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 21 | Date of approval | Expiration of approval | Specific provisions | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| 4 | Azoxystrobin CAS No 131860-33-8 CIPAC No 571 | methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate | ≥ 930 g/kg Toluene maximum content 2 g/kg Z-isomer maximum content 25 g/kg | 1 January 2012 | 31 May 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 azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (1) the fact that the specification of the technical material as commercially manufactured 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; (2) the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (3) the protection of aquatic organisms. The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms. The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013. | ||||
| 5 | Imazalil CAS No 35554-44-0 73790-28-0 (replaced) CIPAC No 335 | (RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazole or allyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether | ≥ 950 g/kg | 1 January 2012 | 31 May 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 imazalil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment Member States shall: (1) pay particular attention to the fact that the specification of the technical material as commercially manufactured 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; (2) pay particular attention to the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels; (3) 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; (4) ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out; (5) pay particular attention to risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) route of degradation of imazalil in soil and surface water systems; (b) environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible; (c) a hydrolysis study to investigate the nature of residues in processed commodities. The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013. | ||||
| 6 | Prohexadione CAS No 127277-53-6 (prohexadione-calcium) CIPAC No 567 (prohexadione) No 567.020 (prohexadione-calcium) | 3,5-dioxo-4-propionylcyclohexanecarboxylic acid | ≥ 890 g/kg (expressed as prohexadione-calcium) | 1 January 2012 | 15 May 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 prohexadione and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. | ||||
| 7 | Spiroxamine CAS No 1181134-30-8 CIPAC No 572 | 8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine (ISO) | ≥ 940 g/kg (diastereomers A and B combined) | 1 January 2012 | 30 November 2029 | 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 spiroxamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (1) the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment; (2) the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (3) the risk to aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment; (b) the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities; (c) the groundwater exposure assessment for metabolite M03 27; (d) the risk to aquatic organisms. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by two years after the adoption of specific guidance and the information set out in points (b), (c) and (d) by 31 December 2013. | ||||
| 8 | Kresoxim-methyl CAS No 143 390-89-0 CIPAC No 568 | methyl (E)-methoxyimino[a-(o-tolyloxy)-o-tolyl]acetate | ≥ 910 g/kg Methanol: max. 5 g/kg Methyl chloride: max. 1 g/kg Toluene: max. 1 g/kg | 1 January 2012 | 31 May 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 kresoxim-methyl and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account. Member States shall pay particular attention to the protection of groundwater under vulnerable conditions; the conditions of authorisation shall include, where appropriate, risk mitigation measures. The applicant shall submit confirmatory information as regards: Groundwater exposure risk assessment, and in particular: — on the lysimeter study to support the statement that the two unidentified peaks observed do not correspond to metabolites individually exceeding the trigger value of 0,1 μg/L, — on the recovery of metabolite BF 490-5 in order to confirm its absence in the lysimeter leachate at levels exceeding 0,1 μg/L, — on a groundwater exposure risk assessment for the late application in apples, pears and grapes. The applicant shall submit to the Member States, the Commission and the Authority such information by 31 December 2013. | ||||
| 9 | Fluroxypyr CAS No 69377-81-7 CIPAC No 431 | 4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid | ≥ 950 g/kg (fluroxypyr-meptyl) The following manufacturing impurity is of toxicological concern and must not exceed the following amount in the technical material: N-methyl-2-pyrrolidone (NMP): < 3 g/kg | 1 January 2012 | 15 February 2027 | PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluroxypyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 shall be taken into account. In this overall assessment, Member States must pay particular attention to: — the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil or with vulnerable climatic conditions; — the risk to aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate. | ||||
| 10 | Tefluthrin CAS No: 79538-32-2 CIPAC No: 451 | 2,3,5,6-tetrafluoro-4-methylbenzyl (1RS, 3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate Tefluthrin is a 1:1 mixture of Z-(1R, 3R) and Z-(1S, 3S) enantiomers. | ≥ 920 g/kg Hexachlorobenzene: not more than 1 mg/kg | 1 January 2012 | 31 May 2027 | PART A Only uses as insecticide may be authorised. The seed coating shall only be performed in professional seed treatment facilities. These facilities shall apply the best available techniques in order to exclude the release of dust clouds during storage, transport and application. 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 tefluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the operators and workers safety and include among the authorised conditions of use the application of adequate personal protective equipment as well as respiratory protective equipment, — the risk to birds and mammals. Risk mitigation measures should be applied to grant a high degree of incorporation in soil and avoidance of spillage, — ensure that the label of treated seed includes the indication that the seeds were treated with tefluthrin and sets out the risk mitigation measures provided for in the authorisation. The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured; (2) a validated analytical method for water; (3) the possible environmental impact of the preferential degradation/conversion of the isomers and an estimation of the relative toxicity and risk assessment for the workers. The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2012, the information set out in point (2) by 31 December 2012, and the information set out in point (3) 2 years after the adoption of a specific guidance document on evaluation of isomers mixture. | ||||
