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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
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· 2011-05-25
2026-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
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| 40 | Deltamethrin CAS No 52918-63-5 CIPAC No 333 | (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate | 980 g/kg | 1 November 2003 | 31 October 2022 | Only uses as insecticide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures, — should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels, — must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate. |
| 40 | Deltamethrin CAS No 52918-63-5 CIPAC No 333 | (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate | 980 g/kg | 1 November 2003 | 31 October 2023 | Only uses as insecticide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures, — should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels, — must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate. |
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| 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 2022 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flufenacet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions, — should pay particular attention to the protection of algae and aquatic plants, — should pay particular attention to the protection of operators. Risk mitigation measures should be applied where appropriate. |
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| 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 2022 | Only uses as insecticide or nematicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosthiazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions; — should pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season; — should pay particular attention to the protection of non-target soil organisms. Risk mitigation measures should be applied where appropriate. In order to mitigate the potential risk to small birds, product authorisations must require that a very high level of incorporation of granules into soil is achieved. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| 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 2023 | 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. |
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| 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 2023 | 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. |
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| 102 | Chlorotoluron (unstated stereochemistry) CAS No 15545-48-9 CIPAC No 217 | 3-(3-chloro-p-tolyl)-1,1-dimethylurea | 975 g/kg | 1 March 2006 | 31 October 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 chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate |
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| 104 | Daminozide CAS No 1596-84-5 CIPAC No 330 | N-dimethylaminosuccinamic acid | 990 g/kg Impurities: — N-nitrosodimethylamine: not more than 2,0 mg/kg — 1,1-dimethylhydrazide: not more than 30 mg/kg | 1 March 2006 | 31 October 2022 | PART A Only uses as growth regulator in 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 daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate |
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| 107 | MCPA CAS No 94-74-6 CIPAC No 2 | 4-chloro-o-tolyloxyacetic acid | ≥ 930 g/kg | 1 May 2006 | 31 October 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 MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones |
| 108 | MCPB CAS No 94-81-5 CIPAC No 50 | 4-(4-chloro-o-tolyloxy)butyric acid | ≥ 920 g/kg | 1 May 2006 | 31 October 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 MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones |
| 102 | Chlorotoluron (unstated stereochemistry) CAS No 15545-48-9 CIPAC No 217 | 3-(3-chloro-p-tolyl)-1,1-dimethylurea | 975 g/kg | 1 March 2006 | 31 October 2023 | 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 chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate |
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| 104 | Daminozide CAS No 1596-84-5 CIPAC No 330 | N-dimethylaminosuccinamic acid | 990 g/kg Impurities: — N-nitrosodimethylamine: not more than 2,0 mg/kg — 1,1-dimethylhydrazide: not more than 30 mg/kg | 1 March 2006 | 31 October 2023 | PART A Only uses as growth regulator in 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 daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate |
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| 107 | MCPA CAS No 94-74-6 CIPAC No 2 | 4-chloro-o-tolyloxyacetic acid | ≥ 930 g/kg | 1 May 2006 | 31 October 2023 | 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 MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones |
| 108 | MCPB CAS No 94-81-5 CIPAC No 50 | 4-(4-chloro-o-tolyloxy)butyric acid | ≥ 920 g/kg | 1 May 2006 | 31 October 2023 | 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 MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones |
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| 110 | Milbemectin Milbemectin is a mixture of M.A3 and M.A4 CAS No M.A3: 51596-10-2 M.A4: 51596-11-3 CIPAC No 660 | M.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one M.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one | ≥ 950 g/kg | 1 December 2005 | 31 July 2023 | PART A Only uses as acaricide or 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 milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. |
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| 158 | Beflubutamid CAS No 113614-08-7 CIPAC No 662 | (RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide | ≥ 970 g/kg | 1 December 2007 | 31 July 2023 | 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 beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 160 | Prosulfocarb CAS No 52888-80-9 CIPAC No 539 | S-benzyl dipropyl(thiocarbamat) | 970 g/kg | 1 November 2008 | 31 October 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 prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone. |
| 161 | Fludioxonil CAS No 131341-86-1 CIPAC No 522 | 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile | 950 g/kg | 1 November 2008 | 31 October 2022 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted and: — must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones, — must pay particular attention to the protection of fish and aquatic invertebrates. Conditions of authorisation should include risk mitigation measures, where appropriate. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. |
| 162 | Clomazone CAS No 81777-89-1 CIPAC No 509 | 2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one | 960 g/kg | 1 November 2008 | 31 October 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 clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones. |
