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
| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions | |
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| 2 | Esfenvalerate CAS No: 66230-04-4 CIPAC No: 481 | (αS)-α-cyano-3-phenoxybenzyl (2S)-2-(4-chlorophenyl)-3-methylbutyrate | 830 g/kg The impurity toluene shall not exceed 10 g/kg in the technical material. | 1 January 2016 | 30 November 2029 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on esfenvalerate, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk from esfenvalerate and the 2SαR-isomer of fenvalerate to aquatic organisms including the risk for bio-accumulation through the food chain, — the risk to honeybees and non-target arthropods, — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. |
| 3 | Metsulfuron-methyl CAS No 74223-64-6 CIPAC No 441.201 | Methyl 2-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)benzoate | 967 g/kg | 1 April 2016 | 31 July 2029 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metsulfuron-methyl, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of consumers, — the protection of groundwater, — the protection of non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority by 30 September 2016 confirmatory information as regards the genotoxic potential of the metabolite triazine-amine (IN-A4098) to confirm that this metabolite is not genotoxic and not relevant for risk assessment. |
| 4 | Benzovindiflupyr CAS No: 1072957-71-1 CIPAC No: not available | N-[(1RS,4SR)-9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide | 960 g/kg (50/50) racemate | 2.3.2016 | 2 January 2029 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benzovindiflupyr, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; (2) the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification; (3) the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water. The applicant shall submit to the Commission, the Member States and the Authority the information requested under points (1) and (2) by 2 September 2016 and the information requested under point (3) within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. |
| 5 | Lambda-Cyhalothrin CAS No 91465-08-6 CIPAC No 463 | A 1:1 mixture of: (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or of (R)-α-cyano-3-phenoxybenzyl (1S)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate | 900 g/kg | 1 April 2016 | 31 January 2029 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on lambda-cyhalothrin, 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: (a) protection of operators, workers and bystanders; (b) metabolites potentially formed in processed commodities; (c) risk to aquatic organisms, mammals and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. The applicants shall submit confirmatory information as regards: 1. a systematic review to assess the evidence available as regards potential sperm effects linked to exposure to lambda-cyhalothrin using guidance available (e.g. EFSA GD on Systematic Review methodology, 2010); 2. toxicological information to assess the toxicological profile of the metabolites V (PBA) and XXIII (PBA(OH)). The applicants shall submit those information to the Commission, the Member States and the Authority by 1 April 2018. |
| 6 | Prosulfuron CAS No 94125-34-5 CIPAC No 579 | 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3- trifluoropropyl)-phenylsulfonyl]-urea | 950 g/kg The impurity 2-(3,3,3-trifluoro-propyl)-benzene sulphonamide shall not exceed 10 g/kg in the technical material. | 1 May 2017 | 15 December 2029 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prosulfuron including its addendum, and in particular Appendices I and II thereto, shall be taken into account. In that overall assessment Member States shall pay particular attention to: — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of consumers, taking into account exposure to metabolites of prosulfuron; — the risk to non-target terrestrial and aquatic plants. Conditions of use shall include risk mitigation measures, where appropriate. |
| 7 | Pendimethalin CAS No 40487-42-1 CIPAC No 357 | N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene | 900 g/kg 1,2-dichloroethane ≤ 1 g/kg Total N-Nitroso compounds: max 100 ppm, of which N-Nitroso-pendimethalin: < 45 ppm. | 1 September 2017 | 15 January 2027 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pendimethalin, and in particular Appendices I and II thereof, shall be taken into account. In their overall assessment Member States shall 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 the specification of the technical material, — the protection of operators, — the protection of birds, mammals and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. In particular, personal protective equipment such as gloves, coverall and sturdy footwear has to be worn to ensure that the AOEL is not exceeded for the operator. The applicant shall submit confirmatory information to the Commission, the Member States and the Authority as regards: 1. the potential for bioaccumulation, in particular a reliable BCF value for bluegill sunfish (Lepomis macrochirus); 2. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water. The applicant shall submit the confirmatory information requested under point 1 by 31 December 2018. The applicant shall submit the confirmatory information requested under point 2 within a period of two years of the publication by the Commission of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. |
