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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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Changes on 2019-05-30
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| 33 | Cinidon-ethyl CAS No 142891-20-1 CIPAC No 598 | (Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate | 940 g/kg | 1 October 2002 | 30 September 2012 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions, — should pay particular attention to the protection of aquatic organisms. Conditions of authorisation must include risk mitigation measures, where appropriate. |
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| 35 | Famoxadone CAS No 131807-57-3 CIPAC No 594 | 3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione | 960 g/kg | 1 October 2002 | 30 June 2019 | Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms; — Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — Member States should pay particular attention to the protection of operators. |
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| 37 | Metalaxyl-M CAS No 70630-17-0 CIPAC No 580 | Methyl(R)-2-{[(2,6-dimethylphenyl)methoxy-acetyl] amino} propionate | 910 g/kg | 1 October 2002 | 30 June 2019 | Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Metalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: — particular attention should be given to the potential for groundwater contamination by the active substance or its degradation products CGA 62826, and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate. |
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| 39 | Flumioxazine CAS No 103361-09-7 CICAP No 578 | N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide | 960 g/kg | 1 January 2003 | 30 June 2019 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States: — must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate. |
| 35 | Famoxadone CAS No 131807-57-3 CIPAC No 594 | 3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione | 960 g/kg | 1 October 2002 | 30 June 2020 | Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms; — Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — Member States should pay particular attention to the protection of operators. |
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| 37 | Metalaxyl-M CAS No 70630-17-0 CIPAC No 580 | Methyl(R)-2-{[(2,6-dimethylphenyl)methoxy-acetyl] amino} propionate | 910 g/kg | 1 October 2002 | 30 June 2020 | Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Metalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: — particular attention should be given to the potential for groundwater contamination by the active substance or its degradation products CGA 62826, and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate. |
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| 39 | Flumioxazine CAS No 103361-09-7 CICAP No 578 | N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide | 960 g/kg | 1 January 2003 | 30 June 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 flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States: — must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate. |
| 40 | Deltamethrin CAS No 52918-63-5 CIPAC No 333 | (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate | 980 g/kg | 1 November 2003 | 31 October 2019 | Only uses as insecticide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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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| 43 | Ethoxysulfuron CAS No 126801-58-9 CIPAC No 591 | 3-(4,6-dimethoxypyrimidin-2-yl)-1-(2-ethoxyphenoxy-sulfonyl)urea | 950 g/kg | 1 July 2003 | 30 June 2013 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethoxysulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. Member States should pay particular attention to the protection of non-target aquatic plants and algae in drainage canals. Risk mitigation measures should be applied where appropriate. |
| 44 | Foramsulfuron CAS No 173159-57-4 CIPAC No 659 | 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea | 940 g/kg | 1 July 2003 | 31 July 2019 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on foramsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied, where appropriate. |
| 44 | Foramsulfuron CAS No 173159-57-4 CIPAC No 659 | 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea | 940 g/kg | 1 July 2003 | 31 July 2020 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on foramsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied, where appropriate. |
| 45 | Oxadiargyl CAS No 39807-15-3 CIPAC No 604 | 5-tert-butyl-3-(2,4-dichloro-5-propargyloxyphenyl)-1,3,4 oxadiazol-2-(3H)-one | 980 g/kg | 1 July 2003 | 30 June 2013 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiargyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of algae and aquatic plants. Risk mitigation measures should be applied where appropriate. |
| 46 | Cyazofamid CAS No 120116-88-3 CIPAC No 653 | 4-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide | 935 g/kg | 1 July 2003 | 31 July 2019 | Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyazofamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms; — Member States must pay particular attention to the degradation kinetics of the metabolite CTCA in soil, especially for Northern European regions. Risk mitigation measures or use restrictions should be applied where appropriate. |
| 46 | Cyazofamid CAS No 120116-88-3 CIPAC No 653 | 4-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide | 935 g/kg | 1 July 2003 | 31 July 2020 | Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyazofamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms; — Member States must pay particular attention to the degradation kinetics of the metabolite CTCA in soil, especially for Northern European regions. Risk mitigation measures or use restrictions should be applied where appropriate. |
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| 48 | Beta-cyfluthrin CAS No 68359-37-5 (unstated stereochemistry) CIPAC No 482 | (1RS,3RS;1RS,3SR)-3- (2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylic acid (SR)-α-cyano- (4-fluoro-3-phenoxy-phenyl)methyl ester | 965 g/kg | 1 January 2004 | 31 October 2019 | Only use as insecticide may be authorised Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops. For the implementation of the uniform principles, the conclusions of the review report on beta-cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures. |
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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. |
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| 83 | Alpha-cypermethrin CAS No 67375-30-8 CIPAC No | Racemate comprising (S)-α- cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate and (R)-α- cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate (= cis-2 isomer pair of cypermethrin) | 930 g/kg CIS-2 | 1 March 2005 | 31 July 2019 | Only uses as insecticide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on alpha-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. — Member States must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures. |