| 11 | Oxyfluorfen CAS No 42874-03-3 CIPAC No 538 | 2-chloro-α,α,α-trifluoro-p-tolyl 3-ethoxy-4-nitrophenyl ether | ≥ 970 g/kg Impurities: N,N-dimethylnitrosamine: not more than 50 μg/kg | 1 January 2012 | 31 May 2027 | PART A Only uses as herbicide for banded applications close to ground from autumn to early spring may be authorised, at a rate not exceeding 150 g active substance per hectare, per 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 oxyfluorfen, 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: — operator safety and ensure that conditions of use impose the application of adequate personal protective equipment where appropriate, — the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants. Conditions of authorisation shall include risk mitigation measures such as no-spray buffer zones and drift reducing nozzles and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate. | ||||
| 12 | 1-naphthylacetamide CAS No 86-86-2 CIPAC No 282 | 2-(1-naphthyl)acetamide | ≥ 980 g/kg | 1 January 2012 | 30 November 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 1-naphthylacetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account. In this overall assessment Member States: (a) shall pay particular attention to the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (c) shall pay particular attention to the risk to aquatic organisms; (d) shall pay particular attention to the risk to non-target plants; (e) shall pay particular attention to the risk to birds. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the risk to non-target plants; (2) the long-term risk to birds. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013. | ||||
| 13 | 1-naphthylacetic acid CAS No 86-87-3 CIPAC No 313 | 1-naphthylacetic acid | ≥ 980 g/kg | 1 January 2012 | 30 November 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 1-naphthylacetic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account. In this overall assessment Member States: (a) shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; (b) shall pay particular attention to the dietary exposure situation of consumers in view of future revisions of maximum residue levels; (c) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; (d) shall pay particular attention to the risk to aquatic organisms; (e) shall pay particular attention to the risk to birds. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the route and rate of degradation in soil including an assessment of the potential for photolysis; (2) the long-term risk to birds. The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013. | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| 15 | Fluazifop P CAS No 83066-88-0 (fluazifop-P) CIPAC No 467 (fluazifop-P) | (R)-2-{4-[5-(trifluoromethyl)-2-pyridyloxy]phenoxy}propionic acid (fluazifop-P) | ≥ 900 g/kg in fluazifop P-butyl The following impurity 2-chloro-5-(trifluoromethyl)pyridine must not exceed 1,5 g/kg in the material as manufactured. | 1 January 2012 | 30 November 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 fluazifop-P, 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. In this overall assessment Member States shall: — pay particular attention to consumer safety as regards the occurrence in groundwater of the metabolite compound X 25; — pay particular attention to operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate; — pay particular attention to the protection of surface water and groundwater in vulnerable zones; — pay particular attention to the risk for non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured, including information on the relevance of the impurity R154719; (2) the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies; (3) the potential long-term risk to herbivorous mammals; (4) the fate and behaviour in the environment of the metabolite compounds X 25 and IV 26; (5) the potential risk to fish and aquatic invertebrates for the metabolite compound IV 26. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3), (4) and (5) by 31 December 2013. | ||||
| 16 | Terbuthylazine CAS No 5915-41-3 CIPAC No 234 | N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine | ≥ 950 g/kg The following impurities are of toxicological concern and must not exceed the following levels in the technical material: — Propazine: maximum of 9 g/kg — Atrazine: maximum of 1 g/kg — Simazine: maximum of 9 g/kg | 1 January 2012 | 31 May 2027 | PART A Only uses as herbicide may be authorised. Use shall be limited to one application every three years on the same field at a maximum dose of 850 g terbuthylazine per hectare. 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 terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 and updated by the Standing Committee on Plants, Animals, Food and Feed on 24 March 2021 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the consumer risk assessment from exposure to metabolites of terbuthylazine, — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, — the risk to mammals and earthworms. Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate. | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| 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 | 15 November 2027 | 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. | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| 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 October 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 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. | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| 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 | 15 March 2027 | 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. | ||||
| 29 | Trichoderma asperellum (strain T34) CECT number: 20417 | Not applicable | 1 × 1010 cfu/g | 1 June 2013 | 15 October 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 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. | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| 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 | 15 October 2027 | 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. | ||||
| 32 | Trichoderma atroviride strain I-1237 CNCM number: I-1237 | Not applicable | Image omitted; see official source cfu/g (Image omitted; see official source spores/g) | 1 June 2013 | 15 October 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 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. | ||||
| 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 May 2028 | For the implementation 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 34 to groundwater under vulnerable conditions. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 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 | 30 June 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 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. | ||||
| 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 | 15 November 2026 | For the implementation 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) 35 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 36. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015. | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| 37 | Candida oleophilastrain O Collection number: MUCL40654 | Not applicable | Nominal content: 3 × 1010 CFU/g dried product Range: 6 × 109 – 1 × 1011 CFU/g dried product | 1 October 2013 | 31 May 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 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. | ||||
| 38 | Helicoverpa armigera nucleopolyhedrovirus DSMZ number: BV-0003 | Not applicable | Minimum concentration: 1,44 × 1013 OB/l (occlusion bodies/l) | 1 June 2013 | 15 October 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 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. | ||||
