| Number | Common name, identification numbers | IUPAC name | Purity | Date of approval | Expiration of approval | Specific provisions |
|---|
| 1 | ImazalilCAS No 73790-28-0, 35554-44-0CIPAC No 335 | (+)-1-(β-allyloxy-2,4-dichlorophenylethyl)imidazole or (+)-allyl 1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether | 975 g/kg | 1 January 1999 | 31 December 2011 | Only uses as fungicide may be authorized.For the following uses the following particular conditions apply:- post-harvest fruit, vegetable and potato treatments may only be authorised when an appropriate decontamination system is available or a risk assessment has demonstrated to the authorizing Member State that the discharge of the treatment solution does not have an unacceptable risk to the environment and in particular to aquatic organisms,
- post-harvest treatment of potatoes may only be authorised when a risk assessment has demonstrated to the authorizing Member State that the discharge of the processing waste from treated potatoes does not have an unacceptable risk to aquatic organisms,
- outdoor foliar uses may only be authorised when a risk assessment has demonstrated to the authorizing Member State that the use has no unacceptable effects on human and animal health and the environment.
Date of Standing Committee on Plant Health at which the review report was finalised: 11 July 1997. |
| 2 | AzoxystrobinCAS No 131860-33-8CIPAC No 571 | Methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy] phenyl}-3-methoxyacrylate | 930 g/kg (Z isomer max. 25 g/kg) | 1 July 1998 | 31 December 2011 | Only uses as fungicide may be authorised.In the decision making according to the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, particular attention should be given to the impact on aquatic organisms. Authorisation conditions should include appropriate risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 22 April 1998. |
| 3 | Kresoxim-MethylCAS No 143390-89-0CIPAC No 568 | Methyl (E)-2-methoxyimino-2-[2-(o-tolyloxymethyl) phenyl]acetate | 910 g/kg | 1 February 1999 | 31 December 2011 | Only uses as fungicide 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 shall pay particular attention to the protection of groundwater under vulnerable conditions.Date of Standing Committee on Plant Health at which the review report was finalised: 16 October 1998. |
| 4 | SpiroxamineCAS No 1181134-30-8CIPAC No 572 | (8-tert-Butyl-1,4-dioxa-spiro [4.5] decan-2-ylmethyl)-ethyl-propyl-amine | 940 g/kg (diastereomers A and B combined) | 1 September 1999 | 31 December 2011 | Only uses as a fungicide 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 and must ensure that the conditions of authorisation include appropriate protective measures,
- 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: 12 May 1999. |
| 5 | AzimsulfuronCAS No 120162-55-2CIPAC 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 | 1 October 1999 | 31 December 2011 | Only uses as herbicide may be authorised.Aerial applications may not 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 impact on aquatic organisms and terrestrial non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures (e.g. in rice cultivation minimum holding periods for water prior to discharge).Date of Standing Committee on Plant Health at which the review report was finalised: 2 July 1999. |
| 6 | FluroxypyrCAS No 69377-81-7CIPAC No 431 | 4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid | 950 g/kg | 1 December 2000 | 31 December 2011 | 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:- shall take into account the additional information requested in point 7 of the Review Report,
- 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.
Member States shall inform the Commission if the requested additional trials and information as outlined in point 7 of the Review Report were not submitted by 1 December 2000.Date of Standing Committee on Plant Health at which the review report was finalised: 30 November 1999. |
| 7 | Metsulfuron methylCAS No 74223-64-6 | Methyl-2-(4-methoxy-6-methyl-1,3,5,-triazin-2-ylcarbamoylsulfamoyl)benzoate | 960 g/kg | 1 July 2001 | 30. June 2016 | 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. |
| 8 | Prohexadione CalciumCAS No 127277-53-6CIPAC No 567 | Calcium 3,5-dioxo-4-propionylcyclohexanecarboxylate | 890 g/kg | 1 October 2000 | 31 December 2011 | Only uses as plant growth regulator may be authorised.Date of Standing Committee on Plant Health at which the review report was finalised: 16 June 2000. |
| 9 | TriasulfuronCAS No 82097-50-5CIPAC 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 | 30. June 2016 | 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 | EsfenvalerateCAS No 66230-04-4CIPAC No 481 | (S)-α-Cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate | 830 g/kg | 1 August 2001 | 30. June 2016 | 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 | BentazoneCAS No 25057-89-0CIPAC No 366 | 3-isopropyl-(1H)-2,1,3-benzothiadiazin-4-(3H)-one-2,2-dioxide | 960 g/kg | 1 August 2001 | 30 June 2018 | 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-cyhalothrinCAS No 91465-08-6CIPAC 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 | 30. June 2016 | 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 | FenhexamidCAS No 126833-17-8CIPAC 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 | AmitroleCAS No 61-82-5CIPAC No 90 | H-[1,2,4]-triazole-3-ylamine | 900 g/kg | 1 January 2002 | 30. June 2016 | Only uses as herbicide may be authorisedFor the implementation 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.
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| 15 | DiquatCAS 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 | 30 June 2019 | 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.
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| 16 | PyridateCAS No 55512-33.9CIPAC 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.
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| 17 | ThiabendazoleCAS No 148-79-8CIPAC No 323 | 2-Thiazol-4-yl-1H-benzimidazole | 985 g/kg | 1 January 2002 | 30. June 2017 | 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. |
| 18 | Paecilomyces fumosoroseusApopka strain 97, PFR 97 or CG 170, ATCC20874 | Not applicable | The absence of secondary metabolites should be checked in each fermentation broth by HPLC | 1 July 2001 | 31 December 2015 | Only uses as an insecticide may be authorised.Each fermentation broth should be checked by HPLC to ensure that no secondary metabolites are present.Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001. |
| 19 | DPX KE 459 (flupyrsulfuron-methyl)CAS No 144740-54-5CIPAC No 577 | 2-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-6-trifluromethylnicotinate monosodium salt | 903 g/kg | 1 July 2001 | 30 June 2018 | 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-methylCAS No 135158-54-2CIPAC No 597 | Benzo[1,2,3]thiadiazole-7-carbothioic acid S-methyl ester | 970 g/kg | 1 November 2001 | 30. June 2016 | 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 |
| 21 | CyclanilideCAS No 113136-77-9CIPAC 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. |
| 22 | Ferric phosphateCAS No 10045-86-0CIPAC 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 | PymetrozineCAS No 123312-89-0CIPAC 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 | 30 June 2019 | 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-ethylCAS No 129630-19-9CIPAC No 605 | Ethyl-2-chloro-5-(4-chloro-5-difluoromethoxy-1-mhypyrazol-3-yl)-4-fluorophenoxyacetate | 956 g/kg | 1 November 2001 | 30. June 2016 | 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 | GlyphosateCAS No 1071-83-6CIPAC No 284 | N-(phosphonomethyl)-glycin | 950 g/kg | 1 July 2002 | 6 months from the date of receipt of the opinion of the Committee for Risk Assessment of the European Chemicals Agency by the Commission or 31 December 2017, whichever is the earlier | 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 amended in the Standing Committee on Plants, Animals, Food and Feed on 27 June 2016 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,
- must pay particular attention to risks from the use in specific areas referred to in Article 12(a) of Directive 2009/128/EC,
- must pay particular attention to compliance of pre-harvest uses with good agricultural practices.
Member States shall ensure that plant protection products containing glyphosate do not contain the co-formulant POE-tallowamine (CAS No 61791-26-2). |
| 26 | Thifensulfuron-methylCAS No 79277-27-3CIPAC 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 January 2023 | Only uses as herbicide may be authorisedFor the implementation 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.
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| 27 | 2,4-DCAS No 94-75-7CIPAC No 1 | (2,4-dichlorophenoxy) acetic acid | 960 g/kg | 1 October 2002 | 30. June 2016 | Only uses as herbicide may be authorisedFor the implementation 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.
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| 28 | IsoproturonCAS No 34123-59-6CIPAC No 336 | 3-(4-isopropylphenyl)-1,1-dimethylurea | 970 g/kg | 1 January 2003 | 30. June 2016 | Only uses as herbicide may be authorisedFor the implementation 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.
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| 29 | EthofumesateCAS No 26225-79-6CICAP No 223 | (±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-ylmethanesulfonate | 960 g/kg | 1 March 2003 | 31 July 2017 | Only uses as herbicide may be authorisedFor the implementation 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 | IprovalicarbCAS No 140923-17-7CICAP No 620 | {2-Methyl-1-[1-(4-methylphenyl)ethylcarbonyl] propyl}-carbamic acid isopropylester | 950 g/kg (provisional specification) | 1 July 2002 | 30. June 2016 | 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.
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| 31 | ProsulfuronCAS No 94125-34-5CICAP 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 | 30. June 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 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.
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| 32 | SulfosulfuronCAS No 141776-32-1CICAP 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.
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| 33 | Cinidon-ethylCAS No 142891-20-1CIPAC 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. |
| 34 | Cyhalofop butylCAS No 122008-85-9CIPAC No 596 | Butyl-(R)-2-[4(4-cyano-2-fluorophenoxy) phenoxy]propionate | 950 g/kg | 1 October 2002 | 30. June 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 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.