| 84 | Benalaxyl CAS No 71626-11-4 CIPAC No 416 | Methyl N-phenylacetyl–N-2, 6–xylyl–DL-alaninate | 960 g/kg | 1 March 2005 | 31 July 2019 | Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benalaxyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 85 | Bromoxynil CAS No 1689-84-5 CIPAC No 87 | 3,5 dibromo – 4- hydroxybenzonitrile | 970 g/kg | 1 March 2005 | 31 July 2019 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bromoxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals, in particular if the substance is applied in winter, and of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 86 | Desmedipham CAS No 13684-56-5 CIPAC No 477 | ethyl 3′-phenylcarbamoyloxycarbanilate ethyl 3-phenylcarbamoyloxyphenylcarbamate | Min. 970 g/kg | 1 March 2005 | 31 July 2019 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on desmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms and earthworms. Risk mitigation measures should be applied if appropriate |
| 83 | Alpha-cypermethrin CAS No 67375-30-8 CIPAC No | Racemate comprising (S)-α- cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate and (R)-α- cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate (= cis-2 isomer pair of cypermethrin) | 930 g/kg CIS-2 | 1 March 2005 | 31 July 2020 | Only uses as insecticide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on alpha-cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. — Member States must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures. |
| 84 | Benalaxyl CAS No 71626-11-4 CIPAC No 416 | Methyl N-phenylacetyl–N-2, 6–xylyl–DL-alaninate | 960 g/kg | 1 March 2005 | 31 July 2020 | Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benalaxyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 85 | Bromoxynil CAS No 1689-84-5 CIPAC No 87 | 3,5 dibromo – 4- hydroxybenzonitrile | 970 g/kg | 1 March 2005 | 31 July 2020 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bromoxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals, in particular if the substance is applied in winter, and of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 86 | Desmedipham CAS No 13684-56-5 CIPAC No 477 | ethyl 3′-phenylcarbamoyloxycarbanilate ethyl 3-phenylcarbamoyloxyphenylcarbamate | Min. 970 g/kg | 1 March 2005 | 31 July 2020 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on desmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms and earthworms. Risk mitigation measures should be applied if appropriate |
| 87 | Ioxynil CAS No 13684-83-4 CIPAC No 86 | 4- hydroxy- 3,5- di-iodobenzonitrile | 960 g/kg | 1 March 2005 | 28 February 2015 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ioxynil, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied in winter and to aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 88 | Phenmedipham CAS No 13684-63-4 CIPAC No 77 | methyl 3-(3-methylcarbaniloyloxy)carbanilate; 3-methoxycarbonylaminophenyl 3′-methylcarbanilate | Min. 970 g/kg | 1 March 2005 | 31 July 2019 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phenmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 88 | Phenmedipham CAS No 13684-63-4 CIPAC No 77 | methyl 3-(3-methylcarbaniloyloxy)carbanilate; 3-methoxycarbonylaminophenyl 3′-methylcarbanilate | Min. 970 g/kg | 1 March 2005 | 31 July 2020 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phenmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 89 | Pseudomonas chlororaphis Strain: MA 342 CIPAC No 574 | Not applicable | The amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the fermentate at the point of formulation of the product must not exceed the LOQ (2 mg/l). | 1 October 2004 | 30 April 2020 | Only uses as fungicide for seed dressing in closed seed dressing machinery may be authorised. When granting authorisations, the conclusions of the review report on Pseudomonas chlororaphis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account. In this overall assessment, Member States should pay particular attention to the safety of operators and workers. Risk mitigation measures should be applied where appropriate. |
| 90 | Mepanipyrim CAS No 110235-47-7 CIPAC No 611 | N-(4-methyl-6-prop-1-ynylpyrimidin-2-yl)aniline | 960 g/kg | 1 October 2004 | 30 April 2020 | Only uses as fungicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mepanipyrim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 30 March 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. |
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| 97 | S-metolachlor CAS No 87392-12-9 (S-isomer) 178961-20-1 (R-isomer) CIPAC No 607 | Mixture of: (aRS, 1 S)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (80-100 %) and: (aRS, 1 R)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (20-0 %) | ≥ 960 g/kg | 1 April 2005 | 31 July 2019 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on s-metolachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites CGA 51202 and CGA 354743, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied where appropriate. |
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| 99 | Etoxazole CAS No 153233-91-1 CIPAC No 623 | (RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro-1,3-oxazol-4-yl] phenetole | ≥ 948 g/kg | 1 June 2005 | 31 July 2019 | Only uses as acaricide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on etoxazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. |
| 97 | S-metolachlor CAS No 87392-12-9 (S-isomer) 178961-20-1 (R-isomer) CIPAC No 607 | Mixture of: (aRS, 1 S)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (80-100 %) and: (aRS, 1 R)-2-chloro-N-(6-ethyl-o-tolyl)-N-(2-methoxy-1-methylethyl)acetamide (20-0 %) | ≥ 960 g/kg | 1 April 2005 | 31 July 2020 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on s-metolachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential for groundwater contamination, particularly of the active substance and its metabolites CGA 51202 and CGA 354743, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied where appropriate. |
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| 99 | Etoxazole CAS No 153233-91-1 CIPAC No 623 | (RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro-1,3-oxazol-4-yl] phenetole | ≥ 948 g/kg | 1 June 2005 | 31 July 2020 | Only uses as acaricide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on etoxazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. |
| 100 | Tepraloxydim CAS No 149979-41-9 CIPAC No 608 | (EZ)-(RS)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one | ≥ 920 g/kg | 1 June 2005 | 31. May 2015 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tepraloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2004 shall be taken into account. In this overall assessment, Member States should pay particular attention to the protection of terrestrial non-target arthropods. Risk mitigation measures should be applied where appropriate. |
