HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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1 Toelatingsnummer N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 UITBREIDING TOELATING Gelet op de aanvraag d.d. 22 juli 2010 ( UG) van BASF Nederland B.V. Groningensingel EA ARNHEM tot uitbreiding van de gebruiksdoeleinden van de toelating als bedoeld in artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden voor het gewasbeschermingsmiddel, op basis van de werkzame stoffen boscalid en pyraclostrobine Signum gelet op 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 23, eerste lid, Wet gewasbeschermingsmiddelen en biociden, BESLUIT HET COLLEGE als volgt: 1.1 Uitbreiding 1. Het gebruiksgebied van het middel Signum wordt met ingang van datum dezes uitgebreid met de toepassingen in Spaanse peper en in bloemisterijgewassen, boomkwekerijgewassen en vaste planten. 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 onder A bij dit besluit is voorgeschreven. Signum N 1

2 1.4 Classificatie en etikettering Gelet op artikel 31 en artikel 65 van de Verordening EG/1107/2009 worden voorschriften gegeven. Dit leidt tot de volgende voorschriften: De aanduidingen, welke moeten worden vermeld, worden hierbij vastgesteld als volgt: aard van het preparaat: Water dispergeerbaar granulaat werkzame stof: gehalte: pyraclostrobine 6,7 % boscalid 26,7 % de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: diisobutylnaftaleensulfonzuur, natriumzout PICTOGRAM(MEN) pictogram: GHS06giftig GHS09milieu SIGNAALWOORD Gevaar Gevarenaanduidingen H301 H410 Giftig bij inslikken. Zeer giftig voor in het water levende organismen, met langdurige gevolgen. Voorzorgsmaatregelen SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt. P273 Voorkom lozing in het milieu. P301 + P310 NA INSLIKKEN: Onmiddellijk een ANTIGIFCENTRUM of een arts raadplegen. P391 Gelekte/gemorste stof opruimen. P501 Inhoud/verpakking afvoeren naar inzamelpunt voor gevaarlijk of bijzonder afval. Aanvullende etiketelementen EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen. Signum N 2

3 Behalve de voorgeschreven aanduidingen en vermeldingen moeten op de verpakking voorkomen: a. letterlijk en zonder enige aanvulling: het wettelijk gebruiksvoorschrift De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I. b. hetzij letterlijk, hetzij naar zakelijke inhoud: de gebruiksaanwijzing De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B. De tekst mag worden aangevuld met technische aanwijzingen voor een goede bestrijding mits deze niet met die tekst in strijd zijn. c. bij het toelatingsnummer een cirkel met daarin de aanduiding W.13. De nieuwe etikettering dient bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen met codering W.12 mogen worden opgemaakt. 2 DETAILS VAN DE AANVRAAG 2.1 Aanvraag Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel Signum (12630 N), een middel op basis van de werkzame stoffen boscalid en pyraclostrobine. Het middel is bij besluit van 6 september 2013 reeds toegelaten tot 1 september 2023 als schimmelbestrijdingsmiddel: a) in de teelt van aardappelen b) in de teelt van karwij c) in de teelt van crambe d) in de onbedekte teelt van pruim, kers en morel e) in de onbedekte teelt van aalbessen, frambozen en bramen f) in de teelt van aardbei g) in de bedekte teelt van sla h) in de bedekte teelt van andijvieachtigen i) in de teelt van veldsla j) in de teelt van rucola k) in de bedekte, nietgrondgebonden teelt van tomaat, paprika, aubergine l) in de onbedekte teelt van boerenkool m) in de teelt van amsoi, choisum, paksoi, comatsuna, Chinese kool n) in de onbedekte teelt van sluitkool, bloemkool, broccoli, Chinese broccoli, spruitkool o) in de bedekte teelt van radijs p) in de teelt van rettich en daikon q) in de teelt van wortel r) in de teelt van uien en sjalotten s) in de teelt van prei t) in de onbedekte teelt van asperge u) in de teelt van aromatische kruidgewassen v) in de teelt van vruchtbomen en vruchtboomonderstammen van pruim, kers en morel w) in greens van golfterreinen x) in de graszodenteelt y) in de bedekte veredelings en zaadteelt van akkerbouw en groentegewassen Met onderliggende aanvraag wordt toelating als schimmelbestrijdingsmiddel gevraagd: Signum N 3

4 z) in de bedekte niet grondgebonden teelt van Spaanse pepers aa) in de teelt van landbouwstambonen(droog te oogsten) ab) in de teelt van stamslabonen, stamsnijbonen, stokslabonen, stoksnijbonen, spekbonen, pronkbonen en peulen ac) in de teelt van cichorei ad) in de teelt van bloemisterijgewassen, boomkwekerijgewassen en vaste planten Aanvrager heeft de volgende aangevraagde toepassingen gedurende de behandeling van de aanvraag teruggetrokken: aa) in de teelt van landbouwstambonen(droog te oogsten) ab) in de teelt van stamslabonen, stamsnijbonen, stokslabonen, stoksnijbonen, spekbonen, pronkbonen en peulen ac) in de teelt van cichorei 2.2 Informatie met betrekking tot de stof De werkzame stof boscalid is bij Richtlijn 2008/44/EC d.d. 4 april 2008 van de Europese Commissie van de Europese Gemeenschappen opgenomen in Bijlage I van Richtlijn 91/414/EEG. De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011). De werkzame stof pyraclostrobine is bij Richtlijn 2004/30/EG d.d. 10 maart 2004 van de Europese Commissie van de Europese Gemeenschappen opgenomen in Bijlage I van Richtlijn 91/414/EEG. De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011). 2.3 Karakterisering van het middel Signum is een preventief werkend combinatieproduct op basis van boscalid en pyraclostrobine. Boscalid behoort tot de chemische groep van de pyridinecarboxamides (Succinate dehydrogenase inhibitors). Enkele werkzame stoffen binnen deze groep zijn o.a. flutolanil, mepronil, carboxin, fenfuram en thifluzamide. Boscalid remt de ademhaling in de mitochondria in de schimmel, waardoor essentiële bouwstenen niet meer worden gevormd (succinate dehydrogenase) en de schimmelgroei wordt geremd. Het middel remt de kieming van de schimmelsporen. Boscalid werkt preventief en is systemisch. Pyraclostrobine behoort tot de groep van de methoxy carbamaten (Quinone outside inhibitors). Enkele werkzame stoffen binnen deze groep zijn o.a. kresoximmethyl, azoxystrobin, famoxadone en trifloxystrobine. Pyraclostrobine remt de mitochondrische ademhaling. Het middel remt de kieming van schimmelsporen en de groei van de kiembuis op het bladoppervlak. Pyraclostrobine is niet systemisch. 2.4 Voorgeschiedenis De aanvraag is op 26 juli 2010 ontvangen; op 6 oktober 2010 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 1 maart 2011 is de aanvraag in behandeling genomen. 3 RISICOBEOORDELINGEN De beoordeling van deze aanvraag is conform RGB (hoofdstuk 2) en de Evaluation Manual Fysische en chemische eigenschappen De aard en de hoeveelheid van de werkzame stoffen en de in humaantoxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen Signum N 4

5 van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht. 3.2 Analysemethoden De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die vanuit humaantoxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd gebruik. 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 Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het werkzaam is. 3.6 Eindconclusie Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Signum op basis van de werkzame stoffen boscalid en pyraclostrobine voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu. 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, 31 januari 2014 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN, ir. J.F. de Leeuw voorzitter Signum N 5

6 Dit middel is uitsluitend bestemd voor professioneel gebruik HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I bij het besluit d.d. 31 januari 2014 tot uitbreiding van de toelating van het middel Signum, toelatingnummer N A. WETTELIJK GEBRUIKSVOORSCHRIFT Toegestaan is uitsluitend het gebruik als schimmelbestrijdingsmiddel: a) in de teelt van aardappelen b) in de teelt van karwij c) in de teelt van crambe d) in de onbedekte teelt van pruim, kers en morel e) in de onbedekte teelt van aalbessen, frambozen en bramen f) in de teelt van aardbei g) in de bedekte teelt van sla h) in de bedekte teelt van andijvieachtigen i) in de teelt van veldsla j) in de teelt van rucola k) in de bedekte, nietgrondgebonden teelt van tomaat, paprika, aubergine, Spaanse peper l) in de onbedekte teelt van boerenkool m) in de teelt van amsoi, choisum, paksoi, comatsuna, Chinese kool n) in de onbedekte teelt van sluitkool, bloemkool, broccoli, Chinese broccoli, spruitkool o) in de bedekte teelt van radijs p) in de teelt van rettich en daikon q) in de teelt van wortel r) in de teelt van uien en sjalotten s) in de teelt van prei t) in de onbedekte teelt van asperge u) in de teelt van aromatische kruidgewassen v) in de teelt van bloemisterijgewassen, boomkwekerijgewassen en vaste planten w) in de teelt van vruchtbomen en vruchtboomonderstammen van pruim, kers en morel x) in greens van golfterreinen y) in de graszodenteelt z) in de bedekte veredelings en zaadteelt van akkerbouw en groentegewassen Voor de onbedekte teelt van boomkwekerijgewassen, bloemisterijgewassen en vaste planten geldt dat de planten niet hoger mogen zijn dan 150 cm. Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden. Om in het water levende organismen te beschermen is toepassing in de teelt en opkweek (waarbij in de opkweek de bomen > 150 cm) van kers, morel en pruim op percelen die grenzen aan oppervlaktewater alleen toegestaan vóór 1 mei met minstens één van de volgende driftreducerende maatregelen: Signum N 1

7 in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het perceel bespoten dient te worden. Wannerspuit met reflectiescherm en venturidoppen (Lechler ID 90015C). Om in het water levende organismen te beschermen is toepassing in de teelt en opkweek (waarbij in de opkweek de bomen > 150 cm) van kers, morel en pruim op percelen die grenzen aan oppervlaktewater alleen toegestaan vanaf 1 mei met minstens één van de volgende driftreducerende maatregelen: er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of: in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het perceel bespoten dient te worden. Wannerspuit met reflectiescherm en venturidoppen (Lechler ID 90015C). Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van crambe, daikon, aromatische kruidgewassen, rettich, rucola, veldsla, graszodenteelt en in greens van golfterreinen uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater gebruik wordt gemaakt van minimaal 90% driftreducerende doppen. Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van bloemisterijgewassen, boomkwekerijgewassen en vaste planten, amsoi, boerenkool, choisum, paksoi, comatsuna en Chinese kool uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater gebruik wordt gemaakt van minimaal 75% driftreducerende spuitdoppen. Om het grondwater te beschermen mag dit product niet worden gebruikt in grondgebonden, bedekte teelten in grondwaterbeschermingsgebieden. Behandelde karwij en crambe niet voor menselijke en/of dierlijke productie bestemmen en/of in de handel brengen. Resistentiemanagement Dit middel bevat de werkzame stoffen pyraclostrobin en boscalid. Pyraclostrobin behoort tot de methoxycarbamaten. De Frac code is 11. Boscalid behoort tot de pyridinecarboxamiden. De Frac code is 7. 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. Veiligheidstermijn De termijn tussen de laatste toepassing en de oogst mag niet korter zijn dan: 1 dag voor aardbei, tomaat en aubergine 3 dagen voor aalbessen, frambozen, bramen, paprika en Spaanse peper 7 dagen voor pruim, kers en morel 14 dagen voor boerenkool, amsoi, paksoi, choisum, comatsuna, Chinese kool, rucola, rettich, daikon, aromatische kruidgewassen, sluitkool, bloemkool, broccoli, Chinese broccoli, spruitkool, asperge, prei, radijs, andijvieachtigen en sla 21 dagen voor veldsla, uien en sjalotten 28 dagen voor wortel Het middel is uitsluitend bestemd voor professioneel gebruik. B. GEBRUIKSAANWIJZING Signum N 2

8 Het gebruik in de teelten van karwij, crambe, veldsla, rucola, rettich, daikon, aromatische kruidgewassen en de graszodenteelt en in bedekte teelten van sla, andijvieachtigen, radijs, amsoi, paksoi, choisum, comatsuna en Chinese kool is op basis van een derdenuitbreiding. Deze derdenuitbreiding is aangevraagd door de Stichting Trustee Bijzondere Toelatingen. Er is voor deze uitbreiding 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 greens van golfterreinen is op basis van een derdenuitbreiding. Deze derdenuitbreiding is aangevraagd door de Nederlandse Golf Federatie. Er is voor deze uitbreiding 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 onbedekte teelt van boerenkool, amsoi, choisum, paksoi, comatsuna en Chinese kool is beoordeeld conform de vereenvoudigde uitbreidingsprocedure. Er zijn voor deze uitbreidingen 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. Algemeen Signum is een preventief en systemisch werkend middel op basis van de werkzame stoffen boscalid en pyraclostrobin. Indien er geen ervaring is opgedaan met het middel in een bepaald gewas of ras, dient een proefbespuiting uitgevoerd te worden om de verdraagzaamheid van het gewas of ras te testen. De planten dienen tijdens de behandeling goed en volledig bevochtigd te worden. Toepassingen Aardappelen, ter bestrijding van Alternaria solani. Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Wanneer de omstandigheden voor uitbreiding van de ziekte gunstig zijn, dient men de behandeling om de 1421 dagen te herhalen. Signum bij voorkeur toepassen in combinatie met een Phytophthora middel. Het middel kan afwisselend met een ander effectief schimmelbestrijdingsmiddel met een ander werkingsmechanisme of in een blok van maximaal 2 opeenvolgende behandelingen toegepast worden. Indien gespoten wordt in een blok, dient na dit blok 2 maal een ander effectief schimmelbestrijdingsmiddel met een ander werkingsmechanisme te worden aangewend. Signum niet vaker dan 4 keer per teelt toepassen. Dosering: 0,2 kg middel/ha Karwij, ter bestrijding van verbruining (Mycocentrospora acerina). De eerste behandeling in het begin van de bloei uitvoeren, indien nodig herhalen met een interval van 23 weken. Maximaal 2 toepassingen per teelt uitvoeren. Dosering: 1 kg middel/ha Crambe, ter bestrijding van bladvlekkenziekte (Alternaria brassicae en Alternaria brassicicola). De eerste behandeling in het begin van de bloei uitvoeren, indien nodig herhalen met een interval van 23 weken. Maximaal 2 toepassingen per teelt uitvoeren. Dosering: 1 kg middel/ha Signum N 3

9 Onbedekte teelt van pruim, kers en morel, ter bestrijding van tak en bloesemsterfte (Monilia laxa) en vruchtrot (Monilia laxa en Monilia fructigena). Een behandeling uitvoeren in de bloei of zodra de eerste aantasting van Monilia zichtbaar wordt. Afhankelijk van de infectiedruk en de rasgevoeligheid de behandeling zonodig om de 710 dagen herhalen. Met het oog op mogelijke resistentievorming maximaal 2 opeenvolgende behandelingen met het middel uitvoeren. Na dit blok van 2 toepassingen minstens 2 keer een daartoe toegelaten middel toepassen met een ander werkingsmechanisme. De bomen dienen tijdens de behandeling goed en volledig bevochtigd te worden. Signum niet vaker dan 3 maal per jaar toepassen. Dosering: 0,05% (50 g middel per 100 liter water) met een maximum van 0,75 kg middel per ha. Onbedekte teelt van aalbessen, frambozen en bramen, ter bestrijding van vruchtrot (Botryotinia fuckeliana). De eerste behandeling uitvoeren zodra de eerste symptomen worden waargenomen. De behandeling zonodig na 7 dagen herhalen. Het middel bij voorkeur afwisselen met een daartoe toegelaten middel met een ander werkingsmechanisme. Signum niet vaker dan 2 maal per jaar toepassen. Dosering: 1,8 kg middel/ha Aardbei (grondgebonden bedekte teelt), (nietgrondgebonden bedekte teelt) en (onbedekte teelt), ter bestrijding van vruchtrot (Botrytis cinerea). De eerste behandeling uitvoeren vanaf het moment dat de bloemstelen gaan strekken. De behandeling zonodig na 7 dagen herhalen. Het middel afwisselen met een daartoe toegelaten middel met een ander werkingsmechanisme. Signum niet vaker dan 2 maal per jaar toepassen. Dosering: 1,8 kg middel/ha Bedekte teelt van sla en andijvieachtigen, ter bestrijding van smet (Botryotinia fuckeliana, Rhizoctonia solani en Sclerotinia sclerotiorium). De toepassing kan al binnen één week na het uitplanten plaats vinden (d.w.z. na het aanslaan van de planten ). Na de behandeling niet meer schoffelen. Wanneer de omstandigheden voor uitbreiding van de ziekte gunstig zijn, dient de behandeling na 14 dagen te worden herhaald. Signum niet vaker dan 2 maal per teelt toepassen. Indien nodig afwisselen met een middel met een ander werkingsmechanisme. Dosering: 1,5 kg middel/ha Veldsla, ter bestrijding van smet (Botryotinia fuckeliana, Rhizoctonia solani en Sclerotinia sclerotiorium). Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Signum niet vaker dan 1 maal per teelt toepassen. Dosering: 1,5 kg middel/ha Rucola, ter bestrijding van smet (Botryotinia fuckeliana, Rhizoctonia solani en Sclerotinia sclerotiorium). De toepassing kan al binnen één weftomaek na het uitplanten plaats vinden (d.w.z. na het aanslaan van de planten ). Na de behandeling niet meer schoffelen. Wanneer de omstandigheden voor uitbreiding van de ziekte gunstig zijn, dient de behandeling na 14 dagen te worden herhaald. Signum niet vaker dan 2 maal per teelt toepassen. Indien nodig afwisselen met een middel met een ander werkingsmechanisme. Dosering: 1,5 kg middel/ha Bedekte, nietgrondgebonden teelt van tomaat, paprika, aubergine en Spaanse peper, ter bestrijding van Botrytis (Botryotinia fuckeliana) en meeldauw (Leveillula taurica). De eerste behandeling uitvoeren zodra symptomen op blad of stengels worden waargenomen. Indien nodig de behandeling na 714 dagen herhalen. Signum niet vaker dan 3 maal per teelt toepassen. Signum N 4

10 Dosering: 0,1 % (100 gram middel per 100 liter water) Onbedekte teelt van boerenkool, amsoi, paksoi, choisum, comatsuna en Chinese kool, ter bestrijding van spikkelziekte (Alternaria brassicae en Alternaria brassicicola). Een behandeling uitvoeren zodra een aantasting wordt waargenomen. De behandelingen indien nodig herhalen met intervallen van 7 dagen. Signum niet vaker dan 3 maal per teelt toepassen. Dosering: 1 kg middel/ha Bedekte teelt van amsoi, paksoi, choisum, comatsuna en Chinese kool, ter bestrijding van spikkelziekte (Alternaria brassicae en Alternaria brassicicola). Een behandeling uitvoeren zodra een aantasting wordt waargenomen. De behandelingen indien nodig herhalen met intervallen van 14 dagen. Signum niet vaker dan 2 maal per teelt toepassen. Dosering: 1 kg middel/ha Onbedekte teelt van rode kool, savooienkool, spitskool, witte kool, bloemkool, broccoli, spruitkool, ter bestrijding van ringvlekkenziekte (Mycosphaerella brassicicola). Na het uitplanten een behandeling uitvoeren zodra een aantasting wordt waargenomen. De behandeling indien nodig herhalen met een interval van 1421 dagen. Met het oog op mogelijke resistentievorming mogen maximaal 50% van de bespuitingen met Signum worden uitgevoerd. Het middel dient te worden afgewisseld met een daartoe toegelaten middel met een ander werkingsmechanisme of, indien gespoten wordt in een blok, maximaal 2 opeenvolgende behandelingen met het middel uitvoeren. Na een blok dient 2 maal een daartoe toegelaten middel met een ander werkingsmechanisme te worden aangewend. ter bestrijding van witte roest (Albugo candida). Een behandeling uitvoeren zodra een aantasting wordt waargenomen. De behandeling indien nodig herhalen met een interval van 1421 dagen. ter bestrijding van spikkelziekte (Alternaria brassicae en Alternaria brassicicola). Een behandeling uitvoeren zodra een aantasting wordt waargenomen. De behandeling indien nodig herhalen met een interval van 14 dagen. Dosering: 1 kg middel/ha Signum niet vaker dan 3 maal per teelt toepassen. Bedekte teelt van radijs, ter bestrijding van smet (Botryotinia fuckeliana en Rhizoctonia solani). Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Signum niet vaker dan 1 maal per teelt toepassen. Dosering: 1,5 kg middel/ha Rettich en daikon, ter bestrijding van smet (Botryotinia fuckeliana en Rhizoctonia solani). Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Signum niet vaker dan 1 maal per teelt toepassen. Dosering: 1,5 kg middel/ha Wortel, ter bestrijding van loofverbruining (Alternaria dauci). Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Wanneer de omstandigheden voor uitbreiding van de ziekte gunstig zijn, dient de behandeling om de 34 weken herhaald te worden. Met het oog op mogelijke resistentievorming mogen maximaal 50% van de bespuitingen met Signum worden uitgevoerd. Het middel dient te worden afgewisseld met een daartoe toegelaten middel met een ander werkingsmechanisme of, indien gespoten wordt in een blok, maximaal 2 opeenvolgende behandelingen met het middel uitvoeren. Na een blok dient 2 maal een daartoe toegelaten middel met een ander werkingsmechanisme te worden aangewend. Signum niet vaker dan 3 maal per teelt toepassen. Signum N 5

11 Dosering: 0,75 kg middel/ha Uien en sjalotten, ter bestrijding van bladvlekkenziekten (Phytophthora porri, Alternaria porri en Cladosporium alliiporri) en roest (Puccinia allii). Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Wanneer de omstandigheden voor uitbreiding van de ziekte gunstig zijn, dient de behandeling om de 710 dagen herhaald te worden. Signum niet vaker dan 2 maal per teelt toepassen. Dosering: 1,5 kg middel/ha Prei, ter bestrijding van bladvlekkenziekten (Phytophthora porri, Alternaria porri en Cladosporium alliiporri) en roest (Puccinia allii). Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Wanneer de omstandigheden voor uitbreiding van de ziekte gunstig zijn, dient de behandeling om de 1014 dagen herhaald te worden. Met het oog op mogelijke resistentievorming mogen maximaal 50% van de bespuitingen met Signum worden uitgevoerd. Het middel dient te worden afgewisseld met een daartoe toegelaten middel met een ander werkingsmechanisme of, indien gespoten wordt in een blok, maximaal 2 opeenvolgende behandelingen met het middel uitvoeren. Na een blok dient 2 maal een daartoe toegelaten middel met een ander werkingsmechanisme te worden aangewend. Signum niet vaker dan 3 maal per teelt toepassen. Dosering: 1,5 kg middel/ha Onbedekte teelt van asperge, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana) en stengelsterfte (Stemphylium herbareum) De behandeling uitvoeren vanaf begin augustus tot eind september. De behandeling na 14 dagen herhalen. Het middel bij voorkeur afwisselen met een daartoe toegelaten middel met een ander werkingsmechanisme. Signum niet vaker dan 3 maal per jaar toepassen. Dosering: 0,75 kg middel/ha Aromatische kruidgewassen, ter bestrijding van smet (Botryotinia fuckeliana, Rhizoctonia solani en Sclerotinia sclerotiorium). De toepassing kan al binnen één week na het uitplanten plaats vinden (d.w.z. na het aanslaan van de planten ). Na de behandeling niet meer schoffelen. Wanneer de omstandigheden voor uitbreiding van de ziekte gunstig zijn, dient de behandeling na 14 dagen te worden herhaald. Signum niet vaker dan 2 maal per teelt toepassen. Indien nodig afwisselen met een middel met een ander werkingsmechanisme. Dosering: 1,5 kg middel/ha Bloemisterijgewassen, boomkwekerijgewassen en vaste planten, ter bestrijding van Botryotinia fuckeliana, Rhizoctonia solani en Sclerotinia. Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Indien nodig de behandeling herhalen met een interval van 1214 dagen. Signum niet vaker dan 2 maal per teelt toepassen. Dosering: 1,5 kg middel/ha Teelt van vruchtboomonderstammen en vruchtbomen van pruim, kers en morel, ter bestrijding van tak en bloesemsterfte (Monilia laxa) en vruchtrot (Monilia laxa en Monilia fructigena). Een behandeling uitvoeren in de bloei of zodra de eerste aantasting van Monilia zichtbaar wordt. Afhankelijk van de infectiedruk en de rasgevoeligheid de behandeling zonodig om de 710 dagen herhalen. Met het oog op mogelijke resistentievorming maximaal 2 opeenvolgende behandelingen met het middel uitvoeren. Na dit blok van 2 toepassingen minstens 2 keer een daartoe toegelaten middel toepassen met een ander werkingsmechanisme. De bomen dienen tijdens de behandeling goed en volledig bevochtigd te worden. Signum niet vaker dan 3 maal per jaar toepassen. Signum N 6

12 Dosering: 0,05% (50 g middel per 100 liter water) met een maximum van 0,75 kg middel per ha. Greens van golfterreinen, ter bestrijding van Fusarium, dollar spot en antracnose. Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Wanneer de omstandigheden voor uitbreiding van de ziekte gunstig zijn, dient na 24 weken nogmaals behandeld te worden. Signum mag niet vaker dan 2 keer per seizoen worden toegepast. Het middel dient verspoten te worden met 90%driftreductiedoppen in percelen die grenzen aan oppervlaktewater. Dosering 1,5 kg middel/ha Graszodenteelt, ter bestrijding van sneeuwschimmel. Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Wanneer de omstandigheden voor uitbreiding van de ziekte gunstig zijn, dient een extra behandeling na 24 weken uitgevoerd te worden. Met het oog op mogelijke resistentievorming mogen maximaal 50% van de bespuitingen met Signum worden uitgevoerd. Signum niet vaker dan 2 maal per teelt toepassen. Dosering: 1,5 kg middel/ha Bedekte veredelings en zaadteelt van akkerbouw en groentegewassen, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). De eerste behandeling uitvoeren zodra symptomen op blad of stengel worden waargenomen. Indien nodig de behandeling na 714 dagen herhalen. Signum niet vaker dan 2 maal per teelt toepassen. Dosering: 0,1% (100 g middel/100 liter water). Signum N 7

13 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II bij het besluit d.d. 31 januari 2014 tot uitbreiding van de toelating van het middel Signum, toelatingnummer N RISKMANAGEMENT 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 Appendix 2 Reference list Page 1

14 1. Identity of the plant protection product 1.1 Applicant BASF Nederland B.V. Groningensingel EA Arnhem The Netherlands 1.2 Identity of the active substance Common name Boscalid Name in Dutch Boscalid Chemical name 2ChloroN(4'chlorobiphenyl2yl)nicotinamide (IUPAC name) CAS no EC no Not assigned The active substance was included on August 1 st, 2008 in Annex I of Directive 91/414/EEC. 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 Pyraclostrobin Name in Dutch Pyraclostrobin Chemical name methyl N(2{[1(4chlorophenyl)1Hpyrazol3yl]oxymethyl}phenyl) N methoxy carbamate (IUPAC) CAS no EC no not assigned The active substance was included on June 1 st, 2004 in Annex I of Directive 91/414/EEC. 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 Name Signum Formulation type WG Content active substance Pyraclostrobin: 6.7 %m/m pure a.s. Boscalid: 26.7 %m/m pure a.s. The formulation was not part of the assessment of either active substance for inclusion in Annex I of Directive 91/414/EEC. 1.4 Function Fungicide 1.5 Uses applied for This application is for extension with the uses in dry harvested beans, green bean, slicing bean, bush bean runner bean and pods, hot peppers, chicory, floriculture, tree nursery and perennial plants. 1.6 Background to the application The application concerns an extension of the present authorization with the uses mentioned above under 1.5. However, during the evaluation process the applicant withdrew the applications for the uses in dry harvested beans, green bean, slicing bean, bush bean runner bean and pods, and chicory. Only where relevant, updates are being made in the assessment. Page 2

15 1.7 Packaging details Material: Capacity: Type of closure and size of opening: Other information HDPE 1, 5 or 10 L 1L: 42mm opening, PE screw cap, HFseal 5 and 10L: 54mm opening, PE screw cap, HFseal All containers are ADR compliant. Bottles may be packed in cardboard boxes. The combination packs meet UN 4G/Y requirements Detailed instructions for safe disposal See application form and MSDS. 2. Physical and chemical properties 2.1 Active substance: boscalid Data on the identity and the physical and chemical properties is taken from the List of Endpoints (Review Report, January 2008 SANCO/3919/2007 rev. 5). Changes and/or additions are taken up in italics. Common name (ISO) Boscalid Development Code BAS 510 F Chemical name (IUPAC) Chemical name (CA) CIPAC No 673 CAS No EEC No not assigned FAO SPECIFICATION not assigned Minimum purity 960 g/kg Identity of relevant impurities (of None toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg) Molecular formula Molecular mass Structural formula 2ChloroN(4'chlorobiphenyl2yl)nicotinamide 2ChloroN(4'chloro[1,1'biphenyl]2yl)3 pyridinecarboxamide C 18 H 12 Cl 2 N 2 O g/mol O N Cl N H Cl Physicalchemical properties Melting point C (capillary method, 99.7 %) 145 C (DSC method, 99.7 %) Boiling point none (decomposition occurs at 300 o C. No boiling point was determined). Appearance white crystalline solid, odourless (min 99.4 %) Page 3

