5-carboxamide); (2) the risk to aquatic organisms from the photolysis metabolites IN-LBA22 (2-{[(4Z)-2-bromo-4H-pyrazolo[1,5-d]pyrido[3,2-b][1,4]oxazin-4-ylidene] amino}-5-chloro-N,3-dimethylbenzamide), IN-LBA23 (2-[3-bromo-1-(3-hydroxypyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one) and IN-LBA24 (2-(3-bromo-1H-pyrazol-5-yl)-6-chloro-3,8-dimethylquinazolin-4(3H)-one). The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016.
▼M96
63	Sodium silver thiosulfate CAS No not allocated CIPAC No 762	Not applicable	≥ 10,0 g Ag/kg Expressed as silver (Ag)	1 May 2014	30 April 2024	PART AOnly indoor uses in non-edible crops shall be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium silver thiosulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to (a) the protection of operators and workers; (b) limiting the possible release of silver ions through disposal of used solutions; (c) the risk to terrestric vertebrates and soil invertebrates from the use of sewage sludge in agriculture. Conditions of use shall include risk mitigation measures, where appropriate.
▼M101
64	Pyridalyl CAS No 179101-81-6 CIPAC No 792	2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether	≥ 910 g/kg	1 July 2014	30 June 2024	PART AOnly uses in greenhouses with permanent structure may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyridalyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to: (a) the risk to re-entry workers; (b) the risk to groundwater when the substance is applied in regions with vulnerable soils and/or climatic conditions; (c) the risk to birds, mammals and aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards: (1) the toxicological and ecotoxicological information to address the relevance of impurities 4, 13, 16, 22 and 23; (2) the relevance of the metabolite HTFP and, concerning that metabolite, the groundwater risk assessment for all uses on crops in greenhouse; (3) the risk to aquatic invertebrates. The applicant shall submit to the Commission, the Member States and the Authority the relevant information as regards point (1) by 31 December 2014 and information as regards point (2) and (3) by 30 June 2016.The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential groundwater contamination from the metabolite HTFP in vulnerable zones by 30 June 2016. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 30 June 2018.
▼M105
65	S-abscisic acid CAS No 21293-29-8 CIPAC No Not allocated	(2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acid or (7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid	960 g/kg	1 July 2014	30 June 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on S-abscisic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate.
▼M104
66	L-ascorbic acid CAS No 50-81-7 CIPAC No 774	(5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5H)-one	≥ 990 g/kg The following relevant impurities shall not exceed: Methanol: ≤ 3 g/kg Heavy Metals: ≤ 10 mg/kg (expressed as Pb)	1 July 2014	30 June 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on L-ascorbic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to aquatic and soil organisms; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the natural background of L-ascorbic acid in the environment confirming a low chronic risk for fish and a low risk for aquatic invertebrates, algae, earthworms and soil microorganisms; (2) the risk to contaminate groundwater. The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.
▼M99
67	Spinetoram CAS No 935545-74-7 CIPAC No 802	XDE-175-J (Major factor) (2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione XDE_175-L (Minor factor) (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione	≥ 830 g/kg 50-90 % XDE-175-J; and 50-10 % XDE-175-L Tolerance limits (g/kg): XDE-175-J = 581-810 XDE-175-L = 83-270	1 July 2014	30 June 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spinetoram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to aquatic and soil organisms; (b) the risk to non-target arthropods in-field; (c) the risk to bees during the application (overspray) and subsequently. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the equivalence between the stereochemistry of metabolites identified in the metabolism/degradation studies and in the testing material used for the toxicity and ecotoxicity studies. The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 December 2014.
▼M108
68	1,4-dimethylnaphthalene CAS No 571-58-4 CIPAC No 822	1,4-dimethylnaphthalene	≥ 980 g/kg	1 July 2014	30 June 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1,4-dimethylnaphthalene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and of workers at re-entry and during inspection of the warehouse; (b) the risk to aquatic organisms and fish-eating mammals the active substance is discharged from warehouses into air and surface water without further treatment. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the residue definition for the active substance. The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.
▼M109
69	Amisulbrom CAS No 348635-87-0 CIPAC No 789	3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide	≥ 985 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole: ≤ 2 g/kg	1 July 2014	30 June 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amisulbrom, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic and soil organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-significance of photodegradation in the soil metabolism of amisulbrom concerning the metabolites 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole and 1-(dimethylsulfamoyl)-1H-1,2,4-triazole-3-sulfonic acid to contaminate groundwater; (2) the low potential of amisulbrom (FOCUS drainage scenarios only) and metabolites 1-(dimethylsulfamoyl)-1H-1,2,4-triazole-3-sulfonic acid, 1H-1,2,4-triazole-3-sulfonic acid, 1H-1,2,4-triazole, N,N-dimethyl-1H-1,2,4-triazole-3-sulfonamide, 2-acetamido-4-fluorobenzoic acid, 2-acetamido-4-fluoro-hydroxybenzoic acid and 2,2′-oxybis(6-fluoro-2-methyl-1,2-dihydro-3H-indol-3-one) to contaminate surface water or to expose aquatic organisms by runoff; (3) depending on the outcome of the assessment under (1) and (2), where there is considerable photodegradation in soil or where there is high potential for contamination or exposure, additional analytical methods to determine all compounds of the residue definition for monitoring in surface water; (4) the risk from secondary poisoning for birds and mammals by 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole; (5) the potential for causing endocrine disrupting effects in birds and fish by amisulbrom and its metabolite 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole. The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) to (4) by 30 June 2016 and under point (5) within two years after the adoption of pertinent OECD test guidelines on endocrine disruption.