| 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 × 109 CFU/g Maximum 3,0 × 109 CFU/g | 1 October 2013 | 31 May 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 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. | ||||
| 40 | Potassium phosphonates (no ISO name) CAS No 13977-65-6 for potassium hydrogen phosphonate 13492-26-7 for dipotassium phosphonate Mixture: none CIPAC No 756 (for potassium phosphonates) | Potassium hydrogen phosphonate, Dipotassium phosphonate | 31,6 to 32,6 % phosphonate ions (sum of hydrogen phosphonate and phosphonate ions) 17,8 to 20,0 % potassium ≥ 990 g/kg on dry weight basis | 1 October 2013 | 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 potassium phosphonates, 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 to birds and mammals, — the risk of eutrophication of surface water, if the substance is applied in regions or under conditions favouring a quick oxidation of the active substance in surface water. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the long-term risk to insectivorous birds. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015. | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| 42 | Spodoptera littoralis nucleopolyhedrovirus DSMZ number: BV-0005 | Not applicable | Maximum concentration: 1 × 1012 OB/l (occlusion bodies/l) | 1 June 2013 | 15 October 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 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. | ||||
| 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 October 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 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. | ||||
| ————— | ————— | ————— | ————— | ————— | ————— | ————— | ||||
| 45 | Eugenol CAS No 97-53-0 CIPAC No 967 | 4-allyl-2-methoxyphenol | ≥ 990 g/kg Relevant impurity: methyl eugenol maximum 0,1 % of the technical material | 1 December 2013 | 15 April 2028 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on eugenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate, — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions, — the risk to aquatic organisms, — the risk to insectivorous birds. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the storage stability (2 years) at ambient temperature on the formulated product; (b) data comparing natural background exposure situations of eugenol and methyl eugenol in relation to exposure from the use of eugenol as a plant protection product. This data shall cover human exposure as well as exposure of birds and aquatic organisms; (c) the groundwater exposure assessment for potential metabolites of eugenol, in particular for methyl eugenol. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015. | ||||
| 46 | Geraniol CAS No 106-24-1 CIPAC No 968 | (E) 3,7-dimethyl-2,6-octadien-1-ol | ≥ 980 g/kg | 1 December 2013 | 15 April 2028 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on geraniol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to — the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms; — the risk to birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) data comparing natural background exposure situations of geraniol in relation to exposure from the use of geraniol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms; (b) the groundwater exposure. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015. | ||||
| 47 | Thymol CAS No 89-83-8 CIPAC No 969 | 5-methyl-2-propan-2-yl-phenol | ≥ 990 g/kg | 1 December 2013 | 15 April 2028 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thymol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to — the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms; — the risk to birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) data comparing natural background exposure situations of thymol in relation to exposure from the use of thymol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms; (b) the long-term and reproductive toxicity, in a form of a full report (in English) of the Combined Test of Repeated Oral-Administration Toxicity and Reproductive Toxicity of Thymol; (c) the groundwater exposure. The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015. | ||||
| 48 | Sedaxane CAS No 874967-67-6 (trans isomer: 599197-38-3/cis isomer: 599194-51-1) CIPAC No 833 | mixture of 2 cis-isomers 2′-[(1RS,2RS)-1,1′-bicycloprop-2-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxanilide and 2 trans-isomers 2′-[(1RS,2SR)-1,1′-bicycloprop-2-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxanilide | ≥ 960 g/kg Sedaxane (range 820-890 g/kg for the 2 trans-isomers 50:50 mixture of enantiomers and range 100-150 g/kg for the 2 cis-isomers 50:50 mixture of enantiomers) | 1 February 2014 | 31 October 2027 | PART A Only uses for seed treatment 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 sedaxane, 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: (a) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (b) the long-term risk to birds and mammals. Conditions of authorisation shall include risk mitigation measures, where appropriate. The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolite CSCD465008 in vulnerable zones, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards the relevance of the metabolite CSCD465008, and the corresponding groundwater risk assessment, if sedaxane is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’. The notifier shall submit to the Commission, the Member States and the Authority the relevant information within six months from the application date of the Regulation classifying sedaxane. | ||||
| 49 | Emamectin CAS No emamectin: 119791-41-2 (formerly 137335-79-6) and 123997-28-4 emamectin benzoate: 155569-91-8 (formerly 137512-74-4 and 179607-18-2) emamectin B1a benzoate: 138511-97-4 emamectin B1b benzoate: 138511-98-5 CIPAC No emamectin: 791 emamectin benzoate: 791.412 | Emamectin 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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside Emamectin 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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside Emamectin B1a benzoate: (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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside benzoate Emamectin B1b benzoate: (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-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside benzoate | ≥ 950 g/kg as emamectin benzoate anhydrous (a mixture of min. 920 g/kg emamectin B1a benzoate and max. 50 g/kg emamectin B1b benzoate) | 1 May 2014 | 15 November 2026 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on emamectin, 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 risk to non-target invertebrates; — 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 risk of enantio-selective metabolisation or degradation. The applicant shall submit to the Commission, Member States and the Authority the relevant information two years after adoption of the pertinent guidance document on evaluation of isomer mixtures. | ||||
Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.
This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence.
EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.