16 Relative density d 20 4 = (99.7 %) Surface tension 66.0 mn/m 0.5 % (w/w) and 61.7 mn/m 1.0 % (w/w) (98.16 %, both at 20 C) 72.1 mn/m 0.5 % (w/w) and 72.4 mn/m 1.0 % (w/w) (99.7 %, both at 20 C) Vapour pressure 7.2 x 10 7 Pa at 20 C Henry's law constant x 10 5 Pa m³/mol Solubility in water 4.6 mg/l at 20 C (99.4 %) No dissociation in water, therefore no ph dependency Solubility in organic solvents Solubility at 20 C in g/l (99.4 %) nheptane < 10 g/l Toluene 2025 g/l Dichloromethane g/l Methanol 4050 g/l Acetone g/l Ethyl acetate 6780 g/l N,NDimethylformamide > 250 g/l Acetonitrile 4050 g/l 1Octanol < 10 g/l 2Propanol < 10 g/l olive oil < 10 g/l Partition coefficient (log P ow ) 2.96 (ph 7.1, 21 C) No dissociation in water, therefore no ph dependency Hydrolytic stability (DT 50 ) Stable between ph 4 and ph 9 Dissociation constant No dissociation in water UV/VIS absorption (max.) 207 nm (ε 31534) 228 nm (ε 19834) 290 nm (ε 1529) 300 nm (ε 531) Photostability in water (DT 50 ) Stable, no degradation observed Quantum yield of direct phototransformation Smaller than 2.45 x 10 4 in water at λ >290 nm Flammability not highly flammable No autoflammability was observed up to 400 C Explosive properties None (statement) Oxidising properties The chemical structure of the active substance gives no evidence of oxidising properties 2.2 Active substance: pyraclostrobin Data on the identity and the physical and chemical properties are taken from the List of Endpoints (November 2003). Changes and/or additions are taken up in italics. Active substance (ISO Common Pyraclostrobin Name) Chemical name (IUPAC) methyl N(2{[1(4chlorophenyl)1Hpyrazol3 yl]oxymethyl}phenyl) Nmethoxy carbamate Chemical name (CA) carbamic acid, [2[[[1(4chlorophenyl)1Hpyrazol3 yl]oxy]methyl]phenyl]methoxy, methyl ester CIPAC No 657 CAS No EEC No (EINECS or ELINCS) not assigned Page 4

17 FAO Specification (including year of publication) Minimum purity of the active substance as manufactured (g/kg) Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg) not applicable, new active substance 975 max dimethyl sulfate (DMS) Molecular formula C 19 H 18 Cl N 3 O 4 Molecular mass g/mol Structural formula Cl N N O O O N O Physicalchemical properties Melting point (state purity) C (99.8 %) Boiling point (state purity) no boiling point up to decomposition at 200 C, (99.8 %) Temperature of decomposition 200 C (99.8 %) Appearance (state purity) white to light beige cristaline solid (99.8 %) Relative density (state purity) Density: g/cm 3 (99.8 %, 20 C) Surface tension 71.8 mn/m at 0.5 % (w/w) (20 C) 71.5 mn/m at 2.0 % (w/w) (20 C) (98.5 %) Vapour pressure (in Pa, state 2.6 x 10 8 (20 C) temperature) Henry s law constant (in Pa m 3 mol 1 ) x 10 6 Solubility in water (in g/l or mg/l, state 19 ± 1.7 g/l at 20 C in deionised water (ph of 5.8) temperature) Solubility in organic solvents (in g/l or mg/l, state temperature) Partition coefficient (log P ow ) (state ph and temperature) Hydrolytic stability (DT 50 ) (state ph and temperature) There is no dissociation in water therefore ph dependence on solubility is not applicable. In g/l at 20 C nheptane : 3.7 2propanol : 30.0 octanol: 24.2 olive oil: 28.0 methanol:100.8 acetone: >500 ethyl acetate: >500 acetonitrile: >500 dichloromethane: >500 toluene: > (20 C, 99.8 %) Effect of ph was not investigated since there is no dissociation in water. ph 5: stable ph 7: stable Page 5

18 ph 9: stable (very slow degradation observed) In the DAR, temperatures at which the tests were performed were not stated. Dissociation constant not applicable. No indication of dissociation in water. UV/VIS absorption (max.) (if 2.5 x 10 4 L mol 1 cm 1 at 205 nm absorption >290 nm state ε at 2.4 x 10 4 L mol 1 cm 1 at 275 nm (22 C, 99.8 %) wavelength) Photostability (DT 50 ) (aqueous, DT 50 < 2 h (mean value of tolyl and chlorophenyllabel) at 22 C sunlight, state ph) Quantum yield of direct photo 2.17 x 10 1 transformation in water at λ > 290 nm Photochemical oxidative degradation Halflife = 1.87 h in air Flammability not considered highly flammable; Autoflammability autoflammability: 510 C Oxidative properties Not oxidising Explosive properties no potential for explosivity as evident from the structural formula 2.3 Plant protection product: Signum The range of the application concentration of the plant protection product is %. Section (Annex point) Study Guidelines and GLP Findings Evaluation and conclusion B (IIIA 2.1) B (IIIA 2.1) B (IIIA 2.1) B (IIIA 2.2) B (IIIA 2.2) B (IIIA 2.3) B (IIIA 2.3) B (IIIA 2.3) B (IIIA 2.4) Appearance: physical state Appearance: colour Appearance: odour Explosive properties Oxidising properties Flammability Autoflammability Flash point Acidity/ alkalinity Visual Solid fine granule Acceptable Visual Dark brown Acceptable EEC A14 GLP: yes EEC A17 GLP: yes EEC A10 GLP: yes EEC A16 GLP: yes Not determined Not explosive Not oxidising Not highly flammable Acceptable Acceptable Acceptable Acceptable 246 o C Acceptable Not applicable Not applicable Page 6

19 Section (Annex point) B (IIIA 2.4) B (IIIA 2.5) B (IIIA 2.5) B (IIIA 2.6) B (IIIA 2.6) B (IIIA 2.7) Study ph Surface tension Viscosity Relative density Bulk (tap) density Storage stability Guidelines and GLP CIPAC MT75 GLP: yes CIPAC MT169 GLP: yes CIPAC MT46 GLP: yes Findings CIPAC D water 1.0%: %: 6.5 Purified water 1.0%: %: 6.5 After 2 years storage no significant change in ph was observed. Not applicable Not applicable Not applicable 526 g/l (loose) 597 g/l (tapped) Stable for 14 days at 54 o C, including all relevant technical properties. Evaluation and conclusion Acceptable Acceptable Acceptable B (IIIA 2.7) Shelf life Stability at low temperatures: not applicable for solid products. Chemical stability No significant change in a.i. content was observed after 2 years storage at both 20 o C and 30 o C. The product is considered chemically stable. Acceptable Physical stability Based on the results of the tests of ph, wettability, foam persistence, suspensibility, spontaneity of dispersion, attrition resistance, dry sieving, wet sieving, particle size distribution before and after storage, the product is considered physically stable. Packaging Page 7

20 Section (Annex point) Study Guidelines and GLP Findings The packaging was proven suitable for its content (PE laminated bag). Evaluation and conclusion B (IIIA 2.8) B (IIIA 2.8) B (IIIA 2.8) Wettability Persistent foaming Suspensibility CIPAC MT and GLP: yes CIPAC MT47.1 GLP: yes CIPAC MT47 GLP: yes CIPAC MT184 GLP: yes CIPAC MT184 GLP: yes The proposed packaging for the Dutch market are bottles made of HDPE. Both the tested and proposed packaging are ADR compliant and their contact surface with the product is PE. Therefore the packaging types are considered comparable. After 2 years the wettability was within the range of 1 minute (17s). Initial results are not taken into account, because the product was agitated, which is not allowed for this test. 1% dispersion in CIPAC D water After one minute 5 ml of foam was observed. After 2 years storage at 20 o C and 30 o C 8 ml foam persisted after 1 minute. 0.01% in CIPAC D: no foam after 1 minute. 1.0% in CIPAC D: 7 ml after one minute. 1% dispersion in CIPAC D water Before and after storage for 2 years at both 20 o C and 30 o C, the suspensibility was within an acceptable range (99 100%) 0.2% in CIPAC D: boscalid 98% pyraclostrobin 98% 1.0% in CIPAC D: Acceptable, based on the results after 2 years storage. Acceptable (see below). Acceptable. It is considered unlikely that >60 ml foam will be formed after one minute at a concentration of 1.5%. Acceptable (see below). Acceptable. It is considered unlikely that suspensibility will drop below the limit of 60% at the Page 8

21 Section (Annex point) B (IIIA 2.8) B (IIIA 2.8) B (IIIA 2.8) B (IIIA 2.8) B (IIIA 2.8) B (IIIA 2.8) Study Spontaneity of dispersion Dilution stability Dry sieve test Guidelines and GLP CIPAC MT174 GLP: yes CIPAC MT174 GLP: yes CIPAC MT58 and MT170 GLP: yes Wet sieve test CIPAC MT167 and MT185 GLP: yes Particle size distribution Content of dust/fines Laser light diffraction method GLP: yes See also B CIPAC MT171 GLP: yes Findings boscalid 99% pyraclostrobin 99% Before and after storage for 2 years at both 20 o C and 30 o C, the spontaneity of dispersion was within acceptable limits (95 97%) Evaluation and conclusion lowest and higher proposed inuse concentrations. Acceptable 100% Acceptable Not applicable 90% > 125 microns 90% < 500 microns Fines portion : 0.1% < 50 microns before storage and 0.3% after 2 years storage at 20 o C. Residue on a 75 micron sieve: 0% before and after 2 years storage at both 20 o C and 30 o C. d 10% = 0.8% d 50% = 2.8% d 90% = 8.2% Before storage: % (2 mg dust). After storage at 20 o C: % 30 o C: % Acceptable Acceptable Acceptable Acceptable B (IIIA 2.8) B (IIIA Attrition and friability Emulsifiability, re CIPAC MT178 GLP: yes CIPAC MT178.2 GLP: yes The product is classified as nearly dust free 100% Acceptable The attrition resistance was measured only after 2 years storage and was within acceptable limits (98 99%). Not applicable Acceptable Page 9

22 Section Study (Annex point) 2.8) emulsifiability and emulsion B (IIIA 2.8) B (IIIA 2.8) B (IIIA 2.8) B (IIIA 2.8) B (IIIA 2.8) stability Stability of dilute emulsion Flowability Pourability (rinsibility) Dustability Adherence and distribution to seeds Physical compatibility with other products Chemical compatibility with other products Guidelines and GLP CIPAC MT171 GLP: yes Findings Not applicable Spontaneous Not applicable Not applicable Not applicable Various BASF products were tested in aqueous tank mixes with Signum. Although the instructions for use do not propose mixing with other products, Acrobat Plus (WG), Polyram WG, Decis (EC), Fastac 100 EC and Stratos Ultra (EC) were tested and can be mixed with the product if mixed with a running agitator. See Evaluation and conclusion Acceptable Acceptable Acceptable Conclusion The physical and chemical properties of the active substances and the plant protection product are sufficiently described by the available data. Neither the active substances nor the product has any physical or chemical properties, which would adversely affect the use according to the proposed use and label instructions. 2.3 Data requirements None. Page 10

23 3. Methods of analysis 3.1. Analytical methods in technical material and plant protection product Active substance: boscalid Description and data on the analytical methods are taken from the List of Endpoints of boscalid (DAR, November 2007). Changes and/or additions are taken up in italics. Technical as (principle of method) HPLCUV Impurities in technical as (principle of method) Preparation (principle of method) HPLCUV; GC/MS Method CFA598 (HPLCUV) for the determination of pyraclostrobin and boscalid in WG formulations Active substance: pyraclostrobin Description and data on the analytical methods are taken from the List of Endpoints of pyraclostrobin (DAR, November 2003). Changes and/or additions are taken up in italics. Technical as (principle of method) HPLCUV; reversed phase column Impurities in technical as (principle of method) Preparation (principle of method) HPLCUV; reversed phase column. GCFID Method CFA598 (HPLCUV) for the determination of pyraclostrobin and boscalid in WG formulations Conclusion The analytical methods for the technical a.s. and the impurities have been assessed in the DARs of the active substances and are acceptable. Acceptable validation was submitted for the method to determine the active substances in the plant protection product. 3.2 Residue analytical methods Active substance: boscalid Description and data on the analytical methods are taken from the List of Endpoints of boscalid (DAR, November 2007). Changes and/or additions are taken up in italics. Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes) GCMS method for the determination of boscalid only LOQ: 0.01 mg/kg (wheat, lemon, tomato, cabbage, lettuce) 0.02 mg/kg (oil rape seed) 0.05 mg/kg (hops, recovery = 63 %) Confirmatory method: 3 mass fragments ILV: yes Food/feed of animal origin (principle of method and LOQ for LCMS/MS method for the determination of boscalid only LOQ: 0.05 mg/kg (apple, cherry, grapes, strawberry, carrot, onions, tomato, broccoli, cabbage, leek, dwarf beans, oilseed rape) Confirmatory method: not required for HPLCMS/MS methods. ILV: no GCECD LOQ = 0.01 mg/kg (milk) and mg/kg (muscle, liver, Page 11

24 methods for monitoring purposes) Soil (principle of method and LOQ) Water (principle of method and LOQ) Air (principle of method and LOQ) Body fluids and tissues (principle of method and LOQ) kidney, fat, egg) Methods for nicobifen (boscalid) and metabolite M510F01 confirmation: GCMS ILV: GCECD GCMS method for the determination of boscalid only LOQ: 0.01 mg/kg Confirmatory method: 4 mass fragments GCMS method for the determination of boscalid only LOQ: 0.05 µg/l (drinking water) LOQ: 0.5 µg/l (surface water) Confirmatory method: 4 mass fragments LCMS/MS method L0127/01 for the determination of boscalid in surface water and drinking water. LOQ = 0.03 µg/kg (surface and drinking water) Confirmatory method: not required for LCMS/MS GCMS method for the determination of boscalid only LOQ = 1.5 µg/m 3 Confirmatory method : 3 mass fragments Not required, not classified as (very) toxic Based on the proposed extension of the use of the plant protection product, analytical methods for determination of residues in food/feed of plant origin are required for watery (beans), dry (dried beans) and special matrices (chilli pepper, chicory). Definition of the residue and proposed MRLs for boscalid Matrix Proposed definition of the residue for Proposed MRL monitoring Food/feed of plant origin Boscalid EU MRL: 0.05* mg/kg and above Food/feed of animal origin Boscalid and M510F01 EU MRL: 0.7 mg/kg (meat, fat), 0.3 mg/kg (kidney and offal), 0.2 mg/kg (liver), 0.1 mg/kg (milk), 0.05* mg/kg (eggs and others) Required LOQ Soil Boscalid 0.05 mg/kg (default) Drinking water Boscalid 0.1 µg/l (Dutch drinking water guideline) Surface water Boscalid 0.1 µg/l Air Boscalid 0.03 mg/m 3 (derived from the AOEL [0.1 mg/kg/d] according to Body fluids and tissues The active substance is not classified as (very) toxic thus no definition of the residue is proposed. SANCO/825/00) No requirements. The residue analytical methods, included in the above List of Endpoints, are suitable for monitoring of the MRLs of the claimed watery and dry matrices. Due to the low dietary intake of the special matrices chilli pepper and chicory, and the low mammalian toxicity of the active Page 12

25 substance boscalid, there is no need for validated methods for chilli pepper and chicory. The residue analytical methods for soil and air, evaluated in the DAR, are acceptable and suitable for monitoring of residues in the environment. For surface water, the residue analytical method in the DAR was insufficiently validated: the LOQ is higher than the required 0.1 µg/l. Therefore, the applicant provided an additional acceptably validated LCMS/MS method with a LOQ of 0.03 µg/kg Active substance: pyraclostrobin Description and data on the analytical methods are taken from the List of Endpoints of pyraclostrobin (DAR, November 2003). Changes and/or additions are taken up in italics. Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes) Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes) LCMS/MS method for determination of pyraclostrobin and metabolite BF 5003 LOQ: 0.02 mg/kg (wheat, grapes, peanut, HPLCUV orange) Confirmatory method: not required for HPLCMS/MS ILV: yes HPLCUV method for the determination of pyraclostrobin only LOQ: 0.01 mg/kg (milk) and 0.05 mg/kg (muscle, liver, kidney, fat and eggs) Confirmatory method: HPLCUV with different column ILV: yes Soil (principle of method and LOQ) Water (principle of method and LOQ) Air (principle of method and LOQ) Body fluids and tissues (principle of method and LOQ) GCMS or LC/MSMS method for the determination of pyraclostrobin and metabolite BF LOQ: 0.01 mg/kg (milk) and 0.05 mg/kg (muscle, liver, kidney, fat and eggs) Confirmatory method: for milk both GCMS and HPLC MS/MS methods were validated. For other matrices no confirmatory method is required (HPLCMS/MS) ILV: no LCMS/MS or HPLCUV LOQ: 0.01 mg/kg (pyraclostrobin, BF5003, BF5007 and BF5006) Confirmatory method: HPLCAPIMS LCMS/MS LOQ: 0.05 µg/l (drinking and surface water, pyraclostrobin only) Confirmatory method: not required for HPLCMS/MS HPLCUV method for the determination of pyraclostrobin only LOQ = 0.3 µg/m 3 Confirmatory method: LCMS HPLCUV 0.05 mg/kg (liver, kidney) HPLCUV 0.05 mg/kg (blood) Determined analytes: pyraclostrobin Confirmatory method: different column type Based on the proposed extension of the use of the plant protection product, analytical methods for determination of residues in food/feed of plant origin are required for watery (beans), dry (dried beans) and special matrices (chilli pepper, chicory). Page 13

26 Definition of the residue and MRLs for pyraclostrobin Matrix definition of the residue for Proposed MRL monitoring Food/feed of plant origin pyraclostrobin EU MRL: 0.02* mg/kg and above Food/feed of animal origin pyraclostrobin EU MRL: 0.01* mg/kg (milk), 0.05* mg/kg (others) Required LOQ Soil pyraclostrobin, BF5003, BF5007 and 0.05 mg/kg (default) BF5006 Drinking water Pyraclostrobin 0.1 µg/l (Dutch drinking water guideline) Surface water Pyraclostrobin 0.1 µg/l Air Pyraclostrobin mg/m 3 (derived from the AOEL [0.015 mg/kg bw] according to SANCO/825/00) Body fluids and tissues The active substance is classified as toxic pyraclostrobin No requirements. The residue analytical methods, included in the above List of Endpoints, are suitable for monitoring of the MRLs of the claimed watery and dry matrices. Due to the low dietary intake of the special matrices chilli pepper and chicory, and the low mammalian toxicity of the active substance pyraclostrobin, there is no need for validated methods for chilli pepper and chicory. The residue analytical methods for water, soil and air, evaluated in the DAR, are acceptable and suitable for monitoring of residues in the environment. Conclusion The submitted analytical methods meet the requirements. The methods are specific and sufficiently sensitive to enable their use for enforcement of the MRLs and for monitoring of residues in the environment. 3.3 Data requirements None. 4. Mammalian toxicology List of Endpoints Boscalid Boscalid is a new active substance, included in Annex I of 91/414/EEC. The final List of Endpoints presented below is taken from the final review report on boscalid (SANCO/3919/2007 rev 5, d.d. 21 January 2008). Where relevant, some additional remarks/information are given in italics. Absorption, distribution, excretion and metabolism in mammals Rate and extent of absorption: Approx. 44 % (based on bile excretion within Page 14

27 Distribution: Potential for accumulation: Rate and extent of excretion: Toxicologically significant compounds: Metabolism in animals: 48 h and urinary excretion within 6 h, low dose) Widely distributed. Highest residues in liver and adipose tissue (8h, low dose) In highdose females, highest residues were observed in thyroid and kidney No evidence Complete excretion of low dose within 48 h (approx. 20 % via urine and 80 % via faeces) Parent and metabolites Extensive (< 1 % of absorbed dose excreted as parent via urine or bile), 38 metabolites identified in rat matrices. Major pathway was hydroxylation at the diphenyl moiety and subsequent O glucuronidation Acute toxicity Rat LD50 oral Rat LD50 dermal Rat LC50 inhalation Skin irritation Eye irritation Skin sensitization (test method used and result) > 5000 mg/kg bw > 2000 mg/kg bw > 6.7 mg/l air (noseonly dust exposure) Nonirritant Nonirritant Not a skin sensitiser (M&K test) Short term toxicity Target / critical effect Lowest relevant oral NOAEL / NOEL Lowest relevant dermal NOAEL / NOEL Lowest relevant inhalation NOAEL / NOEL Liver, thyroid Dog 1yr: 800 ppm (22 mg/kg bw/d) Rat 28day: 1000 mg/kg bw/d No studies submitted, not required. Genotoxicity No genotoxic potential 1 Boscalid was negative in the Ames test, gene mutation test with mammalian cells, chromosome abberation test with CHO cells, and a UDS test with primary rat hepatocytes in vitro, and also in the micronucleus test in mice in vivo. Long term toxicity and carcinogenicity Target / critical effect Lowest relevant NOAEL / NOEL Carcinogenicity Liver, thyroid Rat 2yr: 100 ppm (4.4 mg/kg bw/d) Slight increase of thyroid follicular cell adenomas; not relevant to man. No classification and labelling necessary. Page 15

28 Reproductive toxicity Reproduction target / critical effect Slightly reduced viability and decreased pup wt during lactation in the presence of parental adverse effects Lowest relevant reproductive NOAEL / NOEL ppm ( 1165 mg/kg bw/d) 2 Developmental target / critical effect Delayed ossification in rabbits and rats in the presence of maternal toxicity at the limit dose Lowest relevant developmental NOAEL / NOEL Rat & rabbit: 300 mg/kg bw/d 3 2 NOAEL for parental and offspring toxicity: 11 mg/kg bw/d. Effects on reproduction were not observed (NOAEL 1165 mg/kg bw/d). 3 NOAEL for developmental and maternal toxicity. Delayed neurotoxicity No studies submitted, not required. Other toxicological studies Mechanism studies: Boscalid is an inducer of cytochrome P450; T3 and T4 levels are decreased and TSH is increased. The increased metabolism of T4 via hepatic enzyme conjugation appeared to be responsible for the increased TSH. Studies performed on metabolites or impurities: Parachlorobenzoic acid (degradation product in aquatic environment): literature survey data indicates that parachlorobenzoic acid exhibits higher acute oral toxicity than nicobifenboscalid. No concern from limited invitro genotoxicity data. Acute oral toxicity studies and bacterial reverse mutation assays for impurities , , and resulted in LD50 values > 2000 mg/kg bw and no evidence for a genotoxic potential. Immunotoxicity: No toxic potential on cellular and humoral immune functions. Medical data No data (new compound) Summary Value Study Safety factor ADI 0.04 mg/kg bw Rat 2yr oral 100 feed AOEL systemic 0.1 mg/kg bw/d Dog 1yr oral feed; corrected for 44 % oral absorption 100* Page 16

29 ARfD (acute reference dose) Not allocated Not necessary, based on low acute toxicity and lack of developmental toxicity concerns * corrected for 44% oral absorption Dermal absorption Formulation (BAS F): Rat in vivo: 7 %; rat/human invitro dermal penetration ratio: 1 7 % human dermal absorption proposed for use in exposure calculations 4 4 The dermal absorption studies are performed with the formulation with code BAS F. This product is a water dispersable granulate with 50% boscalid. In the in vivo study the animals were exposed to a high dose level of 1 mg/cm 2 and a low dose of 0.01 mg/cm 2. The potential absorbed dose for the high dose was 23% (exposure period 10 hours) and for the low, most relevant dose 7%. The invitro absorption through rat epidermal membranes was the same as through human epidermal membranes at low and intermediate dose levels (0.01 and 0.1 mg/cm²) and approx. 4fold greater at the high concentration level (1.00 mg/cm²). The results obtained for the low and intermediate concentrations were considered to be the most relevant, because these concentration levels fall in the range of the expected operator exposure. Pyraclostrobin Pyraclostrobin is a new active substance, included in Annex I of 91/414/EEC. The final List of Endpoints presented below is taken from the final review report on pyraclostrobin (SANCO/1420/2001 final, d.d. 8 September 2004). Where relevant, some additional remarks/information are given in italics. Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1) Rate and extent of absorption Rapid absorption: Tmax ~1 hour; 50% (based on urinary and biliary excretion within 48 hours) Distribution Widely, highest concentrations in the liver Potential for accumulation None Rate and extent of excretion Complete within 5 d; mainly via faeces (8090 %, biliary excretion amounting to 35 %), via urine 1115 % Toxicologically significant compounds Parent compound and metabolites (animals, plants and environment) Metabolism in animals Extensive (> 95 %) with nearly 50 metabolites occurring Main metabolic pathways included N demethoxylation, hydroxylation, cleavage of ester bond and further oxidation of the resulting molecule parts, conjugation with glucoronic acid or sulphate Acute toxicity (Annex IIA, point 5.2) Rat LD 50 oral > 5000 mg/kg bw (Mouse: mortality at 300 mg/kg bw) Rat LD 50 dermal > 2000 mg/kg bw Rat LC 50 inhalation 0.69 mg/l 1 Skin irritation Irritating Eye irritation Not irritating Skin sensitization (test method used and result) Not sensitising (M&K maximisation test) mg/l is based on a pyraclostrobin solution in acetone. A 40% solution in Solvesso results in 4.07 < LC50 < 7.3 mg/l and a classification with Xn, R20 Page 17

30 Short term toxicity (Annex IIA, point 5.3) Target / critical effect Reduced body weight, gastrointestinal tract, red blood cells; diarrhoea (dog); hepatocellular hypertrophy (rat); white blood cells and lymphatic organs (mouse) Lowest relevant oral NOAEL / NOEL 90day mouse: 30 ppm (4 mg/kg bw/d) 2 Lowest relevant dermal NOAEL / NOEL 28 day rat: > 250 mg/kg bw/d (systemic) Lowest relevant inhalation NOAEL / NOEL No data not required (because of physical and chemical properties) 2 based on effects on body weight after 90 days in the carcinogenicity study in male mice Genotoxicity (Annex IIA, point 5.4) No genotoxic potential 3 3 Pyraclostrobin was negative in the following in vitro tests: Ames test, CHO/HPRTtest, chromosome abberation test with CHO V79 cells, and a UDStest with rat hepatocytes. Pyraclostrobin was negative in an in vivo micronucleus test in mice. Long term toxicity and carcinogenicity (Annex IIA, point 5.5) Target / critical effect Reduced body weight; (rat & mouse); liver cell necrosis (rat) Lowest relevant NOAEL / NOEL Chronic rat (75 ppm) 3 mg/kg bw/d Carcinogenicity No carcinogenic potential Reproductive toxicity (Annex IIA, point 5.6) Reproduction target / critical effect Reduced pup body weight gain in the presence of parental toxicity Lowest relevant reproductive NOAEL / NOEL 75 ppm (8.2 mg/kg bw/d) 4 Developmental target / critical effect Developmental effects in rats and embryotoxicity (including malformations) in rabbits at maternally toxic doses Lowest relevant developmental NOAEL / NOEL 5 mg/kg bw/d (rabbit) 5 Lowest relevant maternal NOAEL / NOEL 3 mg/kg bw/d (rabbit) 5 4 The NOAEL for parental toxicity was 8.2 mg/kg bw/d (based on decreased food intake and decreased body weight gain at 25 mg/kg bw/d). 5 The effects are not statistically significant when compared to controles. Statistical significance was noted when compared to historical control values. Malformations were noted at doses were severe maternal toxicity was noted. Therefore, no classification with R63. The NOAEL for maternal toxicity in the rabbit was 3 mg/kg bw/day (based on decreased food intake and decreased body weight gain at 5 mg/kg bw/day). Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 5.7) No neurotoxic potential (rat, acute and 13wk studies) Other toxicological studies (Annex IIA, point 5.8) Three water metabolites (BF50011, 50013, ) proved negative in the Ames test Medical data (Annex IIA, point 5.9) Limited data (new compound); no human health problems identified Page 18