▼M102
70	Valifenalate CAS No 283159-90-0 CIPAC No 857	Methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate	≥ 980 g/kg	1 July 2014	30 June 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on valifenalate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential of metabolite S5 to contaminate groundwater. The notifier shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.
▼M103
71	Thiencarbazone CAS No 317815-83-1 CIPAC No 797	Methyl 4-[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H-1,2,4-triazol-1-yl)carbonylsulfamoyl]-5-methylthiophene-3-carboxylate	≥ 950 g/kg	1 July 2014	30 June 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiencarbazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to (a) the risk to groundwater if the substance is applied under vulnerable geographical or climatic conditions; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. That confirmatory information shall consist of the results of a monitoring programme to assess the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. The applicant shall submit to the Commission, the Member States and the Authority this monitoring programme by 30 June 2016 and the results in form of a monitoring report by 30 June 2018.
▼M114
72	Acequinocyl CAS No 57960-19-7 CIPAC No 760	3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate	≥ 960 g/kg	1 September 2014	31 August 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acequinocyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of workers and operators; — the risk to birds, mammals and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) an analytical method for residues in body fluids and tissues; (b) the acceptability of the long-term risk to small granivorous birds and small herbivorous and frugivorous mammals, concerning the use on apple and pear orchards; (c) the acceptability of the long-term risk to small omnivorous and small herbivorous mammals, concerning the use on outdoor ornamentals. The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.
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73	Ipconazole CAS No 125225-28-7 (mixture of diastereoisomers) 115850-69-6 (ipconazole cc, cis isomer) 115937-89-8 (ipconazole ct, trans isomer) CIPAC No 798	(1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol	≥ 955 g/kg Ipconazole cc: 875 – 930 g/kg Ipconazole ct: 65 – 95 g/kg	1 September 2014	31 August 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ipconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: 1. the risk to granivorous birds; 2. the protection of workers and operators; 3. the risk to fish. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the acceptability of the long-term risk to granivorous birds; (b) the acceptability of the risk to soil macro-organisms; (c) the risk of enantio-selective metabolisation or degradation; (d) the potential endocrine disrupting properties of ipconazole for birds and fish. The applicant shall submit to the Commission, the Member States and the Authority the information under (a) and (b) by 31 August 2016, the information under (c) within two years after adoption of the pertinent guidance document on evaluation of isomer mixtures and the information under (d) within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of test guidelines agreed at EU level.
▼M119
74	Flubendiamide CAS No 272451-65-7 CIPAC No 788	3-iodo-N'-(2-mesyl-1,1-dimethylethyl)-N-{4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]-o-tolyl}phthalamide	≥ 960 g/kg	1 September 2014	31 August 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flubendiamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to aquatic invertebrates; (b) the potential presence of residues in rotational crops. Conditions of use shall include risk mitigation measures, where appropriate.
▼M111
75	Bacillus pumilus QST 2808 USDA Agricultural Research Service (NRRL) Patent culture collection in Peoria Illinois, USA under the reference number B-30087	Not applicable	≥ 1 × 1012 CFU/kg	1 September 2014	31 August 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus pumilus QST 2808, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus pumilus QST 2808 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the identification of the aminosugar produced by Bacillus pumilus QST 2808; (b) analytical data for the content of that aminosugar in the production batches. The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.
▼M123
76	Metobromuron CAS No 3060-89-7 CIPAC No 168	3-(4-bromophenyl)-1-methoxy-1-methylurea	≥ 978 g/kg	1 January 2015	31 December 2024	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metobromuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of workers and operators; (b) the risk to birds, mammals, aquatic organisms and terrestrial non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the toxicological assessment of the metabolites CGA 18236, CGA 18237, CGA 18238 and 4-bromoaniline; (b) the acceptability of the long-term risk to birds and mammals. The applicant shall submit that information to the Commission, the Member States and the Authority by 31 December 2016.
▼M124
77	Aminopyralid CAS No 150114-71-9 CIPAC No 771	4-amino-3,6-dichloropyridine-2-carboxylic acid	≥ 920 g/kg The following relevant impurity shall not exceed a certain threshold: Picloram ≤ 40 g/kg	1 January 2015	31 December 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aminopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions; (b) the risk to aquatic macrophytes and terrestrial non-target plants; (c) chronic risk to fish. Conditions of use shall include risk mitigation measures, where appropriate.
▼M129
78	Metaflumizone CAS No 139968-49-3 CIPAC No 779	(EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-4-(trifluoromethoxy)carbanilohydrazide	≥ 945 g/kg (90-100 % E-isomer 10-0 % Z-isomer) The following relevant impurities shall not exceed a certain threshold: Hydrazine ≤ 1 mg/kg 4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kg Toluene ≤ 2 g/kg	1 January 2015	31 December 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metaflumizone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to fish and sediment dwelling organisms; (b) the risk to snail- or earthworm-eating birds. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification; (2) information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains. The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 June 2015 and under (2) by 31 December 2016.
▼M126
79	Streptomyces lydicus strain WYEC 108 Collection number: American Type Culture Collection (USDA) ATCC 55445	Not applicable	Minimum concentration: 5,0 × 108 CFU/g	1 January 2015	31 December 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Streptomyces lydicus strain WYEC 108, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to aquatic organisms; (b) the risk to soil dwelling organisms. Conditions of use shall include risk mitigation measures, where appropriate.
