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 |
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| 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 (7); (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. |
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| 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 (5); — 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 (5) and IV (6); (5) the potential risk to fish and aquatic invertebrates for the metabolite compound IV (6). 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. |
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| 22 | Metam CAS No 144-54-7 CIPAC No 20 | Methyldithiocarbamic acid | ≥ 965 g/kg Expressed as metam-sodium on a dry weight basis ≥ 990 g/kg Expressed as metam-potassium on a dry weight basis Relevant impurities: methylisothiocyanate (MITC) — max. 12 g/kg on dry weight basis (metam-sodium), — max. 0,42 g/kg on dry weight basis (metam-potassium). N,N’-dimethylthiourea (DMTU) — max. 23 g/kg on a dry weight basis (metam-sodium), — max. 6 g/kg on a dry weight basis (metam-potassium). | 1 July 2012 | 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. |
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| 24 | Fluxapyroxad CAS No 907204-31-3 CIPAC No 828 | 3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide | ≥ 950 g/kg The impurity toluene must not exceed 1 g/kg in the technical material | 1 January 2013 | 31 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. |
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| 28 | Phosphane CAS No 7803-51-2 CIPAC No 127 | Phosphane | ≥ 994 g/kg The relevant impurity arsane must not exceed 0,023 g/kg in the technical material | 1 April 2013 | 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. |
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| 31 | Cyflumetofen CAS No 400882-07-7 CIPAC No 721 | 2-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate | ≥ 975 g/kg (racemic) | 1 June 2013 | 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 | cfu/g ( 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 (14) 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) (15) 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 (16). The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015. |
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| 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. |
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| 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. |
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| 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. |
| 50 | Pseudomonas sp. strain DSMZ 13134 Collection number: DSMZ 13134 | Not applicable | Minimum concentration: 3×1014 cfu/kg | 1 February 2014 | 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 review report on Pseudomonas sp. strain DSMZ 13134, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pseudomonas sp. strain DSMZ 13134 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit information to confirm the absence of an acute intratracheal and intraperitoneal toxicity/infectivity/pathogenicity potential. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016. |
| 51 | Fluopyram CAS No 658066-35-4 CIPAC No 807 | N-{2-[3-chloro-5-(trifluoromethyl)-2-pyridyl]ethyl}-α,α,α-trifluoro-o-toluamide | ≥ 960 g/kg | 1 February 2014 | 15 June 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 fluopyram, 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 birds and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the long-term risk to insectivorous birds; (2) the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals. The applicant shall submit to the Commission, Member States and the Authority the information set out in point 1 by 1 February 2016 and the information set out in point 2 within two years after adoption of the corresponding OECD test guidelines on endocrine disruption. |
| 52 | Aureobasidium pullulans (strains DSM 14940 and DSM 14941) Collection number: German Collection of Microorganisms and cell Cultures (DSMZ) with the accession numbers DSM 14940 and DSM 14941 | Not applicable | Minimum 5,0 × 109 CFU/g for each strain; Maximum 5,0 × 1010 CFU/g for each strain | 1 February 2014 | 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 review report on Aureobasidium pullulans (strains DSM 14940 and DSM 14941), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Aureobasidium pullulans (strains DSM 14940 and DSM 14941) is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. |
| 53 | Pyriofenone: CAS No 688046-61-9 CIPAC No 827 | (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone | ≥ 965 g/kg | 1 February 2014 | 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 review report on pyriofenone, 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. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) the identity of two impurities to fully support the provisional specification; (b) the toxicological relevance of the impurities present in the proposed technical specification except for the one impurity for which an acute oral study and an Ames test were provided. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016. |
| 54 | Disodium phosphonate CAS No 13708-85-5 CIPAC No 808 | disodium phosphonate | 281-337 g/kg (TK) ≥ 917 g/kg (TC) | 1 February 2014 | 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 disodium phosphonate, 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 eutrophication of surface water. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards (a) the chronic risk to fish; (b) the long term risk to earthworms and soil macro-organisms. The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016. |
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| 56 | Orange oil CAS No 8028-48-6 (Orange extract) 5989-27-5 (D-limonene) CIPAC No 902 | (R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene | ≥ 945 g/kg (of D-limonene) The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E) | 1 May 2014 | 31 December 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 orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the metabolite fate of orange oil and the route and rate of degradation in soil and on the validation of endpoints used in the ecotoxicological risk assessment. The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016. |
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| 58 | Benalaxyl-M CAS No 98243-83-5 CIPAC No 766 | Methyl N-(phenylacetyl)-N-(2,6-xylyl)-D-alaninate | ≥ 950 g/kg | 1 May 2014 | 30 September 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 benalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of workers at re-entry, — the risk to groundwater from the metabolites BM-M2 (N-(malonyl)-N-(2,6-xylyl)-DL-alanine) and BM-M3 (N-(malonyl)-N-(2,6-xylyl)-D-alanine), when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. |
| 59 | Tembotrione CAS No 335104-84-2 CIPAC No 790 | 2-{2-chloro-4-mesyl-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl}cyclohexane-1,3-dione | ≥ 945 g/kg The following relevant impurities must not exceed a certain threshold in the technical material: Toluene: ≤ 10 g/kg HCN: ≤ 1 g/kg | 1 May 2014 | 31 December 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 tembotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 61 | Pyroxsulam CAS No 422556-08-9 CIPAC No 793 | N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-(trifluoromethyl)pyridine-3-sulfonamide | ≥ 965 g/kg | 1 May 2014 | 30 September 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 pyroxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to groundwater, when the active substance is applied in regions with vulnerable soil or climatic conditions; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the toxicological relevance of impurity number 3 (as referred to in the review report); (2) the acute toxicity of the metabolite PSA; (3) the toxicological relevance of metabolite 6-Cl-7-OH-XDE-742. The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016. |
| 62 | Chlorantraniliprole CAS No 500008-45-7 CIPAC No 794 | 3-bromo-4'-chloro-1-(3-chloro-2-pyridyl)-2'-methyl-6'-(methylcarbamoyl) pyrazole-5-carboxanilide | ≥ 950 g/kg The following relevant impurities must not exceed a certain threshold in the technical material: Acetonitrile: ≤ 3 g/kg 3-picoline: ≤ 3 g/kg Methanesulfonic acid: ≤ 2 g/kg | 1 May 2014 | 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 chlorantraniliprole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and to soil macroorganisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the risk to groundwater from the active substance and its metabolites IN-EQW78 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one), IN-ECD73 (2,6-dichloro-4-methyl-11H-pyrido[2,1-b]quinazolin-11-one), IN-F6L99 (3-bromo-N-methyl-1H-pyrazole-5-carboxamide), IN-GAZ70 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-8-methylquinazolin-4(1H)-one) and IN-F9N04 (3-bromo-N-(2-carbamoyl-4-chloro-6-methylphenyl)-1-(3-chloropyridin-2-yl)-1H-pyrazole-5-carboxamide); (2) the risk to aquatic organisms from the photolysis metabolites IN-LBA22 (2-{[(4Z)-2-bromo-4H-pyrazolo[1,5-d]pyrido[3,2-b][1,4]oxazin-4-ylidene] amino}-5-chloro-N,3-dimethylbenzamide), IN-LBA23 (2-[3-bromo-1-(3-hydroxypyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one) and IN-LBA24 (2-(3-bromo-1H-pyrazol-5-yl)-6-chloro-3,8-dimethylquinazolin-4(3H)-one). The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016. |
| 63 | Sodium silver thiosulfate CAS No not allocated CIPAC No 762 | Not applicable | ≥ 10,0 g Ag/kg Expressed as silver (Ag) | 1 May 2014 | 31 December 2026 | PART A Only indoor uses in non-edible crops shall be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium silver thiosulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to (a) the protection of operators and workers; (b) limiting the possible release of silver ions through disposal of used solutions; (c) the risk to terrestric vertebrates and soil invertebrates from the use of sewage sludge in agriculture. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 65 | S-abscisic acid CAS No 21293-29-8 CIPAC No Not allocated | (2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acid or (7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid | 960 g/kg | 1 July 2014 | 15 September 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 S-abscisic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 68 | 1,4-dimethylnaphthalene CAS No 571-58-4 CIPAC No 822 | 1,4-dimethylnaphthalene | ≥ 980 g/kg | 1 July 2014 | 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 1,4-dimethylnaphthalene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and of workers at re-entry and during inspection of the warehouse; (b) the risk to aquatic organisms and fish-eating mammals the active substance is discharged from warehouses into air and surface water without further treatment. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the residue definition for the active substance. The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016. |
| 69 | Amisulbrom CAS No 348635-87-0 CIPAC No 789 | 3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide | ≥ 985 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole: ≤ 2 g/kg | 1 July 2014 | 15 September 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 amisulbrom, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic and soil organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-significance of photodegradation in the soil metabolism of amisulbrom concerning the metabolites 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole and 1-(dimethylsulfamoyl)-1H-1,2,4-triazole-3-sulfonic acid to contaminate groundwater; (2) the low potential of amisulbrom (FOCUS drainage scenarios only) and metabolites 1-(dimethylsulfamoyl)-1H-1,2,4-triazole-3-sulfonic acid, 1H-1,2,4-triazole-3-sulfonic acid, 1H-1,2,4-triazole, N,N-dimethyl-1H-1,2,4-triazole-3-sulfonamide, 2-acetamido-4-fluorobenzoic acid, 2-acetamido-4-fluoro-hydroxybenzoic acid and 2,2′-oxybis(6-fluoro-2-methyl-1,2-dihydro-3H-indol-3-one) to contaminate surface water or to expose aquatic organisms by runoff; (3) depending on the outcome of the assessment under (1) and (2), where there is considerable photodegradation in soil or where there is high potential for contamination or exposure, additional analytical methods to determine all compounds of the residue definition for monitoring in surface water; (4) the risk from secondary poisoning for birds and mammals by 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole; (5) the potential for causing endocrine disrupting effects in birds and fish by amisulbrom and its metabolite 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole. The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) to (4) by 30 June 2016 and under point (5) within two years after the adoption of pertinent OECD test guidelines on endocrine disruption. |
| 70 | Valifenalate CAS No 283159-90-0 CIPAC No 857 | Methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate | ≥ 980 g/kg | 1 July 2014 | 1 March 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 valifenalate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential of metabolite S5 to contaminate groundwater. The notifier shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016. |
