HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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1 Toelatingsnummer HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 UITBREIDING TOELATING Gelet op de aanvraag d.d. 27 september 2013 ( NLKUGB) van Bayer CropScience SA-N.V. Energieweg RT MIJDRECHT tot uitbreiding van de gebruiksdoeleinden van de toelating van het gewasbeschermingsmiddel, op basis van de werkzame stoffen tebuconazool en prothioconazool gelet op artikel 51 (EG) nr 1107/2009 en artikel 2.2 Regeling gewasbescherming en biociden, BESLUIT HET COLLEGE als volgt: 1.1 Uitbreiding 1. Het gebruiksgebied van het middel wordt met ingang van datum dezes uitgebreid met de toepassing in de teelt van peulvruchten. Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II bij dit besluit. 2. De toelating geldt tot 1 september Samenstelling, vorm en verpakking De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend. 1.3 Gebruik Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I bij dit besluit is voorgeschreven. 1

2 1.4 Classificatie en etikettering Gelet op artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 29, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden, 1. De aanduidingen, welke ingevolge artikelen en van de Wet milieubeheer en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt: aard van het preparaat: Emulgeerbaar concentraat werkzame stof: tebuconazool prothioconazool gehalte: 125 g/l 125 g/l letterlijk en zonder enige aanvulling: andere zeer giftige, giftige, bijtende of schadelijke stof(fen): - gevaarsymbool: Xn N aanduiding: Schadelijk Milieugevaarlijk Waarschuwingszinnen: R38 -Irriterend voor de huid. R51/53 -Vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken. R63 -Mogelijk gevaar voor beschadiging van het ongeboren kind. Veiligheidsaanbevelingen: S21 -Niet roken tijdens gebruik. S36/37 -Draag geschikte handschoenen en beschermende kleding. S61 -Voorkom lozing in het milieu. Vraag om speciale instructies / veiligheidsgegevenskaart. Specifieke vermeldingen: DPD01 -Volg de gebruiksaanwijzing om gevaar voor mens en milieu te voorkomen. 2. Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten voorgeschreven aanduidingen en vermeldingen moeten op de verpakking voorkomen: 2

3 a. letterlijk en zonder enige aanvulling: het wettelijk gebruiksvoorschrift De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I. b. bij het toelatingsnummer een cirkel met daarin de aanduiding W.3. De nieuwe etikettering dient bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen mogen worden opgemaakt. 2 DETAILS VAN DE AANVRAAG 2.1 Aanvraag Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel (), een middel op basis van de werkzame stoffen tebuconazool en prothioconazool. Het middel is bij besluit van 27 oktober 2006 reeds toegelaten als schimmelbestrijdingsmiddel door een gewasbehandeling in de teelt van: a) winter- en zomertarwe en triticale; b) graszaadteelt; c) graszodenteelt. Het middel is bij dit besluit toegelaten tot 1 september Met onderliggende aanvraag wordt toelating als schimmelbestrijdingsmiddel door een gewasbehandeling in de teelt van peulvruchten gevraagd. 2.2 Informatie met betrekking tot de stof Tebuconazool is per 1 september 2009 geplaatst op Bijlage I van Richtlijn 91/414 (Richtlijn 2008/125/EG, d.d. 19 december 2008). De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011) en geplaatst op bijlage I. Prothioconazool is per 1 augustus 2008 geplaatst op Bijlage I van Richtlijn 91/414 (Richtlijn 2008/44/EG, d.d. 4 april 2008). De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011) en geplaatst op bijlage I. 2.3 Karakterisering van het middel is een middel op basis van de werkzame stoffen prothioconazool en tebuconazool. Prothioconazool en tebuconazool zijn triazolen en behoren tot de groep van ergosterol biosynthese remmers (EBR). De werking is gebaseerd op het voorkomen van infectie door het remmen van de sterol-biosynthese. Het remt de C14-demethylase in de sterol-biosynthese van de schimmel. Prothioconazool is systemisch en heeft zowel een preventieve als een curatieve werking. In Nederland zijn diverse middelen toegelaten op basis van prothioconazool. Tebuconazool is systemisch en wordt opgenomen door de vegetatieve delen van de plant, met name het blad. Vervolgens wordt de stof opwaarts getransporteerd naar andere delen van de plant. Tebuconazool heeft een preventieve en curatieve werking. De bestrijding van schimmelinfecties wordt bevorderd door een vroegtijdige diagnose van de aantasting. In Nederland zijn diverse middelen toegelaten op basis van tebuconazool. 2.4 Voorgeschiedenis De aanvraag is op 1 oktober 2013 ontvangen; op 30 september 2013 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 7 april 2014 is de aanvraag in behandeling genomen. 3

4 3 RISICOBEOORDELINGEN Rgb d.d. 13 juni 2011 en Evaluation Manual Fysische en chemische eigenschappen De identiteit en de fysische en chemische eigenschappen van het middel en de werkzame stof wijzigen niet. 3.2 Analysemethoden De analysemethoden voor de werkzame stoffen en het middel wijzigen niet. Voor de toegelaten toepassingen voldoen de vereiste residuanalysemethoden. 3.3 Risico voor de mens Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht. 3.4 Risico voor het milieu Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht. 3.5 Werkzaamheid Het aspect werkzaamheid (inclusief fytotoxiciteit) is niet beoordeeld conform artikel 51 Verordening (EG) 1107/ Eindconclusie Bij gebruik volgens het Wettelijk Gebruiksvoorschrift heeft het middel op basis van de werkzame stoffen tebuconazool en prothioconazool geen schadelijke uitwerking op de gezondheid van de mens en het milieu. 4 Respijtperiode (aflever- en/of opgebruiktermijn) Aangezien het een uitbreiding betreft is een respijtperiode niet van toepassing. Oude verpakkingen mogen dan ook worden opgemaakt. Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld. Wageningen, 9 mei 2014 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN, ir. J.F. de Leeuw voorzitter 4