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| 35 | FamoxadoneCAS No 131807-57-3CIPAC No 594 | 3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione | 960 g/kg | 1 October 2002 | 30 June 2022 | 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.
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| 36 | FlorasulamCAS No 145701-23-1CIPAC 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.
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| 37 | Metalaxyl-MCAS No 70630-17-0CIPAC No 580 | Methyl(R)-2-{[(2,6-dimethylphenyl)methoxy-acetyl] amino} propionate | 910 g/kg | 1 October 2002 | 30 June 2020 | 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.
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| 38 | PicolinafenCAS No 137641-05-5CIPAC No 639 | 4′-Fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide | 970 g/kg | 1 October 2002 | 30 June 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 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.
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| 39 | FlumioxazineCAS No 103361-09-7CICAP 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 | 30 June 2022 | 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.
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| 40 | DeltamethrinCAS No 52918-63-5CIPAC 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 2022 | Only uses as insecticide may be authorisedFor the implementation 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.
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| 41 | ImazamoxCAS No 114311-32-9CIPAC No 619 | (±)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-(methoxymethyl) nicotinic acid | 950 g/kg | 1 July 2003 | 31 July 2018 | 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 | OxasulfuronCAS No 144651-06-9CIPAC No 626 | Oxetan-3-yl 2[(4,6-dimethylpyrimidin-2-yl) carbamoyl-sulfamoyl] benzoate | 930 g/kg | 1 July 2003 | 31 July 2018 | 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 | EthoxysulfuronCAS No 126801-58-9CIPAC 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 | ForamsulfuronCAS No 173159-57-4CIPAC No 659 | 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea | 940 g/kg | 1 July 2003 | 31 July 2020 | 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 | OxadiargylCAS No 39807-15-3CIPAC 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 | CyazofamidCAS No 120116-88-3CIPAC No 653 | 4-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide | 935 g/kg | 1 July 2003 | 31 July 2021 | 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-DBCAS No 94-82-6CIPAC No 83 | 4-(2,4-dichlorophenoxy) butyric acid | 940 g/kg | 1 January 2004 | 31. October 2017 | Only use as herbicide may be authorisedFor the implementation 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.
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| 48 | Beta-cyfluthrinCAS 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 October 2020 | Only use as insecticide may be authorisedUses 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.
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| 49 | CyfluthrinCAS 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 authorisedUses 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.
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| 50 | IprodioneCAS No 36734-19-7CIPAC No 278 | 3-(3,5-dichlorophenyl)-Nisopropyl-2,4-dioxo-imidazolidine-1-carboximide | 960 g/kg | 1 January 2004 | 31 October 2018 | 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.
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| 51 | LinuronCAS No 330-55-2CIPAC No 76 | 3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea | 900 g/kg | 1 January 2004 | 31. July 2017 | Only use as herbicide may be authorisedFor the implementation 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.
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| 52 | Maleic hydrazideCAS No 123-33-1CIPAC No 310 | 6-hydroxy-2H-pyridazin-3-one | 940 g/kg. | 1 January 2004 | 31. October 2017 | Only use as growth regulator may be authorisedFor the implementation 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.
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| 53 | PendimethalinCAS No 40487-42-1CIPAC No 357 | N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene | 900 g/kg | 1 January 2004 | 31 July 2018 | Only use as herbicide may be authorisedFor the implementation 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.
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| 54 | PropinebCAS 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 January 2019 | Only uses as fungicide may be authorisedFor the implementation 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
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| 55 | PropyzamideCAS No 23950-58-5CIPAC No 315 | 3,5-dichloro-N-(1,1-dimethyl-prop-2-ynyl)benzamide | 920 g/kg | 1 April 2004 | 31 January 2019 | Only uses as herbicide may be authorisedFor the implementation 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
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| 56 | MecopropCAS No 7085-19-0CIPAC 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.
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| 57 | Mecoprop-PCAS No 16484-77-8CIPAC No 475 | (R)-2-(4-chloro-o-tolyloxy)-propionic acid | 860 g/kg | 1 June 2004 | 31 January 2022 | 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.
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| 58 | PropiconazoleCAS No 60207-90-1CIPAC 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 January 2019 | 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.
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| 59 | TrifloxystrobinCAS No 141517-21-7CIPAC 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 | 31 July 2018 | 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 ethylCAS No 128639-02.1CIPAC 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 | 31 July 2018 | 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 | MesotrioneCAS No 104206-8CIPAC No 625 | 2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione | 920 g/kgThe 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 | 31. July 2017 | 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 | FenamidoneCAS No 161326-34-7CIPAC No 650 | (S)-5-methyl-2-methylthio-5-phenyl-3-phenylamino-3,5-dihydroimidazol-4-one | 975 g/kg | 1 October 2003 | 31 July 2019 | 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 | IsoxaflutoleCAS No 141112-29-0CIPAC No 575 | 5-cyclopropyl-4-(2-methylsulfonyl-4-trifluoromethylbenzoyl) isoxazole | 950 g/kg | 1 October 2003 | 31 July 2019 | 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.
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| 64 | FlurtamoneCAS 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 October 2019 | 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 | FlufenacetCAS No 142459-58-3CIPAC No 588 | 4′-fluoro-N-isopropyl-2-[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yloxy]acetanilide | 950 g/kg | 1 January 2004 | 31 October 2022 | 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 | IodosulfuronCAS 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. October 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 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-pCAS No 163515-14-8CIPAC 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 October 2019 | 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 | PicoxystrobinCAS No 117428-22-5CIPAC 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. October 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 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 | FosthiazateCAS No 98886-44-3CIPAC No 585 | (RS)-S-sec-butyl O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate | 930 g/kg | 1 January 2004 | 31 October 2022 | 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 | SilthiofamCAS No 175217-20-6CIPAC No 635 | N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide | 950 g/kg | 1 January 2004 | 31 October 2018 | 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 minitansStrain 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. October 2017 | 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.
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| 72 | MolinateCAS No 2212-67-1CIPAC 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.
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| 73 | ThiramCAS No 137-26-8CIPAC No 24 | - tetramethylthiuram disulfide;
- bis (dimethylthiocarbamoyl)-disulfide
| 960 g/kg | 1 August 2004 | 30 April 2019 | 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.
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| 74 | ZiramCAS No 137-30-4CIPAC No 31 | Zinc bis (dimethyldithiocarbamate) | 950 g/kg (FAO-specification)- Arsenic: maximum 250 mg/kg
- Water: maximum 1,5 %
| 1 August 2004 | 30 April 2022 | 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.