▼M131
80	Meptyldinocap CAS No 6119-92-2 CIPAC No 811	Mixture of 75-100 % (RS)-2-(1-methylheptyl)-4,6-dinitrophenyl crotonate and 25-– 0 % (RS)-2-(1-methylheptyl)-4,6-dinitrophenyl isocrotonate	≥ 900 g/kg (mixture of trans- and cis-isomers with a defined ratio range of 25:1 to 20:1) Relevant impurity: 2,6-dinitro-4-[(4RS)-octan-4-yl]phenyl (2E/Z)-but-2-enoate max content 0,4 g/kg	1 April 2015	31 March 2015	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on meptyldinocap, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 May 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to operators; (b) the risk to aquatic invertebrates. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the groundwater exposure assessment for metabolites (3RS)-3-(2-hydroxy-3,5-dinitro-phenyl)-butanoic acid (X103317) and (2RS)-2-(2-hydroxy-3,5-dinitro-phenyl)-propionic acid (X12335709); (b) the possible impact of any preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment. The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (a) by 31 March 2017 and the information set out in point (b) two years after the adoption of specific guidance by the Commission.
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81	Chromafenozide CAS No 143807-66-3 CIPAC No 775	N′-tert-butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide	≥ 935 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg	1 April 2015	31 March 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions; (b) the risk to non-target Lepidoptera in off-crop areas; (c) the risk to sediment-dwelling organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment; (2) the assessment of the risk to sediment dwelling organisms from metabolite M-010; (3) the leaching potential of metabolites M-006 and M-023 to groundwater. The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.
▼M132
82	Gamma-cyhalothrin CAS No 76703-62-3 CIPAC No 768	(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or (S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate	≥ 980 g/kg	1 April 2015	31 March 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on gamma-cyhalothrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the safety of operators and workers; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) analytical methods for the monitoring of residues in body fluids, tissues and environmental matrices; (2) the toxicity profile of the metabolites CPCA, PBA and PBA(OH); (3) the long-term risk to wild mammals; (4) the potential for biomagnification in terrestrial and aquatic food chains. The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 March 2017.
▼M130
83	Bacillus amyloliquefaciens subsp. plantarum strain D747 Accession number in the Agricultural Research Culture Collection (NRRL), Peoria, Illinois, USA: B-50405 Deposit number in the International Patent Organism Depositary, Tokyo, Japan: FERM BP-8234.	Not applicable	Minimum concentration: 2,0 × 1011 CFU/g	1 April 2015	31 March 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus amyloliquefaciens subsp. plantarum strain D747, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus amyloliquefaciens subsp. plantarum strain D747 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
▼M151
84	Terpenoid blend QRD 460 CIPAC No: 982	Terpenoid blend QRD 460 is a blend of three components: — α-terpinene: 1-isopropyl-4-methylcyclohexa-1,3-diene; — p-cymene: 1-isopropyl-4-methylbenzene; — d-limonene: (R)-4-isopropenyl-1-methylcyclohexene.	The nominal concentration of each component in the active substance as manufactured should be as follows: — α-terpinene: 59,7 %; — p-cymene: 22,4 %; — d-limonene: 17,9 %. Each component should have a minimum purity as follows: — α-terpinene: 89 %; — p-cymene: 97 %; — d-limonene: 93 %.	10 August 2015	10 August 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on terpenoid blend QRD-460, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the stability of formulations on storage; (b) the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; (c) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (d) the protection of surface water and aquatic organisms; (e) the protection of bees and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the technical specification of the active substance as manufactured (5 batch analysis for the blend should be provided), supported by acceptable and validated methods of analysis. It should be confirmed that there are no relevant impurities present in the technical material; (2) the equivalence of the material used in the toxicological and ecotoxicological studies with the confirmed technical specification. The applicant shall submit that information to the Commission, the Member States and the Authority by 10 February 2016.
▼M149
86	Halauxifen-methyl CAS No:943831-98-9 CIPAC No: 970.201 (halauxifen-methyl) 970 (halauxifen)	methyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)pyridine-2-carboxylate	≥ 930 g/kg	5 August 2015	5 August 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on halauxifen-methyl, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — The risk to aquatic and non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: — The technical specification of the active substance as manufactured (based on commercial scale production). The relevance of impurities present in the technical material should be confirmed, — The compliance of the toxicity batches with the technical specification. The applicant shall submit that information to the Commission, the Member States and the Authority by 5 February 2016.
▼M152
88	Sulfoxaflor CAS No: 946578-00-3 CIPAC No: 820	[methyl(oxo){1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide	≥ 950 g/kg	18 August 2015	18 August 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfoxaflor, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to bees and other non-target arthropods; (b) the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust; (b) risk to honey bees foraging in nectar or pollen in succeeding crops and flowering weeds; (c) the risk to pollinators other than honey bees; (d) the risk to bee brood. The applicant shall submit that information to the Commission, the Member States and the Authority by 18 August 2017.
(1) Further details on identity and specification of active substance are provided in the review report. (2) 2-hydroxy-4,6-dimethoxypyrimidine. (3) 2,4-dihydroxy-6-methoxypyrimidine. (4) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate. (5) 5-(trifluoromethyl)-2(1H)-pyridinone. (6) 4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol. (7) M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide. (8) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol. (9) 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid. (10) 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene. (11) 4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid. (12) 3-phenoxybenzaldehyde. (13) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)). (14) 7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid. (15) 3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1H-pyrazole-4-carboxylic acid. (16) 3-chloro-1-methyl-5-sulfamoyl-1H-pyrazole-4-carboxylic acid.