5 Dit middel is uitsluitend bestemd voor professioneel gebruik HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I bij het besluit d.d. 9 mei 2014 tot uitbreiding van de toelating van het middel, toelatingnummer Wettelijk Gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als schimmelbestrijdingsmiddel door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden. Toepassingsgebied Te bestrijden organisme Wintertarwe Bladvlekkenziekte 1, echte meeldauw 2, DTR 3, bruine roest 4, gele roest 5, aarfusarium 6 Triticale Bladvlekkenziekte 1, echte meeldauw 2, DTR 3, bruine roest 4, gele roest 5, aarfusarium 6 Zomertarwe Bladvlekkenziekte 1, echte meeldauw 2, DTR 3, bruine roest 4, gele roest 5, aarfusarium 6 Dosering (middel) per toepassing Maximaal aantal behandelingen per teeltcyclus of per 12 maanden Minimum interval tussen toepassingen in dagen Veiligheidstermijn in dagen of uiterst gewasstadium waarop toegepast mag worden 1 l/ha dagen 1 l/ha dagen 1 l/ha dagen 1

6 Toepassingsgebied Engels raaigras Te bestrijden organisme Zwarte roest 7, kroonroest 8, bruinevlekkenroest 9, oranjestrepenroest 10, bladvlekkenziekte 11 1 Septoria tritici; 2 Erysiphe graminis; 3 Pyrenophora tritici-repentis; 4 Puccinia recondita; 5 Puccinia striiformis; 6 Fusarium spp.; 7 Puccinia graminis; 8 Puccinia coronata; 9 Puccinia brachypodii; 10 Puccinia poarum; 11 Drechslera spp., Dosering (middel) per toepassing Maximaal aantal behandelingen per teeltcyclus of per 12 maanden Minimum interval tussen toepassingen in dagen Veiligheidstermijn in dagen of uiterst gewasstadium waarop toegepast mag worden 1 l/ha 1-35 dagen Het gebruik in de graszaadteelt van Italiaans, Frans, Westerwolds en gekruist raaigras, zwenkgras, beemdgras, timothee, kropaar, struisgras, kamgras, ruwe smele, fakkelgras en het gebruik in de graszodenteelt is beoordeeld conform de vereenvoudigde uitbreidingsprocedure. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in deze toepassingsgebieden komt voor risico en verantwoordelijkheid van de gebruiker. Het gebruik in de teelt van peulvruchten is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in dit toepassingsgebied komt voor risico en verantwoordelijkheid van de gebruiker. 2

7 Toepassingsgebied Te bestrijden organisme Graszodenteelt Kroonroest 8, bladvlekkenziekte 11, fusarium 6 6 Fusarium spp.; 7 Puccinia graminis; 8 Puccinia coronata; 9 Puccinia brachypodii; 10 Puccinia poarum; 11 Drechslera spp., 12 Botrytis cinerea; 13 Sclerotinia sclerotiorum; 14 Puccinia phaseoli/uromyces phaseoli; Dosering (middel) per toepassing Maximaal aantal toepassingen per 12 maanden Maximaal aantal liter/kg middel per ha per 12 maanden Minimum interval tussen toepassingen in dagen Peulvruchten Grauwe schimmel 12, rattenkeutelziekte 13, roest 14 1 l/ha dagen Graszaadteelt (m.u.v. Engels raaigras) Zwarte roest 7, kroonroest 8, bruine-vlekkenroest 9, oranje-strepenroest 10, bladvlekkenziekte 11 1 l/ha dagen 1 l/ha dagen Veiligheidstermijn in dagen of uiterst gewasstadium waarop toegepast mag worden Toepassingsvoorwaarden Dit middel is schadelijk voor niet-doelwitarthropoden. Vermijd onnodige blootstelling. Resistentiemanagement Dit middel bevat de werkzame stoffen prothioconazool en tebuconazool. Prothioconazool en tebuconazool behoren tot de triazolen. De Frac code voor beide stoffen is 3. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen. 3

8 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II bij het besluit d.d. 9 mei 2014 tot uitbreiding van de toelating van het middel, toelatingnummer Contents Page 1. Identity of the plant protection product Physical and chemical properties Methods of analysis Mammalian toxicology Residues Environmental fate and behaviour Ecotoxicology Efficacy Conclusion Classification and labelling Appendix 1 Table of authorised uses... 1 Appendix 2 Reference list

9 1. Identity of the plant protection product 1.1 Applicant Bayer CropSciences SA-N.V. Energieweg RT Mijdrecht 1.2 Identity of the active substance The identity of the active substance(s) does not change Common name Name in Dutch Prothioconazool Chemical name CAS no EC no Not allocated (RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]- 2,4-dihydro-1,2,4-triazole-3-thione [IUPAC] The active substance was included in Annex I of Directive 91/414/EEC on 1 August From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC Common name Name in Dutch Tebuconazool Chemical name (RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)- pentan-3-ol [IUPAC] CAS no EC no The active substance was included in Annex I of Directive 91/414/EEC on 1 September From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC. 1.3 Identity of the plant protection product The identity of the plant protection product does not change. Name Formulation type Content active substance EC : 125 g/l : 125 g/l The formulation is not part of the assessment of the active substance for inclusion in Annex I of Directive 91/414/EC. 1.4 Function Fungicide 1.5 Uses applied for See GAP (Appendix I). 1.6 Background to the application It concerns a simplified extension of the authorization with minor uses. 5

