Reform history
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances Text with EEA relevance
100 versions
· 2011-05-25
2026-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2025-11-16
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2025-07-28
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2025-05-28
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2025-05-15
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2025-03-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-12-02
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-09-29
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-07-31
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-05-23
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-05-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-02-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-12-16
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-08-02
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-04-18
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-04-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-03-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2023-01-20
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-12-12
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-09-28
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-03-27
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-03-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2022-02-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-12-19
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-10-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-08-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-04-06
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-04-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-03-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2021-02-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-12-12
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-11-26
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-10-20
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-10-06
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-08-03
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-08-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-06-03
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-04-09
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2020-02-03
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-12-29
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-08-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-05-30
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-04-14
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-02-20
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2019-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-12-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-10-17
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-08-14
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-06-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-03-22
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2018-01-23
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-12-16
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-12-05
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-09-28
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-06-08
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2017-04-03
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
Changes on 2017-04-03
@@ -54,8 +54,7 @@
| | | | | | | |
| 15 | Diquat CAS No 2764-72-9 (ion), 85-00-7 (dibromide) CIPAC No 55 | 9,10-Dihydro-8a,10a-diazoniaphenanthrene ion (dibromide) | 950 g/kg | 1 January 2002 | 30. June 2017 | 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. |
| ————— | | | | | | |
| | | | | | | |
| 17 | Thiabendazole CAS No 148-79-8 CIPAC 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. |
| ————— | | | | | | |
| ————— | | | | | | |
| | | | | | | |
| 19 | DPX KE 459 (flupyrsulfuron-methyl) CAS No 144740-54-5 CIPAC No 577 | 2-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-6-trifluromethylnicotinate monosodium salt | 903 g/kg | 1 July 2001 | 30. June 2017 | 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. |
@@ -98,7 +97,8 @@
| 48 | Beta-cyfluthrin CAS No 68359-37-5 (unstated stereochemistry) CIPAC No 482 | (1RS,3RS;1RS,3SR)-3- (2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylic acid (SR)-α-cyano- (4-fluoro-3-phenoxy-phenyl)methyl ester | 965 g/kg | 1 January 2004 | 31. October 2017 | Only use as insecticide may be authorised Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops. For the implementation of the uniform principles, the conclusions of the review report on beta-cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures. |
| 49 | Cyfluthrin CAS No 68359-37-5 (unstated stereochemistry) CIPAC No 385 | (RS),-α-cyano-4-fluoro-3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethycyclopropanecarboxylate | 920 g/kg | 1 January 2004 | 31 December 2013 | Only use as insecticide may be authorised Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops. For the implementation of the uniform principles, the conclusions of the review report on cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures. |
| 50 | Iprodione CAS No 36734-19-7 CIPAC No 278 | 3-(3,5-dichlorophenyl)-Nisopropyl-2,4-dioxo-imidazolidine-1-carboximide | 960 g/kg | 1 January 2004 | 31. October 2017 | Only uses as fungicide and nematicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iprodione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment, Member States: — should pay particular attention to the potential for groundwater contamination when the active substance is applied at high use rates (in particular use in turf) on acidic soils (pH below 6) under vulnerable climatic conditions, — must carefully consider the risk to aquatic invertebrates if the active substance is applied directly adjacent to surface waters. Risk mitigation measures should be applied, where appropriate. |
| 51 | Linuron CAS No 330-55-2 CIPAC No 76 | 3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea | 900 g/kg | 1 January 2004 | 31. 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 linuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of wild mammals, non-target arthropods and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, — must pay particular attention to the protection of operators. |
| ————— | | | | | | |
| | | | | | | |
| 52 | Maleic hydrazide CAS No 123-33-1 CIPAC No 310 | 6-hydroxy-2H-pyridazin-3-one | 940 g/kg. | 1 January 2004 | 31. October 2017 | Only use as growth regulator may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on maleic hydrazide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, — must pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate. |
| 53 | Pendimethalin CAS No 40487-42-1 CIPAC No 357 | N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene | 900 g/kg | 1 January 2004 | 31. 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 pendimethalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health 3 December 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of aquatic organisms and non-target terrestrial plants. Conditions of authorisation must include risk mitigation measures, where appropriate, — must pay particular attention to the possibility of short-range transport of the active substance in air. |
| 54 | Propineb CAS No 12071-83-9 (monomer), 9016-72-2 (homopolymer) CIPAC No 177 | Polymeric zinc 1,2-propylenebis(dithiocarbamate) | The technical active substance should comply with the FAO specification | 1 April 2004 | 31 January 2018 | Only uses as fungicide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propineb, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions — Member States should pay particular attention to the protection of small mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate — Member States should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels |
@@ -113,7 +113,8 @@
| 63 | Isoxaflutole CAS No 141112-29-0 CIPAC No 575 | 5-cyclopropyl-4-(2-methylsulfonyl-4-trifluoromethylbenzoyl) isoxazole | 950 g/kg | 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 isoxaflutole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures or monitoring programs should be applied where appropriate. |
| 64 | Flurtamone CAS No 96525-23-4 | (RS)-5-methylamino-2-phenyl-4-(a,a,a-trifluoro-m-tolyl) furan-3 (2H)-one | 960 g/kg | 1 January 2004 | 31. 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 flurtamone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of algae and other aquatic plants. Risk mitigation measures should be applied where appropriate. |
| 65 | Flufenacet CAS No 142459-58-3 CIPAC No 588 | 4′-fluoro-N-isopropyl-2-[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yloxy]acetanilide | 950 g/kg | 1 January 2004 | 31. 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 flufenacet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of algae and aquatic plants, — should pay particular attention to the protection of operators. Risk mitigation measures should be applied where appropriate. |
| 66 | Iodosulfuron CAS No 185119-76-0 (parent) 144550-36-7 (iodosulfuron-methyl-sodium) CIPAC No 634 (parent) 634.501 (iodosulfuron-methyl-sodium) | 4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-ureidosulfonyl]benzoate | 910 g/kg | 1 January 2004 | 31. 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-p CAS No 163515-14-8 CIPAC No 638 | S-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy-1-methylethyl)-acetamide | 890 g/kg (preliminary value based on a pilot plant) | 1 January 2004 | 31. 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 dimethenamid-p, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential of the metabolites of dimethenamid-p for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| 68 | Picoxystrobin CAS No 117428-22-5 CIPAC No 628 | Methyl (E)-3-methoxy-2-{2-[6-(trifluoromethyl) -2- pyridyloxymethyl]phenyl} acrylate | 950 g/kg (preliminary value based on a pilot plant) | 1 January 2004 | 31. 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 | Fosthiazate CAS No 98886-44-3 CIPAC No 585 | (RS)-S-sec-butyl O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate | 930 g/kg | 1 January 2004 | 31. October 2017 | 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. |
@@ -263,107 +264,107 @@
| 207 | Trichoderma asperellum (formerly T. harzianum) STRAIN: ICC012 Culture collection No CABI CC IMI 392716 STRAIN: Trichoderma asperellum (formerly T. viride T25) T25 Culture collection No CECT 20178 STRAIN: Trichoderma asperellum (formerly T. viride TV1) TV1 Culture collection No MUCL 43093 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2019 | PART 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 reports on Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008) and Trichoderma asperellum (formerly T. viride T25 and TV1) T25 and TV1 (SANCO/1868/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 208 | Trichoderma gamsii (formerly T. viride) STRAINS: ICC080 Culture collection No IMI CC number 392151 CABI | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2019 | PART 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 Trichoderma viride (SANCO/1868/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 209 | Verticillium albo-atrum (formerly Verticillium dahliae) STRAIN: Verticillium albo-atrum isolate WCS850 Culture collection No CBS 276.92 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2019 | PART 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 Verticillium albo-atrum (formerly Verticillium dahliae) WCS850 (SANCO/1870/2008), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 210 | Abamectin CAS No 71751-41-2 avermectin B1a CAS No 65195-55-3 Avermectin B1b CAS No 65195-56-4 abamectin CIPAC No 495 | AvermectinB1a (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside AvermectinB1b (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside | ≥ 850 g/kg | 1 May 2009 | 30 April 2019 | PART A Only uses as insecticide, acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing abamectin for uses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information are provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on (abamectin), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the residues in food of plant origin and evaluate the dietary exposure of consumers, — the protection of bees, non-target arthropods, birds, mammals and aquatic organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, waiting periods, should be applied where appropriate. The Member States concerned shall request the submission of: — further studies on the specification, — information to further address the risk assessment for birds and mammals, — information to address the risk to aquatic organisms with respect to the major soil metabolites, — information to address the risk to groundwater with respect to the metabolite U8. They shall ensure that the notifiers provide such studies to the Commission within two years from the approval. |
| 210 | Abamectin CAS No 71751-41-2 avermectin B1a CAS No 65195-55-3 Avermectin B1b CAS No 65195-56-4 abamectin CIPAC No 495 | AvermectinB1a (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside AvermectinB1b (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11.13,22-tetramethyl-2-oxo-3.7,19-trioxatetracyclo[15.6.1.14,8 020,24]pentacosa-10.14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside | ≥ 850 g/kg | 1 May 2009 | 30 April 2019 | PART A Only uses as insecticide, acaricide and nematicide may be authorised. PART B In assessing applications to authorise plant protection products containing abamectin for uses other than citrus, lettuce and tomatoes, Member States shall pay particular attention to the criteria in Article 4(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 | Epoxiconazole CAS No 135319-73-2 (formerly 106325-08-0) CIPAC No 609 | (2RS, 3SR)-1-[3-(2-chlorophenyl)-2,3-epoxy-2-(4-fluorophenyl)propyl]-1H-1.2,4-triazole | ≥ 920 g/kg | 1 May 2009 | 30 April 2019 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on epoxiconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, — the dietary exposure of consumers to the epoxiconazole (triazole) metabolites, — the potential for long-range transport via air, — the risk to aquatic organisms, birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further studies addressing the potential endocrine disrupting properties of epoxiconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. The Member States concerned shall ensure that the notifier presents to the Commission not later than 30 June 2009 a monitoring programme to assess the long-range atmospheric transport of epoxiconazole and related environmental risks. The results of this monitoring shall be submitted as a monitoring report to the Commission by 31 December 2011 at the latest. The concerned Member States shall ensure that the notifier submits within two years from the approval, at the latest, information on residues of epoxiconazole metabolites in primary crops, rotational crops and products of animal origin and information to further address the long-term risk to herbivorous birds and mammals. |
| 212 | Fenpropimorph CAS No 67564-91-4 CIPAC No 427 | (RS)-cis-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine | ≥ 930 g/kg | 1 May 2009 | 30 April 2019 | PART 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 fenpropimorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, such as restrictions of the daily work rate, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles. The Member States concerned shall request the submission of further studies to confirm the mobility in soil of the metabolite BF-421-7. They shall ensure that the notifiers at whose request fenpropimorph has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 213 | Fenpyroximate CAS No 134098-61-6 CIPAC No 695 | tert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate | > 960 g/kg | 1 May 2009 | 30 April 2019 | PART A Only uses as acaricide may be authorised. The following uses must not be authorised: — applications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpyroximate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. The Member States concerned shall request the submission of information to further address: — the risk to aquatic organisms from metabolites containing the benzyl moiety, — the risk of biomagnification in aquatic food chains. They shall ensure that the notifiers at whose request fenpyroximate has been included in this Annex provide such information to the Commission within two years from the approval. |
| 214 | Tralkoxydim CAS No 87820-88-0 CIPAC No 544 | (RS)-2-[(EZ)-1-(ethoxyimino)propyl]-3-hydroxy-5-mesitylcyclohex-2-en-1-one | ≥ 960 g/kg | 1 May 2009 | 30 April 2019 | PART A Only uses as herbicide 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 tralkoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of the groundwater, in particular from the soil metabolite R173642 when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of herbivorous mammals. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of: — information to further address the long-term risk to herbivorous mammals arising from the use of tralkoxydim. They shall ensure that the notifiers at whose request tralkoxydim has been included in this Annex provide such information to the Commission within two years from the approval. |
| 215 | Aclonifen CAS No 74070-46-5 CIPAC No 498 | 2-chloro-6-nitro-3-phenoxyaniline | ≥ 970 g/kg The impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established. | 1 August 2009 | 31 July 2019 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the residues in rotational crops and evaluate the dietary exposure of consumers, — the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants. They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval. |