General provisions applying to all substances listed in this Part: the Commission shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make them available to them on specific request.

Number	Common Name, Identification Numbers	IUPAC Name	Purity (1)	Date of approval	Specific provisions
1	Equisetum arvense L. CAS No: not allocated CIPAC No: not allocated	Not applicable	European Pharmacopeia	1 July 2014	Equisetum arvense L. may be used in accordance with the specific conditions included in the conclusions of the review report on Equisetum arvense L. (SANCO/12386/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.
▼M116
2	Chitosan hydrochloride CAS no: 9012-76-4	Not applicable	European Pharmacopeia Max content of heavy metals: 40 ppm	1 July 2014	Chitosan hydrochloride shall comply with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011. Chitosan hydrochloride may be used in accordance with specific conditions included in the conclusions of the review report on Chitosan hydrochloride (SANCO/12388/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014.
▼M125
3	Sucrose CAS no: 57-50-1	α-D-glucopyranosyl-(1→2)-β-D-fructofuranoside or β-D-fructofuranosyl-(2→1)-α-D-glucopyranoside	Food grade	1 January 2015	Only uses as basic substance being an elicitor of the crop's natural defence mechanisms are approved. Sucrose shall be used in accordance with the specific conditions included in the conclusions of the review report on sucrose (SANCO/11406/2014) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014.
▼M144
4	Calcium Hydroxide CAS No 1305-62-0	Calcium Hydroxide	920 g/kg Food gradeThe following impurities are of toxicological concern and must not exceed the levels below (expressed in mg/kg on dry matter): Barium 300 mg/kg Fluoride 50 mg/kg Arsenic 3 mg/kg Lead 2 mg/kg.	1 July 2015	Calcium hydroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on Calcium Hydroxide (SANCO/10148/2015) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 20 March 2015.
▼M147
5	Vinegar CAS No: 90132-02-8	Not available	Food grade containing a maximum of 10 % acetic acid.	1 July 2015	Only uses as basic substance being a fungicide and bactericide are approved. Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof.
▼M148
6	Lecithins CAS No: 8002-43-5 CIPAC No: not allocated Einecs 232-307-2	Not allocated	As described in the Annex to Regulation (EU) No 231/2012.	1 July 2015	Only uses as basic substance being a fungicide are approved. Lecithins shall be used in accordance with the specific conditions included in the conclusions of the review report on lecithins (SANCO/12798/2014) and in particular Appendices I and II thereof.
▼M146
7	Salix spp. cortex CAS No: not allocated CIPAC No: not allocated	Not applicable	European Pharmacopeia	1 July 2015	Salix cortex shall be used in accordance with the specific conditions included in the conclusions of the review report on Salix spp. cortex (SANCO/12173/2014) and in particular Appendices I and II thereof.
▼M153
8	Fructose CAS No: 57-48-7	β-D-fructofuranose	Food grade	1 October 2015	Only uses as basic substance being an elicitor of the crop's natural defence mechanisms are approved. Fructose shall be used in accordance with the specific conditions included in the conclusions of the review report on fructose (SANCO/12680/2014) and in particular Appendices I and II thereof.
(1) Further details on identity, specification and manner of use of basic substance are provided in the review report.

		Official Journal
		No	page	date
►M1	COMMISSION IMPLEMENTING REGULATION (EU) No 541/2011 of 1 June 2011	L 153	187	11.6.2011
►M2	COMMISSION IMPLEMENTING REGULATION (EU) No 542/2011 of 1 June 2011	L 153	189	11.6.2011
►M3	COMMISSION IMPLEMENTING REGULATION (EU) No 702/2011 of 20 July 2011	L 190	28	21.7.2011
►M4	COMMISSION IMPLEMENTING REGULATION (EU) No 703/2011 of 20 July 2011	L 190	33	21.7.2011
►M5	COMMISSION IMPLEMENTING REGULATION (EU) No 704/2011 of 20 July 2011	L 190	38	21.7.2011