| 101 | Chlorothalonil CAS No 1897-45-6 CIPAC No 288 | Tetrachloroisophthalonitrile | 985 g/kg — Hexachlorobenzene: not more than 0,04 g/kg — Decachlorobiphenyl: not more than 0,03 g/kg | 1 March 2006 | 31 October 2019 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorothalonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee onthe Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Members States must pay particular attention to the protection of: — aquatic organisms, — groundwater, in particular with regards to the active substance and its metabolites R417888 and R611965 (SDS46851), when the substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of use should include risk mitigation measures, where appropriate. |
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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 2019 | PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate |
| 103 | Cypermethrin CAS No 52315-07-8 CIPAC No 332 | (RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate (4 isomer pairs: cis-1, cis-2, trans-3, trans-4) | 900 g/kg | 1 March 2006 | 31 October 2019 | PART A Only uses as insecticide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cypermethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate |
| 104 | Daminozide CAS No 1596-84-5 CIPAC No 330 | N-dimethylaminosuccinamic acid | 990 g/kg Impurities: — N-nitrosodimethylamine: not more than 2,0 mg/kg — 1,1-dimethylhydrazide: not more than 30 mg/kg | 1 March 2006 | 31 October 2019 | 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 2019 | PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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 2019 | PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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 |
| 109 | Bifenazate CAS No 149877-41-8 CIPAC No 736 | Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate | ≥ 950 g/kg | 1 December 2005 | 31 July 2019 | PART A Only uses as acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing bifenazate for uses other than on ornamental plants in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. |
| 110 | Milbemectin Milbemectin is a mixture of M.A3 and M.A4 CAS No M.A3: 51596-10-2 M.A4: 51596-11-3 CIPAC No 660 | M.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one M.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one | ≥ 950 g/kg | 1 December 2005 | 31 July 2019 | 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. |
| 109 | Bifenazate CAS No 149877-41-8 CIPAC No 736 | Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate | ≥ 950 g/kg | 1 December 2005 | 31 July 2020 | PART A Only uses as acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing bifenazate for uses other than on ornamental plants in greenhouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorization is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. |
| 110 | Milbemectin Milbemectin is a mixture of M.A3 and M.A4 CAS No M.A3: 51596-10-2 M.A4: 51596-11-3 CIPAC No 660 | M.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one M.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one | ≥ 950 g/kg | 1 December 2005 | 31 July 2020 | 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. |
| 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. |
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| 138 | Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713 Culture collection No: NRRL B -21661 CIPAC No not allocated | Not applicable | | 1 February 2007 | 30 April 2020 | PART A Only uses as fungicide and bactericide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus subtilis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. |
| 139 | Spinosad CAS No 131929-60-7 (Spinosyn A) 131929-63-0 (Spinosyn D) CIPAC No 636 | Spinosyn A: (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione Spinosyn D: (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D | ≥ 850 g/kg | 1 February 2007 | 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 spinosad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. In this overall assessment Member States — must pay particular attention to the protection of aquatic organisms; — must pay particular attention to the risk to earthworms when the substance is used in glasshouses. Conditions of use shall include risk mitigation measures, where appropriate. |
| 140 | Thiamethoxam CAS No 153719-23-4 CIPAC No 637 | (E,Z)-3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine | ≥ 980 g/kg | 1 February 2007 | 30 April 2019 | PART A Only uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiamethoxam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 and the conclusions of the revised addendum of the review report on thiamethoxam as finalised in the Standing Committee on Plants, Animals, Food and Feed on 27 April 2018 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the risk to groundwater; — the risk to aquatic organisms; — the risk to bees and bumble bees released for pollination in permanent greenhouses; — the exposure of bees via the consumption of contaminated water from the permanent greenhouses. Member States shall ensure that the seed coating shall only be performed in professional seed treatment facilities. Those facilities must apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised. Conditions of use shall include risk mitigation measures, where appropriate. |
| 141 | Fenamiphos CAS No 22224-92-6 CIPAC No 692 | (RS)-ethyl 4-methylthio-m-tolyl isopropyl-phosphoramidate | ≥ 940 g/kg | 1 August 2007 | 31 July 2019 | PART A Only uses as nematicide applied by drip irrigation in greenhouses with permanent structure 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 fenamiphos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, soil non-target organisms and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate. |
| 142 | Ethephon CAS No 16672-87-0 CIPAC No 373 | 2-chloroethyl-phosphonic acid | ≥ 910 g/kg (technical material — TC) The manufacturing impurities MEPHA (Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid) and 1,2-Dichloroethane are of toxicological concern and must not exceed respectively 20 g/kg and 0,5 g/kg in the technical material. | 1 August 2007 | 31 July 2019 | PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. |
| 141 | Fenamiphos CAS No 22224-92-6 CIPAC No 692 | (RS)-ethyl 4-methylthio-m-tolyl isopropyl-phosphoramidate | ≥ 940 g/kg | 1 August 2007 | 31 July 2020 | PART A Only uses as nematicide applied by drip irrigation in greenhouses with permanent structure 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 fenamiphos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic organisms, soil non-target organisms and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate. |
| 142 | Ethephon CAS No 16672-87-0 CIPAC No 373 | 2-chloroethyl-phosphonic acid | ≥ 910 g/kg (technical material — TC) The manufacturing impurities MEPHA (Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid) and 1,2-Dichloroethane are of toxicological concern and must not exceed respectively 20 g/kg and 0,5 g/kg in the technical material. | 1 August 2007 | 31 July 2020 | PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. |