| 71 | Thiencarbazone CAS No 317815-83-1 CIPAC No 797 | Methyl 4-[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H-1,2,4-triazol-1-yl)carbonylsulfamoyl]-5-methylthiophene-3-carboxylate | ≥ 950 g/kg | 1 July 2014 | 1 March 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 thiencarbazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to (a) the risk to groundwater if the substance is applied under vulnerable geographical or climatic conditions; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. That confirmatory information shall consist of the results of a monitoring programme to assess the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. The applicant shall submit to the Commission, the Member States and the Authority this monitoring programme by 30 June 2016 and the results in form of a monitoring report by 30 June 2018. |
| 72 | Acequinocyl CAS No 57960-19-7 CIPAC No 760 | 3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate | ≥ 960 g/kg | 1 September 2014 | 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 acequinocyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of workers and operators; — the risk to birds, mammals and aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) an analytical method for residues in body fluids and tissues; (b) the acceptability of the long-term risk to small granivorous birds and small herbivorous and frugivorous mammals, concerning the use on apple and pear orchards; (c) the acceptability of the long-term risk to small omnivorous and small herbivorous mammals, concerning the use on outdoor ornamentals. The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016. |
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| 76 | Metobromuron CAS No 3060-89-7 CIPAC No 168 | 3-(4-bromophenyl)-1-methoxy-1-methylurea | ≥ 978 g/kg | 1 January 2015 | 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 metobromuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of workers and operators; (b) the risk to birds, mammals, aquatic organisms and terrestrial non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (a) the toxicological assessment of the metabolites CGA 18236, CGA 18237, CGA 18238 and 4-bromoaniline; (b) the acceptability of the long-term risk to birds and mammals. The applicant shall submit that information to the Commission, the Member States and the Authority by 31 December 2016. |
| 77 | Aminopyralid CAS No 150114-71-9 CIPAC No 771 | 4-amino-3,6-dichloropyridine-2-carboxylic acid | ≥ 920 g/kg The following relevant impurity shall not exceed a certain threshold: Picloram ≤ 40 g/kg | 1 January 2015 | 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 aminopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions; (b) the risk to aquatic macrophytes and terrestrial non-target plants; (c) chronic risk to fish. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 79 | Streptomyces lydicus strain WYEC 108 Collection number: American Type Culture Collection (USDA) ATCC 55445 | Not applicable | Minimum concentration: 5,0 × 108 CFU/g | 1 January 2015 | 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 Streptomyces lydicus strain WYEC 108, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to aquatic organisms; (b) the risk to soil dwelling organisms. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 83 | Bacillus amyloliquefaciens subsp. plantarum strain D747 Accession number in the Agricultural Research Culture Collection (NRRL), Peoria, Illinois, USA: B-50405 Deposit number in the International Patent Organism Depositary, Tokyo, Japan: FERM BP-8234. | Not applicable | Minimum concentration: 2,0 × 1011 CFU/g | 1 April 2015 | 31 August 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 Bacillus amyloliquefaciens subsp. plantarum strain D747, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 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 Bacillus amyloliquefaciens subsp. plantarum strain D747 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
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| 85 | Fenhexamid CAS No: 126833-17-8 CIPAC No: 603 | N-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexane-1-carboxamide | ≥ 975 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: — toluene: max. 1 g/kg, — 4-amino-2,3-dichlorophenol: max. 3 g/kg. | 1 January 2016 | 31 December 2030 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenhexamid, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators during field crop handheld operations, — the protection of workers re-entering indoor-treated crops, — the risk to aquatic organisms, — the long-term risk to mammals for field uses. Conditions of use shall include risk mitigation measures, where appropriate. |
| 86 | Halauxifen-methyl CAS No:943831-98-9 CIPAC No: 970.201 (halauxifen-methyl) 970 (halauxifen) | methyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)pyridine-2-carboxylate | ≥ 930 g/kg | 5 August 2015 | 5 January 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 halauxifen-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 risk to aquatic and non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: — The technical specification of the active substance as manufactured (based on commercial scale production). The relevance of impurities present in the technical material should be confirmed, — The compliance of the toxicity batches with the technical specification. The applicant shall submit that information to the Commission, the Member States and the Authority by 5 February 2016. |
| 87 | Pyridate CAS No: 55512-33-9 CIPAC No: 447 | O-6-chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate | ≥ 900 g/kg | 1 January 2016 | 31 December 2030 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyridate, 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, non-target terrestrial plants, and herbivorous mammals. Conditions of use shall include risk mitigation measures, where appropriate. |
| 88 | Sulfoxaflor CAS No: 946578-00-3 CIPAC No: 820 | [methyl(oxo){1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide | ≥ 950 g/kg | 18 August 2015 | 18 January 2028 | Only uses in permanent greenhouses may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfoxaflor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 29 May 2015 and updated on 28 January 2022, shall be taken into account. In this overall assessment, Member States shall pay particular attention to the risk to bees and bumble bees released for pollination, when products containing the substance are applied in greenhouses. Conditions of use shall include risk mitigation measures, where appropriate. |
| 89 | Sulfosulfuron CAS No: 141776-32-1 CIPAC No: 601 | 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-ethylsulfonylimidazo[1,2-a]pyridine-3-ylsulfonyl)urea | ≥ 980 g/kg The following relevant impurity must not exceed a certain threshold in the technical material: Phenol: < 2 g/kg | 1 January 2016 | 31 December 2030 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfosulfuron, 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 groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to soil non-target macro-organisms other than earthworms, non-target terrestrial plants and aquatic organisms. |
| 90 | Florasulam CAS No 145701-23-1 CIPAC No 616 | 2′,6′,8-trifluoro-5-methoxy[1,2,4]triazolo[1,5-c]pyrimidine-2-sulfonanilide | ≥ 970 g/kg Impurity: 2,6-DFA, not more than 2 g/kg | 1 January 2016 | 31 December 2030 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on florasulam, 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 and non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. |
| 91 | Flupyradifurone CAS No: 951659-40-8 CIPAC No: 987 | 4-[(6-chloro-3-pyridylmethyl)(2,2-difluoroethyl) amino]furan-2(5H)-one | ≥ 960 g/kg | 9 December 2015 | 9 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 flupyradifurone, 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 workers and operators, — the risk to non-target arthropods, aquatic invertebrates and small herbivorous mammals, — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions, — residues in animal matrices and rotational crops. 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 some individual impurities, (2) the compliance of the toxicity batches with the confirmed technical specification, (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. The applicant shall submit to the Commission, the Member States and the Authority the information requested under point (1) and (2) by 9 June 2016, the information requested under point (3) within 2 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. |
| 92 | Rescalure CAS No: 67601-06-3 CIPAC No: Not available | (3S,6R)-(3S,6S)-6-isopropenyl-3-methyldec-9-en-1-yl acetate | ≥ 750 g/kg The ratio of (3S,6R)/(3S,6S) shall be in a range of 55/45 to 45/55. The purity range for each isomer shall be 337,5 g/kg to 412,5 g/kg. | 18 December 2015 | 18 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 rescalure, and in particular Appendices I and II thereof, shall be taken into account. |
| 93 | Mandestrobin CAS No: 173662-97-0 CIPAC No: Not available | (RS)-2-methoxy-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide | ≥ 940 g/kg (on a dry weight basis) Xylenes (ortho, meta, para), ethyl benzene max. 5 g/kg (TK) | 9 December 2015 | 9 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 mandestrobin, 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, — 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. 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 some individual impurities; (2) the compliance of the toxicity batches with the confirmed technical specification. The applicant shall submit that information to the Commission, the Member States and the Authority by 9 June 2016. |
| 94 | 2,4-D CAS No: 94-75-7 CIPAC No: 1 | (2,4-dichlorophenoxy) acetic acid | ≥ 960 g/kg Impurities: Free phenols (expressed as 2,4-DCP): not more than 3 g/kg. Sum of dioxins and furans (WHO-TCDD TEQ) (13): not more than 0,01 mg/kg. | 1 January 2016 | 31 December 2030 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-D, 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, terrestrial organisms and consumers in cases of uses above 750 g/ha. Conditions of use shall include risk mitigation measures, where appropriate. The notifier shall submit to the Commission, the Member States and the Authority: (1) confirmatory information in the form of the submission of the complete study results from the existing extended one-generation study; (2) confirmatory information in the form of the submission of the Amphibian Metamorphosis Assay (AMA) (OECD (2009) Test No 231) as to verify the potential endocrine properties of the substance. The information set out in point (1) shall be submitted by 4 June 2016 and the information set out in point (2) by 4 December 2017. |
| 95 | Pyraflufen-ethyl CAS No 129630-19-9 CIPAC No 605.202 | ethyl [2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxy]acetate | ≥ 956 g/kg | 1 April 2016 | 31 March 2031 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraflufen-ethyl, 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 aquatic organisms, — the protection of non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. |
| 96 | Iprovalicarb CAS No 140923-17-7 CIPAC No 620 | isopropyl [(1S)-2-methyl-1-{[(1RS)-1-p-tolylethyl]carbamoyl}propyl]carbamate | ≥ 950 g/kg Impurities: Toluene: not more than 3 g/kg | 1 April 2016 | 31 March 2031 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iprovalicarb, 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 groundwater from the relevant soil metabolite PMPA (17) when the active substance is applied in regions with low clay containing soil types, — the safety of operators and workers, — the protection of aquatic organisms in the case of formulated products containing other active substances. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority, confirmatory information as regards the genotoxic potential of soil metabolite PMPA. This information shall be submitted by 30 September 2016. |
| 97 | Pinoxaden CAS No 243973-20-8 CIPAC No 776 | 8-(2,6-diethyl-p-tolyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropionate | ≥ 970 g/kg Toluene max. content 1 g/kg | 1 July 2016 | 31 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 pinoxaden, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 29 January 2016 shall be taken into account. In this 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 Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolite M2 in vulnerable zones, where appropriate. The applicant shall submit confirmatory information as regards: (a) a validated method of analysis of metabolites M11, M52, M54, M55 and M56 in ground water; (b) the relevance of the metabolites M3, M11, M52, M54, M55 and M56, and the corresponding groundwater risk assessment, if pinoxaden is classified under Regulation (EC) No 1272/2008 as H361d (suspected of damaging the unborn child). The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in point (a) by 30 June 2018 and the information set out in point (b) within six months from the notification of the classification decision under Regulation (EC) No 1272/2008 concerning pinoxaden. |
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| 99 | Cyantraniliprole CAS No: 736994-63-1 CIPAC No: Not allocated. | 3-bromo-1-(3-chloro-2-pyridyl)-4′-cyano-2′-methyl-6′-(methylcarbamoyl)pyrazole-5-carboxanilide | ≥ 940 g/kg IN-Q6S09 max. 1 mg/kg IN-RYA13 max. 20 mg/kg methanesulfonic acid max. 2 g/kg acetonitrile max. 2 g/kg heptane max. 7 g/kg 3-picoline max. 3 g/kg. | 14 September 2016 | 14 September 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 cyantraniliprole, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to operators; (b) the risk to aquatic organisms, bees and other non-target arthropods; (c) the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses; (d) 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. The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards 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 within 2 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. |