| 160 | Prosulfocarb CAS No 52888-80-9 CIPAC No 539 | S-benzyl dipropyl(thiocarbamat) | 970 g/kg | 1 November 2008 | 31 October 2023 | 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 prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone. |
| 161 | Fludioxonil CAS No 131341-86-1 CIPAC No 522 | 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile | 950 g/kg | 1 November 2008 | 31 October 2023 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted and: — must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones, — must pay particular attention to the protection of fish and aquatic invertebrates. Conditions of authorisation should include risk mitigation measures, where appropriate. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. |
| 162 | Clomazone CAS No 81777-89-1 CIPAC No 509 | 2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one | 960 g/kg | 1 November 2008 | 31 October 2023 | 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 clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones. |
| 163 | Benthiavalicarb CAS No 413615-35-7 CIPAC No 744 | [(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid | ≥ 910 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: 6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg bis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg | 1 August 2008 | 31 July 2023 | 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 benthiavalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety, — the protection of non-target arthropods. Conditions of use shall include adequate risk mitigation measures, where appropriate. In assessing applications to authorise plant protection products containing benthiavalicarb for uses other than in glasshouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| 164 | Boscalid CAS No 188425-85-6 CIPAC No 673 | 2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide | ≥ 960 g/kg | 1 August 2008 | 31 July 2023 | 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 boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention — to the operator safety, — to the long term risk to birds and soil organisms, — to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include adequate risk mitigation measures, where appropriate. |
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| 168 | Prothioconazole CAS No 178928-70-6 CIPAC No 745 | (RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione | ≥ 970 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: — Toluene: < 5 g/kg — Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD) | 1 August 2008 | 31 July 2023 | 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 prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety in spray applications. Conditions of use shall include adequate protective measures, — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of: — information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin, — a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds, — information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment. They shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 169 | Amidosulfuron CAS No 120923-37-7 CIPAC No 515 | 3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea or 1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea | ≥ 970 g/kg | 1 January 2009 | 31 December 2022 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. |
| 170 | Nicosulfuron CAS No 111991-09-4 CIPAC No 709 | 2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide or 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea | ≥ 910 g/kg | 1 January 2009 | 31 December 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 nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions, — the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone, — the protection of groundwater and surface water under vulnerable soil and climatic conditions. |
| 171 | Clofentezine CAS No 74115-24-5 CIPAC No 418 | 3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine | ≥ 980 g/kg (dry material) | 1 January 2009 | 31 December 2022 | PART A Only uses as 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 clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate; — the potential for long range transport via air; — the risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier presents to the Commission a monitoring programme to assess the potential for long-range atmospheric transport of clofentezine and the related environmental risks by 31 July 2011. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State and to the Commission by 31 July 2013. The Member States concerned shall ensure that the notifier submits to the Commission confirmatory studies on clofentezine metabolites relating to their toxicological and environmental risk assessment by 30 June 2012. |
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| 172 | Dicamba CAS No 1918-00-9 CIPAC No 85 | 3,6-dichloro-2-methoxybenzoic acid | ≥ 850 g/kg | 1 January 2009 | 31 December 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 dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of non-target plants. Conditions of use shall include adequate risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the identification and quantification of a group of soil transformation products formed in a soil incubation study; (b) the potential for long range transport through the atmosphere. The notifier shall submit this information to the Member States, the Commission and the Authority by 30 November 2013. |
| 173 | Difenoconazole CAS No 119446-68-3 CIPAC No 687 | 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether | ≥ 940g/kg Toluene maximum content: 5 g/kg | 1 January 2009 | 31 December 2022 | 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 difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) further data on the specification of the technical material; (b) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin; (c) the potential for endocrine disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 (<sup>16</sup>); (d) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012, the information set out in points (b) and (c) by 30 November 2013 and the information set out in point (d) within 2 years from the adoption of specific guidance. |