| 143 | Flusilazole (<sup>2</sup>) CAS No 85509-19-9 CIPAC No 435 | Bis(4-fluorophenyl)(methyl) (1H-1,2.4-triazol-1-ylmethyl)silane | 925 g/kg | 1 January 2007 | 30 June 2008 (<sup>2</sup>) | PART A Only uses as fungicide on the following crops may be authorised: — cereals other than rice (<sup>2</sup>), — maize (<sup>2</sup>), — rape seed (<sup>2</sup>), — sugar beet (<sup>2</sup>), at rates not exceeding 200 g active substance per hectare per application. The following uses must not be authorised: — air application, — knapsack and hand-held applications, neither by amateur nor by professional users, — home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of: — aquatic organisms. An appropriate distance must be kept between treated areas and surface water bodies. This distance may depend on the application or not of drift reducing techniques or devices, — birds and mammals. Conditions of authorisation shall include risk mitigation measures, such as a judicious timing of the application and the selection of those formulations which, as a result of their physical presentation or the presence of agents that ensure an adequate avoidance, minimise the exposure of the concerned species, — operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flusilazole, and in particular Appendices I and II thereof, shall be taken into account. Member States must ensure that the authorisation holders report at the latest on 31 December of each year on incidences of operator health problems. Member States may require that elements, such as sales data and a survey of use patterns, are provided so that a realistic picture of the use conditions and the possible toxicological impact of flusilazole can be obtained. Member States shall request the submission of further studies to address the potential endocrine disrupting properties of flusilazole within two years after the adoption of the Test Guidelines on endocrine disruption by the Organisation for Economic Cooperation and Development (OECD). They shall ensure that the notifier at whose request flusilazole has been included in this Annex provide such studies to the Commission within two years of the adoption of the above test guidelines. |
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| 144 | Carbendazim CAS N<sup>o</sup> 10605-21-7 CIPAC N<sup>o</sup> 263 | Methyl benzimidazol-2-ylcarbamate | ≥ 980 g/kg Relevant impurities 2-amino-3-hydroxyphenazine (AHP): not more than 0,0005 g/kg 2,3-diaminophenazine (DAP): not more than 0,003 g/kg | 1 June 2011 | 30 November 2014 | PART A Only uses as fungicide on the following crops may be authorised: — cereals — rape seed — sugar and fodder beet — maize at rates not exceeding — 0,25 kg active substance per hectare per application for cereals and rape seed; — 0,075 kg active substance per hectare per application for sugar and fodder beet — 0,1 kg active substance per hectare per application for maize. The following uses must not be authorised: — air application; — knapsack and handheld applications neither by amateur nor by professional users; — home gardening. Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of: — aquatic organisms. Appropriate drift mitigation measures must be applied to minimise the exposure of surface water bodies. This should include keeping a distance between treated areas and surface water bodies alone or in combination with the use of drift-reducing techniques or devices; — earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, and, if necessary, the degree of concentration of the active substance; — birds (long term risk). Depending on the results of the risk assessment for specific uses, targeted mitigation measures to minimise the exposure may become necessary; — operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carbendazim, and in particular Appendices I and II thereof, shall be taken into account. The Member States concerned shall request that the applicant provides the following to the Commission: — by 1 December 2011 at the latest, information as regards the toxicological and ecotoxicological relevance of the impurity AEF037197; — by 1 June 2012 at the latest, the examination of the studies included in the list in the draft re-assessment report of 16 July 2009 (Volume 1, Level 4 ‘Further information’, pp. 155 – 157); — by 1 June 2013 at the latest, information on the fate and behaviour (route of aerobic degradation in soil) and the long term risk to birds. |
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| 145 | Captan CAS No 133-06-02 CIPAC No 40 | N-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide | ≥ 910 g/kg Impurities: Perchloromethylmercaptan (R005406): not more than 5 g/kg Folpet: not more than 10 g/kg Carbon tetrachloride not more than 0,1 g/Kg | 1 October 2007 | 31 July 2019 | PART A Only uses as fungicide can be authorised. PART B In assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; — the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate; — the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures. The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 146 | Folpet CAS No 133-07-3 CIPAC No 75 | N-(trichloromethylthio) phthalimide | ≥ 940 g/kg Impurities: Perchloromethylmercaptan (R005406): not more than 3,5 g/kg Carbon tetrachloride not more than 4 g/kg | 1 October 2007 | 31 July 2019 | PART A Only uses as fungicide can be authorised. PART B In assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; — the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 147 | Formetanate CAS No 23422-53-9 CIPAC No 697 | 3-dimethylaminomethyleneaminophenyl methylcarbamate | ≥ 910 g/kg | 1 October 2007 | 31 July 2019 | PART A Only uses as insecticide and acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 148 | Methiocarb CAS No 2032-65-7 CIPAC No 165 | 4-methylthio-3,5-xylyl methylcarbamate | ≥ 980 g/kg | 1 October 2007 | 31 July 2019 | PART A Only uses as repellent in seed treatment and insecticide may be authorised. PART B In assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methiocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of birds, mammals and non-target arthropods, ensuring that the conditions of authorisation include risk mitigation measures, where appropriate; — the operator and bystander safety, ensuring that the conditions of use prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers. |
| 149 | Dimethoate CAS No 60-51-5 CIPAC No 59 | O,O-Dimethyl-S-(N-methylcarbamoylmethyl) phosphorodithioate; 2-Dimethoxy-phosphinothioylthio-N-methylacetamide | ≥ 950 g/kg Impurities: — omethoate: not more than 2 g/kg — isodimethoate: not more than 3 g/kg | 1 October 2007 | 31 July 2019 | PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethoate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water; — must pay particular attention to the dietary exposure of consumers; — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops. They shall ensure that the notifier at whose request dimethoate has been included in this Annex provides such studies to the Commission within two years from the approval. |