| 100 | Isofetamid CAS No: 875915-78-9 CIPAC No: 972 | N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide | ≥ 950 g/kg | 15 September 2016 | 15 September 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 isofetamid, 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 risk to operators, workers and aquatic organisms, in particular fish. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the 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 process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water. The applicant shall submit the information requested under points (1) and (2) by 15 March 2017 and the information requested under point (3) within 2 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. |
| 101 | Bacillus amyloliquefaciens strain MBI 600. Accession number in the National Collection of Industrial, Marine and Food Bacteria Ltd (NCIMB), Scotland: NCIMB 12376 Deposit number in the American Type Culture Collection (ATCC): SD-1414 | Not applicable | Minimum concentration: 5,0 × 1014 CFU/kg | 16 September 2016 | 16 September 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 Bacillus amyloliquefaciens strain MBI 600, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites; (b) the protection of operators and workers, taking into account that Bacillus amyloliquefaciens strain MBI 600 is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| 102 | Ethofumesate CAS No 26225-79-6 CIPAC No 233 | (RS)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl methanesulfonate | ≥ 970 g/kg The following impurities are of toxicological concern and must not exceed the following levels in the technical material: — EMS; ethyl methane sulfonate: maximum of 0,1 mg/kg — iBMS; iso-butyl methane sulfonate: maximum of 0,1 mg/kg | 1 November 2016 | 31 October 2031 | 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 ethofumesate, 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. |
| 103 | Picolinafen CAS No 137641-05-5 CIPAC No 639 | 4′-fluoro-6-(α,α,α-trifluoro-m-tolyloxy)pyridine-2-carboxanilide | ≥ 980 g/kg | 1 November 2016 | 30 June 2031 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on picolinafen, 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 impurities in the technical active substance; — the protection of mammals, especially of large herbivorous mammals; — the protection of non-target terrestrial plants; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of aquatic organisms, especially to algae. Conditions of use shall include risk mitigation measures, where appropriate. |
| 104 | Thifensulfuron-methyl CAS No 79277-27-3 CIPAC No 452 | methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)thiophene-2-carboxylate | ≥ 960 g/kg | 1 November 2016 | 31 October 2031 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thifensulfuron-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 groundwater; — the protection of non-target plants and aquatic organisms. Conditions of use shall include risk mitigation measures and the obligation to monitor the groundwater, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the absence of genotoxicity of metabolites IN-A4098 and its derivative IN-B5528, IN-A5546 and IN-W8268; (2) mechanistic data to rule out an endocrine mediated mode of action for mammary gland tumours; (3) the risk to aquatic organisms from thifensulfuron-methyl and metabolite IN-D8858 and the risk to soil organisms from metabolites IN-JZ789 and 2 acid 3 triuret; (4) the relevance of the metabolites IN-A4098, IN-L9223 and IN-JZ789 if thifensulfuron-methyl is classified as reprotoxic category 2 under Regulation (EC) No 1272/2008 and the risk that those metabolites contaminate groundwater. The applicant shall submit the information requested under point (1) by 31 March 2017, under points (2) and (3) by 30 June 2017 and under point (4) within six months after the notification of the classification decision concerning thifensulfuron-methyl. |
| 105 | Thiabendazole | 2-(thiazol-4-yl)benzimidazole | ≥ 985 g/kg | 1 April 2017 | 31 March 2032 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiabendazole, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and consumers, — the protection of groundwater, — the control of waste water from post-harvest uses. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit by 31 March 2019 to the Commission, the Member States and the Authority confirmatory information regarding Level 2 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of thiabendazole. |
| CAS No 148-79-8 CIPAC No 323 | ||||||
| 106 | Oxathiapiprolin CAS No: 1003318-67-9 CIPAC No: 985 | 1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone | ≥ 950 g/kg | 3 March 2017 | 3 March 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 oxathiapiprolin, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the 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. The applicant shall submit the information requested under points (1) and (2) by 3 September 2017. |
| 107 | Iodosulfuron CAS No 185119-76-0 (parent) CAS No 144550-36-7 (iodosulfuron-methyl-sodium) CIPAC No 634 (parent) CIPAC No 634.501 (iodosulfuron-methyl-sodium) | 4-iodo-2-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoylsulfamoyl]benzoic acid (iodosulfuron) sodium ({[5-iodo-2-(methoxycarbonyl)phenyl]sulfonyl}carbamoyl)(4-methoxy-6-methyl-1,3,5-triazin-2-yl)azanide (iodosulfuron-methyl-sodium) | ≥ 910 g/kg (expressed as iodosulfuron-methyl-sodium) | 1 April 2017 | 31 March 2032 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iodosulfuron, 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 consumers, — the risk to non-target terrestrial plants, — the risk to aquatic plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the genotoxic potential of the metabolite triazine-amine (IN-A4098), in order to confirm that this metabolite is not genotoxic and not relevant for the risk assessment; (2) the effect of water treatment processes on the nature of residues present in drinking water. The applicant shall submit the information requested under point (1) 1 October 2017 and the information requested under point (2) by 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. |
| 108 | Flazasulfuron CAS No 104040-78-0 CIPAC No 595 | 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulphonyl)urea | ≥ 960 g/kg | 1 August 2017 | 31 July 2032 | 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 flazasulfuron, 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 aquatic plants, — the protection 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 use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within a period of two years a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission. |
| 109 | Beauveria bassiana strain NPP111B005 Accession number in the CNCM (Collection Nationale de Culture de Microorganismes) — Institut Pasteur, Paris, France: I-2961. | Not applicable | Max. level of beauvericin 24 μg/L | 7 June 2017 | 7 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 review report on Beauveria bassiana strain NPP111B005, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, taking into account that Beauveria bassiana strain NPP111B005 is to be considered, as any micro-organism, as a potential sensitizer, and paying special attention to exposure through inhalation, — the maximum level of the metabolite beauvericin in the formulated product. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. Conditions of use shall include risk mitigation measures, where appropriate. |
| 110 | Beauveria bassiana strain 147 Accession number in the CNCM (Collection nationale de cultures de micro-organismes) — Institut Pasteur, Paris, France: I-2960. | Not applicable | Max. level of beauvericin: 24 μg/L | 6 June 2017 | 6 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 review report on Beauveria bassiana strain 147, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, taking into account that Beauveria bassiana strain 147 is to be considered, as any micro-organism, as a potential sensitizer, and paying special attention to exposure through inhalation, — the maximum level of the metabolite beauvericin in the formulated product. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. Conditions of use shall include risk mitigation measures, where appropriate. |
| 111 | Mesosulfuron (parent) Mesosulfuron-methyl (variant) CAS No 208465-21-8 (mesosulfuron-methyl) CIPAC No 663 (mesosulfuron) CIPAC No 663.201 (mesosulfuron-methyl | Mesosulfuron-methyl: methyl-2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-(methanesulfonamido)-p-toluate Mesosulfuron: 2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-methanesulfonamido-p-toluic acid | ≥ 930 g/kg (expressed as mesosulfuron-methyl) | 1 July 2017 | 30 June 2032 | 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 mesosulfuron 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 aquatic organisms and non-target terrestrial plants; — the protection of groundwater. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within a period of two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission. |
| 112 | Mesotrione CAS No 104206-82-8 CIPAC No 625 | Mesotrione 2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione | ≥ 920 g/kg R287431 max 2 mg/kg R287432 max 2 g/kg 1,2-dichloroethane max 1 g/kg | 1 June 2017 | 31 May 2032 | 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 mesotrione, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, — the protection of groundwater in vulnerable regions, — the protection of mammals, aquatic and non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: 1. the genotoxic profile of the metabolite AMBA; 2. the potential endocrine disrupting mode of action of the active substance in particular level 2 and 3 tests, currently indicated in the OECD Conceptual framework (OECD 2012) and analysed in the EFSA Scientific opinion on the hazard assessment of endocrine disruptors; 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 to the Commission, the Member States and the Authority the relevant information requested under point 1 by 1 July 2017 and the relevant information requested under point 2 by 31 December 2017. The applicant shall submit to the Commission, the Member States and the Authority the confirmatory information requested under point 3 within a period of 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 being made public by the Commission. |
| 113 | Cyhalofop-butyl CAS No 122008-85-9 CIPAC No 596 | butyl (R)-2-[4-(4-cyano-2-fluorophenoxy) phenoxy]propionate | 950 g/kg | 1 July 2017 | 30 June 2032 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyhalofop-butyl, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, — the technical specification, — the protection of non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. |
| 114 | Propoxycarbazone (parent) Propoxycarbazone-sodium (variant) CAS No 145026-81-9 (propoxycarbazone) CAS No 181274-15-7 (propoxycarbazone-sodium) CIPAC No 655 (propoxycarbazone) CIPAC No 655.011 (propoxycarbazone-sodium) | Propoxycarbazone: methyl 2-[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazole-1-carboxamido)sulfonyl]benzoate Propoxycarbazone-sodium: sodium {[2-(methoxycarbonyl)phenyl]sulfonyl}[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-yl)carbonyl]azanide | ≥ 950g/kg (expressed as Propoxycarbazone-sodium) | 1 September 2017 | 31 August 2032 | 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 propoxycarbazone, 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 aquatic organisms, in particular aquatic plants and of and non-target terrestrial plants, — 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. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within a period of 2 years of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission. |
| 115 | Benzoic acid CAS No 65-85-0 CIPAC No 622 | Benzoic acid | ≥ 990 g/kg | 1 September 2017 | 31 August 2032 | 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 benzoic acid and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators, ensuring that conditions of use impose the use of adequate personal protective equipment. Conditions of use shall include risk mitigation measures, where appropriate. |
| 116 | 2,4-DB CAS No 94-82-6 CIPAC No 83 | 4-(2,4-dichlorophenoxy) butyric acid | ≥ 940 g/kg Impurities: Free phenols (expressed as 2,4-dichlorophenol (2,4-DCP)): max. 15 g/kg. Dibenzo-p-dioxins and polychlorinated dibenzofurans (TCDD toxic equivalents (TEQ)): max. 0,01 mg/kg. | 1 November 2017 | 31 October 2032 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-DB, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, — the protection of consumers from products of animal origin, — the protection of wild mammals, — the protection of soil non-target organisms, — the protection of aquatic organisms, — the protection of non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. |
| 117 | Maleic hydrazide CAS No 123-33-1 CIPAC No 310 | 6-hydroxy-2H-pyridazin-3-one | ≥ 979 g/kg The impurity hydrazine shall not exceed 0,028 mg/kg in the technical material. | 1 November 2017 | 31 October 2032 | 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 maleic hydrazide, and in particular Appendices I and II thereto, as well as its addendum, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of consumers; — the operator and worker safety; the conditions of the use shall include the application of adequate personal protective equipment. Conditions of use shall include risk mitigation measures, where appropriate. |