►M6	COMMISSION IMPLEMENTING REGULATION (EU) No 705/2011 of 20 July 2011	L 190	43	21.7.2011
►M7	COMMISSION IMPLEMENTING REGULATION (EU) No 706/2011 of 20 July 2011	L 190	50	21.7.2011
►M8	COMMISSION IMPLEMENTING REGULATION (EU) No 736/2011 of 26 July 2011	L 195	37	27.7.2011
►M9	COMMISSION IMPLEMENTING REGULATION (EU) No 740/2011 of 27 July 2011	L 196	6	28.7.2011
►M10	COMMISSION IMPLEMENTING REGULATION (EU) No 786/2011 of 5 August 2011	L 203	11	6.8.2011
►M11	COMMISSION IMPLEMENTING REGULATION (EU) No 787/2011 of 5 August 2011	L 203	16	6.8.2011
►M12	COMMISSION IMPLEMENTING REGULATION (EU) No 788/2011 of 5 August 2011	L 203	21	6.8.2011
►M13	COMMISSION IMPLEMENTING REGULATION (EU) No 797/2011 of 9 August 2011	L 205	3	10.8.2011
►M14	COMMISSION IMPLEMENTING REGULATION (EU) No 798/2011 of 9 August 2011	L 205	9	10.8.2011
►M15	COMMISSION IMPLEMENTING REGULATION (EU) No 800/2011 of 9 August 2011	L 205	22	10.8.2011
►M16	COMMISSION IMPLEMENTING REGULATION (EU) No 806/2011 of 10 August 2011	L 206	39	11.8.2011
►M17	COMMISSION IMPLEMENTING REGULATION (EU) No 807/2011 of 10 August 2011	L 206	44	11.8.2011
►M18	COMMISSION IMPLEMENTING REGULATION (EU) No 810/2011 of 11 August 2011	L 207	7	12.8.2011
►M19	COMMISSION IMPLEMENTING REGULATION (EU) No 820/2011 of 16 August 2011	L 209	18	17.8.2011
►M20	COMMISSION IMPLEMENTING REGULATION (EU) No 974/2011 of 29 September 2011	L 255	1	1.10.2011
►M21	COMMISSION IMPLEMENTING REGULATION (EU) No 993/2011 of 6 October 2011	L 263	1	7.10.2011
►M22	COMMISSION IMPLEMENTING REGULATION (EU) No 1022/2011 of 14 October 2011	L 270	20	15.10.2011
►M23	COMMISSION IMPLEMENTING REGULATION (EU) No 1100/2011 of 31 October 2011	L 285	10	1.11.2011
►M24	COMMISSION IMPLEMENTING REGULATION (EU) No 1134/2011 of 9 November 2011	L 292	1	10.11.2011
►M25	COMMISSION IMPLEMENTING REGULATION (EU) No 1143/2011 of 10 November 2011	L 293	26	11.11.2011
M26	COMMISSION IMPLEMENTING REGULATION (EU) No 1278/2011 of 8 December 2011	L 327	49	9.12.2011
►M27	COMMISSION IMPLEMENTING REGULATION (EU) No 87/2012 of 1 February 2012	L 30	8	2.2.2012
►M28	COMMISSION IMPLEMENTING REGULATION (EU) No 127/2012 of 14 February 2012	L 41	12	15.2.2012
►M29	COMMISSION IMPLEMENTING REGULATION (EU) No 287/2012 of 30 March 2012	L 95	7	31.3.2012
►M30	COMMISSION IMPLEMENTING REGULATION (EU) No 359/2012 of 25 April 2012	L 114	1	26.4.2012
►M31	COMMISSION IMPLEMENTING REGULATION (EU) No 369/2012 of 27 April 2012	L 116	19	28.4.2012
►M32	COMMISSION IMPLEMENTING REGULATION (EU) No 571/2012 of 28 June 2012	L 169	46	29.6.2012
►M33	COMMISSION IMPLEMENTING REGULATION (EU) No 582/2012 of 2 July 2012	L 173	3	3.7.2012
►M34	COMMISSION IMPLEMENTING REGULATION (EU) No 589/2012 of 4 July 2012	L 175	7	5.7.2012
►M35	COMMISSION IMPLEMENTING REGULATION (EU) No 595/2012 of 5 July 2012	L 176	46	6.7.2012
►M36	COMMISSION IMPLEMENTING REGULATION (EU) No 597/2012 of 5 July 2012	L 176	54	6.7.2012
►M37	COMMISSION IMPLEMENTING REGULATION (EU) No 608/2012 of 6 July 2012	L 177	19	7.7.2012
►M38	COMMISSION IMPLEMENTING REGULATION (EU) No 637/2012 of 13 July 2012	L 186	20	14.7.2012
►M39	COMMISSION IMPLEMENTING REGULATION (EU) No 735/2012 of 14 August 2012	L 218	3	15.8.2012
►M40	COMMISSION IMPLEMENTING REGULATION (EU) No 746/2012 of 16 August 2012	L 219	15	17.8.2012
►M41	COMMISSION IMPLEMENTING REGULATION (EU) No 1037/2012 of 7 November 2012	L 308	15	8.11.2012
►M42	COMMISSION IMPLEMENTING REGULATION (EU) No 1043/2012 of 8 November 2012	L 310	24	9.11.2012
►M43	COMMISSION IMPLEMENTING REGULATION (EU) No 1197/2012 of 13 December 2012	L 342	27	14.12.2012
►M44	COMMISSION IMPLEMENTING REGULATION (EU) No 1237/2012 of 19 December 2012	L 350	55	20.12.2012
►M45	COMMISSION IMPLEMENTING REGULATION (EU) No 1238/2012 of 19 December 2012	L 350	59	20.12.2012
►M46	COMMISSION IMPLEMENTING REGULATION (EU) No 17/2013 of 14 January 2013	L 9	5	15.1.2013
►M47	COMMISSION IMPLEMENTING REGULATION (EU) No 22/2013 of 15 January 2013	L 11	8	16.1.2013
►M48	COMMISSION IMPLEMENTING REGULATION (EU) No 175/2013 of 27 February 2013	L 56	4	28.2.2013
►M49	COMMISSION IMPLEMENTING REGULATION (EU) No 187/2013 of 5 March 2013	L 62	10	6.3.2013