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| 176 | Lenacil CAS No 2164-08-1 CIPAC No 163 | 3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione | ≥ 975 g/kg | 1 January 2009 | 31 December 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 lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies; — the protection of the groundwater, where the active substance is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission confirmatory information on the identity and characterisation of soil metabolites Polar B and Polars and metabolites M1, M2 and M3 whichoccurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. They shall ensure that the notifier provides such information to the Commission by 30 June 2012. If a decision on the classification of lenacil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (<sup>3</sup>) identifies the need for further information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3, Polar B and Polars, the Member States concerned shall request the submission of such information. They shall ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision. |
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| 178 | Picloram CAS No 1918-02-1 CIPAC No 174 | 4-amino-3,5,6-trichloropyridine-2-carboxylic acid | ≥ 920 g/kg | 1 January 2009 | 31 December 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 picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In the overall assessment Member States must pay particular attention to: — the potential for ground water contamination where picloram is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate; The Member States concerned shall ensure that the notifier submits to the Commission: — further information to confirm that the monitoring analytical method applied in residue trials correctly quantifies the residues of picloram and its conjugates; — a soil photolysis study to confirm the evaluation of picloram degradation. They shall ensure that the notifier provides such information to the Commission by 30 June 2012. |
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| 180 | Bifenox CAS No 42576-02-3 CIPAC No 413 | Methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate | ≥ 970 g/kg impurities: max. 3 g/kg 2,4-dichlorophenol max. 6 g/kg 2,4-dichloroanisole | 1 January 2009 | 31 December 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 bifenox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; (b) the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops; (c) the environmental conditions leading to the potential formation of nitrofen. Member States shall impose restrictions as regards the conditions of use, where appropriate in view of point (c). |
| 181 | Diflufenican CAS No 83164-33-4 CIPAC No 462 | 2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide | ≥ 970 g/kg | 1 January 2009 | 31 December 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 diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate. |
| 182 | Fenoxaprop-P CAS No 113158-40-0 CIPAC No 484 | (R)-2[4-[(6-chloro-2-benzoxazolyl)oxy]-phenoxy]-propanoic acid | ≥ 920 g/kg | 1 January 2009 | 31 December 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 fenoxaprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of non target plants, — the presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure, — the persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 183 | Fenpropidin CAS No 67306-00-7 CIPAC No 520 | (R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine | ≥ 960 g/kg (racemate) | 1 January 2009 | 31 December 2022 | 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 fenpropidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone. The Member States concerned shall request the submission of: — information to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin. They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval. |
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| 186 | Tritosulfuron CAS No 142469-14-5 CIPAC No 735 | 1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea | ≥ 960 g/kg The following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material: 2-Amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine: <0,2 g/kg | 1 December 2008 | 30 November 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 tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic organisms, — the protection of small mammals. Conditions of use shall include risk mitigation measures, where appropriate. |
| 169 | Amidosulfuron CAS No 120923-37-7 CIPAC No 515 | 3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea or 1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea | ≥ 970 g/kg | 1 January 2009 | 31 December 2023 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. |
| 170 | Nicosulfuron CAS No 111991-09-4 CIPAC No 709 | 2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide or 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea | ≥ 910 g/kg | 1 January 2009 | 31 December 2023 | 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 nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions, — the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone, — the protection of groundwater and surface water under vulnerable soil and climatic conditions. |
| 171 | Clofentezine CAS No 74115-24-5 CIPAC No 418 | 3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine | ≥ 980 g/kg (dry material) | 1 January 2009 | 31 December 2023 | PART A Only uses as 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 clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate; — the potential for long range transport via air; — the risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier presents to the Commission a monitoring programme to assess the potential for long-range atmospheric transport of clofentezine and the related environmental risks by 31 July 2011. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State and to the Commission by 31 July 2013. The Member States concerned shall ensure that the notifier submits to the Commission confirmatory studies on clofentezine metabolites relating to their toxicological and environmental risk assessment by 30 June 2012. |
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| 172 | Dicamba CAS No 1918-00-9 CIPAC No 85 | 3,6-dichloro-2-methoxybenzoic acid | ≥ 850 g/kg | 1 January 2009 | 31 December 2023 | 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 dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of non-target plants. Conditions of use shall include adequate risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the identification and quantification of a group of soil transformation products formed in a soil incubation study; (b) the potential for long range transport through the atmosphere. The notifier shall submit this information to the Member States, the Commission and the Authority by 30 November 2013. |