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| 75 | MesosulfuronCAS No 400852-66-6CIPAC No 441 | 2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-(methanesulfonamido)-p-toluic acid | 930 g/kg | 1 April 2004 | 31 January 2018 | 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 | PropoxycarbazoneCAS No 145026-81-9CIPAC 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 January 2018 | 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 | ZoxamideCAS No 156052-68-5CIPAC No 640 | (RS)-3,5-Dichloro-N-(3-chloro-1-ethyl-1-methylacetonyl)-p-toluamide | 950 g/kg | 1 April 2004 | 31 January 2019 | 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 | ChlorprophamCAS No 101-21-3CIPAC No 43 | Isopropyl 3-chlorophenylcarbamate | 975 g/kg | 1 February 2005 | 31 July 2019 | 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 acidCAS No 65-85-0CIPAC No 622 | benzoic acid | 990 g/kg | 1 June 2004 | 31 January 2018 | 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 | FlazasulfuronCAS No 104040-78-0CIPAC No 595 | 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulphonyl)urea | 940 g/kg | 1 June 2004 | 31 January 2018 | 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 | PyraclostrobinCAS No 175013-18-0CIPAC No 657 | methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate | 975 g/kgThe 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 January 2022 | 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 | QuinoxyfenCAS No 124495-18-7CIPAC No 566 | 5, 7-dichloro-4 (ρ-fluorophenoxy) quinoline | 970 g/kg | 1 September 2004 | 30 April 2019 | 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-cypermethrinCAS No 67375-30-8CIPAC No | Racemate comprising- (S)-α- cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylateand
- (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 | 31 July 2020 | 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 | BenalaxylCAS No 71626-11-4CIPAC No 416 | Methyl N-phenylacetyl–N-2, 6–xylyl–DL-alaninate | 960 g/kg | 1 March 2005 | 31 July 2021 | 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 | BromoxynilCAS No 1689-84-5CIPAC No 87 | 3,5 dibromo – 4- hydroxybenzonitrile | 970 g/kg | 1 March 2005 | 31 July 2021 | 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 | DesmediphamCAS No 13684-56-5CIPAC No 477 | - ethyl 3′-phenylcarbamoyloxycarbanilate
- ethyl 3-phenylcarbamoyloxyphenylcarbamate
| Min. 970 g/kg | 1 March 2005 | 31 July 2020 | 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 | IoxynilCAS No 13684-83-4CIPAC 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 | PhenmediphamCAS No 13684-63-4CIPAC No 77 | - methyl 3-(3-methylcarbaniloyloxy)carbanilate;
- 3-methoxycarbonylaminophenyl 3′-methylcarbanilate
| Min. 970 g/kg | 1 March 2005 | 31 July 2022 | 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 chlororaphisStrain: MA 342CIPAC 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 | 30 April 2022 | 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 | MepanipyrimCAS No 110235-47-7CIPAC No 611 | N-(4-methyl-6-prop-1-ynylpyrimidin-2-yl)aniline | 960 g/kg | 1 October 2004 | 30 April 2022 | 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 | AcetamipridCAS No 160430-64-8CIPAC No Not yet allocated | (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine | ≥ 990 g/kg | 1 January 2005 | 30 April 2018 | 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 | ThiaclopridCAS No 111988-49-9CIPAC No 631 | (Z)-N-{3-[(6-Chloro-3-pyridinyl)methyl]-1,3-thiazolan-2-yliden}cyanamide | ≥ 975 g/kg | 1 January 2005 | 30 April 2020 | 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 quisqualisStrain: AQ 10Culture collection No CNCM I-807CIPAC NoNot allocated | Not applicable | | 1 April 2005 | 31 July 2018 | 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 | ImazosulfuronCAS No 122548-33-8CIPAC 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 | 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 | LaminarinCAS No 9008-22-4CIPAC 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 | 31 July 2018 | 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 | MethoxyfenozideCAS No 161050-58-4CIPAC No 656 | N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide | ≥ 970 g/kg | 1 April 2005 | 31 July 2019 | 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-metolachlorCAS 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 | 31 July 2022 | 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 catenulatumStrain: J1446Culture collection No DSM 9212CIPAC NoNot allocated | Not applicable | | 1 April 2005 | 31 July 2019 | 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 | EtoxazoleCAS No 153233-91-1CIPAC 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 | 31 July 2021 | 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 | TepraloxydimCAS No 149979-41-9CIPAC 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 | 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 | ChlorothalonilCAS No 1897-45-6CIPAC 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 | 31 October 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 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 15545-48-9CIPAC No 217 | 3-(3-chloro-p-tolyl)-1,1-dimethylurea | 975 g/kg | 1 March 2006 | 31 October 2022 | 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 | CypermethrinCAS No 52315-07-8CIPAC 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 | 31 October 2022 | 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
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| 104 | DaminozideCAS No 1596-84-5CIPAC No 330 | N-dimethylaminosuccinamic acid | 990 g/kgImpurities:- N-nitrosodimethylamine: not more than 2,0 mg/kg
- 1,1-dimethylhydrazide: not more than 30 mg/kg
| 1 March 2006 | 31 October 2022 | 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 23564-05-8CIPAC No 262 | Dimethyl 4,4′-(o-phenylene)bis(3-thioallophanate) | 950 g/kg | 1 March 2006 | 31 October 2020 | 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 | TribenuronCAS 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 | 31 October 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 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 | MCPACAS No 94-74-6CIPAC No 2 | 4-chloro-o-tolyloxyacetic acid | ≥ 930 g/kg | 1 May 2006 | 31 October 2022 | 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 | MCPBCAS No 94-81-5CIPAC No 50 | 4-(4-chloro-o-tolyloxy)butyric acid | ≥ 920 g/kg | 1 May 2006 | 31 October 2022 | 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 | BifenazateCAS No 149877-41-8CIPAC No 736 | Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate | ≥ 950 g/kg | 1 December 2005 | 31 July 2022 | 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 | MilbemectinMilbemectin is a mixture of M.A3 and M.A4CAS 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 | 31 July 2022 | 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 | ChlorpyrifosCAS No 2921-88-2CIPAC No 221 | O,O-diethyl-O-3,5,6-trichloro-2-pyridyl phosphorothioate | ≥ 970 g/kgThe 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 | 31 January 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 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-methylCAS No 5598-13-0CIPAC No 486 | O,O-dimethyl-O-3,5,6-trichloro-2-pyridyl phosphorothioate | ≥ 960 g/kgThe 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 | 31 January 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 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 | ManebCAS No 12427-38-2CIPAC No 61 | manganese ethylenebis (dithiocarbamate) (polymeric) | ≥ 860 g/kgThe manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the maneb content. | 1 July 2006 | 31 January 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 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 | MancozebCAS No 8018-01-7 (formerly 8065-67-5)CIPAC No 34 | Manganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc salt | ≥ 800 g/kgThe manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the mancozeb content. | 1 July 2006 | 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 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 | MetiramCAS No 9006-42-2CIPAC No 478 | Zinc ammoniate ethylenebis(dithiocarbamate) — poly[ethylenebis(thiuramdisulfide)] | ≥ 840 g/kgThe manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the metiram content. | 1 July 2006 | 31 January 2022 | 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 | OxamylCAS No 23135-22-0CIPAC No 342 | N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide | 970 g/kg | 1 August 2006 | 31 January 2022 | 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 3100-04-7CIPAC No not allocated | 1-methylcyclopropene | ≥ 960 g/kgThe 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 | 31 October 2019 | 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 | ForchlorfenuronCAS No 68157-60-8CIPAC No 633 | 1-(2-chloro-4-pyridinyl)-3-phenylurea | ≥ 978 g/kg | 1 April 2006 | 31 October 2018 | 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 | IndoxacarbCAS No 173584-44-6CIPAC 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 | 31 October 2022 | 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 | WarfarinCAS No 81-81-2CIPAC 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 | ClothianidinCAS No 210880-92-5CIPAC No 738 | (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine | ≥ 960 g/kg | 1 August 2006 | 31 January 2019 | PART AOnly uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.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 revised addendum of the review report on clothianidin as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.In this overall assessment Member States must pay particular attention to:- the risk to groundwater;
- the risk to bees and bumble bees released for pollination in permanent greenhouses;
- the exposure of bees via the consumption of contaminated water from the permanent greenhouses.
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.Conditions of use shall include risk mitigation measures, where appropriate. |
| 122 | PethoxamidCAS No 106700-29-2CIPAC No 655 | 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide | ≥ 940 g/kg | 1 August 2006 | 31 January 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 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 | ClodinafopCAS No 114420-56-3CIPAC No 683 | (R)-2-[4-(5-chloro-3-fluoro- 2 pyridyloxy)-phenoxy]-propionic acid | ≥ 950 g/kg (expressed as clodinafop-propargyl) | 1 February 2007 | 30 April 2022 | 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 | PirimicarbCAS No 23103-98-2CIPAC No 231 | 2-dimethylamino-5,6-dimethylpyrimidin-4-yl dimethylcarbamate | ≥ 950 g/kg | 1 February 2007 | 30 April 2022 | 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 | RimsulfuronCAS 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 | 30 April 2022 | 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-methylCAS No 57018-04-9CIPAC 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 | 30 April 2020 | 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 | TriticonazoleCAS No 131983-72-7CIPAC No 652 | (±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol | ≥ 950 g/kg | 1 February 2007 | 30 April 2022 | 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 | DimoxystrobinCAS No 149961-52-4CIPAC No 739 | (E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide | ≥ 980 g/kg | 1 October 2006 | 31 January 2022 | 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 | ClopyralidCAS No 1702-17-6CIPAC No 455 | 3,6-dichloropyridine-2-carboxylic acid | ≥ 950 g/kg | 1 May 2007 | 30 April 2022 | 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 | CyprodinilCAS No 121522-61-2CIPAC No 511 | (4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine | ≥ 980 g/kg | 1 May 2007 | 30 April 2022 | 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 | FosetylCAS No 15845-66-6CIPAC No 384 | Ethyl hydrogen phosphonate | ≥ 960 g/kg (expressed as fosetyl-Al) | 1 May 2007 | 30 April 2022 | 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 | TrinexapacCAS No 104273-73-6CIPAC No 732 | 4-(cyclopropyl-hydroxymethylene)-3,5-dioxo- cyclohexanecarboxylic acid | ≥ 940 g/kg (expressed as trinexapac-ethyl) | 1 May 2007 | 30 April 2022 | 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-PCAS No 15165-67-0CIPAC No 476 | (R)-2-(2,4-dichlorophenoxy) propanoic acid | ≥ 900 g/kg | 1 June 2007 | 30 April 2022 | 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 | MetconazoleCAS 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 | 30 April 2022 | 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.
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| 135 | PyrimethanilCAS No 53112-28-0CIPAC 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 | 30 April 2022 | 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 | TriclopyrCAS No 055335-06-3CIPAC No 376 | 3,5,6-trichloro-2-pyridyloxyacetic acid | ≥ 960 g/kg(as Triclopyr butoxyethyl ester) | 1 June 2007 | 30 April 2022 | 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.