| 216 | Imidacloprid CAS No 138261-41-3 CIPAC No 582 | (E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine | ≥ 970 g/kg | 1 August 2009 | 31 July 2019 | PART A Only professional uses as insecticide may be authorised. Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June: barley, millet, oats, rice, rye, sorghum, triticale, wheat. Foliar treatments shall not be authorised for the following cereals: barley, millet, oats, rice, rye, sorghum, triticale, wheat. Uses as seed treatment, soil treatment or foliar application shall not be authorised for the following crops with the exception of uses in greenhouses and with the exception of foliar treatment after flowering: Alfalfa (*Medicago sativa*) almonds (*Prunus amygdalus*; *P. communis; Amygdalus communis*) anise (*Pimpinella anisum*); badian or star anise (*Illicium verum*); caraway (*Carum carvi*); coriander (*Coriandrum sativum*); cumin (*Cuminum cyminum*); fennel (*Foeniculum vulgare*); juniper berries (*Juniperus communis*) apples (*Malus pumila*; *M. sylvestris*; *M. communis*; *Pyrus malus*) apricots (*Prunus armeniaca*) avocados (*Persea americana*) bananas (*Musa sapientum*; *M. cavendishii*; *M. nana*) beans (*Phaseolus* spp.) blackberry (*Rubus fruticosus*) blueberries, European blueberry, wild bilberry, whortleberry (*Vaccinium myrtillus*); American blueberry (*V. corymbosum*) broad beans, horse beans (*Vicia faba* var. *major*; var. *equina*; var. *Minor*) buckwheat (*Fagopyrum esculentum*) carobs, carob-tree, locust bean (*Ceratonia siliqua*) castor oil seed (*Ricinus communis*) cherries (*Prunus avium*) chestnuts (*Castanea* spp.) chick peas (*Cicer arietinum*) chillies (*Capsicum frutescens*; *C. annuum*); allspice, Jamaica pepper (*Pimenta officinalis*) clovers (*Trifolium* spp.) coffee (*Coffea* spp. *arabica, robusta, liberica*) cotton (*Gossypium* spp.) cowpeas, black eyed peas (*Vigna unguiculata*) cranberries (*Vaccinium macrocarpon*); European cranberries (*Vaccinum oxycoccus*) cucumbers (*Cucumis sativus*) currants black (*Ribes nigrum*); red and white (*R. rubrum*) dates (*Phoenix dactylifera*) elderberries (*Sambucus nigra*) gooseberries (*Ribes uva-crispa*) grapefruit *(C. paradisi*) grapes (*Vitis vinifera*) groundnuts/peanuts (*Arachis hypogea*) hazelnut (*Corylus avellana*) hemp (*Cannabis sativa*) japanese rose (*Rosa rugosa*) kiwi fruit (*Actinidia chinensis*) leguminous: birdsfoot/trefoil (*Lotus corniculatus*); lespedeza (*Lespedeza* spp.); kudzu (*Pueraria lobata*); sesbania (*Sesbania* spp.); sainfoin, esparcette (*Onobrychis sativa*); sulla (*Hedysarum coronarium*) lemons and limes Lemon (*Citrus limon*); sour lime (*C. aurantiifolia*); sweet lime (*C. limetta*) lentils (*Lens esculenta; Ervum lens*) linseed (*Linum usitatissimum*) lupins (*Lupinus* spp.) maize/corn (*Zea mays*) melon seeds (*Cucumis melo*) mustard seeds: white mustard (*Brassica alba*; *B. hirta*; *Sinapis alba*); black mustard (*Brassica nigra; Sinapis nigra*) okra (*Abelmoschus esculentus*); gombo (*Hibiscus esculentus*) olives (*Olea europaea*) oranges: sweet orange (*Citrus sinensis*); bitter orange (*C. aurantium*) peaches and nectarines (*Prunus persica*; *Amygdalus persica*; *Persica laevis*) pears (*Pyrus communis*) peas garden pea (*Pisum sativum*); field pea (*P. arvense*) peppermint (*Mentha* spp.: *M. piperita*) persimmons (*Diospyros kaki*: *D. virginiana*) pistachios (*Pistacia vera*) plums and sloes greengage, mirabelle, damson (*Prunus domestica*); sloe (*P. spinosa*) poppy seed (*Papaver somniferum*) pumpkins, squash, gourds and marrows (*Cucurbita* spp.) pyrethrum, (*Chrysanthemum cinerariifolium*) quinces (*Cydonia oblonga*; *C. vulgaris*; *C. japonica*) rapeseed (*Brassica napus* var. *oleifera*) raspberries (*Rubus idaeus*) safflower seed (*Carthamus tinctorius*) serradella/birds foot (*Ornithopus sativus*) sesame seed (*Sesamum indicum*) soybeans (*Glycine soja*) spices: bay leaves (*Laurus nobilis*); dill seed (*Anethum graveolens*); fenugreek seed (*Trigonella foenumgraecum*); saffron (*Crocus sativus*); thyme (*Thymus vulgaris*); turmeric (*Curcuma longa*) strawberries (*Fragaria* spp.) sunflower seed (*Helianthus annuus*) tangerine (*Citrus tangerina*); mandarin (*Citrus reticulata*) clementine (*C. unshiu*); turnips andturnip rapes (*Brassica rapa* var. *rapifera* and *oleifera* spp.) vetches Spring/common vetch (*Vicia sativa*) viper’s Grass (*Scorzonera hispanica*) walnuts (*Jugland* spp.: *J. regia*) watermelons (*Citrullus vulgaris*) ornamentals flowering in year of treatment. PART B In assessing applications to authorise plant protection products containing imidacloprid, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 and the conclusions of the addendum of the review report on imidacloprid as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the impact on aquatic organisms, non-target arthropods, earthworms, other soil macroorganisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Member States shall ensure that: — the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised, — adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission, — the conditions of the authorisation, include, where appropriate, risk mitigation measures to protect bees, — monitoring programmes are initiated to verify the real exposure of bees to imidacloprid in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. Conditions of use shall include risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the risk to pollinators other than honey bees; (b) the risk to honey bees foraging in nectar or pollen in succeeding crops; (c) the potential uptake via roots to flowering weeds; (d) the risk to honey bees foraging on insect honey dew; (e) the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure; (f) the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure; (g) the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen. The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2014. |
| 217 | Metazachlor CAS No 67129-08-2 CIPAC No 411 | 2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide | ≥ 940 g/kg The manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,05 % is established. | 1 August 2009 | 31 July 2019 | PART A Only 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 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 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 acid CAS No 64-19-7 CIPAC 838 | acetic acid | ≥ 980 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as herbicide 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 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 sulphate CAS No 7784-26-1 (dodecahydrate), 7784-25-0 (anhydrous) CIPAC No 840 | Aluminium ammonium sulphate | ≥ 960 g/kg (expressed as dodecahydrate) ≥ 502 g/kg (anhydrous) | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent 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 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 silicate CAS No 1332-58-7 CIPAC No 841 | Not available Chemical name: Aluminium silicate | ≥ 999,8 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent 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 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. |
| 215 | Aclonifen CAS No 74070-46-5 CIPAC No 498 | 2-chloro-6-nitro-3-phenoxyaniline | ≥ 970 g/kg The impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established. | 1 August 2009 | 31 July 2022 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the residues in rotational crops and evaluate the dietary exposure of consumers, — the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants. They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval. |
| 216 | Imidacloprid CAS No 138261-41-3 CIPAC No 582 | (E)-1-(6-Chloro-3-pyridinylmethyl)-N-nitroimidazolidin-2-ylideneamine | ≥ 970 g/kg | 1 August 2009 | 31 July 2022 | PART A Only professional uses as insecticide may be authorised. Uses as seed treatment or soil treatment shall not be authorised for the following cereals, when such cereals are sown from January to June: barley, millet, oats, rice, rye, sorghum, triticale, wheat. Foliar treatments shall not be authorised for the following cereals: barley, millet, oats, rice, rye, sorghum, triticale, wheat. Uses as seed treatment, soil treatment or foliar application shall not be authorised for the following crops with the exception of uses in greenhouses and with the exception of foliar treatment after flowering: Alfalfa (*Medicago sativa*) almonds (*Prunus amygdalus*; *P. communis; Amygdalus communis*) anise (*Pimpinella anisum*); badian or star anise (*Illicium verum*); caraway (*Carum carvi*); coriander (*Coriandrum sativum*); cumin (*Cuminum cyminum*); fennel (*Foeniculum vulgare*); juniper berries (*Juniperus communis*) apples (*Malus pumila*; *M. sylvestris*; *M. communis*; *Pyrus malus*) apricots (*Prunus armeniaca*) avocados (*Persea americana*) bananas (*Musa sapientum*; *M. cavendishii*; *M. nana*) beans (*Phaseolus* spp.) blackberry (*Rubus fruticosus*) blueberries, European blueberry, wild bilberry, whortleberry (*Vaccinium myrtillus*); American blueberry (*V. corymbosum*) broad beans, horse beans (*Vicia faba* var. *major*; var. *equina*; var. *Minor*) buckwheat (*Fagopyrum esculentum*) carobs, carob-tree, locust bean (*Ceratonia siliqua*) castor oil seed (*Ricinus communis*) cherries (*Prunus avium*) chestnuts (*Castanea* spp.) chick peas (*Cicer arietinum*) chillies (*Capsicum frutescens*; *C. annuum*); allspice, Jamaica pepper (*Pimenta officinalis*) clovers (*Trifolium* spp.) coffee (*Coffea* spp. *arabica, robusta, liberica*) cotton (*Gossypium* spp.) cowpeas, black eyed peas (*Vigna unguiculata*) cranberries (*Vaccinium macrocarpon*); European cranberries (*Vaccinum oxycoccus*) cucumbers (*Cucumis sativus*) currants black (*Ribes nigrum*); red and white (*R. rubrum*) dates (*Phoenix dactylifera*) elderberries (*Sambucus nigra*) gooseberries (*Ribes uva-crispa*) grapefruit *(C. paradisi*) grapes (*Vitis vinifera*) groundnuts/peanuts (*Arachis hypogea*) hazelnut (*Corylus avellana*) hemp (*Cannabis sativa*) japanese rose (*Rosa rugosa*) kiwi fruit (*Actinidia chinensis*) leguminous: birdsfoot/trefoil (*Lotus corniculatus*); lespedeza (*Lespedeza* spp.); kudzu (*Pueraria lobata*); sesbania (*Sesbania* spp.); sainfoin, esparcette (*Onobrychis sativa*); sulla (*Hedysarum coronarium*) lemons and limes Lemon (*Citrus limon*); sour lime (*C. aurantiifolia*); sweet lime (*C. limetta*) lentils (*Lens esculenta; Ervum lens*) linseed (*Linum usitatissimum*) lupins (*Lupinus* spp.) maize/corn (*Zea mays*) melon seeds (*Cucumis melo*) mustard seeds: white mustard (*Brassica alba*; *B. hirta*; *Sinapis alba*); black mustard (*Brassica nigra; Sinapis nigra*) okra (*Abelmoschus esculentus*); gombo (*Hibiscus esculentus*) olives (*Olea europaea*) oranges: sweet orange (*Citrus sinensis*); bitter orange (*C. aurantium*) peaches and nectarines (*Prunus persica*; *Amygdalus persica*; *Persica laevis*) pears (*Pyrus communis*) peas garden pea (*Pisum sativum*); field pea (*P. arvense*) peppermint (*Mentha* spp.: *M. piperita*) persimmons (*Diospyros kaki*: *D. virginiana*) pistachios (*Pistacia vera*) plums and sloes greengage, mirabelle, damson (*Prunus domestica*); sloe (*P. spinosa*) poppy seed (*Papaver somniferum*) pumpkins, squash, gourds and marrows (*Cucurbita* spp.) pyrethrum, (*Chrysanthemum cinerariifolium*) quinces (*Cydonia oblonga*; *C. vulgaris*; *C. japonica*) rapeseed (*Brassica napus* var. *oleifera*) raspberries (*Rubus idaeus*) safflower seed (*Carthamus tinctorius*) serradella/birds foot (*Ornithopus sativus*) sesame seed (*Sesamum indicum*) soybeans (*Glycine soja*) spices: bay leaves (*Laurus nobilis*); dill seed (*Anethum graveolens*); fenugreek seed (*Trigonella foenumgraecum*); saffron (*Crocus sativus*); thyme (*Thymus vulgaris*); turmeric (*Curcuma longa*) strawberries (*Fragaria* spp.) sunflower seed (*Helianthus annuus*) tangerine (*Citrus tangerina*); mandarin (*Citrus reticulata*) clementine (*C. unshiu*); turnips andturnip rapes (*Brassica rapa* var. *rapifera* and *oleifera* spp.) vetches Spring/common vetch (*Vicia sativa*) viper’s Grass (*Scorzonera hispanica*) walnuts (*Jugland* spp.: *J. regia*) watermelons (*Citrullus vulgaris*) ornamentals flowering in year of treatment. PART B In assessing applications to authorise plant protection products containing imidacloprid, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imidacloprid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 and the conclusions of the addendum of the review report on imidacloprid as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the impact on aquatic organisms, non-target arthropods, earthworms, other soil macroorganisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Member States shall ensure that: — the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised, — adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission, — the conditions of the authorisation, include, where appropriate, risk mitigation measures to protect bees, — monitoring programmes are initiated to verify the real exposure of bees to imidacloprid in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. Conditions of use shall include risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the risk to pollinators other than honey bees; (b) the risk to honey bees foraging in nectar or pollen in succeeding crops; (c) the potential uptake via roots to flowering weeds; (d) the risk to honey bees foraging on insect honey dew; (e) the potential guttation exposure and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure; (f) the potential exposure to dust drift following drill and the acute and the long-term risk to colony survival and development, and the risk to bee brood resulting from such exposure; (g) the acute and long term risk to colony survival and development and the risk to bee brood for honeybees from ingestion of contaminated nectar and pollen. The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2014. |
| 217 | Metazachlor CAS No 67129-08-2 CIPAC No 411 | 2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide | ≥ 940 g/kg The manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,05 % is established. | 1 August 2009 | 31 July 2021 | PART A Only 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 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 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 acid CAS No 64-19-7 CIPAC 838 | acetic acid | ≥ 980 g/kg | 1 September 2009 | 31 August 2022 | PART A Only uses as herbicide 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 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 sulphate CAS No 7784-26-1 (dodecahydrate), 7784-25-0 (anhydrous) CIPAC No 840 | Aluminium ammonium sulphate | ≥ 960 g/kg (expressed as dodecahydrate) ≥ 502 g/kg (anhydrous) | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent 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 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 silicate CAS No 1332-58-7 CIPAC No 841 | Not available Chemical name: Aluminium silicate | ≥ 999,8 g/kg | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent 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 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 acetate CAS No 631-61-8 CIPAC No not allocated | Ammonium acetate | ≥ 970 g/kg Relevant impurity: Heavy metals as Pb maximum 10 ppm | 1 September 2009 | 31 August 2019 | PART A Only uses as attractant 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 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 meal CAS No: 90989-74-5 CIPAC No: 909 | Not available | ≥ 990 g/Kg | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1069/2009 (<sup>17</sup>) and Regulation (EU) No 142/2011 (<sup>18</sup>). PART B In assessing applications to authorise plant protection products containing blood meal for uses other than with direct application localised on individual plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013. |
| 223 | Calcium carbide CAS No: 75-20-7 CIPAC No: 910 | Calcium acetylide | ≥ 765 g/kg Containing 0,08 – 0,9 g/kg Calcium Phosphide | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent 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 amended review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 224 | Calcium carbonate CAS No: 471-34-1 CIPAC No: 843 | Calcium carbonate | ≥ 995 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent 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 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 dioxide CAS No: 124-38-9 CIPAC No: 844 | Carbon dioxide | ≥ 99,9 % Relevant impurities: phosphane max. 0,3 ppm v/v benzene max. 0,02 ppm v/v carbon monoxide max. 10 ppm v/v methanol max. 10 ppm v/v hydrogen cyanide max. 0,5 ppm v/v | 1 September 2009 | 31 August 2019 | PART A Only uses as a fumigant 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 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 benzoate CAS No 3734-33-6 CIPAC No 845 | Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate | ≥ 975g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent may be authorised. PART B In 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 | Ethylene CAS No 74-85-1 CIPAC No 839 | Ethylene | ≥ 90 % Relevant impurity: ethylene oxide, max content 1 mg/kg | 1 September 2009 | 31 August 2019 | PART A Only indoor uses as plant growth regulator by professional users 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 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 tree CAS No Tea Tree Oil 68647-73-4 Main components: terpinen-4-ol 562-74-3 γ-terpinene 99-85-4 α-terpinene 99-86-5 1,8-cineole 470-82-6 CIPAC No 914 | Tea Tree Oil is a complex mixture of chemical substances. | Main components: terpinen-4-ol ≥ 300 g/kg γ-terpinene ≥ 100 g/kg α-terpinene ≥ 50 g/kg 1,8-cineole ≥ 1 g/kg Relevant impurity: Methyl eugenol: maximum 1 g/kg of the technical material | 1 September 2009 | 31 August 2019 | PART A Only uses as fungicide in greenhouse 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 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 residues CAS No: not allocated CIPAC No 915 | Not available | ≥ 40 % of cleaved fatty acids Relevant impurity: Ni maximum 200 mg/kg | 1 September 2009 | 31 August 2019 | PART A Only 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 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 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 C20 CAS No 112-05-0 (Pelargonic Acid) 67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts) 124-07-2 (Caprylic Acid) 334-48-5 (Capric Acid) 143-07-7 (Lauric Acid) 112-80-1 (Oleic Acid) 85566-26-3 (Fatty acids C8-C10 Me esters) 111-11-5 (Methyl octanoate) 110-42-9 (Methyl decanoate) CIPAC No not allocated | Nonanoic acid Caprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case) Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case) Fatty acids, C7-C10, Me esters | ≥ 889 g/kg (Pelargonic Acid) ≥ 838 g/kg fatty acids ≥ 99 % fatty acid methyl esters | 1 September 2009 | 31 August 2019 | PART A Only uses as insecticide, acaricide, and herbicide and plant growth regulator 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 fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 231 | Garlic extract CAS No 8008-99-9 CIPAC No not allocated | Food grade garlic juice concentrate | ≥ 99,9 % | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent, insecticide and nematicide 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 garlic extract (SANCO/2612/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 232 | Gibberellic acid CAS No 77-06-5 CIPAC No 307 | (3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acid Alt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid | ≥ 850 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as plant growth regulator 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 gibberellic acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 233 | Gibberellins CAS No GA4: 468-44-0 GA7: 510-75-8 GA4A7 mixture: 8030-53-3 CIPAC No not allocated | GA4: (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acid GA7: (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid | Review report (SANCO/2614/2008). | 1 September 2009 | 31 August 2019 | PART A Only uses as plant growth regulator 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 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 proteins CAS No not allocated CIPAC No 901 | Not available | Review report (SANCO/2615/2008) | 1 September 2009 | 31 August 2019 | PART A Only uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009 (<sup>17</sup>) and Commission Regulation (EU) No 142/2011 (<sup>18</sup>). 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 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)sulphate or iron(2+) sulfate | Iron(II)sulfate anhydrous: ≥ 350 g/kg total iron. Relevant impurities: arsenic, 18 mg/kg cadmium, 1,8 mg/kg chromium, 90 mg/kg lead, 36 mg/kg mercury, 1,8 mg/kg expressed on the basis of the anhydrous variant | 1 September 2009 | 31 August 2019 | PART A Only uses as herbicide 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 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 61790-53-2 CIPAC No 647 | Kieselgur (no IUPAC name) Diatomaceous earth Amorphous silicon dioxide Silica Diatomite | The product consists of 100 % diatomaceous earth. Maximum 0,1 % of particles of crystalline silica with diameter below 50 μm | 1 September 2009 | 31 August 2019 | PART A Only indoor uses as insecticide and acaricide by professional users 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 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). |