| 150 | Dimethomorph CAS No 110488-70-5 CIPAC No 483 | (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl]morpholine | ≥ 965 g/kg | 1 October 2007 | 31 July 2019 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethomorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; — to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 145 | Captan CAS No 133-06-02 CIPAC No 40 | N-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide | ≥ 910 g/kg Impurities: Perchloromethylmercaptan (R005406): not more than 5 g/kg Folpet: not more than 10 g/kg Carbon tetrachloride not more than 0,1 g/Kg | 1 October 2007 | 31 July 2020 | PART A Only uses as fungicide can be authorised. PART B In assessing applications to authorise plant protection products containing captan for uses other than tomatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on captan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; — the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate; — the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures. The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 146 | Folpet CAS No 133-07-3 CIPAC No 75 | N-(trichloromethylthio) phthalimide | ≥ 940 g/kg Impurities: Perchloromethylmercaptan (R005406): not more than 3,5 g/kg Carbon tetrachloride not more than 4 g/kg | 1 October 2007 | 31 July 2020 | PART A Only uses as fungicide can be authorised. PART B In assessing applications to authorise plant protection products containing folpet for uses other than winter wheat Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on folpet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; — the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 147 | Formetanate CAS No 23422-53-9 CIPAC No 697 | 3-dimethylaminomethyleneaminophenyl methylcarbamate | ≥ 910 g/kg | 1 October 2007 | 31 July 2020 | PART A Only uses as insecticide and acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 148 | Methiocarb CAS No 2032-65-7 CIPAC No 165 | 4-methylthio-3,5-xylyl methylcarbamate | ≥ 980 g/kg | 1 October 2007 | 31 July 2020 | PART A Only uses as repellent in seed treatment and insecticide may be authorised. PART B In assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methiocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of birds, mammals and non-target arthropods, ensuring that the conditions of authorisation include risk mitigation measures, where appropriate; — the operator and bystander safety, ensuring that the conditions of use prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers. |
| 149 | Dimethoate CAS No 60-51-5 CIPAC No 59 | O,O-Dimethyl-S-(N-methylcarbamoylmethyl) phosphorodithioate; 2-Dimethoxy-phosphinothioylthio-N-methylacetamide | ≥ 950 g/kg Impurities: — omethoate: not more than 2 g/kg — isodimethoate: not more than 3 g/kg | 1 October 2007 | 31 July 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 dimethoate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water; — must pay particular attention to the dietary exposure of consumers; — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops. They shall ensure that the notifier at whose request dimethoate has been included in this Annex provides such studies to the Commission within two years from the approval. |
| 150 | Dimethomorph CAS No 110488-70-5 CIPAC No 483 | (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl]morpholine | ≥ 965 g/kg | 1 October 2007 | 31 July 2020 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dimethomorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment; — to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 151 | Glufosinate CAS No 77182-82-2 CIPAC No 437.007 | ammonium(DL)-homoalanin-4-yl(methyl)phosphinate | 950 g/kg | 1 October 2007 | 31. July 2018 | PART A Only uses as herbicide for band or spot application may be authorised at rates not exceeding 750 g active substance/ha (treated surface) per application and maximum two applications per year. PART B In assessing applications to authorise plant protection products containing glufosinate, notably as regards the operator and consumer exposure, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on glufosinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the operator, worker and bystander safety; conditions of authorisation shall include protective measures, where appropriate; (b) the potential for groundwater contamination, where the active substance is applied in regions with vulnerable soil or climatic conditions; (c) the protection of mammals, non-target arthropods and non-target plants. Conditions of authorisation shall include the application of drift reducing nozzles and spray shields and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate. |
| 152 | Metribuzin CAS No 21087-64-9 CIPAC No 283 | 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one | ≥ 910 g/kg | 1 October 2007 | 31 July 2019 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing metribuzin for uses other than in post-emergence selective herbicide in potatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metribuzin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of algae, aquatic plants, non-target plants outside the treated field and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further data to confirm the risk assessment for groundwater. They shall ensure that the notifiers at whose request metribuzin has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 153 | Phosmet CAS No 732-11-6 CIPAC No 318 | O,O-dimethyl S-phthalimidomethyl phosphorodithioate; N-(dimethoxyphosphinothioylthiomethyl)phatalimide | ≥ 950 g/kg Impurities: — phosmet oxon: not more than 0,8 g/kg — iso phosmet: not more than 0,4 g/kg | 1 October 2007 | 31 July 2019 | PART A Only uses as insecticide and acaricide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phosmet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water, — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds (acute risk) and herbivorous mammals (long term risk). They shall ensure that the notifier at whose request phosmet has been included in this Annex provides such studies to the Commission within two years from the approval. |
| 154 | Propamocarb CAS No 24579-73-5 CIPAC No 399 | Propyl 3-(dimethylamino) propylcarbamate | ≥ 920 g/kg | 1 October 2007 | 31 July 2019 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing propamocarb for uses other than foliar applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, as regards worker exposure and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propamocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Conditions of authorisation should include protective measures, where appropriate; — the transfer of soil residues for rotating or succeeding crops; — the protection of surface and groundwater in vulnerable zones; — the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. |
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| 156 | Pirimiphos-methyl CAS No 29232-93-7 CIPAC No 239 | O-2-diethylamino-6-methylpyrimidin-4-yl O,O-dimethylphosphorothioate | > 880 g/kg | 1 October 2007 | 31 July 2019 | PART A Only uses as insecticide for post harvest storage can be authorised. Hand-held applications shall not be authorised. PART B In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. |