| 8 | Imazamox CAS No 114311-32-9 CIPAC No 619 | 2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]-5-methoxymethylnicotinic acid | ≥ 950 g/kg The impurity cyanide ion (CN–) shall not exceed 5 mg/kg in the technical material. | 1 November 2017 | 30 June 2027 | 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 imazamox, 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 consumers; — the protection of aquatic plants and of non-target terrestrial plants; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programs shall be initiated to verify potential groundwater contamination from imazamox and metabolites CL 312622 and CL 354825 in vulnerable zones, where appropriate. |
| 9 | Propyzamide CAS No 23950-58-5 CIPAC No 315 | 3,5-dichloro-N-(1,1-dimethylprop-2-ynyl) benzamide | 920 g/kg | 1 July 2018 | 30 November 2027 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on propyzamide and in particular Appendices I and II thereof, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the protection of operators, — the protection of groundwater in vulnerable areas, — the protection of birds, mammals, non-target plants, soil and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. In particular, personal protective equipment such as gloves, coverall and sturdy footwear has to be worn to ensure that the AOEL is not exceeded for the operator. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the completion of assessment of toxicological profile of metabolites identified in significant concentration in primary and rotational crops; 2. the soil degradation of major metabolite RH- 24580; 3. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water. The applicant shall submit the information mentioned under point (1) by 31 October 2018 and the information mentioned under point (2) by 30 April 2019. The applicant shall submit the confirmatory information mentioned in point (3) within two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater be made public by the Commission. |
| 10 | Copper compounds: | 1 January 2019 | 30 June 2029 | Only uses resulting in a total application of maximum 28 kg of copper per hectare over a period of 7 years shall be authorised. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council, the conclusions of the review report on copper compounds and in particular Appendices I and II thereto, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment and other mitigation measures as appropriate; — the protection of water and non-target organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate; — the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, do not exceed the minimum necessary to achieve the desired effects and do not cause any unacceptable effect on the environment taking into account background levels of copper at the application site, and, where the information is available, copper input from other sources. Member States may in particular decide to set a maximum annual application rate not exceeding 4 kg/ha of copper. | ||
| Copper hydroxide CAS No 20427-59-2 CIPAC No 44.305 | Copper (II) hydroxide | ≥ 573 g/kg | ||||
| Copper oxychloride CAS No 1332-65-6 or 1332-40-7 CIPAC No 44.602 | Dicopper chloride trihydroxide | ≥ 550 g/kg | ||||
| Copper oxide CAS No 1317-39-1 CIPAC No 44.603 | Copper oxide | ≥ 820 g/kg | ||||
| Bordeaux mixture CAS No 8011-63-0 CIPAC No 44.604 | Not allocated | ≥ 245 g/kg | ||||
| Tribasic copper sulphate CAS No 12527-76-3 CIPAC No 44.306 | Not allocated | ≥ 490 g/kg The following impurities shall not exceed the following levels: Arsenic max. 0,1 mg/g Cu Cadmium max. 0,1 mg/g Cu Lead max. 0,3 mg/g Cu Nickel max. 1 mg/g Cu Cobalt max. 3 mg/kg Mercury max. 5 mg/kg Chromium max. 100 mg/kg Antimony max. 7 mg/kg | ||||
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| 13 | etoxazole CAS No 153233-91-1 CIPAC No 623 | (RS)-5-tert-butyl-2-[2-(2,6-difluorophenyl)-4,5-dihydro1,3-oxazol-4-yl]phenetole | ≥ 948 g/kg | 1 February 2021 | 31 January 2028 | Only uses on ornamental plants in permanent greenhouses shall 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 etoxazole, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — possible uptake of persistent soil metabolites in rotational crops; — the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment. The applicant shall submit to the Commission, the Member States and the Authority by 5 January 2023 confirmatory information as regards points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, including an updated assessment of the information already submitted and, where relevant, further information. |