31 Summary (Annex IIA, point 5.10) Value Study Safety factor ADI 0.03 mg/kg Chronic rat study 100 bw AOEL systemic mg/kg bw Rabbit, developmental toxicity study (maternal toxicity; 50% oral absorption) 100 ARfD (acute reference dose) 0.03 mg/kg bw Rabbit, developmental toxicity study (maternal toxicity) Dermal absorption (Annex IIIA, point 7.3) EC formulation (BAS 500 F): 2.6% (rat, in vivo); in vitro data suggest much lower permeability of human skin; 1% used for calculation based on in vitro/in vivo data 6 6 Dermal absorption was studied in an in vivo study with rats at doses of 0.015, en mg/cm 2. Doses of mg/cm 2 are equivalent to doses at mixing and loading. At mg/cm2 the highest dermal absorption was noted: 2.6%. From in vitro dermal absorption data, it was concluded that the dermal absorption through rat skin was 12 times higher than through human skin. The dermal absorption in humans is therefore maximally 2.6/12 = 0.22%. The notifier and RMS proposed to use the value of 1% for dermal absorption. Local effects Boscalid: Boscalid does not produce local effects, neither after a single nor repeated exposure Pyraclostrobin: Pyraclostrobin produces local effects after a single exposure (skin irritation), but these local effects are covered in the risk assessment/management by means of assignment of R and Sphrases, if necessary (the formulation Signum is not irritating to the skin after a single exposure). In a dermal 28day study with rats, the NOAEL for systemic toxicity was 250 mg/kg bw/d, the highest dose tested, but signs of dermal irritation were observed at all dose levels (40, 100, and 250 mg/kg bw/d). At 40 mg/kg bw/d epidermal thickening was observed in 5 females (10 females were tested). At higher doses, epidermal thickening, hyperkeratosis, scale formation and slight erythema were observed. For the overall risk assessment, the local effects are however less critical than the systemic effects. Data requirements active substance Boscalid and pyraclostrobin: No additional data requirements are identified. 4.1 Toxicity of the formulated product (IIIA 7.1) The formulation Signum needs to be classified as R22 Harmful if swallowed, based on the acute oral toxicity (200 < LD 50 rat < 500 mg/kg bw). The formulation Signum does not need to be classified on the basis of its acute dermal (LD 50 rat >2000 mg/kg bw), and inhalation toxicology (LC 50 rat > 5.6 mg/l). The formulation Signum is considered not irritating to skin and eyes. The formulation Signum does not have sensitising properties in a modified Buehler test Data requirements formulated product Boscalid and pyraclostrobin: No additional data requirements are identified. 4.2 Dermal absorption (IIIA 7.3) Boscalid For the current assessment a WG formulation with a lower concentration boscalid in the 100 Page 19

32 concentrate, but comparable concentration of spray dilution is considered, compared to the formulation studied in the DAR. As the undiluted formulation is a WG, it can be assumed that the difference in percentage active substance (26.7% compared to 50% in the formulation studied in the DAR) is of limited influence on the dermal absorption. Therefore, for the current assessment a dermal absorption of 7% for both the undiluted and the spray formulation is considered (see List of Endpoints). Pyraclostrobin It can be assumed that the dermal absorption of pyraclostrobin in an EC formulation (evaluated in the DAR) is worst case to the dermal absorption of pyraclostrobin in an WG formulation Signum. Therefore, for the current assessment 1% is used for the concentrate and spray dilution (see List of Endpoints). 4.3 Available toxicological data relating to nonactive substances (IIIA 7.4) The available toxicological data relating to nonactive substances will be taken into account in the classification and labelling of the formulated product. 4.4 Exposure/risk assessments Operator exposure/risk According to the Dutch Plant Protection Products and Biocides Regulations the risk assessment is performed according to a tiered approach. There are four possible tiers: Tier 1: Risk assessment using the EUAOEL without the use of PPE Tier 2: Risk assessment using the NLAOEL without the use of PPE Tier 3: Refinement of the risk assessment using new dermal absorption data Tier 4: Prescription of PPE Boscalid Tier 1 Calculation of the EUAOEL / Tolerable Limit Value (TLV) For boscalid no TLV has been set. The AOEL will be used for the risk assessment. Since boscalid is included in Annex I of 91/414/EEC, the semichronic EUAOEL of 0.1 mg/kg bw/day (= 7 mg/day for a 70kg operator/worker), based on the 1year dog study, is applied (see List of Endpoints). Since the AOEL is based on a 1year dog study, the AOEL also covers operator exposure that might exceed three months. Exposure/risk Exposure to boscalid during mixing and loading and application of Signum is estimated with models. The exposure is estimated for the unprotected operator. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined. In the Table below the estimated internal exposure is compared with the systemic EUAOEL. For each application method, the exposure is only estimated with the highest dose. Page 20

33 0.01 Table T.1 Internal operator exposure to boscalid and risk assessment for the use of Signum Route Estimated internal exposure a (mg /day) Systemic EUAOEL (mg/day) Riskindex b Mechanical downward spraying on dry harvested beans, cichorei, floriculture and perennial plants (uncovered, 1.5 kg/ha) Mixing/ Respiratory Loading c Dermal Application d Respiratory <0.01 Dermal Total Mechanical upward spraying on green beans, slicing beans, bush beans, runner beans and tree nursery (uncovered, 1.8 kg/ha) Mixing/ Loading c Respiratory Dermal Application d Respiratory Dermal Total Manual downward spraying on dry harvested beans, cichorei, floriculture and perennial plants (uncovered, 1.5 kg/ha) Mixing/ Respiratory <0.01 Loading c Dermal <0.01 Application f Respiratory Dermal Total Manual upward spraying on green beans, slicing beans, bush beans, runner beans and tree nursery (uncovered, 1.8 kg/ha) Mixing/ Respiratory <0.01 Loading c Dermal <0.01 Application e Respiratory Dermal Total Manual up and downward spraying on hot peppers, floriculture, tree nursery and perennial plants (covered, 1.5 kg/ha) Mixing/ Respiratory Loading and application g Dermal Total a Internal exposure was calculated with: biological availability via the dermal route: 7% (concentrate) and 7% (spray dilution) (see 4.2) biological availability via the respiratory route: 100% (worst case) b The riskindex is calculated by dividing the internal exposure by the systemic AOEL. c External exposure is estimated with NLmodel. d External exposure is estimated with EUROPOEM. Page 21

34 e f g External exposure is estimated with German model (90 th percentile) External exposure is estimated with UK model External exposure is estimated with Dutch Greenhouse model Since the EUAOEL is exceeded without the use of PPE, a tier 2 assessment has to be performed using the NLAOEL. Tier 2 Calculation of the NLAOEL The risk index calculated with the EUAOEL is >1. Therefore, the Plant Protection Products and Biocides Regulations (NL: Rgb) prescribes the calculation of the risk with an AOEL based on allometric extrapolation (known as the NLAOEL). This method takes into account the caloric demand of the species studied and results in a more specific value than the EU AOEL for which a standard factor of 100 is applied. The calculation of the systemic AOEL for semichronic exposure is based on the NOAEL of 34 mg/kg bw/d in the 90day toxicity study with rats. Calculations from other studies result in higher AOELs. The NOAEL of 11 mg/kg bw/day from the two generation reproduction toxicity study is not used as the effects at the LOAEL of 113 mg/kg bw/day (histopathological changes in the liver and pupsweight decrease) were marginal. Therefore, the NOAEL of the 90day rat study is considered more representative for the semichronic NOAEL of the rat. Safety factors are used to compensate for the uncertainties, which arise, for example, from extrapolation from the tested species to humans and the differences between experimental circumstances, and to ensure that at the acceptable exposure level no adverse health effects will occur. Used factors are: extrapolation rat human on basis of caloric demand 4 other interspecies differences: 3 intraspecies differences: (professional use) 3 biological availability via oral route: 44%* weight of professional operator/worker: 70 kg * If the absorbed dose is significantly lower (<80%) than the administered dose, this is adjusted by a correction factor equal to the percentage absorption. AOEL systemic : 34 x 0.44 x 70 / (4 x 3 x 3) = 29 mg/day Exposure/risk Table T.2 Internal operator exposure to boscalid and risk assessment for the use of Signum Route Estimated internal exposure a (mg /day) Systemic NLAOEL (mg/day) Riskindex b Mechanical upward spraying on green beans, slicing beans, bush beans, runner beans and tree nursery (uncovered, 1.8 kg/ha) Mixing/ Respiratory <0.01 Loading c Dermal Application d Respiratory <0.01 Dermal Page 22

35 Route Estimated internal exposure a (mg /day) Systemic NLAOEL (mg/day) Riskindex b Total Manual downward spraying on dry harvested beans, cichorei, floriculture and perennial plants (uncovered, 1.5 kg/ha) Mixing/ Respiratory <0.01 Loading c Dermal <0.01 Application f Respiratory Dermal Total Manual upward spraying on green beans, slicing beans, bush beans, runner beans and tree nursery (uncovered, 1.8 kg/ha) Mixing/ Respiratory <0.01 Loading c Dermal <0.01 Application e Respiratory Dermal Total a Internal exposure was calculated with: biological availability via the dermal route: 7% (concentrate) and 7% (spray dilution) (see 4.2) biological availability via the respiratory route: 100% (worst case) b The riskindex is calculated by dividing the internal exposure by the systemic AOEL. c External exposure is estimated with NLmodel. d External exposure is estimated with EUROPOEM. e f External exposure is estimated with German model (90 th percentile) External exposure is estimated with UK model Since the NLAOEL is not exceeded without the use of PPE, a higher tier assessment is not required. Pyraclostrobin Tier 1 Calculation of the EUAOEL / Tolerable Limit Value (TLV) For pyraclostrobin no TLV has been set. The AOEL will be used for the risk assessment. Since pyraclostrobin is included in Annex I of 91/414/EEC, the semichronic EUAOEL of mg/kg bw/d (=1.05 mg/day for a person of 70 kg), based on the developmental toxicity study in rabbit, is applied (see List of Endpoints). Furthermore, the semichronic EUAOEL can also be considered as a chronic AOEL since the chronic study has the same NOAEL (3 mg/kg bw/d). Exposure/risk Exposure to pyraclostrobin during mixing and loading and application of Signum is estimated with models. The exposure is estimated for the unprotected operator. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined. In the Table below the estimated internal exposure is compared with the systemic EUAOEL. Page 23

36 For each application method, the exposure is only estimated with the highest dose Table T.4 Internal operator exposure to pyraclostrobin and risk assessment for the use of Signum Route Estimated internal exposure a (mg /day) Systemic EUAOEL (mg/day) Riskindex b Mechanical downward spraying on dry harvested beans, cichorei, floriculture and perennial plants (uncovered, 1.5 kg/ha) Mixing/ Respiratory Loading c Dermal Application d Respiratory Dermal Total Mechanical upward spraying on green beans, slicing beans, bush beans, runner beans and tree nursery (uncovered, 1.8 kg/ha) Mixing/ Loading c Respiratory Dermal Application d Respiratory Dermal Total Manual downward spraying on dry harvested beans, cichorei, floriculture and perennial plants (uncovered, 1.5 kg/ha) Mixing/ Respiratory <0.01 Loading c Dermal <0.01 Application f Respiratory Dermal Total Manual upward spraying on green beans, slicing beans, bush beans, runner beans and tree nursery (uncovered, 1.8 kg/ha) Mixing/ Respiratory <0.01 Loading c Dermal <0.01 Application e Respiratory Dermal Total Manual up and downward spraying on hot peppers, floriculture, tree nursery and perennial plants (covered, 1.5 kg/ha) Mixing/ Respiratory Loading and application g Dermal Total a Internal exposure was calculated with: biological availability via the dermal route: 1% (concentrate) and 1% (spray dilution) (see 4.2) biological availability via the respiratory route: 100% (worst case) b The riskindex is calculated by dividing the internal exposure by the systemic AOEL. Page 24

37 c External exposure is estimated with NLmodel. d External exposure is estimated with EUROPOEM. e f g External exposure is estimated with German model (90 th percentile) External exposure is estimated with UK model External exposure is estimated with Dutch Greenhouse model Since the EUAOEL is not exceeded without the use of PPE, a higher tier assessment is not required Bystander exposure/risk Boscalid and pyraclostrobin The bystander exposure is only a fraction of the operator exposure. Based on the low riskindex for the operator, no exposure calculations are performed for bystanders Worker exposure/risk Shortly after application it is possible to perform reentry activities during which intensive contact with the treated crop will occur. Therefore, worker exposure is calculated. The exposure is estimated for the unprotected worker. In the Tables below the estimated internal exposure is compared with the systemic EUAOEL. These calculations also include exposure due to crop inspections tasks. For reentry activities in the field the transfer coefficient of large fruit is used and for reentry activities in greenhouses, the transfer coefficient of ornamentals is used. Boscalid Tier 1 Table T.6 Internal worker exposure to boscalid and risk assessment after application of Signum Route Estimated internal exposure a (mg /day) Systemic EUAOEL (mg/day) Riskindex b Reentry activities in various crops (uncovered) Respiratory c 7.0 c Dermal Total Reentry activities in various crops (covered) a b c Respiratory Dermal Total External exposure was estimated with EUROPOEM II. Internal exposure was calculated with: biological availability via the dermal route: 7% (see 4.2) biological availability via the respiratory route: 100% (worst case) The riskindex is calculated by dividing the internal exposure by the systemic AOEL. No model is available to calculate the respiratory internal exposure. However, the respiratory internal exposure can be considered negligible in view of the fact that boscalid is not volatile and no spraying of the product occurs during reentry activities. Since the EUAOEL is not exceeded without the use of PPE, a higher tier assessment is not required. Page 25

38 Pyraclostrobin Tier 1 Table T.7 Internal worker exposure to pyraclostrobin and risk assessment after application of Signum Route Estimated internal exposure a (mg /day) Reentry activities in various crops (uncovered) Systemic EUAOEL (mg/day) Riskindex b Respiratory c 1.05 c Dermal Total Reentry activities in various crops (covered) a b c Respiratory Dermal Total External exposure was estimated with EUROPOEM II. Internal exposure was calculated with: biological availability via the dermal route: 1% (see 4.2) biological availability via the respiratory route: 100% (worst case) The riskindex is calculated by dividing the internal exposure by the systemic AOEL. No model is available to calculate the respiratory internal exposure. However, the respiratory internal exposure can be considered negligible in view of the fact that pyraclostrobin is not volatile and no spraying of the product occurs during reentry activities. Since the EUAOEL is not exceeded without the use of PPE, a higher tier assessment is not required Reentry See Worker exposure/risk. Overall conclusion of the exposure/risk assessments of operator, bystander, and worker The product complies with the Uniform Principles. Operator exposure Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure to boscalid and pyraclostrobine as a result of the application of Signum in various beans, pepper, chicory and ornamentals. Bystander exposure Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to pyraclostrobin and boscalid during application of Signum according to the intended uses. Worker exposure Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure during reentry Page 26

39 activities according to the intended uses, due to exposure to pyraclostrobin and boscalid after application of Signum. These conclusions are also valid for the simultaneous exposure to boscalid and pyraclostrobin. 4.5 Appropriate mammalian toxicology and operator exposure endpoints relating to the product and approved uses See List of Endpoints. 4.6 Data requirements Based on this evaluation, no additional data requirements are identified. 4.7 Combination toxicology The formulation Signum is a mixture of two active substances. The combined toxicological effect of these two active substances has not been investigated with regard to repeated dose toxicity. Possibly, the combined exposure to these active substances may lead to a different toxicological profile than the profile that is based on the individual substances. For boscalid the liver is the critical target organ (enzyme induction). Pyraclostrobin has other critical effects and the most important critical effect is reduced body weight. The mechanism of the liver effects of pyraclostrobin is not clear, but it does not seem to be enzyme induction (at lower dose levels, liver weight was decreased instead of increased, while hepatocellular hypertrophy was observed). Based on the toxicological profiles, an additive effect is therefore not expected. In conclusion, an additive effect is not expected. 5. Residues Boscalid The List of Endpoints presented below is the last revision before publishing the review report ( ) 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) grapes (fruit), lettuce (leaf vegetables), beans (pulses) radish, lettuce, wheat yes no hydrolytic decomposition during simulation of pasteurisation (ph 4, 90 C), baking, boiling, brewing (ph 5, 100 C) or during sterilisation (ph 6, 120 C) yes Boscalid Boscalid not applicable Page 27

40 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 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) goat, hen 6 days for eggs 14 days for milk (cow feeding study) Boscalid and the hydroxylated metabolite M510F01 (including its conjugates), expressed as boscalid Boscalid and M510F01 (including its conjugates) expressed as boscalid Bound residues in liver and minor metabolites in milk (as M510F53) not applicable Yes yes (log P ow = 2.96), in livestock feeding study residues in fat and cream at 1x dose Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5) after application of 2.1 kg as/ha to bare soil and PBIs of 30, 120, 270, 365 days the major residue in following crops was parent boscalid, except for wheat grain. Residues of parent: mg/kg (lettuce); mg/kg (radish leaf), mg/kg (radish root) mg/kg (wheat grain), mg/kg (wheat forage), mg/kg (wheat straw) From the results it cannot be excluded that residues above the LOQ (0.05 mg/kg) may occur in succeeding crops. This is confirmed by the results of a field test with residues of boscalid in wheat plants at 0.10 mg/kg and in wheat straw at 0.75 mg/kg. The potentiality of residues in succeeding crops is accounted for in the dietary risk assessment and in the setting of MRLs by setting 0.5 mg/kg for commodities not covered by residue or rotational crop trials. Page 28

41 Stability of residues (Annex IIA, point 6 Introduction, Annex IIIA, point 8 Introduction) Food of animal origin: (milk, muscle, liver) boscalid and metabolite M510F01 stable for 5 months under frozen conditions Food of plant origin (Wheat plant, wheat grain, wheat straw, oilseed rape seed, sugar beet, white cabbage, peach, pea) boscalid stable for at least 24 months under frozen conditions 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 22 mg/kg diet (beef cattle) yes 1.6 mg/kg diet yes 2.9 mg/kg diet 10 mg/kg diet (dairy cws) Potential for accumulation (yes/no): no no no Metabolism studies indicate potential level of residues 0.01 mg/kg in edible tissues (yes/no) yes yes Feeding studies (Specify the feeding rate in cattle and poultry studies considered as relevant) 20 mg/kg DM for beef, 1 mg/kg DM for hen Residue levels in matrices : Mean (max) mg/kg Muscle < 0.05 (high dose) < 0.05 (low dose) < 0.05 (extrapol. from ruminants) Liver 0.18 (high dose) < 0.1 (low dose) < 0.1 Kidney 0.24 (high dose) not applicable < 0.1 Fat 0.27 (high dose) < 0.1 (low dose) < 0.1 Milk 0.05 (high dose) Eggs < 0.02 Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4) Crop/ process/ processed product Number of studies Processing factors Transfer factor Yield factor Amount transferred (%) (Optional) Grapes must, cold 1 (4 trials) must, after short time heating 1 (4 trials) 0.45 Page 29

42 0.48 must, after mash heating 1 (4 trials) wine, from must, cold 1 (4 trials) wine from must, after short time heating 1 (4 trials) Wine from must, after mash heating 1 (4 trials) wet pomace 1 (4 trials) Peas Peas/Washed peas 1 (4 trials) only 0.50 Peas/Wash water one trial with RAC residues > LOQ 0.43 Cooked peas, residues in RAC < 0.36 canned peas, < LOQ (residues boiled water, vegetable stock (0.05 mg/kg) in processe d product < 0.05 mg/kg) Pyraclostrobin Pyraclostrobin is included in Annex I of directive 91/414/EEC by Directive 04/30/EC d.d. March 10th, 2004 and approved under Reg. (EC) No 1107/2009 (repealing Directive 91/414/EEC) according to Reg. (EU) 540/2011. The List of Endpoints is dated November Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6) Plant groups covered wheat (cereals), grapes (fruit), potatoes (root and tuber vegetable) Rotational crops radish, lettuce, wheat Plant residue definition for monitoring Pyraclostrobin Plant residue definition for risk Pyraclostrobin assessment Conversion factor (monitoring to risk None assessment) Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6) Animals covered lactating goat, laying hen Animal residue definition for monitoring Pyraclostrobin Animal residue definition for risk liver (except poultry liver) and milk fat only: assessment Pyraclostrobin and its metabolites containing the 1(4chlorophenyl)1Hpyrazole or the 1 (4chloro2hydroxyphenyl)1Hpyrazole moiety, sum expressed as pyraclostrobin Conversion factor (monitoring to risk assessment) cream: 6 liver: not applicable, no pyraclostrobin in liver to be expected Page 30

43 Metabolism in rat and ruminant similar Yes (yes/no) Fat soluble residue: (yes/no) yes (Log Po/w 3.99) Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5) 30, 120, 365 days plant back interval after application of 0.9 kg a.s./ha: TRR in the edible parts for human consumption are very low (radish roots, lettuce: < mg/kg; wheat grain: < mg/kg). No accumulation of Pyraclostrobin or its degradation products [radish, lettuce < mg/kg; wheat straw < mg/kg; wheat grain: not detectable] Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction) Food of animal origin: Pyraclostrobin stable for 8 month Metabolite BF (model compound) with slow degradation but stable enough to evaluate the submitted feeding study (analysed within 6 month). Plant (peanut nutmeat, peanut oil, wheat grain, wheat straw, sugarbeet tops, sugarbeet roots, tomatoes, grape juice): Pyraclostrobin, metabolite BF 5003 stable for 18 month Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3) Intakes by livestock 0.1 mg/kg diet/day: Ruminant: yes/no 7.0 mg/kg dry feed Poultry: yes/no 0.3 mg/kg dry feed Pig: yes/no 0.3 mg/kg dry feed Muscle < 0.05 < 0.05 < 0.05 Liver < 0.05 < 0.05 < 0.05 Kidney < 0.05 < 0.05 < 0.05 Fat < 0.05 < 0.05 < 0.05 Milk < 0.01 not applicable not applicable Eggs not applicable < 0.05 not applicable Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4) Crop/processed crop Number of studies Transfer factor grapes / must, juice, wine 4 trials 0.03 grapes / wet pomace 4 trials 3.9 grapes / rasins 1 (2 trials) 2.7 barley/pot barley 1 trial 0.7 barley/pearling dust 1 trial 11 barley/malt 4 trials 1.2 barley/malt germs 1 trial 2.3 % Transference * Page 31

44 barley/spent grain 1 trial 10 barley/trubs (flocs) 1 trial 0.7 barley/beer yeast 1 trial 0.7 barley/beer 4 trials 0.7 wheat/flour, middlings, shorts wheat/ germ * Calculated on the basis of distribution in the different portions, parts or products as determined through balance studies. Comments on/additions to List of Endpoints No additional comments 5.1 Summary of residue data Metabolism in plants Boscalid Metabolism was studied in grapes, lettuce and beans. Metabolism was also investigated in rotational crops lettuce, radish and wheat. In all cases, the main metabolite was boscalid. Metabolism was found to be essentially the same in the different crop categories, and covers the intended uses. Pyraclostrobin Metabolism was studied in wheat, grapes and potatoes. Main metabolite was pyraclostrobin. Metabolism was found to be essentially the same in the different crop categories, and covers the intended uses Metabolism in livestock Boscalid Metabolism was investigated in lactating goat and laying hen. Main metabolites were boscalid (all matrices) and M510F01 (milk, liver). Metabolism was found to be essentially the same in goat, hen and rat. Therefore, no study in pig is required. Pyraclostrobin Metabolism was investigated in lactating goat and laying hen. Main metabolite was pyraclostrobin. Metabolism was found to be essentially the same in goat, hen and rat. Therefore, no study in pig is required Residue definition (plant and animal) Boscalid The residue definition in plants is boscalid parent, for monitoring and risk assessment. Since metabolism in grapes, lettuce and beans (primary crops) and lettuce, radish and wheat (rotational crops) is similar, the residue definition applies to all crops. The residue definition in animal products is boscalid and the hydroxylated metabolite M510F01 (including its conjugates), expressed as boscalid for monitoring. The residue definition for risk assessment is Boscalid and M510F01 (including its conjugates) expressed as boscalid, including bound residues in liver and minor metabolites in milk (as M510F53). Pyraclostrobin The residue definition in plants is pyraclostrobin parent, for monitoring and risk assessment. Since metabolism in wheat, grapes and potatoes is similar, the residue definition applies to all crops. Page 32

45 It was found that low residues will only occur in milk fat and liver of ruminants. Next to pyraclostrobin, also its metabolites containing the 1(4chlorophenyl)1Hpyrazole or the 1 (4chloro2hydroxyphenyl)1Hpyrazole moiety are relevant residues. For the sake of simplicity the residue definition for all animal products is pyraclostrobin parent for monitoring, although no pyraclostrobin was found in liver. For risk assessment, a conversion factor of 6 for milk and fat is proposed. Since no pyraclostrobin is found in liver, no conversion factor could be set. However, since no residues above LOQ (0.05 mg/kg) are expected, this is considered acceptable Stability of residues Boscalid Food of animal origin: (milk, muscle, liver) boscalid and Metabolite M510F01 stable for 5 months. Food of plant origin (wheat plant, wheat grain, wheat straw, oilrape seed, sugar beet, white cabbage, peach, pea): boscalid stable for 24 months. Pyraclostrobin Food of animal origin: Pyraclostrobin stable for 8 months. Metabolite BF (model compound) with slow degradation but stable enough to evaluate the submitted feeding study (analysed within 6 months). Plant (peanut nutmeat, peanut oil, wheat grain, wheat straw, sugarbeet tops, sugarbeet roots, tomatoes, grape juice): Pyraclostrobin, metabolite BF 5003 stable for 18 months Supervised residue trials Boscalid and pyraclostrobin Sweet pepper (protected) (cgapnl: 3x 0.4kg boscalid and 0.10kg pyraclostrobin/ha, interval: 714 days, PHI: 3 days) Eight supervised residue trials in protected sweet pepper have been submitted, which are summarised in RIKILT report CTB 2003_564 (May 2003). The trials are performed according to GAP. Samples are taken at PHI 0, 3, 7 and 14 days. The residue levels selected (PHI 3 days) are presented in table R1. The residue levels show sufficiently that the EUMRLs of 3 mg/kg for boscalid and 0.5 mg/kg for pyraclostrobin are not exceeded. Residue data with sweet pepper can be extrapolated to chilli pepper (hot pepper). Table R1: Selected residue levels from supervised residue trials Crop Boscalid Pyraclostrobin Sweet Pepper chilli pepper/ hot pepper Residue levels (mg/kg) 0.29, 0.36, 0.39, 0.51, 0.59, 0.76, 0.86, 1.33 STMR (mg/kg) HR (mg/k g) Residue levels (mg/kg) , 0.08, 0.08, 0.13, 0.13, 0.17, 0.177, 0.30 STMR (mg/kg) HR (mg/kg) Residues in succeeding crops Boscalid Boscalid shows a degree of persistency. The substance also appears in numerous secondary (rotational) crops. In the EFSA reasoned opinion on Modification of existing MRLs for boscalid in various crops (EFSA Journal 2010;8(9):1780) there is an information about boscalid residues in succeeding crops: Boscalid is known to be persistent in the soil and therefore the MRLs for primary crops have to account also for additional residues which may occur in a crop via root uptake when it is Page 33