| 152 | Metribuzin CAS No 21087-64-9 CIPAC No 283 | 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one | ≥ 910 g/kg | 1 October 2007 | 31 July 2020 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing metribuzin for uses other than in post-emergence selective herbicide in potatoes Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metribuzin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of algae, aquatic plants, non-target plants outside the treated field and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further data to confirm the risk assessment for groundwater. They shall ensure that the notifiers at whose request metribuzin has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 153 | Phosmet CAS No 732-11-6 CIPAC No 318 | O,O-dimethyl S-phthalimidomethyl phosphorodithioate; N-(dimethoxyphosphinothioylthiomethyl)phatalimide | ≥ 950 g/kg Impurities: — phosmet oxon: not more than 0,8 g/kg — iso phosmet: not more than 0,4 g/kg | 1 October 2007 | 31 July 2020 | PART A Only uses as insecticide and acaricide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phosmet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones and reduction of run-off and drainage inputs to surface water, — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds (acute risk) and herbivorous mammals (long term risk). They shall ensure that the notifier at whose request phosmet has been included in this Annex provides such studies to the Commission within two years from the approval. |
| 154 | Propamocarb CAS No 24579-73-5 CIPAC No 399 | Propyl 3-(dimethylamino) propylcarbamate | ≥ 920 g/kg | 1 October 2007 | 31 July 2020 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing propamocarb for uses other than foliar applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, as regards worker exposure and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propamocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Conditions of authorisation should include protective measures, where appropriate; — the transfer of soil residues for rotating or succeeding crops; — the protection of surface and groundwater in vulnerable zones; — the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate. |
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| 156 | Pirimiphos-methyl CAS No 29232-93-7 CIPAC No 239 | O-2-diethylamino-6-methylpyrimidin-4-yl O,O-dimethylphosphorothioate | > 880 g/kg | 1 October 2007 | 31 July 2020 | PART A Only uses as insecticide for post harvest storage can be authorised. Hand-held applications shall not be authorised. PART B In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. |
| 157 | Fipronil CAS No 120068-37-3 CIPAC No 581 | (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile | ≥ 950 g/kg | 1 October 2007 | 30 September 2017 | PART A Only uses as insecticide for use as seed treatment may be authorised. Uses shall only be authorised for seeds intended to be sown in greenhouses and seeds of leek, onions, shallots and the group of *Brassica* vegetables intended to be sown in fields and harvested before flowering. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2007 and the conclusions of the addendum of the review report on fipronil as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the packaging of the marketed products to avoid the generation of photodegradation products of concern; (b) the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (c) the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees. Member States shall also ensure that: (a) the seed coating shall only be performed in professional seed treatment facilities; those facilities shall apply the best available techniques in order to ensure that the release of dust during application to the seed, storage, and transport can be minimised; (b) adequate seed drilling equipment shall be used to ensure a high degree of incorporation in soil, minimisation of spillage and minimisation of dust emission; (c) the label of the treated seeds shall include the indication that the seeds were treated with fipronil and sets out the risk mitigation measures provided for in the authorisation; (d) monitoring programmes shall be initiated to verify the real exposure of bees to fipronil in areas extensively used by bees for foraging or by beekeepers, where and as appropriate. Conditions of use shall include risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the risk to pollinators other than honey bees; (b) the acute and long-term risk to colony survival and development, and the risk to bee brood from plant and soil metabolites, except the soil photolysis metabolites; (c) the potential exposure to dust drift emitted during the drilling procedure and the acute and long-term risk to colony survival and development, and the risk to bee brood for situations where bees forage on vegetation exposed to dust drift; (d) the acute and long-term risk to colony survival and development, and the risk to bee brood from foraging on insect honeydew; (e) the potential exposure to guttation fluid and the acute and long-term risk to colony survival and development, and the risk to bee brood; (f) the potential exposure to residues in nectar and pollen, honeydew and guttation fluid of succeeding crops or weeds occurring in fields, including the persistent soil metabolites (RPA 200766, MB 46136 and MB 45950). The notifier shall submit that information to the Commission, the Member States and the Authority by 30 March 2015. |
| 158 | Beflubutamid CAS No 113614-08-7 CIPAC No 662 | (RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide | ≥ 970 g/kg | 1 December 2007 | 31 July 2019 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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. |
| 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 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 beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
| 159 | Spodoptera exigua nuclear polyhedrosis virus CIPAC No Not allocated | Not applicable | | 1 December 2007 | 30 November 2017 | PART 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 Spodoptera exigua NPV, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account. |
| 160 | Prosulfocarb CAS No 52888-80-9 CIPAC No 539 | S-benzyl dipropyl(thiocarbamat) | 970 g/kg | 1 November 2008 | 31 October 2019 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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 2019 | 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 2019 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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 2019 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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 2019 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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. |