10 1.7 Packaging details Packaging description Packaging details do not change. 2. Physical and chemical properties The physical and chemical properties of the active substances and the formulation do not change. 3. Methods of analysis 3.1 Analytical methods in technical material and plant protection product The analytical methods for the technical material and the plant protection product do not change. 3.2 Residue analytical methods The proposed extension for use involves application on crops that can be extrapolated from the current authorisation based on their crop group (matrix) and their MRL. Therefore, the proposed extension remains within the existing risk envelope for the section residue analytical methods for food/feed of plant and animal origin. The residue analytical methods for air, soil and water were accepted during the assessment which led to the original authorization of. This simplified extension does not give rise to re-assess these residue analytical methods. 3.3 Conclusion The proposed extension for use is covered by the risk envelope of the existing authorisation for the section residue analytical methods. 4. Mammalian toxicology The proposed extension for use involves an application on the crop (pulses) for which the risk assessment can be extrapolated from the current authorisation based on the method of application and dosage (mechanical downward application with a maximum dosage of 1 L product/ha). Therefore, the proposed extension remains within the existing risk envelope for the section mammalian toxicology (operator, bystander and worker). 5. Residues List of Endpoints The List of Endpoints presented below is taken from the EFSA Scientific report on prothioconazole ((2007) 106; 1-98). Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6) 6

11 Plant groups covered Rotational crops Plant residue definition for monitoring Plant residue definition for risk assessment Conversion factor (monitoring to risk assessment) Cereals (wheat) Oilseeds (peanut) Wheat / Swiss chard / Turnips -desthio (JAU 6476-desthio) Sum of prothioconazole-desthio and all metabolites containing the 2-(1- chlorocyclopropyl)-3-(2- chlorophenyl)-2- hydroxypropyl-2h-1,2,4-triazole moiety) expressed as prothioconazole-desthio. This definition is provisional and will need to be reconsidered regarding the triazole derivative metabolites 2 (cereal grain and oilseeds) Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6) Animals covered Animal residue definition for monitoring Animal residue definition for risk assessment Conversion factor (monitoring to risk assessment) Metabolism in rat and ruminant similar (yes/no) Lactating ruminants (goat) laying hens (chicken) Sum of prothioconazole-desthio and its glucuronide conjugate, expressed as prothioconazole-desthio (JAU 4676-desthio) Sum of prothioconazole-desthio and all metabolites containing the 2-(1- chlorocyclopropyl)-3-(2-chlorophenyl)-2- hydroxypropyl-2h-1,2,4-triazole moiety) expressed as prothioconazole-desthio. This definition is provisional and will need to be reconsidered regarding the triazole derivative metabolites 10 Milk 2 Liver 10 Muscle 2 Kidney 4 Fat Yes Fat soluble residue: (yes/no) Yes, Log P ow for JAU 6476-desthio =

12 Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5) Wheat / Swiss chard / Turnips (cf. "Metabolism in plants") Stability of residues (Annex IIA, point 6.0, Annex IIIA, point 8 introduction) JAU 6476-desthio (M04): > 1.5 years in wheat green matter > 1.5 years in wheat grain > 1.5 years in wheat straw Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3) Ruminant: Poultry: Pig: Conditions of requirement of feeding studies Expected intakes by livestock 0.1 mg/kg diet (dry weight basis) (yes/no - If yes, specify the level) Yes - Dairy cattle 0.41 mg/kg DM; - beef cattle 1.02 mg/kg DM, corresponding to and mg/kg bw resp. No No Potential for accumulation (yes/no): No No No Metabolism studies indicate potential level of residues 0.01 mg/kg in edible tissues (yes/no) Not conclusive due to high dose level No No Feeding studies (lactating cow, 0.13 mg/kg bw) Residue levels in matrices : Mean (max) mg/kg Muscle <0.01 Not required Not required Liver 0.02 Not required Not required Kidney <0.01 Not required Not required Fat <0.01 Not required Not required Milk <0.004 Eggs Not required Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4) Crop/processed crop Number of studies Transfer factor % Transference Not applicable (na), no residue 8

13 The List of Endpoints presented below was taken from the EFSA Scientific Report on tebuconazole ((2008) 176; 1-109). Additions and comments are typed in italics. Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6) Plant groups covered Rotational crops Metabolism in rotational crops similar to metabolism in primary crops? Processed commodities Residue pattern in processed commodities similar to residue pattern in raw commodities? Plant residue definition for monitoring Plant residue definition for risk assessment Conversion factor (monitoring to risk assessment) Foliar Treatment: Cereals (wheat), oilseed (peanut), fruit (grape) Seed Treatment: Cereals (wheat) Kale, wheat, beet root Yes, the metabolites identified in primary crops and rotational crops are in a high degree the same. Metabolites found in rotational crops but not in the primary crop are only found in minor amounts and evaluated to be of no toxicological significance. Baking, brewing and boiling (100 ºC at ph 5 for 60 min.), sterilisation (120 ºC at ph 6 for 20 min.) and pasteurisation (90 ºC at ph 4 for 20 min.). The study has been performed with radioactive labelled tebuconazole only parent compound was found. Sum of enantiomers contained in tebuconazole (Provisional, pending outcome of a global risk assessment on TDMs) for both primary and rotational crops Sum of enantiomers contained in tebuconazole (for both primary and rotational crops) An additional residue definition is needed for TDMs (triazole, triazole alanine, triazole acetic acid and triazole lactic acid) harmonised for all active substances of the triazole chemical class None Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6) Animals covered Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring Lactating goat, laying hens Residues were low throughout the studies and only few data are measured. In eggs it look likes a plateau is reached 2 days after the first dose. + hydroxy-tebuconazole and their conjugates (sum of enantiomers) expressed as tebuconazole (Provisional, pending the outcome of a global risk assessment on TDMs) 9