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| 137 | MetrafenoneCAS No 220899-03-6CIPAC No 752 | 3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone | ≥ 940 g/kg | 1 February 2007 | 30 April 2022 | 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 713Culture collection No: NRRL B -21661CIPAC No not allocated | Not applicable | | 1 February 2007 | 30 April 2022 | 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 | SpinosadCAS 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 | 30 April 2022 | 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 | ThiamethoxamCAS No 153719-23-4CIPAC 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 | 30 April 2019 | PART AOnly uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.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 revised addendum of the review report on thiamethoxam as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.In this overall assessment Member States must pay particular attention to:- the risk to groundwater;
- the risk to aquatic organisms;
- the risk to bees and bumble bees released for pollination in permanent greenhouses;
- the exposure of bees via the consumption of contaminated water from the permanent greenhouses.
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.Conditions of use shall include risk mitigation measures, where appropriate. |
| 141 | FenamiphosCAS No 22224-92-6CIPAC No 692 | (RS)-ethyl 4-methylthio-m-tolyl isopropyl-phosphoramidate | ≥ 940 g/kg | 1 August 2007 | 31 July 2021 | 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 | EthephonCAS No 16672-87-0CIPAC 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 | 31 July 2022 | 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 | FlusilazoleCAS No 85509-19-9CIPAC No 435 | Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane | 925 g/kg | 1 January 2007 | 30 June 2008 | PART AOnly uses as fungicide on the following crops may be authorised:- cereals other than rice,
- maize,
- rape seed,
- sugar beet,
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 shall ensure 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. |
| 144 | CarbendazimCAS No 10605-21-7CIPAC No 263 | Methyl benzimidazol-2-ylcarbamate | ≥ 980 g/kgRelevant 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.
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| 145 | CaptanCAS No 133-06-02CIPAC No 40 | N-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide | ≥ 910 g/kgImpurities:- 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 | 31 July 2022 | 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 | FolpetCAS No 133-07-3CIPAC No 75 | N-(trichloromethylthio) phthalimide | ≥ 940 g/kgImpurities:- Perchloromethylmercaptan (R005406): not more than 3,5 g/kg
- Carbon tetrachloride not more than 4 g/kg
| 1 October 2007 | 31 July 2022 | 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 | FormetanateCAS No 23422-53-9CIPAC No 697 | 3-dimethylaminomethyleneaminophenyl methylcarbamate | ≥ 910 g/kg | 1 October 2007 | 31 July 2022 | 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 | MethiocarbCAS No 2032-65-7CIPAC No 165 | 4-methylthio-3,5-xylyl methylcarbamate | ≥ 980 g/kg | 1 October 2007 | 31 July 2020 | 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.
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| 149 | DimethoateCAS No 60-51-5CIPAC No 59 | O,O-Dimethyl-S-(N-methylcarbamoylmethyl) phosphorodithioate; 2-Dimethoxy-phosphinothioylthio-N-methylacetamide | ≥ 950 g/kgImpurities:- omethoate: not more than 2 g/kg
- isodimethoate: not more than 3 g/kg
| 1 October 2007 | 31 July 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 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 | DimethomorphCAS No 110488-70-5CIPAC No 483 | (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl]morpholine | ≥ 965 g/kg | 1 October 2007 | 31 July 2022 | 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 | GlufosinateCAS No 77182-82-2CIPAC No 437.007 | ammonium(DL)-homoalanin-4-yl(methyl)phosphinate | 950 g/kg | 1 October 2007 | 31. July 2018 | 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 | MetribuzinCAS No 21087-64-9CIPAC No 283 | 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one | ≥ 910 g/kg | 1 October 2007 | 31 July 2022 | 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 | PhosmetCAS No 732-11-6CIPAC No 318 | O,O-dimethyl S-phthalimidomethyl phosphorodithioate; N-(dimethoxyphosphinothioylthiomethyl)phatalimide | ≥ 950 g/kgImpurities:- phosmet oxon: not more than 0,8 g/kg
- iso phosmet: not more than 0,4 g/kg
| 1 October 2007 | 31 July 2022 | 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 | PropamocarbCAS No 24579-73-5CIPAC No 399 | Propyl 3-(dimethylamino) propylcarbamate | ≥ 920 g/kg | 1 October 2007 | 31 July 2022 | 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.
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| 155 | ethoprophosCAS No 13194-48-4CIPAC No 218 | O-ethyl S,S-dipropyl phosphorodithioate | > 940 g/kg | 1 October 2007 | 31 July 2019 | 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-methylCAS No 29232-93-7CIPAC No 239 | - O-2-diethylamino-6-methylpyrimidin-4-yl
- O,O-dimethylphosphorothioate
| > 880 g/kg | 1 October 2007 | 31 July 2022 | 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.
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| 157 | FipronilCAS No 120068-37-3CIPAC No 581 | (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile | ≥ 950 g/kg | 1 October 2007 | 30 September 2017 | 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 | BeflubutamidCAS No 113614-08-7CIPAC No 662 | (RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide | ≥ 970 g/kg | 1 December 2007 | 31 July 2022 | 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 virusCIPAC NoNot 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 | ProsulfocarbCAS No 52888-80-9CIPAC No 539 | S-benzyl dipropyl(thiocarbamat) | 970 g/kg | 1 November 2008 | 31 October 2022 | 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.
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| 161 | FludioxonilCAS No 131341-86-1CIPAC No 522 | 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile | 950 g/kg | 1 November 2008 | 31 October 2022 | 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 | ClomazoneCAS No 81777-89-1CIPAC No 509 | 2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one | 960 g/kg | 1 November 2008 | 31 October 2022 | 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.
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| 163 | BenthiavalicarbCAS No 413615-35-7CIPAC No 744 | [(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid | ≥ 910 g/kgThe 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 2022 | 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 | BoscalidCAS No 188425-85-6CIPAC No 673 | 2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide | ≥ 960 g/kg | 1 August 2008 | 31 July 2022 | 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 | CarvoneCAS 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 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 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 | FluoxastrobinCAS No 361377-29-9CIPAC 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 2022 | 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 2022 | 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 | ProthioconazoleCAS No 178928-70-6CIPAC No 745 | (RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione | ≥ 970 g/kgThe 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 2022 | 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 | AmidosulfuronCAS No 120923-37-7CIPAC No 515 | - 3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)ureaor
- 1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea
| ≥ 970 g/kg | 1 January 2009 | 31 December 2022 | 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 | NicosulfuronCAS No 111991-09-4CIPAC No 709 | - 2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamideor
- 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea
| ≥ 910 g/kg | 1 January 2009 | 31 December 2022 | 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.
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| 171 | ClofentezineCAS No 74115-24-5CIPAC No 418 | 3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine | ≥ 980 g/kg (dry material) | 1 January 2009 | 31 December 2022 | 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. |
| 172 | DicambaCAS No 1918-00-9CIPAC No 85 | 3,6-dichloro-2-methoxybenzoic acid | ≥ 850 g/kg | 1 January 2009 | 31 December 2022 | 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 | DifenoconazoleCAS No 119446-68-3CIPAC 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/kgToluene maximum content: 5 g/kg | 1 January 2009 | 31 December 2022 | 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;
- (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. |
| 174 | DiflubenzuronCAS No 35367-38-5CIPAC 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 2020 | PART AOnly uses as insecticide in non-edible crops 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 diflubenzuron, and in particular Appendices I and II thereof, as amended in the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 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, terrestrial organisms and non-target arthropods including bees;
- the potential unintended exposure of food and feed crops to diflubenzuron from uses on non-edible crops (e.g. through spray drift);
- the protection of workers, residents and bystanders.
Member States shall ensure that crops treated with diflubenzuron do not enter the food and feed chain.Conditions of use shall include adequate risk mitigation measures, where appropriate.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. |
| 175 | ImazaquinCAS No 81335-37-7CIPAC 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. |
| 176 | LenacilCAS No 2164-08-1CIPAC No 163 | 3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione | ≥ 975 g/kg | 1 January 2009 | 31 December 2022 | 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 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 | OxadiazonCAS No 19666-30-9CIPAC 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 | PicloramCAS No 1918-02-1CIPAC No 174 | 4-amino-3,5,6-trichloropyridine-2-carboxylic acid | ≥ 920 g/kg | 1 January 2009 | 31 December 2022 | 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 | PyriproxyfenCAS No 95737-68-1CIPAC No 715 | 4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether | ≥ 970 g/kg | 1 January 2009 | 31 December 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 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 | BifenoxCAS No 42576-02-3CIPAC 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 2022 | 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 | DiflufenicanCAS No 83164-33-4CIPAC No 462 | 2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide | ≥ 970 g/kg | 1 January 2009 | 31 December 2022 | 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.