| 222 | Blood meal CAS No: 90989-74-5 CIPAC No: 909 | Not available | ≥ 990 g/Kg | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1069/2009 (<sup>17</sup>) and Regulation (EU) No 142/2011 (<sup>18</sup>). PART B In assessing applications to authorise plant protection products containing blood meal for uses other than with direct application localised on individual plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013. |
| 223 | Calcium carbide CAS No: 75-20-7 CIPAC No: 910 | Calcium acetylide | ≥ 765 g/kg Containing 0,08 – 0,9 g/kg Calcium Phosphide | 1 September 2009 | 31 August 2022 | PART A Only uses as repellent 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 amended review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 224 | Calcium carbonate CAS No: 471-34-1 CIPAC No: 843 | Calcium carbonate | ≥ 995 g/kg | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent 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 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 dioxide CAS No: 124-38-9 CIPAC No: 844 | Carbon dioxide | ≥ 99,9 % Relevant impurities: phosphane max. 0,3 ppm v/v benzene max. 0,02 ppm v/v carbon monoxide max. 10 ppm v/v methanol max. 10 ppm v/v hydrogen cyanide max. 0,5 ppm v/v | 1 September 2009 | 31 August 2020 | PART A Only uses as a fumigant 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 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 benzoate CAS No 3734-33-6 CIPAC No 845 | Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate | ≥ 975g/kg | 1 September 2009 | 31 August 2022 | PART A Only uses as repellent may be authorised. PART B In 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 | Ethylene CAS No 74-85-1 CIPAC No 839 | Ethylene | ≥ 90 % Relevant impurity: ethylene oxide, max content 1 mg/kg | 1 September 2009 | 31 August 2022 | PART A Only indoor uses as plant growth regulator by professional users 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 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 tree CAS No Tea Tree Oil 68647-73-4 Main components: terpinen-4-ol 562-74-3 γ-terpinene 99-85-4 α-terpinene 99-86-5 1,8-cineole 470-82-6 CIPAC No 914 | Tea Tree Oil is a complex mixture of chemical substances. | Main components: terpinen-4-ol ≥ 300 g/kg γ-terpinene ≥ 100 g/kg α-terpinene ≥ 50 g/kg 1,8-cineole ≥ 1 g/kg Relevant impurity: Methyl eugenol: maximum 1 g/kg of the technical material | 1 September 2009 | 31 August 2020 | PART A Only uses as fungicide in greenhouse 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 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 residues CAS No: not allocated CIPAC No 915 | Not available | ≥ 40 % of cleaved fatty acids Relevant impurity: Ni maximum 200 mg/kg | 1 September 2009 | 31 August 2020 | PART A Only 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 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 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 C20 CAS No 112-05-0 (Pelargonic Acid) 67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts) 124-07-2 (Caprylic Acid) 334-48-5 (Capric Acid) 143-07-7 (Lauric Acid) 112-80-1 (Oleic Acid) 85566-26-3 (Fatty acids C8-C10 Me esters) 111-11-5 (Methyl octanoate) 110-42-9 (Methyl decanoate) CIPAC No not allocated | Nonanoic acid Caprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case) Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case) Fatty acids, C7-C10, Me esters | ≥ 889 g/kg (Pelargonic Acid) ≥ 838 g/kg fatty acids ≥ 99 % fatty acid methyl esters | 1 September 2009 | 31 August 2020 | PART A Only uses as insecticide, acaricide, and herbicide and plant growth regulator 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 fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 231 | Garlic extract CAS No 8008-99-9 CIPAC No not allocated | Food grade garlic juice concentrate | ≥ 99,9 % | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent, insecticide and nematicide 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 garlic extract (SANCO/2612/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 232 | Gibberellic acid CAS No 77-06-5 CIPAC No 307 | (3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acid Alt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid | ≥ 850 g/kg | 1 September 2009 | 31 August 2020 | PART A Only uses as plant growth regulator 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 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 2020 | PART A Only uses as plant growth regulator 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 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 proteins CAS No not allocated CIPAC No 901 | Not available | Review report (SANCO/2615/2008) | 1 September 2009 | 31 August 2020 | PART A Only uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009 (<sup>17</sup>) and Commission Regulation (EU) No 142/2011 (<sup>18</sup>). 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 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)sulphate or iron(2+) sulfate | Iron(II)sulfate anhydrous: ≥ 350 g/kg total iron. Relevant impurities: arsenic, 18 mg/kg cadmium, 1,8 mg/kg chromium, 90 mg/kg lead, 36 mg/kg mercury, 1,8 mg/kg expressed on the basis of the anhydrous variant | 1 September 2009 | 31 August 2020 | PART A Only uses as herbicide 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 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 61790-53-2 CIPAC No 647 | Kieselgur (no IUPAC name) Diatomaceous earth Amorphous silicon dioxide Silica Diatomite | The product consists of 100 % diatomaceous earth. Maximum 0,1 % of particles of crystalline silica with diameter below 50 μm | 1 September 2009 | 31 August 2020 | PART A Only indoor uses as insecticide and acaricide by professional users 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 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 | Limestone CAS No: 1317-65-3 CIPAC No: 852 | Calcium carbonate | ≥ 980 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent 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 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 ketone CAS No 112-12-9 CIPAC No 846 | Undecan-2-one | ≥ 985 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent 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 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 allocated CIPAC No: not allocated | Steam distilled and solvent extracted Black pepper – *Piper nigrum* | It is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 % | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent may be authorised. PART B In 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 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. |
| | | | | | | |
| 240 | Plant oils/citronella oil CAS No 8000-29-1 CIPAC No 905 | Citronella Oil is a complex mixture of chemical substances. The main components are: Citronellal (3,7-dimethyl-6-octenal). Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol). Citronellol (3,7-dimethyl-6-octan-2-ol). Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate). | The sum of the following impurities must not exceed 0,1 % of technical material: methyl eugenol and methyl-isoeugenol. | 1 September 2009 | 31 August 2019 | PART A Only uses as herbicide 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 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 oil CAS No 84961-50-2 (clove oil) 97-53-0 (Eugenol — main component) CIPAC No 906 | Clove Oil is a complex mixture of chemical substances. The main component is eugenol. | ≥ 800 g/kg Relevant impurity: methyl eugenol maximum 0,1 % of the technical material | 1 September 2009 | 31 August 2019 | PART A Only indoor uses as post-harvest fungicide and bactericide 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 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 oil CAS No: 8002-13-9 CIPAC No: not allocated | Rape seed oil | Rape seed oil is a complex mixture of fatty acids Relevant impurity: Maximum 2 % of erucic acid | 1 September 2009 | 31 August 2019 | PART A Only uses as insecticide and acaricide 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 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 oil CAS No 8008-79-5 CIPAC No 908 | Spearmint oil | ≥ 550 g/kg as (R)-Carvone | 1 September 2009 | 31 August 2019 | PART A Only 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 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 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 carbonate CAS No 298-14-6 CIPAC No 853 | Potassium hydrogen carbonate | ≥ 99,5 % Impurities: Pb max. 10 mg/kg As max. 3 mg/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as fungicide and insecticide 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 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. |
| 239 | Pepper dust extraction residue (PDER) CAS No: not allocated CIPAC No: not allocated | Steam distilled and solvent extracted Black pepper – *Piper nigrum* | It is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 % | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent may be authorised. PART B In 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 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. |
| | | | | | | |
| 240 | Plant oils/citronella oil CAS No 8000-29-1 CIPAC No 905 | Citronella Oil is a complex mixture of chemical substances. The main components are: Citronellal (3,7-dimethyl-6-octenal). Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol). Citronellol (3,7-dimethyl-6-octan-2-ol). Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate). | The sum of the following impurities must not exceed 0,1 % of technical material: methyl eugenol and methyl-isoeugenol. | 1 September 2009 | 31 August 2022 | PART A Only uses as herbicide 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 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 oil CAS No 84961-50-2 (clove oil) 97-53-0 (Eugenol — main component) CIPAC No 906 | Clove Oil is a complex mixture of chemical substances. The main component is eugenol. | ≥ 800 g/kg Relevant impurity: methyl eugenol maximum 0,1 % of the technical material | 1 September 2009 | 31 August 2022 | PART A Only indoor uses as post-harvest fungicide and bactericide 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 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 oil CAS No: 8002-13-9 CIPAC No: not allocated | Rape seed oil | Rape seed oil is a complex mixture of fatty acids Relevant impurity: Maximum 2 % of erucic acid | 1 September 2009 | 31 August 2020 | PART A Only uses as insecticide and acaricide 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 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 oil CAS No 8008-79-5 CIPAC No 908 | Spearmint oil | ≥ 550 g/kg as (R)-Carvone | 1 September 2009 | 31 August 2022 | PART A Only 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 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 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 carbonate CAS No 298-14-6 CIPAC No 853 | Potassium hydrogen carbonate | ≥ 99,5 % Impurities: Pb max. 10 mg/kg As max. 3 mg/kg | 1 September 2009 | 31 August 2020 | PART A Only uses as fungicide and insecticide 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 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 110-60-1 CIPAC No 854 | Butane-1,4-diamine | ≥ 990 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as attractant 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 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: 8003-34-7 CIPAC No 32 Extract A: extractives of Chrysanthemum cinerariaefolium: 89997- 63-7 Pyrethrin 1: CAS 121- 21-1 Pyrethrin 2: CAS 121- 29-9 Cinerin 1: CAS 25402- 06-6 Cinerin 2: CAS 121- 20-0 Jasmolin 1: CAS 4466- 14-2 Jasmolin 2: CAS 1172- 63-0 Extract B: Pyrethrin 1: CAS 121-21-1 Pyrethrin 2: CAS 121- 29-9 Cinerin 1: CAS 25402- 06-6 Cinerin 2: CAS 121- 20-0 Jasmolin 1: CAS 4466- 14-2 Jasmolin 2: CAS 1172- 63-0 | Pyrethrins are a complex mixture of chemical substances. | Extract A: ≥ 500 g/kg Pyrethrins Extract B: ≥ 480 g/kg Pyrethrins | 1 September 2009 | 31 August 2019 | PART A Only uses as insecticide 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 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 sand CAS No: 14808-60-7, 7637-86-9 CIPAC No: 855 | Quartz, Silicon dioxide | ≥ 915 g/kg Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.) | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent may be authorised. PART B In 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 oil CAS No 100085-40-3 CIPAC No 918 | Fish oil | ≥ 99 % Relevant impurity: Dioxine max. 6 pg/kg for animal feed Hg max. 0,5 mg/kg feed derived from fish and other sea food processing Cd max. 2 mg/kg feed of animal origin except in feed for domestic pets Pb max. 10 mg/kg PCBs max. 5 mg/kg | 1 September 2009 | 31 August 2019 | PART A Only 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 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 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 fat CAS No 98999-15-6 CIPAC No not allocated | Sheep Fat | Pure sheep fat containing a maximum of 0,18 % w/w/water. | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1069/2009 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 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 8002-26-4 CIPAC No 911 | Not available | The qualitative parameters below comprise the specification of repellents by smell of animal or plant origin/tall oil crude: acid number: min. 125 mgKOH/g water content: max. 2 % rosin acid content: min. 35 % (proposed) ash content: max. 0,2 % pH: approx. min. 5,5 unsaponifiables: max. 12 % free mineral acids: max. 0,02 % | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent applied by glove or brush 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 amended review report on repellents by smell of animal or plant origin/tall oil crude (SANCO/2631/2008) and in particular Appendices I and II thereof,as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In assessing applications to authorise plant protection products containing Repellents by smell of animal or plant origin/tall oil crude for uses other than as a repellent in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorisation is granted. In this overall assessment Member States shall pay particular attention to: — the protection of operator, worker and bystander; — the risk to non target species. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall request the submission of confirmatory information as regards: (a) the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers; (b) the toxicological profile of repellents by smell of animal or plant origin/tall oil crude. The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014. |
| 251 | *Repellents by smell of animal or plant origin/tall oil pitch*: CAS No 8016-81-7 CIPAC No 912 | Not available | Complex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids. | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent 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 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. |