►M50	COMMISSION IMPLEMENTING REGULATION (EU) No 188/2013 of 5 March 2013	L 62	13	6.3.2013
►M51	COMMISSION IMPLEMENTING REGULATION (EU) No 190/2013 of 5 March 2013	L 62	19	6.3.2013
►M52	COMMISSION IMPLEMENTING REGULATION (EU) No 200/2013 of 8 March 2013	L 67	1	9.3.2013
►M53	COMMISSION IMPLEMENTING REGULATION (EU) No 201/2013 of 8 March 2013	L 67	6	9.3.2013
►M54	COMMISSION IMPLEMENTING REGULATION (EU) No 350/2013 of 17 April 2013	L 108	9	18.4.2013
►M55	COMMISSION IMPLEMENTING REGULATION (EU) No 355/2013 of 18 April 2013	L 109	14	19.4.2013
►M56	COMMISSION IMPLEMENTING REGULATION (EU) No 356/2013 of 18 April 2013	L 109	18	19.4.2013
►M57	COMMISSION IMPLEMENTING REGULATION (EU) No 365/2013 of 22 April 2013	L 111	27	23.4.2013
►M58	COMMISSION IMPLEMENTING REGULATION (EU) No 366/2013 of 22 April 2013	L 111	30	23.4.2013
►M59	COMMISSION IMPLEMENTING REGULATION (EU) No 367/2013 of 22 April 2013	L 111	33	23.4.2013
►M60	COMMISSION IMPLEMENTING REGULATION (EU) No 368/2013 of 22 April 2013	L 111	36	23.4.2013
►M61	COMMISSION IMPLEMENTING REGULATION (EU) No 369/2013 of 22 April 2013	L 111	39	23.4.2013
►M62	COMMISSION IMPLEMENTING REGULATION (EU) No 373/2013 of 23 April 2013	L 112	10	24.4.2013
►M63	COMMISSION IMPLEMENTING REGULATION (EU) No 375/2013 of 23 April 2013	L 112	15	24.4.2013
►M64	COMMISSION IMPLEMENTING REGULATION (EU) No 378/2013 of 24 April 2013	L 113	5	25.4.2013
►M65	COMMISSION IMPLEMENTING REGULATION (EU) No 485/2013 of 24 May 2013	L 139	12	25.5.2013
►M66	COMMISSION IMPLEMENTING REGULATION (EU) No 532/2013 of 10 June 2013	L 159	6	11.6.2013
►M67	COMMISSION IMPLEMENTING REGULATION (EU) No 533/2013 of 10 June 2013	L 159	9	11.6.2013
►M68	COMMISSION IMPLEMENTING REGULATION (EU) No 546/2013 of 14 June 2013	L 163	17	15.6.2013
►M69	COMMISSION IMPLEMENTING REGULATION (EU) No 568/2013 of 18 June 2013	L 167	33	19.6.2013
►M70	COMMISSION IMPLEMENTING REGULATION (EU) No 570/2013 of 17 June 2013	L 168	18	20.6.2013
►M71	COMMISSION IMPLEMENTING REGULATION (EU) No 762/2013 of 7 August 2013	L 213	14	8.8.2013
►M72	COMMISSION IMPLEMENTING REGULATION (EU) No 767/2013 of 8 August 2013	L 214	5	9.8.2013
►M73	COMMISSION IMPLEMENTING REGULATION (EU) No 781/2013 of 14 August 2013	L 219	22	15.8.2013
►M74	COMMISSION IMPLEMENTING REGULATION (EU) No 790/2013 of 19 August 2013	L 222	6	20.8.2013
►M75	COMMISSION IMPLEMENTING REGULATION (EU) No 798/2013 of 21 August 2013	L 224	9	22.8.2013
►M76	COMMISSION IMPLEMENTING REGULATION (EU) No 802/2013 of 22 August 2013	L 225	13	23.8.2013
►M77	COMMISSION IMPLEMENTING REGULATION (EU) No 826/2013 of 29 August 2013	L 232	13	30.8.2013
►M78	COMMISSION IMPLEMENTING REGULATION (EU) No 827/2013 of 29 August 2013	L 232	18	30.8.2013
►M79	COMMISSION IMPLEMENTING REGULATION (EU) No 828/2013 of 29 August 2013	L 232	23	30.8.2013
►M80	COMMISSION IMPLEMENTING REGULATION (EU) No 829/2013 of 29 August 2013	L 232	29	30.8.2013
►M81	COMMISSION IMPLEMENTING REGULATION (EU) No 832/2013 of 30 August 2013	L 233	3	31.8.2013
►M82	COMMISSION IMPLEMENTING REGULATION (EU) No 833/2013 of 30 August 2013	L 233	7	31.8.2013
►M83	COMMISSION IMPLEMENTING REGULATION (EU) No 1031/2013 of 24 October 2013	L 283	17	25.10.2013
►M84	COMMISSION IMPLEMENTING REGULATION (EU) No 1089/2013 of 4 November 2013	L 293	31	5.11.2013
►M85	COMMISSION IMPLEMENTING REGULATION (EU) No 1124/2013 of 8 November 2013	L 299	34	9.11.2013
►M86	COMMISSION IMPLEMENTING REGULATION (EU) No 1136/2013 of 12 November 2013	L 302	34	13.11.2013
►M87	COMMISSION IMPLEMENTING REGULATION (EU) No 1150/2013 of 14 November 2013	L 305	13	15.11.2013
►M88	COMMISSION IMPLEMENTING REGULATION (EU) No 1165/2013 of 18 November 2013	L 309	17	19.11.2013
►M89	COMMISSION IMPLEMENTING REGULATION (EU) No 1166/2013 of 18 November 2013	L 309	22	19.11.2013
►M90	COMMISSION IMPLEMENTING REGULATION (EU) No 1175/2013 of 20 November 2013	L 312	18	21.11.2013
►M91	COMMISSION IMPLEMENTING REGULATION (EU) No 1176/2013 of 20 November 2013	L 312	23	21.11.2013