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| 182 | Fenoxaprop-PCAS No 113158-40-0CIPAC No 484 | (R)-2[4-[(6-chloro-2-benzoxazolyl)oxy]-phenoxy]-propanoic acid | ≥ 920 g/kg | 1 January 2009 | 31 December 2022 | 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 | FenpropidinCAS No 67306-00-7CIPAC No 520 | (R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine | ≥ 960 g/kg (racemate) | 1 January 2009 | 31 December 2022 | 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 | QuinoclamineCAS No 2797-51-5CIPAC 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 | ChloridazonCAS No 1698-60-8CIPAC No 111 | 5-amino-4-chloro-2-phenylpyridazin-3(2H)-one | 920 g/kgThe 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 | TritosulfuronCAS No 142469-14-5CIPAC No 735 | 1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea | ≥ 960 g/kgThe 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 2022 | 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 | FlutolanilCAS No 66332-96-5CIPAC No 524 | α,α,α-trifluoro-3′-isopropoxy-o-toluanilide | ≥ 975 g/kg | 1 March 2009 | 28 February 2022 | 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 | BenfluralinCAS No 1861-40-1CIPAC No 285 | N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine | ≥ 960 g/kgImpurities:- ethyl-butyl-nitrosamine: max. 0,1 mg/kg
| 1 March 2009 | 28 February 2022 | 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 | FluazinamCAS No 79622-59-6CIPAC No 521 | 3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine | ≥ 960 g/kgImpurities: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 2022 | 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 | FuberidazoleCAS No 3878-19-1CIPAC 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 | MepiquatCAS No 15302-91-7CIPAC No 440 | 1,1-dimethylpiperidinium chloride (mepiquat chloride) | ≥ 990 g/kg | 1 March 2009 | 28 February 2022 | 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 | DiuronCAS No 330-54-1CIPAC No 100 | 3-(3,4-dichlorophenyl)-1,1-dimethylurea | ≥ 930 g/kg | 1 October 2008 | 30 September 2020 | 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. aizawaiSTRAIN: ABTS-1857Culture collection: No SD-1372,STRAIN: GC-91Culture collection: No NCTC 11821 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2022 | 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: AM65-52Culture collection: No ATCC-1276 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2022 | 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 351Culture collection: No ATCC SD-1275
- STRAIN: PB 54Culture collection: No CECT 7209
- STRAIN: SA 11Culture collection: No NRRL B-30790
- STRAIN: SA 12Culture collection: No NRRL B-30791
- STRAIN: EG 2348Culture collection: No NRRL B-18208
| Not applicable | No relevant impurities | 1 May 2009 | 30 April 2022 | 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. TenebrionisSTRAIN: 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 74040Culture collection: No ATCC 74040
- STRAIN: GHACulture collection: No ATCC 74250
| Not applicable | Max level of beauvericin: 5 mg/kg | 1 May 2009 | 30 April 2022 | 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 | 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 2022 | 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 6Culture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 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 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/F52Culture 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 2022 | 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 giganteaSTRAIN: VRA 1985Culture collection: No DSM 16202STRAIN: VRA 1986Culture collection: No DSM 16203STRAIN: FOC PG B20/5Culture collection: No IMI 390096STRAIN: FOC PG SP log 6Culture collection: No IMI 390097STRAIN: FOC PG SP log 5Culture collection: No IMI 390098STRAIN: FOC PG BU 3Culture collection: No IMI 390099STRAIN: FOC PG BU 4Culture collection: No IMI 390100STRAIN: FOC PG97/1062/116/1.1Culture collection: No IMI 390102STRAIN: FOC PG B22/SP1287/3.1Culture collection: No IMI 390103STRAIN: FOC PG SH 1Culture collection: No IMI 390104STRAIN: FOC PG B22/SP1190/3.2Culture collection: No IMI 390105 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2020 | PART A Only uses as fungicide may be authorised.PART B 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 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 oligandrumSTRAINS: M1Culture collection No ATCC 38472 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2022 | 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: K61Culture collection: No DSM 7206 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2022 | 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 206040Culture collection No IMI 206040, ATCC 20476;
- STRAIN: T11Culture collection: NoSpanish type culture collection CECT 20498, identical with IMI 352941
| Not applicable | No relevant impurities | 1 May 2009 | 30 April 2022 | 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 polysporumSTRAIN: Trichoderma polysporum IMI 206039Culture 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 2022 | 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: ICC012Culture collection No CABI CC IMI 392716
- STRAIN: Trichoderma asperellum(formerly T. viride T25) T25Culture collection No CECT 20178
- STRAIN: Trichoderma asperellum(formerly T. viride TV1) TV1Culture collection No MUCL 43093
| Not applicable | No relevant impurities | 1 May 2009 | 30 April 2022 | 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:ICC080Culture collection No IMI CC number 392151 CABI | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2022 | 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 WCS850Culture collection No CBS 276.92 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 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 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 | - AbamectinCAS No 71751-41-2
- avermectin B1aCAS No 65195-55-3
- Avermectin B1bCAS No 65195-56-4
- abamectinCIPAC 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 2022 | PART AOnly uses as insecticide, acaricide and nematicide 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 and of the addendum to the review report on abamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed dated 24 January 2017 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, soil organisms, birds, mammals and aquatic organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones and waiting periods, should be applied where appropriate.
The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water by two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. |
| 211 | EpoxiconazoleCAS 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 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 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 | FenpropimorphCAS No 67564-91-4CIPAC 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 | FenpyroximateCAS No 134098-61-6CIPAC No 695 | tert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate | > 960 g/kg | 1 May 2009 | 30 April 2022 | 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 | TralkoxydimCAS No 87820-88-0CIPAC 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 | AclonifenCAS No 74070-46-5CIPAC No 498 | 2-chloro-6-nitro-3-phenoxyaniline | ≥ 970 g/kgThe impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established. | 1 August 2009 | 31 July 2022 | 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 | ImidaclopridCAS No 138261-41-3CIPAC No 582 | (E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine | ≥ 970 g/kg | 1 August 2009 | 1 December 2020 | PART AOnly uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.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 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 revised addendum of the review report on imidacloprid as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account.In this overall assessment Member States must pay particular attention to:- the risk to bees and bumble bees released for pollination in permanent greenhouses,
- the impact on aquatic organisms,
- the exposure of bees via the consumption of contaminated water from the permanent greenhouses.
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.Conditions of use shall include risk mitigation measures, where appropriate. |
| 217 | MetazachlorCAS No 67129-08-2CIPAC No 411 | 2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide | ≥ 940 g/kgThe manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,05 % is established. | 1 August 2009 | 31 July 2022 | 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. |
| 218 | Acetic acidCAS No 64-19-7CIPAC 838 | acetic acid | ≥ 980 g/kg | 1 September 2009 | 31 August 2022 | 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. |
| 219 | Aluminium ammonium sulphateCAS 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 2022 | 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. |
| 220 | Aluminium silicateCAS No 1332-58-7CIPAC No 841 | Not availableChemical name: Aluminium silicate | ≥ 999,8 g/kg | 1 September 2009 | 31 August 2022 | 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. |
| 221 | Ammonium acetateCAS No 631-61-8CIPAC No not allocated | Ammonium acetate | ≥ 970 g/kgRelevant 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. |
| 222 | Blood mealCAS No: 90989-74-5CIPAC No: 909 | Not available | ≥ 990 g/Kg | 1 September 2009 | 31 August 2021 | PART AOnly uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 10Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.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 carbideCAS No: 75-20-7CIPAC No: 910 | Calcium acetylide | ≥ 765 g/kgContaining 0,08 – 0,9 g/kg Calcium Phosphide | 1 September 2009 | 31 August 2022 | 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 carbonateCAS No: 471-34-1CIPAC No: 843 | Calcium carbonate | ≥ 995 g/kg | 1 September 2009 | 31 August 2022 | 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. |
| 225 | Carbon dioxideCAS No: 124-38-9CIPAC 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 2022 | 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. |
| 226 | Denathonium benzoateCAS No 3734-33-6CIPAC No 845 | Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate | ≥ 975g/kg | 1 September 2009 | 1 December 2020 | 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. |
| 227 | EthyleneCAS No 74-85-1CIPAC No 839 | Ethylene | ≥ 90 %Relevant impurity: ethylene oxide, max content 1 mg/kg | 1 September 2009 | 31 August 2022 | 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. |
| 228 | Extract from tea treeCAS No Tea Tree Oil 68647-73-4Main 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 2022 | 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. |
| 229 | Fat distillation residuesCAS No: not allocatedCIPAC No 915 | Not available | ≥ 40 % of cleaved fatty acidsRelevant impurity: Ni maximum 200 mg/kg | 1 September 2009 | 31 August 2022 | 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. |
| 230 | Fatty acids C7 to C20CAS 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 2022 | 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 extractCAS No 8008-99-9CIPAC No not allocated | Food grade garlic juice concentrate | ≥ 99,9 % | 1 September 2009 | 31 August 2021 | 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 acidCAS No 77-06-5CIPAC 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 2022 | 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 2022 | 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. |