| 173 | Difenoconazole CAS No 119446-68-3 CIPAC No 687 | 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether | ≥ 940g/kg Toluene maximum content: 5 g/kg | 1 January 2009 | 31 December 2023 | 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 difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) further data on the specification of the technical material; (b) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin; (c) the potential for endocrine disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 (<sup>16</sup>); (d) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012, the information set out in points (b) and (c) by 30 November 2013 and the information set out in point (d) within 2 years from the adoption of specific guidance. |
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| 176 | Lenacil CAS No 2164-08-1 CIPAC No 163 | 3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione | ≥ 975 g/kg | 1 January 2009 | 31 December 2023 | 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 lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies; — the protection of the groundwater, where the active substance is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission confirmatory information on the identity and characterisation of soil metabolites Polar B and Polars and metabolites M1, M2 and M3 whichoccurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. They shall ensure that the notifier provides such information to the Commission by 30 June 2012. If a decision on the classification of lenacil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (<sup>3</sup>) identifies the need for further information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3, Polar B and Polars, the Member States concerned shall request the submission of such information. They shall ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision. |
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| 178 | Picloram CAS No 1918-02-1 CIPAC No 174 | 4-amino-3,5,6-trichloropyridine-2-carboxylic acid | ≥ 920 g/kg | 1 January 2009 | 31 December 2023 | 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 picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In the overall assessment Member States must pay particular attention to: — the potential for ground water contamination where picloram is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate; The Member States concerned shall ensure that the notifier submits to the Commission: — further information to confirm that the monitoring analytical method applied in residue trials correctly quantifies the residues of picloram and its conjugates; — a soil photolysis study to confirm the evaluation of picloram degradation. They shall ensure that the notifier provides such information to the Commission by 30 June 2012. |
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| 180 | Bifenox CAS No 42576-02-3 CIPAC No 413 | Methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate | ≥ 970 g/kg impurities: max. 3 g/kg 2,4-dichlorophenol max. 6 g/kg 2,4-dichloroanisole | 1 January 2009 | 31 December 2023 | 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 bifenox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; (b) the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops; (c) the environmental conditions leading to the potential formation of nitrofen. Member States shall impose restrictions as regards the conditions of use, where appropriate in view of point (c). |
| 181 | Diflufenican CAS No 83164-33-4 CIPAC No 462 | 2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide | ≥ 970 g/kg | 1 January 2009 | 31 December 2023 | 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 diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate. |
| 182 | Fenoxaprop-P CAS No 113158-40-0 CIPAC No 484 | (R)-2[4-[(6-chloro-2-benzoxazolyl)oxy]-phenoxy]-propanoic acid | ≥ 920 g/kg | 1 January 2009 | 31 December 2023 | 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 fenoxaprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of non target plants, — the presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure, — the persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 183 | Fenpropidin CAS No 67306-00-7 CIPAC No 520 | (R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine | ≥ 960 g/kg (racemate) | 1 January 2009 | 31 December 2023 | 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 fenpropidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone. The Member States concerned shall request the submission of: — information to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin. They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval. |
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| 186 | Tritosulfuron CAS No 142469-14-5 CIPAC No 735 | 1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea | ≥ 960 g/kg The following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material: 2-Amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine: <0,2 g/kg | 1 December 2008 | 30 November 2023 | 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 tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic organisms, — the protection of small mammals. Conditions of use shall include risk mitigation measures, where appropriate. |
| 187 | Flutolanil CAS No 66332-96-5 CIPAC No 524 | α,α,α-trifluoro-3′-isopropoxy-o-toluanilide | ≥ 975 g/kg | 1 March 2009 | 28 February 2023 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 188 | Benfluralin CAS No 1861-40-1 CIPAC No 285 | N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine | ≥ 960 g/kg Impurities: — ethyl-butyl-nitrosamine: max. 0,1 mg/kg | 1 March 2009 | 28 February 2023 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report onbenfluralin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of the operators’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the residues in food of plant and animal origin and evaluate the dietary exposure of consumers, — the protection of birds, mammals, surface waters and aquatic organisms. In relauion to these identified risks, sisk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall request the submission of further studies on rotational crops metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 189 | Fluazinam CAS No 79622-59-6 CIPAC No 521 | 3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine | ≥ 960 g/kg Impurities: 5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidine — not more than 2 g/kg | 1 March 2009 | 28 February 2023 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of the operators’ and workers’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the residues in food of plant and animal origin and evaluate the dietary exposure of consumers, — the protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Annex provide such studies to the Commission within two years from the approval. |
