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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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| 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 2023 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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 | 15 February 2025 | 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. |
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| 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 | 15 March 2025 | 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 2023 | Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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. |
| 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 | 15 November 2024 | 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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| 108 | MCPB CAS No 94-81-5 CIPAC No 50 | 4-(4-chloro-o-tolyloxy)butyric acid | ≥ 920 g/kg | 1 May 2006 | 31 October 2023 | PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones |
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| 110 | Milbemectin Milbemectin is a mixture of M.A3 and M.A4 CAS No M.A3: 51596-10-2 M.A4: 51596-11-3 CIPAC No 660 | M.A3: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one M.A4: (10E,14E,16E,22Z)-(1R,4S,5′S,6R,6′R,8R,13R,20R,21R,24S)-6′-ethyl-21,24-dihydroxy-5′,11,13,22-tetramethyl-3,7,19-trioxatetracyclo[15.6.1. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one | ≥ 950 g/kg | 1 December 2005 | 31 July 2023 | PART A Only uses as acaricide or insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. |
| 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 | 15 February 2025 | PART A Only uses as acaricide or insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. |
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| 115 | Metiram CAS No 9006-42-2 CIPAC No 478 | Zinc ammoniate ethylenebis(dithiocarbamate) — poly[ethylenebis(thiuramdisulfide)] | ≥ 840 g/kg The manufacturing impurity ethylene thiourea is considered to be of toxicological concern and must not exceed 0,5 % of the metiram content. | 1 July 2006 | 31 January 2024 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metiram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. Member States must pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions. Member States must pay particular attention to the residues in food and evaluate the dietary exposure of consumers. Member States must pay particular attention to the protection of birds, mammals, aquatic organisms and non target arthropods and must ensure that the conditions of authorisation include risk mitigation measures. Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals. They shall ensure that the notifiers at whose request metiram has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 116 | Oxamyl CAS No 23135-22-0 CIPAC No 342 | N,N-dimethyl-2-methylcarbamoyloxyimino-2-(methylthio) acetamide | 970 g/kg | 1 August 2006 | 31 October 2023 | PART A Only uses as nematicide and insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxamyl, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2005 shall be taken into account. In this overall assessment, — Member States must pay particular attention to the protection of birds and mammals, earthworms, aquatic organisms, surface water, and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate. — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for ground water contamination in acidic soils, birds and mammals and earthworms. They shall ensure that the notifiers at whose request oxamyl has been included in this Annex provide such studies to the Commission within two years from the approval. |
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| 135 | Pyrimethanil CAS No 53112-28-0 CIPAC No not allocated | N-(4,6-dimethylpyrimidin-2-yl) aniline | ≥ 975 g/kg (the manufacturing impurity cyanamide is considered to be of toxicological concern and must not exceed 0,5 g/kg in the technical material) | 1 June 2007 | 15 March 2025 | 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 pyrimethanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment. The Member States concerned shall request the submission of further studies to confirm the risk assessment to fish. They shall ensure that the notifiers at whose request pyrimethanil has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 136 | Triclopyr CAS No 055335-06-3 CIPAC No 376 | 3,5,6-trichloro-2-pyridyloxyacetic acid | ≥ 960 g/kg (as Triclopyr butoxyethyl ester) | 1 June 2007 | 15 December 2024 | PART A Only uses as herbicide may be authorised. Only uses with a total application per year of maximum 480 g active substance per hectare shall be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014 shall be taken into account. In this overall assessment Member States: — shall pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated in vulnerable zones, where appropriate, — shall pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| 137 | Metrafenone CAS No 220899-03-6 CIPAC No 752 | 3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone | ≥ 940 g/kg | 1 February 2007 | 15 December 2024 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metrafenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| 138 | Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713 Culture collection No: NRRL B -21661 CIPAC No not allocated | Not applicable | | 1 February 2007 | 15 August 2024 | 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. |
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| 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 | 15 March 2025 | 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. |
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| 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 2023 | PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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. |
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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 2023 | 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 2023 | 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 2023 | 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. |
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| 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 2023 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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. |
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| 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 2023 | 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. |
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| 154 | Propamocarb CAS No 24579-73-5 CIPAC No 399 | Propyl 3-(dimethylamino) propylcarbamate | ≥ 920 g/kg | 1 October 2007 | 31 July 2023 | 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 2023 | 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. |
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| 158 | Beflubutamid CAS No 113614-08-7 CIPAC No 662 | (RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide | ≥ 970 g/kg | 1 December 2007 | 31 July 2023 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
| 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 | 15 November 2024 | 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. |
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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 | 15 November 2024 | 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 | 15 February 2025 | 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 | 15 February 2025 | 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. |
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| 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 | 15 February 2025 | 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. |
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| 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 | 15 February 2025 | 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. |
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| 154 | Propamocarb CAS No 24579-73-5 CIPAC No 399 | Propyl 3-(dimethylamino) propylcarbamate | ≥ 920 g/kg | 1 October 2007 | 15 June 2025 | 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 | 15 June 2025 | 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. |
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| 158 | Beflubutamid CAS No 113614-08-7 CIPAC No 662 | (RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide | ≥ 970 g/kg | 1 December 2007 | 31 October 2026 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 160 | Prosulfocarb CAS No 52888-80-9 CIPAC No 539 | S-benzyl dipropyl(thiocarbamat) | 970 g/kg | 1 November 2008 | 31 October 2023 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone. |
| 161 | Fludioxonil CAS No 131341-86-1 CIPAC No 522 | 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile | 950 g/kg | 1 November 2008 | 31 October 2023 | PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted and: — must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones, — must pay particular attention to the protection of fish and aquatic invertebrates. Conditions of authorisation should include risk mitigation measures, where appropriate. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. |
| 162 | Clomazone CAS No 81777-89-1 CIPAC No 509 | 2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one | 960 g/kg | 1 November 2008 | 31 October 2023 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones. |
| 163 | Benthiavalicarb CAS No 413615-35-7 CIPAC No 744 | [(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamic acid | ≥ 910 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: 6,6′-difluoro-2,2′-dibenzothiazole: < 3,5 mg/kg bis(2-amino-5-fluorophenyl) disulfide: < 14 mg/kg | 1 August 2008 | 31 July 2023 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benthiavalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety, — the protection of non-target arthropods. Conditions of use shall include adequate risk mitigation measures, where appropriate. In assessing applications to authorise plant protection products containing benthiavalicarb for uses other than in glasshouses, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| 164 | Boscalid CAS No 188425-85-6 CIPAC No 673 | 2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide | ≥ 960 g/kg | 1 August 2008 | 31 July 2023 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention — to the operator safety, — to the long term risk to birds and soil organisms, — to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include adequate risk mitigation measures, where appropriate. |
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| 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 2023 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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. |
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| 168 | Prothioconazole CAS No 178928-70-6 CIPAC No 745 | (RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione | ≥ 970 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: — Toluene: < 5 g/kg — Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD) | 1 August 2008 | 31 July 2023 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety in spray applications. Conditions of use shall include adequate protective measures, — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of: — information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin, — a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds, — information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment. They shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 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 | 15 November 2024 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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 | 15 April 2026 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention — to the operator safety, — to the long term risk to birds and soil organisms, — to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include adequate risk mitigation measures, where appropriate. |
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| 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 | 15 June 2025 | 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. |
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| 168 | Prothioconazole CAS No 178928-70-6 CIPAC No 745 | (RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione | ≥ 970 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: — Toluene: < 5 g/kg — Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD) | 1 August 2008 | 15 August 2025 | 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 2023 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. |
| 170 | Nicosulfuron CAS No 111991-09-4 CIPAC No 709 | 2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide or 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea | ≥ 910 g/kg | 1 January 2009 | 31 December 2023 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions, — the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone, — the protection of groundwater and surface water under vulnerable soil and climatic conditions. |