| 246 | Pyrethrins: 8003-34-7 CIPAC No 32 Extract A: extractives of Chrysanthemum cinerariaefolium: 89997- 63-7 Pyrethrin 1: CAS 121- 21-1 Pyrethrin 2: CAS 121- 29-9 Cinerin 1: CAS 25402- 06-6 Cinerin 2: CAS 121- 20-0 Jasmolin 1: CAS 4466- 14-2 Jasmolin 2: CAS 1172- 63-0 Extract B: Pyrethrin 1: CAS 121-21-1 Pyrethrin 2: CAS 121- 29-9 Cinerin 1: CAS 25402- 06-6 Cinerin 2: CAS 121- 20-0 Jasmolin 1: CAS 4466- 14-2 Jasmolin 2: CAS 1172- 63-0 | Pyrethrins are a complex mixture of chemical substances. | Extract A: ≥ 500 g/kg Pyrethrins Extract B: ≥ 480 g/kg Pyrethrins | 1 September 2009 | 31 August 2022 | PART A Only uses as insecticide 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 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 sand CAS No: 14808-60-7, 7637-86-9 CIPAC No: 855 | Quartz, Silicon dioxide | ≥ 915 g/kg Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.) | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent may be authorised. PART B In 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 oil CAS No 100085-40-3 CIPAC No 918 | Fish oil | ≥ 99 % Relevant impurity: Dioxine max. 6 pg/kg for animal feed Hg max. 0,5 mg/kg feed derived from fish and other sea food processing Cd max. 2 mg/kg feed of animal origin except in feed for domestic pets Pb max. 10 mg/kg PCBs max. 5 mg/kg | 1 September 2009 | 31 August 2020 | PART A Only 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 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 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 fat CAS No 98999-15-6 CIPAC No not allocated | Sheep Fat | Pure sheep fat containing a maximum of 0,18 % w/w/water. | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1069/2009 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 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 8002-26-4 CIPAC No 911 | Not available | The qualitative parameters below comprise the specification of repellents by smell of animal or plant origin/tall oil crude: acid number: min. 125 mgKOH/g water content: max. 2 % rosin acid content: min. 35 % (proposed) ash content: max. 0,2 % pH: approx. min. 5,5 unsaponifiables: max. 12 % free mineral acids: max. 0,02 % | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent applied by glove or brush 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 amended review report on repellents by smell of animal or plant origin/tall oil crude (SANCO/2631/2008) and in particular Appendices I and II thereof,as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In assessing applications to authorise plant protection products containing Repellents by smell of animal or plant origin/tall oil crude for uses other than as a repellent in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorisation is granted. In this overall assessment Member States shall pay particular attention to: — the protection of operator, worker and bystander; — the risk to non target species. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall request the submission of confirmatory information as regards: (a) the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers; (b) the toxicological profile of repellents by smell of animal or plant origin/tall oil crude. The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014. |
| 251 | *Repellents by smell of animal or plant origin/tall oil pitch*: CAS No 8016-81-7 CIPAC No 912 | Not available | Complex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids. | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent 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 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 allocated CIPAC No not allocated | See algae extract | See algae extract is a complex mixture. Main components as markers: mannitol, fucoidans and alginates. Review report SANCO/2634/2008 | 1 September 2009 | 31 August 2019 | PART A Only uses as plant growth regulator 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 sea algae extract (SANCO/2634/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 253 | Sodium aluminium silicate CAS No 1344-00-9 CIPAC No not allocated | Sodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O | 1 000 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as repellent 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 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. |
| 253 | Sodium aluminium silicate CAS No 1344-00-9 CIPAC No not allocated | Sodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O | 1 000 g/kg | 1 September 2009 | 31 August 2020 | PART A Only uses as repellent 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 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 hypochlorite CAS No: 7681-52-9 CIPAC: 848 | Sodium hypochlorite | Sodium hypochlorite: 105 g/kg-126 g/kg (122 g/L-151 g/L) technical concentrate 10-12 % (w/w) expressed as chlorine | 1 September 2009 | 31 August 2019 | PART A Only indoor uses as disinfectant 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 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 2019 | PART A Only uses as attractants 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 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. |
| 255 | Straight Chain Lepidopteran Pheromones | Review report (SANCO/2633/2008) | Review report (SANCO/2633/2008) | 1 September 2009 | 31 August 2020 | PART A Only uses as attractants 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 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 hydrochloride CAS No 593-81-7 CIPAC No not allocated | Trimethylamine hydrochloride | ≥ 988 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as attractant 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 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 | Urea CAS No 57-13-6 CIPAC No 913 | Urea | ≥ 98 % w/w | 1 September 2009 | 31 August 2019 | PART A Only uses as attractant and 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 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. |
| ————— | | | | | | |
| ————— | | | | | | |
| | | | | | | |
| 260 | Aluminium phosphide CAS No 20859-73-8 CIPAC No 227 | Aluminium phosphide | ≥ 830 g/kg | 1 September 2009 | 31 August 2019 | PART A Only 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 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 aluminium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of consumers and ensure that the spent ready-to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied; — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; — the protection of operators and workers during fumigation for indoor uses; — the protection of workers at re-entry (after fumigation period) for indoor uses; — the protection of bystanders against leaking of gas for indoor uses; — the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. |
| 261 | Calcium phosphide CAS No 1305-99-3 CIPAC No 505 | Calcium phosphide | ≥ 160 g/kg | 1 September 2009 | 31 August 2019 | PART A Only 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 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 calcium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; — the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. |
| 262 | Magnesium phosphide CAS No 12057-74-8 CIPAC No 228 | Magnesium phosphide | ≥ 880 g/kg | 1 September 2009 | 31 August 2019 | PART A Only 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 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 magnesium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of consumers and ensure that the spent ready-to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied; — the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; — the protection of operators and workers during fumigation for indoor uses; — the protection of workers at re-entry (after fumigation period) for indoor uses; — the protection of bystanders against leaking of gas for indoor uses; — the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. |
| 263 | Cymoxanil CAS No 57966-95-7 CIPAC No 419 | 1-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea | ≥ 970 g/kg | 1 September 2009 | 31 August 2019 | PART 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 cymoxanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. |
| 264 | Dodemorph CAS No 1593-77-7 CIPAC No 300 | cis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine | ≥ 950 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as fungicide on ornamentals in glasshouse 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 dodemorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions; — conditions of authorisation should include risk mitigation measures, where appropriate. |
| 265 | 2,5-Dichlorobenzoic acid methylester CAS No 2905-69-3 CIPAC No 686 | methyl-2,5-dichlorobenzoate | ≥ 995 g/kg | 1 September 2009 | 31 August 2019 | PART A Only indoor uses as plant growth regulator and fungicide for grafting of grapevines 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 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. |
| 266 | Metamitron CAS No 41394-05-2 CIPAC No 381 | 4-amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one | ≥ 960 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate; — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to birds and mammals, and non-target terrestrial plants. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. |
| 267 | Sulcotrione CAS No 99105-77-8 CIPAC No 723 | 2-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione | ≥ 950 g/kg Impurities: — hydrogen cyanide: not more than 80 mg/kg — toluene: not more than 4 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as herbicide 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 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. |
| 257 | Urea CAS No 57-13-6 CIPAC No 913 | Urea | ≥ 98 % w/w | 1 September 2009 | 31 August 2020 | PART A Only uses as attractant and 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 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. |
| ————— | | | | | | |
| ————— | | | | | | |
| | | | | | | |
| 260 | Aluminium phosphide CAS No 20859-73-8 CIPAC No 227 | Aluminium phosphide | ≥ 830 g/kg | 1 September 2009 | 31 August 2022 | PART A Only 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 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 aluminium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of consumers and ensure that the spent ready-to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied; — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; — the protection of operators and workers during fumigation for indoor uses; — the protection of workers at re-entry (after fumigation period) for indoor uses; — the protection of bystanders against leaking of gas for indoor uses; — the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. |
| 261 | Calcium phosphide CAS No 1305-99-3 CIPAC No 505 | Calcium phosphide | ≥ 160 g/kg | 1 September 2009 | 31 August 2022 | PART A Only 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 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 calcium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; — the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. |
| 262 | Magnesium phosphide CAS No 12057-74-8 CIPAC No 228 | Magnesium phosphide | ≥ 880 g/kg | 1 September 2009 | 31 August 2022 | PART A Only 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 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 magnesium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of consumers and ensure that the spent ready-to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied; — the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment; — the protection of operators and workers during fumigation for indoor uses; — the protection of workers at re-entry (after fumigation period) for indoor uses; — the protection of bystanders against leaking of gas for indoor uses; — the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate; — the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate. |
| 263 | Cymoxanil CAS No 57966-95-7 CIPAC No 419 | 1-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea | ≥ 970 g/kg | 1 September 2009 | 31 August 2021 | 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 cymoxanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. |
| 264 | Dodemorph CAS No 1593-77-7 CIPAC No 300 | cis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine | ≥ 950 g/kg | 1 September 2009 | 31 August 2022 | PART A Only uses as fungicide on ornamentals in glasshouse 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 dodemorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions; — conditions of authorisation should include risk mitigation measures, where appropriate. |
| 265 | 2,5-Dichlorobenzoic acid methylester CAS No 2905-69-3 CIPAC No 686 | methyl-2,5-dichlorobenzoate | ≥ 995 g/kg | 1 September 2009 | 31 August 2022 | PART A Only indoor uses as plant growth regulator and fungicide for grafting of grapevines 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 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. |
| 266 | Metamitron CAS No 41394-05-2 CIPAC No 381 | 4-amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one | ≥ 960 g/kg | 1 September 2009 | 31 August 2022 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate; — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to birds and mammals, and non-target terrestrial plants. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. |
| 267 | Sulcotrione CAS No 99105-77-8 CIPAC No 723 | 2-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione | ≥ 950 g/kg Impurities: — hydrogen cyanide: not more than 80 mg/kg — toluene: not more than 4 g/kg | 1 September 2009 | 31 August 2022 | PART A Only uses as herbicide 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 sulcotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — the risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the degradation in soil and water of the cyclohexadione moiety and the long-term risk to insectivorous birds. They shall ensure that the notifier at whose request sulcotrione has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. |
| 268 | Tebuconazole CAS No 107534-96-3 CIPAC No 494 | (RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-pentan-3-ol | ≥ 905 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as fungicide and plant growth regulator 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 tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers to the tebuconazole (triazole) metabolites; — the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole; — the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. |
| 269 | Triadimenol CAS No 55219-65-3 CIPAC No 398 | (1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol | ≥ 920 g/kg isomer A (1RS,2SR), isomer B (1RS,2RS) Diastereomer A, RS + SR, range: 70 to 85 % Diastereomer B, RR + SS, range: 15 to 30 % | 1 September 2009 | 31 August 2019 | PART 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 triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure; — the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission: — further information on the specification; — information to further address the risk assessment for birds and mammals. — information to further address the risk of endocrine disrupting effects on fish. They shall ensure that the notifier at whose request triadimenol has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. |
| 270 | Methomyl CAS No 16752-77-50 CIPAC No 264 | S-methyl (EZ)-N-(methylcarbamoyloxy)thioacetimidate | ≥ 980 g/kg | 1 September 2009 | 31 August 2019 | PART A Only 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 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 methomyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 June 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the operator safety: conditions of use shall prescribe the use of adequate personal protective equipment. Special attention shall be paid to the exposure of operators using knapsacks or other hand-held application equipment, — the protection of birds, — the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles, — the protection of non-target arthropods, in particular bees: risk mitigation measures to avoid all contact with bees shall be applied. Member States shall ensure that methomyl-based formulations contain effective repelling and/or emetic agents. Where appropriate, conditions of authorisation shall include further risk mitigation measures. |
| 271 | Bensulfuron CAS No 83055-99-6 CIPAC No 502.201 | α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluic acid (bensulfuron) methyl α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluate (bensulfuron-methyl) | ≥ 975 g/kg | 1 November 2009 | 31 October 2019 | PART A Only uses as a herbicide 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 bensulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to the following: — the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions. The Member States concerned shall ensure that the notifier submits to the Commission: — further studies on the specification, — information to further address the route and rate of degradation of bensulfuron-methyl under aerobic flooded soil conditions, — information to address the relevance of metabolites for the consumer risk assessment. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. |
| 272 | Sodium 5-nitroguaiacolate CAS No 67233-85-6 CIPAC number not allocated | Sodium 2-methoxy-5-nitrophenolate | ≥ 980 g/kg | 1 November 2009 | 31 October 2019 | PART A Only use as plant growth regulator 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodiump-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. |
| 273 | Sodium o-nitrophenolate CAS No 824-39-5 CIPAC number not allocated | Sodium 2-nitrophenolate; sodium o-nitrophenolate | ≥ 980 g/kg The following impurities are of toxicological concern: Phenol Max content: 0,1 g/kg 2,4 dinitrophenol max content: 0,14 g/kg 2,6 dinitrophenol max content: 0,32 g/kg | 1 November 2009 | 31 October 2019 | PART A Only use as plant growth regulator 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. |
| 274 | Sodium p-nitrophenolate CAS No 824-78-2 CIPAC number not allocated | Sodium 4-nitrophenolate; sodium p-nitrophenolate | ≥ 998 g/kg The following impurities are of toxicological concern: Phenol max content: 0,1 g/kg 2,4 dinitrophenol max content: 0,07 g/kg 2,6 dinitrophenol max content: 0,09 g/kg | 1 November 2009 | 31 October 2019 | PART A Only use as plant growth regulator 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. |
| 275 | Tebufenpyrad CAS No 119168-77-3 CIPAC No 725 | N-(4-tert-butylbenzyl)-4-chloro-3-ethyl-1-methylpyrazole-5-carboxamide | ≥ 980 g/kg | 1 November 2009 | 31 October 2019 | PART A Only uses as acaricide and insecticide may be authorised. PART B In assessing applications to authorise plant protection products containing tebufenpyrad in formulations other than water soluble bags Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tebufenpyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, — the protection of insectivorous birds and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. The Member States concerned shall ensure that the notifier submits to the Commission: — further information confirming that no relevant impurities are present, — information to further address the risk to insectivorous birds. They shall ensure that the notifier provides such information to the Commission by 31 October 2011. |