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| 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 2023 | 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. |
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| 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 sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. |
| 273 | Sodium o-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 2022 | 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. |
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| 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 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 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. |
| 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 2023 | 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 2023 | 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. |
| 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 2023 | 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 2023 | 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 2023 | 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 2023 | 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. |
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| 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 2023 | 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. |
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| 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 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 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 2022 | | |
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| 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 2022 | 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 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 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. |
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| 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 2022 | 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 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 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 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 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. |
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| 292 | sulphur CAS No 7704-34-9 CIPAC No 18 | sulphur | ≥ 990 g/kg | 1 January 2010 | 31 December 2022 | 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 2022 | 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 2022 | Part A Only uses as insecticide, acaricide 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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, including its addendum, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
| 295 | Paraffin oil CAS No 8042-47-5 CIPAC No n.a. | paraffin oil | European Pharmacopoeia. 6,0 | 1 January 2010 | 31 December 2022 | 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. |
| 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 2023 | 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 2023 | | |
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| 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 2023 | 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 2023 | 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. |
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| 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 2023 | 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 2023 | 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 2023 | 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. |
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| 292 | sulphur CAS No 7704-34-9 CIPAC No 18 | sulphur | ≥ 990 g/kg | 1 January 2010 | 31 December 2023 | 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 2023 | 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 2023 | Part A Only uses as insecticide, acaricide 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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, including its addendum, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
| 295 | Paraffin oil CAS No 8042-47-5 CIPAC No n.a. | paraffin oil | European Pharmacopoeia. 6,0 | 1 January 2010 | 31 December 2023 | 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 2023 | 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 2023 | 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 2023 | 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 2022 | 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 2023 | 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 2023 | PART A Only uses as an insecticide in greenhouses with a permanent structure 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 Plants, Animals, Food and Feed shall be taken into account. In this overall assessment, Member States must pay particular attention to: (a) releases from greenhouses, such as condensation water, drain water, soil or artificial substrate, in order to preclude risks to aquatic organisms; (b) the protection of pollinator colonies purposely placed in the greenhouse; (c) the protection of operators and workers, so as to ensure that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate; (d) the protection of consumers in the case of processed commodities. Member States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport. Conditions of authorisation shall include risk mitigation measures and provide for adequate labelling of plant protection products. |
| 301 | 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 2023 | 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 2023 | 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. |
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| 5 | Imazalil CAS No 35554-44-0 73790-28-0 (replaced) CIPAC No 335 | (RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazole or allyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether | ≥ 950 g/kg | 1 January 2012 | 31 December 2024 | 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 imazalil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment Member States shall: (1) pay particular attention to the fact that the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material; (2) pay particular attention to the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels; (3) pay particular attention to the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure; (4) ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out; (5) pay particular attention to risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) route of degradation of imazalil in soil and surface water systems; (b) environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible; (c) a hydrolysis study to investigate the nature of residues in processed commodities. The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013. |