| 118 | Glyphosate CAS No: 1071-83-6 CIPAC No: 284 | N-(phosphonomethyl)glycine | ≥ 950 g/kg The following impurities are of toxicological concern and shall not exceed the following levels in the technical material: — N-nitroso-glyphosate (NNG): &amp;amp;lt; 1 mg/kg — formaldehyde: < 1 g/kg — triethylamine: ≤ 2g/kg — formic acid: ≤ 4 g/kg — N,N-bis(phosphonomethyl) glycine (glyphosine): ≤ 3 g/kg | 16 December 2023 | 15 December 2033 | Only uses as herbicide may be authorised. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on glyphosate, 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 co-formulants present in glyphosate-containing plant protection products, taking into account in particular the criteria for identification of unacceptable co-formulants as set out in Commission Implementing Regulation (EU) 2023/574 (29); — the consumer exposure assessment with regards to residues that may be present in succeeding crops grown in rotation; — the protection of groundwater in vulnerable areas and of surface waters, in particular those used for the abstraction of drinking water, considering specifically uses on sealed surfaces; — the protection of small herbivorous mammals. Member States shall, where considered necessary impose mitigation measures such as limiting the timing of use, the number of applications or the maximum dose rate. The following maximum application rates shall not be exceeded unless the outcome of the risk assessment undertaken for the specific uses for which authorisation is applied for demonstrates that a higher rate does not lead to any unacceptable effects on small herbivorous mammals: — — For use in agriculture: 1,44 kg glyphosate per hectare, per year; — For use to control invasive species in agricultural and non-agricultural areas: 1,8 kg glyphosate per hectare, per year; — For use in non-agricultural areas: 3,6 kg glyphosate per hectare, per year; — the protection of non-target terrestrial and aquatic plants from exposure by spray drift; — indirect effects on biodiversity via trophic interactions once relevant methods and guidance to identify such effects are agreed at Union level. In the absence of such methods and guidance, Member States may apply methods which they consider appropriate to determine the potential indirect effects of plant protection products containing glyphosate and which take into account their local agro-environmental conditions. When doing so, if they identify any such possible indirect effects on biodiversity, Member States shall set specific conditions or restrictions of use for plant protection products containing glyphosate, considering in particular if practical alternative control or prevention methods with lower impacts on biodiversity are available; — uses by non-professional users; — compliance of pre-harvest uses with the provisions of Directive 2009/128/EC in conjunction with Article 55 of Regulation (EC) No 1107/2009. Uses for desiccation to control the time point of harvest or to optimise threshing shall not be authorised. Conditions of use shall include risk mitigation measures, including combinations thereof, as required. In particular, drift shall be reduced for spray applications made by professional users in agricultural fields. By default, to protect non-target terrestrial plants, an in-field non-sprayed buffer strip of at least 5 to 10 m from the field border depending on the particular use and drift reduction nozzles reducing spray drift by at least 75 %, or other risk mitigation measures with equivalent reduction of drift, shall be required, unless the outcome of the risk assessment undertaken for the specific plant protection product use indicates that such risk mitigation measures are not needed or can be lowered because there are no unacceptable risks caused by spray drift. In addition, Member States may set monitoring requirements when granting authorisations, in order to complement the monitoring under Directive 2000/60/EC of the European Parliament and of the Council (30) and Directive 2009/128/EC. Member States shall ensure that use of plant protection products containing glyphosate is minimised or prohibited in the specific areas listed in Article 12(a) of Directive 2009/128/EC. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the possible indirect effects on biodiversity via trophic interactions, within three years from the date of applicability of a relevant guidance document endorsed by the Standing Committee on Plants, Animals, Food and Feed. |
| 119 | Acetamiprid CAS No 135410-20-7 CIPAC No 649 | (E)-N1-[(6-Chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine | ≥ 990 g/kg | 1 March 2018 | 28 February 2033 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on acetamiprid, 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 risk to aquatic organisms, bees and other non-target arthropods, — the risk to birds and mammals, — the risk to consumers, — the risk to operators. Conditions of use shall include risk mitigation measures, where appropriate. |
| 120 | Bentazone CAS No 25057-89-0 CIPAC No 366 | 3-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one 2,2- dioxide | ≥ 960 g/kg 1,2-dichloroethane < 3 mg/kg | 1 June 2018 | 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 bentazone, 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 technical specification, — the protection of operators and workers, — the risk to birds and mammals, — the protection of groundwater, particularly but not only in drinking water protected areas, and shall carefully consider the timing of application, soil and/or climatic conditions. Conditions of use shall include risk mitigation measures where appropriate. The applicant shall submit by 1 February 2019 to the Commission, the Member States and the Authority confirmatory information as regards Level 2/3 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of bentazone. |
| 121 | Silthiofam CAS No 175217-20-6 CIPAC No 635 | N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide | ≥ 980 g/kg | 1 July 2018 | 30 June 2033 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on silthiofam 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 regions, — the protection of birds, mammals and earthworms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the 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; 2. the relevance of the metabolites M2 and M6 taking into account any relevant classification for silthiofam in accordance with Regulation (EC) No 1272/2008, in particular as reprotoxic category 2. The applicant shall submit the information mentioned in point (1) 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 is made public by the Commission and the information requested under point (2) within one year after the publication in the European Chemicals Agency (ECHA) webpage of the opinion adopted by the Committee for risk assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to silthiofam. |
| 122 | Forchlorfenuron CAS No 68157-60-8 CIPAC No 633 | 1-(2-chloro-4-pyridyl)-3-phenylurea | ≥ 978 g/kg | 1.6.2018 | 31.5.2033 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on forchlorfenuron, 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 consumers as regards the potential risk from metabolites in fruit crops with edible peels. Conditions of use shall include risk mitigation measures, where appropriate. |
| 123 | Zoxamide CAS No 156052-68-5 CIPAC No 640 | (RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide | ≥ 953 g/kg | 1 July 2018 | 30 June 2033 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on zoxamide, 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 groundwater from metabolite RH-141455, — the protection of bees, aquatic organisms and earthworms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater is made public by the Commission. |
| 124 | Trifloxystrobin CAS No 141517-21-7 CIPAC No 617 | methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate | ≥ 975 g/kg AE 1344136 (max. 4 g/kg) | 1 August 2018 | 31 July 2033 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on trifloxystrobin, 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 groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions; — the protection of aquatic organisms, bees, and of fish-eating birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for trifloxystrobin in accordance with Regulation (EC) No 1272/2008, in particular as toxic for reproduction category 2; (2) 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. The applicant shall submit the information requested under point (1) within one year after the publication, on the website of the European Chemicals Agency (ECHA), of the opinion adopted by the Committee for Risk Assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to trifloxystrobin. The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission. |
| 125 | Carfentrazone-ethyl CAS No 128639-02-1 CIPAC No 587.202 | Ethyl (RS)-2-chloro-3-[2-chloro-4-fluoro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H- 1,2,4-triazol-1-yl]phenyl]propionate | ≥ 910 g/kg | 1 August 2018 | 31 July 2033 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carfentrazone-ethyl, 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 groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions; — the protection of soil non-target organisms; — the protection of aquatic organisms; — the protection of non-target terrestrial higher plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for carfentrazone-ethyl in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (19), in particular as carcinogen category 2; (2) the effect of water treatment processes on the nature of residues present in drinking water. The applicant shall submit the information mentioned in point (1) within one year after the publication on the website of the European Chemicals Agency of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to carfentrazone-ethyl. The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission. |
| 126 | Fenpicoxamid CAS No: 517875-34-2 CIPAC No: 991 | (3S,6S,7R,8R)-8-benzyl-3-{3-[(isobutyryloxy)methoxy]-4-methoxypyridine-2-carboxamido}-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl isobutyrate | ≥ 750 g/kg | 11 October 2018 | 11 October 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 fenpicoxamid, 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 impact of processing on the consumer risk assessment, — 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) and the compliance of the toxicity batches with the confirmed technical specification; 2. the effect of water treatment processes on the nature of residues present in drinking water; 3. the endocrine disrupting potential of fenpicoxamid as regards the thyroid modality/pathway, providing in particular mechanistic data to clarify according to Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 (20), whether the effects observed in the studies submitted for approval are or are not related to a thyroid endocrine disrupting mode of action. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 1 by 11 October 2019, in point 2 within 2 years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission and in point 3 by 10 November 2020. |
| 127 | Pethoxamid CAS No 106700-29-2 CIPAC No 665 | 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide | ≥ 940 g/kg Impurities: Toluene: max 3 g/kg. | 1 December 2018 | 30 November 2033 | PART A Use shall be limited to one application every two years in the same field at a maximum dose of 1 200 g active substance 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 renewal report on pethoxamid, 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 risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions; — the risk to aquatic organisms and earthworms; — the risk to consumers from residues in the succeeding crops or in case of crop failure. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council (19), in particular as carcinogen category 2; 2. the effect of water treatment processes on the nature of residues present in drinking water; 3. the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action. The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested. The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission. The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605 (20) amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA. |
| 128 | Tribenuron (parent) CAS No 106040-48-6 CIPAC No 546 | 2-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid | ≥ 960 g/kg (expressed as tribenuron-methyl) | 1 February 2019 | 30 January 2034 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on tribenuron, 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, in particular to residues on animal products, — the protection of groundwater, — the protection of aquatic organisms and of non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. |
| 129 | Metschnikowia fructicola strain NRRL Y-27328 Accession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USA | Not applicable | Minimum concentration: 1 × 1010 CFU/g | 27 December 2018 | 27 December 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 Metschnikowia fructicola strain NRRL Y-27328, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, taking into account that Metschnikowia fructicola strain NRRL Y-27328 is to be considered as a potential sensitizer. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer. Conditions of use shall include risk mitigation measures, where appropriate. |