46 planted as a rotational crop. A default MRL of 0.5 mg/kg was set by the peer review for all annual crops in order to cover possible boscalid residues in crop when it is grown in rotation in cases where no specific residue trials or rotational crop study data are available. The recent rotational crop field studies indicate variations in residue uptake between different crop groups. EFSA, based on these studies, performed an estimate whether or not a significant uptake of boscalid residues from the soil is expected which would contribute to the residue levels for the annual crops under consideration. Where a significant residue uptake could not be excluded, the MRL proposal presented by EFSA took into account the additional residue via soil uptake. Pyraclostrobin No detectable residues are expected in rotational crops Residues from livestock feeding studies Boscalid Dietary intake of beef cattle was calculated by EFSA during the review of existing MRLs (2010), using data from both import tolerances and all previous M Rl applications and the DAR. Dietary intake for beef cattle was maximally mg/kg dry feed. In a feeding study with lactating cows the residues (28day average) of boscalid + M510F01 + M510F02 in milk at dose levels of 20.2 mg/kg dry diet was mg/kg. The average residues of boscalid + M510F01 + M510F02 after 28 days in muscle, fat, liver and kidney at a dose level of 20.2 mg/kg dry diet was <0.05, 0.27, 0.18 and 0.24 mg/kg respectively (highest residue values were not reported except for muscle: a single value of mg/kg). Dietary intake for poultry was calculated by EFSA during the review of existing MRLs (2010), using data from both import tolerances and all previous M Rl applications and the DAR.. Dietary intake was calculated to be maximally 3.28 mg/kg dry feed. No feeding study was available, but from the available metabolism study with hen performed at 12 mg/kg dry feed (4.3 N) TRR was found to be mg/kg in egg, mg/kg in meat, mg/kg in fat and mg/kg in liver. At the expected feeding rate of 2.8 mg/kg dry feed residues (TRR) for all products are expected to be < 0.05 mg/kg. These values are covered by the proposed tmrls of 0.7mg/kg for mammalian products (meat, far), 0.2 mg/kg mammalian liver, 0.3 mg/kg in mammalian kidney and edible offal and 0.1 mg/kg in milk. For poultry products: 0.05 mg/kg in meat and kidney, 0.1 mg/kg in fat, liver and edible offal and eggs for which an MRL of 0.05 *mg/kg is proposed. Pyraclostrobin The results from the livestock feeding studies were based on a dietary intake calculation as presented in the Draft Assessment Report which was adopted unchanged in the MRL harmonisation report presented to the Pesticide Residue Working Group in January 2005 (See List of Endpoints) Calculation of the ADI and the ARfD Boscalid The ADI was based on the NOAEL of 4 mg/kg bw/d from the 2year oral rat study giving rise to effects in the thyroid and liver at the near higher dose group. Using a safety factor of 100, the ADI was established at 0.04 mg/kg bw/d (see List of Endpoints human toxicology). An ARfD was not allocated, since boscalid shows no acute toxic properties at the expected dose level. Pyraclostrobin Page 34

47 The ADI was based on the NOAEL of 3 mg/kg bw/d from developmental studies giving rise to developmental effects in rats and embryotoxicity (including malformations) in rabbits at maternally toxic doses. Using a safety factor of 100, the ADI was established at 0.03 mg/kg bw/d (see List of Endpoints human toxicology). The ARfD was based on the NOAEL of 3 mg/kg bw/d from developmental studies giving rise to developmental effects in rats and embryotoxicity (including malformations) in rabbits at maternally toxic doses. Using a safety factor of 100, the ARfD was established at 0.03 mg/kg bw/d (see List of Endpoints human toxicology). 5.2 Maximum Residue Levels MRLs for both boscalid and pyraclostrobin are established in Regulation (EC) 396/2005. Boscalid Current MRL for boscalid in peppers is 3 mg/kg. Pyraclostrobin Current MRLs for pyraclostrobin in peppers is 0.5 mg/kg 5.3 Consumer risk assessment Boscalid Risk assessment for chronic exposure through diet A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA PRIMo rev. 2.0, containing all available Member State diets, and the temporary EUMRLs and the STMR values available in the EFSA reasoned opinion on Modification of existing MRLs for boscalid in various crops (EFSA Journal 2010;8(9):1780). The maximum TMDI is 77.8 % of the ADI for the IE adult diet. The TMDI is 33.4% and 69.4% of the ADI for the Dutch general population and Dutch children ages 16, respectively. Risk assessment for acute exposure through diet A calculation of the Estimated Short Term Intake (ESTI) was not carried out since an ARfD was not established (not necessary). Pyraclostrobin Risk assessment for chronic exposure through diet A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA PRIMo rev. 2.0, containing all available Member State diets, and the EUMRLs available in Annex II of Regulation (EC) 396/2005.The maximum TMDI is 65.8% of the ADI for the German child population. The TMDI is 28.3% and 55.1% of the ADI for the Dutch general population and Dutch children ages 16, respectively. Risk assessment for acute exposure through diet A calculation of the Estimated Short Term Intake (ESTI) was carried out using EFSA PRIMo rev. 2.0 and the harmonised EUMRLs of the intended use and accompanying HRs for peppers. Percentage of the ESTI is 63 % of the ARfD for pepper for the German child. Conclusion The product complies with the Uniform Principles. No risk is foreseen for consumers when authorising Signum with regard to boscalid and pyraclostrobin following the requested intended uses. Data requirement No data requirements were identified. Page 35

48 6. Environmental fate and behaviour Risk assessment is done in accordance with Chapter 2/10 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). List of Endpoints Fate/behaviour Boscalid is a new substance placed on Annex I per August 1, For boscalid, the List of Endpoints of November 2007 (new format for LoEP) is used. This LoEP is also used in the reregistration procedure for Signum. The most recent LoEP (draft LoEP from EFSA conclusion of 01/2008, old format) cannot be used, since this list lacks important relevant details for fate and behaviour (no or less information on higher tier studies, no individual endpoint values). The values presented in the scientific content of this list are the same as the values presented in the LoEP of 01/2008. Pyraclostrobin is a new substance, placed on Annex I (June,1, 2004; final LoEP on Circa is from October 2003). For the risk assessment the final List of Endpoints is used. This LoEP is also used in the reregistration procedure for Signum. List of Endpoints Fate/behaviour Boscalid (November 2007) Route of degradation (aerobic) in soil (Annex IIA, point ) Mineralisation after 100 days 8 % after 119 d, [diphenyl 14 C]label (n = 1) 15% after 119 d, [pyridine 14 C]label (n = 1) Nonextractable residues after 100 days 49 % after 119 d, [diphenyl 14 C]label (n = 1) 33 % after 119 d, [pyridine 14 C]label (n = 1) Metabolites requiring further consideration name and/or code, % of applied (range and maximum) No major metabolites Route of degradation in soil Supplemental studies (Annex IIA, point ) Anaerobic degradation Mineralisation after 100 days 74 % after 120 d, [diphenyl 14 CX]label (n = 1) 77 % after 120 d, [pyridine 14 CY]label (n = 1) Nonextractable residues after 100 days 16 % after 120 d, [diphenyl 14 CX]label (n = 1) 14 % after 120 d, [pyridine 14 CY]label (n = 1) Metabolites that may require further consideration for risk assessment name and/or code, % of applied (range and maximum) No major metabolites Soil photolysis Metabolites that may require further consideration for risk assessment name and/or code, % of applied (range and maximum) No major metabolites (after 15 d: 91 % parent, 6 % bound residues, 0.2 % CO 2, DT 50 : 135 d) Page 36

49 Rate of degradation in soil (Annex IIA, point , Annex IIIA, point 9.1.1) Laboratory studies Parent Aerobic conditions Soil type X 1 ph t. o C / % MWHC DT 50 /DT 90 (d) DT 50 (d) 20 C pf2/10kpa St. (r 2 ) Method of calculation Bruch West 20 C / 40 % 108 / st order Li 35 b 20 C / 40 % 322 / nr 1 st order Lufa C / 40 % 384 / nr 1 st order US soil 20 C / 40 % 376 / nr 1 st order Minto (Canada) 20 C / 40 % 133 / st order Geometric mean/median nr not reported geom. mean 232 / 399 median 322 / Field studies Parent Aerobic conditions Soil type (indicate if bare or cropped soil was used). Location (country or USA state). X 1 ph Depth (cm) DT 50 (d) actual DT 90 (d) actual St. (r 2 ) DT 50 (d) Norm. Method of calculation Stetten (3 replicates) DU2/15/97 Germany > Best fit arithm. mean Schifferstadt (3 replicates) DU3/06/97 Germany > Best fit arithm. mean Manzanilla ALO/05/98 Alcala del Rio ALO/06/98 Grossharrie D05/03/98 Spain > Best fit Spain > * Best fit Germany > * Best fit 1 This column is reserved for any other property that is considered to have a particular impact on the degradation rate. Page 37

50 Field studies Parent Aerobic conditions Soil type (indicate if bare or cropped soil was used). Location (country or USA state). X 1 ph Depth (cm) DT 50 (d) actual DT 90 (d) actual St. (r 2 ) DT 50 (d) Norm. Method of calculation Geometric mean /median arithm. mean 96.3 geom. mean, 78.3 median 78.0 > 365 arithm. mean 139 geom. mean 130 * because of the high standard deviations of the degradation rate, a reasonable calculation of the halflife is not possible Met 1 No major metabolites Soil type Location ph Depth (cm) DT 50 (d) actual DT 90 (d) actual St. (r2) DT 50 (d) Norm. Method of calculation Geometric mean/median ph dependence (yes / no) (if yes type of dependence) Accumulation study No a) Germany, loamy sand/sandy loam , application to vines Annual application rate: g as/ha (2100 g as/ha) Plateau reached after approx. 3 years according to ModelMaker evaluation ModelMaker assessment: minimum plateau: 2000 g as/ha (95 % of AR) maximum plateau: 3100 g as/ha (148 % of AR) measured concentrations: June 2002, June 2003 (representing minimum plateau): mean 2608 g as/ha (124 % of AR) October 2001, October 2002, August 2002 (representing maximum plateau): mean 2900 g as/ha (138 % of AR) b) Germany, sandy loam and ongoing, 3year crop rotation with vegetables and cereals 1998, 2001, 2004: g as/ha and g as/ha, vegetables (2100 g as/ha) 1999, 2002: g as/ha and g as/ha, vegetables (1700 g as/ha) 2000, 2003: Page 38

51 no application, spring wheat Overall average annual application rate: 1270 g as/ha ModelMaker assessment (based on data until 2004) minimum plateau: 1200 g as/ha (95 % of AR) maximum plateau: 2200 g as/ha (174 % of AR) measured concentrations (data until 2004): after the last application in 2002: 2545 g as/ha (150 % of applied rate in the preceeding year) before the first application in 2004: 1096 g as/ha Soil accumulation and plateau concentration a) PECsoil for upper 5 cm layer based on data from soil accumulation studies vines: modelled concns mg/kg (413 g as/ha) measured concns mg/kg (208 g as/ha) beans: meas. + mod. concns mg/kg (708 g as/ha) measured concns mg/kg (480 g as/ha) b) Minimum and maximum plateau concentration predicted with the simulation model FOCUSPEARL for the scenarios Hamburg and Châteaudun. vines with application of g as/ha per year and crop interception of 50 % vegetables with application of g as/ha per year and crop interception of 70 %. Both use maximum standardised field halflife (DT50 of 212 d) for calculation. vines: Hamburg min mg/kg (390 g as/ha), max mg/kg (680 g as/ha) Châteaudun min mg/kg (290 g as/ha), max mg/kg (590 g as/ha) beans: Hamburg min mg/kg (390 g as/ha), max mg/kg (680 g as/ha) Châteaudun min mg/kg (300 g as/ha), max mg/kg (590 g as/ha) Scenario Interceptio n (%) Crop type Min. Plateau [kg/ha] Max. Plateau [kg/ha] Jokioinen 80 Bean s Hamburg 80 Bean s Sevilla 80 Bean s Hamburg 85 Vine s Page 39

52 Piacenza 85 Vine s Laboratory studies Parent Anaerobic conditions Soil type X 2 ph t. o C / % MWHC DT 50 / DT 90 (d) DT 50 (d) 20 C pf2/10kpa St. (r 2 ) Method of calculation Bruch West 99/060/01 (silty sand) Bruch West 98/060/02 (sandy loam) diphe nyllabel pyridi nelabel C/ flooded 261 / n.r. 1 st order C/ flooded 345 / n.r. 1 st order Geometric mean/median n.r. not reported geom. mean 300 / median: / Met 1 No major metabolites Soil type X 1 ph t. o C / % MWHC DT 50 / DT 90 (d) f. f. k dp /k f DT 50 (d) 20 C pf2/10kpa St. (r 2 ) Method of calculation Geometric mean/median Soil adsorption/desorption (Annex IIA, point 7.1.2) Parent Soil Type OC % Soil ph K d (ml/g) K oc (ml/g) K f (ml/g) K foc (ml/g) 1/n LUFA Bruch West Li 35 b USA USA CAN This column is reserved for any other property that is considered to have a particular impact on the de26.4gradation rate. Page 40

53 Arithmetic mean/median arithm.mea n 9.8 median 6.5 arithm.mea n 771 median 715 arithm. mean ph dependence, Yes or No No Metabolite 1 No major metabolites Soil Type OC % Soil ph K d (ml/g) K oc (ml/g) K f (ml/g) K foc (ml/g) 1/n Arithmetic mean/median ph dependence (yes or no) Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2) Column leaching Aged residues leaching Lysimeter/ field leaching studies Not required 0 % radioactivity in leachate Not required, no leaching expected. See also PECgw Route and rate of degradation in water (Annex IIA, point 7.2.1) Hydrolytic degradation of the active substance and metabolites > 10 % ph 4: stable (no major metabolites) ph 7: stable (no major metabolites) ph 9: stable (no major metabolites) Photolytic degradation of active substance and metabolites above 10 % DT 50 : not reported (stable) (no major metabolites) Quantum yield of direct phototransformation in water at Σ > 290 nm Readily biodegradable (yes/no) < 2.45 * 104 No Degradation in water / sediment Parent water: 17.4 % after 100 d sediment: 79.9 % after 100 d Water / sediment system ph water phase ph sed. t. o C DT 50 DT 90 whole sys. (d) St. (r 2 ) DT 50 DT 90 Water (d) St. (r 2 ) DT 50 DT 90 sed. (d) St. (r 2 ) Method of calculation System A Kellmetschweiher Values by far exceeding 9 / 133 Values by far exceeding graphical determinat ion after Page 41

54 System B Berghäuser Altrhein the duration of the experimen t, for both systems and both labelling positions Reliable extrapolati on of DT 90 not possible 3 / 43 the duration of the experimen t, for both systems and both labelling positions Reliable extrapolati on of DT 90 not possible fitting of compartm ent model Geometric mean/median geom.mea n 5.2 / 75.6 Accumulation plateau after 8 yr: 217 % (calculation) Metabolite 1 No major metabolites Water / sediment system ph water phase ph sed. t. o C DT 50 DT 90 whole sys. St. (r 2 ) DT 50 DT 90 Water r 2 DT 50 DT 90 sed. St. (r 2 ) Method of calculation Geometric mean/median Mineralisation and non extractable residues Water / sediment system ph water phase ph sed. Mineralisation x % after n d (end of the study) Nonextractable residues in sed. max % after n d Nonextractable residues in sed. max % after n d (end of the study) System A % after 100 d 13 % after 100 d Kellmetschweiher System B % after 100 d 10 % after 100 d Berghäuser Altrhein Degradation in water / sediment (outdoor study*) Parent water: 19.8 % after 103 d sediment: 28.2 % after 103 d Water / sediment system ph water phase ph sed. t. o C DT 50 DT 90 whole sys. St. (r 2 ) DT 50 DT 90 Water St. (χ 2 ) DT 50 DT 90 sed. St. (χ 2 ) Method of calculation System A Kellmetschweiher 8.8 n.r. ~ / 370 (46 % of as after 120 days in water and sediment) / n.r. 16 / n.r / n.r First order Best fit (graphical determinati on) Accumulation plateau after 8 yr: 27.2 % (calculation) Page 42

55 * nonstandardised test, considered as additional information, not used for standard PECcalculation, used for highertiered PEC calculation with consideration of accumulation in soil n.r. not reported Recalculated kinetics for the total system, DT50 of 90 days used for risk assessment by Ctgb: Water / sediment system ph water phase ph sed. t. o C DT 50 DT 90 whole sys. χ 2 DT 50 DT 90 Water St. (χ 2 ) DT 50 DT 90 sed. St. (χ 2 ) Method of calculation System A Kellmetschweiher 8.8 n.r. ~20 90/ (M0 90.3, k 0.008) First order FOCUS kinetics spreadsheet, visual acceptable Metabolite 1: M510F64: water: max. 9.0 % at 14 d and 9.4 % at 30 d Water / sediment system ph water phase ph sed. t. o C DT 50 DT 90 whole sys. St. (r 2 ) DT 50 DT 90 water r 2 DT 50 DT 90 sed. St. (r 2 ) Method of calculation System A 8.8 n.r. ~20 8 / n.r. First order Geometric mean/median 8 / n.r. Mineralisation and non extractable residues Water / sediment system ph water phase ph sed. Mineralisation x % after n d (end of the study) Nonextractable residues in sed. max % after n d Nonextractable residues in sed. max % after n d (end of the study) System A Kellmetschweiher Kellmetschweiher 8.8 n.r after 120 d* 48.3 % after 103 d 20.5 % after 120 d * calculated as material balance difference Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3) Direct photolysis in air Quantum yield of direct phototransformation < Photochemical oxidative degradation in air Photolytically stable in water. Photolysis in air not expected. Not stable under influence of radicals, (see DT 50 photochemical oxidative degradation). DT 50: < 1.1 d AOPWIN Version 1.88, [OH radicals] = cm 3 Volatilisation from plant surfaces:about 1 % in 24 hours from soil: about 0.5 % in 24 hours Metabolites None Page 43

56 Residues requiring further assessment Environmental occurring metabolite requiring further assessment by other disciplines (toxicology and ecotoxicology). Soil: parent (default) Surface Water: parent (default) Sediment: parent (default) Ground water: parent (default) Air: parent (default) Monitoring data, if available (Annex IIA, point 7.4) Soil (indicate location and type of study) Surface water (indicate location and type of study) Ground water (indicate location and type of study) Air (indicate location and type of study) None None None None Points pertinent to the classification and proposed labelling with regard to fate and behaviour data R 53 List of Endpoints Fate/behaviour pyraclostrobin (October 2003) Route of degradation (aerobic) in soil (Annex IIA, point ) Mineralisation after 100 days 4 % after 87 d (tolyllabel, route study) 5 % after 91 d (chlorophenyllabel, route study) Nonextractable residues after % after 87 d (tolyllabel, route study) days 56.1 % after 91 d (chlorophenyllabel, route study) Major metabolites name and/or code, BF 5006, max. 31 % after 120 days (rate studies) % of applied (range and maximum) BF 5007, max. 13 % after 62 days (rate studies) Route of degradation in soil Supplemental studies (Annex IIA, point ) Anaerobic degradation no residues of the parent after 120 days, bound residues: 61 % (tolyllabel), 37 % (chlorophenyllabel). Major metabolite BF 5003: max 95.8 % after 14 d (tolyllabel), 80 % after 14 d (chlorophenyllabel) Soil photolysis after 15 days: 6474 % parent, 12 % bound residues, 2 % CO 2, no major metabolites (> 10 %) Rate of degradation in soil (Annex IIA, point , Annex IIIA, point 9.1.1) Method of calculation ModelMaker 3.0.3/3.0.4 (Cherwell Scientific (Notifier) Publishing Limited) Laboratory studies (range or median, DT 50lab as (20 C, aerobic): days with n value, with r 2 value) (5 soils) DT 50lab BF 5006 (tolyllabel, route study): 129 d DT 50lab BF 5006 (chlorphenyllabel, route study): Page 44

57 Field studies (state location, range or median with n value) Method of calculation (Rapporteur) Field studies (state location, range or median with n value) 166 d DT 50lab BF 5007 (tolyllabel, route study): 112 d DT 50lab BF 5007 (chlorphenyllabel, route study): 159 d DT 90lab as (20 C, aerobic): days (5 soils) DT 90lab BF 5006 (tolyllabel, route study): 428 d DT 90lab BF 5006 (chlorphenyllabel, route study): 552 d DT 90lab BF 5007 (tolyllabel, route study): 372 d DT 90lab BF 5007 (chlorphenyllabel, route study): 529 d DT 50lab (5 C, aerobic): > 120 days DT 50lab (20 C, anaerobic): 3 days degradation in the saturated zone: not relevant DT 50f : 2 37 days, 6 locations (3 Germany, 2 Spain, 1 Sweden) DT 90f : days Timme and Frehse, 1 st order kinetics DT 50f : 8 55 days, 6 locations (3 Germany, 2 Spain, 1 Sweden). DT50 of 34.4 d considered as realistic worst case and used for PEC soil calculations Metabolites not found in amounts above the limit of quantification. BF 5006 found sporadically. DT 90f : days Soil adsorption/desorption (Annex IIA, point 7.1.2) K f /K oc K d ph dependence (yes / no) (if yes type of dependence) Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2) Active substance ( 14 CChlorphenolring) soils: 3 German, 2 US, 1 Canadian Koc (no average value calculated because of extremely high range) Kd /n = (arithmetic mean: 0.95 (calculated from DAR) No BF 5006 Koc = /n not available.due to low water solubility only one concentration considered. BF 5007 Koc = /n not available. Due to low water solubility only one concentration considered. Page 45

58 Column leaching Aged residues leaching Lysimeter/ field leaching studies 0 % in leachate, all radioactivity in top soil layer 0 % in leachate, all radioactivity in top soil layer based on K oc and DT 50 values, no leaching expected Studies not available, not required. Route and rate of degradation in water (Annex IIA, point 7.2.1) Hydrolysis of active substance and major ph 5, 25 C: stable metabolites (DT 50 ) (state ph and temperature) ph 7, 25 C: stable ph 9, 25 C: stable Photolytic degradation of active substance DT 50 parent : 12 days and major metabolites BF 50011:max. 45 % after 21 days BF 50013:max. 17 % after 6 days BF 50014:max. 21 % after 3 hours BF 50015:max. 27 % after 1 day 500M58:max. 23 % after 1 day Readily biodegradable (yes/no) No Best fit Degradation in water/sediment Degradation in water/sediment DT 50 water DT 90 water DT 50 sediment DT 90 sediment DT 50 whole system DT 90 whole system DT 50 water DT 90 water pond system: 3 days; river system: 1 day pond system: 41 days; river system: 9 days pond system: 33 days; river system: 9 days pond system: 105 days; river system: no calc.possible pond system: 27 days; river system: 29 days** pond system: 89 days; river system: 96 days** ** = low r² value (0.5593) (added from EU evaluation and authoriation site (final decision report)) 1 st order (Timme and Frehse) pond system: 8.7 days; river system: 1 day pond system: 28.9 days; river system: not extrap. DT 50 entire system DT 90 entire system pond system: 26.8 days; river system: 29 days** pond system: 89 days; river system: 96 days** ** = low r² value (0.5593) NB: Ctgb cannot retrieve the system values from the DAR or the addenda. A first order fit on the total of a.s. in water and sediment was performed using the FOCUS kinetics excel sheet (using Solver) Whole system (SFO): pond system (A): DT d; DT d (chi2 6.5, M0 91.6, k 0.027)) river system (B): DT d; DT d (chi2 10.0, M0 98.9, k 0.094) Page 46

59 geomean DT 50system of 13.8 days used for Risk assessment Mineralisation % in 100 days Nonextractable residues % 100 days Distribution in water / sediment systems (active substance) Distribution in water / sediment systems (metabolites) pond system: sediment max. 53 % after 14 days, decreasing to 7 % after 100 days river system: sediment max. 62 % after 2 days, decreasing to 10 % after 100 days BF 5003: in water: max. 2 %, in sediment: max. 12 % (pond system) after 100 days; max. 66 % (river system) after 14 days, decreasing to 29 % after 100 days BF 5006: (only in pond system) in sediment max. 7 % after 61 days BF 5007: (only in pond system) in sediment max. 6 % after 61 days Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3) Direct photolysis in air see photochemical oxidative degradation Quantum yield of direct phototransformation Photochemical oxidative degradation in air (DT 50 ) Volatilisation 2.17 x 10 1 < 2 hours (According to Atkinson, AOP) from plant surfaces: about 3 % in 24 hours from soil: < 1 % in 24 hours Definition of the Residue (Annex IIA, point 7.3) Relevant to the environment Soil: parent, BF5006, BF5007 Groundwater: parent, BF5006, BF5007 Surface water including sediment: parent, BF5003, BF 50011, BF Monitoring data, if available (Annex IIA, point 7.4) Soil (indicate location and type of study) None Surface water (indicate location and type of study) Ground water (indicate location and type of study) Air (indicate location and type of study) None None None Appendix A: Metabolite names, codes and other relevant information of the plant protection product Signum with a.s. boscalid and pyraclostrobin. The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of boscalid and pyraclostrobin. The parent compound structure of Page 47

60 boscalid and pyraclostrobin is shown first in this list and followed by degradate or related compounds. Compoun d name Code numbe r(s) Boscalid (CAS no) IUPAC name 2ChloroN(4' chlorobiphenyl 2 yl)nicotinamide Structural formula C 18 H 12 Cl 2 N 2 O Structure Molecul ar Weight [g/mol] Observed in study (% of occurrence/ formation) O Parent, all compartments N Cl N H M510F64 Pyraclostr obin (CAS no) methyl N(2 {[1(4 chlorophenyl) 1Hpyrazol3 yl]oxymethyl}p henyl) N methoxy carbamate C 19 H 18 Cl N 3 O 4 Cl % in surface water Cl Parent, all N O N compartments BF % in soil BF % in soil 6.1 Fate and behaviour in soil Persistence in soil Article 2.8 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion persistence. If for the evaluation of the product a higher tier risk assessment is necessary, a standard is to be set according to the MPCINS 3 method. Currently this method equals the method described in the Technical Guidance Document (TGD). Additional guidance is presented in RIVM 4 report / Preceding the harmonisation of the persistence assessment in The Netherlands with regulation 1107/EG, the EU approach for persistence assessment is followed. For the current application this means the following: boscalid The following laboratory DT50 values are available for the active substance boscalid: 108, 322, 384, 376, 133 days (geomean 232 days). There are no major metabolites O O N 3 INS: international and national quality standards for substances in the Netherlands. 4 RIVM: National institute of public health and the environment /2007: P.L.A. van Vlaardingen and E.M.J. Verbruggen, Guidance for the derivation of environmental risk limits within the framework of 'International and national environmental quality standards for substances in the Netherlands' (INS). Revision Page 48

61 Due to the exceeding of the threshold value of 60 days for the mean DT 50 (lab) for boscalid, it must be demonstrated by means of field dissipation studies that the field DT 50 is < 90 days. The following field data are provided in the List of Endpoints: Individual DT 50 values of 55.7 days (Arithmetic mean of 3 replicates, Stetten, Germany), days (Arithmetic mean of 3 replicates, Schifferstadt, Germany) and 144 days. Geomean: days (best fit kinetics). Only representative trials are used, therefore, Spanish trials are excluded. From the results it is shown that the mean field DT50 is > 90 days. Based on the above, the proposed applications of the plant protection product Signum do not meet the standards for persistence as laid down in the RGB. Therefore an additional ecotoxicological assessment is needed based on the PECplateau summed up with the PIEC from one season. pyraclostrobin The following laboratory DT 50 values are available for the active substance pyraclostrobin: 12, 101, 50, 38 and 86 days (geomean 45.6 days). The mean DT 50 value of the a.s. can thus be established to be <90 days. Furthermore it can be excluded that after 100 days there will be more than 70% of the initial dose present as bound (nonextractable) residues together with the formation of less than 5% of the initial dose as CO 2. Field studies indicate a realistic worstcase DT 50 field value of 34.4 days. In this way, for pyraclostrobin, the standards for persistence as laid down in the RGB are met. Metabolites BF5006 (max. observed 31 %) and BF5007 (13 %) are formed in major amounts in the laboratory degradation studies. For the metabolite BF5006 the following DT 50 values are available: 129 and 166 days (geomean days). For the metabolite BF5007 the following DT 50 values are available: 112 and 159 days (geomean days). Due to the exceeding of the threshold value of 60 days for the mean DT 50 (lab) for metabolites BF 5006 and BF 5007, it has to be demonstrated by means of field dissipation studies that the field DT 50 is < 90 days. The following field data are provided: In field experiments performed on four locations in Europe (each relevant for the Dutch situation), metabolite BF5007 was not found, BF 5006 was found sporadically and at concentrations just above the detection limit. It is not likely that long term accumulation will take place and that effects on non target organisms will occur. From the results it is shown that the metabolites are not major under field conditions. Therefore, the standards for persistence are met. PECsoil boscalid The concentration of the a.s. boscalid in soil is needed to assess the risk for soil organisms (earthworms, microorganisms). The PECsoil is calculated for the upper 5 cm of soil using a soil bulk density of 1500 kg/m 3. The logpow is almost > 3 (2.96) for boscalid. Moreover, since the LogKow is determined using the HPLC method, ionisation to NH + cannot be excluded, and calculated values of LogKow are >3. Therefore, a PEC 21days is calculated for the assessment of secondary poisoning of birds and mammals through the consumption of earthworms. Furthermore, boscalid is persistent and therefore a plateau concentration is needed. Page 49