| 171 | Clofentezine CAS No 74115-24-5 CIPAC No 418 | 3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine | ≥ 980 g/kg (dry material) | 1 January 2009 | 31 December 2023 | PART A Only uses as acaricide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material; — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate; — the potential for long range transport via air; — the risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier presents to the Commission a monitoring programme to assess the potential for long-range atmospheric transport of clofentezine and the related environmental risks by 31 July 2011. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State and to the Commission by 31 July 2013. The Member States concerned shall ensure that the notifier submits to the Commission confirmatory studies on clofentezine metabolites relating to their toxicological and environmental risk assessment by 30 June 2012. |
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| 191 | Mepiquat CAS No 15302-91-7 CIPAC No 440 | 1,1-dimethylpiperidinium chloride (mepiquat chloride) | ≥ 990 g/kg | 1 March 2009 | 29 February 2024 | 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. |
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| 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 | 15 August 2024 | 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 | 15 August 2024 | 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 | 15 August 2024 | 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. |
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| 197 | Beauveria bassiana STRAIN: ATCC 74040 Culture collection: No ATCC 74040 STRAIN: GHA Culture collection: No ATCC 74250 | Not applicable | Max level of beauvericin: 5 mg/kg | 1 May 2009 | 30 September 2025 | 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 Beauveria bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
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| 213 | Fenpyroximate CAS No 134098-61-6 CIPAC No 695 | tert-butyl (E)-alpha-(1,3-dimethyl-5-phenoxypyrazol-4-ylmethyleneamino-oxy)-p-toluate | > 960 g/kg | 1 May 2009 | 15 June 2026 | PART A Only uses as acaricide may be authorised. The following uses must not be authorised: — applications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpyroximate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. The Member States concerned shall request the submission of information to further address: — the risk to aquatic organisms from metabolites containing the benzyl moiety, — the risk of biomagnification in aquatic food chains. They shall ensure that the notifiers at whose request fenpyroximate has been included in this Annex provide such information to the Commission within two years from the approval. |
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| 215 | Aclonifen CAS No 74070-46-5 CIPAC No 498 | 2-chloro-6-nitro-3-phenoxyaniline | ≥ 970 g/kg The impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established. | 1 August 2009 | 31 July 2023 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the residues in rotational crops and evaluate the dietary exposure of consumers, — the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants. They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval. |
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| 217 | Metazachlor CAS No 67129-08-2 CIPAC No 411 | 2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide | ≥ 940 g/kg The manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,05 % is established. | 1 August 2009 | 31 July 2023 | PART A Only uses as herbicide may be authorised. Applications shall be limited to a total dose of not more than 1,0 kg metazachlor/ha in a three-year period on the same field. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate. If metazachlor is classified under Regularion (EC) No 1272/2008 as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer. They shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision. |
| 215 | Aclonifen CAS No 74070-46-5 CIPAC No 498 | 2-chloro-6-nitro-3-phenoxyaniline | ≥ 970 g/kg The impurity phenol is of toxicological concern and a maximum level of 5 g/kg is established. | 1 August 2009 | 31 October 2026 | PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material, — the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure, — the residues in rotational crops and evaluate the dietary exposure of consumers, — the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate. The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants. They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval. |
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| 217 | Metazachlor CAS No 67129-08-2 CIPAC No 411 | 2-chloro-N-(pyrazol-1-ylmethyl)acet-2′,6′-xylidide | ≥ 940 g/kg The manufacturing impurity toluene is considered to be of toxicological concern and a maximum level of 0,05 % is established. | 1 August 2009 | 31 October 2026 | PART A Only uses as herbicide may be authorised. Applications shall be limited to a total dose of not more than 1,0 kg metazachlor/ha in a three-year period on the same field. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, — the protection of aquatic organisms, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate. If metazachlor is classified under Regularion (EC) No 1272/2008 as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer. They shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision. |
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| 218 | Acetic acid CAS No 64-19-7 CIPAC 838 | acetic acid | ≥ 980 g/kg | 1 September 2009 | 31 August 2023 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators, the protection of groundwater and the protection of aquatic organisms. Conditions of use shall include, where appropriate, risk mitigation measures. The notifier shall submit confirmatory information as regards: — the acute and long-term risk to birds and mammals, — the risk to honeybees, — the risk to non-target arthropods. The notifier shall submit that information to the Commission, the Member States and the Authority by 31 December 2015. |
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| 294 | Paraffin oils CAS No 64742-46-7 CAS No 72623-86-0 CAS No 97862-82-3 CIPAC No n.a. | paraffin oil | European Pharmacopoeia 6.0 | 1 January 2010 | 31 December 2023 | Part A Only uses as insecticide, acaricide and fungicide may be authorised. Part B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, including its addendum, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
| 295 | Paraffin oil CAS No 8042-47-5 CIPAC No n.a. | paraffin oil | European Pharmacopoeia. 6,0 | 1 January 2010 | 31 December 2023 | PART A Only uses as insecticide and acaricide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on paraffin oil 8042-47-5, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. The Member States concerned shall request: The submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6,0 They shall ensure that the notifier provides such information to the Commission by 30 June 2010. |
| 296 | Cyflufenamid CAS No 180409-60-3 CIPAC No 759 | (Z)-N-[α-(cyclopropylmethoxyimino) – 2,3-difluoro-6-(trifluoromethyl)benzyl]-2-phenylacetamide | > 980 g/kg | 1 April 2010 | 31 March 2024 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyflufenamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 October 2009 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| 297 | Fluopicolide CAS No 239110-15-7 CIPAC No 787 | 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide | ≥ 970 g/kg The impurity toluene must not exceed 3 g/kg in the technical material. | 1 June 2010 | 31 May 2023 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the protection of aquatic organisms, — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — to the risk to operators during application, — the potential for long range transport via air. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest. |
| 297 | Fluopicolide CAS No 239110-15-7 CIPAC No 787 | 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide | ≥ 970 g/kg The impurity toluene must not exceed 3 g/kg in the technical material. | 1 June 2010 | 31 August 2026 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the protection of aquatic organisms, — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — to the risk to operators during application, — the potential for long range transport via air. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest. |
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| 299 | 2-phenylphenol (including its salts such as the sodium salt) CAS No 90-43-7 CIPAC No 246 | biphenyl-2-ol | ≥ 998 g/kg | 1 January 2010 | 31 December 2023 | PART A Only uses as a post-harvest fungicide for indoor use may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2-phenylphenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009, as amended in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account. In this overall assessment Member States must pay particular attention: — to the protection of operators and workers and ensure that conditions of use prescribe the application of adequate personal protective equipment, — to put in place appropriate waste management practices to handle the waste solution remaining after application, including the cleaning water of the drenching and other application systems. Member States permitting the release of wastewater into the sewage system, shall ensure that a local risk assessment is carried out. The Member States concerned shall ensure that the notifier submits to the Commission: — further information on the potential for skin depigmentation for workers and consumers due to possible exposure to the metabolite 2-phenylhydroquinone (PHQ) on citrus peel, — further information to confirm that the analytical method applied in residue trials correctly quantifies the residues of 2-phenylphenol, PHQ and their conjugates. They shall ensure that the notifier provides such information to the Commission by 31 December 2011. Furthermore, the Member States concerned shall ensure that the notifier submits to the Commission further information to confirm the residue levels occurring as a result of application techniques other than those in drench chambers. They shall ensure that the notifier provides such information to the Commission by 31 December 2012. |
| 300 | Malathion CAS No 121-75-5 CIPAC No 12 | diethyl (dimethoxyphosphinothioylthio)succinate or S-1,2-bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioate racemate | ≥ 950 g/kg Impurities: Isomalathion: not more than 2 g/kg | 1 May 2010 | 31 July 2026 | PART A Only uses as an insecticide in greenhouses with a permanent structure may be authorised. Authorisations shall be limited to professional users. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on malathion, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account. In this overall assessment, Member States must pay particular attention to: (a) releases from greenhouses, such as condensation water, drain water, soil or artificial substrate, in order to preclude risks to aquatic organisms; (b) the protection of pollinator colonies purposely placed in the greenhouse; (c) the protection of operators and workers, so as to ensure that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate; (d) the protection of consumers in the case of processed commodities. Member States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport. Conditions of authorisation shall include risk mitigation measures and provide for adequate labelling of plant protection products. |
| 301 | Penoxsulam CAS No 219714-96-2 CIPAC No 758 | 3-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-α,α,α-trifluorotoluene-2-sulfonamide | > 980 g/kg The impurity Bis-CHYMP 2-chloro-4-[2-(2-chloro-5-methoxy-4-pyrimidinyl)hydrazino]-5-methoxypyrimidine must not exceed 0,1 g/kg in the technical material | 1 August 2010 | 31 July 2023 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penoxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the protection of aquatic organisms, — the dietary exposure of consumers to residues of the metabolite BSCTA in succeeding rotational crops, — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information to address the off-field risk to higher aquatic plants. They shall ensure that the notifier provides such information to the Commission by 31 July 2012. The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| 302 | Proquinazid CAS No 189278-12-4 CIPAC No 764 | 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one | > 950 g/kg | 1 August 2010 | 31 July 2023 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on proquinazid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account. In this overall assessment, Member States must pay particular attention: — to the long-term risk to earthworm-eating birds for uses in grapevine, — to the risk to aquatic organisms, — the dietary exposure of consumers to proquinazid residues in products of animal origin and in succeeding rotational crops, — to the operator safety. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
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| 304 | Metalaxyl CAS No 57837-19-1 CIPAC No 365 | Methyl N-(methoxyacetyl)-N-(2,6-xylyl)-DL-alaninate | 950 g/kg The impurity 2,6-dimethylaniline was considered of toxicological concern and a maximum level of 1 g/kg is established. | 1 July 2010 | 30 June 2023 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account. Member States must pay particular attention to the potential contamination of groundwater by the active substance or its degradation products CGA 62826 and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied where appropriate. |