| 130 | Beauveria bassiana strain IMI389521 Accession number in the CABI Genetic Resource Collection: IMI389521 | Not applicable | Max. level of beauvericin: 0,09 mg/kg | 19 February 2019 | 19 February 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 Beauveria bassiana strain IMI389521, 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 storage stability of the formulation(s) containing B. bassiana strain IMI389521 including the level of the metabolite beauvericin content after storage; — the content of the metabolite beauvericin produced under the application conditions; — the risk posed by beauvericin in infected insects present in the stored grain. Measures are required to ensure that such products do not enter the food and feed chain, taking into account the natural background level of beauvericin on cereal grains; — the protection of operators and workers, taking into account that B. bassiana strain IMI389521 is to be considered, as any micro-organism, as a potential sensitiser. The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (21). Conditions of use shall include risk mitigation measures where appropriate. |
| 131 | Beauveria bassiana strain PPRI 5339 Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757 | Not applicable | Max. level of beauvericin: 0,5 mg/kg | 20 February 2019 | 20 February 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 Beauveria bassiana strain PPRI 5339, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339; — the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval; — the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer. The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (21). Conditions of use shall include risk mitigation measures where appropriate. |
| 132 | Mefentrifluconazole CAS No: 1417782-03-6 CIPAC No: Not assigned | (2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol | ≥ 970 g/kg The impurity N, N-dimethylformamide shall not exceed 0,5 g/kg in the technical material. The impurity toluene shall not exceed 1 g/kg in the technical material The impurity 1,2,4-(1H)-triazole shall not exceed 1 g/kg in the technical material | 20 March 2019 | 20 March 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 mefentrifluconazole, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, such as buffer zones and/or vegetative strips, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification; 2. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water. The applicant shall submit the information referred to in point 1 by 20 March 2020 and the information referred to in point 2 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. |
| 133 | Flutianil CAS No [958647-10-4] CIPAC No 835 | (Z)-3-(2-methoxyphenyl)-1,3-thiazolidin-2-ylideneacetonitrile | ≥ 985 g/kg | 14 April 2019 | 14 April 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 flutianil, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, — the risk to aquatic organisms, — the risk to groundwater from metabolites, if the substance is applied under vulnerable soil or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification; 2. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water; 3. an updated assessment of the information submitted and, where relevant further information, confirming that flutianil is not an endocrine disruptor in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, applying also the ECHA and EFSA guidance for identification of endocrine disruptors (22). The applicant shall submit the information: — referred to in point 1 by 14 April 2020; — referred to in point 2 within two years from the date of publication, from the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater; and — referred to in point 3 by 14 April 2021. |
| 134 | Isoxaflutole CAS No 141112-29-0 CIPAC No 575 | (5-cyclopropyl-1,2-oxazol-4-yl)(α,α,α-trifluoro-2-mesyl-p-tolyl)methanone | ≥ 972 g/kg | 1 August 2019 | 31 July 2034 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on isoxaflutole, 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 groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic organisms, wild mammals and 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 confirmatory information as regards 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. The applicant shall submit this information within 2 years from the date of publication, by the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. The applicant shall also provide an updated assessment to confirm that isoxaflutole is not an endocrine disruptor within the meaning of points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 and in accordance with the guidance for identification of endocrine disruptors (23) by 10 May 2021. |
| 135 | carvone 2244-16-8 (d-carvone = S-carvone = (+)-carvone) Carvone: 602 d-carvone: not allocated | (S)-5-isopropenyl-2-methylcyclohex-2-en-1-one Or (S)-p-mentha-6,8-dien-2-one | 923 g/kg d-carvone | 1 August 2019 | 31 July 2034 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on carvone, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment. Conditions of use shall include risk mitigation measures, where appropriate. In particular, consideration should be given to the necessary time period before entry into storage rooms after the application of plant protection products containing carvone. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: — the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water. The applicant shall submit that information 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. |
| 136 | 1-methylcyclopropene CAS No 3100-04-7 CIPAC No 767 | 1-methylcyclopropene | ≥ 980 g/kg (technical concentrate) The following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate): — 1-chloro-2-methylpropene: maximum of 0,2 g/kg, — 3-chloro-2-methylpropene: maximum of 0,2 g/kg. For 1-methylcyclopropene generated in situ, Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %. | 1 August 2019 | 31 July 2034 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1-methylcyclopropene, 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 groundwater, when the substance is applied in regions with vulnerable soil and climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the presence of methallyl alcohol in soil and aquatic compartments and, if formed in relevant amounts, information on its toxicological properties and potential risk to aquatic and soil organisms and as regards the effect of water treatment processes on the nature of residues present in drinking water. The confirmatory information shall be submitted by 27 May 2027. |
| 137 | Dimethenamid-P CAS No 163515-14-8 CIPAC No 638 | (S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide | ≥ 930 g/kg The following impurity is of toxicological concern and must not exceed the following level in the technical material: 1,1,1,2-Tetrachloroethane (TCE): ≤ 1,0 g/kg | 1 September 2019 | 31 August 2034 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on dimethenamid-P, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of groundwater, in particular regarding the metabolites of dimethenamid-P; — the protection of aquatic organisms and small herbivorous mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water. The applicant shall submit the requested information 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. |
| 138 | Tolclofos-methyl CAS No 57018-04-9 CIPAC No 479 | O-2,6-dichloro-p-tolylO, O-dimethyl phosphorothioate O-2,6-dichloro-4-methylphenyl O, O-dimethyl phosphorothioate | ≥ 960 g/kg The following impurity is of toxicological concern and must not exceed the following level in the technical material: Methanol max. 1 g/kg | 1 September 2019 | 31 August 2034 | Only for use on ornamentals and on potatoes. 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 tolclofos-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 risk to aquatic organisms and mammals, — the risk to consumers, in particular the potential risk from metabolite DM-TM-CH2OH in potatoes, — the risk to operators, workers and bystanders; Conditions of use shall include risk mitigation measures, where appropriate. |
| 139 | Florpyrauxifen-benzyl CAS No: 1390661-72-9 CIPAC No: 990.227 | benzyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5-fluoropyridine-2-carboxylate | ≥ 920 g/kg The impurity toluene shall not exceed 3 g/kg in the technical material. | 24 July 2019 | 24 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 22 March 2019, 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 aquatic and terrestrial non-target plants. Conditions of use shall include risk mitigation measures such as buffer zones and/or drift reduction nozzles, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 by 24 July 2021. |
| 140 | Metalaxyl-M CAS No 70630-17-0 (R) CIPAC No 580 | methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate | 920 g/kg The following relevant impurities shall not exceed a certain threshold: 2,6-dimethylphenylamine: max. content 0,5 g/kg 4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide: max. content 1 g/kg 2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester): max. content 10 g/kg | 1 June 2020 | 31 May 2035 | When used for seed treatment where treated seeds are to be sown outdoors, Member States shall, impose appropriate restrictions concerning the sowing density and require the use of precision drilling equipment. A sowing density above 2 000 000 seeds/ha shall not be exceeded unless the outcome of the risk assessment undertaken for the specific uses for which authorisation is applied for demonstrates that a higher rate does not lead to any unacceptable effects on birds and mammals. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl-M, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured, — the protection of operators and workers, ensuring that the conditions of use prescribe the use 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 protection of non-target arthropods, birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water, by 10 July 2026. |
| 141 | Foramsulfuron CAS No 173159-57-4 CIPAC No 659 | 1-(4,6-dimethoxypyrimidin-2-yl)-3-[2-(dimethylcarbamoyl)-5-formamidophenylsulfonyl]urea | ≥ 973 g/kg | 1 June 2020 | 31 May 2035 | 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 foramsulfuron, 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 risk to consumers and operators, — the risk to aquatic organisms and non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards 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, 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. |
| 142 | Pyriproxyfen. 2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine. CIPAC No: 715. CAS No: 95737-68-1. EC No (Einecs or ELINCS): 429-800-1 | 4-phenoxyphenyl (RS)-2(2-pyridyloxy) propyl ether | ≥ 970 g/kg Max. impurity: Toluene 5 g/Kg | 1 August 2020 | 31 July 2035 | 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 pyriproxyfen 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 dietary exposure of consumers to residues of pyriproxyfen, — the protection of sediment-dwelling organisms and aquatic organisms, — the protection of bees. As regards the protection of sediment-dwelling organisms and aquatic organisms, for outdoor use of the plant protection products containing pyriproxyfen Member States shall include in the specific conditions appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for sediment-dwelling organisms and aquatic organisms. As regards the protection of bees, for outdoor use of plant protection products containing pyriproxyfen Member States shall include in the specific conditions a restriction of application to periods outside of the flowering of bee attractive crops, and appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for bees and bee larvae. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water. The applicant shall submit the requested confirmatory information 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. |
| 143 | Kieselgur (Diatomaceous earth) CAS No 61790-53-2 CIPAC No 647 | No IUPAC name exists for kieselgur Other synonyms: Diatomaceous earth, Diatomite | 1 000 g/kg Minimum content of amorphous silica of 800 g/kg The following impurity is of toxicological concern and must not exceed the following level in the technical material: Crystalline silica with particle size below 10 μm – maximum of 1 g/kg | 1 February 2021 | 31 January 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on kieselgur (diatomaceous earth), and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention to the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment, in particular respiratory protective equipment, and other risk mitigation measures, where appropriate. Only indoor use is permitted. Member States shall assess any extension of the use pattern beyond use in closed storage environments, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Regulation (EU) No 546/2011. Conditions of use shall include risk mitigation measures, where appropriate. |
| 144 | Garlic extract Marker components: diallylsulfide (DAS1), diallyldisulfide (DAS 2), diallyltrisulfide (DAS3), diallyltetrasulfide (DAS 4) CAS No 8000-78-0 8008-99-9 CIPAC No 916 | Garlic extract | 1 000 g/kg | 1 March 2021 | 29 February 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on garlic extract, and in particular Appendices I and II thereto, shall be taken into account. On the basis of the proposed and supported uses (as listed in Appendix II), the following issues have been identified as requiring particular and short term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate: — The risk to aquatic organisms. |
| 145 | Streptomyces strain K61 | Not applicable | No relevant impurities | 1 July 2021 | 30 June 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Streptomyces strain K61 and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use. Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination (21). |