62 pyraclostrobin The logk ow of pyraclostrobin is > 3 (3.99). Therefore, PEC 21days is calculated for pyraclostrobin to address secondary poisoning of birds and mammals through the consumption of earthworms. The following input data are used for the calculation: PEC soil: Active substance boscalid: Maximum field DT 50 for degradation in soil: days (worstcase DT 50 field) Molecular mass: g/mol Active substance pyraclostrobin: Maximum field DT 50 for degradation in soil: 34.4 days (worstcase DT 50 field) Molecular mass: g/mol Metabolite BF5006: Maximum DT 50 for degradation in soil (20 C): 166 days Molecular weight: g/mol Correction factor: 0.31 (maximum observed fraction) * 1.65 (relative molar ratio = M metabolite/m parent) = Metabolite BF5007: Maximum DT 50 for degradation in soil (20 C): 159 days Molecular weight: g/mol Correction factor: 0.13 (maximum observed fraction) * 1.62 (relative molar ratio = M metabolite/m parent) = See Table M.1 for other input values and results. For the soil bound glasshouse uses the PEC plateau is relevant as the soil may be used for other purposes in the long term. Table M.1 PECsoil calculations for a.s. boscalid and pyraclostrobin and metabolites BF5006 and BF5007 (5 cm and 20 cm) Use Substance Rate [kg a.s./ha] Dry Boscalid harvested Pyraclostrobin beans, BF5006 green BF5007 bean, bush bean, runner bean,pods (F) Freq Interval [days] Fraction on soil * PIEC soil [mg a.s./kg] (5 cm) PEC soil,21d [mg a.s./kg] (5 cm) PEC plateau [mg a.s./kg] (20 cm) PEC plateau + PIEC soil [mg a.s./kg] PEC plateau + PEC soil,21d [mg a.s./kg] Hot Boscalid Page 50

63 Use Substance Rate [kg a.s./ha] peppers (G) Cichorei (F) Floriculture (G) Floriculture (F) Tree nursery (G) Tree nursery (F) Perennial plants (G) Perennial Plants (F) Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Freq Interval [days] Fraction on soil * PIEC soil [mg a.s./kg] (5 cm) PEC soil,21d [mg a.s./kg] (5 cm) PEC plateau [mg a.s./kg] (20 cm) PEC plateau + PIEC soil [mg a.s./kg] * fraction on soil is detemined as 1 interception value; interception values derived from Table 1.5 in generic guidance for FOCUS groundwater scenarios. Interception values are based on the respective BBCH codes and the following extrapolations between crops have been used: for hot peppers: carrots/tomatoes; for cichorei: sugar beets, for floriculture: sunflower (as conservative estimate); for tree nursery and perennial plants; vines (worst case, table 1.5). These exposure concentrations are examined against ecotoxicological threshold values in section Leaching to shallow groundwater Article 2.9 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion leaching to groundwater. The leaching potential of the active substances boscalid and pyraclostrobin and metabolites BF5006 and BF5007 is calculated in the first tier using Pearl and the FOCUS Kremsmünster scenario. Input variables are the actual worstcase application rates [ kg/ha for boscalid and kg/ha for pyraclostrobin], the crops [beans, PEC plateau + PEC soil,21d [mg a.s./kg] Page 51

64 further scenarios used are: carrots for hot peppers, sugar beet for chicory, winter cereals (default) for floriculture and vines for tree nursery and perennial plants] and an interception value appropriate to the crop stage of Date of yearly application is May 25 th for spring scenarios and November 1 st for autumn scenarios. For metabolites all available data concerning substance properties are regarded. Metabolites BF5006 and BF5007 are included in the calculations. No other metabolites occurred above > 10 % of AR, > 5 % of AR at two consecutive sample points or had an increasing tendency. The following input data are used for the calculation: PEARL: Active substance boscalid: Geometric mean lab DT 50 for degradation in soil (20 C): 232 days* Arithmetic mean K om (phindependent): 447 L/kg (771/1.724) 1/n: Saturated vapour pressure: 7.2 x 10 7 Pa at 20 C Solubility in water: 4.6 mg/l at 20 C Molecular weight: g/mol Plant uptake factor: 0 Q10: 2.2 Active substance pyraclostrobin: Geometric mean lab DT 50 for degradation in soil (20 C): 45.6 days Mean K om (phindependent): 5473 L/kg. 1/n: 0.95 Saturated vapour pressure: 2.6 x 10 8 Pa (20 C) Solubility in water: 19 g/l (at 20 C in deionised water (ph of 5.8)) Molecular weight: g/mol Plant uptake factor: 0 Q10: 2.2 Metabolite BF 5006: Geometric mean lab DT 50 for degradation in soil (20 C): days Mean K om (phindependent): L/kg. 1/n: 1 (default for metabolites in absence of data) Saturated vapour pressure: see parent Solubility in water: see parent Molecular weight: g/mol Formation fraction: 0.31 (maximum observed 31%) Plant uptake factor: 0 Q10: 2.2 Metabolite BF 5007: Geometric mean lab DT 50 for degradation in soil (20 C): days Mean K om (phindependent): L/kg. 1/n: 1 (default for metabolites in absence of data) Page 52

65 Saturated vapour pressure: see parent Solubility in water: see parent Molecular weight: g/mol Formation fraction: 0.13 (maximum observed 13%) Plant uptake factor: 0 Q10: 2.2 Other parameters: standard settings of PEARL * it is not clear if field data for boscalid are normalised according to FOCUS (first order kinetics) since best fit is indicated. The DAR does not clarify whether SFO or other first order kinetics was applied either. Therefore the assessment is done with the geomean of the lab data, in line with earlier Dutch assessments. The following concentrations are predicted for the a.s. boscalid and pyraclostrobin and the metabolites BF5006 and BF5007 following the realistic worstcase GAP, see Table M.2. Table M.2. Leaching of a.s. boscalid and pyraclostrobin and metabolites BF5006 and BF5007 as predicted by PEARL Use Substance Rate Frequency Interval Fraction PEC substance [kg/ha] [days] Intercepted * groundwater [µg/l] spring autumn Dry harvested beans, green bean, bush bean, runner bean,pods (F) Hot peppers (G) Cichorei (F) Floriculture (G) Floriculture (F) Tree nursery (G) Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF ** ** ** ** ** ** ** ** ** ** ** ** <0.001 <0.001 <0.001 < <0.001 <0.001 <0.001 < <0.001 <0.001 <0.001 < <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 < <0.001 <0.001 < <0.001 <0.001 <0.001 Page 53

66 Use Substance Rate substance [kg/ha] Tree nursery (F) Perennial plants (G) Perennial Plants (F) Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF5007 Boscalid Pyraclostrobin BF5006 BF ** ** ** ** ** ** Frequency Interval [days] Fraction Intercepted * PEC groundwater [µg/l] spring autumn <0.001 <0.001 < <0.001 <0.001 < <0.001 <0.001 <0.001 * interception values derived from Table 1.6 in generic guidance for FOCUS groundwater scenarios. Interception values are based on the respective BBCH codes and the following interpolations between crops have been used: for hot peppers: carrots/tomatoes; for cichorei: sugar beets, for floriculture: sunflower (as conservative estimate); for tree nursery and perennial plants; vines (worst case, table 1.5). ** application rate for metabolites is calculated via the transformation scheme. Results of Pearl using the Kremsmünster scenario are examined against the standard of 0.01 µg/l. This is the standard of 0.1 µg/l with an additional safety factor of 10 for vulnerable groundwater protection areas (NLspecific situation). From Table M.2 it reads that the expected leaching based on the PEARLmodel calculations for the a.s. boscalid and pyraclostrobin and its metabolites BF5006 and BF5007 is smaller than 0.01 µg/l for all proposed applications. Hence, the applications meet the standards for leaching as laid down in the RGB. Monitoring data Boscalid There are no data available regarding the presence of the substance boscalid in groundwater. Pyraclostrobin There are no data available regarding the presence of the substance pyraclostrobin in groundwater. Regarding the presence of metabolites BF5006 and BF5007 no monitoring data are available. Conclusions The proposed applications of the product comply with the requirements laid down in the RGB concerning persistence and leaching in soil. For boscalid, a higher tier assessment for persistence is performed in Chapter 7. Ecotoxicology. 6.2 Fate and behaviour in water Page 54

67 6.2.1 Rate and route of degradation in surface water Article 2.10c of the Plant Protection Products and Biocides Regulations (RGB) prescribes the use of Dutch specific drift percentages. The exposure concentrations of the active substances boscalid and pyraclostrobin in surface water have been estimated for the various proposed uses using calculations of surface water concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of the active substance. The spray drift percentage depends on the use. For the applications applied for no drift reducing measures were proposed. For glasshouse applications, an emission of 0.1% is used. For tree nursery, only use on crops <150 cm is applied for. Therefore, a drift value of 1% applies (downward spraying). Concentrations in surface water are calculated using the model TOXSWA. The following input data are used for the calculation: TOXSWA: Active substance boscalid: DT 50 for degradation in water at 20 C: 90 days (n=1, total system DT50 in higher tier outdoor study, recalculated by Ctgb) DT 50 for degradation in sediment at 20 C: 1000 days (default). Mean K om for suspended organic matter: 447 L/kg Mean K om for sediment: 447 L/kg 1/n: Saturated vapour pressure: 7.2 x 10 7 Pa at 20 C Solubility in water: 4.6 mg/l at 20 C Molecular weight: g/mol Active substance pyraclostrobin: Geomean DT 50 for degradation in water at 20 C: 13.8 (recalculated by Ctgb on the basis of the study in the DAR) DT 50 for degradation in sediment at 20 C: 1000 days (default) K om for suspended organic matter: 5473 L/kg K om for sediment: 5473 L/kg 1/n: 0.95 Saturated vapour pressure: 2.6 x 10 8 Pa (20 C) Solubility in water: 19 g/l (at 20 C in deionised water (ph of 5.8)) Molecular weight: g/mol Other parameters: standard settings TOXSWA When no separate degradation halflives (DegT50 values) are available for the water and sediment compartment (accepted level PII values), the system degradation halflife (DegT50system, level PI) is used as input for the degrading compartment and a default value of 1000 days is to be used for the compartment in which no degradation is assumed. This is in line with the recommendations in the FOCUS Guidance Document on Degradation Page 55

68 Kinetics. For metabolites, the level MI values are used (system DegT50 value) only, since level MII criteria have not been fully developed under FOCUS Degradation Kinetics. In Table M.3a, the drift percentages and calculated surface water concentrations for the active substances boscalid and pyraclostrobin for each intended use are presented. Table M.3a. Overview of surface water concentrations for active substance boscalid and pyraclostrobin in the edgeoffield ditch following spring application Use Substance Rate a.s. [kg/ha] Freq. Interval Drift [%] PIEC [µg/l] * PEC21 [µg/l] * PEC28 [µg/l] * Dry harvested beans, green bean, bush bean, runner bean,pods (F) Hot peppers (G) Cichorei (F) Floriculture (G) Floriculture (F) Tree nursery (G) Tree nursery (F) Perennial plants (G) Perennial Plants (F) Boscalid Pyraclostrobin Boscalid Pyraclostrobin Boscalid Pyraclostrobin Boscalid Pyraclostrobin Boscalid Pyraclostrobin Boscalid Pyraclostrobin Boscalid Pyraclostrobin Boscalid Pyraclostrobin Boscalid Pyraclostrobin ** *** ** *** ** *** ** *** ** * calculated according to TOXSWA; **standard drift for downward sprayed field applications; *** standard drift for glasshouse applications PECsediment To address the risk to sediment organisms, a PEC sediment value is needed for boscalid. The PECsediment values calculated with TOXSWA are expressed in g a.s./m 3 sediment. This PECsed has to be converted to mg a.s./kg sed dw by dividing it by the dry weight (DW) bulk density. It is assumed that the substance will be present mainly in the top 1 cm layer. This layer has a dry weight bulk density of 80 kg/m 3. The maximum PEC value in sediment in the top 1 cm of sediment is reached at day 0 after application. See Table M.3b for calculation of Page 56

69 PECsediment. PECsediment Table M.3b Maximum sediment concentration for active substance boscalid in the edgeoffield ditch following spring application Use Substance Rate drift PECsediment a.s. [kg/ha] [%] [g a.s./m 3 sediment] * [mg a.s./kg sediment DW] ** Dry harvested beans, green bean, bush bean, runner bean,pods (F) Hot peppers (G) Cichorei (F) Floriculture (G) Floriculture (F) Tree nursery (G) Tree nursery (F) Perennial plants (G) Perennial Plants (F) Spring*** spring Boscalid E02 (day 24) Boscalid E03 (day 26.5) Boscalid E03 (day 25) Boscalid E03 (day 25.5) Boscalid E02 (day 24) Boscalid E03 (day 25.5) Boscalid E02 (day 24.5) Boscalid E03 (day 25.5) Boscalid E02 (day 24) * TOXSWA output ** calculated as (PECsed in g/m 3 / 80 kg/m 3 )*1000 (conversion of g/kg to mg/kg) *** all maximum occurenbces at first day after last application The exposure concentrations in surface water and sediment are compared to the ecotoxicological threshold values in section 7.2. Monitoring data Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90 th percentile. The Pesticide Atlas on internet ( is used to evaluate measured concentrations of plant protection products in Dutch surface water, and to assess whether the observed concentrations exceed threshold values. Dutch water boards have a wellestablished programme for monitoring plant protection product contamination of surface waters. In the Pesticide Atlas, these monitoring data are processed into a graphic format accessible online and aiming to provide an insight into measured plant protection product contamination of Dutch surface waters against Page 57

70 environmental standards. Recently, the new version 2.0 was released. This new version of the Pesticide Atlas does not contain the land use correlation analysis needed to draw relevant conclusions for the authorisation procedure. Instead a link to the land use analysis performed in version 1.0 is made, in which the analysis is made on the basis of data aggregation based on grid cells of either 5 x 5 km or 1 x 1 km. Data from the Pesticide Atlas are used to evaluate potential exceeding of the authorisation threshold and the MPC (adhoc or according to INS) threshold. For examination against the drinking water criterion, another database (VEWIN) is used, since the drinking water criterion is only examined at drinking water abstraction points. For the assessment of the proposed applications regarding the drinking water criterion, see next section. Boscalid The active substance boscalid was observed in the surface water (most recent data from 2010). In Table M.4a the number of observations in the surface water are presented. In the Pesticide Atlas, surface water concentrations are compared to the authorisation threshold value of 12.5 µg/l ( , C , consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case 0.1*NOEC fish ) and to the indicative Maximum Permissible Concentration (MPC) of 0.55 µg/l as presented in the Pesticide Atlas (data source for the MPC: Zoeksysteem normen voor het waterbeheer, Currently, this MPC value is not harmonised, which means that not all available ecotoxicological data for this substance are included in the threshold value. In the near future and in the framework of the Water Framework Directive, new quality criteria will be developed which will include both MPC data as well as authorisation data. The currently available MPC value is reported here for information purposes. Pending this policy development, however, no consequences can be drawn for the proposed applications. Table M.4a Monitoring data in Dutch surface water (from version 2.0) Total no of locations (2010) n > authorisation threshold n > indicative/ad hoc MPC threshold n > MPCINS threshold * 184** 1(>2*auth. threshold) 2 (1* > MPC; 1* >5*MPC) n.a. * n.a.: no MPCINS available. ** the number of observations at each location varies between 1 and 30, total number of measurements is 862 in The correlation of exceedings with land use is derived from the 1.0 version of the Pesticide Atlas. Hence, the correlation is not based on the exact same monitoring data. However, this is the best available information and therefore it is used in this assessment. No significant correlation between exceeding and land use is established, due to an insufficient number of exceedings.. Therefore, no consequences can be drawn from the observed exceeding. Pyraclostrobin The active substance pyraclostrobin was observed in the surface water (most recent data Page 58

71 from 2010). In Table M.4b the number of observations in the surface water are presented. In the Pesticide Atlas, surface water concentrations are compared to the authorisation threshold value of 1.75 µg/l ( , C , consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case HC 5 fish (lower limit)) and to the indicative Maximum Permissible Concentration (MPC) of µg/l as presented in the Pesticide Atlas (data source for the MPC: Zoeksysteem normen voor het waterbeheer, For substance pyraclostrobin, an MPCINS value of µg/l is available (RIVM report 11925, November 2009). This value is identical to the value presented in the Pesticide Atlas. Therefore, if threshold exceedings are correlated to the proposed use, this may have consequences for the authorisation. Table M.4b. Monitoring data in Dutch surface water (from version 2.0) Total no of locations (2010) n > authorisation threshold n > indicative/ad hoc MPC threshold n > MPCINS threshold * 75** 1(12*auth. threshold) 10 (1*>MTR; 3*>2*MTR; 6*>5*MTR) (8 of the exceedings in north of NoordHolland) * = exceeding expected to be equal to the exceeding of the indicative/ad hoc MPC value ** the number of observations at each location varies between 1 and 30, total number of measurements is 378 in The correlation of exceedings with land use is derived from the 1.0 version of the Pesticide Atlas. Hence, the correlation is not based on the exact same monitoring data. However, this is the best available information and therefore it is used in this assessment. No significant correlation between exceeding and land use is established, due to an insufficient number of exceedings. Therefore, no consequences can be drawn from the observed exceeding. Drinking water criterion Article 2.b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90 th percentile. It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005 (Awb 04/37 (General Administrative Law Act)) that when considering an application, Ctgb should, on the basis of the scientific and technical knowledge and taking into account the data submitted with the application, also judge the application according to the drinking water criterion surface water intended for drinking water production. The assessment methodology followed is developed by the WG implementation drinking water criterion and outlined in Alterra report = 6 Adriaanse et al. (2008). Development of an assessment methodology to evaluate agricultural use of plant protection products for drinking water production from surface waters A proposal for the registration procedure in the Netherlands. AlterraReport 1635 Page 59

72 Substances are categorized as new substances on the Dutch market (less than 3 years authorisation) or existing substances on the Dutch market (authorised for more than 3 years). For new substances, a preregistration calculation is performed. For existing substances, the assessment is based on monitoring data of VEWIN (drinking water board). o If for an existing substance based on monitoring data no problems are expected by VEWIN, Ctgb follows this VEWIN assessment. o If for an existing substance based on monitoring data a potential problem is identified by VEWIN, Ctgb assesses whether the 90 th percentile of the monitoring data meet the drinking water criterion at each individual drinking water abstraction point. Boscalid Boscalid has been on the Dutch market for > 3 years (authorised since ). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by Ctgb about the product and its active substance, Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. Ctgb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the RGB are met. Pyraclostrobin Pyraclostrobin has been on the Dutch market for > 3 years (authorised since ). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by Ctgb about the product and its active substance, Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. Ctgb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the RGB are met. The standards for surface water destined for the production of drinking water as laid down in the RGB are met. 6.3 Fate and behaviour in air Route and rate of degradation in air Boscalid The vapour pressure is 7.2 x 10 7 Pa at 20 C. The Henry constant is 5.18 x 10 8 kpa m³/mol at 20 C. The halflife in air is < 1.1 d. Pyraclostrobin The vapour pressure is 2.6 x 10 8 Pa at 20 C. The Henry constant is x 10 6 kpa m³/mol at 20 C. The halflife in air is < 2 hours. Since at present there is no framework to assess fate and behaviour in air of plant protection products, for the time being this issue is not taken into consideration. 6.4 Appropriate fate and behaviour endpoints relating to the product and approved uses See List of Endpoints. Page 60

73 6.5 Data requirements No data required. The following restriction sentences were proposed by the applicant: None Based on the current assessment, the following has to be stated in the GAP/legal instructions for use: t) in de onbedekte teelt van bloemisterijgewassen, boomkwekerijgewassen en vaste planten, waarbij geldt dat deze kleiner dan 150 cm dienen te zijn en neerwaarts bespoten dienen te worden. To be confirmed by ecotox 6.6 Overall conclusions fate and behaviour It can be concluded that: 1. the active substance pyraclostrobin and its metabolites meet the standards for persistence in soil as laid down in the RGB. 2. For active substance boscalid, a higher tier assessment for persistence is performed in Chapter 7. Ecotoxicology. 3. all proposed applications of the active substances boscalid and pyraclostrobin meet the standards for leaching to the shallow groundwater as laid down in the RGB. 4. all proposed applications of metabolites BF 5006 and BF 5007 meet the standards for leaching to shallow groundwater as laid down in the RGB. 5. all proposed applications of the active substances boscalid and pyraclostrobin meet the standards for surface water destined for the production of drinking water as laid down in the RGB. 7. Ecotoxicology Risk assessment is done 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). In the lists of endpoints for boscalid and pyraclostrobin, Ctgb comments on the DAR s, on the LoE and additional formulation data for Signum (evaluated in RIVM report 10343a01, 04/2006) are included. Additional studies were summarised and evaluated by RIVM (birds and mammals) in reports 12284A00 (September 2009) and 12373A00 (November 2009). Additions/clarifications are given in italics. List of Endpoints Ecotoxicology Boscalid Boscalid is a new active substance. The final List of Endpoints presented below is therefore taken from the Review Report on boscalid (SANCO/3919/2007 rev 5, d.d. 21 January 2008). Additions are added in italic. Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3) Species Test substance Time scale Endpoint (mg/kg bw/day) Endpoint (mg/kg feed) Page 61

74 Birds Colinus virginianus As Acute LD 50 > 2000 Colinus virginianus As Shortterm LD 50 > Colinus virginianus as Longterm* NOAEDD 24.1 LC 50 > 5000 NOAEL300 Mammals rat. As Acute LD 50 > 5000 rat As Longterm* NOEAEDD 67 Additional higher tier studies NOEAEC 1000 * Option for refinement longterm risk: For boscalid the halflife on plant material (lettuce) was determined to be days (geometric mean 2.09, n = 8). Measured initial residues in vegetable crops The applicant has submitted ( UG) initial residue values for boscalid from own field trials in vegetable crops and a calculation of the RUD value, based upon these trials (by from 18/12/2008). The RUD is derived from studies which were performed in different vegetable crops with BAS 516 GA F and BAS F, two very similar formulations to the current in The Netherlands registered formulation BAS F (Signum N). Only from the crop lettuce both studies from Southern and the Northern European residue regions are taken into account. This is no problem as no degradation is regarded as all the data are taken at 0 days after the last applications. The plant parts analyzed are leaves and inflorescence from cabbage species including sprouts and heads. From leek and lettuce the leaves were analyzed and from carrots the whole plant including root were analyzed. Foliar Residue Unit Dose (RUD) for Boscalid (BAS 510 F) in leafy crops Table 10.1/1 Foliar residues of boscalid in leafy crops after two to four applications Enduse product [BAS code] Crop Number of appl. Interval [d] Application rate [kg a.s./ha] BBCH at last application Measured residue [mg a.s./kg] Calculated RUD [mg/kg] BASF DocID 516 GA F lettuce ,1 2001/ GA F lettuce ,8 516 GA F lettuce / GA F lettuce GA F lettuce GA F lettuce GA F lettuce GA F lettuce GA F lettuce GA F lettuce GA F lettuce / GA F lettuce Page 62

75 Table 10.1/1 Foliar residues of boscalid in leafy crops after two to four applications Enduse product [BAS code] Crop Number of appl. Interval [d] Application rate [kg a.s./ha] BBCH at last application Measured residue [mg a.s./kg] Calculated RUD [mg/kg] 516 GA F lettuce GA F lettuce GA F lettuce GA F lettuce GA F lettuce GA F lettuce BASF DocID 516 GA F leek / GA F leek GA F leek GA F leek GA F leek / GA F leek GA F leek GA F leek GA F leek GA F Cauliflower / GA F Brussels Sprouts GA F Cabbage GA F Brussels Sprouts > GA F Cabbage GA F Kale GA F Brussels Sprouts GA F Cauliflower GA F Brussels Sprouts 516 GA F Red Cabbage 516 GA F Red Cabbage GA F Kale GA F Broccoli GA F Cauliflower / GA F Red Cabbage GA F Broccoli GA F Brussels Sprouts GA F Broccoli GA F Brussels Sprouts 516 GA F White cabbage 516 GA F Green cabbage Page 63

76 Table 10.1/1 Foliar residues of boscalid in leafy crops after two to four applications Enduse product [BAS code] Crop 516 GA F Red Cabbage 516 GA F Green cabbage 516 GA F Brussels Sprouts Number of appl. Interval [d] Application rate [kg a.s./ha] BBCH at last application Measured residue [mg a.s./kg] Calculated RUD [mg/kg] GA F Cauliflower GA F Brussels Sprouts 516 GA F Brussels Sprouts GA F Cabbage GA F White cabbage 516 GA F Green cabbage BASF DocID 516 GA F carrots / GA F carrots GA F carrots GA F carrots Arithmetic mean (n = 61) Range %tile Arithmetic mean (n = 61) 12.26* Range %tile 24.69* * Only Northern European residue trials Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2, Annex IIIA, point 10.2) Group Test substance Timescale (Test type) Endpoint Toxicity (mg/l) Laboratory tests Fish O. mykiss. as static 96 h Mortality, EC O. mykiss as flowthrough 97 d (ELS) NOEC Page 64

77 Group Test substance Timescale (Test type) Endpoint O. mykiss BAS F static 96 h LC Aquatic invertebrate Toxicity (mg/l) D. magna as static 48 h EC * D. magna as semistatic 21 d NOEC 1.31 D. magna BAS F static 48 h EC Sediment dwelling organisms C. riparius as static 28 d NOEC 1.0 C. riparius as static 28 d spiked sediment NOEC mg/kg Algae P. subcapitata as static 96 h E r C as E b C P. subcapitata BAS F static 72 h E r C E b C Higher plant none Microcosm or mesocosm tests Not required * According to the LoEP of 01/2008. This is incorrect. The value should be 5.33 mg/l as given in the LoEP of 11/2008. Bioconcentration Active substance Metabolite 1 log P O/W 2.96 No major metabolites Bioconcentration factor (BCF) 1 92 Annex VI Trigger for the bioconcentration factor Clearance time (days) (CT 50 ) (CT 90 ) Level and nature of residues (%) in organisms after the 14 day depuration phase 1 only required if log P O/W > 3. * based on total 14 C or on specific compounds > 100 for non readily biodegradable substances Max. 1.0 d Max. 3.3 d n.r. Page 65

78 Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4) Test substance Acute oral toxicity (LD 50 µg/bee) Acute contact toxicity (LD 50 µg/bee) as 166 µg as/bee 200 µg as/bee Preparation µg prep./bee LD 50 = 100 µg prep/bee Field or semifield tests Not required 1 for preparations indicate whether endpoint is expressed in units of as or preparation Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5) Laboratory tests with standard sensitive species Species Test Substance Endpoint Typhlodromus pyri BAS F Mortality > 1800 Effect (LR 50 g as/ha) Aphidius rhopalosiphi BAS F Mortality > 1800 Page 66

79 Further laboratory and extended laboratory studies Species Typhlodromus pyri Typhlodromus pyri Typhlodromus pyri Typhlodromus pyri Typhlodromus pyri Aphidius rhopalosiphi Aphidius rhopalosiphi Aphidius rhopalosiphi Aphidius rhopalosiphi Aphidius rhopalosiphi Chrysopa carnea Life stage Protonymph s Protonymph s Protonymph s Protonymph s Protonymph s Imagines Imagines Imagines Imagines Imagines Test substance, substrate and duration Dose (g as/ha) BAS F 46 Mortality Fecundity BAS F 115 Mortality Fecundity BAS F 288 Mortality Fecundity BAS F 700 Mortality Fecundity BAS F 1800 Mortality Fecundity BAS F Mortality Fecundity BAS F Mortality Fecundity BAS F 800 Mortality Fecundity BAS F 1200 Mortality Fecundity BAS F 1800 Mortality Fecundity Larvae BAS F 1200 Mortality Fecundity Pardosa spp. Adults BAS F 1200 Mortality Food uptake Poecilus cupreus Imagin es Field or semifield tests BAS F 1200 Mortality Food uptake Endpoint % effect Trigger value 0 30 % 0 30 % % 30 % 30 % 0 30 % 0 30 % 0 30 % % 30 % 30 % 30 % 30 % Page 67

80 Species Life stage Test substance, substrate and duration Dose (g as/ha) Endpoint % effect Trigger value Test material Species Test No. of Dosage per appl. Effect (%) appl. (g as/ha) Final bonitation* Predatory mites BAS F T. pyri Field / 0 BAS F T. pyri Field / 6 BAS F T. pyri Field / 2.8 BAS F T. pyri Field / 5.0 BAS F T. pyri Field / 9 BAS F T. pyri Field / 9 * 7 / 27 days resp. 29 days after last application Effects on earthworms, other soil macroorganisms and soil microorganisms (Annex IIA, points 8.4 and 8.5, Annex IIIA, points 10.6 and 10.7) Test organism Test substance Time scale Endpoint 1 Earthworms Eisenia fetida as Acute 14 days LC 50 > 1000 mg boscalid / kg (corrected > 500 mg as/kg) Eisenia fetida Preparation Acute LC 50 > 1000 mg BAS F / kg (corrected > 500 mg form./kg) Eisenia fetida Preparation Chronic NOEC 3.6 kg BAS F /ha (corrected 1.8 kg form./ha; equivalent to mg boscalid/kg) Metabolite 1 Acute No major metabolite Collembola as Chronic NOEC mg as/kg d.w.soil (mg as/ha) Folsomia candida Preparation** Chronic NOEC 125 mg form./kg soil (mortality) NOEC > 1000 mg form./kg soil (reproduction) Metabolite 1 Soil microorganisms Page 68