| 301 | Penoxsulam CAS No 219714-96-2 CIPAC No 758 | 3-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-α,α,α-trifluorotoluene-2-sulfonamide | > 980 g/kg The impurity Bis-CHYMP 2-chloro-4-[2-(2-chloro-5-methoxy-4-pyrimidinyl)hydrazino]-5-methoxypyrimidine must not exceed 0,1 g/kg in the technical material | 1 August 2010 | 15 May 2026 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penoxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the protection of aquatic organisms, — the dietary exposure of consumers to residues of the metabolite BSCTA in succeeding rotational crops, — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the notifier submits to the Commission further information to address the off-field risk to higher aquatic plants. They shall ensure that the notifier provides such information to the Commission by 31 July 2012. The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
| 302 | Proquinazid CAS No 189278-12-4 CIPAC No 764 | 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one | > 950 g/kg | 1 August 2010 | 15 May 2026 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on proquinazid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account. In this overall assessment, Member States must pay particular attention: — to the long-term risk to earthworm-eating birds for uses in grapevine, — to the risk to aquatic organisms, — the dietary exposure of consumers to proquinazid residues in products of animal origin and in succeeding rotational crops, — to the operator safety. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
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| 304 | Metalaxyl CAS No 57837-19-1 CIPAC No 365 | Methyl N-(methoxyacetyl)-N-(2,6-xylyl)-DL-alaninate | 950 g/kg The impurity 2,6-dimethylaniline was considered of toxicological concern and a maximum level of 1 g/kg is established. | 1 July 2010 | 30 September 2026 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account. Member States must pay particular attention to the potential contamination of groundwater by the active substance or its degradation products CGA 62826 and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied where appropriate. |
| 305 | Flonicamid (IKI-220) CAS No 158062-67-0 CIPAC No 763 | N-cyanomethyl-4-(trifluoromethyl)nicotinamide | ≥ 960 g/kg The impurity toluene must not exceed 3 g/kg in the technical material. | 1 September 2010 | 31 August 2023 | PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flonicamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010, shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the risk to operators and re-entry workers, — the risk to bees. Conditions of authorisation shall include risk mitigation measures where appropriate. The Member States shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
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| 314 | Zinc phosphide CAS No 1314-84-7 CIPAC No 69 | Trizinc diphosphide | ≥ 800 g/kg | 1 May 2011 | 31 July 2024 | PART A Only uses as rodenticide in the form of ready-to-use baits placed in bait stations or target locations may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on zinc phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account. In this overall assessment Member States should pay particular attention to: — the protection of non target organisms. Risk mitigation measures should be applied as appropriate in particular to avoid the spread of baits where only part of the content has been consumed. |
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| 316 | Cycloxydim CAS No 101205-02-1 CIPAC No 510 | (5RS)-2-[(EZ)-1-(ethoxyimino)butyl]-3-hydroxy-5-[(3RS)-thian-3-yl]cyclohex-2-en-1-one | ≥ 940 g/kg | 1 June 2011 | 31 May 2023 | PART 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 cycloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information concerning the methods for analysis of residues of cycloxydim in plant and animal products. The Member States concerned shall ensure that the applicant submits such methods of analysis to the Commission by 31 May 2013. |
| 316 | Cycloxydim CAS No 101205-02-1 CIPAC No 510 | (5RS)-2-[(EZ)-1-(ethoxyimino)butyl]-3-hydroxy-5-[(3RS)-thian-3-yl]cyclohex-2-en-1-one | ≥ 940 g/kg | 1 June 2011 | 31 August 2026 | 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 cycloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of further information concerning the methods for analysis of residues of cycloxydim in plant and animal products. The Member States concerned shall ensure that the applicant submits such methods of analysis to the Commission by 31 May 2013. |
| 317 | 6-Benzyladenine CAS No 1214-39-7 CIPAC No 829 | N6-benzyladenine | ≥ 973 g/kg | 1 June 2011 | 31 August 2024 | PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 6-benzyladenine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate. |
| 318 | Bromuconazole CAS No 116255-48-2 CIPAC No 680 | 1-[(2RS,4RS:2RS,4SR)-4-bromo-2-(2,4-dichlorophenyl)tetrahydrofurfuryl]-1H-1,2,4-triazole | ≥ 960 g/kg | 1 February 2011 | 31 January 2024 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bromuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment, Member States shall pay particular attention to: — operator's safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones. The Member States concerned shall ensure that the applicant presents to the Commission: — further information on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; — information to further address the long term risk to herbivorous mammals. They shall ensure that the applicant at whose request bromuconazole has been included in this Annex provides such confirmatory information to the Commission by 31 January 2013 at the latest. The Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of bromuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. |
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| 320 | Buprofezin CAS No 953030-84-7 CIPAC No 681 | (Z)-2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one | ≥ 985 g/kg | 1 February 2011 | 31 January 2024 | PART A Only uses as insecticide and acaricide on non-edible crops may be authorised. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on buprofezin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the operators' and workers' safety and ensure that conditions of use impose the use of adequate personal protective equipment where appropriate, — the application of an appropriate waiting period for rotational crops in greenhouses, — the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures, where appropriate. Conditions of authorisation shall include risk mitigation measures, where appropriate. |
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| 322 | Hymexazol CAS No 10004-44-1 CIPAC No 528 | 5-methylisoxazol-3-ol (or 5-methyl-1,2-oxazol-3-ol) | ≥985 g/kg | 1 June 2011 | 31 May 2023 | PART A Only uses as fungicide for seed pelleting of sugar beets in professional seed treatment facilities may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on hymexazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the operators and workers safety. Conditions of authorisation shall include protective measures, where appropriate, — the risk to granivorous birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards the nature of residues in root crops and the risk for granivorous birds and mammals. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. |
| 322 | Hymexazol CAS No 10004-44-1 CIPAC No 528 | 5-methylisoxazol-3-ol (or 5-methyl-1,2-oxazol-3-ol) | ≥985 g/kg | 1 June 2011 | 31 August 2026 | PART A Only uses as fungicide for seed pelleting of sugar beets in professional seed treatment facilities may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on hymexazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the operators and workers safety. Conditions of authorisation shall include protective measures, where appropriate, — the risk to granivorous birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards the nature of residues in root crops and the risk for granivorous birds and mammals. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. |
| 323 | Dodine CAS No 2439-10-3 CIPAC No 101 | 1-dodecylguanidinium acetate | ≥ 950 g/kg | 1 June 2011 | 31 August 2024 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dodine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the potential long-term risk to birds and mammals; — the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures; — the risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures; — the monitoring of residue levels in pome fruit. The Member States concerned shall request the submission of confirmatory information as regards: — long-term risk assessment for birds and mammals, — risk assessment in natural surface water systems where major metabolites have potentially formed. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. |
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| 326 | Indolylbutyric acid CAS No 133-32-4 CIPAC No 830 | 4-(1H-indol-3-yl)butyric acid | ≥ 994 g/kg | 1 June 2011 | 31 May 2023 | PART A Only uses as plant growth regulator in ornamentals may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on indolylbutyric acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the operators and workers safety. Conditions of authorisation shall include the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure. The Member States concerned shall request the submission of further information to confirm: — the absence of clastogenicity potential of indolylbutyric acid; — the vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study; — the natural background concentration of indolylbutyric acid in the soil. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. |
| 326 | Indolylbutyric acid CAS No 133-32-4 CIPAC No 830 | 4-(1H-indol-3-yl)butyric acid | ≥ 994 g/kg | 1 June 2011 | 15 March 2026 | PART A Only uses as plant growth regulator in ornamentals may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on indolylbutyric acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the operators and workers safety. Conditions of authorisation shall include the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure. The Member States concerned shall request the submission of further information to confirm: — the absence of clastogenicity potential of indolylbutyric acid; — the vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study; — the natural background concentration of indolylbutyric acid in the soil. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. |
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| 328 | Tau-fluvalinate CAS No 102851-06-9 CIPAC No 786 | (RS)-α-cyano-3-phenoxybenzyl N-(2-chloro- α,α α- trifluoro-p-tolyl)-D-valinate (Isomer ratio 1:1) | ≥ 920 g/kg (1:1 ratio of R-α-cyano and S-α-cyano isomers) Impurities: Toluene: not more than 5 g/kg | 1 June 2011 | 31 August 2024 | PART 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 tau-fluvalinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to aquatic organisms and ensure that conditions of use prescribe the application of adequate risk mitigation measures; — the risk to non-target arthropods and ensure that conditions of use prescribe the application of adequate risk mitigation measures; — the test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material commercially manufactured. The Member States concerned shall request the submission of confirmatory information as regards: — the risk of bioaccumulation/biomagnification in the aquatic environment; — the risk to non-target arthropods; The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. The Member States concerned shall ensure that the applicant submits confirmatory information, two years after the adoption of specific guidance, as regards: — the possible impact on the environment of the potential enantio-selective degradation in environmental matrices. |
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| 329 | Clethodim CAS No *99129-21-2* CIPAC No 508 | (5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyloxyimino]propyl}-5-[(2RS)-2-(ethylthio)propyl]-3-hydroxycyclohex-2-en-1-one | ≥ 930 g/kg Impurities: toluene max. 4 g/kg | 1 June 2011 | 31 May 2023 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clethodim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 December 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection to aquatic organisms, birds and mammals, and shall ensure that conditions of use include the application of adequate risk mitigation measures. The Member States concerned shall request the submission of confirmatory information, on the basis of most recent scientific knowledge, as regards: — the soil and groundwater exposure assessments, — the residue definition for risk assessment. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. |