| 14 | Cypermethrin CAS No 52315-07-8 CIPAC No 332 | (RS)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate or (RS)-α-cyano-3-phenoxybenzyl-(1RS)-cis-trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate | 920 g/kg cis:trans: 40/60 to 60/40 The following impurities are of toxicological concern and must not exceed the following levels in the technical material: hexane: 5g/kg | 1 February 2022 | 31 January 2029 | Authorisations shall be limited to professional users. When authorising plant protection products containing cypermethrin for spray applications outdoors, in order to ensure the protection of non-target organisms, in particular aquatic organisms and non-target arthropods, including bees: — risk mitigation measures achieving reduction of drift shall be required that lead to exposure ≤ 5,8 mg a.s./ha in off-crop areas and, in addition, for spring applications to concentrations in water bodies ≤ 0,0038 μg a.s./L, — only uses outside flowering of the crop and when no flowering weeds are present 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 cypermethrin, and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention to: — the protection of aquatic organisms, non-target arthropods, including bees; — consumer risk assessment; — the technical specification of the active substance used in plant protection products. Where considered appropriate, Member States shall set monitoring requirements when granting authorisations in accordance with Article 6(i) of the Regulation (EC) No 1107/2009, in order to complement the monitoring under Directives of the European Parliament and of the Council 2000/60/EC (3) and 2009/128/EC (4). The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the toxicological profile of the metabolites bearing the 3-phenoxybenzoyl moiety; 2. the relative toxicity of individual cypermethrin isomers, in particular the enantiomer (1S cis αR); 3. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water. 4. Points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 The applicant shall submit: — the information referred to in point 1 by 15 December 2022; — the information referred to in point 2 by 15 December 2023; and — the information referred to in point 3 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. As regards Points 3.6.5 and 3.8.2 of Annex II toRegulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity shall be submitted by 15 December 2023. |
| 15 | metconazole CAS No: 125116-23-6 (unstated stereochemistry) CIPAC No: 706 | (1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol | ≥ 940 g/kg (sum of cis- and trans-isomers), with cis-metconazole (CL 354801) level not less than 800 g/kg and not more than 950 g/kg The following impurities shall not exceed the following levels in the technical material: — toluene: 2 g/kg — ethylcyclohexane: 2 g/kg | 1 September 2024 | 31 August 2031 | Use 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 renewal report on metconazole, 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 consumer exposure assessment with regards to residues that may be present in the primary crops and succeeding crops grown in rotation; — the protection of operators and bystanders/residents; — the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: 1. the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water; 2. the general toxicity profile of the metabolites M11 and M21 should be further investigated in order to confirm the appropriate toxicological reference values applicable to them. Moreover, confirmation of the presence of M11 and M21 and their ratio among the monohydroxylated metconazole compounds in crops, in order to confirm the residue definition for risk assessment. The applicant shall submit the confirmatory information referred to in point 1 by 15 July 2026 and in point 2 by 15 July 2026 to the Commission, Member States and the Authority. |
| 16 | Quinolin-8-ol CAS No: 148-24-3 CIPAC No: 677 | Quinolin-8-ol | ≥ 990 g/kg | 1 July 2025 | 30 June 2032 | Only uses by drip-irrigation by professional users in permanent greenhouses that allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment may be authorised. Authorisations shall only be granted for uses where a closed transfer system for loading and mixing the plant protection product into the application equipment is available. A pre-harvest interval of at least 22 days after the last application must be respected and the soil in which crops are grown in permanent greenhouses shall not be re-used outside the greenhouse within 1 year after the last application. 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 quinolin-8-ol, 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 necessary personal protective equipment for operators and workers. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-dietary exposure for workers and operators, in particular a study examining exposure to workers and operators under realistic conditions of use; (2) confined rotational crops metabolism data addressing the fate of the parent compound in succeeding crops; (3) studies or information to confirm a lack of clastogenic and aneugenic potential for quinolin-8-ol. The applicant shall submit the information under points 1 and 2 by 2 July 2027 and under point 3 by 2 July 2026. |
| (1) Further details on identity and specification of active substance are provided in the review report. (2) 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). (3) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). (4) Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of EN 5 EN pesticides (OJ L 309, 24.11.2009, p. 71). |
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