►M92	COMMISSION IMPLEMENTING REGULATION (EU) No 1177/2013 of 20 November 2013	L 312	28	21.11.2013
►M93	COMMISSION IMPLEMENTING REGULATION (EU) No 1178/2013 of 20 November 2013	L 312	33	21.11.2013
►M94	COMMISSION IMPLEMENTING REGULATION (EU) No 1187/2013 of 21 November 2013	L 313	42	22.11.2013
►M95	COMMISSION IMPLEMENTING REGULATION (EU) No 1192/2013 of 22 November 2013	L 314	6	23.11.2013
►M96	COMMISSION IMPLEMENTING REGULATION (EU) No 1195/2013 of 22 November 2013	L 315	27	26.11.2013
►M97	COMMISSION IMPLEMENTING REGULATION (EU) No 1199/2013 of 25 November 2013	L 315	69	26.11.2013
M98	COMMISSION IMPLEMENTING REGULATION (EU) No 85/2014 of 30 January 2014	L 28	34	31.1.2014
►M99	COMMISSION IMPLEMENTING REGULATION (EU) No 140/2014 of 13 February 2014	L 44	35	14.2.2014
►M100	COMMISSION IMPLEMENTING REGULATION (EU) No 141/2014 of 13 February 2014	L 44	40	14.2.2014
►M101	COMMISSION IMPLEMENTING REGULATION (EU) No 143/2014 of 14 February 2014	L 45	1	15.2.2014
►M102	COMMISSION IMPLEMENTING REGULATION (EU) No 144/2014 of 14 February 2014	L 45	7	15.2.2014
►M103	COMMISSION IMPLEMENTING REGULATION (EU) No 145/2014 of 14 February 2014	L 45	12	15.2.2014
►M104	COMMISSION IMPLEMENTING REGULATION (EU) No 149/2014 of 17 February 2014	L 46	3	18.2.2014
►M105	COMMISSION IMPLEMENTING REGULATION (EU) No 151/2014 of 18 February 2014	L 48	1	19.2.2014
►M106	COMMISSION IMPLEMENTING REGULATION (EU) No 154/2014 of 19 February 2014	L 50	7	20.2.2014
►M107	COMMISSION IMPLEMENTING REGULATION (EU) No 187/2014 of 26 February 2014	L 57	24	27.2.2014
►M108	COMMISSION IMPLEMENTING REGULATION (EU) No 192/2014 of 27 February 2014	L 59	20	28.2.2014
►M109	COMMISSION IMPLEMENTING REGULATION (EU) No 193/2014 of 27 February 2014	L 59	25	28.2.2014
►M110	COMMISSION IMPLEMENTING REGULATION (EU) No 462/2014 of 5 May 2014	L 134	28	7.5.2014
►M111	COMMISSION IMPLEMENTING REGULATION (EU) No 485/2014 of 12 May 2014	L 138	65	13.5.2014
►M112	COMMISSION IMPLEMENTING REGULATION (EU) No 486/2014 of 12 May 2014	L 138	70	13.5.2014
►M113	COMMISSION IMPLEMENTING REGULATION (EU) No 487/2014 of 12 May 2014	L 138	72	13.5.2014
►M114	COMMISSION IMPLEMENTING REGULATION (EU) No 496/2014 of 14 May 2014	L 143	1	15.5.2014
►M115	COMMISSION IMPLEMENTING REGULATION (EU) No 504/2014 of 15 May 2014	L 145	28	16.5.2014
►M116	COMMISSION IMPLEMENTING REGULATION (EU) No 563/2014 of 23 May 2014	L 156	5	24.5.2014
►M117	COMMISSION IMPLEMENTING REGULATION (EU) No 571/2014 of 26 May 2014	L 157	96	27.5.2014
►M118	COMMISSION IMPLEMENTING REGULATION (EU) No 629/2014 of 12 June 2014	L 174	33	13.6.2014
►M119	COMMISSION IMPLEMENTING REGULATION (EU) No 632/2014 of 13 May 2014	L 175	1	14.6.2014
►M120	COMMISSION IMPLEMENTING REGULATION (EU) No 678/2014 of 19 June 2014	L 180	11	20.6.2014
►M121	COMMISSION IMPLEMENTING REGULATION (EU) No 878/2014 of 12 August 2014	L 240	18	13.8.2014
►M122	COMMISSION IMPLEMENTING REGULATION (EU) No 880/2014 of 12 August 2014	L 240	22	13.8.2014
►M123	COMMISSION IMPLEMENTING REGULATION (EU) No 890/2014 of 14 August 2014	L 243	42	15.8.2014
►M124	COMMISSION IMPLEMENTING REGULATION (EU) No 891/2014 of 14 August 2014	L 243	47	15.8.2014
►M125	COMMISSION IMPLEMENTING REGULATION (EU) No 916/2014 of 22 August 2014	L 251	16	23.8.2014
►M126	COMMISSION IMPLEMENTING REGULATION (EU) No 917/2014 of 22 August 2014	L 251	19	23.8.2014
►M127	COMMISSION IMPLEMENTING REGULATION (EU) No 918/2014 of 22 August 2014	L 251	24	23.8.2014
►M128	COMMISSION IMPLEMENTING REGULATION (EU) No 921/2014 of 25 August 2014	L 252	3	26.8.2014
►M129	COMMISSION IMPLEMENTING REGULATION (EU) No 922/2014 of 25 August 2014	L 252	6	26.8.2014
►M130	COMMISSION IMPLEMENTING REGULATION (EU) No 1316/2014 of 11 December 2014	L 355	1	12.12.2014
►M131	COMMISSION IMPLEMENTING REGULATION (EU) No 1330/2014 of 15 December 2014	L 359	85	16.12.2014
►M132	COMMISSION IMPLEMENTING REGULATION (EU) No 1334/2014 of 16 December 2014	L 360	1	17.12.2014
►M133	COMMISSION IMPLEMENTING REGULATION (EU) 2015/51 of 14 January 2015	L 9	22	15.1.2015
►M134	COMMISSION IMPLEMENTING REGULATION (EU) 2015/58 of 15 January 2015	L 10	25	16.1.2015