| 146 | Cyazofamid CAS No: 120116-88-3 CIPAC No: 653 | 4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide | ≥ 935 g/kg | 01/08/2021 | 31/07/2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cyazofamid, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the specification of the technical material as commercially manufactured; (b) the impact of processing on the consumer risk assessment; (c) the protection of non-target arthropods and earthworms. The applicant shall submit to the Commission, the Member States and the Authority 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. points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605. The applicant shall submit the requested information referred to in point 1 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 point 2 the applicant shall provide an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity by 16 June 2023 |
| 147 | Clopyralid CAS No 1702-17-6 CIPAC No 455 | 3,6-dichloropyridine-2-carboxylic acid or 3,6dichloropicolinic acid | ≥ 950 g/kg | 1 October 2021 | 30 September 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on clopyralid, 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 specification of the technical material as commercially manufactured; — the protection of operators, ensuring that conditions of use for operators include the application of adequate personal protective equipment; — possible presence of clopyralid residues in rotational crops; — the possible transfer of clopyralid residues via compost or manure of animals whose feed originates from treated areas, to avoid damage to susceptible crops; — the protection of groundwater under vulnerable conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water. The applicant shall submit this information 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. |
| 148 | Purpureocillium lilacinum strain 251 | Not applicable | No relevant impurities | 1 March 2022 | 28 February 2037 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Purpureocillium lilacinum strain 251, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (21); (b) the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. Conditions of use shall include risk mitigation measures, where appropriate. |
| 149 | Flumioxazin CAS No 103361-09-7 CIPAC No 578 | N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide | ≥ 960 g/kg | 1 March 2022 | 28 February 2037 | 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 flumioxazin, 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 specification of the technical material that is authorised for use in plant protection products; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine disrupting properties in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 (24) by 1 March 2024. |
| 150 | Carbon dioxide CAS No: 124-38-9 CIPAC No: 844 | Carbon dioxide | 999 g/kg The following impurities are of toxicological concern and shall not exceed the following levels in the technical material: phosphane max. 0,3 ppm v/v benzene max. 0,02 ppm v/v carbon monoxide max. 10 ppm v/v methanol max. 10 ppm v/v hydrogen cyanide max. 0,5 ppm v/vv | 1 May 2022 | 30 April 2037 | 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 carbon dioxide, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — adequate ventilation (e.g. with a ‘certificate of gas clearance’) before humans can re-enter treated and/or surrounding areas (i.e. chambers, buildings and silos). — the need of buffer zones for residents (subjected to revision considering the wind-speeds in the different Member States). Conditions of use shall include risk mitigation measures, where appropriate. |
| 151 | Beauveria bassiana strain 203 Accession number at Centraal Bureau voor Schimmelcultures (Fungal Biodiversity Centre, Institute of the Royal Netherlands Academy of Arts and Sciences, Utrecht, Netherlands): CBS 121097 | Not applicable | Max. level of beauvericin: 80 μg/kg in the formulated product. | 19 April 2022 | 18 April 2032 | Only uses on ornamental palm trees 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 review report on Beauveria bassiana strain 203, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: a) the maximum level of the metabolite beauvericin in the plant protection product; b) the protection of operators and workers, taking into account that the species Beauveria basssiana, irrespective of the strain, is a potential human allergen by both skin and inhalatory exposure, and therefore ensuring that adequate personal protective equipment is included as a condition of use. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (21). Conditions of use shall include risk mitigation measures, where appropriate. |
| 152 | Bifenazate 149877-41-8 736 | isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate | 980 g/kg Toluene is of toxicological concern and must not exceed 0,7 g/kg in the technical material. | 1 July 2022 | 30 June 2037 | Only uses on non-edible crops 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 bifenazate, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment; — the risk to bees and bumble bees released for pollination in permanent greenhouses. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit by 24 May 2024 to the Commission, the Member States and the Authority confirmatory information as regards points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, in particular an updated assessment of the information submitted previously and, where relevant, further information to confirm the absence of endocrine activity. |
| 153 | Straight Chain Lepidopteran Pheromones (aldehydes) | Details are provided in the Review Report SANTE/10828/2021 | Details are provided in the Review Report SANTE/10828/2021 | 1 September 2022 | 30 August 2037 | 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 Straight Chain Lepidopteran Pheromones, and in particular Appendices I and II thereof, shall be taken into account. Member States shall pay particular attention to the efficacy of plant protection products containing either the individual single substances or blends thereof when evaluating applications for authorisation. Conditions of use shall include risk mitigation measures, where appropriate. |
| 154 | Straight Chain Lepidopteran Pheromones (alcohols) | Review Report SANTE SANTE/10828/2021 | Review Report SANTE SANTE/10828/2021 | 1 September 2022 | 30 August 2037 | 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 Straight Chain Lepidopteran Pheromones, and in particular Appendices I and II thereof, shall be taken into account. Member States shall pay particular attention to the efficacy of plant protection products containing either the individual single substances or blends thereof when evaluating applications for authorisation. Conditions of use shall include risk mitigation measures, where appropriate. |
| 155 | Pythium oligandrum strain M1 Culture collection No ATCC 38472 | Not applicable | No relevant impurities | 1 March 2023 | 28 February 2038 | 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 Pythium oligandrum strain M1, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured, — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers and that physical effects on the respiratory system due to the remnants of culture medium and co-formulants in the Microbial Pest Control Product (MPCP) cannot be excluded. Conditions of use shall include risk mitigation measures, such as: — adequate personal protective and respiratory protective equipment for operators using products containing Pythium oligandrum strain M1. |
| 156 | Pseudomonas chlororaphis strain MA 342 Culture collection: NCIMB, UK: NCIMB 40616 | Not applicable | The amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the in the Microbial Pest Control Agent (MPCA) must not exceed the LOQ (2.0 μg/ml). | 1 March 2023 | 28 February 2038 | Only uses as fungicide for seed dressing in closed seed dressing machinery may be authorised. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Pseudomonas chlororaphis strain MA 342, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the level of the metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the Microbial Pest Control Agent (MPCA), which must not exceed 2 μg/ml; — the protection of operators and workers, taking into account that Pseudomonas chlororaphis strain MA 342 is to be considered, as any micro-organism, as a potential sensitiser, and paying special attention to exposure through inhalation. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process, shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the phylogenetic taxonomic identification of the micro-organism in accordance with point 1.3 (identity, taxonomy and phylogeny) of Annex II, Part B of Commission Regulation (EU) 2022/1439 (25); 2. the secondary metabolite DDR in accordance with SANCO/2020/12258 (26), in particular on its degradation rate; 3. the potential for gene transfer of antibiotic resistance from Pseudomonas chlororaphis strain MA 342 to other micro-organisms in accordance with SANTE/2020/12260 (27). The applicant shall submit the requested information referred to in points 1, 2 and 3 by 23 February 2025. |
| 157 | Abamectin CAS No 71751-41-2 Avermectin B1a CAS No 65195-55-3 Avermectin B1b CAS No 65195-56-4 Abamectin CIPAC No 495 | Avermectin B1a (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside Avermectin B1b (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside | ≥ 850 g/kg abamectin (sum of avermectin B1a and avermectin B1b), min. 800 g/kg avermectin B1a and max. 200 g/kg avermectin B1b | 1 April 2023 | 31 March 2038 | Only uses which allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment may be authorised, in particular uses in permanent greenhouses. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Abamectin, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, such as the the use of gloves; — The effect of photolysis on the levels of pesticide residues in crops. Particular attention is required to ensure that available residue trials on crops reflect the most critical residue situation. Where appropriate, depending on the zone, seasonal restrictions for the timing of application shall be applied (cf. representative uses excluded application from November till February). |
| 158 | Bacillus amyloliquefaciens strain QST 713 | n.a. | The nominal content of Bacillus amyloliquefaciens strain QST 713 in the technical product and formulation is Minimum: 1 × 1012 CFU/kg Maximum: 3 × 1013 CFU/kg No relevant impurities | 1 July 2023 | 30 June 2038 | When authorising plant protection products containing Bacillus amyloliquefaciens strain QST 713 for spray applications outdoors, in order to ensure the protection of non-target organisms, including bees, Member States shall: — only authorise field applications in flowering crops or in presence of flowering weed in the field outside the daily foraging period of bees; — implement risk mitigation measures which aim to reduce drift to off-field areas (e.g. considering the application of buffer zones and drift reduction nozzles). For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Bacillus amyloliquefaciens strain QST 713, and in particular Appendices I and II thereof, shall be taken into account. In addition, Member States shall pay particular attention to: — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (28) — the specification of the technical material as commercially manufactured used in plant protection products; — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. |
| 159 | Bacillus thuringiensis subsp. aizawai strain ABTS-1857 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. aizawai strain ABTS-1857 and in particular Appendices I and II thereto, are taken into account. In this overall assessment the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (28); — the protection of wild pollinators (in particular honey bee larvae and bumble bees). Conditions of use shall include specific risk mitigation measures, where appropriate. Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. aizawai strain ABTS-1857 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. aizawai strain ABTS-1857 below 105 CFU/g at harvest. The applicant shall submit to the Commission, the Member States and the Authority additional information as regards: — data in at least one representative edible crop (i.e. peppers and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. aizawai strain ABTS-1857 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State. The applicant shall submit the requested information by 13 December 2025. |
| 160 | Bacillus thuringiensis subsp. aizawai GC-91 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. aizawai GC-91 and in particular Appendices I and II thereto, are taken into account. In this overall assessment the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (28); — the protection of wild pollinators (in particular honey bee larvae and bumble bees). Conditions of use shall include specific risk mitigation measures, where appropriate. Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp aizawai GC-91 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. aizawai GC-91 below 105 CFU/g at harvest. The applicant shall submit to the Commission, the Member States and the Authority additional information as regards: — data in at least one representative edible crop (i.e. pome fruits, grapes and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. aizawai GC-91 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State. The applicant shall submit the requested information by 13 December 2025. |