| 234 | Hydrolysed proteinsCAS No not allocatedCIPAC No 901 | Not available | Review report (SANCO/2615/2008) | 1 September 2009 | 31 August 2022 | PART AOnly uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009 and Commission 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 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. |
| 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)sulphateoriron(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 2022 | 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. |
| 236 | Kieselgur (diatomaceous earth)CAS No 61790-53-2CIPAC No 647 | Kieselgur (no IUPAC name)Diatomaceous earthAmorphous silicon dioxideSilicaDiatomite | 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 2021 | 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). |
| 237 | LimestoneCAS No: 1317-65-3CIPAC 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. |
| 238 | Methyl nonyl ketoneCAS No 112-12-9CIPAC No 846 | Undecan-2-one | ≥ 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. |
| 239 | Pepper dust extraction residue (PDER)CAS No: not allocatedCIPAC 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. |
| 240 | Plant oils/citronella oilCAS No 8000-29-1CIPAC 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 2022 | 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. |
| 241 | Plant oils/clove oilCAS 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/kgRelevant impurity: methyl eugenol maximum 0,1 % of the technical material | 1 September 2009 | 31 August 2022 | 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. |
| 242 | Plant oils/rape seed oilCAS No: 8002-13-9CIPAC No: not allocated | Rape seed oil | Rape seed oil is a complex mixture of fatty acidsRelevant impurity: Maximum 2 % of erucic acid | 1 September 2009 | 31 August 2022 | 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. |
| 243 | Plant oils/spear mint oilCAS No 8008-79-5CIPAC No 908 | Spearmint oil | ≥ 550 g/kg as (R)-Carvone | 1 September 2009 | 31 August 2022 | 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. |
| 244 | Potassium hydrogen carbonateCAS No 298-14-6CIPAC No 853 | Potassium hydrogen carbonate | ≥ 99,5 %Impurities:- Pb max. 10 mg/kg
- As max. 3 mg/kg
| 1 September 2009 | 31 August 2022 | 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. |
| 245 | 1,4-diaminobutane (putrescine)CAS No 110-60-1CIPAC 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. |
| 246 | Pyrethrins: 8003-34-7CIPAC No 32Extract A: extractives of Chrysanthemum cinerariaefolium:89997- 63-7Pyrethrin 1: CAS 121- 21-1Pyrethrin 2: CAS 121- 29-9Cinerin 1: CAS 25402- 06-6Cinerin 2: CAS 121- 20-0Jasmolin 1: CAS 4466- 14-2Jasmolin 2: CAS 1172- 63-0Extract B:Pyrethrin 1: CAS 121-21-1Pyrethrin 2: CAS 121- 29-9Cinerin 1: CAS 25402- 06-6Cinerin 2: CAS 121- 20-0Jasmolin 1: CAS 4466- 14-2Jasmolin 2: CAS 1172- 63-0 | Pyrethrins are a complex mixture of chemical substances. | Extract A: ≥ 500 g/kg PyrethrinsExtract B: ≥ 480 g/kg Pyrethrins | 1 September 2009 | 31 August 2022 | 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. |
| 247 | Quartz sandCAS No: 14808-60-7, 7637-86-9CIPAC No: 855 | Quartz, Silicon dioxide | ≥ 915 g/kgMaximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.) | 1 September 2009 | 31 August 2022 | 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. |
| 248 | Fish oilCAS No 100085-40-3CIPAC 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 2022 | 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. |
| 249 | Repellents by smell of animal or plant origin/sheep fatCAS No 98999-15-6CIPAC No not allocated | Sheep Fat | Pure sheep fat containing a maximum of 0,18 % w/w/water. | 1 September 2009 | 31 August 2022 | 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. |
| 250 | Repellents by smell of animal or plant origin/tall oil crude:CAS No 8002-26-4CIPAC 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 2020 | 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 8016-81-7CIPAC 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 2020 | 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. |
| 252 | Sea-algae extract (formerly sea algae extract and sea weeds)CAS No not allocatedCIPAC 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 silicateCAS No 1344-00-9CIPAC No not allocated | Sodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O | 1000 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. |
| 254 | Sodium hypochloriteCAS No: 7681-52-9CIPAC: 848 | Sodium hypochlorite | Sodium hypochlorite: 105 g/kg-126 g/kg (122 g/L-151 g/L) technical concentrate10-12 % (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. |
| 255 | Straight Chain Lepidopteran Pheromones | Review report (SANCO/2633/2008) | Review report (SANCO/2633/2008) | 1 September 2009 | 31 August 2022 | 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. |
| 256 | Trimethylamine hydrochlorideCAS No 593-81-7CIPAC 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. |
| 257 | UreaCAS No 57-13-6CIPAC No 913 | Urea | ≥ 98 % w/w | 1 September 2009 | 31 August 2022 | 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. |
| 258 | Z-13-hexadecen-11-yn-1-yl acetateCAS No 78617-58-0CIPAC: 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. |
| 259 | Z,Z,Z,Z-7,13,16,19- docosatetraen-1-yl isobutyrateCAS No 135459-81-3CIPAC: 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. |
| 260 | Aluminium phosphideCAS No 20859-73-8CIPAC No 227 | Aluminium phosphide | ≥ 830 g/kg | 1 September 2009 | 31 August 2022 | 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.
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| 261 | Calcium phosphideCAS No 1305-99-3CIPAC No 505 | Calcium phosphide | ≥ 160 g/kg | 1 September 2009 | 1 December 2020 | 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.
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| 262 | Magnesium phosphideCAS No 12057-74-8CIPAC No 228 | Magnesium phosphide | ≥ 880 g/kg | 1 September 2009 | 31 August 2022 | 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.
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| 263 | CymoxanilCAS No 57966-95-7CIPAC No 419 | 1-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea | ≥ 970 g/kg | 1 September 2009 | 31 August 2022 | 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.
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| 264 | DodemorphCAS No 1593-77-7CIPAC No 300 | cis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine | ≥ 950 g/kg | 1 September 2009 | 31 August 2022 | 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.
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| 265 | 2,5-Dichlorobenzoic acid methylesterCAS No 2905-69-3CIPAC No 686 | methyl-2,5-dichlorobenzoate | ≥ 995 g/kg | 1 September 2009 | 31 August 2022 | 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 | MetamitronCAS No 41394-05-2CIPAC 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 2022 | 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 | SulcotrioneCAS No 99105-77-8CIPAC No 723 | 2-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione | ≥ 950 g/kgImpurities:- hydrogen cyanide: not more than 80 mg/kg
- toluene: not more than 4 g/kg
| 1 September 2009 | 31 August 2022 | 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 | TebuconazoleCAS No 107534-96-3CIPAC 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 2022 | 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 | TriadimenolCAS No 55219-65-3CIPAC 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/kgisomer 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 | MethomylCAS No 16752-77-50CIPAC 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 | BensulfuronCAS No 83055-99-6CIPAC 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 2022 | 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-nitroguaiacolateCAS No 67233-85-6CIPAC number not allocated | Sodium 2-methoxy-5-nitrophenolate | ≥ 980 g/kg | 1 November 2009 | 31 October 2022 | 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. |
| 273 | Sodium o-nitrophenolateCAS No 824-39-5CIPAC number not allocated | Sodium 2-nitrophenolate; sodium o-nitrophenolate | ≥ 980 g/kgThe 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 2022 | 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-nitrophenolateCAS No 824-78-2CIPAC number not allocated | Sodium 4-nitrophenolate; sodium p-nitrophenolate | ≥ 998 g/kgThe 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 2022 | 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 | TebufenpyradCAS No 119168-77-3CIPAC No 725 | N-(4-tert-butylbenzyl)-4-chloro-3-ethyl-1-methylpyrazole-5-carboxamide | ≥ 980 g/kg | 1 November 2009 | 31 October 2022 | 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/kgImpurities- 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 2022 | 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. |
| 277 | Copper compounds: | | | 1 December 2009 | 31 January 2019 | 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 hydroxideCAS No 20427-59-2CIPAC No 44.305 | Copper (II) hydroxide | ≥ 573 g/kg |
| Copper oxychlorideCAS No 1332-65-6 or 1332-40-7CIPAC No 44.602 | Dicopper chloride trihydroxide | ≥ 550 g/kg |
| Copper oxideCAS No 1317-39-1CIPAC No 44.603 | Copper oxide | ≥ 820 g/kg |
| Bordeaux mixtureCAS No 8011-63-0CIPAC No 44.604 | Not allocated | ≥ 245 g/kg |
| Tribasic copper sulphateCAS No 12527-76-3CIPAC No 44.306 | Not allocated | ≥ 490 g/kgThe 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.
|
| 278 | PropaquizafopCAS No 111479-05-1CIPAC No 173 | 2-isopropylidenamino-oxyethyl (R)-2-[4-(6-chloro-quinoxalin-2-yloxy)phenoxy]propionate | ≥ 920 g/kgToluene maximum content 5 g/kg | 1 December 2009 | 30 November 2022 | 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 | | |
| Quizalofop-P-tefurylCAS No 119738-06-6CIPAC No 641.226 | (RS)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate | ≥ 795 g/kg | 1 December 2009 | 30 November 2022 | 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-ethylCAS No 100646-51-3CIPAC No 641.202 | ethyl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate | ≥ 950 g/kg | 1 December 2009 | 30 November 2022 |
| 280 | TeflubenzuronCAS No 83121-18-0CIPAC 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-cypermethrinCAS No 52315-07-8CIPAC 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/kgImpurities:- toluene: max 2 g/kg
- tars: max 12,5 g/kg
| 1 December 2009 | 1 December 2020 | 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 | ChlorsulfuronCAS No 64902-72-3CIPAC No 391 | 1-(2-chlorophenylsulfonyl)-3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea | ≥ 950 g/kgImpurities:- 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 | CyromazineCAS No 66215-27-8CIPAC 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 | DimethachlorCAS No 50563-36-5CIPAC No 688 | 2-chloro-N-(2-methoxyethyl)acet-2′,6′-xylidide | ≥ 950 g/kgImpurity 2,6-dimethylaniline: Not more than 0,5 g/kg | 1 January 2010 | 31 December 2022 | 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 | EtofenproxCAS No 80844-07-1CIPAC No 471 | - 2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl
- ether
| ≥ 980 g/kg | 1 January 2010 | 31 December 2022 | 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 | LufenuronCAS No 103055-07-8CIPAC 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.
