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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
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General provisions applying to all substances listed in this Part:
—for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;
—Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.
— for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;
— Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.
| Number | Common name, identification numbers | IUPAC name | Purity (<sup>1</sup>) | Date of approval | Expiration of approval | Specific provisions |
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| 56 | Mecoprop CAS No 7085-19-0 CIPAC No 51 | (RS)-2-(4-chloro-o-tolyloxy)-propionic acid | 930 g/kg | 1 June 2004 | 31 May 2014 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States should pay particular attention to the protection of non-target arthropods. Risk mitigation measures should be applied, where appropriate. |
| 57 | Mecoprop-P CAS No 16484-77-8 CIPAC No 475 | (R)-2-(4-chloro-o-tolyloxy)-propionic acid | 860 g/kg | 1 June 2004 | 31 January 2020 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 57 | Mecoprop-P CAS No 16484-77-8 CIPAC No 475 | (R)-2-(4-chloro-o-tolyloxy)-propionic acid | 860 g/kg | 1 June 2004 | 31 January 2021 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. |
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| 81 | Pyraclostrobin CAS No 175013-18-0 CIPAC No 657 | methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate | 975 g/kg The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product. | 1 June 2004 | 31 January 2020 | Only uses as fungicide or plant growth regulator may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of aquatic organisms, especially fish, — should pay particular attention to the protection of terrestrial arthropods and earthworms. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| 81 | Pyraclostrobin CAS No 175013-18-0 CIPAC No 657 | methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate | 975 g/kg The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product. | 1 June 2004 | 31 January 2021 | Only uses as fungicide or plant growth regulator may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of aquatic organisms, especially fish, — should pay particular attention to the protection of terrestrial arthropods and earthworms. Risk mitigation measures should be applied where appropriate. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
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| 111 | Chlorpyrifos CAS No 2921-88-2 CIPAC No 221 | O,O-diethyl-O-3,5,6-trichloro-2-pyridyl phosphorothioate | ≥ 970 g/kg The impurity O,O,O,O-tetraethyl dithiopyrophosphate (Sulfotep) was considered of toxicological concern and a maximum level of 3 g/Kg is established. | 1 July 2006 | 31 January 2020 | PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorpyrifos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request chlorpyrifos has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 112 | Chlorpyrifos-methyl CAS No 5598-13-0 CIPAC No 486 | O,O-dimethyl-O-3,5,6-trichloro-2-pyridyl phosphorothioate | ≥ 960 g/kg The impurities O,O,O,O-tetramethyl dithiopyrophosphate (Sulfotemp) and OOO-trimethyl-O-(3,5,6-trichloro-2-pyridinyl) diphosphorodithioate (Sulfotemp -ester) were considered of toxicological concern and a maximum level of 5 g/Kg is established for each impurity. | 1 July 2006 | 31 January 2020 | PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorpyrifos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals in case of outdoor uses. They shall ensure that the notifiers at whose request chlorpyrifos-methyl has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 113 | Maneb CAS No 12427-38-2 CIPAC No 61 | manganese ethylenebis (dithiocarbamate) (polymeric) | ≥ 860 g/kg The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the maneb content. | 1 July 2006 | 31 January 2017 | 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 maneb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity. They shall ensure that the notifiers at whose request maneb has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 114 | Mancozeb CAS No 8018-01-7 (formerly 8065-67-5) CIPAC No 34 | Manganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc salt | ≥ 800 g/kg The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the mancozeb content. | 1 July 2006 | 31 January 2020 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mancozeb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity. They shall ensure that the notifiers at whose request mancozeb has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 115 | Metiram CAS No 9006-42-2 CIPAC No 478 | Zinc ammoniate ethylenebis(dithiocarbamate) — poly[ethylenebis(thiuramdisulfide)] | ≥ 840 g/kg The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the metiram content. | 1 July 2006 | 31 January 2020 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request metiram has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 116 | Oxamyl CAS No 23135-22-0 CIPAC No 342 | N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide | 970 g/kg | 1 August 2006 | 31 January 2020 | PART A Only uses as nematicide and insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account. In this overall assessment, — Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate. — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms. They shall ensure that the notifiers at whose request oxamyl has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 114 | Mancozeb CAS No 8018-01-7 (formerly 8065-67-5) CIPAC No 34 | Manganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc salt | ≥ 800 g/kg The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the mancozeb content. | 1 July 2006 | 31 January 2021 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mancozeb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for groundwater contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods and ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for developmental toxicity. They shall ensure that the notifiers at whose request mancozeb has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 115 | Metiram CAS No 9006-42-2 CIPAC No 478 | Zinc ammoniate ethylenebis(dithiocarbamate) — poly[ethylenebis(thiuramdisulfide)] | ≥ 840 g/kg The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the metiram content. | 1 July 2006 | 31 January 2021 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request metiram has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 116 | Oxamyl CAS No 23135-22-0 CIPAC No 342 | N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide | 970 g/kg | 1 August 2006 | 31 January 2021 | PART A Only uses as nematicide and insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account. In this overall assessment, — Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate. — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms. They shall ensure that the notifiers at whose request oxamyl has been included in this Annex provide such studies to the Commission within two years from the approval. |