| 329 | Clethodim CAS No *99129-21-2* CIPAC No 508 | (5RS)-2-{(1EZ)-1-[(2E)-3-chloroallyloxyimino]propyl}-5-[(2RS)-2-(ethylthio)propyl]-3-hydroxycyclohex-2-en-1-one | ≥ 930 g/kg Impurities: toluene max. 4 g/kg | 1 June 2011 | 31 August 2026 | 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 clethodim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 December 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection to aquatic organisms, birds and mammals, and shall ensure that conditions of use include the application of adequate risk mitigation measures. The Member States concerned shall request the submission of confirmatory information, on the basis of most recent scientific knowledge, as regards: — the soil and groundwater exposure assessments, — the residue definition for risk assessment. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. |
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| 330 | Bupirimate CAS No 41483-43-6 CIPAC No 261 | 5-butyl-2-ethylamino-6-methylpyrimidine-4-yl dimethylsulfamate | ≥ 945 g/kg Impurities: Ethirimol: max. 2 g/kg Toluene: max. 3 g/kg | 1 June 2011 | 31 August 2024 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bupirimate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, — the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigations, where appropriate, — the in-field risk to non-target arthropods. The Member States concerned shall request the submission of confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured, by appropriate analytical data; including information on the relevance of the impurities, (2) the equivalence between the specifications of the technical material; as commercially manufactured, and those of the test material used in the toxicity dossiers, (3) the kinetic parameters, the soil degradation and the adsorption and desorption parameter for the major soil metabolite DE-B (<sup>6</sup>). The Member States concerned shall ensure that the applicant submits such confirmatory data and information to the Commission set out in point (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013. |
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| 335 | Fluometuron CAS No: 2164-17-2 CIPAC No: 159 | 1,1-dimethyl-3-(α,α,α -trifluoro-m-tolyl)urea | ≥ 940 g/kg | 1 June 2011 | 31 August 2024 | PART A Only uses as herbicide on cotton may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluometuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall: — pay particular attention to the protection of the operators and workers and ensure that conditions of use include the application of adequate personal protective equipment; — pay particular attention to the protection of the groundwater where the active substance is applied in regions with vulnerable soil and/or climatic conditions; they shall ensure that conditions of authorisation include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential leaching of fluometuron and soil metabolites desmethyl-fluometuron and trifluoromethylaniline in vulnerable areas, where appropriate; — pay particular attention to the risk to non-target soil macro-organisms others than earthworms and non-target plants, and ensure that conditions of authorisation include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the applicants submit to the Commission confirmatory information as regards: (a) the toxicological properties of the plant metabolite trifluoroacetic acid; (b) the analytical methods for the monitoring of fluometuron in air; (c) the analytical methods for the monitoring of the soil metabolite trifluoromethylaniline in soil and water; (d) the relevance for ground water of the soil metabolites desmethyl-fluometuron and trifluoromethylaniline, if fluometuron is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’. The Member States concerned shall ensure that the applicants submit to the Commission the information set out in points (a), (b) and (c) by 31 March 2013 and the information set out in point (d) within six months from the notification of the decision classifying fluometuron. |
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| 339 | Dazomet CAS No 533-74-4 CIPAC No 146 | 3,5-dimethyl-1,3,5-thiadiazinane-2-thione or tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione | ≥ 950 g/kg | 1 June 2011 | 31 May 2023 | PART A Only uses as nematicide, fungicide, herbicide and insecticide may be authorised. Only application as soil fumigant may be authorised. Use shall be limited to one application every third year. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dazomet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to operators, workers and bystanders; — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (a) the potential groundwater contamination by methyl isothiocyanate; (b) the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks; (c) the acute risk to insectivorous birds; (d) the long term risk to birds and mammals. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013. |
| 340 | Metaldehyde CAS No 108-62-3 (tetramer) 9002-91-9 (homopolymer) CIPAC No 62 | r-2, c-4, c-6, c-8-tetramethyl-1,3,5,7- tetroxocane | ≥ 985 g/kg acetaldehyde max. 1,5 g/kg | 1 June 2011 | 31 May 2023 | PART A Only uses as molluscicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metaldehyde, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to operators and workers; — the dietary exposure situation of consumers in view of future revisions of maximum residue levels; — the acute risk and long term risk to birds and mammals. Member States shall ensure that authorisations shall contain an effective dog repellent agent. Conditions of use shall include risk mitigation measures, where appropriate. |
| 339 | Dazomet CAS No 533-74-4 CIPAC No 146 | 3,5-dimethyl-1,3,5-thiadiazinane-2-thione or tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione | ≥ 950 g/kg | 1 June 2011 | 31 August 2026 | PART A Only uses as nematicide, fungicide, herbicide and insecticide may be authorised. Only application as soil fumigant may be authorised. Use shall be limited to one application every third year. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dazomet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to operators, workers and bystanders; — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (a) the potential groundwater contamination by methyl isothiocyanate; (b) the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks; (c) the acute risk to insectivorous birds; (d) the long term risk to birds and mammals. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013. |
| 340 | Metaldehyde CAS No 108-62-3 (tetramer) 9002-91-9 (homopolymer) CIPAC No 62 | r-2, c-4, c-6, c-8-tetramethyl-1,3,5,7- tetroxocane | ≥ 985 g/kg acetaldehyde max. 1,5 g/kg | 1 June 2011 | 31 August 2026 | PART A Only uses as molluscicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metaldehyde, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to operators and workers; — the dietary exposure situation of consumers in view of future revisions of maximum residue levels; — the acute risk and long term risk to birds and mammals. Member States shall ensure that authorisations shall contain an effective dog repellent agent. Conditions of use shall include risk mitigation measures, where appropriate. |
| 341 | Sintofen CAS No 130561-48-7 CIPAC No 717 | 1-(4-chlorophenyl)-1,4-dihydro-5-(2-methoxyethoxy)-4-oxocinnoline-3-carboxylic acid | ≥ 980 g/kg Impurities: 2-methoxyethanol, not more than 0,25 g/kg N,N-dimethylformamide, not more than 1,5 g/kg | 1 June 2011 | 31 August 2024 | PART A Only uses as a plant growth regulator on wheat for hybrid seed production not intended for human consumption may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sintofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate risk mitigation measures. They shall ensure that wheat treated with sintofen does not enter the food and feed chain. The Member States concerned shall request the submission of confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured, supported by appropriate analytical data; (2) the relevance of the impurities present in the technical specifications, except of the impurities 2-methoxyethanol and N,N-dimethylformamide; (3) the relevance of the test material used in the toxicity and ecotoxicity dossiers in view of the specification of the technical material; (4) the metabolic profile of sintofen in rotational crops. The Member States concerned shall ensure that the applicant submits to the Commission: the information set out in points (1) (2) and (3) by 30 November 2011 and the information set out in point (4) by 31 May 2013. |
| 342 | Fenazaquin CAS No 120928-09-8 CIPAC No 693 | 4-tert-butylphenethyl quinazolin-4-yl ether | ≥ 975 g/kg | 1 June 2011 | 31 May 2023 | PART A Only uses as acaricide in greenhouses may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011, and of the addendum to the review report on fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 22 March 2018, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of aquatic organisms; (b) the protection of operators, also ensuring that the conditions of the use include the application of adequate personal protective equipment; (c) the protection of bees; (d) the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses; (e) the risk to consumers, in particular from the residues generated during processing; (f) the conditions of use to avoid exposure to residues of fenazaquin with respect to crops for human and animal consumption. Conditions of use shall include risk mitigation measures, where appropriate. |
| 342 | Fenazaquin CAS No 120928-09-8 CIPAC No 693 | 4-tert-butylphenethyl quinazolin-4-yl ether | ≥ 975 g/kg | 1 June 2011 | 31 August 2026 | PART A Only uses as acaricide in greenhouses may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011, and of the addendum to the review report on fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 22 March 2018, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of aquatic organisms; (b) the protection of operators, also ensuring that the conditions of the use include the application of adequate personal protective equipment; (c) the protection of bees; (d) the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses; (e) the risk to consumers, in particular from the residues generated during processing; (f) the conditions of use to avoid exposure to residues of fenazaquin with respect to crops for human and animal consumption. Conditions of use shall include risk mitigation measures, where appropriate. |
| 343 | Azadirachtin CAS No 11141-17-6 (azadirachtin A) CIPAC No 627 (azadirachtin A) | Azadirachtin A: dimethyl (2aR,3S,4S,4aR,5S,7aS,8S,10R,10aS,10bR)-10-acetoxy-3,5-dihydroxy-4-[(1aR,2S,3aS,6aS,7S,7aS)-6a-hydroxy-7a-methyl-3a,6a,7,7a-tetrahydro-2,7-methanofuro[2,3-b]oxireno[e]oxepin-1a(2H)-yl]-4-methyl-8-{[(2E)-2-methylbut-2-enoyl]oxy}octahydro-1H-naphtho[1,8a-c:4,5-b′c′]difuran-5,10a(8H)-dicarboxylate. | Expressed as azadirachtin A: ≥ 111 g/kg Sum of the aflatoxins B1, B2, G1, G2 must not exceeding 300 μg/kg of the azadirachtin A content. | 1 June 2011 | 31 August 2024 | PART A For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azadirachtin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 and of the addendum to the review report on azadirachtin, and in particular Appendices I and II thereto, as finalised by the Standing Committee on Plants, Animals, Food and Feed on 17 July 2020 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (1) the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; (2) the protection of non-target arthropods and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azadirachtin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels; — the protection of non target arthropods and aquatic organisms. Risk mitigation measures shall be applied where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: — the relationship between azadirachtin A and the rest of the active components in the neem seeds extract with respect to amount, biological activity and persistence, in order to confirm the lead active compound approach with regard to azadirachtin A and to confirm specification of the technical material, residue definition and groundwater risk assessment. The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 December 2013. |
| 344 | Diclofop CAS No 40843-25-2 (parent) CAS No 257-141-8 (diclofop-methyl) CIPAC No 358 (parent) CIPAC No 358.201 (diclofop-methyl) | Diclofop (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionic acid Diclofop-methyl methyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate | ≥ 980 g/kg (expressed as diclofop-methyl) | 1 June 2011 | 31 May 2023 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on diclofop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall: — pay particular attention to the operators and workers safety and include as a condition for authorisation the application of adequate personal protective equipment; — pay particular attention to the risk to aquatic organisms and non target plants and require risk mitigation measures to be applied. The Member States concerned shall request the submission of confirmatory information as regards: (a) a metabolism study on cereals; (b) an update of the risk assessment concerning the possible environmental impact of the preferential degradation/conversion of the isomers. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 31 May 2013 and the information set out in point (b) at latest two years after the adoption of a specific guidance document on evaluation of isomers mixtures. |