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| 287 | PenconazoleCAS No 66246-88-6CIPAC No 446 | (RS) 1-[2-(2,4-dichloro-phenyl)-pentyl]-1H-[1,2,4] triazole | ≥ 950 g/kg | 1 January 2010 | 31 December 2022 | 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-allateCAS No 2303-17-5CIPAC No 97 | S-2,3,3-trichloroallyl di-isopropyl(thiocarbamate) | ≥ 940 g/kgNDIPA (Nitroso-diisopropylamine)max. 0,02 mg/kg | 1 January 2010 | 31 December 2022 | 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 | TriflusulfuronCAS No 126535-15-7CIPAC No 731 | 2-[4-dimethylamino-6-(2,2,2-trifluoroethoxy)-1,3,5-triazin-2-ylcarbamoylsulfamoyl]-m-toluic acid | ≥ 960 g/kg | 1 January 2010 | 31 December 2022 | 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 | DifenacoumCAS No 56073-07-5CIPAC 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. |
| 291 | Didecyldimethylammonium chlorideCAS: not allocatedCIPAC: not allocated | Didecyldimethylammonium chloride is a mixture of alkyl-quaternary ammonium salts with typical alkyl chain lengths of C8, C10 and C12, with more than 90 % of C10 | ≥ 70 % (Technical concentrate) | 1 January 2010 | 31 December 2019 | PART AOnly indoor uses for ornamental plants as bactericide, fungicide, herbicide and algaecide 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 didecyldimethylammonium chloride, 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 must pay particular attention to:- the protection of the operator and worker 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 aquatic organisms.
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 specification of the active substance as manufactured by 1 January 2010 and on the risk to aquatic organisms by 31 December 2011. |
| 292 | sulphurCAS No 7704-34-9CIPAC No 18 | sulphur | ≥ 990 g/kg | 1 January 2010 | 31 December 2022 | 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 | TetraconazoleCAS No 112281-77-3CIPAC 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 2022 | 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 2022 | 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 oilCAS No 8042-47-5CIPAC No n.a. | paraffin oil | European Pharmacopoeia. 6,0 | 1 January 2010 | 31 December 2022 | 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.
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| 296 | CyflufenamidCAS No 180409-60-3CIPAC No 759 | (Z)-N-[α-(cyclopropylmethoxyimino) – 2,3-difluoro-6-(trifluoromethyl)benzyl]-2-phenylacetamide | > 980 g/kg | 1 April 2010 | 31 March 2023 | 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 | FluopicolideCAS No239110-15-7CIPAC No 787 | 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide | ≥ 970 g/kgThe impurity toluene must not exceed 3 g/kg in the technical material. | 1 June 2010 | 31 May 2023 | 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 | HeptamaloxyloglucanCAS No870721-81-6CIPAC NoNot available | Full IUPAC name in footnote (1)- Xyl p: xylopyranosyl
- Glc p: glucopyranosyl
- Fuc p: fucopyranosyl
- Gal p: galactopyranosyl
- Glc-ol: glucitol
| ≥ 780 g/kgThe impurity Patulin must not exceed 50 μg/kg in the technical material. | 1 June 2010 | 31 May 2022 | 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 90-43-7CIPAC No 246 | biphenyl-2-ol | ≥ 998 g/kg | 1 January 2010 | 31 December 2022 | 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 | MalathionCAS No 121-75-5CIPAC No 12 | - diethyl (dimethoxyphosphinothioylthio)succinateor
- S-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioateracemate
| ≥ 950 g/kgImpurities:Isomalathion: not more than 2 g/kg | 1 May 2010 | 30 April 2022 | PART AOnly uses as an insecticide in greenhouses with a permanent structure 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 Plants, Animals, Food and Feed shall be taken into account.In this overall assessment, Member States must pay particular attention to:- (a)releases from greenhouses, such as condensation water, drain water, soil or artificial substrate, in order to preclude risks to aquatic organisms;
- (b)the protection of pollinator colonies purposely placed in the greenhouse;
- (c)the protection of operators and workers, so as to ensure that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate;
- (d)the protection of consumers in the case of processed commodities.
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.Conditions of authorisation shall include risk mitigation measures and provide for adequate labelling of plant protection products. |
| 301 | PenoxsulamCAS No 219714-96-2CIPAC 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/kgThe impurityBis-CHYMP2-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 2023 | 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 | ProquinazidCAS No 189278-12-4CIPAC No 764 | 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one | > 950 g/kg | 1 August 2010 | 31 July 2022 | 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 | SpirodiclofenCAS No 148477-71-8CIPAC No 737 | 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate | > 965 g/kgThe 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 | MetalaxylCAS No 57837-19-1CIPAC No 365 | Methyl N-(methoxyacetyl)-N-(2,6-xylyl)-DL-alaninate | 950 g/kgThe impurity 2,6-dimethylaniline was considered of toxicological concern and a maximum level of 1 g/kg is established. | 1 July 2010 | 30 June 2023 | 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 158062-67-0CIPAC No 763 | N-cyanomethyl-4-(trifluoromethyl)nicotinamide | ≥ 960 g/kgThe impurity toluene must not exceed 3 g/kg in the technical material. | 1 September 2010 | 31 August 2023 | 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 | TriflumizoleCAS No 99387-89-0CIPAC No 730 | (E)-4-chloro-α,α,α-trifluoro-N-(1-imidazol-1-yl-2-propoxyethylidene)-o-toluidine | ≥ 980 g/kgImpurities: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.
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| 307 | Sulfuryl fluorideCAS No 002699-79-8CIPAC No 757 | Sulfuryl fluoride | > 994 g/kg | 1 November 2010 | 31 October 2023 | PART AOnly uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures may be authorised insofar:- (a)these structures are empty; or
- (b)where food or feed commodities are present in a fumigated facility, the users and the food business operators ensure that only the food or feed commodities compliant with the existing maximum residue levels for sulfuryl fluoride and fluoride ion set by Regulation (EC) No 396/2005 of the European Parliament and of the Council may enter the food and feed chain; to this purpose, the users and the food business operators shall fully implement measures equivalent to the HACCP principles as laid down in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council; in particular, the users shall identify the critical control point at which control is essential to prevent maximum residue levels to be exceeded, and establish and implement effective monitoring procedures at that critical control point.
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 Plants, Animals, Food and Feed on 7 December 2016 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 only products complying with the existing MRLs 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 notifier shall submit to the Commission, Member States and the Authority monitoring data on tropospheric concentrations of sulfuryl fluoride every fifth year, starting from 30 June 2017. 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). |
| 308 | FEN 560 (also called fenugreek or fenugreek seed powder)CAS NoNoneCIPAC NoNoneThe 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-PCAS No Acid: 95977-29-0Ester: 72619-32-0CIPAC No Acid: 526Ester: 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 at rates not exceeding 0,052 kg active substance per hectare per application, and only one application may be authorised every 3 years.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:- the protection of groundwater from the relevant soil metabolite DE-535 pyridinone when the active substance is applied in regions with vulnerable soil and/or climatic conditions,
- the safety of operators and ensure that conditions of use 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 consumer safety as regards the occurrence in groundwater of metabolite DE-535 pyridinol.
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| 310 | NapropamideCAS No 15299-99-7 | (RS)-N,N-diethyl-2-(1-naphthyloxy)propionamide | ≥ 930 g/kg(Racemic mixture)Relevant impurityToluene: not more than 1,4 g/kg | 1 January 2011 | 31 December 2023 | 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 | QuinmeracCAS No 90717-03-6CIPAC No 563 | 7-chloro-3-methylquinoline-8-carboxylic acid | ≥ 980 g/kg | 1 May 2011 | 31 July 2024 | 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 | MetosulamCAS No 139528-85-1CIPAC 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.
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| 313 | PyridabenCAS No 96489-71-3CIPAC No 583 | 2-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyrididazin-3(2H)-one | >980 g/kg | 1 May 2011 | 30 April 2023 | 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 phosphideCAS No 1314-84-7CIPAC No 69 | Trizinc diphosphide | ≥ 800 g/kg | 1 May 2011 | 31 July 2024 | 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.
