LegalizeCommission 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
| Number | Common name, identification numbers | IUPAC name | Purity 1 | Date of approval | Expiration of approval | Specific provisions | |
|---|---|---|---|---|---|---|---|
| 323 | Dodine CAS No 2439-10-3 CIPAC No 101 | 1-dodecylguanidinium acetate | ≥ 950 g/kg | 1 June 2011 | 30 June 2028 | 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 January 2028 | 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 January 2027 | 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. | |
| 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 | 15 December 2027 | 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. | |
| 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 January 2027 | 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 6. 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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| 333 | 1-decanol CAS No 112-30-1 CIPAC No 831 | Decan-1-ol | ≥ 960 g/kg | 1 June 2011 | 30 June 2028 | PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1-decanol, 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 consumers from residues in case of use on food or feed crops; — the risk for operator and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms; — the risk to non-target arthropods and bees that may be exposed to the active substance by visiting flowering weeds present in the crop at time of application. Risk mitigation measures shall be applied, where appropriate. The Member States concerned shall request the submission of confirmatory information, as regards the risk to aquatic organisms and of information confirming the groundwater, surface water and sediment exposure assessments. The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013. | |
| 334 | Isoxaben CAS No 82558-50-7 CIPAC No 701 | N-[3-(1-ethyl-1-methylpropyl)-1,2-oxazol-5-yl]-2,6-dimethoxybenzamide | ≥ 910 g/kg Toluene: ≤ 3 g/kg | 1 June 2011 | 31 January 2027 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isoxaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, the risk to non-target terrestrial plants and the potential leaching of metabolites to groundwater. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: (a) the specification of the technical material, as commercially manufactured, (b) the relevance of the impurities; (c) the residues in rotational crops; (d) the potential risk to aquatic organisms. The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a) and (b) by 30 November 2011 and the information set out in points (c) and (d) by 31 May 2013. | |
| 335 | Fluometuron CAS No: 2164-17-2 CIPAC No: 159 | 1,1-dimethyl-3-(α,α,α -trifluoro-m-tolyl)urea | ≥ 940 g/kg | 1 June 2011 | 15 January 2030 | 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 | 30 November 2029 | 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 | 15 October 2028 | 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 | 15 January 2030 | 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 | 15 August 2028 | 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 January 2027 | 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 January 2029 | 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 January 2027 | 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 | 15 January 2030 | 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 January 2029 | 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 January 2027 | 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. | |
| 351 | Dithianon CAS No 3347-22-6 CIPAC No 153 | 5,10-dihydro-5,10-dioxonaphtho[2,3-b]-1,4-dithiine-2,3-dicarbonitrile | ≥ 930 g/kg | 1 June 2011 | 31 January 2027 | 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 dithianon, 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, — pay particular attention to the operator safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate, — pay particular attention to the long-term risks to birds; conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards: — the storage stability and the nature of residues in processed products, — the aquatic and groundwater exposure assessment for phthalic acid, — the risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol. The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013. | |
| 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 January 2027 | 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 14; (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 October 2027 | 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 15; 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. |
1
(1)
Further details on identity and specification of active substances are provided in their review reports.
2
(2)
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.
3
(3)
OJ L 353, 31.12.2008, p. 1.
4
(4)
2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide.
5
(5)
2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide.
6
(6)
De-ethyl-bupirimate.
7
(7)
2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.
8
(8)
(2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.
9
(9)
2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.
10
(10)
2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.
11
(11)
2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.
12
(12)
2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.
13
(13)
(2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.
14
(14)
(4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.
15
(15)
R42819: (4RS)-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one.
16
(16)
1-[2-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-1H-[1,2,4]triazol-yl]-ethanol.
17
(17)
OJ L 300, 14.11.2009, p. 1.
18
(18)
OJ L 54, 26.2.2011, p. 1.
19
(19)
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).
20
(20)
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
Active substances approved under Regulation (EC) No 1107/2009
General provisions applying to all substances listed in this Part:
- — for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;
- — Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.
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