| 344 | Diclofop CAS No 40843-25-2 (parent) CAS No 257-141-8 (diclofop-methyl) CIPAC No 358 (parent) CIPAC No 358.201 (diclofop-methyl) | Diclofop (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionic acid Diclofop-methyl methyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate | ≥ 980 g/kg (expressed as diclofop-methyl) | 1 June 2011 | 31 August 2026 | 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 diclofop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall: — pay particular attention to the operators and workers safety and include as a condition for authorisation the application of adequate personal protective equipment; — pay particular attention to the risk to aquatic organisms and non target plants and require risk mitigation measures to be applied. The Member States concerned shall request the submission of confirmatory information as regards: (a) a metabolism study on cereals; (b) an update of the risk assessment concerning the possible environmental impact of the preferential degradation/conversion of the isomers. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 31 May 2013 and the information set out in point (b) at latest two years after the adoption of a specific guidance document on evaluation of isomers mixtures. |
| 345 | Lime sulphur CAS No 1344 - 81 - 6 CIPAC No 17 | Calcium polysulfide | ≥ 290 g/Kg. | 1 June 2011 | 31 August 2024 | PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on lime sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — operator safety and shall ensure that the conditions of authorisation include appropriate protective measures; — to the protection of aquatic organisms and non target arthropods and shall ensure that the conditions of use include risk mitigation measures as appropriate. |
| 346 | Aluminium sulfate CAS No 10043-01-3 CIPAC not available | Aluminium sulfate | 970 g/kg | 1 June 2011 | 31 August 2024 | PART A Only indoor uses as post-harvest bactericide for ornamental plants may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium sulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. The Member States concerned shall request the submission of confirmatory information as regards the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data. The Member States concerned shall ensure that the applicant submits such information to the Commission by 30 November 2011. |
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| 348 | Paclobutrazol CAS No 76738-62-0 CIPAC No 445 | (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol | ≥ 930 g/kg | 1 June 2011 | 31 May 2023 | PART 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 paclobutrazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic plants and ensure that conditions of use include the risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured; (2) the analytical methods in soil and surface water for the metabolite NOA457654; (3) the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; (4) the potential endocrine disrupting properties of paclobutrazol; (5) the potential adverse effects of breakdown products of the different optical structures of paclobutrazol and its metabolite CGA 149907 on the environmental compartments soil, water and air. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011, the information set out in points (3) by 31 May 2013, the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption and the information set out in point (5) within two years after the adoption of specific guidance. |
| 348 | Paclobutrazol CAS No 76738-62-0 CIPAC No 445 | (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol | ≥ 930 g/kg | 1 June 2011 | 31 August 2026 | 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 paclobutrazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic plants and ensure that conditions of use include the risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured; (2) the analytical methods in soil and surface water for the metabolite NOA457654; (3) the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin; (4) the potential endocrine disrupting properties of paclobutrazol; (5) the potential adverse effects of breakdown products of the different optical structures of paclobutrazol and its metabolite CGA 149907 on the environmental compartments soil, water and air. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011, the information set out in points (3) by 31 May 2013, the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption and the information set out in point (5) within two years after the adoption of specific guidance. |
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| 350 | Tebufenozide CAS No 112410-23-8 CIPAC No 724 | N-tert-butyl-N′-(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide | ≥ 970 g/kg Relevant impurity t-butyl hydrazine < 0,001 g/kg | 1 June 2011 | 31 August 2024 | 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 tebufenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall: — pay particular attention to the safety of operators and workers after re-entry and ensure that conditions of authorisation prescribe appropriate protective equipment; — pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — pay particular attention to the protection of aquatic organism and ensure that conditions of use prescribe adequate mitigation measures; — pay particular attention to the risk to Lepidoptera non-target insects. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information, as regards: (1) the relevance of metabolites RH-6595, RH-2651, M2; (2) the degradation of tebufenozide in anaerobic soils and soils of alkaline pH. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 31 May 2013. |
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| 352 | Hexythiazox CAS No 78587-05-0 CIPAC No 439 | (4RS,5RS)-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide | ≥ 976 g/kg (1:1 mixture of (4R, 5R) and (4S, 5S)) | 1 June 2011 | 31 August 2024 | PART 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 hexythiazox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate; — the operators and workers safety. Conditions of use shall include protective measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (a) the toxicological relevance of the metabolite PT-1-3 (<sup>14</sup>); (b) the potential occurrence of the metabolite PT-1-3 in processed commodities; (c) the potential adverse effects of hexythiazox on bee brood; (d) the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) two years after the adoption of specific guidance. |
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| 354 | Flurochloridone CAS No *61213-25-0* CIPAC No 430 | *(3RS,4RS;3RS,4SR)-3-chloro-4-chloromethyl-1-(α,α,α-trifluoro-m-tolyl)-2-pyrrolidone* | ≥ 940 g/kg. Relevant impurities: Toluene: max 8 g/kg | 1 June 2011 | 31 May 2023 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flurochloridone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 February 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: 1. the risk for non-target plants and aquatic organisms; 2. the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the applicant submits to the Commission further confirmatory information as regards: 1. the relevance of impurities other than toluene; 2. the compliance of ecotoxicological test material with the technical specifications; 3. the relevance of the groundwater metabolite R42819 (<sup>15</sup>); 4. the potential endocrine disrupting properties of flurochloridone. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 1 December 2011, the information set out in point (3) by 31 May 2013 and the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption. |
| 354 | Flurochloridone CAS No *61213-25-0* CIPAC No 430 | *(3RS,4RS;3RS,4SR)-3-chloro-4-chloromethyl-1-(α,α,α-trifluoro-m-tolyl)-2-pyrrolidone* | ≥ 940 g/kg. Relevant impurities: Toluene: max 8 g/kg | 1 June 2011 | 15 March 2026 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flurochloridone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 February 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: 1. the risk for non-target plants and aquatic organisms; 2. the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall ensure that the applicant submits to the Commission further confirmatory information as regards: 1. the relevance of impurities other than toluene; 2. the compliance of ecotoxicological test material with the technical specifications; 3. the relevance of the groundwater metabolite R42819 (<sup>15</sup>); 4. the potential endocrine disrupting properties of flurochloridone. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 1 December 2011, the information set out in point (3) by 31 May 2013 and the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption. |
| (<sup>1</sup>) Further details on identity and specification of active substances are provided in their review reports. (<sup>2</sup>) Suspended by order of the General Court of 19 July 2007 in case T-31/07 R, Du Pont de Nemours (France) SAS and others v Commission, [2007] ECR II-2767. (<sup>3</sup>) OJ L 353, 31.12.2008, p. 1. (<sup>4</sup>) 2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide. (<sup>5</sup>) 2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide. (<sup>6</sup>) De-ethyl-bupirimate. (<sup>7</sup>) 2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate. (<sup>8</sup>) (2*RS*)-2-hydroxy-2-methyl-*N*-phenyl-1,4-oxathiane-3-carboxamide 4-oxide. (<sup>9</sup>) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide. (<sup>10</sup>) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide. (<sup>11</sup>) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide. (<sup>12</sup>) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide. (<sup>13</sup>) (2*RS*)-2-hydroxy-2-methyl-*N*-phenyl-1,4-oxathiane-3-carboxamide 4-oxide. (<sup>14</sup>) (4*S*,5*S*)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4*R*,5*R*)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one. (<sup>15</sup>) R42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one. (<sup>16</sup>) 1-[2-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-1H-[1,2,4]triazol-yl]-ethanol. (<sup>17</sup>) OJ L 300, 14.11.2009, p. 1. (<sup>18</sup>) OJ L 54, 26.2.2011, p. 1. (<sup>19</sup>) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). (<sup>20</sup>) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1). | | | | | | |
### PART B
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| 22 | Metam CAS No 144-54-7 CIPAC No 20 | Methyldithiocarbamic acid | ≥ 965 g/kg Expressed as metam-sodium on a dry weight basis ≥ 990 g/kg Expressed as metam-potassium on a dry weight basis Relevant impurities: methylisothiocyanate (MITC) — max. 12 g/kg on dry weight basis (metam-sodium), — max. 0,42 g/kg on dry weight basis (metam-potassium). *N,N’*-dimethylthiourea (DMTU) — max. 23 g/kg on a dry weight basis (metam-sodium), — max. 6 g/kg on a dry weight basis (metam-potassium). | 1 July 2012 | 30 June 2023 | PART A Only uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field. The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed. The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications. Authorisations shall be limited to professional users. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account. In this overall assessment Member States: (a) shall pay particular attention to the protection of operators and shall ensure that the conditions of use include risk mitigation measures such as application of adequate personal protective equipment and a limitation in the daily work rate; (b) shall pay particular attention to the protection of workers and shall ensure that the conditions of use include risk mitigation measures, such as use of adequate personal protective equipment, re-entry period and limitation in the daily work rate; (c) shall pay particular attention to the protection of bystanders and residents and shall ensure that the conditions of use include risk mitigation measures, such as an appropriate buffer zone during and until 24 hours after the application from the perimeter of the application area to any occupied residences and areas used by the general public with obligation to use warning signs and ground markers; (d) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and shall ensure that the conditions of use include risk mitigation measures, such as appropriate buffer zone; (e) shall pay particular attention to the risk to non-target organisms and shall ensure that conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information on methyl isothiocyanate as regards: (1) the assessment of the long-range atmospheric transport potential and related environmental risks; (2) the potential groundwater contamination. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014. |