| 276 | Chlormequat CAS No 7003-89-6 (chlormequat) CAS No 999-81-5 (chlormequat chloride) CIPAC No 143 (chlormequat) CIPAC No 143.302 (chlormequat chloride) | 2-chloroethyltrimethylammonium (chlormequat) 2-chloroethyltrimethylammonium chloride (chlormequat chloride) | ≥ 636 g/kg Impurities 1,2-dichloroethane: max 0,1 g/kg (on the dry chlormequat chloride content) Chloroethene (vinylchloride): max 0,0005 g/kg (on the dry chlormequat chloride content) | 1 December 2009 | 30 November 2019 | PART A Only uses as plant growth regulator on cereals and non edible crops may be authorised. PART B In 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. |
| 271 | Bensulfuron CAS No 83055-99-6 CIPAC No 502.201 | α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluic acid (bensulfuron) methyl α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluate (bensulfuron-methyl) | ≥ 975 g/kg | 1 November 2009 | 31 October 2022 | PART A Only uses as a herbicide 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 bensulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to the following: — the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions. The Member States concerned shall ensure that the notifier submits to the Commission: — further studies on the specification, — information to further address the route and rate of degradation of bensulfuron-methyl under aerobic flooded soil conditions, — information to address the relevance of metabolites for the consumer risk assessment. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. |
| 272 | Sodium 5-nitroguaiacolate CAS No 67233-85-6 CIPAC number not allocated | Sodium 2-methoxy-5-nitrophenolate | ≥ 980 g/kg | 1 November 2009 | 31 October 2022 | PART A Only use as plant growth regulator 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodiump-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. |
| 273 | Sodium o-nitrophenolate CAS No 824-39-5 CIPAC number not allocated | Sodium 2-nitrophenolate; sodium o-nitrophenolate | ≥ 980 g/kg The following impurities are of toxicological concern: Phenol Max content: 0,1 g/kg 2,4 dinitrophenol max content: 0,14 g/kg 2,6 dinitrophenol max content: 0,32 g/kg | 1 November 2009 | 31 October 2022 | PART A Only use as plant growth regulator 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. |
| 274 | Sodium p-nitrophenolate CAS No 824-78-2 CIPAC number not allocated | Sodium 4-nitrophenolate; sodium p-nitrophenolate | ≥ 998 g/kg The following impurities are of toxicological concern: Phenol max content: 0,1 g/kg 2,4 dinitrophenol max content: 0,07 g/kg 2,6 dinitrophenol max content: 0,09 g/kg | 1 November 2009 | 31 October 2022 | PART A Only use as plant growth regulator 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. |
| 275 | Tebufenpyrad CAS No 119168-77-3 CIPAC No 725 | N-(4-tert-butylbenzyl)-4-chloro-3-ethyl-1-methylpyrazole-5-carboxamide | ≥ 980 g/kg | 1 November 2009 | 31 October 2022 | PART A Only uses as acaricide and insecticide may be authorised. PART B In assessing applications to authorise plant protection products containing tebufenpyrad in formulations other than water soluble bags Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tebufenpyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, — the protection of insectivorous birds and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. The Member States concerned shall ensure that the notifier submits to the Commission: — further information confirming that no relevant impurities are present, — information to further address the risk to insectivorous birds. They shall ensure that the notifier provides such information to the Commission by 31 October 2011. |
| 276 | Chlormequat CAS No 7003-89-6 (chlormequat) CAS No 999-81-5 (chlormequat chloride) CIPAC No 143 (chlormequat) CIPAC No 143.302 (chlormequat chloride) | 2-chloroethyltrimethylammonium (chlormequat) 2-chloroethyltrimethylammonium chloride (chlormequat chloride) | ≥ 636 g/kg Impurities 1,2-dichloroethane: max 0,1 g/kg (on the dry chlormequat chloride content) Chloroethene (vinylchloride): max 0,0005 g/kg (on the dry chlormequat chloride content) | 1 December 2009 | 30 November 2021 | PART A Only uses as plant growth regulator on cereals and non edible crops may be authorised. PART B In 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 2018 | PART A Only uses as bactericide and fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing copper for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on copper compounds, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate, — the protection of water and non-target organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate, — the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects and do not cause any unacceptable effect on the environment taking into account background levels of copper at the application site. The notifiers shall present to the Commission, the Authority and the Member States a monitoring programme for vulnerable areas where the contamination of the soil and water (including sediments) by copper is a concern or may become one. That monitoring programme shall be submitted by 31 July 2015. The interim results of such monitoring programme shall be submitted as interim report to the Rapporteur Member State, the Commission and the Authority by 31 December 2016. Final results shall be submitted by 31 December 2017. |
| Copper hydroxide CAS No 20427-59-2 CIPAC No 44.305 | Copper (II) hydroxide | ≥ 573 g/kg | | | | |
@@ -372,31 +373,33 @@
| Bordeaux mixture CAS No 8011-63-0 CIPAC No 44.604 | Not allocated | ≥ 245 g/kg | | | | |
| Tribasic copper sulphate CAS No 12527-76-3 CIPAC No 44.306 | Not allocated | ≥ 490 g/kg The following impurities are of toxicological concern and must not exceed the levels below (expressed in g/g): Lead max 0,0005 g/g of copper content; Cadmium max 0,0001 g/g of copper content; Arsenic max 0,0001 g/g of copper content. | | | | |
| | | | | | | |
| 278 | Propaquizafop CAS No 111479-05-1 CIPAC No 173 | 2-isopropylidenamino-oxyethyl (R)-2-[4-(6-chloro-quinoxalin-2-yloxy)phenoxy]propionate | ≥ 920 g/kg Toluene maximum content 5 g/kg | 1 December 2009 | 30 November 2019 | PART A Only uses as herbicide 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 propaquizafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, — the protection of non-target arthropods and ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. The Member States concerned shall ensure that the notifier submits to the Commission: — further information on the relevant impurity Ro 41-5259, — information to further address the risk to aquatic organisms and to non-target arthropods. They shall ensure that the notifier provides such information to the Commission by 30 November 2011. |
| 279 | Quizalofop-P: | | | 1 December 2009 | 30 November 2019 | PART A Only uses as herbicide 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 quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information on the risk to non-target arthropods. They shall ensure that the notifier provides such information to the Commission by 30 November 2011. |
| Quizalofop-P-ethyl CAS No 100646-51-3 CIPAC No 641.202 | ethyl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate | ≥ 950 g/kg | | | | |
| Quizalofop-P-tefuryl CAS No 119738-06-6 CIPAC No 641.226 | (RS)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate | ≥ 795 g/kg | | | | |
| 278 | Propaquizafop CAS No 111479-05-1 CIPAC No 173 | 2-isopropylidenamino-oxyethyl (R)-2-[4-(6-chloro-quinoxalin-2-yloxy)phenoxy]propionate | ≥ 920 g/kg Toluene maximum content 5 g/kg | 1 December 2009 | 30 November 2021 | PART A Only uses as herbicide 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 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-tefuryl CAS No 119738-06-6 CIPAC No 641.226 | (RS)-Tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate | ≥ 795 g/kg | 1 December 2009 | 30 November 2019 | PART A Only uses as herbicide 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 quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information on the risk to non-target arthropods. They shall ensure that the notifier provides such information to the Commission by 30 November 2011. | |
| Quizalofop-P-ethyl CAS No 100646-51-3 CIPAC No 641.202 | ethyl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenoxy]propionate | ≥ 950 g/kg | 1 December 2009 | 30 November 2021 | | |
| | | | | | | |
| 280 | Teflubenzuron CAS No 83121-18-0 CIPAC No 450 | 1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea | ≥ 970 g/kg | 1 December 2009 | 30 November 2019 | PART A Only uses as insecticide in glasshouses (on artificial substrate or closed hydroponic systems) may be authorised. PART B In assessing applications to authorise plant protection products containing teflubenzuron for uses other than on tomatoes in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on teflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and workers safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate, — the protection of aquatic organisms. Releases from glasshouse application must be minimised and, in any case, should not have the potential to reach in significant levels water bodies in the vicinity, — the protection of bees which should be prevented from accessing the glasshouse, — the protection of pollinator colonies purposely placed in the glasshouse, — the safe disposal of condensation water, drain water and substrate in order to preclude risks to non-target organisms and contamination of surface water and groundwater. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| 281 | Zeta-cypermethrin CAS No 52315-07-8 CIPAC No 733 | Mixture of the stereoisomers (S)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2 dimethylcyclopropanecarboxylate where the ratio of the (S);(1RS,3RS) isomeric pair to the (S);(1RS,3SR) isomeric pair lies in the ratio range 45-55 to 55-45 respectively | ≥ 850 g/kg Impurities: toluene: max 2 g/kg tars: max 12,5 g/kg | 1 December 2009 | 30 November 2019 | PART A Only uses as insecticide may be authorised. PART B In 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. |
| 281 | Zeta-cypermethrin CAS No 52315-07-8 CIPAC No 733 | Mixture of the stereoisomers (S)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2 dimethylcyclopropanecarboxylate where the ratio of the (S);(1RS,3RS) isomeric pair to the (S);(1RS,3SR) isomeric pair lies in the ratio range 45-55 to 55-45 respectively | ≥ 850 g/kg Impurities: toluene: max 2 g/kg tars: max 12,5 g/kg | 1 December 2009 | 30 November 2021 | PART A Only uses as insecticide may be authorised. PART B In assessing applications to authorise plant protection products containing zeta-cypermethrin for uses other than in cereals, notably as regards the exposure of consumers to mPBAldehyde, a degradation product that may be formed during processing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on zeta-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate, — the protection of birds, aquatic organisms, bees, non-target arthropods and non-target soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the fate and behaviour (aerobic degradation in soil), the long-term risk to birds, aquatic organisms and non-target arthropods. They shall ensure that the notifier at whose request zeta-cypermethrin has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest. |
| 282 | Chlorsulfuron CAS No 64902-72-3 CIPAC No 391 | 1-(2-chlorophenylsulfonyl)-3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea | ≥ 950 g/kg Impurities: 2-Chlorobenzenesulfonamide (IN-A4097) not more than 5 g/kg and 4-methoxy-6-methyl-1,3,5-triazin-2-amine (IN-A4098) not more than 6 g/kg | 1 January 2010 | 31 December 2019 | PART A Only uses as herbicide 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 chlorsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. The Member States concerned shall: — ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010. If chlorsulfuron is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN-A4097, IN-A4098, IN-JJ998, IN-B5528 and IN-V7160 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance. |
| 283 | Cyromazine CAS No 66215-27-8 CIPAC No 420 | N-cyclopropyl-1,3,5-triazine-2,4,6-triamine | ≥ 950 g/kg | 1 January 2010 | 31 December 2019 | PART A Only uses as insecticide in greenhouses may be authorised. PART B In assessing applications to authorise plant protection products containing cyromazine for uses other than in tomatoes, notably as regards the exposure of consumers, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyromazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic organisms, — the protection of pollinators. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite NOA 435343 and on the risk to aquatic organisms. They shall ensure that the notifier at whose request cyromazine has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest. |
| 284 | Dimethachlor CAS No 50563-36-5 CIPAC No 688 | 2-chloro-N-(2-methoxyethyl)acet-2′,6′-xylidide | ≥ 950 g/kg Impurity 2,6-dimethylaniline: Not more than 0,5 g/kg | 1 January 2010 | 31 December 2019 | PART A Only uses as herbicide in application max. of 1,0 kg/ha only every third year on the same field 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 dimethachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 in vulnerable zones, where appropriate. The Member States concerned shall: — ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010. If dimethachlor is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance. |
| 285 | Etofenprox CAS No 80844-07-1 CIPAC No 471 | 2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl ether | ≥ 980 g/kg | 1 January 2010 | 31 December 2019 | PART A Only uses as insecticide 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 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. |
| 284 | Dimethachlor CAS No 50563-36-5 CIPAC No 688 | 2-chloro-N-(2-methoxyethyl)acet-2′,6′-xylidide | ≥ 950 g/kg Impurity 2,6-dimethylaniline: Not more than 0,5 g/kg | 1 January 2010 | 31 December 2021 | PART A Only uses as herbicide in application max. of 1,0 kg/ha only every third year on the same field 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 dimethachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 in vulnerable zones, where appropriate. The Member States concerned shall: — ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010. If dimethachlor is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance. |
| 285 | Etofenprox CAS No 80844-07-1 CIPAC No 471 | 2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl ether | ≥ 980 g/kg | 1 January 2010 | 31 December 2021 | PART A Only uses as insecticide 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 etofenprox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of bees and non-target arthropods; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate. The Member States concerned shall: — ensure that the notifier submits to the Commission further information on the risk to aquatic organisms including the risk to sediment dwellers and biomagnification, — the submission of further studies on the endocrine disruption potential in aquatic organisms (fish full life cycle study). They shall ensure that the notifiers provide such studies to the Commission by 31 December 2011. |
| 286 | Lufenuron CAS No 103055-07-8 CIPAC No 704 | (RS)-1-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoro-propoxy)-phenyl]-3-(2,6-difluorobenzoyl)-urea | ≥ 970 g/kg | 1 January 2010 | 31 December 2019 | PART A Only indoor uses or use in outdoor bait stations as insecticide 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 lufenuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the high persistency in the environment and the high risk for bioaccumulation and shall ensure that the use of lufenuron has no adverse long-term effects on non-target organisms, — the protection of birds, mammals, soil non-target organisms, bees, non-target arthropods, surface waters and aquatic organisms in vulnerable situations. The Member States concerned shall: — ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010. |
| 287 | Penconazole CAS No 66246-88-6 CIPAC No 446 | (RS) 1-[2-(2,4-dichloro-phenyl)-pentyl]-1H-[1,2,4] triazole | ≥ 950 g/kg | 1 January 2010 | 31 December 2019 | PART A Only uses as fungicides 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 penconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite CGA179944 in acidic soils. They shall ensure that the notifier at whose request penconazole has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest. |
| 288 | Tri-allate CAS No 2303-17-5 CIPAC No 97 | S-2,3,3-trichloroallyl di-isopropyl (thiocarbamate) | ≥ 940 g/kg NDIPA (Nitroso-diisopropylamine) max. 0,02 mg/kg | 1 January 2010 | 31 December 2019 | PART A Only uses as herbicide 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 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. |
| 287 | Penconazole CAS No 66246-88-6 CIPAC No 446 | (RS) 1-[2-(2,4-dichloro-phenyl)-pentyl]-1H-[1,2,4] triazole | ≥ 950 g/kg | 1 January 2010 | 31 December 2021 | PART A Only uses as fungicides 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 penconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite CGA179944 in acidic soils. They shall ensure that the notifier at whose request penconazole has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest. |
| 288 | Tri-allate CAS No 2303-17-5 CIPAC No 97 | S-2,3,3-trichloroallyl di-isopropyl (thiocarbamate) | ≥ 940 g/kg NDIPA (Nitroso-diisopropylamine) max. 0,02 mg/kg | 1 January 2010 | 31 December 2021 | PART A Only uses as herbicide 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 tri-allate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the dietary exposure of consumers to residues of tri-allate in treated crops as well as in succeeding rotational crops and in products of animal origin — the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, — the potential for ground water contamination by the degradation products TCPSA when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission: — further information to assess the primary plant metabolism, — further information on the fate and behaviour of the soil metabolite diisopropylamine, — further information on the potential for biomagnification in aquatic food chains, — information to further address the risk to fish-eating mammals and the long-term risk to earthworms. They shall ensure that the notifier provides such information to the Commission by 31 December 2011. |