14 Animal residue definition for risk assessment Conversion factor (monitoring to risk assessment) Metabolism in rat and ruminant similar (yes/no) Fat soluble residue: (yes/no) + hydroxy-tebuconazole and their conjugates (sum of enantiomers) expressed as tebuconazole (Provisional) An additionnal residue definition is needed for TDMs, harmonised for all active substances of the triazole chemical class. None Yes. Yes Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5) Grape is a permanent crop and studies concerning residues in succeeding crops are not necessary. The metabolism in primary and rotational crops are similar. However, the situation in rotational crops should be reconsidered as it seems that rather high amounts of triazole metabolites can be found in rotational crops. Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 Introduction) Peaches, prunes, grapes, apples, cherries: 30 months Wheat, grain, straw and forage (cereals): 30 months Peanut nutmeat (oil seed): 30 months Wheat flour and bran (cereals): 24 months Peanut oil (oil seeds): 24 months Raisin (fruit): 24 months Cattle, liver, muscle, kidney, fat, milk: 23 weeks Chicken, liver, muscle, fat, egg: 23 weeks Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3) Expected intakes by livestock 0.1 mg/kg diet (dry weight basis) (yes/no - If yes, specify the level) Ruminant: Poultry: Pig: Conditions of requirement of feeding studies Yes. dairy cattle: 5.45 beef cattle: 8.7 (mg/kg dry matter) Yes. 1.6 mg/kg dry matter Not calculated Potential for accumulation (yes/no): No No No Metabolism studies indicate potential level of residues 0.01 mg/kg in Not at expected intake levels for Not at expected Not at expected 10

15 Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3) edible tissues (yes/no) Ruminant: Poultry: Pig: Conditions of requirement of feeding studies dairy and beef cattle Muscle 25, 75 and 250 mg/kg dry matter: <0.05 Liver intake levels for poultry intake levels by pigs Feeding studies (Specify the feeding rate in cattle and poultry studies considered as relevant) Residue levels in matrices : Mean (max) mg/kg 25 mg/kg dry matter: <0.06 (0.07) 75 mg/kg dry matter: 0.08 (0.12) 250 mg/kg dry matter: 0.14 (0.20) Kidney 25, 75 and 250 mg/kg dry matter: <0.05 Fat 25, 75 and 250 mg/kg dry matter: <0.05 2, 6 and 20 mg/kg dry matter: < and 6 mg/kg dry matter: < mg/kg dry matter: mg/kg dry matter: < , 6 and 20 mg/kg dry matter: <0.05 Milk 25, 75 and 250 mg/kg dry matter: <0.01 Eggs 2, 6 and 20 mg/kg dry matter: <0.025 Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4) Not required Not required Not required Not required Crop/ process/ processed product Number of studies Processing factors Transfer factor Yield factor Amount transferred (%) (Optional) Grapes to must Grapes to wine Barley grain to pearl barley Barley grain to beer (0.1, 0.11, 0.15, 0.17, 0.34, 0.36, 0.44, 0.57, 0.65) (0.09, 0.11, 2 x 0.12, 0.16, 0.24, 0.29, 0.41, 0.43, 0.67) (0.2, 0.22, 2 x 0.32) (2 x 0.02, 2 x 0.03) 11

16 Apple to washed apple Apple to dried apple Apple to apple sauce Apple to apple juice Apple to apple pomace (0.34, 1.1) (0.28, 0.54) (0.26, 0.46) (<0.12, 0.14) 2 13 (7.1, 18) Comments on/additions to List of Endpoints : See below, regarding the triazole moiety. : is a plant protection product containing a triazole moiety. It has been discussed in EU whether triazole metabolites should be included in the residue definition of plant protection products containing a triazole moiety. Considering the recommendations of the PRAPeR experts meeting 14 (23-26 January 2007) on toxicology, concluding that toxicological end points and reference values should be adopted for triazole derivative metabolites (TDMs), the meeting of experts agreed that separate risk assessments have to be performed for the parent compound and TDMs respectively and consequently, separate residue definitions have to be to set, one for the parent tebuconazole and the second covering the TDMs (1,2,4-triazole, triazole alanine, triazole acetic acid and triazole lactic acid). Therefore, residue definitions for tebuconazole for monitoring and risk assessment for plant products were provisionally proposed as tebuconazole only. The plant residue definition for TDMs should be reconsidered when a general approach on triazole compounds and their triazole derivative metabolites is defined. The EFSA PPR Panel issued a scientific opinion on this issue: Scientific Opinion on Risk Assessment for a Selected Group of Pesticides from the Triazole Group to Test Possible Methodologies to Assess Cumulative Effects from Exposure through Food from these Pesticides on Human Health (EFSA Journal 2009; 7 (9); 1167). Overall, the PPR Panel concludes that although a tiered approach is an appropriate way to address cumulative dietary risk assessment it cannot yet be applied on a routine basis, as first some lacuna s should be resolved. Ctgb agrees with this point of view. 5.1 Summary of residue data The following assessment is based on the EFSA Scientific report on prothioconazole ((2007) 106; 1-98), the Evaluation Report on the modification of MRLs for prothioconazole in pulses prepared by France, the draft Reasoned Opinion on the review of the existing MRLs for prothioconazole (Article 12 MRL-review), the EFSA Scientific Report on tebuconazole ((2008) 176; 1-109), the Reasoned Opinion on modification of the existing MRLs for tebuconazole in pulses (EFSA Journal 2011;9(6):2282) and the Article 12 MRL-review for tebuconazole (EFSA Journal 2011;9(8):2239). Only points that are not covered by the List of Endpoints or that need clarification are discussed below Metabolism in plants Metabolism was investigated in wheat (cereals) and peanut (pulses/oilseed) in the draft assessment report. The only main metabolite was desthio-prothioconazole. These studies cover the intended use on pulses, which belong to the group pulses/oilseed. 12