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| 6 | Prohexadione CAS No 127277-53-6 *(prohexadione-calcium)* CIPAC No 567 *(prohexadione)* No 567.020 *(prohexadione-calcium)* | 3,5-dioxo-4-propionylcyclohexanecarboxylic acid | ≥ 890 g/kg (expressed as prohexadione-calcium) | 1 January 2012 | 31 December 2022 | 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 prohexadione and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. |
| 6 | Prohexadione CAS No 127277-53-6 *(prohexadione-calcium)* CIPAC No 567 *(prohexadione)* No 567.020 *(prohexadione-calcium)* | 3,5-dioxo-4-propionylcyclohexanecarboxylic acid | ≥ 890 g/kg (expressed as prohexadione-calcium) | 1 January 2012 | 31 December 2023 | 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 prohexadione and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. |
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| 7 | Spiroxamine CAS No 1181134-30-8 CIPAC No 572 | 8-*tert*-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine (ISO) | ≥ 940 g/kg (diastereomers A and B combined) | 1 January 2012 | 31 December 2023 | 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 spiroxamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (1) the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment; (2) the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (3) the risk to aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment; (b) the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities; (c) the groundwater exposure assessment for metabolite M03 (<sup>7</sup>); (d) the risk to aquatic organisms. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by two years after the adoption of specific guidance and the information set out in points (b), (c) and (d) by 31 December 2013. |
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| 16 | Terbuthylazine CAS No 5915-41-3 CIPAC No 234 | N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine | ≥ 950 g/kg The following impurities are of toxicological concern and must not exceed the following levels in the technical material: — Propazine: maximum of 9 g/kg — Atrazine: maximum of 1 g/kg — Simazine: maximum of 9 g/kg | 1 January 2012 | 31 December 2024 | PART A Only uses as herbicide may be authorised. Use shall be limited to one application every three years on the same field at a maximum dose of 850 g terbuthylazine per hectare. 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 terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 and updated by the Standing Committee on Plants, Animals, Food and Feed on 24 March 2021 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the consumer risk assessment from exposure to metabolites of terbuthylazine, — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the risk to mammals and earthworms. Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate. |
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| 18 | 8-hydroxyquinoline CAS No 148-24-3 (8-hydroxyquinoline) CIPAC No 677 (8-hydroxyquinoline) | 8-quinolinol | ≥ 990 g/kg | 1 January 2012 | 31 December 2021 | PART A Only uses as fungicide and bactericide in greenhouses 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 8-hydroxyquinoline, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate. The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards: (1) the method of analysis for air; (2) a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013. |
| 18 | 8-hydroxyquinoline CAS No 148-24-3 (8-hydroxyquinoline) CIPAC No 677 (8-hydroxyquinoline) | 8-quinolinol | ≥ 990 g/kg | 1 January 2012 | 31 December 2023 | PART A Only uses as fungicide and bactericide in greenhouses 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 8-hydroxyquinoline, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate. The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards: (1) the method of analysis for air; (2) a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013. |
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| 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 May 2025 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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. |
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| 25 | Fenpyrazamine CAS No 473798-59-3 CIPAC No 832 | S-allyl 5-amino-2,3-dihydro-2-isopropyl-3-oxo-4-(o-tolyl)pyrazole-1-carbothioate | ≥ 960 g/kg The following manufacturing impurity is of toxicological concern and must not exceed the following amount in the technical material: Hydrazine: maximum content: < 0,0001 % (1 mg/kg) | 1 January 2013 | 31 December 2022 | 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 fenpyrazamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 and the Standing Committee on Plants, Animals, Food and Feed on 18 May 2020 shall be taken into account. The purity given in this entry is based on a commercial plant production. |
| 25 | Fenpyrazamine CAS No 473798-59-3 CIPAC No 832 | S-allyl 5-amino-2,3-dihydro-2-isopropyl-3-oxo-4-(o-tolyl)pyrazole-1-carbothioate | ≥ 960 g/kg The following manufacturing impurity is of toxicological concern and must not exceed the following amount in the technical material: Hydrazine: maximum content: < 0,0001 % (1 mg/kg) | 1 January 2013 | 31 December 2023 | 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 fenpyrazamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 and the Standing Committee on Plants, Animals, Food and Feed on 18 May 2020 shall be taken into account. The purity given in this entry is based on a commercial plant production. |
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| 26 | *Adoxophyes orana granulovirus* Culture collection No DSM BV-0001 CIPAC No 782 | Not applicable | No relevant impurities | 1 February 2013 | 31 January 2024 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Adoxophyes orana granulovirus*, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account. |
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| 54 | Disodium phosphonate CAS No 13708-85-5 CIPAC No 808 | disodium phosphonate | 281-337 g/kg (TK) ≥ 917 g/kg (TC) | 1 February 2014 | 31 January 2026 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on disodium phosphonate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to eutrophication of surface water. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) the chronic risk to fish; (b) the long term risk to earthworms and soil macro-organisms. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016. |