| 161 | Bacillus thuringiensis subsp. israelensis strain AM65-52 Culture collection No ATCC 1276 | Not applicable | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the renewal report on Bacillus thuringiensis subsp. israelensis strain AM65-52, and in particular Appendices I and II thereof, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (28). — the protection of wild pollinators and of aquatic organisms (e.g. aquatic invertebrates from Diptera taxon in particular) in case of uses in open field. Conditions of use shall include specific risk mitigation measures, where appropriate. Conditions of use shall include risk mitigation measures, such as: — adequate personal protective equipment for operators using products containing Bacillus thuringiensis subsp. israelensis strain AM65-52; — In case of authorisation of uses on edible crops, a minimum time period of 3 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. israelensis AM65-52 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. israelensis AM65-52 below 105 CFU/g at harvest. |
| 162 | Bacillus thuringiensis subsp. kurstaki ABTS-351 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki ABTS-351 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (28). Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. kurstaki ABTS-351 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki ABTS-351 below 105 CFU/g as recommended by EFSA. The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards: — Data in at least one representative edible crop (i.e. on cabbage and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki ABTS-351 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025. |
| 163 | Bacillus thuringiensis subsp. kurstaki EG2348 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki EG2348 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (28). Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp kurstaki EG2348 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki EG2348 below 105 CFU/g as recommended by EFSA. The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards: — data in at least one representative edible crop (i.e. on pome fruits and solanaceous vegetables during the fruiting period) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki EG2348 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025. |
| 164 | Bacillus thuringiensis subsp. kurstaki PB 54 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki PB 54 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (28). Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. kurstaki PB 54 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki PB 54 below 105 CFU/g as recommended by EFSA. The applicant shall submit to the Commission, the Member States and the Authority additional information as regards: — data in at least one representative edible crop (i.e. on stone fruits and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki PB 54 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 14 December 2025. |
| 165 | Bacillus thuringiensis subsp. kurstaki SA-11 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki SA-11 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (28). Conditions of use shall include the following risk mitigation measures: — a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp kurstaki SA-11 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki SA-11 below 105 CFU/g as recommended by EFSA. The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards: — data in at least one representative edible crop (i.e. on pome fruits and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki SA-11 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State. by 13 December 2025. |
| 166 | Bacillus thuringiensis subsp. kurstaki SA-12 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki SA-12 and in particular Appendices I and II thereto, are taken into account. In this overall assessment, the Member States shall pay particular attention to: — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use; — the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 (28). Conditions of use shall include the following risk mitigation measures: — A minimum time period of 1 day shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. kurstaki SA-12 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki SA-12 below 105 CFU/g as recommended by EFSA. The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards: — data in at least one representative edible crop (i.e. on pome fruits and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki SA-12 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025. |
| 167 | Aluminium ammonium sulfate (dodecahydrate) CAS No: 7784-26-1 CIPAC No: 840 | Aluminium ammonium sulfate | — 975 g/kg — Anhydrous - Not less than 510 g/kg — No relevant impurities | 1.2.2024 | 31.1.2039 | For the implementation 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 ammonium sulfate, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers where relevant, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of aquatic organisms when the substance is applied in regions with acidic or basic soil conditions; — the protection of bees from spray applications during the flowering period of adjacent fields or when flowering weeds are present in the treated field; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions (i.e. situations when soil pH is lower than 5,5, e.g. grassland in upland areas, areas of coniferous forestry and areas of ericaceous ornamental plant growing); — the authorisation, for use on row and combinable crops, as a barrier treatment only on field edges. Conditions of use shall include risk mitigation measures where relevant. |
| 168 | Ethephon CAS No: 16672-87-0 CIPAC No: 373 | 2-chloroethylphosphonic acid | ≥ 692 g/kg (TK) ≥ 910 g/kg (TC, theoretical) The following impurities are of toxicological concern and shall not exceed the following levels in the technical material: TK: 1,2-dichloroethane < 0,3 g/kg 2-chloroethanol < 0,3 g/kg TC (theoretical): 1,2-dichloroethane < 0,5 g/kg 2-chloroethanol < 0,3 g/kg | 1 February 2024 | 31 January 2039 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethephon, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of bystanders and residents, ensuring that conditions of use include the use of drift reduction equipment during application. Conditions of use shall include risk mitigation measures, where appropriate. |
| 169 | Trinexapac-ethyl CAS No 95266-40-3 CIPAC No 732.202 | ethyl (1RS,4EZ)-4-cyclopropyl(hydroxy)methylene-3,5-dioxocyclohexanecarboxylate | ≥ 950 g/kg The following impurities shall not exceed the following levels in the technical material: — toluene: 3 g/kg — ethyl (1RS)-3-hydroxy-5-oxocyclohex-3-ene-1-carboxylate (CGA158377): 6 g/kg | 1 May 2024 | 30 April 2039 | 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 trinexapac-ethyl, 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 technical material used in plant protection products, in particular when carrying out assessments of equivalence in accordance with Article 38 of Regulation (EC) No 1107/2009; — the assessment of consumer intake from the diet taking into account the residues of the metabolites of trinexapac-ethyl and the impact of processing; — the levels of residues of the metabolites of trinexapac-ethyl, when straw is used as animal feeding stuff. Conditions of use shall include restrictions for feeding of straw to animals and risk mitigation measures, where appropriate. The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues of trinexapac-ethyl and its metabolites present in surface water, when surface water is abstracted for drinking water, by 1 April 2026. |
| 170 | Captan CAS No 133-06-2 CIPAC No 40 | N-[(trichloromethyl)thio]cyclohex-4-ene-1,2 -dicarboximide | ≥ 930 g/kg perchloromethylmercaptan: ≤ 5 g/kg folpet: ≤ 10 g/kg carbon tetrachloride: ≤ 0,1 g/kg | 1 November 2024 | 31 October 2039 | For outdoor uses the following conditions shall apply: — only uses outside flowering of the crop and when no flowering weeds are present in the rows of the treated crops may be authorised, — Member States shall require that applications in orchards (e.g. apples, cherries) are only done with application equipment that increases the precision and accuracy of the application (e.g. emission shields, shielded sprayers, hooded sprayers, tunnel sprayers, sensor-controlled sprayers), and, while maintaining the application rate on the target surfaces, achieves an average reduction of at least 61 % of the applied plant protection product (per hectare) and a minimum of 20 % reduction of plant protection product loss to the ground compared to applications via conventional application equipment and practice. 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 captan, and in particular Appendices I and II thereto, shall be taken into account. In addition, risk mitigations such as no-spray buffer zones from field margins, shall be required, when appropriate, by the Member States on the basis of their risk assessment to protect bees and aquatic organisms. In this overall assessment Member States shall pay particular attention to: — the compliance with the technical specification of the active substance contained in the plant protection product for which applications for authorisation are submitted, — the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment taking into account the high skin sensitising potential of the active substance, — the protection of bystanders and residents ensuring that conditions of use include adequate risk mitigation measures taking into account the high skin sensitising potential of the active substance. In addition, Member States may set monitoring requirements when granting authorisations, in order to supplement the monitoring under Directives 2000/60/EC (31) and 2009/128/EC (32) of the European Parliament and of the Council. Within two years from 24 September 2024, the applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: (1) the effect of water treatment processes on the nature of residues of captan’s metabolites THPI and THPAM present in ground water, when it is abstracted for drinking water; (2) the relevance of metabolites THPI and THPAM that may occur in groundwater, taking into account the proposal of classification of captan as toxic to reproduction Category 2 and as STOT-RE Category 1 in the Opinion of the Risk Assessment Committee of the European Chemicals Agency of 14 September 2023; (3) the storage stability of captan in high acid content matrices, in compliance with the relevant OECD Test Guideline; and Furthermore, within 18 months from 24 September 2024, the applicant shall submit to the Commission, the Member States and the Authority: (4) information and exposure data demonstrating that the pesticide application equipment used on orchards increases the precision and accuracy of the application and achieves a reduction of exposure of at least 61 % of the applied plant protection product (per hectare) and a minimum of 20 % reduction of plant protection product loss to the ground compared to applications via conventional equipment and practices. |
| 171 | Metrafenone CAS No: 220899-03-6 CIPAC No: 752 | 3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone | ≥ 980 g/kg The impurity dimethyl sulphate shall not exceed 0,01 g/kg in the technical material. | 1 November 2024 | 31 October 2039 | 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 metrafenone, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers; — the consumer exposure assessment with regards to residues that may be present in food. Conditions of use shall include risk mitigation measures, where appropriate. 1) An updated assessment for point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 to confirm the absence of endocrine activity concerning the T-modality of non-target organisms other than mammals, including where relevant, further information. 2) An updated assessment of the genotoxicity of the metabolites CL 1500834 and CL 3000402. The applicant shall submit the information related to point 1 by 29 March 2026 and the information related to point 2 by 29 December 2024. |
| 172 | Folpet CAS No: 133-07-3 CIPAC No: 75 | N-[(trichloromethyl)thio]phthalimide | ≥ 940 g/kg The following impurities shall not exceed the following levels in the technical material: — (trichloro(chlorosulfanyl) methane) (PCMM): 2 g/kg — carbon tetrachloride: 2 g/kg — captan: 3 g/kg — carbon disulphide: 2,5 g/kg | 1 November 2024 | 31 October 2039 | 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 folpet, 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 aquatic organisms, ensuring a minimum of 95 % spray drift reduction next to water bodies such as that provided by a 20 m no spray buffer zone unless the outcome of the risk assessment undertaken for the specific plant protection product use indicates that such risk mitigation measures are not needed or can be lowered because there are no unacceptable risks caused by spray drift; — the protection of operators (use of PPE for operators during mixing, loading and application) and workers (use of workwear and protective gloves for re-entry activities); and — the protection of bystanders and residents, ensuring that conditions of use include the adequate risk mitigation measures, such as drift reduction equipment, with the aim of minimising exposure. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information to determine the levels of phthalic acid deriving from the use of folpet taking into account the background levels of phthalic acid in wheat and barley during residue field trials for the uses listed in Appendix II of the renewal report only. The applicant shall submit to the Commission, the Member States and the Authority this information by 25 March 2025. |