17 In the DAR the metabolism is reported in three crop groups: cereals (wheat), oilseed (peanut) and fruit (grape). The metabolism in the three crop groups was similar. No further data are required Metabolism in livestock Metabolism was investigated in lactating goat and laying hen. The only main metabolite in both species was desthio-prothioconazole. It is concluded that all metabolites other than desthio-prothioconazole occur in low amounts. However, all together these metabolites form a considerable amount of the total residue. The metabolism in ruminants is similar to that in rat; metabolism studies in pigs are therefore. No further data are required. In the DAR the metabolism is reported in lactating ruminants (goats), and laying poultry (hens). The metabolism in ruminants is similar to that in rat; metabolism studies in pigs are therefore not required. No further data are required Residue definition (plant and animal) The plant residue definition for monitoring is prothioconazole-desthio (JAU 6476-desthio). The plant residue definition for risk assessment (all crop groups) is: desthio-prothioconazole plus all metabolites containing the 2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2- hydroxypropyl-2h-1,2,4-triazole moiety, expressed as prothioconazole-desthio. A conversion factor was set: 3 for cereal and rapeseed straw and 2 for grains (cereals, oilseeds). The residue definition for all animal products for monitoring is the sum of desthioprothioconazole and its glucuronide conjugate, expressed as prothioconazole-desthio. The residue definition for risk assessment is desthio-prothioconazole plus all metabolites containing the 2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl-2H-1,2,4-triazole moiety, expressed as prothioconazole-desthio. The residue definitions are provisional and will be reconsidered regarding the TDMs. See List of Endpoints. The residue definitions are provisional and will be reconsidered regarding the TDMs Stability of residues Desthio-prothioconazole was found to be stable for 1.5 years in cereal matrices. belong to the crop category dry matrix, so the stability of residues was sufficiently proven. In the DAR the stability during frozen storage is reported for several crops. The matrices for which an extension is requested are covered. No further data are required Supervised residue trials (cgap-nl: 2x 125 g/ha, PHI 35d) Several supervised residue trials were submitted by the applicant. The trials are summarised in the French Evaluation Report. Four trials were conducted with field peas in NEU and four trials were conducted with field beans in NEU. The trials were performed according to the proposed GAP, except for one trial in which the PHI was 48 days whereas 35 days were 13

18 required. However, the result of this trial is similar as trials performed according to the PHI of 35 days. Furthermore, one NEU trial on peas was disregarded by EFSA in the Reasoned Opinion for tebuconazole on pulses (these are the same trials) as the application took place at the growth stage of 81 which corresponds to a totally different physiological stage of the plant. The trials on dry peas and dry beans can be extrapolated to the whole group of pulses. Residue trials only reported residue levels of prothioconazole-desthio, which is compatible with the residue definition for monitoring. However, the provisional residue definition for risk assessment is sum of prothioconazole-desthio and all metabolites containing the 2-(1- chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl-2h-1,2,4-triazole moiety, expressed as prothioconazole-desthio. In order to estimate residues for risk assessment, an approximate conversion factor of 2 has been derived for cereal grain and oilseeds/pulses. The residue levels selected from trials with prothioconazole are presented in table R1. Residue levels are supported by the MRL of 1 mg/kg. Table R1: Selected residue levels from trials with prothioconazole Crop Residue levels according to the residue STMR HR definition for monitoring (mg/kg) (mg/kg) (mg/kg) Field peas: 2x <0.01; 0.01 Field beans: 2x <0.01; 0.01; (cgap-nl: 2x 125 g/ha, PHI 35d) In the same residue trials as presented above for prothioconazole, also tebuconazole was applied. The trials are summarised in the Reasoned Opinion for tebuconazole on pulses. Crop samples were analysed for parent tebuconazole; no information was provided on the magnitude of the residues of the TDMs in dry pulses. EFSA accepted these trials, however, one NEU trial on peas was disregarded as the application took place at the growth stage of 81 which corresponds to a totally different physiological stage of the plant. Since the use in SEU is more critical, 7 trials in NEU are considered sufficient. The residue levels selected from trials with tebuconazole and risk assessment are presented in table R2. Residue levels are supported by the MRL of 0.3 mg/kg for dry beans and 0.2 mg/kg for the rest of the crops in the group dry pulses. Table R2: Selected residue levels from trials with tebuconazole Crop Residue levels (mg/kg) STMR HR (mg/kg) (mg/kg) Field peas: 0.01; 0.02; 0.06 Field beans: <0.01; 0.01; 0.02; Residues in succeeding crops In succeeding crops, the residue pattern is similar to that observed in primary crops. The residue definitions proposed for primary crops are evenly valid. The peer review concluded that when prothioconazole is applied according to the representative uses, no residue of any metabolite above 0.01 mg/kg is expected in edible parts of rotational crops. Therefore rotational crop field studies were not performed and no plant back restrictions were proposed. Considering that the conditions of use supported in the framework of this application are similar to those investigated in the peer review, the conclusions of the peer review are applicable also for the crops under consideration. Thus, provided that prothioconazole is applied according to the intended GAPs, no significant residues of metabolites containing the 14