| 289 | Triflusulfuron CAS No 126535-15-7 CIPAC No 731 | 2-[4-dimethylamino-6-(2,2,2-trifluoroethoxy)-1,3,5-triazin-2-ylcarbamoylsulfamoyl]-m-toluic acid | ≥ 960 g/kg | 1 January 2010 | 31 December 2019 | PART A Only uses as a herbicide 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 triflusulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the dietary exposure of consumers to residues of metabolites IN-M7222 and IN-E7710 in succeeding rotational crops and in products of animal origin, — the protection of aquatic organisms and aquatic plants from the risk arising from triflusulfuron and the metabolite IN-66036 and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate, — the potential for ground water contamination by the degradation products IN-M7222 and IN-W6725 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate. If triflusulfuron is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites IN-M7222, IN-D8526 and IN-E7710 with respect to cancer. They shall ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance. |
| 290 | Difenacoum CAS No 56073-07-5 CIPAC No 514 | 3-[(1RS,3RS;1RS,3SR)-3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl]-4-hydroxycoumarin | ≥ 905 g/kg | 1 January 2010 | 30 December 2019 | PART A Only 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 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 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. |
| ————— | | | | | | |
| | | | | | | |
| 292 | sulphur CAS No 7704-34-9 CIPAC No 18 | sulphur | ≥ 990 g/kg | 1 January 2010 | 31 December 2019 | PART A Only uses as fungicide and acaricide 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 sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submit to the Commission further information to confirm the risk assessment for birds, mammals, sediment dwelling organisms and non-target arthropods. They shall ensure that the notifier at whose request sulphur has been included in this Annex provide such data to the Commission at latest by 30 June 2011. |
| 293 | Tetraconazole CAS No 112281-77-3 CIPAC No 726 | (RS)-2-(2,4-dichlorophenyl)-3-(1H-1.2,4-triazol-1-yl)-propyl-1.1,2,2-tetrafluoroethyl ether | ≥ 950 g/kg (racemic mixture) Impurity toluene: not more than 13 g/kg | 1 January 2010 | 31 December 2019 | PART 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 tetraconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. The Member States concerned shall request: — the submission of further information on a refined consumer risk assessment, — further information on the specification regarding ecotoxicology, — further information on the fate and behaviour of potential metabolites in all relevant compartments, — the refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods, — further information on the potential for endocrine disrupting effects to birds, mammals and fish. They shall ensure that the notifier provides such information to the Commission by 31 December 2011. |
| 294 | Paraffin oils CAS No 64742-46-7 CAS No 72623-86-0 CAS No 97862-82-3 CIPAC No n.a. | paraffin oil | European Pharmacopoeia 6.0 | 1 January 2010 | 31 December 2019 | PART A Only uses as insecticide and acaricide 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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, and in particular Appendices I and II thereto shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall request: — the submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6.0. They shall ensure that the notifiers provides such information to the Commission by 30 June 2010. |
| 295 | Paraffin oil CAS No 8042-47-5 CIPAC No n.a. | paraffin oil | European Pharmacopoeia. 6,0 | 1 January 2010 | 31 December 2019 | PART A Only uses as insecticide and acaricide 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 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. |
| 292 | sulphur CAS No 7704-34-9 CIPAC No 18 | sulphur | ≥ 990 g/kg | 1 January 2010 | 31 December 2020 | PART A Only uses as fungicide and acaricide 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 sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submit to the Commission further information to confirm the risk assessment for birds, mammals, sediment dwelling organisms and non-target arthropods. They shall ensure that the notifier at whose request sulphur has been included in this Annex provide such data to the Commission at latest by 30 June 2011. |
| 293 | Tetraconazole CAS No 112281-77-3 CIPAC No 726 | (RS)-2-(2,4-dichlorophenyl)-3-(1H-1.2,4-triazol-1-yl)-propyl-1.1,2,2-tetrafluoroethyl ether | ≥ 950 g/kg (racemic mixture) Impurity toluene: not more than 13 g/kg | 1 January 2010 | 31 December 2021 | 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 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 2020 | PART A Only uses as insecticide and acaricide 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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, and in particular Appendices I and II thereto shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall request: — the submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6.0. They shall ensure that the notifiers provides such information to the Commission by 30 June 2010. |
| 295 | Paraffin oil CAS No 8042-47-5 CIPAC No n.a. | paraffin oil | European Pharmacopoeia. 6,0 | 1 January 2010 | 31 December 2020 | PART A Only uses as insecticide and acaricide 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 paraffin oil 8042-47-5, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall request: The submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6,0 They shall ensure that the notifier provides such information to the Commission by 30 June 2010. |
| 296 | Cyflufenamid CAS No 180409-60-3 CIPAC No 759 | (Z)-N-[α-(cyclopropylmethoxyimino) – 2,3-difluoro-6-(trifluoromethyl)benzyl]-2-phenylacetamide | > 980 g/kg | 1 April 2010 | 31 March 2020 | PART 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 cyflufenamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 October 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| 297 | Fluopicolide CAS No 239110-15-7 CIPAC No 787 | 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide | ≥ 970 g/kg The impurity toluene must not exceed 3 g/kg in the technical material. | 1 June 2010 | 31 May 2020 | PART 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 fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the protection of aquatic organisms, — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — to the risk to operators during application, — the potential for long range transport via air. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest. |
| 298 | Heptamaloxyloglucan CAS No 870721-81-6 CIPAC No Not available | Full IUPAC name in footnote (1) Xyl p: xylopyranosyl Glc p: glucopyranosyl Fuc p: fucopyranosyl Gal p: galactopyranosyl Glc-ol: glucitol | ≥ 780 g/kg The impurity Patulin must not exceed 50 μg/kg in the technical material. | 1 June 2010 | 31 May 2020 | PART A Only uses as plant growth regulator 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 heptamaloxyloglucan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account. |
| 299 | 2-phenylphenol (including its salts such as the sodium salt) CAS No 90-43-7 CIPAC No 246 | biphenyl-2-ol | ≥ 998 g/kg | 1 January 2010 | 31 December 2019 | PART A Only uses as a post-harvest fungicide for indoor use 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 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. |
| 299 | 2-phenylphenol (including its salts such as the sodium salt) CAS No 90-43-7 CIPAC No 246 | biphenyl-2-ol | ≥ 998 g/kg | 1 January 2010 | 31 December 2021 | PART A Only uses as a post-harvest fungicide for indoor use 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 2-phenylphenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009, as amended in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account. In this overall assessment Member States must pay particular attention: — to the protection of operators and workers and ensure that conditions of use prescribe the application of adequate personal protective equipment, — to put in place appropriate waste management practices to handle the waste solution remaining after application, including the cleaning water of the drenching and other application systems. Member States permitting the release of wastewater into the sewage system, shall ensure that a local risk assessment is carried out. The Member States concerned shall ensure that the notifier submits to the Commission: — further information on the potential for skin depigmentation for workers and consumers due to possible exposure to the metabolite 2-phenylhydroquinone (PHQ) on citrus peel, — further information to confirm that the analytical method applied in residue trials correctly quantifies the residues of 2-phenylphenol, PHQ and their conjugates. They shall ensure that the notifier provides such information to the Commission by 31 December 2011. Furthermore, the Member States concerned shall ensure that the notifier submits to the Commission further information to confirm the residue levels occurring as a result of application techniques other than those in drench chambers. They shall ensure that the notifier provides such information to the Commission by 31 December 2012. |
| 300 | Malathion CAS No 121-75-5 CIPAC No 12 | diethyl (dimethoxyphosphinothioylthio)succinate or S-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioate racemate | ≥ 950 g/kg Impurities: Isomalathion: not more than 2 g/kg | 1 May 2010 | 30 April 2020 | PART A Only uses as insecticide may be authorised. Authorisations shall be limited to professional users. 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 malathion, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment; — the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones; — the protection of insectivorous birds and honey bees: conditions of authorisation shall include risk mitigation measures, where appropriate. As regards bees, the necessary indications shall be provided on the labelling and the accompanying instructions as to avoid exposure. Member States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport. Where appropriate, conditions of authorisation shall include further risk mitigation measures. The Member States concerned shall ensure that the notifier presents to the Commission: — information confirming the consumer risk assessment and the acute and long-term risk assessment for insectivorous birds; — information on the quantification of the different potency of malaoxon and malathion. |
| 301 | Penoxsulam CAS No 219714-96-2 CIPAC No 758 | 3-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-α,α,α-trifluorotoluene-2-sulfonamide | > 980 g/kg The impurity Bis-CHYMP 2-chloro-4-[2-(2-chloro-5-methoxy-4-pyrimidinyl)hydrazino]-5-methoxypyrimidine must not exceed 0,1 g/kg in the technical material | 1 August 2010 | 31 July 2020 | PART A Only uses as herbicide 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 penoxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the protection of aquatic organisms, — the dietary exposure of consumers to residues of the metabolite BSCTA in succeeding rotational crops, — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information to address the off-field risk to higher aquatic plants. They shall ensure that the notifier provides such information to the Commission by 31 July 2012. The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| 302 | Proquinazid CAS No 189278-12-4 CIPAC No 764 | 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one | > 950 g/kg | 1 August 2010 | 31 July 2020 | PART 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 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. |
@@ -404,7 +407,7 @@
| 304 | Metalaxyl CAS No 57837-19-1 CIPAC No 365 | Methyl N-(methoxyacetyl)-N-(2,6-xylyl)-DL-alaninate | 950 g/kg The impurity 2,6-dimethylaniline was considered of toxicological concern and a maximum level of 1 g/kg is established. | 1 July 2010 | 30 June 2020 | PART 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 metalaxyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account. Member States must pay particular attention to the potential contamination of groundwater by the active substance or its degradation products CGA 62826 and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied where appropriate. |
| 305 | Flonicamid (IKI-220) CAS No 158062-67-0 CIPAC No 763 | N-cyanomethyl-4-(trifluoromethyl)nicotinamide | ≥ 960 g/kg The impurity toluene must not exceed 3 g/kg in the technical material. | 1 September 2010 | 31 August 2020 | PART A Only uses as insecticide 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 flonicamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010, shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the risk to operators and re-entry workers, — the risk to bees. Conditions of authorisation shall include risk mitigation measures where appropriate. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| 306 | Triflumizole CAS No 99387-89-0 CIPAC No 730 | (E)-4-chloro-α,α,α-trifluoro-N-(1-imidazol-1-yl-2-propoxyethylidene)-o-toluidine | ≥ 980 g/kg Impurities: Toluene: not more than 1 g/kg | 1 July 2010 | 30 June 2020 | PART A Only uses as fungicide in greenhouses on artificial substrates 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 triflumizole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the operator and worker safety: conditions of use shall prescribe the use of adequate personal protective equipment, — the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, as appropriate, risk mitigation measures. |
| 307 | Sulfuryl fluoride CAS No 002699-79-8 CIPAC No 757 | Sulfuryl fluoride | > 994 g/kg | 1 November 2010 | 31 October 2020 | PART A Only uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures — which are empty; or — where conditions of use ensure that consumer exposure is acceptable; may be authorised. PART 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 sulfuryl fluoride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that such products do not enter the food and feed chain, — the risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration. Measures are required to ensure that they wear self containing breathing apparatus or other appropriate personal protective equipment, — the risk to bystanders by applying an appropriate exclusion zone around the fumigated structure. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information and in particular, confirmatory data on: — the mill processing conditions necessary to ensure that residues of fluoride ion in flour, bran and grain do not exceed the natural background levels, — tropospheric concentrations of sulfuryl fluoride. Measured concentrations should be updated regularly. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air), — estimates of sulfuryl fluoride atmospheric lifetime based on worst case scenario, with respect to the global warming potential (GWP). They shall ensure that the notifier provides such information to the Commission by 31 August 2012. |
| 307 | Sulfuryl fluoride CAS No 002699-79-8 CIPAC No 757 | Sulfuryl fluoride | > 994 g/kg | 1 November 2010 | 31 October 2020 | PART A Only 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 (<sup>19</sup>) 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 (<sup>20</sup>); 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 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 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/m<sup>3</sup> of tropospheric air). |
| 308 | FEN 560 (also called fenugreek or fenugreek seed powder) CAS No None CIPAC No None The active substance is prepared from the seed powder of Trigonella foenum-graecum L. (fenugreek). | Not applicable | 100 % fenugreek seed powder without any additive and no extraction; the seed being of human food grade quality. | 1 November 2010 | 31 October 2020 | PART A Only uses as elicitor of the crop's self-defence mechanisms 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 FEN 560 (fenugreek seed powder), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In this overall assessment, Member States must pay particular attention to the risk to operators, workers and bystanders. Conditions of authorisation shall include risk mitigation measures where appropriate. |
| 309 | Haloxyfop-P CAS No Acid: 95977-29-0 Ester: 72619-32-0 CIPAC No Acid: 526 Ester: 526.201 | Acid: (R)-2-[4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy]propanoic acid Ester: Methyl (R)-2-{}{4-[3-chloro-5-(trifluoromethyl)-2-pyridyloxy]phenoxy}}propionate | ≥ 940 g/kg (Haloxyfop-P-methyl ester) | 1 January 2011 | 31 December 2020 | PART A Only 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 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 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. |
| 310 | Napropamide CAS No 15299-99-7 | (RS)-N,N-diethyl-2-(1-naphthyloxy)propionamide | ≥ 930 g/kg (Racemic mixture) Relevant impurity Toluene: not more than 1,4 g/kg | 1 January 2011 | 31 December 2020 | PART A Only uses as herbicide 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 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. |
@@ -417,7 +420,7 @@
| 317 | 6-Benzyladenine CAS No 1214-39-7 CIPAC No 829 | N6-benzyladenine | ≥ 973 g/kg | 1 June 2011 | 31 May 2021 | PART A Only uses as plant growth regulator 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 6-benzyladenine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate. |
| 318 | Bromuconazole CAS No 116255-48-2 CIPAC No 680 | 1-[(2RS,4RS:2RS,4SR)-4-bromo-2-(2,4-dichlorophenyl)tetrahydrofurfuryl]-1H-1,2,4-triazole | ≥ 960 g/kg | 1 February 2011 | 31 January 2021 | PART 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 bromuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment, Member States shall pay particular attention to: — operator's safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones. The Member States concerned shall ensure that the applicant presents to the Commission: — further information on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; — information to further address the long term risk to herbivorous mammals. They shall ensure that the applicant at whose request bromuconazole has been included in this Annex provides such confirmatory information to the Commission by 31 January 2013 at the latest. The Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of bromuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. |