| 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 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 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 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 boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention — to the operator safety, — to the long term risk to birds and soil organisms, — to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include adequate risk mitigation measures, where appropriate. |
| 165 | Carvone CAS No 99-49-0 (d/l mixture) CIPAC No 602 | 5-isopropenyl-2-methylcyclohex-2-en-1-one | ≥ 930 g/kg with a d/l ratio of at least 100:1 | 1 August 2008 | 31 July 2019 | PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carvone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to the operator safety. Conditions of use shall include risk mitigation measures, where appropriate. |
| 166 | Fluoxastrobin CAS No 361377-29-9 CIPAC No 746 | (E)-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime | ≥ 940 g/kg | 1 August 2008 | 31 July 2019 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield, — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate, — the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of: — data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures, — data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff. They shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 167 | Paecilomyces lilacinus (Thom) Samson 1974 strain 251 (AGAL: No 89/030550) CIPAC No 753 | Not applicable | | 1 August 2008 | 31 July 2019 | PART A Only uses as nematicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Paecilomyces lilacinus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers), — the protection of leaf dwelling non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. |
| 168 | Prothioconazole CAS No 178928-70-6 CIPAC No 745 | (RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione | ≥ 970 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: — Toluene: < 5 g/kg — Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD) | 1 August 2008 | 31 July 2019 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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. |
| 166 | Fluoxastrobin CAS No 361377-29-9 CIPAC No 746 | (E)-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime | ≥ 940 g/kg | 1 August 2008 | 31 July 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 fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield, — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate, — the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of: — data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures, — data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff. They shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 167 | Paecilomyces lilacinus (Thom) Samson 1974 strain 251 (AGAL: No 89/030550) CIPAC No 753 | Not applicable | | 1 August 2008 | 31 July 2020 | PART A Only uses as nematicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Paecilomyces lilacinus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety (although there was no need to set an AOEL, as a general rule, microorganisms should be considered as potential sensitisers), — the protection of leaf dwelling non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. |
| 168 | Prothioconazole CAS No 178928-70-6 CIPAC No 745 | (RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione | ≥ 970 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: — Toluene: < 5 g/kg — Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD) | 1 August 2008 | 31 July 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 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 2019 | 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 2019 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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 2019 | 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. |
@@ -258,7 +259,7 @@
| 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. |
| 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. |
| 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 2019 | 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. |
| 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. |
| 195 | Bacillus thuringiensis subsp. kurstaki STRAIN: ABTS 351 Culture collection: No ATCC SD-1275 STRAIN: PB 54 Culture collection: No CECT 7209 STRAIN: SA 11 Culture collection: No NRRL B-30790 STRAIN: SA 12 Culture collection: No NRRL B-30791 STRAIN: EG 2348 Culture collection: No NRRL B-18208 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 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. kurstaki ABTS 351 (SANCO/1541/2008), PB 54 (SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
@@ -366,7 +367,7 @@
| 265 | 2,5-Dichlorobenzoic acid methylester CAS No 2905-69-3 CIPAC No 686 | methyl-2,5-dichlorobenzoate | ≥ 995 g/kg | 1 September 2009 | 31 August 2022 | PART A Only indoor uses as plant growth regulator and fungicide for grafting of grapevines may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. |
| 266 | Metamitron CAS No 41394-05-2 CIPAC No 381 | 4-amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one | ≥ 960 g/kg | 1 September 2009 | 31 August 2022 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate; — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to birds and mammals, and non-target terrestrial plants. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. |
| 267 | Sulcotrione CAS No 99105-77-8 CIPAC No 723 | 2-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione | ≥ 950 g/kg Impurities: — hydrogen cyanide: not more than 80 mg/kg — toluene: not more than 4 g/kg | 1 September 2009 | 31 August 2022 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulcotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — the risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information on the degradation in soil and water of the cyclohexadione moiety and the long-term risk to insectivorous birds. They shall ensure that the notifier at whose request sulcotrione has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. |
| 268 | Tebuconazole CAS No 107534-96-3 CIPAC No 494 | (RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-pentan-3-ol | ≥ 905 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as fungicide and plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers to the tebuconazole (triazole) metabolites; — the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole; — the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. |
| 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 2020 | PART A Only uses as fungicide and plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers to the tebuconazole (triazole) metabolites; — the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole; — the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. |
| 269 | Triadimenol CAS No 55219-65-3 CIPAC No 398 | (1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol | ≥ 920 g/kg isomer A (1RS,2SR), isomer B (1RS,2RS) Diastereomer A, RS + SR, range: 70 to 85 % Diastereomer B, RR + SS, range: 15 to 30 % | 1 September 2009 | 31 August 2019 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure; — the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission: — further information on the specification; — information to further address the risk assessment for birds and mammals. — information to further address the risk of endocrine disrupting effects on fish. They shall ensure that the notifier at whose request triadimenol has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. |