19 phenyl-ring are expected in rotational crops. However, the possible occurrence of TDMs in rotational crops cannot be excluded and should be therefore reconsidered in a comprehensive assessment taking into account all active substances which produce these common metabolites. The magnitude of tebuconazole residues in rotational crops was evaluated in the framework of the peer review in four rotational crop field trials. EFSA concludes in the Reasoned Opinion for the MRL for tebuconazole for pulses that significant levels of tebuconazole (above the LOQ) are not expected in rotational crops provided that tebuconazole is applied according to the intended use on pulses. The actual level of the TDMs in the edible parts of the rotational crops was not addressed. Nevertheless, the studies on the nature of tebuconazole residues in rotational crops indicated that triazole derivative metabolites might be of concern in rotational crops. EFSA recommends that a separate risk assessment is performed for TDMs in rotational crops as soon as a harmonized methodology on the risk assessment of the triazole compounds is available Residues from livestock feeding studies As pulses may also be fed to livestock, the dietary burden has been recalculated in the Evaluation Report from France, but also in the draft Reasoned Opinion on the review of the existing MRLs for prothioconazole (article 12 MRL-review). The results of the dietary burden calculations indicate that the trigger value of 0.1 mg/kg DM is exceeded for all livestock species regardless if pulses are included or not. The contribution of pulses to the total dietary burden is low; the lowest feeding rates used in the cow feeding study reported in the DAR will not be exceeded based on the dietary burden calculation; there is no need to amend the current MRLs for foods of animal origin in view of the intended use on pulses. The dietary burden calculation is described in the Article 12 MRL-review, indicating a significant intake for ruminants, poultry and pigs. During the peer review of Directive 91/414/EEC the magnitude of tebuconazole residues in livestock was investigated in feeding studies with lactating cows and laying hens. In addition, livestock exposure was considered in the Reasoned Opinion for tebuconazole in pulses. It was concluded that the contribution of dry pulses to the livestock dietary burden was insignificant. It is therefore not expected that the amount of tebuconazole residues from the proposed use on pulses would have an impact on the livestock exposure to tebuconazole residues and therefore there is no need to modify the existing MRLs for commodities of animal origin in view of the intended use on pulses Processing factors Not required. Residue levels in raw agricultural commodities are below 0.1 mg/kg. Not required. Residue levels in raw agricultural commodities are below 0.1 mg/kg Calculation of the ADI and the ARfD Calculation of the ADI The ADI is based on the NOAEL of 1 mg/kg bw/d in the 2-year oncogenicity study with rats performed with desthio-prothioconazole. Application of a safety factor for inter- and 15

20 intraspecies differences of 100 results in an ADI of 0.01 mg/kg bw/day (see the List of Endpoints for mammalian toxicology). Calculation of the ARfD The ARfD is based on the NOAEL of 1 mg/kg bw/d in the rat developmental study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ARfD of 0.01 mg/kg bw/day (see the List of Endpoints for mammalian toxicology). Calculation of the ADI The ADI is based on the NOAEL of 3 mg/kg bw/d in the 52-week oral dog study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI of 0.03 mg/kg bw/day. This value is supported by the LOAEL of 10 mg/kg bw/d from the developmental mouse study, when applying a safety factor of 300 (see the List of Endpoints for mammalian toxicology). Calculation of the ARfD The ARfD is based on the LOAEL of 10 mg/kg bw/d from the developmental mouse study. Application of a safety factor for inter- and intraspecies differences of 300 results in an ARfD of 0.03 mg/kg bw/day (see the List of Endpoints for mammalian toxicology). 5.2 Maximum Residue Levels EU-MRLs are present in Annex IIIA of Regulation (EC) 396/2005. The product complies with the MRL Regulation. Notification of MRLs is not necessary. EU-MRLs are present in Annex IIIA of Regulation (EC) 396/2005. The product complies with the MRL Regulation. Notification of MRLs is not necessary. 5.3 Consumer risk assessment Risk assessment for chronic exposure through diet It should be noted that the consumer exposure calculation is considered as provisional pending development of a general approach on how to consider TDMs in the risk assessment. A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out in the French Evaluation Report using EFSA PRIMo rev. 2.0, containing all available Member State diets. The maximum TMDI is 56 % of the ADI for French toddlers. The TMDI is 17.3 % and 48.2 % of the ADI for the Dutch general population and Dutch children ages 1-6, respectively. Risk assessment for acute exposure through diet A calculation of the Estimated Short Term Intake (ESTI) was also carried in the French Evaluation Report out using EFSA PRIMo rev. 2.0 and the highest residue value reported in the field trials for pulses. The highest percentage of the ESTI is 21.9 % of the ARfD for dry beans. ESTI values for the other commodities in all other consumer diets are all lower. It should be noted that the consumer exposure calculation is considered as provisional pending development of a general approach on how to consider TDMs in the risk assessment. A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out in the Article 12 MRL-review using EFSA PRIMo rev. 2.0, containing all available Member State diets. The maximum TMDI is 16.7 % of the ADI for WHO Cluster diet B. The TMDI is 7.6 % and 14.9 % of the ADI for the Dutch general population and Dutch children ages 1-6, respectively. 16

21 Risk assessment for acute exposure through diet A calculation of the Estimated Short Term Intake (ESTI) was also carried out in the Article 12 MRL-review using EFSA PRIMo rev The percentage of the ESTI is below 100 % of the ARfD for all pulses. Conclusion Based on the assessment for residues, no risk for the consumer due to the exposure to prothioconazole and tebuconazole is currently expected. The product complies with the Uniform Principles. 5.4 Data requirements No data requirements were identified. 6. Environmental fate and behaviour The new uses of applied for in pulses have an equal (or lower) risk for persistence in soil, leaching to groundwater, and emission to surface water and sediment compared to the already authorised uses. The drinking water criterion is met. The available and most recent monitoring data in groundwater and surface water have been reviewed and have no consequences for the proposed uses. 7. Ecotoxicology The following aspects of ecotoxicology are included in the application for simplified extension. The risk of the use applied for must be comparable to (meaning equal to or lower than) the risk of the already allowed use. An overview of the points of interest per environmental aspect is given in Table E.1. Table E.1 Overview of risks of points of interest of the use in pulses, compared to the already allowed use in grass sods Environmental Point of interest Equal or Argumentation aspect lower risk Aquatic organisms Y See conclusion emission to surface water and sediment and STP remarks Birds and Dose rate Y The dose is equal. mammals Frequency Y Equal Interval Y Equal Time of application Y Different (interception and season) Focal species and RUD (PD, PT, DT50) Y/N Equal / different The FS, however are different. For the previously authorized uses the scenarios are grasslands and cereals while for the current one the scenarios are leafy crops. Bioaccumulation : Y Equal (see fate) 17