| 173 | Mepiquat chloride CAS No: 24307-26-4 CIPAC No: 440.302 | 1,1-dimethylpiperidinium chloride | ≥ 990 g/kg (theoretical dry technical material, TC) 615-665 g/L (technical concentrate, TK) The impurity N-methylpiperidine shall not exceed 3 g/kg (on theoretical dry weight basis) or 2 g/L (in the technical concentrate, TK). | 1 March 2025 | 29 February 2040 | 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 mepiquat chloride, 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 specification of the technical material as commercially manufactured; — the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment. Conditions of use shall include risk mitigation measures, where appropriate. |
| 174 | Pythium oligandrum B301 | Not applicable | No relevant impurities | 11 February 2025 | 10 February 2035 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pythium oligandrum B301, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use, — the guarantee by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure adherence to the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65 (33). Conditions of use shall include risk mitigation measures, where appropriate. |
| 175 | Lenacil CAS No: 2164-08-01 CIPAC No: 163 | 3-cyclohexyl-6,7-dihydro-1H-cyclopenta[d]pyrimidine-2,4(3H,5H)-dione or 3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione | 975 g/kg | 1 July 2025 | 30 June 2040 | 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 lenacil, and in particular Appendices I and II thereto, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. In this overall assessment Member States shall pay particular attention to the possible need for additional rotational crop field trials and a livestock exposure assessment until the required confirmatory information has been assessed by the rapporteur Member State and evaluated by the Authority. By 25 March 2027, the applicant shall submit to the Commission, the Member States and the Authority confirmatory information on rotational crops field trials, including analysis for known and possible new metabolites. If new metabolites are found, the applicant is requested to perform toxicological studies assessing these metabolites. The applicant is requested to perform an appropriate livestock exposure assessment if necessary. |
| 176 | Milbemectin Milbemectin is a mixture of M.A3 and M.A4 CAS No: M.A3: 51596-10-2 M.A4: 51596-11-3 CIPAC No: 660 | M.A3: (10E,14E,16E)- (1R,4S,5′S,6R,6′R,8R,13R, 20R,21R,24S)- 21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16, 22-tetraene)-6-spiro-2′- (tetrahydropyran)-2-one; M.A4: (10E,14E,16E)- (1R,4S,5′S,6R,6′R,8R,13R, 20R,21R,24S)-6′-ethyl-21,24- dihydroxy-5′,11,13,22-tetramethyl-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene)-6- spiro-2′-(tetrahydropyran)-2-one | ≥ 950 g/kg | 16 November 2025 | 15 November 2040 | 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 milbemectin, 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 specification of the technical material as commercially manufactured; — the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of bees and pollinators that may be exposed to the active substance by visiting the flowers present in the crop at the time of application; — the protection of aquatic organisms. — Conditions of use shall include risk mitigation measures, in particular to reduce drift to terrestrial and aquatic areas outside the treated field, where appropriate. The applicant shall submit confirmatory information as follows: 1. to confirm that the bone marrow was exposed in the available in vivo micronucleus test or to confirm the absence of the aneugenic potential of milbemectin; 2. an in vitro comparative metabolism study with milbemectin (at least in the pivotal species used to characterise milbemectin’s toxicity and in comparison with human metabolism); 3. an in vitro phototoxicity study with milbemectin, testing the range of wavelengths (between 290 and 700 nm) where the absorption coefficient is > 10 L x mol-1 x cm-1; 4. an updated risk assessment for the aquatic sediment organisms in accordance with the EFSA Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters. To allow for proper comparison of the sensitivity with other species, this confirmatory information should include a spiked-sediment test (OECD TG 218) and spiked-water test (OECD TG 219) with Chironomidae exposed to milbemectin, where milbemycin A3/milbemycin A4 is present in the same ratio than in other ecotoxicology studies. The applicant shall submit to the Commission, the Member States and the Authority the information referred to the points above by 5 November 2027. |
| 177 | Spinosad CAS No: Spinosad: 168316-95-8 Spinosyn A: 131929-60-7 Spinosyn D: 131929-63-0 CIPAC No: 636 | Spinosyn A: (50–95 %) (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-β-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione Spinosyn D: (50–5 %) (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-β-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione | ≥ 850 g/kg with 50–95 % of spinosyn A and 5–50 % of spinosyn D | 1 April 2026 | 1 April 2041 | 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 spinosad of 21 January 2026, 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 assessment of the consumer intake, taking into account the residues of the metabolites of spinosad and considering the impact of storage and processing; — the protection of operators, in particular for hand-held applications in low crops; — the protection of wild mammals, aquatic organisms, bees and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) an in vitro interspecies comparative metabolism study; (2) an overall assessment of DNT (developmental neurotoxicity) including the submission of data from an in vitro DNT test battery; (3) the toxicity and magnitude of residues in plant and animal matrices of spinosyn B and K, PsA and MET A-Li-4(5b) to confirm the residue definitions for risk assessment; (4) the effect of water treatment processes on the nature of residues present in drinking water; (5) chronic effects on honeybees (adults and larvae). The applicant shall submit the information referred to in point 1, 3, and 4 to the Commission, the Member States and the Authority by 11 March 2028. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 2 within two years after adoption of a guidance document on assessing DNT. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 5 within two years after the adoption of a guidance document with a revised risk assessment methodology for honeybees. |
| 178 | Bixlozone CAS No: 81777-95-9 CIPAC No: Not allocated | 2-(2,4-dichlorobenzyl)-4,4-dimethylisoxazolidin-3-one | ≥ 960 g/kg The impurity TBAB shall not exceed 2 g/kg in the technical material. | 21 April 2026 | 21 April 2036 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bixlozone 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 co-formulants present in bixlozone-containing plant protection products, taking into account in particular the criteria for identification of unacceptable co-formulants as set out in Implementing Regulation (EU) 2023/574, — the consumer risk assessment, in particular for residues present in succeeding crops, including the setting of appropriate plant-back intervals, — the protection of aquatic organisms and non-target terrestrial plants. 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), the relevance of one of the impurities and the compliance of the toxicity batches with the confirmed technical specification; 2. the natural occurrence of 2,2-dimethyl-3-OH-propionic acid and dimethylmalonic acid; 3. the genotoxic and general toxicity potential of dimethylmalonic acid (free and conjugated), 2,2-dimethyl-3-OH-propionic acid (free and conjugated), F9600-dimethyl-malonamide, F9600-hydroxy-isobutyramide and F9600-3-OH-propanamide; 4. the relevance of the livestock metabolites dimethylmalonic acid, F9600-dimethyl-malonamide and F9600-3-OH-propanamide; 5. 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 referred to in points 1 to 5 of the fourth subparagraph by 21 April 2028. |
| 179 | Pyrimethanil CAS No: 53112-28-0 CIPAC No: 714 | N-(4,6-dimethylpyrimidin-2-yl) aniline | ≥ 975 g/kg The following impurities shall not exceed the following levels in the technical material: — cyanamide: 0,5 g/kg; — aniline: 4 g/kg; — acetylacetone: 0,1 g/kg. | 1 May 2026 | 30 April 2041 | 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 pyrimethanil, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of bystanders and residents, ensuring that drift reduction measures are applied, where necessary; — the protection of aquatic organisms, bees and other pollinators. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the toxicity of the metabolite M605F004, including its conjugates, and the metabolite M605F007, to confirm the relevant residue definitions for risk assessment; (2) the effect of water treatment processes on the residues of pyrimethanil or its metabolites present in water abstracted for the production of drinking water, in accordance with the EFSA and ECHA Guidance document on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water; (3) the degradation of pyrimethanil in soil, including where relevant the identification and characterisation of metabolites. If the information indicates the relevance of the metabolite U2, soil, surface water, sediment and groundwater exposure and risk assessment for the metabolite U2 shall be provided. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1.2 and 3 by 11 March 2028. |
| 180 | Paraffin oil (Not ISO) Paraffin, light liquid ‘‘Paraffinum Perliquidum’’ (European Pharmacopoeia, EurPharm) CAS No: 8042-47-5 CIPAC No: 898 | White mineral oil (petroleum) (Not IUPAC) | 1 000 g/kg The impurity Polycyclic Aromatic Hydrocarbons (PAHs) shall not exceed 0,3 mg/kg in the technical material in accordance with the European Pharmacopoeia. | 1 July 2026 | 30 June 2041 | 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 paraffin oil (CAS 8042-47-5), 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 risk assessment, in particular to ensure compliance with maximum levels that are set in Union law for total mineral oil aromatic hydrocarbon (MOAH); — the protection of aquatic organisms, non-target arthropods in off field area and bees. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information to: (1) demonstrate the compliance of technical grade paraffin oil with the maximum level of PAH (PAH4- benzo(a)pyrene, benz(a)anthracene, benzo(b) fluoranthene and chrysene and PAH8) in the technical specification (0,3 mg/kg) with validated analytical methods for the determination of those PAHs in the technical paraffin oil and the formulations for the representative uses as proposed by the applicant; (2) complete the consumer risk assessment, where exposure to PAH residues shall be estimated using an approach based on application rate and yield rate for the representative uses as proposed by the applicant. This risk assessment shall be carried out based on that estimated exposure. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 12 May 2027. |
| (1) Further details on identity and specification of active substance are provided in the review report. (2) 2-hydroxy-4,6-dimethoxypyrimidine. (3) 2,4-dihydroxy-6-methoxypyrimidine. (4) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate. (5) 5-(trifluoromethyl)-2(1H)-pyridinone. (6) 4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol. (7) M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide. (8) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol. (9) 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid. (10) 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene. (11) 4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid. (12) 3-phenoxybenzaldehyde. (13) Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)). (14) 7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid. (15) 3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1H-pyrazole-4-carboxylic acid. (16) 3-chloro-1-methyl-5-sulfamoyl-1H-pyrazole-4-carboxylic acid. (17) p-methyl-phenethylamine. (18) OJ L 353, 31.12.2008, p. 1. (19) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (20) 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). (21) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (22) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311; ECHA-18-G-01-EN. (23) Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311 (24) https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R0605&from=EN (25) Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (OJ L 227, 1.9.2022, p. 8). (26) Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258): https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180653_microorganism-metabolites-concern_202011.pdf. (27) Guidance on the approval and low-risk criteria linked to ‘antimicrobial resistance’ applicable to microorganisms used for plant protection (SANTE/2020/12260): https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180652_microorganism-amr_202011.pdf. (28) pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu). (29) Commission Implementing Regulation (EU) 2023/574 of 13 March 2023 setting out detailed rules for the identification of unacceptable coformulants in plant protection products in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (OJ L 75, 14.3.2023, p. 7). (30) 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). (31) 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, ELI: http://data.europa.eu/eli/dir/2000/60/oj). (32) 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 pesticides (OJ L 309, 24.11.2009, p. 71, ELI: http://data.europa.eu/eli/dir/2009/128/oj). (33) Organisation for Economic Cooperation and Development (2014), OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products, Series on Pesticides and Biocides, No 65, OECD Publishing, Paris, https://doi.org/10.1787/9789264221642-en. |
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