| 270 | Methomyl CAS No 16752-77-50 CIPAC No 264 | S-methyl (EZ)-N-(methylcarbamoyloxy)thioacetimidate | ≥ 980 g/kg | 1 September 2009 | 31 August 2019 | PART A Only uses as insecticide on vegetables may be authorised at rates not exceeding 0,25 kg active substance per hectare per application and for a maximum of 2 applications per season. Authorisations shall be limited to professional users. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methomyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 June 2009 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the operator safety: conditions of use shall prescribe the use of adequate personal protective equipment. Special attention shall be paid to the exposure of operators using knapsacks or other hand-held application equipment, — the protection of birds, — the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles, — the protection of non-target arthropods, in particular bees: risk mitigation measures to avoid all contact with bees shall be applied. Member States shall ensure that methomyl-based formulations contain effective repelling and/or emetic agents. Where appropriate, conditions of authorisation shall include further risk mitigation measures. |
| 271 | Bensulfuron CAS No 83055-99-6 CIPAC No 502.201 | α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluic acid (bensulfuron) methyl α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluate (bensulfuron-methyl) | ≥ 975 g/kg | 1 November 2009 | 31 October 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. |
@@ -537,7 +538,7 @@
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| 30 | *Zucchini Yellow Mosaic Virus* — weak strain ATCC accession number: PV-593 | Not applicable | ≥ 0,05 mg/l | 1 June 2013 | 31 May 2023 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Zucchini Yellow Mosaic Virus* — weak strain, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to non-target plants, if the crop plants are co-infected with another virus which can be transmitted by aphids. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 31 | Cyflumetofen CAS No 400882-07-7 CIPAC No 721 | 2-methoxyethyl (*RS*)-2-(4-*tert*-butylphenyl)-2-cyano-3-oxo-3-(*α,α,α*-trifluoro-o-tolyl)propionate | ≥ 975 g/kg (racemic) | 1 June 2013 | 31 May 2023 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyflumetofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers; — the protection of groundwater, when the substance is applied in regions with vulnerable soils and/or climatic conditions; — the protection of drinking water; — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, like the use of personal protection equipment, where appropriate. The applicant shall submit confirmatory information as regards: (a) the possible mutagenic potential of the metabolite B3 (2-(trifluoromethyl) benzamide), by excluding an *in vivo* relevance of observed *in vitro* effects by an appropriate test protocol (*in vivo* Comet assay); (b) additional information to establish an ARfD for metabolite B3; (c) further ecotoxicological studies and assessments for aquatic vertebrates that cover their full life-cycle. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 May 2015. |
| 31 | Cyflumetofen CAS No 400882-07-7 CIPAC No 721 | 2-methoxyethyl (*RS*)-2-(4-*tert*-butylphenyl)-2-cyano-3-oxo-3-(*α,α,α*-trifluoro-o-tolyl)propionate | ≥ 975 g/kg (racemic) | 1 June 2013 | 31 May 2023 | Plant protection products containing cyflumetofen shall only be authorised for uses where the level of metabolite B3 in groundwater is expected to be below 0,1 μg/L. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyflumetofen, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account. In this overall assessment, Member States shall pay particular attention to: — the protection of operators and workers; — the protection of groundwater, in particular for metabolite B3, when the substance is applied in regions with vulnerable soils and/or climatic conditions; — the protection of drinking water; — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 32 | *Trichoderma atroviride* strain I-1237 CNCM number: I-1237 | Not applicable | cfu/g ( spores/g) | 1 June 2013 | 31 May 2023 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Trichoderma atroviride* strain I-1237, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that *Trichoderma atroviride* strain I-1237 is to be considered a potential sensitiser. Conditions of use shall include risk mitigation measures where appropriate. |
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@@ -831,6 +832,8 @@
| 14 | *Ampelomyces quisqualis* strain AQ10 | Not applicable | Minimum content of viable spores: 3,0 × 10<sup>12</sup> CFU/kg | 1 August 2018 | 1 August 2033 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on *Ampelomyces quisqualis* strain AQ10, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are *per se* considered as potential sensitizers and ensuring that adequate personal protective equipment is included as a condition of use. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 15 | *Clonostachys rosea* strain J1446 Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212 | Not applicable | Not applicable Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA. | 1 April 2019 | 31 March 2034 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on *Clonostachys rosea* strain J1446, 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 specification of technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern; — the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use; — the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of *Clonostachys rosea* J1446. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbial contamination as referred to in the Working Document SANCO/12116/2012 (<sup>2</sup>). Conditions of use shall include risk mitigation measures, where appropriate. |
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| 16 | ABE-IT 56 (components of lysate of *Saccharomyces cerevisiae* strain DDSF623) | Not Applicable | 1 000 g/kg (active substance) | 20 May 2019 | 20 May 2034 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ABE-IT 56 (components of lysate of *Saccharomyces cerevisiae* strain DDSF623) and in particular Appendices I and II thereof, shall be taken into account. |
| (<sup>1</sup>)Further details on identity and specification of active substance are provided in the review report. (<sup>2</sup>)https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf | | | | | | |
### PART E
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
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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
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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