| 22 | Metam CAS No 144-54-7 CIPAC No 20 | Methyldithiocarbamic acid | ≥ 965 g/kg Expressed as metam-sodium on a dry weight basis ≥ 990 g/kg Expressed as metam-potassium on a dry weight basis Relevant impurities: methylisothiocyanate (MITC) — max. 12 g/kg on dry weight basis (metam-sodium), — max. 0,42 g/kg on dry weight basis (metam-potassium). *N,N’*-dimethylthiourea (DMTU) — max. 23 g/kg on a dry weight basis (metam-sodium), — max. 6 g/kg on a dry weight basis (metam-potassium). | 1 July 2012 | 30 November 2025 | PART A Only uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field. The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed. The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications. Authorisations shall be limited to professional users. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account. In this overall assessment Member States: (a) shall pay particular attention to the protection of operators and shall ensure that the conditions of use include risk mitigation measures such as application of adequate personal protective equipment and a limitation in the daily work rate; (b) shall pay particular attention to the protection of workers and shall ensure that the conditions of use include risk mitigation measures, such as use of adequate personal protective equipment, re-entry period and limitation in the daily work rate; (c) shall pay particular attention to the protection of bystanders and residents and shall ensure that the conditions of use include risk mitigation measures, such as an appropriate buffer zone during and until 24 hours after the application from the perimeter of the application area to any occupied residences and areas used by the general public with obligation to use warning signs and ground markers; (d) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and shall ensure that the conditions of use include risk mitigation measures, such as appropriate buffer zone; (e) shall pay particular attention to the risk to non-target organisms and shall ensure that conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information on methyl isothiocyanate as regards: (1) the assessment of the long-range atmospheric transport potential and related environmental risks; (2) the potential groundwater contamination. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014. |
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| 24 | Fluxapyroxad CAS No 907204-31-3 CIPAC No 828 | 3-(difluoromethyl)-1-methyl-*N*-(3′,4′,5′-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide | ≥ 950 g/kg The impurity toluene must not exceed 1 g/kg in the technical material | 1 January 2013 | 31 May 2025 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluxapyroxad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to groundwater, if the active substance is applied under vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. |
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| 28 | Phosphane CAS No 7803-51-2 CIPAC No 127 | Phosphane | ≥ 994 g/kg The relevant impurity arsane must not exceed 0,023 g/kg in the technical material | 1 April 2013 | 31 March 2024 | Authorisations shall be limited to professional users. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phosphane, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators in and around the treated premises during the treatment as well as during and after the aeration; — the protection of workers in and around the treated premises during the treatment as well as during and after the aeration; — the protection of bystanders around the treated premises during the treatment as well as during and after the aeration. Conditions of use shall include risk mitigation measures, like permanent monitoring of the phosphane concentration by automatic devices, the use of personal protection equipment and setting-up an area around the treated premise where bystanders are denied, where appropriate. |
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| 29 | *Trichoderma asperellum* (strain T34) CECT number: 20417 | Not applicable | 1 × 10<sup>10</sup> cfu/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 asperellum* (strain T34), 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 asperellum* (strain T34) is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures where appropriate. |
| 29 | *Trichoderma asperellum* (strain T34) CECT number: 20417 | Not applicable | 1 × 10<sup>10</sup> cfu/g | 1 June 2013 | 31 October 2025 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Trichoderma asperellum* (strain T34), 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 asperellum* (strain T34) is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures where appropriate. |
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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 | 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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| 33 | Ametoctradin CAS No 865318-97-4 CIPAC No 818 | 5-ethyl-6-octyl [1,2,4]triazolo[1,5-a] pyrimidin-7-amine | ≥ 980 g/kg The impurities amitrole and o-xylene are of toxicological relevance and shall not exceed 50 mg/kg and 2 g/kg respectively in the technical material. | 1 August 2013 | 31 July 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 ametoctradin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the leakage of metabolite M650F04 (<sup>14</sup>) to groundwater under vulnerable conditions. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 34 | Mandipropamid CAS No 374726-62-2 CIPAC No 783 | (RS)-2-(4-chlorophenyl)-N-[3-methoxy-4-(prop-2-ynyloxy)phenethyl]-2-(prop-2-ynyloxy)acetamide | ≥ 930 g/kg The impurity N-{2-[4-(2-chloro-allyloxy)-3-methoxy-phenyl]-ethyl}-2-(4-chloro-phenyl)-2-prop-2-ynyloxy-acetamide is of toxicological relevance and shall not exceed 0,1 g/kg in the technical material. | 1 August 2013 | 31 July 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 mandipropamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential for preferential enantiomeric transformation or racemisation of mandipropamid at the soil surface as a result of soil photolysis. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 July 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 October 2025 | 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 October 2025 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *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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| 33 | Ametoctradin CAS No 865318-97-4 CIPAC No 818 | 5-ethyl-6-octyl [1,2,4]triazolo[1,5-a] pyrimidin-7-amine | ≥ 980 g/kg The impurities amitrole and o-xylene are of toxicological relevance and shall not exceed 50 mg/kg and 2 g/kg respectively in the technical material. | 1 August 2013 | 31 December 2025 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ametoctradin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the leakage of metabolite M650F04 (<sup>14</sup>) to groundwater under vulnerable conditions. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 34 | Mandipropamid CAS No 374726-62-2 CIPAC No 783 | (RS)-2-(4-chlorophenyl)-N-[3-methoxy-4-(prop-2-ynyloxy)phenethyl]-2-(prop-2-ynyloxy)acetamide | ≥ 930 g/kg The impurity N-{2-[4-(2-chloro-allyloxy)-3-methoxy-phenyl]-ethyl}-2-(4-chloro-phenyl)-2-prop-2-ynyloxy-acetamide is of toxicological relevance and shall not exceed 0,1 g/kg in the technical material. | 1 August 2013 | 31 December 2025 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mandipropamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential for preferential enantiomeric transformation or racemisation of mandipropamid at the soil surface as a result of soil photolysis. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 July 2015. |
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| 35 | Halosulfuron-methyl CAS No 100785-20-1 CIPAC No 785.201 | methyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate | ≥ 980 g/kg | 1 October 2013 | 30 September 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 halosulfuron-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 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk of leakage to groundwater of the metabolite ‘halosulfuron’ rearrangement (HSR) (<sup>15</sup>) under vulnerable conditions. This metabolite is considered toxicologically relevant based on the available information for halosulfuron, — the risk to non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and the test material used in the toxicological and ecotoxicological studies; (b) information on the toxicological relevance of the impurities present in the technical specification as commercially manufactured; (c) data to clarify the potential genotoxic properties of chlorosulfonamide acid (<sup>16</sup>). The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015. |
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@@ -539,7 +539,7 @@
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| 37 | *Candida oleophila* strain O Collection number: MUCL40654 | Not applicable | Nominal content: 3 × 10<sup>10</sup> CFU/g dried product Range: 6 × 10<sup>9</sup> – 1 × 10<sup>11</sup> CFU/g dried product | 1 October 2013 | 31 December 2024 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Candida oleophila* strain O, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. |
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| 38 | *Helicoverpa armigera nucleopolyhedrovirus* DSMZ number: BV-0003 | Not applicable | Minimum concentration: 1,44 × 10<sup>13</sup> OB/l (occlusion bodies/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 *Helicoverpa armigera nucleopolyhedrovirus*, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account. |
| 38 | *Helicoverpa armigera nucleopolyhedrovirus* DSMZ number: BV-0003 | Not applicable | Minimum concentration: 1,44 × 10<sup>13</sup> OB/l (occlusion bodies/l) | 1 June 2013 | 31 October 2025 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Helicoverpa armigera nucleopolyhedrovirus*, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account. |
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| 39 | *Paecilomyces fumosoroseus* strain FE 9901 Collection number: USDA-ARS collection of Entomopathogenic Fungal Cultures U.S. Plant Soil and Nutrition laboratory. New York. Accession No ARSEF 4490 | Not applicable | Minimum 1,0 × 10<sup>9</sup> CFU/g Maximum 3,0 × 10<sup>9</sup> CFU/g | 1 October 2013 | 31 December 2024 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Paecilomyces fumosoroseus* strain FE 9901, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, 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 *Paecilomyces fumosoroseus* strain FE 9901 is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures, where appropriate. |
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@@ -547,7 +547,7 @@
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| 41 | Spiromesifen CAS No 283594-90-1 CIPAC No 747 | 3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrate | ≥ 965 g/kg (racemic) The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material. | 1 October 2013 | 30 September 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 spiromesifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the long-term risk to aquatic invertebrates, — the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible, — the protection of workers and operators. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015. |
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| 42 | *Spodoptera littoralis nucleopolyhedrovirus* DSMZ number: BV-0005 | Not applicable | Maximum concentration: 1 × 10<sup>12</sup> OB/l (occlusion bodies/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 *Spodoptera littoralis nucleopolyhedrovirus*, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. |
| 42 | *Spodoptera littoralis nucleopolyhedrovirus* DSMZ number: BV-0005 | Not applicable | Maximum concentration: 1 × 10<sup>12</sup> OB/l (occlusion bodies/l) | 1 June 2013 | 31 October 2025 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Spodoptera littoralis nucleopolyhedrovirus*, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. |
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| 43 | Bixafen CAS No 581809-46-3 CIPAC No 819 | *N*-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide | ≥ 950 g/kg | 1 October 2013 | 31 May 2025 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bixafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the residues of bixafen and of its metabolites in rotational crops; (b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (c) the risk to aquatic organisms; (d) the risk to soil and sediment-dwelling organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 63 | Sodium silver thiosulfate CAS No not allocated CIPAC No 762 | Not applicable | ≥ 10,0 g Ag/kg Expressed as silver (Ag) | 1 May 2014 | 31 July 2024 | PART A Only indoor uses in non-edible crops shall be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium silver thiosulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to (a) the protection of operators and workers; (b) limiting the possible release of silver ions through disposal of used solutions; (c) the risk to terrestric vertebrates and soil invertebrates from the use of sewage sludge in agriculture. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 64 | Pyridalyl CAS No 179101-81-6 CIPAC No 792 | 2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether | ≥ 910 g/kg | 1 July 2014 | 30 June 2025 | PART A Only uses 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 pyridalyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to re-entry workers; (b) the risk to groundwater when the substance is applied in regions with vulnerable soils and/or climatic conditions; (c) the risk to birds, mammals and aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the toxicological and ecotoxicological information to address the relevance of impurities 4, 13, 16, 22 and 23; (2) the relevance of the metabolite HTFP and, concerning that metabolite, the groundwater risk assessment for all uses on crops in greenhouse; (3) the risk to aquatic invertebrates. The applicant shall submit to the Commission, the Member States and the Authority the relevant information as regards point (1) by 31 December 2014 and information as regards point (2) and (3) by 30 June 2016. The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential groundwater contamination from the metabolite HTFP in vulnerable zones by 30 June 2016. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 30 June 2018. |