81 Test organism Test substance Time scale Endpoint 1 Nitrogen mineralisation Carbon mineralisation Field studies 2, * as Metabolite 1 as Metabolite 1 No effects up to 12 kg BAS F/ha (equivalent to 6 kg as/ha or 8 mg as/kg soil) No major metabolite No effects up to 12 kg BAS F/ha (equivalent to 6 kg as/ha or 8 mg as/kg soil) No major metabolite Two field tests on the formulation BAS F 3 were conducted with kg/ha and kg/ha. One year after the last application there was a not significant reduction in abundance and biomass of earthworms of about 30 % in case of the higher application rate. No longlasting effects on overall abundance and biomass of earthworms were observed for the lower test concentration. However for both test concentrations effects on single species of about 30 % in comparison to control still exist one year after the last application. 1 indicate where endpoint has been corrected due to log P o/w > 2.0 (e.g. LC 50corr) 2 litter bag, field arthropod studies not included at 8.3.2/10.5 above and earthworm field studies 3 BAS F = 500 g boscalid /kg * studies are also summarized in RIVM report 09378a01 d.d ** formulation is BAS F, content of nicobifen (boscalid) 500 g/kg (added from DAR) Effects on soil fungi* Chaetomium globosum Fusarium oxysporium Mucor circinelloides Trichoderma viride Phytophthora nicotianae var. parasitica NOEC: 25 mg a.s./kg soil NOEC: 25 mg a.s./kg soil NOEC: 1.57 mg a.s./kg soil NOEC: 1.57 mg a.s./kg soil NOEC: >100 mg a.s./kg soil * data submitted for Dutch application for authorisation for another formulation based on boscalid (Cantus). Effects on nontarget plants (Annex IIA, point 8.6, Annex IIIA, point 10.8) Preliminary screening data Limit test: No phytotoxicity effects > 5 %, max. 8.8 % weight reduction up to 1800 g as/ha Terrestrial nontarget plants * Avena sativa, Daucus carota, Brassica oleracea, Pisum sativum,zea mais,allium cepa NOEC: 3.6 kg BAS F/ha = 2,57 mg w.s./kg *Data from DAR added to the List of Endpoints by Ctgb, copied from C Effects on biological methods for sewage treatment (Annex IIA, point 8.7) Test type/organism endpoint Activated sludge static 0.5 h Respiration rate > 1000 mg/l Page 69

82 Ecotoxicologically relevant compounds (consider parent and all relevant metabolites requiring further assessment from the fate section) Compartment soil water sediment groundwater Boscalid (default) Boscalid (default) Boscalid (default) Boscalid (default) Classification and proposed labelling with regard to ecotoxicological data (Annex IIA, point 10 and Annex IIIA, point 12.3) Active substance N, R 51/53 RMS/peer review proposal Active substance Pyraclostrobin Pyraclostrobin is a new active substance, included in Annex I of 91/414/EEC. The final List of Endpoints presented below is taken from the final review report on pyraclostrobin (SANCO/1420/2001 final, d.d. 8 September 2004). Where relevant, some additional remarks/information are given in italics. Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3) Acute toxicity to mammals LD50 > 5000 mg/kg bw (rat) Longterm toxicity to mammals NOAEL 75 ppm (rat multigeneration study) (DAR: This is equal to 8.2 mg/kg bw/d) Acute toxicity to birds LD50 > 2000 mg/kg bw (bobwhite quail) Dietary toxicity to birds LC50 > 5000 ppm (bobwhite quail and mallard duck) LC50 > 1176 mg/kg bw/d (bobwhite quail) LC50 > 1320 mg/kg bw/d (mallard duck) Reproductive toxicity to birds NOEL 1000 ppm (bobwhite quail and mallard duck) NOEL: 105 mg/kg bw/d (bobwhite quail) NOEL: 128 mg/kg bw/d (mallard duck)noel 1000 ppm Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2, Annex IIIA, point 10.2) Group Test substance Timescale Endpoint Toxicity (mg as/l) Laboratory tests O. mykiss BAS 500 F static 96 h LC (pyraclostrobin) O. mykiss flowthrough NOEC d O. mykiss ELS 98 d NOEC D. magna static 48 h EC D. magna semistatic 21 d NOEC Page 70

83 Group Test substance Timescale Endpoint Toxicity (mg as/l) C. riparius static 28 d NOEC 0.04 P. subcapitata static 96 h E b C Activated sludge Static 0.5 h EC 20 > 1000 O. mykiss BAS F Static 96 h LC (formulated product) D. magna Static 48 h EC P. subcapitata Static 72 h E b C O. mykiss BF Static 96 h LC (metabolite) D. magna Static 48 h EC 50 > 100 S. subspicatus Static 72 h E r C 50 > 100 O. mykiss BF Static 96 h LC (metabolite) D. magna Static 48 h EC 50 > 100 S. subspicatus Static 72 h E b C O. mykiss BF Static 96 h LC 50 > 100 (metabolite) D. magna Static 48 h EC 50 > 100 S. subspicatus Static 72 h E b C Microcosm or mesocosm tests A mesocosm study was conducted with the formulated product BAS F. Four concentration levels ranging from 0.9 µg as/l to 24 µg as/l simulating a vineyard situation with 8 applications in 14 d intervals were investigated. Approximately 260 different taxa of aquatic invertebrates were determined in the study. In most cases only insignifcant transient effects were observed. Affected populations usually recovered until the end of the study. For the mollusc species Bithynia tentaculata and Valvata spec and the mussel species Dreissena polymorpha treatment related effects were observed in the highest treatment level. The NOEC was determined to be 8 µg as/l. Fish were not included in the mesocosm, but they were included in a parallel pond study in the same experiment. One species was tested (Cyprinus carpio). The NOEC of 8 µg as/l also apply to fish. Bioconcentration (Log P OW : 3.99) Bioconcentration factor (BCF) Annex VI Trigger for the bioconcentration factor Clearance time (CT 50 ) < 1 d (CT 90 ) d Level of residues (%) in organisms after the 14 day depuration phase 675 (whole fish, chlorophenyl label) 736 (whole fish tolyl label) > 100 for non readily biodegradable substances Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4) Acute oral toxicity (as) LD 50 > 73.1 µg/bee Acute contact toxicity (as) LD 50 > 100 µg/bee Multiple Dose Test Acute oral toxicity (formulation) LD 50 = 76.9 µg as/ bee Page 71

84 Acute contact toxicity (formulation) LD 50 > 100 µg as/bee Field or semifield tests Not required Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5) Species Stage Test Substance Endpoint Laboratory tests T. pyri Protonymphs BAS F A. Adults BAS rhopalosiphi F C. carnea Larvae BAS F C. septempunctata Larvae BAS F P. cupreus Adults BAS F Pardosa spp Adults BAS F Extended laboratory tests A. rhopalosiphi Adults BAS F C. carnea Adult/LC BAS F C. septempunctata Adults/LC BAS F Dose (kg as/ha) Adverse effects % 1 Annex VI Trigger % Mortality Fertility Mortality Fertility Mortality Fertility Mortality Mortality Food uptake Mortality Food uptake Mortality Fertility Mortality Fertility Mortality Fertility acceptable acceptable acceptable 1 Adverse effect means: x % effect on mortality = x % increase of mortality compared to control y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to control (sublethal parameters are e.g. reproduction, parasitism, food consumption) When effects are favourable for the test organisms, a + sign is used for the sublethal effectpercentages (i.e. increase compared to control) and a sign for mortality effectspercentages (i.e. decrease compared to control). Field tests with BAS F Predatory mites Species Details of uses Dosage per application Total dosage Effects T. pyri 8 applications kg product/ha 2.64 kg product/ha/year 0.0 / 0.0 T. pyri 8 applications kg product/ha 3.14 kg product/ha/year 0.0 / 12 T. pyri 8 applications kg product/ha 3.12 kg product/ha/year 58.1/ 0.0 Summary: Three field tests with T. pyri clearly demonstrated recovery of affected populations within at latest 8 weeks. Effects on earthworms (Annex IIA, point 8.4, Annex IIIA, point 10.6) Page 72

85 Acute toxicity Acute toxicity (formulation BAS F) Reproductive toxicity (formulation BAS F) Acute toxicity (metabolite BF 5006) Acute toxicity (metabolite BF 5007) LC50 = 567 mg a.s./kg LC50 = 282 mg form./kg NOEC = 1 L product/ha (=0,357 mg w.s./kg) LC50 > 1000 mg/kg soil LC50 > 1000 mg/kg soil Field tests with BAS F and BAS F Two field tests were conducted with BAS F 0.03 and 0.06 kg as/ha. In one field test there was no adverse effect on number and biomass of earthworms, on feeding activity (baitlamina) and on overall abundance of collembola. In the second field test a slight effect with the full application rate was observed, but is regarded acceptable. One field test was conducted with BAS F with an application rata of 2 x 0.25 kg as/ha. No long lasting effects on earthworm populations were observed. Effects on soil microorganisms (Annex IIA, point 8.5, Annex IIIA, point 10.7) Nitrogen mineralisation No effects up to 10 L product/ha (respective 2.5 kg as/ha) BAS 5006: No effect up to 750 g/ha BAS 5007: No effect up to 375 g/ha Carbon mineralisation No effects up to 10 L product/ha (respective 2.5 kg as/ha) BAS 5006: No effect up to 750 g/ha BAS 5007: No effect up to 375 g/ha Formulation Signum Several studies with the formulation Signum (BAS F =67 g pyraclostrobin/kg, 267 g boscalid/kg) are available. The studies are summarized and evaluated by the RIVM (report 10343a01, 04/2006). Toxicity values in mg a.s./l represent total a.s. (pyraclostrobin + boscalid). Algae Substance Species Signum Pseudokirchneriella subcapitata Method Duration [h] Criterion Value [mg product/l ] Value [mg total a.s/l] static 72 E r C NOE r C Data on E b C 50 is considered less valid (negative biomass values, not dose related) Invertebrates Substance Species Method Duration [h] Criterion Value product [mg/l] Value total a.s. [mg/ L] Signum Daphnia magna static 48 EC Page 73

86 Fish Substance Species Method Duration [h] Criterion Value product mg/l] Value total a.s. [mg/ L] Signum Oncorhynchus mykiss static 96 LC (Bumble)bees Substance Species Method Duration Criterion Value product [µg/bee] Value a.s. [µg/bee] [h] Signum Apis mellifera oral 48 LD 50 >86.4 >29.8 contact 48 LD 50 >100 >34.5 Nontarget arthropods Form Species Method Dose Dose Parameter [kg total [kg/ha] a.s./ha] [%] Lab.test Mortality 15.6 Reproduction +16 Lab.test Mortality 7.6 Reproduction 48 Lab.test Mortality 37 Reproduction +12 Lab.test Mortality 0 Consumption 1.8 Lab.test Reproduction 8.3 Adverse effects 2 Signum Typhlodromus pyri Signum Aphidius rhopalosiphi Signum Chrysoperla carnea Signum Poecilus cupreus Signum Aleochara biliniata Signum Pardosa spec Lab.test Mortality 2.9 Consumption 2.9 Signum Chrysoperla 2 x x 1.25 Mortality 18.2 carnea Reproduction 2.4 Ext. Lab.test residues on leaves, interval 5 days LR 50 [kg as/ha] >1.86 > Formulation Signum = BAS F (67 g pyraclostrobin/kg, 267 g boscalid/kg) 2 Adverse effect means: x % effect on mortality = x % increase of mortality compared to control y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to control (sublethal parameters are e.g. reproduction, parasitism, food consumption) When effects are favourable for the test organisms, a + sign is used for the sublethal effectpercentages (i.e. increase compared to control) and a sign for mortality effectspercentages (i.e. decrease compared to control). Page 74

87 Field tests Form. Species Crop Dose [g product/ha] Signum Predatory mites Plum 5 x x 750 Results 32% less mites in 150 g/ha treatment, 9 days after application, no significant effects 29 days after application. 87% increase in mites at the 750 g/ha treatment, 29 days after application. No adverse effects at highest treatment Signum Typhlodromus pyri Signum Predatory mites (Euseius finlandicus) Apple 5 x x 750 Cherry 5 x x days after the 3 rd application a significant reduction of 47.4% of mites was found in the 750 g/ha treatment. 4 weeks after 5 th application, no adverse effects were found (28.5% stimulation, not significant) No reduction in mite numbers were found Earthworms Substance Species Soil type OM Criterion Dose product [%] [kg/ha] Signum Eisenia fetida artificial 10 LC 50 >1000 >334 Dose a.s. [kg/ha] Field test (additional information, summarized and evaluated by RIVM, report 12804a00, 01/2011)) Species Location Soil type earthworm Southern field fauna Germany OM [%] silt, sandclay Dose product [kg/ha] 1.5, 3.0 and 4.5 Time of Duration Criterion Significant application [months] effects > 50 % Y/N 16 April abundance biomass N In a reliable field study the effects of application of BAS F (6.5% pyraclostrobin, 26.9% boscalid) on bare soil on earthworm populations were studied. An average of individuals/m 2 was found at study initiation. Analysis of boscalid in the upper 10 cm of the soil surface showed a variation of % of the nominal concentrations for all replicates. On average, 78% was found in the 1.5 kg product/ha treatment, 80% in the 3.0 kg product/ha treatment and 99% in the 4.5 kg product/ha treatment. From the study it can be concluded that BAS F at rates of 1.5, 3.0 and 4.5 kg product/ha did not cause any significant adverse effects on total earthworm abundance and biomass, or on individual species or ecological groups of earthworms at 39 and 179 days after treatment. Toxic reference showed significant effects >50%. Page 75

88 Microorganisms Substance Soil type Dose product [mg/kg] Dose a.s. [mg/kg] Duration [d] Process Maximal effect [%] After... [d] Signum sandy respiration N loam Signum sandy loam respiration N Test on silt loam and nitrification test is considered not reliable Nontarget plants Substance Species Soil type Criterion Value product [kg/ha] Effect at end > 25% at day 28 [Y/N] Value a.s. [g/ha] Signum Brassica napus loamy sand NOEL Signum Brassica napus loamy sand EC 50 biomass >5.4 >1804 Signum Daucus carota loamy sand NOEL Signum Daucus carota loamy sand EC 50 biomass >5.4 >1804 Signum Helianthus loamy sand NOEL annuus Signum Helianthus loamy sand EC 50 biomass >5.4 >1804 annuus Signum Pisum sativum loamy sand NOEL Signum Pisum sativum loamy sand EC 50 biomass >5.4 >1804 Signum Avena sativa loamy sand NOEL Signum Avena sativa loamy sand EC 50 biomass >5.4 >1804 Signum Allium cepa loamy sand NOEL Signum Allium cepa loamy sand EC 50 biomass >5.4 >1804 Dissipation on foliage In reaction on a previous assessment of Signum in C , the applicant submitted a DT 50 foliage calculation performed by BASF. The calculation was summarized and checked by the CTB in August First order nonlinear fit DT50 values Signum Crop Boscalid DT50 [days] r 2 Pyraclostrobin DT50 [days] r 2 Visual fit Lettuce Good Lettuce Good Lettuce Good Lettuce Good Lettuce Good Lettuce Bad for both compounds Lettuce Good Lettuce Good Lettuce Good Geometric mean: 2.09 Geometric mean: 1.51 Page 76

89 Study 1. Selbach A Generic field monitoring of birds in vineyards in France. RIVMreport 12373A00 (November 2009). This generic field study was carried out during spring and summer 2006 in France to obtain estimates of the diet and the proportions of the diets obtained from vineyards by four focal bird species: Emberiza cirlus (cirl bunting), Parus major (great tit), Carduelis cannabina (linnet) and Lullula arborea (woodlark). Results: PT values The mean proportion of the potentially foraging time in vineyards (PT) for cirl buntings was 0.43, for great tits 0.05 for linnets 0.78 and for woodlarks 0.86 (see table below.). These values represent the total time potentially foraging in vineyards. These values include times when birds may not actually be foraging, but information is not available to exclude this possibility. Therefore, the calculated PT values for all four species can be regarded as a conservative assumption. Proportion of diet obtained in vineyards determined by radiotracking and visual observations (PT). Species cirl bunting based on 20 tracked individuals great tit based on 20 tracked individuals Linnet based on 20 tracked individuals Potential foraging time as a proportion of the total potential foraging time 50%tile %tile woodlark based on 20 tracked individuals Mean ± 0.43 (SD 0.24) 0.05 (SD 0.08) 0.78 (SD 0.22) 0.86 (SD 0.20) SD* * SD = standard deviation PD values Cirl buntings ingested invertebrate items and plant seeds in similar proportions (see table below). Great tits fed mainly on invertebrates (adults as well as larvae). Linnets ingested predominately seeds and the diet of woodlarks consisted basically of invertebrates (with adult insects as the most important food item. Page 77

90 Proportion of different food types in the diet (PD) [expressed in proportions of dry weight]. Mean number of animal and plant items actually eaten by focal species foraging in and around vineyards. Species (number of sampl es) Animal matter Plant matter Insects (adults) Insects larvae Other invertebrates cirl bunting 17 samples of faeces and 3 flushing samples great tit 16 samples of faeces and 4 flushing samples linnet 17 samples of faeces and 3 flushing samples woodlark 20 sampl es of faeces Seeds In table 3 the proportions of different food item lengths are provided in case in higher tier risk assessment it will be necessary to differentiate between small and large food items. For the area studied, linnets eat only seeds with a size of less than 5 mm. The other species predominately (± 60%) eat food items smaller or equal to 10 mm and about 20% food items larger than 20 mm. Proportion of different food item lengths in the diet eaten by individual birds in and around vineyards. Length of food item Size class [mm] cirl bunting 17 samples of faeces and 3 flushing samples great tit 16 samples of faeces and 4 flushing samples linnet 17 samples of faeces and 3 flushing samples woodlark > > > > samples of faeces Home range and habitat selection The mean home range is 15 to 20 ha for the cirl bunting the great tit and the woodlark, and 125 ha for the linnet (see table 4). The mean Jacobs index is 0.42 and 0.92 for the cirl bunting and great tit which indicates an avoidance of vineyards as feeding place for those two species in the research area. The mean Jacobs index is 0.43 and 0.45 for the linnet and woodlark which indicates a preference for vineyards as feeding places. Page 78

91 Home range and Jacobs index [D] for the four avian focal species in vineyards Species Mean home range Mean D (range) cirl bunting based on 20 tracked individuals great tit based on 20 tracked individuals Linnet based on 20 tracked individuals woodlark based on 20 tracked individuals 15.1 ha 18.2 ha ha 14 ha 0.42 (0.95 to 0.69) 0.92 (1 to 0.61) 0.34 (0.78 to 1) 0.45 (0.52 to 1) Remarks PT and PD values derived in this study can be used for refinement in higher tier risk assessment in areas with vineyards. In some regions of Europe other buntings or larks will replace the cirl bunting and/or woodlark. The skylark replaces the woodlark in the Netherlands. The linnet can be used as such. Additional information should be presented to evaluate whether the focal species as determined for French vineyards are relevant for the existing and proposed use in the Netherlands (apple and pear, including tree nursery). This is discussed in the risk assessment. Study 2. Staab F., Moosmayer P Generic field monitoring of selected bird species in orchards in southern Germany. RIVMreport 12284A00 (September 2009). A field survey program was carried out from March to October 2005 to identify and quantify bird species found in ten pome fruit orchards in southern Germany. Bird trapping and tagging. Five bird species were chosen as test organisms: Turdus merula (blackbird), Parus major (great tit), Fringilla coelebs (chaffinch), Carduelis cannabina (linnet) and Serinus serinus (serin). All individuals monitored during this study were trapped in pome fruit orchards. Not all trapped birds were tagged. The selection of tracked individuals was made to ensure an equal temporal distribution over the entire duration of the study. Faeces and stomach flushing Faeces samples and stomach flushings were carried out to determine the food items ingested by birds. Endpoints of the study: The proportion of time foraging in all used pome fruit orchards, compared to the total potentially foraging time, was derived from the radiotracking data and visual contact. These values were used to determine the PT values. Results Table B Mean proportion of behavioural categories in pome fruit as detected by complete radiotracking sessions and visual contacts only Species potentially foraging in pome orchards (%) blackbird 23 trackings 23 ind. birds great tit 25 trackings 22 ind. birds chaffinch 24 trackings 21 ind. birds linnet 11 trackings 9 ind. birds serin 11 trackings 9 ind. birds visual radiotr. visual radiotr. visual radiotr. visual radiotr. visual radiotr Page 79

92 inactive (%) reproduction (%) active (excluding foraging) (%) PT values PT values are reported in Table B The single field approach values represent the total time a bird spent potentially foraging in the predominantly used pome fruit orchard during any given tracking session. The multi field approach values represent the total time a bird spent potentially foraging in all pome fruit orchards. Due to the selection of individuals for radiotracking closely associated to pome fruit orchards and the inclusion of all periods of time while foraging could not be excluded, the calculated PT values for the multi field approach can be regarded as a conservative assumption. Table B Proportion of diet obtained in pome fruit orchards determined by combined radiotracking Species blackbird 23 trackings from 23 individual birds great tit 25 trackings from 22 individual birds chaffinch 24 trackings from 21 individual birds linnet 11 trackings from 9 individual birds serin 11 trackings from 9 individual birds Multi field approach: potential foraging time birds spent in all used pome fruit orchards as a proportion of the total potential foraging time 50%tile %tile mean ± SD ± ± ± ± ± Single field approach: potential foraging time birds spent in the preferential used pome fruit orchard as a proportion of the total potential foraging time 50%tile %tile mean ± SD ± ± ± ± ± Diet sample contents Major content in the diet sample volume of blackbirds and great tits were invertebrates, plant material played a minor role. The samples of chaffinches and linnets were mainly composed of plant material, while the diet of serins was exclusively made up of plant matter. Mean number of animal and plant items actually eaten by focal species foraging in and around modern pome fruit spindle bush orchards are reported in Table B Table B Diet components of stomach flushing and faeces samples, mean number per sample. Species (number samples) of animal matter arthropods 5 mm arthropods > 5 mm other invertebrates Blackbird (24) great tit (26) chaffinch (25) linnet (14) serin (11) Page 80

93 plant matter seeds plant material fruits Remarks: The quality of the study is good. The techniques used in this study (radio tracking, visual observations and faecal analysis) are sound techniques to provide information on the occurrence and abundance of birds and their food and to determine whether these species do forage in certain crop types. However, without information of the weight of the stomach flushings and faeces samples, the results from this part of the study can not be used to determine the different proportions of animal and plant matter in the diet of the birds. 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, concentrationaddition is assumed. For plant protection products the TER (ToxicityExposure Ratio) is used as a standard in the risk assessment (except for bees and other nontarget arthropods, where HQvalues 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 )) 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 TERvalue 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/tervalue 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. Page 81

94 7.1 Effects on birds Birds can be exposed to the active substances via natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning. The threshold value for birds is based on the trigger from the RGB. This means that Toxicity Exposure Ratio s (TERs) for acute and shortterm exposure should be 10 and TER for chronic exposure should be 5. Table E.1 presents an overview of toxicity data. Table E.1 Overview of toxicity data for birds for substance pyraclostrobin and boscalid Endpoint Value Pyraclostrobin Acute toxicity to birds: LD 50 >2000 mg a.s./kg bw Dietary toxicity to birds: LC 50 > 1176 mg a.s./kg bw/d Reproductive toxicity to birds: NOEL 105 mg a.s./kg bw/d Boscalid Acute toxicity to birds: LD 50 >2000 mg a.s./kg bw Dietary toxicity to birds: LC 50 >1094 mg a.s./kg bw/d Reproductive toxicity to birds: NOEL 24.1 mg a.s./kg bw/d Natural food and drinking water Sprayed products Procedures for risk assessment for birds comply with the recommendations in the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (Sanco/4145/2000). For the current application, uses can be categorized as leafy crops. Depending on the crop category, different indicator species are chosen. Table E.2 shows which indicator species are relevant for which uses. For the glasshouse uses, only exposure via drinking water and secondary poisoning by fish is taken into account, because no dietary exposure of birds and mammals is expected from uses in the glasshouses. Table E.2 Indicator species per use Use Crop Indicator species floriculture, tree nursery, low; perennial plants (F) Leafy crops medium herbivorous and insectivorous Table E.3ac shows the TER values for birds. The estimated daily uptake values (ETE, Estimated Theoretical Exposure) of both active substances for acute, shortterm and longterm exposure are calculated using the Food Intake Rate of the indicator species (FIR) divided by the body weight of the indicator species (bw), the Residue per Unit Dose (RUD), a timeweightedaverage factor (f TWA, only for long term) and the application rate. For uses with frequency > 1, a MAF (Multiple Application Factor) may be applicable. The ETE is calculated as application rate * (FIR/bw) * RUD * MAF [* f TWA, only for long term]. The ETE is compared to the relevant toxicity figure. TER should be above the trigger for an acceptable risk. Page 82

95 Table E.3a Acute risk for birds for all uses Substance FIR / bw RUD Application rate (kg a.s./ha) MAF Acute ETE (mg/kg bw/d) LD50 (mg/kg bw/d) TER (trigger 10) medium herbivorous bird pyraclostrobin >2000 >232 boscalid >2000 >58.1 combination >46.4 insectivorous bird pyraclostrobin >2000 >368 boscalid >2000 >92.3 combination >73.8 Table E.3b Shortterm risk for birds for all uses Substance FIR / bw RUD Application rate (kg a.s./ha) MAF Shortterm ETE (mg/kg bw/d) LC50 (mg/kg bw/d) TER (trigger 10) medium herbivorous bird pyraclostrobin >1176 >257 boscalid >1094 >59.9 combination >48.6 insectivorous bird pyraclostrobin >1176 >388 boscalid >1094 >90.4 combination >73.3 Table E.3c Longterm risk for birds for all uses Substance FIR / bw RUD Application MAF ftwa rate Longterm NOEL TER ETE (mg/kg bw/d) (kg (mg/kg a.s./ha) bw/d) medium herbivorous bird pyraclostrobin boscalid combination 2.35 insectivorous bird pyraclostrobin boscalid combination 1.88 (trigger 5) Taking the results in Table E.3 into account, it appears that a further refinement is necessary for the longterm risk to birds. As it can be seen boscalid is the substance driving the risk assessment. The refinement of the risk will be performed only for this substance. Page 83

96 Refinement of the longterm risk for herbivorous birds The applicant has submitted a refined RUD value for boscalid for leafy crops of mg/kg (arithmetic mean). In addition, they submitted a refined DT50 for boscalid on leafy crops of 5.5 days resulting in a refined ftwa value of 0.52 DT50: The DT50 of 5.5 days for boscalid was based on residue trials in green cabbage, lettuce and leek, for which DT50 values of resp. 5.9, 2.6 and 7.9 days were calculated by the applicant. The value of 2.6 days for lettuce is in line with the value of 2.09 days for boscalid for lettuce that was evaluated and accepted by Ctgb in earlier assessments (see List of Endpoints, also including residue data in lettuce for pyraclostrobin). Considering the available data, a DT 50 of 5.5 days for both substances is assumed to represent a reasonable worst case for leafy crops and/or weeds, which is in line with the previous assessment of Signum (C / Ctgb decision ). Based on this DT50 value, a refined ftwa of 0.52 is calculated for the worstcase interval of 12 days. For field uses the MAF based on DT d is RUD (leafy crops): The applicant has submitted initial residue values for boscalid from own field trials in vegetable crops and a calculation of the RUD value, based upon these trials (see LoEP). The studies are accepted by Ctgb. The number of applications is equal or higher than proposed application and are thus slightly worst case. Therefore the refined RUD values can be used. For the leafy crops applied for no specific data are available and it is considered appropriate to take the arithmetic mean of all the data. The arithmetic mean is mg/kg. For calculation of the TER values, see table E.4. Table E.4 Refined longterm risk for birds for field uses floriculture, tree nursery, perennial plants Substance FIR / bw RUD Application MAF ftwa Longterm NOEL TER rate (kg a.s./ha) ETE (mg/kg bw/d) (mg/kg bw/d) (trigger 5) medium herbivorous bird (floriculture, tree nursery, low; perennial plants) pyraclostrobin boscalid combination 7.68 Based on the table above an acceptable risk is expected for herbivorous birds from the applications (TER > 5). Refinement of the longterm risk for insectivorous birds Revised arthropod residue data are available in the new GD for birds and mammals (EFSA Journal 2009; 7(12):1483). Based on the state of the art Ctgb agrees to use the revised arthropod residue data as evaluated in the new GD as a higher tier in national risk assessments which are performed according to Sanco/4145/2000. Other aspects of the new GD are used only in risk calculations based fully on the EFSA GD, i.e., the Sanco and the EFSA guidance documents are not mixed otherwise. The revised RUD values for arthropods are given in Table E.5 below. Furthermore, it was determined that a generic DT 50 of 10 days can be used for arthropods. Based on this value, an ftwa of 0.53 can be used for both active substances. Page 84