22 Bees and bumblebees Non-targetarthropods PEC soil and PEC water (see fate) Remarks Dose rate Y Equal Exposure route (e.g. Y Equal spray drift, dust drift) Other relevant Y Equal species (e.g. bumblebees?) remarks Dose rate Y Equal Frequency Y Equal Interval Y Equal Drift rate Y Equal Exposure route (e.g. spray, seed Y Equal treatment) remarks Earthworms Y See conclusion persistence and emission to soil remarks Soil microorganisms Y See conclusion persistence and emission to soil remarks Activated sludge Y See conclusion emission to surface water and sediment and STP remarks Non-target plants Dose rate Y Equal Frequency Y Equal Interval Y Equal Drift rate Y Equal remarks Risk assessment For the current risk assessment the assessment framework is in accordance with Chapter 2 of the RGB published in the Government Gazette (Staatscourant) 188 of 28 September 2007, including the updates of 20 October 2009 (which came into effect on 1 January 2010) and 18 April 2011 (which came into effect on 23 April 2011). is an new active substance included in Annex I of Directive 91/414/EC per 1 st August 2008 (EFSA report (2007) 106 d.d. 12 July 2007). RMS was United Kingdom. is an existing active substance included in Annex I of Directive 91/414/EC per 1 st September 2009 (Directive 2008/125/EC d.d. 19 December 2008). RMS was Denmark. For the risk assessment the List of Endpoints from the review reports are used. Only the relevant parts of the LoEP of pyridate are presented (birds and mammals). 18

23 List of Endpoints Ecotoxicology is an new active substance included in Annex I of Directive 91/414/EC since For the risk assessment the EFSA report (2007) 106 d.d. 12 July 2007) is used. Additions are given in italic. Effects on birds (Annex IIA, point 8.1, Annex IIIA, points 10.1) Organisms Duration Testsubstance Ecotoxicological endpoint* Bobwhite quail Acute a.s. LD 50 > 2000 mg a.s./kg bw Bobwhite quail 5 d dietary a.s. Mallard duck 5 d dietary a.s. Bobwhite quail Mallard duck Bobwhite quail Bobwhite quail Bobwhite quail Reproduction 22 w dietary Reproduction 21 w dietary Acute 5 d dietary Reproduction 20 w dietary a.s. a.s. JAU desthio JAU desthio JAU desthio LC 50 calc. LD 50 LC 50 calc. LD 50 NOEC calc. NOEL NOEC calc. NOEL LD 50 > 5000 mg a.s./kg diet > 1413 mg a.s./ kg bw/day > 5000 mg a.s./kg diet > 2457 mg a.s./kg bw/day 1000 mg a.s./kg diet 86 mg a.s./kg bw/day 700 mg a.s./kg diet 78 mg a.s./kg bw/day > 2000 mg p.m./kg b.w. LC mg p.m./kg diet 1 calc. LD 50 >297 mg p.m./kg bw/d recalculated LD mg/kg bw/d NOEC calc. NOEL Reproduction JAU NOEC Mallard duck 20 w dietary desthio calc. NOEL (*) Bold values are relevant for risk assessment 173 mg p.m./kg diet 14.8 mg p.m./kg bw/day 0 mg p.m./kg diet 63 mg p.m./kg bw/day 1 value represents the dose converted from the test group in which No Effect on mortality or food consumption was reported (1243 mg/kg diet/d multiplied by the mean daily food consumption (6.4 g/d for the 5 day exposure period) divided by the mean bodyweight (26.75 g for the 5 day exposure period). A more precise conversion of the LC50 value requires reanalysis of data using the converted daily dietary doses for each test group. This was done by the applicant and submitted to Ctgb for a previous application (of Moncereen Pro). The recalculated daily dose-lc50 (recalculated also in ECC-report ) amounts 588 mg/kg bw/d. Effects on mammals (Annex IIIA, points 10.3) Organism Duration, Exposure Testsubstance Ecotoxicological endpoint* Rat acute, oral a.s. LD 50(male, female) > 6200 mg a.s./kg bw/d Rat acute, oral EC 250 LD 50(male, female) > 2500 mg a.s./kg bw/d Rat acute, oral FS 100 LD 50(male, female) > 2500 mg a.s./kg bw/d Rat long-term (2-generation), gavage a.s. NOEL parental 9.7 mg a.s./kg bw/d (based on increased liver weight and decreased thymic weights) NOEL reproduction 95.6 mg a.s./kg bw/d 19