►M135	COMMISSION IMPLEMENTING REGULATION (EU) 2015/232 of 13 February 2015	L 39	7	14.2.2015
►M136	COMMISSION IMPLEMENTING REGULATION (EU) 2015/306 of 26 February 2015	L 56	1	27.2.2015
►M137	COMMISSION IMPLEMENTING REGULATION (EU) 2015/307 of 26 February 2015	L 56	6	27.2.2015
►M138	COMMISSION IMPLEMENTING REGULATION (EU) 2015/308 of 26 February 2015	L 56	9	27.2.2015
►M139	COMMISSION IMPLEMENTING REGULATION (EU) 2015/404 of 11 March 2015	L 67	6	12.3.2015
►M140	COMMISSION IMPLEMENTING REGULATION (EU) 2015/415 of 12 March 2015	L 68	28	13.3.2015
►M141	COMMISSION IMPLEMENTING REGULATION (EU) 2015/418 of 12 March 2015	L 68	36	13.3.2015
►M142	COMMISSION IMPLEMENTING REGULATION (EU) 2015/543 of 1 April 2015	L 90	1	2.4.2015
►M143	COMMISSION IMPLEMENTING REGULATION (EU) 2015/553 of 7 April 2015	L 92	86	8.4.2015
►M144	COMMISSION IMPLEMENTING REGULATION (EU) 2015/762 of 12 May 2015	L 120	6	13.5.2015
►M145	COMMISSION IMPLEMENTING REGULATION (EU) 2015/1106 of 8 July 2015	L 181	70	9.7.2015
►M146	COMMISSION IMPLEMENTING REGULATION (EU) 2015/1107 of 8 July 2015	L 181	72	9.7.2015
►M147	COMMISSION IMPLEMENTING REGULATION (EU) 2015/1108 of 8 July 2015	L 181	75	9.7.2015
►M148	COMMISSION IMPLEMENTING REGULATION (EU) 2015/1116 of 9 July 2015	L 182	26	10.7.2015
►M149	COMMISSION IMPLEMENTING REGULATION (EU) 2015/1165 of 15 July 2015	L 188	30	16.7.2015
►M150	COMMISSION IMPLEMENTING REGULATION (EU) 2015/1176 of 17 July 2015	L 192	1	18.7.2015
►M151	COMMISSION IMPLEMENTING REGULATION (EU) 2015/1192 of 20 July 2015	L 193	124	21.7.2015
►M152	COMMISSION IMPLEMENTING REGULATION (EU) 2015/1295 of 27 July 2015	L 199	8	29.7.2015
►M153	COMMISSION IMPLEMENTING REGULATION (EU) 2015/1392 of 13 August 2015	L 215	34	14.8.2015
►M154	COMMISSION IMPLEMENTING REGULATION (EU) 2015/1396 of 14 August 2015	L 216	1	15.8.2015

►C1	Corrigendum, OJ L 026, 28.1.2012, p. 38 (540/2011)
►C2	Corrigendum, OJ L 235, 4.9.2013, p. 12 (200/2013)

	Common Name, Identification Numbers	IUPAC Name	Purity (1)	Date of approval	Expiration of approval	Specific provisions
1	Isaria fumosorosea strain Apopka 97 Deposited in the American Type Culture Collection (ATCC) under the name Paecilomyces fumosoroseus Apopka ATCC 20874	Not applicable	Minimum concentration: 1,0 × 108 CFU/ml Maximum concentration: 2,5 × 109 CFU/ml	1 January 2016	31 December 2030	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Isaria fumosorosea strain Apopka 97, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Isaria fumosorosea strain Apopka 97 is to be considered as a potential sensitiser. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
▼M142
2	COS-OGA CAS No: not allocated CIPAC No: 979	Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues).	≥ 915 g/kg — OGA/COS ratio comprised between 1 and 1,6 — Degree of polymerisation of COS comprised between 5 and 10 — Degree of polymerisation of OGA comprised between 9 and 20 — Degree of methylation of OGA < 10 % — Degree of acetylation of COS < 50 %	22 April 2015	22 April 2030	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on COS-OGA, and in particular Appendices I and II thereof, shall be taken into account.
▼M143
3	Cerevisane (no ISO name adopted) CAS No: not allocated CIPAC No: 980	Not relevant	≥ 924 g/kg	23 April 2015	23 April 2030	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cerevisane, and in particular Appendices I and II thereof, shall be taken into account.
▼M150
4	Pepino mosaic virus strain CH2 isolate 1906 GenBank, accession number JN835466 CIPAC No: not allocated	Not applicable	minimum concentration 5 × 105 viral genome copies per μL	7 August 2015	7 August 2030	Only the use in greenhouses may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pepino mosaic virus strain CH2 isolate 1906, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pepino mosaic virus strain CH2 isolate 1906 is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
(1) Further details on identity and specification of active substance are provided in the review report.