97 Table E.5 Revised RUD values for arthropods Crop/category of insects Crop stage mean 90 th percentile Ground dwelling invertebrates ground directed without interception 1 applications Ground dwelling invertebrates applications directed to with interception 2 crop canopies Insects (foliar dwelling invertebrates 3 ) whole season applications on bare soil, or ground directed applications up to principle growth stage 3, ground directed applications in orchards/vines (e.g. herbicides) 2 applications directed to crop canopies (orchards/vines), ground directed applications on top of crops with principle growth stage of 4 or greater 3 no data are available for canopy dwelling invertebrates in winter or before the leaves appear (interception would be less) See table E.6a for the refined TER values. Table E.6a Refined longterm risk for birds for field uses in floriculture, tree nursery, perennial plants Substance FIR / bw RUD Application MAF ftwa Long NOEL TER rate term ETE (mg/kg bw/d) (kg (mg/kg (trigger a.s./ha) bw/d) 5) insectivorous bird pyraclostrobin boscalid combination 4.91 Taking table E.6a into account the combined TER is very close to the trigger. Keeping in mind that other parameters like PT and PD are still worst case (both are 1), the risk for insectivorous birds is considered acceptable for all uses. drinking water The risk from exposure through drinking surface water is calculated for a small bird with body weight 10 g and a DWI (daily water intake) of 2.7 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is taken into account. Pyraclostrobin The highest PIEC water is µg/l. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>2000 * 0.010) / ( * ) = > Since TER 10, the risk is acceptable. Boscalid The highest PIEC water is µg/l. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>2000 * 0.010) / ( * ) = > Since TER 10, the risk is acceptable. Considering the large TER values, no combined risk is expected Secondary poisoning The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and worms. Examination takes place against the threshold value for chronic exposure of 0.2 times the NOEC value. This means that the TER should be 5. Page 85

98 Fish Pyraclostrobin For pyraclostrobin a BCF of 736 L/kg is available. The highest PEC water(21) (taken from paragraph ) is reached at the use in floriculture, tree nursery and perennial plants and amounts µg/l = mg/l. Indicator species is a 1000g bird eating 206 g fresh fish per day. The TER is then calculated as NOEL / (PEC water(21) * BCF fish * (FIR/bw) = 105 / ( * 736 * 0.21) = Since this is > 5, the risk for birds as a result of consumption of contaminated fish is considered to be small. Boscalid For boscalid a BCF of 92 L/kg is available. The highest PEC water(21) (taken from paragraph ) is reached at the use in floriculture, tree nursery and perennial plants and amounts µg/l = mg/l. Indicator species is a 1000g bird eating 206 g fresh fish per day. The TER is then calculated as NOEL / (PEC water(21) * BCF fish * (FIR/bw) = 24.1 / ( * 92 * 0.21) = 437. Since this is > 5, the risk for birds as a result of consumption of contaminated fish is considered to be small. Combination Considering the high TER values calculated for the separate a.s., the combined risk from secondary poisoning via fish is considered low. Earthworms Pyraclostrobin Since there are no experimental data the bioconcentration factor for earthworms (BCF worm ) is calculated according to the following formula: BCF = ( * Kow) / f oc * K oc. The logk ow of pyraclostrobin is 3.99 and the Koc is 9304 L/kg, which leads to a BCF worm = 0.53 kg soil/kg worm. The highest PEC soil(21) (taken from paragraph 6.1.1) is reached at the use in floriculture and amounts mg/kg soil. Indicator species is a 100g bird eating 113 g fresh worms per day. The risk is then calculated as NOEL / PEC soil(21) * BCF worm * (FIR/bw) = 105 / (0.120 * 0.53 * 1.1) = Since this is >> 5, the risk for birds as a result of consumption of contaminated worms is considered to be small. Boscalid Since there are no experimental data the bioconcentration factor for earthworms (BCF worm ) is calculated according to the following formula: BCF = ( * Kow) / f oc * K oc. The logk ow of boscalid is 2.96 and the Koc is 760 L/kg, which leads to a BCF worm = 0.65 kg soil/kg worm. Because boscalid is persistent the highest PEC plateau + PEC soil(21) (taken from paragraph 6.1.1) will be taken. The highest value is reached at the use in tree floriculture and amounts mg/kg soil. Indicator species is a 100g bird eating 113 g fresh worms per day. The risk is then calculated as NOEL / PEC soil(21) * BCF worm * (FIR/bw) = 24.1 / ( * 0.65 * 1.1) = 60. Since this is > 5, the risk for birds as a result of consumption of contaminated worms is considered to be small. Combination The combined TER is 58. Hence, the combined risk from secondary poisoning via earthworms is considered low. Metabolites: Page 86

99 Soil metabolites of pyraclostrobin: BF 5006 and BF 5007: In field experiments performed on four locations in Europe (each relevant for the Dutch situation), metabolite BF5007 was not found, BF 5006 was found sporadically and at concentrations just above the detection limit. In addition, the available ecotoxicity data (earthworms and soil microorganisms) show no toxicity of these metabolites. Hence, a low risk for birds is expected from these metabolites. Taking the results for secondary poisoning through fish and earthworms into account, the proposed uses meet the standards for secondary poisoning as laid down in the RGB. Conclusions birds The product complies with the RGB. 7.2 Effects on aquatic organisms Aquatic organisms The risk for aquatic organisms is assessed by comparing toxicity values with surface water exposure concentrations from section 6.2. Risk assessment is based on toxicityexposure ratio s (TERs). Toxicity data for aquatic organisms are presented in Table E.8. Table E.8 Overview toxicity endpoints for the active substances Substance Organism Lowest Toxicity value L(E)C 50 [mg/l] NOEC [mg/l] [µg/l] boscalid Acute Algae Daphnids Fish Chronic Daphnids Fish pyraclostrobin Signum (in total a.s.) Acute Algae Daphnids Fish Chronic Daphnids Fish Acute Algae Daphnids Fish These toxicity values are compared to the surface water concentrations calculated in section 6.2. Trigger values for acute exposure are 100 for invertebrates and fish (0.01 times the lowest L(E)C 50 value) and 10 for algae (0.1 times the lowest EC 50 value). Trigger values for chronic exposure are 10 for invertebrates and fish (0.1 times the lowest NOECvalues). For acute and chronic risk, the initial concentration is used (PIEC) for TER calculation. In table E.9 TER values for aquatic organisms are shown for the worstcase use (floriculture, tree nursery and perennial plants). Page 87

100 Table E.9a TER values: acute (worstcase use) Use Substance PECsw [µg a.s./l]* TER st (trigger 10) Floriculture, Tree nursery and Perrenial plants TER st (trigger 100) TER st (trigger 100) Algae Invertebrates Fish boscalid pyraclostrobin combination Signum Table E.9b TER values: chronic (worstcase use) Use Substance PECsw [µg a.s./l]* TER lt (trigger 10) Floriculture, Tree nursery and Perrenial plants Invertebrates boscalid pyraclostrobin combination TER lt (trigger 10) Fish Taking the results in Table E.9a and b into account, the acute TERs for algae are above the relevant Annex VI triggers of 10. The chronic TERs for invertebrates are above the relevant Annex VI triggers of 10. However, the acute TERs for invertebrates and fish for pyraclostrobin, the combination and the formulation are below the trigger of 100 and the chronic TERs for pyraclostrobin and the combination are below the trigger value of 10. Hence, a risk for invertebrates and fish cannot be excluded based on first tier calculations. Therefore, an adequate risk assessment should be provided. Higher tier risk assessment (refinement of the risk assessment) A mesocosm study was conducted with the formulated product BAS F, containing only pyraclostrobin. Four concentration levels ranging from 0.9 µg as/l to 24 µg as/l simulating a vineyard situation with 8 applications in 14 d intervals were investigated. Approximately 260 different taxa of aquatic invertebrates were determined in the study. In most cases only insignifcant transient effects were observed. Affected populations usually recovered before the end of the study. For the mollusc species Bithynia tentaculata and Valvata spec and the mussel species Dreissena polymorpha treatment related effects were observed in the highest treatment level. The NOEC was determined to be 8 µg as/l. Because only one micro/mesocosm study is available, conducted on only one site during one time period, the spatiotemporal variation must be taken into account. From research done by Alterra, it became clear that this variation depends on the toxicity endpoint, which is used for risk assessment. If the NOECvalue is taken as the relevant endpoint, the variation in space and time is in general not large. However, if recovery is taken into account and a NOEAECvalue is established, the spatiotemporal variation is much greater. In that case a safety factor is necessary. Based on available data from Alterra a safety factor of 3 has to be applied to the NOEAECvalue. This value is in most cases sufficiently protective. In this case a NOEC was derived and no safetyfactor is considered necessary. Page 88

101 Fish were not included in the mesocosm, but they were included in a parallel pond study. In the monograph of pyraclostrobin, acute toxicity laboratory studies of seven different fish species are available (see table E.10). Table E.10: Available LC 50 values (fish) for pyraclostrobin Species LC 50 Acute NOEC [µg/l] [µg/l] Oncorhynchus mykiss Lepomis macrochirus Cyprinus carpio Pimephales promelas Oryzias latipes Brachydanio rerio Leuciscus idus melanotus HC Using the HC 5 method is an acceptable refinement method in the Dutch assessment. According to the newest insights (Brock et al., 2011) 7 a safety factor of 3 should be applied on a HC5 for fish based on acute NOEC values. An HC 5 of 4.34 µg/l is calculated from the available data. With a safety factor of 3 the value to be used for the acute risk assessment is 1.45 µg/l. The mesocosm study was also considered for the acute risk assessment. Looking at the acute toxicity data the difference in sensitivity between Oncorhynchus mykiss (the most sensitive test species) and Cyprinus carpio (species used in the mesocosm study (see LoEP)) is about a factor 3 and a sensitivity factor of about 5 on the NOEC of the mesocosm study with Cyprinus carpio is considered protective enough for the acute assessment. This leads to an endpoint of 1.6 µg/l for the acute fish assessment. Because the endpoints derived from the HC5 approach and the mesocosm study are close to each other, and the fact that the HC5 is based on a considerable number of fish species and the mesocosm study was performed with only one fish species, the HC5 in combination with a safety factor of 3, will be used as the final endpoint for the acute risk assessment for fish (i.e µg/l). Based on the first tier risk assessment, there is also a chronic risk. No data are available to compare chronic endpoints. For that reason a safety factor of 10 is applied to the endpoint of 8 µg/l. This leads to an endpoint of 0.8 µg/l for the chronic fish risk assessment. For the other aquatic organisms the derived NOEC value of 8 µg/l from the mesocosm study can be used for risk assessment. No safety factor is required. Conclusion The most critical acute endpoint (pyraclostrobin) for aquatic organisms is 1.45 µg/l. The most critical chronic endpoint (pyraclostrobin) for aquatic organisms is 0.8 µg/l. In Table E.11ab the refined acute and chronic TERs and the combined toxicity with boscalid is calculated. Only the risk for fish is calculated, since the other organisms are at least a factor of 10 less sensitive for boscalid and a factor of 2 for pyraclostrobin. Table E. 11a Refined TER values: acute 7 T.C.M. Brock1, G.H.P. Arts, T.E.M. ten Hulscher, F.M.W. de Jong, R. Luttik, E.W.M. Roex, C.E. Smit and P.J.M. van Vliet (2011). Aquatic effect assessment for plant protection products. Alterra Report Page 89

102 Use Substance TER st TER st (trigger 1) (trigger 100) Fish* Fish* Floriculture, Tree nursery Boscalid 788 and Perrenial plants (worst case) Pyraclostrobin Combination *The trigger for pyraclostrobin is 1. In order to calculate the combination toxicity, the TER is multiplied by 100 (acute) in order to correct for the safety factor of 100 which should be used for boscalid. Table E. 11b Refined TER values: chronic Use Substance TER lt (trigger 1) Floriculture, Tree nursery and Perrenial plants (worst case) Boscalid Pyraclostrobin Combination Fish* 1.18 TER lt (trigger 10) Fish* *The trigger for pyraclostrobin is 1. In order to calculate the combination toxicity, the TER is multiplied by 10 (chronic) in order to correct for the safety factor of 10 which should be used for boscalid. Based on the results from the table above, the acute risk for pyraclostrobin and boscalid is considered to be acceptable. However, the chronic TER for the combination of both active substances is below the trigger value of 10. Hence, drift reduction (minimal 75% drift reduction nozzles) must be applied to reach an acceptable risk. This is necessary for all field uses Risk assessment for bioconcentration For the active substance a BCFvalue of 736 L/kg is available. Since the BCF is above 100 L/kg and the substance pyraclostrobin is not ready biodegradable, there is a risk for bioconcentration. Pyraclostrobin For the active substance pyraclostrobin a BCFvalue of 736 L/kg is available. Since the BCF is above 100 L/kg and the substance is not ready biodegradable, there is a risk for bioconcentration. According to the guidance document on aquatic ecotoxicology the following points should be checked: 1) Direct longterm effects in fish due to bioconcentration; 2) Secondary poisoning for birds and mammals; 3) Biomagnification in aquatic food chains Ad 1) An ELS study should be available if 100 < BCF < 1000 and EC 50 a.s. < 0.1 mg/l. These triggers are exceeded for pyraclostrobin and an ELS study is available. The long term NOEC is 2 µg/l. The TER is then A refined longterm endpoint for fish of 0.8 µg/l is available with a safety factor of 1. The TER is 1.18, higher than the trigger value. Hence, the longterm risk to fish is acceptable. Ad 2) From the assessment of birds and mammals it should appear that there is no risk on secondary poisoning through fish, which is the case for the proposed uses. Ad 3) When the BCF > 1000 and the elimination in the BCF study within 14 days is < 95% and the DT 90 water or sediment > 100 days, a higher tier exposure assessment with regard to the potential for biomagnification in the aquatic food chain should be conducted. These triggers are not exceeded for pyraclostrobin. Hence, the active substance pyraclostrobin meets the standards for bioconcentration as laid down in the RGB. Page 90

103 Boscalid For the active substance boscalid a BCFvalue of 92 L/kg is available. Since the BCF is below 100 L/kg there is a low risk for bioconcentration. Hence, the active substance boscalid meets the standards for bioconcentration as laid down in the RGB Risk assessment for sediment organisms Since the water sediment study indicates that over 10% of pyraclostrobin is found in the sediment after 14 days and the NOEC for daphnids is below 0.1 mg/l, there is a potential risk for sediment organisms. The NOEC for Daphnia for boscalid is >0.1 mg/l, but the a.s. is found in more than 10% of AR in the sediment of a water/sediment study and toxicity endpoints for sediment dwelling organisms are available. Therefore the risk is assessed below. As already stated in the fate section, there are no sediment metabolites that need further consideration. Pyraclostrobin The NOEC value for Chironomus is 0.04 mg a.s./l. When this value is examined against the highest PIEC in water (use in tree nursery), the TER value is 59.1 and the trigger value of 10 is met. Boscalid The waterbased NOEC value for Chironomus is 1.0 mg a.s./l. When this value is examined against the highest PIEC in water (use in tree nursery), the TER value is 292 and the trigger value of 10 is met. The sedimentbased NOEC value for Chironomus is mg a.s./kg. When this value is examined against the highest PEC (0.205 mg a.s./kg sediment) in sediment (use in floriculture, tree nursery and perennial plants), the TER value is 113 and the trigger value of 10 is met. Combination The combined TER for water exposure is Hence, the combined risk for sediment dwelling organisms is considered low. Therefore, the active substances pyraclostrobin and boscalid meet the standards for sediment organisms as laid down in the RGB. Conclusions aquatic organisms The proposed applications meet the standards for aquatic organisms, provided that drift reduction nozzles (minimal 75%) are applied with regard to the field uses. 7.3 Effects on terrestrial vertebrates other than birds Mammals can be exposed to the active substance pyraclostrobin and boscalid via natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning. The threshold value for mammals is based on the trigger from the RGB. This means that the ToxicityExposure Ratio (TER) for acute exposure should be 10 and TER for chronic exposure should be 5. Dietary toxicity is not taken into account for mammals. Table E.12 presents an overview of toxicity data. Page 91

104 Table E.12 Overview of toxicity data for mammals Endpoint Value Pyraclostrobin Acute toxicity to mammals: LD 50 >5000 mg a.s./kg bw Reproductive toxicity to mammals: NOEL 8.2 mg a.s./kg bw/d Boscalid Acute toxicity to mammals: LD 50 >5000 mg a.s./kg bw Reproductive toxicity to mammals: NOEL 67 mg a.s./kg bw/d Natural food and drinking water Sprayed products Procedures for risk assessment for mammals comply with the recommendations in the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (Sanco/4145/2000). For the current application, uses can be categorized as leafy crops. Depending on the crop category different indicator species are chosen. Table E.13 shows which indicator species are relevant for which uses. For the glasshouse uses, only exposure via drinking water and secondary poisoning by fish is taken into account, because no exposure of birds and mammals is expected inside the glasshouses. Table E.13 Indicator species per use Use Crop Indicator species floriculture, tree nursery low, perennial plants Leafy crops medium herbivorous Table E.14ab show the estimated daily uptake values (ETE, Estimated Theoretical Exposure) for acute and longterm exposure, using the Food Intake Rate of the indicator species (FIR) divided by the body weight of the indicator species (bw), the Residue per Unit Dose (RUD), a timeweightedaverage factor (f TWA, only for long term) and the application rate. For uses with frequency of > 1, a MAF (Multiple Application Factor) may be applicable. The ETE is calculated as application rate * (FIR/bw) * RUD * MAF [* f TWA, only for long term]. The ETE is compared to the relevant toxicity figure. TER should be above the trigger for an acceptable risk. Table E.14a Acute risk for mammals for all uses Substance FIR / bw RUD Application rate MAF (kg a.s./ha) Acute ETE (mg/kg bw/d) LD50 (mg/kg bw/d) TER (trigger 10) medium herbivorous mammal pyraclostrobin >5000 >1572 boscalid >5000 >394 combination >315 Page 92

105 Table E.14b Longterm risk for mammals for all uses Substance FIR / bw RUD Application MAF ftwa rate Longterm NOEL TER ETE (mg/kg bw/d) (kg (mg/kg a.s./ha) bw/d) medium herbivorous mammal pyraclostrobin boscalid combination 6.16 (trigger 5) Taking the results in Table E.14 into account, it appears that all proposed uses, meet the standards laid down in the RGB. drinking water The risk from exposure through drinking from surface water is calculated for a small mammal with body weight 10 g and a DWI (daily water intake) of 1.57 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is taken into account. pyraclostrobin The highest PIEC water is µg/l. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = >5000 * 0.010) / ( * ) = > Since TER 10, the risk is acceptable. boscalid The highest PIEC water is µg/l. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = >5000 * 0.010) / ( * ) = > Since TER 10, the risk is acceptable. Considering the high TER values for both active substances, no combined risk is expected Secondary poisoning The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and worms. Examination takes place against the threshold value for chronic exposure of 0.2 times the NOEC value. This means that the TER should be 5. Fish Pyraclostrobin For pyraclostrobin a BCF of 736 L/kg is available. The highest PEC water(21) (taken from paragraph ) is reached at the use in floriculture, tree nursery and perennial plants and amounts µg/l = mg/l. Indicator species is a 1000g mammal eating 206 g fresh fish per day. The TER is then calculated as NOEL / (PEC water(21) * BCF fish * (FIR/bw) = 8.2 / ( * 736 * 0.13) = 220. Since this is > 5, the risk for mammals as a result of consumption of contaminated fish is considered to be small. Boscalid For boscalid a BCF of 92 L/kg is available. The highest PEC water(21) (taken from paragraph ) is reached at the use in floriculture, tree nursery and perennial plants and amounts µg/l = mg/l. Indicator species is a 1000g mammal eating 206 g fresh fish per day. Page 93

106 The TER is then calculated as NOEL / (PEC water(21) * BCF fish * (FIR/bw) = 67 / ( * 92 * 0.13) = Since this is > 5, the risk for mammals as a result of consumption of contaminated fish is considered to be small. Combination The combined TER is 198. Since this is > 5, the risk for mammals as a result of consumption of contaminated fish is considered to be small. Earthworms Pyraclostrobin Since there are no experimental data the bioconcentration factor for earthworms (BCF worm ) is calculated according to the following formula: BCF = ( * Kow) / f oc * K oc. The logk ow of pyraclostrobin is 3.99 and the Koc is 9304 L/kg, which leads to a BCF worm = 0.53 kg soil/kg worm. The highest PEC soil(21) (taken from paragraph 6.1.1) is reached at the use in floriculture and amounts mg/kg soil. Indicator species is a 100g mammal eating 113 g fresh worms per day. The risk is then calculated as NOEL / PEC soil(21) * BCF worm * (FIR/bw) = 8.2 / (0.091 * 0.53 * 1.4) = 121. Since this is > 5, the risk for mammals as a result of consumption of contaminated worms is considered to be small. Boscalid Since there are no experimental data the bioconcentration factor for earthworms (BCF worm ) is calculated according to the following formula: BCF = ( * Kow) / f oc * K oc. The logk ow of boscalid is 2.96 and the Koc is 760 L/kg, which leads to a BCF worm = 0.65 kg soil/kg worm. Because boscalid is persistent the highest PEC plateau + PEC soil(21) (taken from paragraph 6.1.1) will be taken. The highest value is reached at the use in floriculture and amounts mg/kg soil. Indicator species is a 100g mammal eating 113 g fresh worms per day. The risk is then calculated as NOEL / PEC soil(21) * BCF worm * (FIR/bw) = 67 / ( * 0.65 * 1.4) = 138. Since this is > 5, the risk for mammals as a result of consumption of contaminated worms is considered to be small. Combination The combined TER is 64. Since this is > 5, the risk for mammals as a result of consumption of contaminated worms is considered to be small. Metabolites: Soil metabolites of pyraclostrobin: BAS 5006 and BAS 5007: In field experiments performed on four locations in Europe (each relevant for the Dutch situation), metabolite BF5007 was not found, BF 5006 was found sporadically and at concentrations just above the detection limit. In addition, the available ecotoxicity data (earthworms and soil microorganisms) show no toxicity of these metabolites. Hence, a low risk is expected from these metabolites Taking the results for secondary poisoning through fish and earthworms into account, the proposed uses meet the standards for secondary poisoning as laid down in the RGB. Conclusions mammals The product complies with the RGB. 7.4 Effects on bees The risk assessment for bees is based on the ratio between the highest single application rate and toxicity endpoint (LD 50 value). An overview of the risk at the proposed uses is given in Table E.15. Page 94

107 Table E.15 Risk for bees Use Substance Application rate floriculture, tree nursery and perennial plants (worst case) Pyraclostrobin Boscalid Combination Signum [g a.s./ha] [µg/bee] > LD 50 Rate/LD 50 Trigger value >29.8 < <3.79 < Since the ratio rate/ld 50 is below 50, the risk for bees is considered to be low. Hence, all proposed uses meet the standards for bees as laid down in the RGB. Conclusions bees The product complies with the RGB. 7.5 Effects on any other organisms (see annex IIIA ) Effects on nontarget arthropods Field application The risk for nontarget arthopods is assessed by calculating Hazard Quotients. For this, Lethal Rate values (LR 50 ) are needed. Based on LR 50 values from studies with the two standard species Aphidius rhopalosiphi and Typhlodromus pyri an infield and an offfield Hazard Quotient (HQ) can be calculated according to the assessment method established in the SETAC/ESCORT 2 workshop and described in the HTB (v 1.0). Hazard Quotients should be below the trigger value of 2 to meet the standards. The resulting Hazard Quotients are presented in Table E.16. Table E.16 HQvalues for A. rhopalosiphi and T. pyri Application rate MAF 1 Drift factor/ Safety LR 50 HQ (kg a.s./ha) Vegetation factor 2 factor 2 (kg a.s./ha) floriculture, tree nursery and perennial plants (worstcase field applications) Infield A. rhopalosiphi >1.86 <0.46 T. pyri >1.86 <0.46 Offfield A. rhopalosiphi >1.86 <0.046 T. pyri >1.86 < : Multiple Application Factor 2 : offfield: drift factor = 10%, vegetation dilution factor = 10, safety factor = 10 (default values) As the above table shows, both in and offfield HQ values are below the trigger value of 2. The proposed application of the product therefore meets with the standards as laid down in the RGB. Several field studies with predatory mites for the formulation Signum are available. The dose rates were somewhat lower than for the uses under assessment, but the application frequency was higher and it can be concluded that at least the highest dose rate in combination with the frequency in the field studies is relevant for the actual uses. From the results it can be concluded that the effects on mortality are lower than 50% and that the risk for predatory mites is acceptable. Several other studies with nontarget arthropods are available for the formulation Signum. Leaf dwelling arthropods: C. carnea Page 95

108 In a laboratory experiment an increased mortality of 37% was found at a concentration of 1.25 kg a.s./ha. Reproduction was stimulated. In an extended laboratory study, an increased mortality of 18% was found. No significant effects on reproduction were found. The application rate in this test was 2 x 1.25 kg a.s./ha and is representative for the proposed applications. No unacceptable risk is expected for leaf dwelling arthropods at proposed uses of Signum. Soil dwelling artropods: P. cupreus, A. bilineata and Pardosa spec. No significant adverse effects on mortality, reproduction or food consumption was found on P. cupreus, A. bilineata or Pardosa spec in standard laboratory test with Signum. The application rate was 1.25 kg a.s./ha, which is higher than the proposed application rates. No unacceptable risk is expected for soil dwelling arthropods at proposed uses of Signum. Glasshouse applications Other infield criteria apply where natural enemies ( beneficials ) in integrated pest management systems, such as greenhouse crops, are concerned. Effects on beneficials higher than or equal to 30% in the first tier and higher than or equal to 25% for higher tiers are in that case not acceptable, even if recovery occurs at short term. If the available data are taken into account only A. rhopalosiphi and C. carnea show effects grater than 30%: for A. rhopalosiphi 48% effect on reproduction was found at a dose rate of 1.86 kg as/ha and for C. carnea 37% mortality was found at a dose rate of 1.25 kg as/ha. These dose rates are higher than the dose rate in the glasshouse applications, which is kg as/ha x MAF (= 2.3) = 1.15 kg as/ha. Because the effects at the higher dose rates are not far above the trigger value of 30% effects for laboratory tests, an acceptable effect is expected at the proposed dose rates. However, for predatory mites field studies are available (see above). From these studies effects greater than 25% on predatory mites cannot be excluded. Hence, the following warning sentence must be placed on the label: Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden. Hence, the standards for nontarget arthropods are met Earthworms Glasshouse applications For glasshouse uses, management practice includes regular sterilisation of the soil, which prevents the formation of a natural soil organism community within glasshouses. Exposure to natural soils is not expected. However, because boscalid is persistent, a risk assessment is performed with the PEC plateau for the soil bound glasshouse uses since the soil may be used for other purposes in the long term. The risk is covered by the risk assessment for the use in floriculture, because the latter one is more worst case. See table E.17 and E.18 for endpoints, PECsoil and TER values. Field applications The acute risk for earthworms is calculated as TERvalue (trigger value 10). Since the logpow of the active substances > 2, a correction to the reference soil containing 4.7 % organic matter is necessary. Exposure is expressed as the initial PEC soil. PEC soil is calculated in section For glasshouse uses, no exposure of earthworms is expected, since management practice includes regular sterilisation of the soil. Therefore no assessment for glasshouses in performed. Table E.17 presents endpoints, PECsoil and TER values. For pyraclostrobin the PIECsoil is used and for the persistent compound boscalid the PECplateau + PIECsoil. Page 96