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| 127 | Triticonazole CAS No 131983-72-7 CIPAC No 652 | (±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol | ≥ 950 g/kg | 1 February 2007 | 30 April 2020 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing triticonazole for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triticonazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate, — must pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones, — must pay particular attention to the protection of granivorous birds (long term risk). Conditions of authorisation should include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds. They shall ensure that the notifier at whose request triticonazole has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 128 | Dimoxystrobin CAS No 149961-52-4 CIPAC No 739 | (E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide | ≥ 980 g/kg | 1 October 2006 | 31 January 2020 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing dimoxystrobin for indoor uses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States — must pay particular attention to the protection of groundwater, when the active substance is applied in a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions; — must pay particular attention to the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of — a refined risk assessment for birds and mammals considering the formulated active substance; — a comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage. They shall ensure that the notifiers at whose request dimoxystrobin has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 128 | Dimoxystrobin CAS No 149961-52-4 CIPAC No 739 | (E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide | ≥ 980 g/kg | 1 October 2006 | 31 January 2021 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing dimoxystrobin for indoor uses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States — must pay particular attention to the protection of groundwater, when the active substance is applied in a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions; — must pay particular attention to the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of — a refined risk assessment for birds and mammals considering the formulated active substance; — a comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage. They shall ensure that the notifiers at whose request dimoxystrobin has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 129 | Clopyralid CAS No 1702-17-6 CIPAC No 455 | 3,6-dichloropyridine-2-carboxylic acid | ≥ 950 g/kg | 1 May 2007 | 30 April 2020 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing clopyralid for uses other than spring applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of non target plants and groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate. The concerned Member States shall request the submission of further studies to confirm the results on animal metabolism. They shall ensure that the notifiers at whose request clopyralid has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 130 | Cyprodinil CAS No 121522-61-2 CIPAC No 511 | (4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine | ≥ 980 g/kg | 1 May 2007 | 30 April 2020 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — must pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA 304075 in food of animal origin. They shall ensure that the notifiers at whose request cyprodinil has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 131 | Fosetyl CAS No 15845-66-6 CIPAC No 384 | Ethyl hydrogen phosphonate | ≥ 960 g/kg (expressed as fosetyl-Al) | 1 May 2007 | 30 April 2020 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Annex provide such studies to the Commission within two years from the approval. |
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| 184 | Quinoclamine CAS No 2797-51-5 CIPAC No 648 | 2-amino-3-chloro-1,4-naphthoquinone | ≥ 965 g/kg impurity: dichlone (2,3-dichloro-1,4-naphthoquinone) max. 15 g/kg | 1 January 2009 | 31 December 2018 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing quinoclamine for uses other than ornamentals or nursery plants, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on quinoclamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms, — the protection of birds and small mammals. Conditions of use shall include adequate risk mitigation measures, where appropriate. |
| 185 | Chloridazon CAS No 1698-60-8 CIPAC No 111 | 5-amino-4-chloro-2-phenylpyridazin-3(2H)-one | 920 g/kg The manufacturing impurity 4-amino-5-chloro-isomer is considered to be of toxicological concern and a maximum level of 60 g/kg is established. | 1 January 2009 | 31 December 2018 | PART A Only uses as herbicide in application max. of 2,6 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 chloridazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 December 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination from metabolites B and B1 in vulnerable zones, where appropriate. |
| 186 | Tritosulfuron CAS No 142469-14-5 CIPAC No 735 | 1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl)urea | ≥ 960 g/kg The following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material: 2-Amino-4-methoxy-6-(trifluormethyl)-1,3,5-triazine: <0,2 g/kg | 1 December 2008 | 30 November 2020 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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 | 29 February 2020 | 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 | 29 February 2020 | 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 | 29 February 2020 | 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. |
| 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 2021 | 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 2021 | 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 2021 | 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. |
| 190 | Fuberidazole CAS No 3878-19-1 CIPAC No 525 | 2-(2′-furyl)benzimidazole | ≥ 970 g/kg | 1 March 2009 | 28 February 2019 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fuberidazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — long-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply. Conditions of use shall include adequate risk mitigation measures, where appropriate. |
| 191 | Mepiquat CAS No 15302-91-7 CIPAC No 440 | 1,1-dimethylpiperidinium chloride (mepiquat chloride) | ≥ 990 g/kg | 1 March 2009 | 29 February 2020 | PART A Only uses as plant growth regulator may be authorised. PART B In assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. The Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers. |
| 191 | Mepiquat CAS No 15302-91-7 CIPAC No 440 | 1,1-dimethylpiperidinium chloride (mepiquat chloride) | ≥ 990 g/kg | 1 March 2009 | 28 February 2021 | PART A Only uses as plant growth regulator may be authorised. PART B In assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account. The Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers. |
| 192 | Diuron CAS No 330-54-1 CIPAC No 100 | 3-(3,4-dichlorophenyl)-1,1-dimethylurea | ≥ 930 g/kg | 1 October 2008 | 30 September 2020 | PART A Only uses as herbicide at rates not exceeding 0,5 kg/ha (areic average) 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 diuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety; conditions of use shall prescribe the use of personal protective equipment, if appropriate, — the protection of aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| 193 | Bacillus thuringiensis subsp. aizawai STRAIN: ABTS-1857 Culture collection: No SD-1372, STRAIN: GC-91 Culture collection: No NCTC 11821 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2020 | PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp.Aizawai ABTS-1857 (SANCO/1539/2008) and GC-91 (SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
| 194 | Bacillus thuringiensis subsp. israeliensis (serotype H-14) STRAIN: AM65-52 Culture collection: No ATCC-1276 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2020 | PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus thuringiensis subsp. israeliensis (serotype H-14) AM65-52(SANCO/1540/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
@@ -474,9 +474,9 @@
General provisions applying to all substances listed in this Part:
—for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;
—Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.
— for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;
— Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.
| Number | Common Name, Identification Numbers | IUPAC Name | Purity (<sup>1</sup>) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
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