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| 55 | Penflufen CAS No 494793-67-8 CIPAC No 826 | 2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide | ≥ 950 g/kg 1:1 (R:S) ratio of enantiomers | 1 February 2014 | 31 May 2025 | PART A Only uses to treat seeds or other propagating materials before or during sowing or planting, may be authorised, limited to one application every third year 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 penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 and of the addendum to the review report on penflufen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 13 December 2017 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators; (b) the long-term risk to birds; (c) the protection of groundwater, when the substance is applied to regions with vulnerable soil and/or climatic conditions; (d) to the residues in surface water abducted for drinking water purposes, in or from areas where products containing penflufen are used. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the relevance of the metabolite M01 (penflufen-3-hydroxy-butyl) for groundwater if penflufen is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (<sup>18</sup>) as ‘carcinogen category 2’. That information shall be submitted to the Commission, the Member States and the Authority within 6 months from the notification of the classification decision concerning that substance. |
| 55 | Penflufen CAS No 494793-67-8 CIPAC No 826 | 2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide | ≥ 950 g/kg 1:1 (R:S) ratio of enantiomers | 1 February 2014 | 31 May 2025 | PART A Only uses to treat cereal seeds before or during sowing may be authorised, limited to one application every third year 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 penflufen, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment, Member States shall pay particular attention to: (a) the protection of operators; (b) the protection of birds; (c) the protection of groundwater, when the substance is applied to regions with vulnerable soil and/or climatic conditions; (d) to the residues in surface water abducted for drinking water purposes, in or from areas where products containing penflufen are used. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 56 | Orange oil CAS No 8028-48-6 (Orange extract) 5989-27-5 (D-limonene) CIPAC No 902 | (*R*)-4-isopropenyl-1-methylcyclohexene or *p*-mentha-1,8-diene | ≥ 945 g/kg (of D-limonene) The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (*Aurantii dulcis aetheroleum*) and ISO 3140:2011(E) | 1 May 2014 | 31 July 2024 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the metabolite fate of orange oil and the route and rate of degradation in soil and on the validation of endpoints used in the ecotoxicological risk assessment. The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016. |
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| | Common Name, Identification Numbers | IUPAC Name | Purity (<sup>1</sup>) | Date of approval | Expiration of approval | Specific provisions |
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| 1 | Flumetralin CAS No 62924-70-3 CIPAC No 971 | *N*-(2-chloro-6-fluorobenzyl)-*N*-ethyl-α,α,α-trifluoro-2,6-dinitro-*p*-toluidine | 980 g/kg The impurity Nitrosamine (calculated as nitroso-dimethylamine) shall not exceed 0,001 g/kg in the technical material. | 11 December 2015 | 11 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 flumetralin, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (c) the risk to herbivorous mammals; (d) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: 1. the technical specification of the active substance as manufactured (based on commercial scale production); 2. the compliance of the toxicity batches with the confirmed technical specification. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 11 June 2016. |
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| 2 | Esfenvalerate CAS No: 66230-04-4 CIPAC No: 481 | (αS)-α-cyano-3-phenoxybenzyl (2S)-2-(4-chlorophenyl)-3-methylbutyrate | 830 g/kg The impurity toluene shall not exceed 10 g/kg in the technical material. | 1 January 2016 | 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 esfenvalerate, 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 from esfenvalerate and the 2SαR-isomer of fenvalerate to aquatic organisms including the risk for bio-accumulation through the food chain, — the risk to honeybees and non-target arthropods, — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. |
| 1 | Flumetralin CAS No 62924-70-3 CIPAC No 971 | *N*-(2-chloro-6-fluorobenzyl)-*N*-ethyl-α,α,α-trifluoro-2,6-dinitro-*p*-toluidine | 980 g/kg The impurity Nitrosamine (calculated as nitroso-dimethylamine) shall not exceed 0,001 g/kg in the technical material. | 11 December 2015 | 11 December 2023 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flumetralin, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (c) the risk to herbivorous mammals; (d) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: 1. the technical specification of the active substance as manufactured (based on commercial scale production); 2. the compliance of the toxicity batches with the confirmed technical specification. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 11 June 2016. |
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| 2 | Esfenvalerate CAS No: 66230-04-4 CIPAC No: 481 | (αS)-α-cyano-3-phenoxybenzyl (2S)-2-(4-chlorophenyl)-3-methylbutyrate | 830 g/kg The impurity toluene shall not exceed 10 g/kg in the technical material. | 1 January 2016 | 31 December 2023 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on esfenvalerate, 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 from esfenvalerate and the 2SαR-isomer of fenvalerate to aquatic organisms including the risk for bio-accumulation through the food chain, — the risk to honeybees and non-target arthropods, — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 3 | Metsulfuron-methyl CAS No 74223-64-6 CIPAC No 441.201 | Methyl 2-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)benzoate | 967 g/kg | 1 April 2016 | 31 March 2023 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metsulfuron-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 consumers, — the protection of groundwater, — the protection of non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority by 30 September 2016 confirmatory information as regards the genotoxic potential of the metabolite triazine-amine (IN-A4098) to confirm that this metabolite is not genotoxic and not relevant for risk assessment. |
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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
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