| 64 | Pyridalyl CAS No 179101-81-6 CIPAC No 792 | 2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether | ≥ 910 g/kg | 1 July 2014 | 30 June 2024 | PART A Only uses 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 pyridalyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to re-entry workers; (b) the risk to groundwater when the substance is applied in regions with vulnerable soils and/or climatic conditions; (c) the risk to birds, mammals and aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the toxicological and ecotoxicological information to address the relevance of impurities 4, 13, 16, 22 and 23; (2) the relevance of the metabolite HTFP and, concerning that metabolite, the groundwater risk assessment for all uses on crops in greenhouse; (3) the risk to aquatic invertebrates. The applicant shall submit to the Commission, the Member States and the Authority the relevant information as regards point (1) by 31 December 2014 and information as regards point (2) and (3) by 30 June 2016. The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential groundwater contamination from the metabolite HTFP in vulnerable zones by 30 June 2016. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 30 June 2018. |
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| 65 | S-abscisic acid CAS No 21293-29-8 CIPAC No Not allocated | (2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acid or (7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid | 960 g/kg | 1 July 2014 | 30 September 2024 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on S-abscisic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 71 | Thiencarbazone CAS No 317815-83-1 CIPAC No 797 | Methyl 4-[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1*H*-1,2,4-triazol-1-yl)carbonylsulfamoyl]-5-methylthiophene-3-carboxylate | ≥ 950 g/kg | 1 July 2014 | 30 September 2024 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiencarbazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to (a) the risk to groundwater if the substance is applied under vulnerable geographical or climatic conditions; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. That confirmatory information shall consist of the results of a monitoring programme to assess the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. The applicant shall submit to the Commission, the Member States and the Authority this monitoring programme by 30 June 2016 and the results in form of a monitoring report by 30 June 2018. |
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| 72 | Acequinocyl CAS No 57960-19-7 CIPAC No 760 | 3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate | ≥ 960 g/kg | 1 September 2014 | 30 November 2024 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acequinocyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of workers and operators; — the risk to birds, mammals and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) an analytical method for residues in body fluids and tissues; (b) the acceptability of the long-term risk to small granivorous birds and small herbivorous and frugivorous mammals, concerning the use on apple and pear orchards; (c) the acceptability of the long-term risk to small omnivorous and small herbivorous mammals, concerning the use on outdoor ornamentals. The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016. |
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| 73 | Ipconazole CAS No 125225-28-7 (mixture of diastereoisomers) 115850-69-6 (ipconazole cc, cis isomer) 115937-89-8 (ipconazole ct, trans isomer) CIPAC No 798 | (1*RS*,2*SR*,5*RS*;1*RS*,2*SR*,5*SR*)-2-(4-chlorobenzyl)-5-isopropyl-1-(1*H*-1,2,4-triazol-1-ylmethyl) cyclopentanol | ≥ 955 g/kg Ipconazole cc: 875 – 930 g/kg Ipconazole ct: 65 – 95 g/kg | 1 September 2014 | 30 November 2024 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ipconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: 1. the risk to granivorous birds; 2. the protection of workers and operators; 3. the risk to fish. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the acceptability of the long-term risk to granivorous birds; (b) the acceptability of the risk to soil macro-organisms; (c) the risk of enantio-selective metabolisation or degradation; (d) the potential endocrine disrupting properties of ipconazole for birds and fish. The applicant shall submit to the Commission, the Member States and the Authority the information under (a) and (b) by 31 August 2016, the information under (c) within two years after adoption of the pertinent guidance document on evaluation of isomer mixtures and the information under (d) within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of test guidelines agreed at EU level. |
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| 74 | Flubendiamide CAS No 272451-65-7 CIPAC No 788 | 3-iodo-*N*'-(2-mesyl-1,1-dimethylethyl)-*N*-{4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]-o-tolyl}phthalamide | ≥ 960 g/kg | 1 September 2014 | 31 August 2024 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flubendiamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to aquatic invertebrates; (b) the potential presence of residues in rotational crops. Conditions of use shall include risk mitigation measures, where appropriate. |
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@@ -779,7 +778,25 @@
| 156 | *Pseudomonas chlororaphis* strain MA 342 Culture collection: NCIMB, UK: NCIMB 40616 | Not applicable | The amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the in the Microbial Pest Control Agent (MPCA) must not exceed the LOQ (2.0 μg/ml). | 1 March 2023 | 28 February 2038 | Only uses as fungicide for seed dressing in closed seed dressing machinery 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 renewal report on *Pseudomonas chlororaphis* strain MA 342, 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 level of the metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the Microbial Pest Control Agent (MPCA), which must not exceed 2 μg/ml; — the protection of operators and workers, taking into account that *Pseudomonas chlororaphis* strain MA 342 is to be considered, as any micro-organism, as a potential sensitiser, and paying special attention to exposure through inhalation. 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 microbiological contamination as referred to in the Working Document SANCO/12116/2012. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the phylogenetic taxonomic identification of the micro-organism in accordance with point 1.3 (identity, taxonomy and phylogeny) of Annex II, Part B of Commission Regulation (EU) 2022/1439 (<sup>25</sup>); 2. the secondary metabolite DDR in accordance with SANCO/2020/12258 (<sup>26</sup>), in particular on its degradation rate; 3. the potential for gene transfer of antibiotic resistance from *Pseudomonas chlororaphis* strain MA 342 to other micro-organisms in accordance with SANTE/2020/12260 (<sup>27</sup>). The applicant shall submit the requested information referred to in points 1, 2 and 3 by 23 February 2025. |
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| 157 | Abamectin CAS No 71751-41-2 Avermectin B1a CAS No 65195-55-3 Avermectin B1b CAS No 65195-56-4 Abamectin CIPAC No 495 | Avermectin B1a (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside Avermectin B1b (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside | ≥ 850 g/kg abamectin (sum of avermectin B1a and avermectin B1b), min. 800 g/kg avermectin B1a and max. 200 g/kg avermectin B1b | 1 April 2023 | 31 March 2038 | Only uses which allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment may be authorised, in particular uses in permanent greenhouses. 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 Abamectin, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, such as the the use of gloves; — The effect of photolysis on the levels of pesticide residues in crops. Particular attention is required to ensure that available residue trials on crops reflect the most critical residue situation. Where appropriate, depending on the zone, seasonal restrictions for the timing of application shall be applied (cf. representative uses excluded application from November till February). |
| (<sup>1</sup>) Further details on the identity and the specification of the active substance are provided in the renewal report. (<sup>2</sup>) 2-hydroxy-4,6-dimethoxypyrimidine. (<sup>3</sup>) 2,4-dihydroxy-6-methoxypyrimidine. (<sup>4</sup>) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate. (<sup>5</sup>) 5-(trifluoromethyl)-2(1H)-pyridinone. (<sup>6</sup>) 4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol. (<sup>7</sup>) M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide. (<sup>8</sup>) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol. (<sup>9</sup>) 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid. (<sup>10</sup>) 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene. (<sup>11</sup>) 4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid. (<sup>12</sup>) 3-phenoxybenzaldehyde. (<sup>13</sup>) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)). (<sup>14</sup>) 7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid. (<sup>15</sup>) 3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1*H*-pyrazole-4-carboxylic acid. (<sup>16</sup>) 3-chloro-1-methyl-5-sulfamoyl-1*H*-pyrazole-4-carboxylic acid. (<sup>17</sup>) *p*-methyl-phenethylamine. (<sup>18</sup>) OJ L 353, 31.12.2008, p. 1. (<sup>19</sup>) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (<sup>20</sup>) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33). (<sup>21</sup>) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>22</sup>) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311; ECHA-18-G-01-EN. (<sup>23</sup>) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311 (<sup>24</sup>) https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R0605&from=EN (<sup>25</sup>) Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (OJ L 227, 1.9.2022, p. 8). (<sup>26</sup>) Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258): https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180653_microorganism-metabolites-concern_202011.pdf. (<sup>27</sup>) Guidance on the approval and low-risk criteria linked to ‘antimicrobial resistance’ applicable to microorganisms used for plant protection (SANTE/2020/12260): https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180652_microorganism-amr_202011.pdf. | | | | | | |
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| 158 | *Bacillus amyloliquefaciens* strain QST 713 | n.a. | The nominal content of *Bacillus amyloliquefaciens* strain QST 713 in the technical product and formulation is Minimum: 1 × 10<sup>12</sup> CFU/kg Maximum: 3 × 10<sup>13</sup> CFU/kg No relevant impurities | 1 July 2023 | 30 June 2038 | When authorising plant protection products containing *Bacillus amyloliquefaciens* strain QST 713 for spray applications outdoors, in order to ensure the protection of non-target organisms, including bees, Member States shall: — only authorise field applications in flowering crops or in presence of flowering weed in the field outside the daily foraging period of bees; — implement risk mitigation measures which aim to reduce drift to off-field areas (e.g. considering the application of buffer zones and drift reduction nozzles). 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 *Bacillus amyloliquefaciens* strain QST 713, and in particular Appendices I and II thereof, shall be taken into account. In addition, Member States shall pay particular attention to: — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>28</sup>) — the specification of the technical material as commercially manufactured used in plant protection products; — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. |
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| 159 | *Bacillus thuringiensis* subsp*. aizawai* strain ABTS-1857 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on *Bacillus thuringiensis* subsp. *aizawai* strain ABTS-1857 and in particular Appendices I and II thereto, are taken into account. In this overall assessment the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are *per se* considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>28</sup>); — the protection of wild pollinators (in particular honey bee larvae and bumble bees). Conditions of use shall include specific risk mitigation measures, where appropriate. Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing *Bacillus thuringiensis* subsp. *aizawai* strain ABTS-1857 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of *Bacillus thuringiensis* subsp. *aizawai* strain ABTS-1857 below 10<sup>5</sup> CFU/g at harvest. The applicant shall submit to the Commission, the Member States and the Authority additional information as regards: — data in at least one representative edible crop (i.e. peppers and tomatoes) regarding the density decline of viable spores of *Bacillus thuringiensis* subsp. *aizawai* strain ABTS-1857 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 10<sup>5</sup> CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State. The applicant shall submit the requested information by 13 December 2025. |