109 Table E.17 Overview of soil concentrations and acute TERs for earthworms for pyraclostrobin and boscalid Use Substance LC50 corr [mg/kg] TER Floriculture (worst case) Pyraclostrobin Boscalid Combination Signum 266 >470 >157 PIECsoil / PECplateau + PIECsoil [mg/kg] >836 >607 >230 Trigger value In view of the results presented in Table E.17 a low acute risk for earthworms is expected at all proposed uses. Metabolites BF 5006 and BF 5007 are less toxic than the parent pyraclostrobin. The expected concentrations in soil are also lower. Therefore the risk for these metabolites is low. In the subchronic risk assessment for earthworms, a longterm TERvalue is calculated. Examination of the PIEC (pyraclostrobin) or PECplateau + PIEC (boscalid) takes place against the trigger of 0.2*NOEC. See Table E.18. Table E.18 Overview of soil concentrations and chronic TERs for earthworms Use Substance NOEC corr [mg/kg] TER Floriculture (worst case) Pyraclostrobin Boscalid Combination PIECsoil / PECplateau + PIECsoil [mg/kg] Trigger value The chronic threshold value for earthworms resulting from exposure to both the active substances is exceeded. A refined risk assessment based on field studies is performed. Refined risk assessment For both a.s., earthworm field studies are available in the DAR. The applicant also provided a new field study for the formulation Signum. The latter study is considered to be more relevant, since it concerns both active substances. Furthermore, the study can be considered worst case, since the application was made to bare soil. Finally, the study is more easy to be extrapolated, since the frequency in the study is 1, at high application rates. No effects were found at an application of 4.5 kg product/ ha (1.5 kg total a.s./ha). This application rate is considerably higher than the proposed application rates. Furthermore the field test represents a worst case by a single application (no dissipation inbetween intervals) to bare soil (no interception). Therefore the risk to earthworms is considered to be acceptable Other soil macroorganisms Also for other soil macroorganisms data are available for the persistent active substance boscalid. For Folsomia candida a study with a formulation of boscalid (500 g/kg) has been done. The NOEC is 125 mg form/kg soil (= 62.5 mg a.s/kg soil). A longterm TERvalue is calculated. Examination of the PECplateau + PIEC takes place against the trigger of 0.2 * NOEC. See Table E Page 97

110 Table E.19 Overview of soil concentrations and chronic TERs for other soil macroorganisms for the active substance boscalid Use Substance Organism NOEC corr [mg/kg] PECplateau + PIECsoil TER Trigger value Floriculture (worst case) Formulation of boscalid only (500 g/kg) Folsomia candida [mg/kg] The chronic threshold value for other soil macroorganisms resulting from exposure to the active substance boscalid is higher than the trigger value of 5. Hence, the risk is acceptable Effects on soil microorganisms Pyraclostrobin Glasshouse uses For glasshouse uses, management practice includes regular sterilisation of the soil, which prevents the formation of a natural soil organism community within glasshouses. Exposure to natural soils is not expected. Therefore no risk assessment is performed for soil organisms. Field uses No effects were found after 28 days on the nitrogen transformation and carbon mineralization at doses up to 2.5 kg a.s./ha. For metabolites BF 5006 and BF 5007 no effects were found at relevant doses of 750 g/ha and 375 g/ha respectively. Since the reduction percentage is below 25% after 28 days, the standards from the RGB regarding soil microorganisms are met. Boscalid Glasshouse uses For glasshouse uses, management practice includes regular sterilisation of the soil, which prevents the formation of a natural soil organism community within glasshouses. Exposure to natural soils is not expected. However, because boscalid is persistent, a risk assessment is performed with the PEC plateau for the soil bound glasshouse uses since the soil may be used for other purposes in the long term. No effects were found after 28 days on the nitrogen transformation and carbon mineralization at doses up to 6 kg a.s./ha (= 8 mg/kg soil). The highest PECplateau is mg/kg soil (20 cm depth). Hence the risk for soil microorganisms is acceptable. Field uses No effects were found after 28 days on the nitrogen transformation and carbon mineralization at doses up to 6 kg a.s./ha (= 8 mg/kg soil). The PIECsoil + PECplateau is mg/kg soil. Hence the risk for soil microorganisms is acceptable. Signum Since the nitrogen mineralization test was considered unreliable, only information on carbon mineralization is available. No effects were found after 28 days at an application rate of 8.02 mg a.s./ha soil. This is higher than the highest expected concentration for the use in floriculture (0.682 mg a.s./kg). Since for both pyraclostrobin and boscalid no effects on nitrogen transformation rate occurred at application rates considerably higher tan the maximum proposed application rate, it is expected that Signum will not cause unacceptable effects on the nitrogen transformation rate. Therefore, the proposed applications of the product meet the standards for microorganisms. Page 98

111 7.5.4 Effects on activated sludge An EC 50 value of >1000 mg/l is available for both pyraclostrobin and boscalid. Exposure to activated sludge is expected from indoor uses and from outdoor uses on hardened surfaces. Models to calculate the exposure concentration in the sewage treatment plant (STP) are currently available for hardened surfaces, for indoor cultivations of mushrooms and for the potato processing industry. For other indoor uses, models are not available. For the proposed application this means the following: Glasshouse uses For the proposed uses exposure of activated sludge is expected. However, to date there is no module available to calculate influent concentrations in the sewage treatment plant (STP) for these application types. Therefore, the proposed application cannot be examined against the standard for activated sludge as laid down in the RGB. For the time being this issue is not taken into consideration. Field uses For the proposed uses no exposure of activated sludge is expected. Therefore, the proposed applications comply with the standards for activated sludge as laid down in the RGB Effects on nontarget plants The risk assessment for nontarget plants is based on an offcrop situation with a drift percentage of 4.7% The exposure thus equals * the application rate * MAF (in case of multiple application). MAFvalues are taken from ESCORT 2. No offcrop exposure is expected from the glasshouse uses. A TER is calculated with the lowest EC 50 value from a laboratory test with higher plants and the exposure concentration. The lowest EC 50 is >1.804 kg as/ha for all 6 species tested. See table E.20 for TER calculation. Table E.20 Overview of exposure concentrations and TERs for nontarget plants Use Substance Dose MAF Drift% (offfield Exposure EC 50 [kg a.s. /ha] exposure) (kg a.s./ha) [kg a.s./ha] floriculture, tree nursery and perennial plants (worst case) TER Trigger value Signum > The ratio between EC 50 and the exposure concentration is > 5. Therefore, the risk for nontarget plants is considered to be low. Conclusions any other organisms The product complies with the RGB for the aspects nontarget arthropods, earthworms, soil microorganisms, activated sludge and nontarget plants. Considering the acceptable risk of boscalid for earthworms, soil macroorganisms, soil microoranisms and nontarget plants, boscalid meets the standards for persistence. Page 99

112 7.6 Appropriate ecotoxicological endpoints relating to the product and approved uses See List of Endpoints. 7.7 Data requirements None 7.8 Restriction sentences The following restriction sentences were proposed by the applicant: None. Based on the current assessment, the following has to be stated in the GAP/legal instructions for use: In the WG (legal instructions): Om in het water levende organismen te beschermen is de toepassing van het middel in de onbedekte teelt van bloemisterijgewassen, boomkwekerijgewassen en vaste planten op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien er gebruik wordt gemaakt van minimaal 75% driftreducerende spuitdoppen. Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden. In combination with earlier risk assessments; the following restriction sentence should be placed on the label*: Om in het water levende organismen te beschermen is toepassing in de teelt en opkweek (waarbij in de opkweek de bomen > 150 cm) van kers, morel en pruim op percelen die grenzen aan oppervlaktewater alleen toegestaan vóór 1 mei met minstens één van de volgende driftreducerende maatregelen: in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het perceel bespoten dient te worden. Wannerspuit met reflectiescherm en venturidoppen (Lechler ID 90015C). Om in het water levende organismen te beschermen is toepassing in de teelt en opkweek (waarbij in de opkweek de bomen > 150 cm) van kers, morel en pruim op percelen die grenzen aan oppervlaktewater alleen toegestaan na 1 mei met minstens één van de volgende driftreducerende maatregelen: er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of: in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het perceel bespoten dient te worden. Wannerspuit met reflectiescherm en venturidoppen (Lechler ID 90015C). Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van crambe, daikon, tuinkruiden, rettich, rucola, veldsla, graszodenteelt en in greens van golfterreinen uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater gebruik wordt gemaakt van minimaal 90% driftreducerende doppen. Page 100

113 Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van bloemisterijgewassen, boomkwekerijgewassen en vaste planten amsoi, boerenkool, choisum, paksoi, comatsuna en Chinese kool uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater gebruik wordt gemaakt van minimaal 75% driftreducerende spuitdoppen. Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden. * sentences for this assessment highlighted in yellow. 7.9 Overall conclusions regarding ecotoxicology It can be concluded that: 1. all proposed applications of the active substance boscalid meet the standards for persistence as laid down in the RGB. 2. the proposed applications of the formulated product Signum meet the standards for birds as laid down in the RGB. 3. all proposed applications of the formulated product Signum meet the standards for aquatic organisms as laid down in the RGB, provided that drift reducing measures are applied. 4. the active substances pyraclostrobin and boscalid meet the standards for bioconcentration as laid down in the RGB. 5. the proposed applications of the formulated product Signum meet the standards for mammals as laid down in the RGB. 6. all proposed applications of the formulated product Signum meet the standards for bees as laid down in the RGB. 7. all proposed applications of the formulated product Signum meet the standards for nontarget arthropods as laid down in the RGB, provided that in case of the glasshouse applications a warning sentence is placed on the label for IPM purposes. 8. all proposed applications of the formulated product Signum meet the standards for earthworms as laid down in the RGB. 9. all proposed applications of the formulated product Signum meet the standards for soil microorganisms as laid down in the RGB. 10. all proposed field applications of the formulated product Signum meet the standards for activated sludge as laid down in the RGB. 11. all proposed glasshouse applications of the formulated product Signum cannot be examined against the standards for activated sludge as laid down in the RGB; for the time being this issue is not taken into consideration. 12. all proposed applications of the formulated product Signum meet the standards for nontarget plants as laid down in the RGB. 8. Efficacy 8.1 Efficacy evaluation Dose justification Green beans: The proposed dose rate is 1.5 kg/ha Signum. In 5 Dutch effectiveness trials Signum was applied at a dose rate of 1.0 and 1.5 kg/ha. Additionally, Signum was applied at a dose rate of 1.8 kg/ha in 3 of those trials. The treatments consisted of 24 foliar applications which were carried out with an interval of 414 days. Two applications at an interval of 14 days is claimed. The first application was made at flowering. Page 101

114 In all trials the percentage of infected plants in the objects treated with Signum was comparable, regardless of dose rate, and no significant differences occurred between the treatments. The product is currently authorized at the proposed dose rate for several crops, based on the authorization in these crops, and experience for several years in the field, it is reasonable to assume that 1.5 kg/ha is the most optimal dose rate. Chicory Proposed dose rate is 1.5 kg/ha Signum. In 6 French effectiveness trials, Signum was applied at 1.0 and 1.5 kg/ha. In two of the trials Signum was also applied at a dose rate of 0.75 kg/ha. Alternaria spp. The control of infection (severity) given by the proposed dose rate of 1.5 kg/ha was generally slightly higher than the control given by lower dose rates. However, significant differences did not occur. The control of disease (incidence) by 1.5 kg/ha was slightly higher than the control given by 1.0 kg/ha in one of two trials. However, a significant difference occurred only at the beginning of the trial, and the control given by both dose rates was comparable in the other trial. Puccinia spp. The control of infection (severity) by the proposed dose rate of 1.5 kg/ha was comparable to the control given by lower dose rates in three of the trials. In the other three trials the level of control given by the proposed dose rate of 1.5 kg/ha was slightly higher than the control given by lower dose rates. However, a significant difference was found in only one trial. Furthermore, the disease (incidence) was generally controlled slightly better by the proposed dose rate, but the differences were marginal and not significant in both trials performed in 2007 (incidence of disease was not assessed during other trials). Effectiveness Green beans In 12 effectiveness field trials carried out in The Netherlands and Germany in the period , the effectiveness of 1.5 kg/ha Signum was compared to that of several reference products based on iprodion, fludioxonil and cyprodinil, or vinchlozolin. The treatments consisted of 24 foliar applications which were carried out with an interval of 414 days. Two applications at an interval of 14 days are claimed. The first application was made at flowering. Compared to the untreated control, the percentage of plants infected with Sclerotinia sclerotiorum in objects treated with Signum was significantly lower in 9 of the trials. The diseases pressure in the untreated plots in these trials was relatively high towards the end of the trials (583.5% of plants infected). In the other 3 trials the percentage of infected plants in the treated plots was also lower than that in the untreated plots, but disease pressure was very low in these trials (<4% of plants infected) and no significant differences occurred. The percentage of infected plants in objects treated with Signum was generally slightly lower than that in objects treated with the reference product based on iprodion in 11 trials (all trials that included this standard product) but no significant differences occurred. The percentage of infected plants in objects treated with Signum was also slightly lower than that in objects treated with the reference product based on vinchlozolin in 1 trial (only trial that included this standard product), but no significant differences occurred. Furthermore, the percentage of infected plants in the objects treated with Signum was comparable to that in the objects treated with the standard product based on fludioxonil and cyprodinil in 3 trials (all trials that included this standard product). In most trials only a few pods per plant were infected. However in the trial with a moderate Page 102

115 infection percentage of the pods in the untreated object, the percentage of pods infected with S. sclerotiorum in the treated objects was significantly lower than that in the untreated objects. Furthermore, the percentage of infected pods in the objects treated with Signum was comparable to that in the objects treated with the reference product based on iprodion or with the product based on fludioxonil and cyprodinil. Chicory The efficacy of Signum against Alternaria spp. and Puccinia spp. was evaluated in 5 field trials in chicory performed in France. An additional field trial was performed in France to test the efficacy of Signum against Puccinia in chicory. Per year two field trials were performed, in 2005, 2006 and As a standard treatment, two applications were performed with a reference product based on difenoconazole. In 1 trial the Alternaria pressure was very low (<10% of leaf area attacked in the untreated plots), and no clear conclusions could be drawn in respect to control of the severity of the infection. However, the disease pressure (incidence) in the untreated plots of this trial was sufficient to make an evaluation possible. The number of trials was sufficient. Alternaria The efficacy of Signum against Alternaria was demonstrated. The control of Alternaria infection (both incidence and severity) given by Signum at the claimed dose rate of 1.5 kg/ha was generally comparable to the control given by the reference product based on difenoconazole. However, in one trial performed in 2006 the control of the disease (severity) given by the reference product was significantly higher than the control given by Signum 47 days after the last application, which may indicate that the reference product has a somewhat longer residual activity. The weather conditions during this trial were very dry and warm. To allow the fungal diseases to develop under these unfavourable conditions, the second application was performed two weeks later than originally planned, the interval therefore was longer than the one applied for. Puccinia The efficacy of Signum against Puccinia was demonstrated. The control of Puccinia infection (both incidence and severity) given by Signum at the claimed dose rate of 1.5 kg/ha was generally comparable to the control given by the reference product. However, in one trial performed in 2006 the control of the disease (severity) given by the reference product was significantly higher than the control given by Signum 47 days after the last application, which may indicate that the reference product has a somewhat longer residual activity. The weather conditions during this trial were very dry and warm. To allow the fungal diseases to develop under these unfavourable conditions, the second application was performed two weeks later than originally planned, the interval therefore was longer than the one applied for. Combination product Signum is a combination product, based on boscalid and pyraclostrobin. A combination product can be of benefit for a number of reasons: to broaden the efficacy, to improve the efficacy or to decrease phytotoxicity. This should be proven experimentally by investigating the solo components in the same amount as applied by the combination product. However, it is not necessary to prove the benefit for all uses. The current label is an extension, the use of Signum has already been approved in various crops in the Netherlands. Furthermore, the use of fungicide mixtures is a commonly applied strategy to reduce the risk of the development of resistance in the fungi. Signum is a combination of two active ingredients with different modes of action. Page 103

116 Extrapolation possibilities In respect to effectiveness, extrapolation is possible, based on expert judgement, from the registered uses of Signum to use in floriculture, perennial plants and tree nursery crops against Botryotinia fuckeliana, Rhizoctonia solani and Sclerotinia spp. According to the extrapolation document Possibilities for extrapolation of efficacy and crop safety of crop protection products (CTB, May 2004), extrapolation is possible from bush green bean to bush common bean, climbing green beans, climbing common bean, snap bean runner bean and legume/pod (bush & climbing) and dry harvested beans in respect to both effectiveness and phytotoxicity. In respect to effectiveness, extrapolation is possible from sweet pepper to chilli pepper. Conclusion The product complies with the Uniform Principles because it does in accordance with article 2.1: control Puccinia spp. and Alternaria spp. in chicory at the claimed dose rate. control Sclerotinia sclerotiorum in bush common bean, climbing green beans, climbing common bean, snap bean runner bean, legume/pod (bush & climbing) and dryharvested beans control Botryotinia fuckeliana, Rhizoctonia solani and Sclerotinia in floriculture, perennial plants and tree nursery crops. control (Leveillula taurica) in chilli pepper. 8.2 Harmful effects Phytotoxicity Signum in green beans Phytotoxicity was assessed in 9 of the effectiveness trials and crop stand was assessed in 3 trials. The trials in the Netherlands were performed with green bean (Phaseolus vulgaris) varieties Twix, Kaiser, Sedan, Cantane, Nagano, Caddilac, AMS, Avignon and Angers. Two trials in the Netherlands and the trial in Germany were performed with green beans of unknown variety. Signum was applied at the proposed dose rate of 1.5 kg/ha in these trials. No phytotoxicity was observed. Crop stand in treated objects was equal to or better than the crop stand in the untreated control. Crop stand in the objects treated with Signum was comparable to the crop stand in the objects treated with a standard product based on iprodion, fludioxonil and cyprodinil, or vinchlozolin. Signum in chicory Phytotoxicity was assessed in all 6 effectiveness trials. The trials were performed with the chicory varieties Eureka, Opale and Mont Blanc. Signum was applied at the proposed dose rate of 1.5 kg/ha. No phytotoxicity was observed. Signum in cut flowers and pot plants Adverse effects on cut flowers and pot plants was assessed in 12 trials conducted in the Netherlands. The trials with cut flowers (6 trials) were performed with the rose variety Grand Prix, the Gerbera varieties A. Capella and Ezperanza and the Carnation varieties Golem and Grandslam. The trials with pot plants (6 trials) were conducted with the Saintpaulia varieties Spectra pink and Spectra blue, the Cyclamen variety Maxsora and the Ficus Benjamina varieties Danita and Golden king. During the trials assessments were made to determine phytotoxicity, visible spray residue and general crop condition. Cut flowers No phytotoxic symptoms on the flowers or leaves of the crops or any adverse effects on general crop condition were observed in any of the treatments in any of the trials. Very low Page 104

117 (03.3%) and comparable levels of visible spray residue was found for both Signum and the reference product based on iprodion in 3 trials, but no visible residue was found on the flowers in the other 3 trials. Visible spray residue on the leaves was found for both products in all the trials. The percentage of visible residue on leaves in the objects treated with Signum was generally slightly (sometimes significantly) higher than or comparable to that in the objects treated with the reference product based on iprodion. However, in two trials (with rose) higher dose rates of the reference product based on iprodion were used and no clear comparison with the test product can be made. The percentage visible residue on leaves in objects treated with low dose rates was generally significantly lower than that in objects treated with double that dose rate. Pot plants In 3 trials (1 trial with Cyclamen and 2 trials with Saintpaulia) no phytotoxic symptoms were observed in any of the treatments. However, in the 3 other trials (1 trial with Cyclamen and 2 trials with Ficus) some necrosis of the flowers or leaves, and in 1 trial (with Ficus) chlorosis of the leaves was observed. The percentage of leaf or flower area affected in the objects treated with Signum was significantly higher compared to the untreated control in these trials. Furthermore, the percentage of leaf or flower area in the objects treated with the reference product based on iprodion was significantly higher than that in the untreated control in 2 of these trials (with Ficus and Cyclamen respectively), but comparable to that in the untreated control in the other trial (with Ficus). Although the percentage of leaf or flower area affected was generally low in all treated objects and differences between treatments were generally small, the percentage in the objects treated with Signum (0.58%) was generally significantly higher than that in objects treated with the reference product based on iprodion (09.5%). Furthermore, in 2 of the trials the percentage of affected leaf or flower area in objects treated with Signum at the normal dose rate was (significantly) lower than that in the objects treated with the double dose rate in these trials. However, both dose rates were comparable in this respect in one trial. The percentage of visible spray residue on flowers was low (01.5%) and comparable in all treated objects. The percentage visible spray residue on leaves was also generally low (0 16.3%) in all treated objects in all of the trials. In 4 of the trials, objects treated with Signum or the reference product based on iprodion were comparable in respect to visible spray residue on leaves. However, in 2 of these trials (the trials with Saintpaulia), higher dose rates of the reference product based on iprodion were used and no clear comparison with the test product can be made. Furthermore, the percentage visible spray residue on leaves after the third application in the objects treated with Signum (315.5%) was slightly (sometimes significantly) higher than that in the objects treated with the reference product based on iprodion ( %) in the 2 trials conducted with Cyclamen. Furthermore, the percentage visible residue on leaves in objects treated with low dose rates was generally (sometimes significantly) lower than that in objects treated with double that dose rate. No adverse effects on general crop stand were found in any of the trials. Since some phytotoxicity was observed, a warning sentence has been added to the label: Het verdient de aanbeveling middels een proefbespuiting vast te stellen of het betreffende gewas de behandeling verdraagt Yield Green beans In 3 of the effectiveness trials, yield was measured in ton healthy pods per hectare. Yield in the treated objects was generally higher than the yield in the untreated control, but the difference was significant in one trial only. The yield in objects treated with Signum was generally comparable to the yield in objects treated with a standard product based on iprodion or fludioxonil and cyprodinil. Page 105

118 Chicory, cut flowers and pot plants Data on effects on yield was not submitted. Products based on pyraclostrobin and boscalid have already been authorised for usage in numerous crops for a considerable time all over Europe. The use of Signum against fungi is currently authorised in The Netherlands for the use in numerous crops grown out and indoors at a dose rate ranging from kg/ha and for the use in golf greens at a dose rate of 3 kg/ha. Experience shows that adverse effects on yield are not to be expected Effects on succeeding crops or substitution crops Data on effects on succeeding crops or substitution crops was not submitted. Effects are not expected as the active substances and their metabolites have no herbicidal activity. Products based on pyraclostrobin and boscalid have already been authorised for usage in numerous crops for a considerable time all over Europe. The use of Signum against fungi is currently authorised in The Netherlands for the use in numerous crops grown out and indoors at a dose rate ranging from kg/ha and for the use in golf greens at a dose rate of 3 kg/ha. Experience shows that adverse effects on succeeding crops or substitution crops are not to be expected Effects on plants or plant products to be used for propagation Data on effects on plants or plant products to be used for propagation was not submitted. Products based on pyraclostrobin and boscalid have already been authorised for usage in numerous crops for a considerable time all over Europe. The use of Signum against fungi is currently authorised in The Netherlands for the use in numerous crops grown out and indoors at a dose rate ranging from kg/ha and for the use in golf greens at a dose rate of 3 kg/ha. Furthermore, experience in several crops shows that adverse effects on parts of plants used for propagating purposes are not to be expected Effects on adjacent crops Data on effects on adjacent crops was not submitted. Products based on pyraclostrobin and boscalid have already been authorised for usage in numerous crops for a considerable time all over Europe. The use of Signum against fungi is currently authorised in The Netherlands for the use in numerous crops grown out and indoors at a dose rate ranging from kg/ha and for the use in golf greens at a dose rate of 3 kg/ha. Experience shows that impact on other plants is not to be expected. Extrapolation possibilities According to the extrapolation document Possibilities for extrapolation of efficacy and crop safety of crop protection products (CTB, May 2004), extrapolation is possible for phytotoxicity from bush green bean to bush common bean, climbing green beans, climbing common bean, snap bean runner bean, legume/pod (bush & climbing) and dry harvested beans. Furthermore, extrapolations can be made from the data on phytotoxicity in cut flowers and pot plants (indoors floriculture) to floriculture, tree nursery crops and perrenial plants. In respect to phytotoxicity extrapolation is possible from sweet pepper to chilli pepper. Conclusion The product complies with the Uniform Principles because it does not, in accordance with article 2.2., induce any unacceptable side effects on plants or plant products, when used and applied in accordance with the proposed label. 8.5 Resistance Boscalid belongs to the chemical group of the succinate dehygrogenase inhibitors (SDHI) The FRAC code is 7. Pyraclostrobin belongs to the Quinone outside inhibitors the FRAC code is 11. Page 106

119 The outcome of a combined resistance risk analysis was that the risk for development of resistance of the target pathogens Alternaria spp. and Puccinia spp., towards Signum can be estimated to be low to tolerable. However, the risk for development of resistance of Botryotinia fuckeliana and Leveillula taurica can be estimated to be moderate to high and acceptable respectively. Since Alternaria spp. and Puccinia spp may occur alongside these pathogens, management strategies are recommended in order to reduce the risk of resistance development. A common management strategy is the use of fungicide mixtures. Signum is already a combination of two active ingredients which are effective against Alternaria spp. and Puccinia spp.. Both inhibit fungal respiration but there is no risk of crossresistance due to their different sites of action in the electron transport chain. Another important resistance management strategy is the restriction of use. In the label text, the number of applications per season is restricted to two and it is recommended that, if necessary, applications with Signum are alternated with fungicides with different modes of action. The label contains resistance management sentences/warnings. Conclusion The product complies with the Uniform Principles, article as the level of control on the long term is not influenced by the use of this product because of the possible build up of resistance. 8.4 For vertebrate control agents: impact on target vertebrates Because no vertebrates are controlled, this point is not relevant. 8.5 Any other relevant data / information / Data requirements None. 9. Conclusion The authorization of Signum (12630 N) is extended with the use in hot pepper (nonsoil bound protected cultivation), and the use in floriculture, tree nurseries and perennial plants. The product complies with the Uniform Principles. The evaluation is in accordance with the Uniform Principles laid down in appendix VI of Directive 91/414/EEC. The evaluation has been carried out on basis of a dossier that meets the criteria of appendix III of the Directive. 10. Classification and labelling Proposal for the classification and labelling of the formulation Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the coformulants, the method of application and the risk assessments, the following labeling of the preparation is proposed: The identity of all substances in the mixture that contribute to the classification of the mixture *: diisobutylnaphthalenesulfonic acid, sodium salt Pictogram: GHS06 Signal word: Danger GHS09 Page 107

120 Hstatements: H301 Toxic if swallowed. H410 Very toxic to aquatic life with long lasting effects. Pstatements: P273 Avoid release to the environment. P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. P391 Collect spillage. P501 Dispose of contents/container to hazardous or special waste collection point. Supplemental Hazard information: EUH401 To avoid risks to human health and the environment, comply with the instructions for use. SP1 Do not contaminate water with the product or its container. Childresistant fastening obligatory? not applicable Tactile warning of danger obligatory? not applicable Explanation: Pictogram: Hstatements: Pstatements: GHS06: The LD50 value of the formulation toxicity study regarding acute oral toxicity is 200 < LD 50 rat < 500 mg/kg bw and therefore classification with H301 is proposed (GHS06). H301: The LD50 value of the formulation toxicity study regarding acute oral toxicity is 200 < LD 50 rat < 500 mg/kg bw and therefore classification with H301 is proposed. P301 + P310 are highly recommended based on classification with H301. Other: * according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b) In combination with earlier risk assessments; the following restriction sentences should be placed on the label*: Voor de onbedekte teelt van boomkwekerijgewassen, bloemisterijgewassen en vaste planten geldt dat de planten niet hoger mogen zijn dan 150 cm. Om in het water levende organismen te beschermen is toepassing in de teelt en opkweek (waarbij in de opkweek de bomen > 150 cm) van kers, morel en pruim op percelen die grenzen aan oppervlaktewater alleen toegestaan vóór 1 mei met minstens één van de volgende driftreducerende maatregelen: in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het perceel bespoten dient te worden. Wannerspuit met reflectiescherm en venturidoppen (Lechler ID 90015C). Om in het water levende organismen te beschermen is toepassing in de teelt en opkweek (waarbij in de opkweek de bomen > 150 cm) van kers, morel en pruim op percelen die grenzen aan oppervlaktewater alleen toegestaan na 1 mei met minstens één van de volgende driftreducerende maatregelen: er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of: in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het perceel bespoten dient te worden. Page 108

121 Wannerspuit met reflectiescherm en venturidoppen (Lechler ID 90015C). Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van crambe, daikon, tuinkruiden, rettich, rucola, veldsla, graszodenteelt en in greens van golfterreinen uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater gebruik wordt gemaakt van minimaal 90% driftreducerende doppen. Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van bloemisterijgewassen, boomkwekerijgewassen en vaste planten amsoi, boerenkool, choisum, paksoi, comatsuna en Chinese kool uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater gebruik wordt gemaakt van minimaal 75% driftreducerende spuitdoppen. Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden. * sentences for this assessment highlighted in yellow. Page 109

122 Appendix 1A:Table of authorised uses (active substance boscalid) Page 110

123 Appendix 1B: Table of authorised uses (active substance pyraclostrobin) Page 111