| 319 | Myclobutanil CAS No 88671-89-0 CIPAC No 442 | RS)-2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile | ≥ 925 g/kg The impurity 1-methylpyrrolidin-2-one shall not exceed 1 g/kg in the technical material | 1 June 2011 | 31 May 2021 | PART 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 myclobutanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information on the residues of myclobutanil and its metabolites in following growing seasons and information confirming that the available residue data cover all compounds of the residue definition. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 January 2013. |
| 320 | Buprofezin CAS No 953030-84-7 CIPAC No 681 | (Z)-2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one | ≥ 985 g/kg | 1 February 2011 | 31 January 2021 | PART A Only uses as insecticide and acaricide 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 buprofezin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the operators’ and workers’ safety and ensure that conditions of use impose adequate personal protective equipment where appropriate; — the dietary exposure of consumers to the buprofezin (aniline) metabolites in processed food; — the application of an appropriate waiting period for rotational crops in greenhouses; — the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards the processing and conversion factors for consumer risk assessment. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 January 2013. |
| 320 | Buprofezin CAS No 953030-84-7 CIPAC No 681 | (Z)-2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one | ≥ 985 g/kg | 1 February 2011 | 31 January 2021 | PART A Only uses as insecticide and acaricide on non-edible crops 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 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 | Triflumuron CAS No 64628-44-0 CIPAC No: 548 | 1-(2-chlorobenzoyl)-3-[4-trifluoromethoxyphenyl]urea | ≥ 955 g/kg Impurities: — N,N′-bis-[4-(trifluoromethoxy)phenyl]urea: not more than 1 g/kg — 4-trifluoro-methoxyaniline: not more than 5 g/kg | 1 April 2011 | 31 March 2021 | PART A Only uses as insecticide 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 triflumuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account. In this overall assessment, Member States shall pay particular attention to: — the protection of the aquatic environment; — the protection of honey bees. Conditions of authorisation shall include risk mitigation measures, where appropriate. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards the long-term risk to birds, the risk to aquatic invertebrates and the risk to bee brood development. The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 March 2013. |
| 322 | Hymexazol CAS No 10004-44-1 CIPAC No 528 | 5-methylisoxazol-3-ol (or 5-methyl-1,2-oxazol-3-ol) | ≥985 g/kg | 1 June 2011 | 31 May 2021 | PART A Only uses as fungicide for seed pelleting of sugar beets in professional seed treatment facilities 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 hymexazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the operators and workers safety. Conditions of authorisation shall include protective measures, where appropriate, — the risk to granivorous birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards the nature of residues in root crops and the risk for granivorous birds and mammals. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. |
| 323 | Dodine CAS No 2439-10-3 CIPAC No 101 | 1-dodecylguanidinium acetate | ≥ 950 g/kg | 1 June 2011 | 31 May 2021 | PART 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 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. |
@@ -437,7 +440,7 @@
| 334 | Isoxaben CAS No 82558-50-7 CIPAC No 701 | N-[3-(1-ethyl-1-methylpropyl)-1,2-oxazol-5-yl]-2,6-dimethoxybenzamide | ≥ 910 g/kg Toluene: ≤ 3 g/kg | 1 June 2011 | 31 May 2021 | PART A Only uses as herbicide 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 isoxaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, the risk to non-target terrestrial plants and the potential leaching of metabolites to groundwater. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (a) the specification of the technical material, as commercially manufactured, (b) the relevance of the impurities; (c) the residues in rotational crops; (d) the potential risk to aquatic organisms. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a) and (b) by 30 November 2011 and the information set out in points (c) and (d) by 31 May 2013. |
| 335 | Fluometuron CAS No: 2164-17-2 CIPAC No: 159 | 1,1-dimethyl-3-(α,α,α -trifluoro-m-tolyl)urea | ≥ 940 g/kg | 1 June 2011 | 31 May 2021 | PART A Only uses as herbicide on cotton 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 fluometuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall: — pay particular attention to the protection of the operators and workers and ensure that conditions of use include the application of adequate personal protective equipment; — pay particular attention to the protection of the groundwater where the active substance is applied in regions with vulnerable soil and/or climatic conditions; they shall ensure that conditions of authorisation include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential leaching of fluometuron and soil metabolites desmethyl-fluometuron and trifluoromethylaniline in vulnerable areas, where appropriate; — pay particular attention to the risk to non-target soil macro-organisms others than earthworms and non-target plants, and ensure that conditions of authorisation include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the applicants submit to the Commission confirmatory information as regards: (a) the toxicological properties of the plant metabolite trifluoroacetic acid; (b) the analytical methods for the monitoring of fluometuron in air; (c) the analytical methods for the monitoring of the soil metabolite trifluoromethylaniline in soil and water; (d) the relevance for ground water of the soil metabolites desmethyl-fluometuron and trifluoromethylaniline, if fluometuron is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’. The Member States concerned shall ensure that the applicants submit to the Commission the information set out in points (a), (b) and (c) by 31 March 2013 and the information set out in point (d) within six months from the notification of the decision classifying fluometuron. |
| 336 | Carbetamide CAS No 16118-49-3 CIPAC No 95 | (R)-1-(Ethylcarbamoyl)ethyl carbanilate | ≥ 950 g/kg | 1 June 2011 | 31 May 2021 | PART A Only uses as herbicide 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 carbetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (b) the risk to non-target plants; (c) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
| 337 | Carboxin CAS No 5234-68-4 CIPAC No 273 | 5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide | ≥ 970 g/kg | 1 June 2011 | 31 May 2021 | PART A Only 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 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 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 (<sup>7</sup>) in soil, groundwater and surface water and for the monitoring of metabolite M9 (<sup>8</sup>) in groundwater; (e) additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 (<sup>9</sup>) and P/V-55 (<sup>10</sup>), (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 (<sup>11</sup>), P/V-55 (<sup>12</sup>) and M9 (<sup>13</sup>) 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. |
| 337 | Carboxin CAS No 5234-68-4 CIPAC No 273 | 5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide | ≥ 970 g/kg | 1 June 2011 | 31 May 2021 | PART A Only 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 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 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 (<sup>7</sup>) in soil, groundwater and surface water and for the monitoring of metabolite M9 (<sup>8</sup>) in groundwater; (e) additional values regarding the period required for 50 percent dissipation in soil for the soil metabolites P/V-54 (<sup>9</sup>) and P/V-55 (<sup>10</sup>), (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 (<sup>11</sup>), P/V-55 (<sup>12</sup>) and M9 (<sup>13</sup>) if carboxin is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’ The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a), (b) and (c) by 30 November 2011, the information set out in points (d), (e), (f) and (g) by 31 May 2013 and the information set out in point (h) six months after the notification of decision classifying carboxin. |
| 338 | Cyproconazole CAS No 94361-06-5 CIPAC No 600 | (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol | ≥ 940 g/kg | 1 June 2011 | 31 May 2021 | PART 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 cyproconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs); — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (a) the toxicological relevance of the impurities in the technical specification; (b) analytical methods for the monitoring of cyproconazole in soil, body fluids and tissues; (c) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; (d) the long term risk to herbivorous mammals; (e) the possible environmental impact of the preferential degradation and/or conversion of the mixture of isomers. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 30 November 2011, the information set out in points (b), (c) and (d) by 31 May 2013 and the information set out in point (e) two years after the adoption of specific guidance. |
| 339 | Dazomet CAS No 533-74-4 CIPAC No 146 | 3,5-dimethyl-1,3,5-thiadiazinane-2-thione or tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione | ≥ 950 g/kg | 1 June 2011 | 31 May 2021 | PART A Only 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 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 dazomet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to operators, workers and bystanders; — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (a) the potential groundwater contamination by methyl isothiocyanate; (b) the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks; (c) the acute risk to insectivorous birds; (d) the long term risk to birds and mammals. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013. |
| 340 | Metaldehyde CAS No 108-62-3 (tetramer) 9002-91-9 (homopolymer) CIPAC No 62 | r-2, c-4, c-6, c-8-tetramethyl-1,3,5,7- tetroxocane | ≥ 985 g/kg acetaldehyde max. 1,5 g/kg | 1 June 2011 | 31 May 2021 | PART A Only uses as molluscicide 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 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. |
@@ -456,7 +459,7 @@
| 353 | Flutriafol CAS No 76674-21-0 CIPAC No 436 | (RS)-2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol | ≥ 920 g/kg (racemate) Relevant impurities: dimethyl sulphate: max content 0,1 g/kg dimethylformamide: max content 1 g/kg methanol: max content 1 g/kg | 1 June 2011 | 31 May 2021 | PART 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 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 | Flurochloridone CAS No *61213-25-0* CIPAC No 430 | *(3RS,4RS;3RS,4SR)-3-chloro-4-chloromethyl-1-(α,α,α-trifluoro-m-tolyl)-2-pyrrolidone* | ≥ 940 g/kg. Relevant impurities: Toluene: max 8 g/kg | 1 June 2011 | 31 May 2021 | PART A Only uses as herbicide 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 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 (<sup>15</sup>); 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. |
| (<sup>1</sup>)Further details on identity and specification of active substances are provided in their review reports. (<sup>2</sup>)Suspended by order of the General Court of 19 July 2007 in case T-31/07 R, Du Pont de Nemours (France) SAS and others v Commission, [2007] ECR II-2767. (<sup>3</sup>)OJ L 353, 31.12.2008, p. 1. (<sup>4</sup>)2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide. (<sup>5</sup>)2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide. (<sup>6</sup>)De-ethyl-bupirimate. (<sup>7</sup>)2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate. (<sup>8</sup>)(2*RS*)-2-hydroxy-2-methyl-*N*-phenyl-1,4-oxathiane-3-carboxamide 4-oxide. (<sup>9</sup>)2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide. (<sup>10</sup>)2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide. (<sup>11</sup>)2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide. (<sup>12</sup>)2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide. (<sup>13</sup>)(2*RS*)-2-hydroxy-2-methyl-*N*-phenyl-1,4-oxathiane-3-carboxamide 4-oxide. (<sup>14</sup>)(4*S*,5*S*)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4*R*,5*R*)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one. (<sup>15</sup>)R42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one. (<sup>16</sup>)1-[2-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-1H-[1,2,4]triazol-yl]-ethanol. (<sup>17</sup>)OJ L 300, 14.11.2009, p. 1. (<sup>18</sup>)OJ L 54, 26.2.2011, p. 1. | | | | | | |
| (<sup>1</sup>)Further details on identity and specification of active substances are provided in their review reports. (<sup>2</sup>)Suspended by order of the General Court of 19 July 2007 in case T-31/07 R, Du Pont de Nemours (France) SAS and others v Commission, [2007] ECR II-2767. (<sup>3</sup>)OJ L 353, 31.12.2008, p. 1. (<sup>4</sup>)2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide. (<sup>5</sup>)2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide. (<sup>6</sup>)De-ethyl-bupirimate. (<sup>7</sup>)2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate. (<sup>8</sup>)(2*RS*)-2-hydroxy-2-methyl-*N*-phenyl-1,4-oxathiane-3-carboxamide 4-oxide. (<sup>9</sup>)2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide. (<sup>10</sup>)2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide. (<sup>11</sup>)2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide. (<sup>12</sup>)2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide. (<sup>13</sup>)(2*RS*)-2-hydroxy-2-methyl-*N*-phenyl-1,4-oxathiane-3-carboxamide 4-oxide. (<sup>14</sup>)(4*S*,5*S*)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4*R*,5*R*)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one. (<sup>15</sup>)R42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one. (<sup>16</sup>)1-[2-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-1H-[1,2,4]triazol-yl]-ethanol. (<sup>17</sup>)OJ L 300, 14.11.2009, p. 1. (<sup>18</sup>)OJ L 54, 26.2.2011, p. 1. (<sup>19</sup>)Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). (<sup>20</sup>)Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1). | | | | | | |
### PART B
@@ -491,7 +494,7 @@
| | | | | | | |
| 10 | Tefluthrin CAS No: *79538-32-2* CIPAC No: 451 | 2,3,5,6-tetrafluoro-4-methylbenzyl (1*RS, 3RS*)-3-[(*Z*)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate Tefluthrin is a 1:1 mixture of *Z*-(1*R*, 3*R*) and *Z*-(1*S*, 3*S*) enantiomers. | ≥ 920 g/kg Hexachlorobenzene: not more than 1 mg/kg | 1 January 2012 | 31 December 2021 | PART A Only uses as insecticide may be authorised. The seed coating shall only be performed in professional seed treatment facilities. These facilities shall apply the best available techniques in order to exclude the release of dust clouds during storage, transport and application. PART 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 tefluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the operators and workers safety and include among the authorised conditions of use the application of adequate personal protective equipment as well as respiratory protective equipment, — the risk to birds and mammals. Risk mitigation measures should be applied to grant a high degree of incorporation in soil and avoidance of spillage, — ensure that the label of treated seed includes the indication that the seeds were treated with tefluthrin and sets out the risk mitigation measures provided for in the authorisation. The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured; (2) a validated analytical method for water; (3) the possible environmental impact of the preferential degradation/conversion of the isomers and an estimation of the relative toxicity and risk assessment for the workers. The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2012, the information set out in point (2) by 31 December 2012, and the information set out in point (3) 2 years after the adoption of a specific guidance document on evaluation of isomers mixture. |
| | | | | | | |
| 11 | Oxyfluorfen CAS No 42874-03-3 CIPAC No 538 | 2-chloro-α,α,α-trifluoro-*p*-tolyl 3-ethoxy-4-nitrophenyl ether | ≥ 970 g/kg Impurities: N,N-dimethylnitrosamine: not more than 50 μg/kg | 1 January 2012 | 31 December 2021 | PART A Only uses as herbicide for banded applications close to ground from autumn to early spring 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 oxyfluorfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account. In this overall assessment Member States shall: (a) pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; (b) pay particular attention to the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured including information on the relevance of the impurities; (2) the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies; (3) the potential risk to aquatic organisms for the active substance and for the metabolites RH-45469 (<sup>8</sup>), MW 306 (<sup>9</sup>), MW 347 (<sup>10</sup>), MW 274 (<sup>11</sup>) and for the unidentified metabolite Deg 27; (4) the potential risk from bioaccumulation and biomagnification in the aquatic food chain, including sediment dwellers; (5) exposure data for banded application adequate for use as drift mitigation values. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3) to (5) by 31 December 2013. |
| 11 | Oxyfluorfen CAS No 42874-03-3 CIPAC No 538 | 2-chloro-α,α,α-trifluoro-*p*-tolyl 3-ethoxy-4-nitrophenyl ether | ≥ 970 g/kg Impurities: N,N-dimethylnitrosamine: not more than 50 μg/kg | 1 January 2012 | 31 December 2021 | PART A Only uses as herbicide for banded applications close to ground from autumn to early spring may be authorised, at a rate not exceeding 150 g active substance per hectare, per year. 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 oxyfluorfen, 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: — operator safety and ensure that conditions of use impose the application of adequate personal protective equipment where appropriate, — the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants. Conditions of authorisation shall include risk mitigation measures such as no-spray buffer zones and drift reducing nozzles and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate. |
| | | | | | | |