24 Rat Mouse Rat acute, oral acute, oral long-term (2-generation), oral JAU desthio JAU desthio JAU desthio LD 50(female) LD 50(male) LD 50(female) LD 50(male) NOEL parental 2506 mg p.m./kg bw/d 2806 mg p.m./kg bw/d 3459 mg p.m./kg bw/d 2235 mg p.m./kg bw/d 2.5 mg p.m./kg bw/d NOEL reproduction 10 mg p.m./kg bw/d (*) Values in bold are appropriate for use in risk assessment for wild mammals is an existing substance, included in Annex I since For the risk assessment the final List of Endpoints from the EFSA Conclusion (September 2008) is used. Additions are given in italic. Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3) Species Test substance Time scale End point (mg/kg End point (mg/kg feed) bw/day) Birds Colinus virginianus (quail) a.s. Acute LD 50 : 1988 Colinus virginianus (quail) a.s. Short-term LC 50 : > 703 LC 50 : >5000 Colinus virginianus (quail) Met.: Triazole alanine Short-term LC 50 : > 1368 LC 50 : 5000 Colinus virginianus (quail) a.s. Long-term NOEL: 5.8 NOEC: 73.5 Colinus virginianus (quail) a.s. Long-term LOEL: 12.4 LOEC: 156 Mammals Rat a.s. Acute 1700 Rat Folicur EW 250 Acute LD 50: > 2000 mg prep./kg Rat Met.: Triazol alanine Acute LD 50 : > 5000 Rat a.s. Long-term NOEL: 21.6 NOEC: 300 Rabbit a.s. Long-term NOEL: 10 Additional higher tier studies Combination toxicology Combination toxicology is assessed for formulations containing more than one active substance, and for combinations of products, which are made according to the Instructions for Use as a tank mixture. Based on the precautionary principle, concentration-addition is assumed. For pesticides the TER (Toxicity-Exposure Ratio) is used as a standard in the risk assessment (except for bees and other non-target arthropods, where HQ-values are calculated). The TER must be higher than a trigger value to comply with the standards. For the combination risk assessment of formulations containing more than one active substance and for tank mixtures the following formula is used: trigger substance 1 /TER substance 1 + trigger substance 2 /TER substance 2 + trigger substance i /TER substance i. When for each substance the trigger values are equal, the combined TER value can be calculated according to: o TER combi = trigger/((trigger/ter substance 1 )+(trigger/ter substance 2 )+( trigger/ter substance 3 )) 20

25 An acceptable risk is expected when TER combi > trigger. In case of unequal triggers, the combined TER value can be calculated using the following formula: o Trigger combi = trigger substance 1 /trigger substance 2 /trigger substance i o TER combi = trigger combi /((trigger substance 1 /TER substance 1 )+(trigger substance 2 /TER substance 2 )+( trigger substance i /TER substance i )) An acceptable risk is expected when TER combi > trigger combi. In this formula, triggers are the trigger values as mentioned in the corresponding chapter of the HTB (v1.0). In case toxicity of the formulation has been measured, the TER-value of the formulation is calculated with the PEC of the formulation and the toxicity value of the formulation. The PEC of the formulation is the sum of the PECs of the individual active substances. The toxicity value of the formulation is expressed in total amount active substance. Trigger/TER must be smaller than 1. In the risk assessment, the risk of combination toxicology is assessed using the highest trigger/ter-value from the one based on the sum of the individual substances and the one based on formulation studies. When the standard of 1 is breached, the product is not permissable, unless an adequate risk assessment shows that there are no unacceptable effects under field conditions after application of the product according to the proposed GAP. Risk assessment birds and mammals For the previous assessment of, the risk assessment for birds and mammals was conducted according to the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (Sanco/4145/2000). Based on the conclusion of the risk envelope assessment, a risk assessment should be perfomed. In the position paper (BN ) received from the applicant, the risk assessment for birds and mammals is conducted according to the EFSA GD, For the risk assessments performed under the Sanco GD the EFSA GD is used for higher tier refinement. In a pragmatic approach, for the current case Ctgb will use directly the EFSA GD, Effects on birds Birds can be exposed to the formulation via natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning. Toxicity Table E.1 Overview of toxicity data for birds for substance prothioconazole, metabolite JAU 6476-desthio and tebuconazole Endpoint Value Acute toxicity to birds: LD 50 >2000 mg a.s./kg bw Dietary toxicity to birds: LC 50 >1413 mg a.s./kg bw/d Reproductive toxicity to birds: NOEL 78 mg a.s./kg bw/d JAU 6476-desthio Acute toxicity to birds: LD 50 >2000 mg a.s./kg bw 21

26 Endpoint Value Dietary toxicity to birds: LC 50 >297 mg a.s./kg bw/d Reproductive toxicity to birds: NOEL 14.8 mg a.s./kg bw/d Acute toxicity to birds: LD mg a.s./kg bw Dietary toxicity to birds: LC 50 >703 mg a.s./kg bw/d Reproductive toxicity to birds: NOEL 5.8 mg a.s./kg bw/d Metabolites The principal metabolite of prothioconazole in treated crops is JAU 6476-desthio (prothioconazole-desthio). The risk assessment will take account of the presence of this metabolite. No major plant metabolites of tebuconazole were observed. Triazole alanine, a minor plant metabolite (up to 0.4 mg/kg in mature grain) was shown to be of low short-term toxicity (LC50 > 1368 mg/kg bw/d). metabolite 1,2,4-triazole (relevant in soil) has a log Pow < 3 (-1.0). The risk to secondary poisoning is therefore small. Exposure Table E.2 DDD in Reproductive risk assessment for birds (Screening Step) Substance Crop scenario Indicator species Shortcut value mean Rate (kg as/ha) MAF mean TWA DDD (mg/kg/d) NOEL (mg a.s./kg omnivorous bird omnivorous bird Combination 1.02 desthio omnivorous bird *Assuming 100% conversion but corrected for relative molar mass (0.907) bw/d) TER * The screening step gives a TER value of greater than the trigger of 5 for prothioconazole while for tebuconazole, the combination and the metabolites prothioconazole-desthio the TER is below the trigger of 5. The reproductive risk to birds in pulses requires a Tier 1 risk assessment. 22