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| 315 | FenbuconazoleCAS No 114369-43-6CIPAC 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 | CycloxydimCAS No 101205-02-1CIPAC 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 2023 | 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-BenzyladenineCAS No 1214-39-7CIPAC No 829 | N6-benzyladenine | ≥ 973 g/kg | 1 June 2011 | 31 August 2024 | 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 | BromuconazoleCAS No 116255-48-2CIPAC 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 2024 | 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 | MyclobutanilCAS No 88671-89-0CIPAC No 442 | RS)-2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile | ≥ 925 g/kgThe 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 | BuprofezinCAS No 953030-84-7CIPAC No 681 | (Z)-2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one | ≥ 985 g/kg | 1 February 2011 | 31 January 2023 | PART AOnly uses as insecticide and acaricide on non-edible crops 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 Plants, Animals, Food and Feed shall be taken into account.In this overall assessment, Member States must pay particular attention to:- the operators' and workers' safety and ensure that conditions of use impose the use of adequate personal protective equipment where appropriate,
- 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.
Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| 321 | TriflumuronCAS No 64628-44-0CIPAC No: 548 | 1-(2-chlorobenzoyl)-3-[4-trifluoromethoxyphenyl]urea | ≥ 955 g/kgImpurities:- 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 | HymexazolCAS No 10004-44-1CIPAC No 528 | 5-methylisoxazol-3-ol (or 5-methyl-1,2-oxazol-3-ol) | ≥985 g/kg | 1 June 2011 | 31 May 2023 | 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 | DodineCAS No 2439-10-3CIPAC No 101 | 1-dodecylguanidinium acetate | ≥ 950 g/kg | 1 June 2011 | 31 August 2024 | 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 | DiethofencarbCAS No 87130-20-9CIPAC No 513 | isopropyl 3,4-diethoxycarbanilate | ≥ 970 g/kgImpurities: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 | EtridiazoleCAS No 2593-15-9CIPAC 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 acidCAS No 133-32-4CIPAC No 830 | 4-(1H-indol-3-yl)butyric acid | ≥ 994 g/kg | 1 June 2011 | 31 May 2023 | 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 | OryzalinCAS No 19044-88-3CIPAC No 537 | 3,5-dinitro-N4,N4-dipropylsulfanilamide | ≥ 960 g/kgN-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 and OR15 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-fluvalinateCAS No 102851-06-9CIPAC 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 August 2024 | 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.
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| 329 | ClethodimCAS No 99129-21-2CIPAC No 508 | (5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyloxyimino]propyl}-5-[(2RS)-2-(ethylthio)propyl]-3-hydroxycyclohex-2-en-1-one | ≥ 930 g/kgImpurities:toluene max. 4 g/kg | 1 June 2011 | 31 May 2023 | 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. |
| 330 | BupirimateCAS No 41483-43-6CIPAC No 261 | 5-butyl-2-ethylamino-6-methylpyrimidine-4-yl dimethylsulfamate | ≥ 945 g/kgImpurities:- Ethirimol: max. 2 g/kg
- Toluene: max. 3 g/kg
| 1 June 2011 | 31 August 2024 | 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.
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. |
| 331 | Fenbutatin oxideCAS No 13356-08-6CIPAC No 359 | bis[tris(2-methyl-2-phenylpropyl)-tin]oxide | ≥ 970 g/kgImpurities:bis[hydroxybis(2-methyl-2-phenylpropyl)tin]oxide (SD 31723): not more than 3 g/kg | 1 June 2011 | 31 May 2021 | PART AOnly uses as acaricide 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 fenbutatin oxide, 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 technical specification of the impurity content,
- the residue levels in small tomato varieties (cherry tomatoes),
- the operator safety. Conditions of use shall prescribe the application of adequate personal protective equipment, where appropriate;
- the risk to aquatic organisms.
Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of information confirming the results of the risk assessment, on the basis of most recent scientific knowledge, as regards the impurity SD 31723. That information shall concern the following points:- genotoxicological potential;
- ecotoxicological relevance;
- spectra, storage stability and methods of analysis in the formulation.
The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. |
| 332 | FenoxycarbCAS No 79127-80-3CIPAC No: 425 | Ethyl 2-(4-phenoxyphenoxy)ethyl carbamate | ≥ 970 g/kgImpurities: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-decanolCAS No 112-30-1CIPAC No 831 | Decan-1-ol | ≥ 960 g/kg | 1 June 2011 | 31 August 2024 | 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 | IsoxabenCAS No 82558-50-7CIPAC No 701 | N-[3-(1-ethyl-1-methylpropyl)-1,2-oxazol-5-yl]-2,6-dimethoxybenzamide | ≥ 910 g/kgToluene: ≤ 3 g/kg | 1 June 2011 | 31 August 2024 | 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 | FluometuronCAS No: 2164-17-2CIPAC No: 159 | 1,1-dimethyl-3-(α,α,α -trifluoro-m-tolyl)urea | ≥ 940 g/kg | 1 June 2011 | 31 August 2024 | 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 | CarbetamideCAS No 16118-49-3CIPAC 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 | CarboxinCAS No 5234-68-4CIPAC 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 in soil, groundwater and surface water and for the monitoring of metabolite M9 in groundwater;
- (e)additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 and P/V-55,
- (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, P/V-55 and M9 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 | CyproconazoleCAS No 94361-06-5CIPAC 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 | DazometCAS No 533-74-4CIPAC No 146 | - 3,5-dimethyl-1,3,5-thiadiazinane-2-thioneor
- tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione
| ≥ 950 g/kg | 1 June 2011 | 31 May 2023 | 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 | MetaldehydeCAS 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/kgacetaldehyde max. 1,5 g/kg | 1 June 2011 | 31 May 2023 | 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 | SintofenCAS No 130561-48-7CIPAC No 717 | 1-(4-chlorophenyl)-1,4-dihydro-5-(2-methoxyethoxy)-4-oxocinnoline-3-carboxylic acid | ≥ 980 g/kgImpurities:- 2-methoxyethanol, not more than 0,25 g/kg
- N,N-dimethylformamide, not more than 1,5 g/kg
| 1 June 2011 | 31 August 2024 | 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 | FenazaquinCAS No 120928-09-8CIPAC No 693 | 4-tert-butylphenethyl quinazolin-4-yl ether | ≥ 975 g/kg | 1 June 2011 | 31 May 2023 | PART AOnly uses as acaricide 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 thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011, and of the addendum to the review report on fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 22 March 2018, shall be taken into account.In this overall assessment Member States shall pay particular attention to:- (a)the protection of aquatic organisms;
- (b)the protection of operators, also ensuring that the conditions of the use include the application of adequate personal protective equipment;
- (c)the protection of bees;
- (d)the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses;
- (e)the risk to consumers, in particular from the residues generated during processing;
- (f)the conditions of use to avoid exposure to residues of fenazaquin with respect to crops for human and animal consumption.
Conditions of use shall include risk mitigation measures, where appropriate. |
| 343 | AzadirachtinCAS 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/kgSum of the aflatoxins B1, B2, G1, G2 must not exceeding 300 μg/kg of the azadirachtin A content. | 1 June 2011 | 31 August 2024 | PART AFor the implementation 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 thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 and of the addendum to the review report on azadirachtin, and in particular Appendices I and II thereto, as finalised by the Standing Committee on Plants, Animals, Food and Feed on 17 July 2020 shall be taken into account.In this overall assessment Member States shall pay particular attention to:- (1)the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;
- (2)the protection of non-target arthropods and aquatic organisms.
Conditions of use shall include risk mitigation measures, where appropriate.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-methylmethyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate
| ≥ 980 g/kg (expressed as diclofop-methyl) | 1 June 2011 | 31 May 2023 | 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 sulphurCAS No 1344 - 81 - 6CIPAC No 17 | Calcium polysulfide | ≥ 290 g/Kg. | 1 June 2011 | 31 August 2024 | 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 sulfateCAS No 10043-01-3CIPAC not available | Aluminium sulfate | 970 g/kg | 1 June 2011 | 31 August 2024 | 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 | BromadioloneCAS No 28772-56-7CIPAC 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 | PaclobutrazolCAS No 76738-62-0CIPAC 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 2023 | 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 | PencycuronCAS No 66063-05-6CIPAC 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 | TebufenozideCAS No 112410-23-8CIPAC No 724 | N-tert-butyl-N′-(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide | ≥ 970 g/kgRelevant impurityt-butyl hydrazine < 0,001 g/kg | 1 June 2011 | 31 August 2024 | 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 | DithianonCAS No 3347-22-6CIPAC No 153 | 5,10-dihydro-5,10-dioxonaphtho[2,3-b]-1,4-dithiine-2,3-dicarbonitrile | ≥ 930 g/kg | 1 June 2011 | 31 August 2024 | 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 | HexythiazoxCAS No 78587-05-0CIPAC 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 August 2024 | 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;
- (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 | FlutriafolCAS No 76674-21-0CIPAC 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. |
| 354 | FlurochloridoneCAS No 61213-25-0CIPAC 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 2022 | 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;
- 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. |
cfu/g (
spores/g)