| 12 | 1-naphthylacetamide CAS No 86-86-2 CIPAC No 282 | 2-(1-naphthyl)acetamide | ≥ 980 g/kg | 1 January 2012 | 31 December 2021 | PART A Only uses as plant growth regulator 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 1-naphthylacetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account. In this overall assessment Member States: (a) shall pay particular attention to the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (c) shall pay particular attention to the risk to aquatic organisms; (d) shall pay particular attention to the risk to non-target plants; (e) shall pay particular attention to the risk to birds. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the risk to non-target plants; (2) the long-term risk to birds. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013. |
| | | | | | | |
@@ -514,7 +517,7 @@
| | | | | | | |
| 22 | Metam CAS No 144-54-7 CIPAC No 20 | Methyldithiocarbamic acid | ≥ 965 g/kg Expressed as metam-sodium on a dry weight basis ≥ 990 g/kg Expressed as metam-potassium on a dry weight basis Relevant impurities: methylisothiocyanate (MITC) — max. 12 g/kg on dry weight basis (metam-sodium), — max. 0,42 g/kg on dry weight basis (metam-potassium). *N,N’*-dimethylthiourea (DMTU) — max. 23 g/kg on a dry weight basis (metam-sodium), — max. 6 g/kg on a dry weight basis (metam-potassium). | 1 July 2012 | 30 June 2022 | PART A Only uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field. The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed. The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications. Authorisations shall be limited to professional users. PART 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 metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account. In this overall assessment Member States: (a) shall pay particular attention to the protection of operators and shall ensure that the conditions of use include risk mitigation measures such as application of adequate personal protective equipment and a limitation in the daily work rate; (b) shall pay particular attention to the protection of workers and shall ensure that the conditions of use include risk mitigation measures, such as use of adequate personal protective equipment, re-entry period and limitation in the daily work rate; (c) shall pay particular attention to the protection of bystanders and residents and shall ensure that the conditions of use include risk mitigation measures, such as an appropriate buffer zone during and until 24 hours after the application from the perimeter of the application area to any occupied residences and areas used by the general public with obligation to use warning signs and ground markers; (d) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and shall ensure that the conditions of use include risk mitigation measures, such as appropriate buffer zone; (e) shall pay particular attention to the risk to non-target organisms and shall ensure that conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information on methyl isothiocyanate as regards: (1) the assessment of the long-range atmospheric transport potential and related environmental risks; (2) the potential groundwater contamination. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014. |
| | | | | | | |
| 23 | Bifenthrin CAS No 82657-04-3 CIPAC No 415 | 2-methylbiphenyl-3-ylmethyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate or 2-methylbiphenyl-3-ylmethyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate | ≥ 930 g/kg Impurities: Toluene: not more than 5 g/kg | 1 August 2012 | 31 July 2019 | PART A Only uses as insecticide 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 bifenthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the persistency in the environment; (b) the risk for bioaccumulation and biomagnification; (c) the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; (d) the risk to aquatic organisms, in particular fish and invertebrates, non-target arthropods and bees, ensuring that conditions of authorisation include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the residual toxicity for non-target arthropods and the potential for recolonisation; (2) the fate and behaviour of soil metabolite 4'-OH bifenthrin; (3) the degradation in soil of the isomers which constitute bifenthrin, 4'-OH bifenthrin and TFP acid. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points 1, 2 and 3 by 31 July 2014. The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential for bioaccumulation and biomagnification in the aquatic and terrestrial environment by 31 July 2013. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 31 July 2015. |
| 23 | Bifenthrin CAS No 82657-04-3 CIPAC No 415 | 2-methylbiphenyl-3-ylmethyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate or 2-methylbiphenyl-3-ylmethyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate | ≥ 930 g/kg Impurities: Toluene: not more than 5 g/kg | 1 August 2012 | 31 July 2021 | PART A Only uses as insecticide 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 bifenthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the persistency in the environment; (b) the risk for bioaccumulation and biomagnification; (c) the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; (d) the risk to aquatic organisms, in particular fish and invertebrates, non-target arthropods and bees, ensuring that conditions of authorisation include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the residual toxicity for non-target arthropods and the potential for recolonisation; (2) the fate and behaviour of soil metabolite 4'-OH bifenthrin; (3) the degradation in soil of the isomers which constitute bifenthrin, 4'-OH bifenthrin and TFP acid. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points 1, 2 and 3 by 31 July 2014. The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential for bioaccumulation and biomagnification in the aquatic and terrestrial environment by 31 July 2013. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 31 July 2015. |
| | | | | | | |
| 24 | Fluxapyroxad CAS No 907204-31-3 CIPAC No 828 | 3-(difluoromethyl)-1-methyl-*N*-(3′,4′,5′-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide | ≥ 950 g/kg The impurity toluene must not exceed 1 g/kg in the technical material | 1 January 2013 | 31 December 2022 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluxapyroxad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to groundwater, if the active substance is applied under vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| | | | | | | |
@@ -677,6 +680,13 @@
| 103 | Picolinafen CAS No 137641-05-5 CIPAC No 639 | 4′-fluoro-6-(α,α,α-trifluoro-m-tolyloxy)pyridine-2-carboxanilide | ≥ 980 g/kg | 1 November 2016 | 30 June 2031 | For the implementation 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, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the impurities in the technical active substance; — the protection of mammals, especially of large herbivorous mammals; — the protection of non-target terrestrial plants; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of aquatic organisms, especially to algae. Conditions of use shall include risk mitigation measures, where appropriate. |
| | | | | | | |
| 104 | Thifensulfuron-methyl CAS No 79277-27-3 CIPAC No 452 | methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)thiophene-2-carboxylate | ≥ 960 g/kg | 1 November 2016 | 31 October 2031 | For the implementation 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, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of groundwater; — the protection of non-target plants and aquatic organisms. Conditions of use shall include risk mitigation measures and the obligation to monitor the groundwater, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the absence of genotoxicity of metabolites IN-A4098 and its derivative IN-B5528, IN-A5546 and IN-W8268; (2) mechanistic data to rule out an endocrine mediated mode of action for mammary gland tumours; (3) the risk to aquatic organisms from thifensulfuron-methyl and metabolite IN-D8858 and the risk to soil organisms from metabolites IN-JZ789 and 2 acid 3 triuret; (4) the relevance of the metabolites IN-A4098, IN-L9223 and IN-JZ789 if thifensulfuron-methyl is classified as reprotoxic category 2 under Regulation (EC) No 1272/2008 and the risk that those metabolites contaminate groundwater. The applicant shall submit the information requested under point (1) by 31 March 2017, under points (2) and (3) by 30 June 2017 and under point (4) within six months after the notification of the classification decision concerning thifensulfuron-methyl. |
| | | | | | | |
| 105 | Thiabendazole | 2-(thiazol-4-yl)benzimidazole | ≥ 985 g/kg | 1 April 2017 | 31 March 2032 | For the implementation 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, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and consumers, — the protection of groundwater, — the control of waste water from post-harvest uses. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit by 31 March 2019 to the Commission, the Member States and the Authority confirmatory information regarding Level 2 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of thiabendazole. |
| CAS No 148-79-8 CIPAC No 323 | | | | | | |
| | | | | | | |
| 106 | Oxathiapiprolin CAS No: 1003318-67-9 CIPAC No: 985 | 1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone | ≥ 950 g/kg | 3 March 2017 | 3 March 2027 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxathiapiprolin, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; (2) the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification. The applicant shall submit the information requested under points (1) and (2) by 3 September 2017. |
| | | | | | | |
| 107 | Iodosulfuron CAS No 185119-76-0 (parent) CAS No 144550-36-7 (iodosulfuron-methyl-sodium) CIPAC No 634 (parent) CIPAC No 634.501 (iodosulfuron-methyl-sodium) | 4-iodo-2-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoylsulfamoyl]benzoic acid (iodosulfuron) sodium ({[5-iodo-2-(methoxycarbonyl)phenyl]sulfonyl}carbamoyl)(4-methoxy-6-methyl-1,3,5-triazin-2-yl)azanide (iodosulfuron-methyl-sodium) | ≥ 910 g/kg (expressed as iodosulfuron-methyl-sodium) | 1 April 2017 | 31 March 2032 | For the implementation 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, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to consumers, — the risk to non-target terrestrial plants, — the risk to aquatic plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the genotoxic potential of the metabolite triazine-amine (IN-A4098), in order to confirm that this metabolite is not genotoxic and not relevant for the risk assessment; (2) the effect of water treatment processes on the nature of residues present in drinking water. The applicant shall submit the information requested under point (1) 1 October 2017 and the information requested under point (2) 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. |
| (<sup>1</sup>)Further details on identity and specification of active substance are provided in the review report. (<sup>2</sup>)2-hydroxy-4,6-dimethoxypyrimidine. (<sup>3</sup>)2,4-dihydroxy-6-methoxypyrimidine. (<sup>4</sup>)sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate. (<sup>5</sup>)5-(trifluoromethyl)-2(1H)-pyridinone. (<sup>6</sup>)4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol. (<sup>7</sup>)M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide. (<sup>8</sup>)5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol. (<sup>9</sup>)3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid. (<sup>10</sup>)2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene. (<sup>11</sup>)4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid. (<sup>12</sup>)3-phenoxybenzaldehyde. (<sup>13</sup>)Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)). (<sup>14</sup>)7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid. (<sup>15</sup>)3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1*H*-pyrazole-4-carboxylic acid. (<sup>16</sup>)3-chloro-1-methyl-5-sulfamoyl-1*H*-pyrazole-4-carboxylic acid. (<sup>17</sup>) *p*-methyl-phenethylamine. | | | | | | |
### PART C
@@ -710,7 +720,13 @@
| 11 | Diammonium phosphate CAS No: 7783-28-0 | Diammonium hydrogen phosphate | Oenological grade | 29 April 2016 | Diammonium phosphate shall be used in accordance with the specific conditions included in the conclusions of the review report on diammonium phosphate (SANTE/12351/2015) and in particular Appendices I and II thereto. |
| | | | | | |
| 12 | Sunflower oil CAS No: 8001-21-6 | Sunflower oil | Food grade | 2 December 2016 | Sunflower oil shall be used in accordance with the specific conditions included in the conclusions of the review report on sunflower oil (SANTE/10875/2016) and in particular Appendices I and II thereof. |
| (<sup>1</sup>)Further details on identity, specification and manner of use of basic substance are provided in the review report. (<sup>2</sup>)Available online: http://www.fao.org/fao-who-codexalimentarius/standards/list-of-standards/en/ | | | | | |
| | | | | | |
| 13 | Clayed charcoal CAS No 7440-44-0 231-153-3 (Einecs) (activated charcoal) CAS No 1333-86-4 215-609-9 (Einecs) (carbon black) CAS No 1302-78-9 215-108-5 (Einecs) (bentonite) | Not available. | Charcoal: Purity required by Regulation (EU) No 231/2012 (<sup>3</sup>) Bentonite: Purity required by Implementing Regulation (EU) No 1060/2013 (<sup>4</sup>) | 31 March 2017 | Clayed charcoal shall be used in accordance with the specific conditions included in the conclusions of the review report on clayed charcoal (SANTE/11267/2016) and in particular Appendices I and II thereof. |
| | | | | | |
| 14 | *Urtica* spp. CAS No 84012-40-8 (*Urtica dioica* extract) CAS No 90131-83-2 (*Urtica urens* extract) | *Urtica* spp. | European Pharmacopeia | 30 March 2017 | *Urtica* spp. shall be used in accordance with the specific conditions included in the conclusions of the review report on *Urtica* spp. (SANTE/11809/2016) and in particular Appendices I and II thereof. |
| | | | | | |
| 15 | Hydrogen peroxide CAS No 7722-84-1 | Hydrogen peroxide | Solution in water (< 5 %) The hydrogen peroxide used to manufacture the solution shall have a purity according to the FAO JECFA specifications. | 29 March 2017 | Hydrogen peroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on hydrogen peroxide (SANTE/11900/2016) and in particular Appendices I and II thereof. |
| (<sup>1</sup>)Further details on identity, specification and manner of use of basic substance are provided in the review report. (<sup>2</sup>)Available online: http://www.fao.org/fao-who-codexalimentarius/standards/list-of-standards/en/ (<sup>3</sup>)Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1). (<sup>4</sup>)Commission Implementing Regulation (EU) No 1060/2013 of 29 October 2013 concerning the authorisation of bentonite as a feed additive for all animal species (OJ L 289, 31.10.2013, p. 33). | | | | | |
### PART D
@@ -733,6 +749,10 @@
| 6 | *Saccharomyces cerevisae* strain LAS02 Accession number in the collection of the ‘Collection Nationale de Cultures de Microorganismes’ (CNCM) of the Pasteur Institute: CNCM I-3936 | Not applicable | Minimum concentration: 1 × 10<sup>13</sup> CFU/kg | 6 July 2016 | 6 July 2031 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Saccharomyces cerevisiae* strain LAS02, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that *Saccharomyces cerevisiae* strain LAS02 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| | | | | | | |
| 7 | *Trichoderma atroviride* strain SC1 Accession number CBS 122089 in the collection of the Centraalbureau voor Schimmelcultures (CBS) in Utrecht, The Netherland CIPAC No: 988 | Not applicable | minimum concentration 1 × 10<sup>10</sup> CFU/g | 6 July 2016 | 6 July 2031 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Trichoderma atroviride* strain SC1, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| | | | | | | |
| 8 | Mild Pepino Mosaic Virus isolate VC1 Reference number DSM 26973 in the German Collection of Micro-organisms and Cell Cultures (DSMZ) | Not applicable | Nicotine < 0,1 mg/L | 29 March 2017 | 29 March 2032 | Only the use in greenhouses may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Mild Pepino Mosaic Virus isolate VC1, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Mild Pepino Mosaic Virus isolate VC1 is to be considered, as any microorganism, a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| | | | | | | |
| 9 | Mild Pepino Mosaic Virus isolate VX1 Reference number DSM 26974 in the German Collection of Micro-organisms and Cell Cultures (DSMZ) | Not applicable | Nicotine < 0,1 mg/L | 29 March 2017 | 29 March 2032 | Only the use in greenhouses may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Mild Pepino Mosaic Virus isolate VX1, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Mild Pepino Mosaic Virus isolate VX1 is to be considered, as any microorganism, a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| (<sup>1</sup>)Further details on identity and specification of active substance are provided in the review report. | | | | | | |
### PART E
2016-12-12
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-09-16
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-08-22
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-07-06
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-05-13
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-05-02
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-04-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2016-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-12-09
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-11-10
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-09-03
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-08-18
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-07-30
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-04-02
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-04-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2015-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2014-09-15
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2014-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2014-02-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2013-08-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2013-06-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2013-04-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2013-02-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-07-23
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-07-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-05-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
original version
Text at this date