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| 160 | *Bacillus thuringiensis* subsp*. aizawai* GC-91 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on *Bacillus thuringiensis* subsp. *aizawai* GC-91 and in particular Appendices I and II thereto, are taken into account. In this overall assessment the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are *per se* considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>28</sup>); — the protection of wild pollinators (in particular honey bee larvae and bumble bees). Conditions of use shall include specific risk mitigation measures, where appropriate. Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing *Bacillus thuringiensis* subsp *aizawai* GC-91 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of *Bacillus thuringiensis* subsp. *aizawai* GC-91 below 10<sup>5</sup> CFU/g at harvest. The applicant shall submit to the Commission, the Member States and the Authority additional information as regards: — data in at least one representative edible crop (i.e. pome fruits, grapes and tomatoes) regarding the density decline of viable spores of *Bacillus thuringiensis* subsp. *aizawai* GC-91 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 10<sup>5</sup> CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State. The applicant shall submit the requested information by 13 December 2025. |
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| 161 | *Bacillus thuringiensis* subsp. *israelensis* strain AM65-52 Culture collection No ATCC 1276 | Not applicable | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the renewal report on *Bacillus thuringiensis* subsp. *israelensis* strain AM65-52, and in particular Appendices I and II thereof, are taken into account. In this overall assessment, the 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; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>28</sup>). — the protection of wild pollinators and of aquatic organisms (e.g. aquatic invertebrates from Diptera taxon in particular) in case of uses in open field. Conditions of use shall include specific risk mitigation measures, where appropriate. Conditions of use shall include risk mitigation measures, such as: — adequate personal protective equipment for operators using products containing *Bacillus thuringiensis* subsp. *israelensis* strain AM65-52; — In case of authorisation of uses on edible crops, a minimum time period of 3 days shall be kept between the application of plant protection products containing *Bacillus thuringiensis* subsp. *israelensis* AM65-52 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of *Bacillus thuringiensis* subsp. *israelensis* AM65-52 below 10<sup>5</sup> CFU/g at harvest. |
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| 162 | *Bacillus thuringiensis* subsp*. kurstaki* ABTS-351 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on *Bacillus thuringiensis* subsp*. kurstaki* ABTS-351 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are *per se* considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>28</sup>). Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing *Bacillus thuringiensis* subsp. *kurstaki* ABTS-351 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of *Bacillus thuringiensis* subsp. *kurstaki* ABTS-351 below 10<sup>5</sup> CFU/g as recommended by EFSA. The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards: — Data in at least one representative edible crop (i.e. on cabbage and tomatoes) regarding the density decline of viable spores of *Bacillus thuringiensis* subsp. *kurstaki* ABTS-351 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 10<sup>5</sup> CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025. |
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| 163 | *Bacillus thuringiensis* subsp*. kurstaki* EG2348 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on *Bacillus thuringiensis* subsp*. kurstaki* EG2348 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are *per se* considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>28</sup>). Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing *Bacillus thuringiensis* subsp *kurstaki* EG2348 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of *Bacillus thuringiensis* subsp. *kurstaki* EG2348 below 10<sup>5</sup> CFU/g as recommended by EFSA. The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards: — data in at least one representative edible crop (i.e. on pome fruits and solanaceous vegetables during the fruiting period) regarding the density decline of viable spores of *Bacillus thuringiensis* subsp. *kurstaki* EG2348 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 10<sup>5</sup> CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025. |
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| 164 | *Bacillus thuringiensis* subsp*. kurstaki* PB 54 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on *Bacillus thuringiensis* subsp*. kurstaki* PB 54 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are *per se* considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>28</sup>). Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing *Bacillus thuringiensis* subsp. *kurstaki* PB 54 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of *Bacillus thuringiensis* subsp. *kurstaki* PB 54 below 10<sup>5</sup> CFU/g as recommended by EFSA. The applicant shall submit to the Commission, the Member States and the Authority additional information as regards: — data in at least one representative edible crop (i.e. on stone fruits and tomatoes) regarding the density decline of viable spores of *Bacillus thuringiensis* subsp. *kurstaki* PB 54 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 10<sup>5</sup> CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 14 December 2025. |
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| 165 | *Bacillus thuringiensis* subsp*. kurstaki* SA-11 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on *Bacillus thuringiensis* subsp*. kurstaki* SA-11 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are *per se* considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>28</sup>). Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing *Bacillus thuringiensis* subsp *kurstaki* SA-11 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of *Bacillus thuringiensis* subsp. *kurstaki* SA-11 below 10<sup>5</sup> CFU/g as recommended by EFSA. The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards: — data in at least one representative edible crop (i.e. on pome fruits and tomatoes) regarding the density decline of viable spores of *Bacillus thuringiensis* subsp. *kurstaki* SA-11 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 10<sup>5</sup> CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State. by 13 December 2025. |
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| 166 | *Bacillus thuringiensis* subsp*. kurstaki* SA-12 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on *Bacillus thuringiensis* subsp*. kurstaki* SA-12 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are *per se* considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>28</sup>). Conditions of use shall include the following risk mitigation measures: — A minimum time period of 1 day shall be kept between the application of plant protection products containing *Bacillus thuringiensis* subsp. *kurstaki* SA-12 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of *Bacillus thuringiensis* subsp. *kurstaki* SA-12 below 10<sup>5</sup> CFU/g as recommended by EFSA. The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards: — data in at least one representative edible crop (i.e. on pome fruits and tomatoes) regarding the density decline of viable spores of *Bacillus thuringiensis* subsp. *kurstaki* SA-12 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 10<sup>5</sup> CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025. |
| (<sup>1</sup>) Further details on the identity and the specification of the active substance are provided in the renewal report. (<sup>2</sup>) 2-hydroxy-4,6-dimethoxypyrimidine. (<sup>3</sup>) 2,4-dihydroxy-6-methoxypyrimidine. (<sup>4</sup>) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate. (<sup>5</sup>) 5-(trifluoromethyl)-2(1H)-pyridinone. (<sup>6</sup>) 4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol. (<sup>7</sup>) M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide. (<sup>8</sup>) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol. (<sup>9</sup>) 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid. (<sup>10</sup>) 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene. (<sup>11</sup>) 4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid. (<sup>12</sup>) 3-phenoxybenzaldehyde. (<sup>13</sup>) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)). (<sup>14</sup>) 7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid. (<sup>15</sup>) 3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1*H*-pyrazole-4-carboxylic acid. (<sup>16</sup>) 3-chloro-1-methyl-5-sulfamoyl-1*H*-pyrazole-4-carboxylic acid. (<sup>17</sup>) *p*-methyl-phenethylamine. (<sup>18</sup>) OJ L 353, 31.12.2008, p. 1. (<sup>19</sup>) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (<sup>20</sup>) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33). (<sup>21</sup>) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>22</sup>) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311; ECHA-18-G-01-EN. (<sup>23</sup>) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311 (<sup>24</sup>) https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R0605&from=EN (<sup>25</sup>) Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (OJ L 227, 1.9.2022, p. 8). (<sup>26</sup>) Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258): https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180653_microorganism-metabolites-concern_202011.pdf. (<sup>27</sup>) Guidance on the approval and low-risk criteria linked to ‘antimicrobial resistance’ applicable to microorganisms used for plant protection (SANTE/2020/12260): https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180652_microorganism-amr_202011.pdf. (<sup>28</sup>) pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu). | | | | | | |
### PART C
@@ -903,7 +920,7 @@
| 29 | *Pepino Mosaic Virus*, EU strain, mild isolate Abp1 | Not applicable | The impurity nicotine shall not exceed the following values in the technical material: max. 0,005 mg/L in Abp1 TK max. 3,87 x 10<sup>-5</sup> mg/kg in MPCP (Nicotine has been reported to be present in tomato plants, therefore, as the microbial pest control agent (MPCA) is produced in tomato plants, nicotine is present as a consequence of the production method). | 28 June 2021 | 28 June 2036 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Pepino Mosaic Virus*, EU strain, mild isolate Abp1 and *Pepino Mosaic Virus*, CH2 strain, mild isolate Abp2, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: a) the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>2</sup>). b) the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. Conditions of use shall include risk mitigation measures, where appropriate |
| 30 | *Pepino Mosaic Virus*, CH2 strain, mild isolate Abp2 | Not applicable | The impurity nicotine shall not exceed the following values in the technical material: max. 0,007 mg/L in Abp2 TK max. 3,87 x 10<sup>-5</sup> mg/kg in MPCP (Nicotine has been reported to be present in tomato plants, therefore, as the microbial pest control agent (MPCA) is produced in tomato plants, nicotine is present as a consequence of the production method). | 28 June 2021 | 28 June 2036 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on *Pepino Mosaic Virus*, EU strain, mild isolate Abp1 and *Pepino Mosaic Virus*, CH2 strain, mild isolate Abp2, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: a) the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (<sup>2</sup>). b) the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. Conditions of use shall include risk mitigation measures, where appropriate |
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| 31 | Calcium carbonate CAS No 471-34-1 CIPAC No 843 | IUPAC name: Calcium carbonate | 950 g/kg | 1 November 2021 | *31 October 2036* | 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 calcium carbonate, and in particular Appendices I and II thereto, shall be taken into account. |
| 31 | Calcium carbonate CAS No 471-34-1 CIPAC No 843 Limestone CAS No 1317-65-3 CIPAC No 852 | IUPAC name: Calcium carbonate | 950 g/kg | 1 November 2021 | 31 October 2036 | 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 calcium carbonate and the review report on limestone, and in particular Appendices I and II thereto, shall be taken into account. |
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| 32 | Potassium hydrogen carbonate CAS No 298-14-6 CIPAC No 853 | IUPAC name: Potassium hydrogen carbonate | 990 g/kg | 1 November 2021 | 31 October 2036 | 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 of potassium hydrogen carbonate, and in particular Appendices I and II thereto, shall be taken into account. |
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original version
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