Toelatingsnummer 7774 N

Decis EC  

 

7774 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 HERREGISTRATIE TOELATING

 

Gelet op de aanvraag d.d. 28 oktober 2005 (20050352 THG) van

 

Bayer CropScience SA-N.V.

Energieweg 1

3641 RT  MIJDRECHT

 

 

tot herregistratie 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 stof deltamethrin

 

Decis EC

 

gelet op artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 39, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Herregistratie toelating

1.     De toelating van het gewasbeschermingsmiddel Decis EC, welke expireert op
1 februari 2013 wordt voor de in bijlage I genoemde toepassingen verlengd onder nummer 7774 N. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

2.     De toelating geldt tot1 januari 2023.

 

1.2  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.

 

1.4 Classificatie en etikettering

Gelet op artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 29, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden,

 

1.    De aanduidingen, welke ingevolge artikelen 9.2.3.1 en 9.2.3.2 van de Wet milieubeheer en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt:

 

aard van het preparaat: Emulgeerbaar concentraat

 

werkzame stof:

gehalte:

deltamethrin

25 g/l

 

 

 

letterlijk en zonder enige aanvulling:

 

andere zeer giftige, giftige, bijtende of schadelijke stof(fen): nafta, laag kookpunt, aromatisch

 

 

gevaarsymbool:

aanduiding:

Xn

Schadelijk

N

Milieugevaarlijk

 

 

Waarschuwingszinnen: 

 

R10                 -Ontvlambaar.

R20/22            -Schadelijk bij inademing en opname door de mond.

R37/38            -Irriterend voor ademhalingswegen en de huid.

R41                 -Gevaar voor ernstig oogletsel.

R50/53            -Zeer vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

R65                 -Schadelijk: kan longschade veroorzaken na verslikken.

 

 

Veiligheidsaanbevelingen:

 

 

S23d               -Spuitnevel niet inademen.

S24                 -Aanraking met de huid vermijden.

S26                 -Bij aanraking met de ogen onmiddellijk met overvloedig water afspoelen en deskundig medisch advies inwinnen.

S39a               -Een bescherming voor de ogen dragen.

S51                 -Uitsluitend op goed geventileerde plaatsen gebruiken.

S60                 -Deze stof en de verpakking als gevaarlijk afval afvoeren. (Deze zin hoeft niet te worden vermeld op het etiket indien u deelneemt aan het verpakkingenconvenant, en op het etiket het STORL-vignet voert, en ingevolge dit convenant de toepasselijke zin uit de volgende verwijderingszinnen op het etiket vermeldt:

Deze verpakking is bedrijfsafval, mits deze is schoongespoeld, zoals wettelijk is voorgeschreven.

Deze verpakking is bedrijfsafval, nadat deze volledig is geleegd.

Deze verpakking dient nadat deze volledig is geleegd te worden ingeleverd bij een KCA-depot. Informeer bij uw gemeente.)

S61                 -Voorkom lozing in het milieu. Vraag om speciale instructies / veiligheidsgegevenskaart.

 

 

Specifieke vermeldingen:

 

DPD01            -Volg de gebruiksaanwijzing om gevaar voor mens en milieu te voorkomen.

 

2.      Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten voorge­schreven aanduidingen en vermeldingen moeten op de verpakking voorkomen:

 

a.      letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.

 

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.12.

 

1.5 Aflever- en opgebruiktermijn

Het middel Decis EC mag voor de niet meer toegelaten etikettering:

1.      tot 1 januari 2014 nog worden gebruikt en in voorraad of voorhanden worden gehouden;

2.      tot 1 juli 2013 nog op de markt worden gebracht.

 

 

2 DETAILS VAN DE AANVRAAG EN TOELATING

 

2.1 Aanvraag

Het betreft een aanvraag tot herregistratie van de toelating van het middel Decis EC
(7774 N), een middel op basis van de werkzame stof deltamethrin. De herregistratie wordt aangevraagd voor de toelating als insectenbestrijdingsmiddel

a)      in de teelt van consumptieaardappelen, zetmeelaardappelen en pootaardappelen;

b)      in de teelt van suikerbieten en voederbieten;

c)      in de teelt van granen;

d)      in de teelt van maïs;

e)      in de teelt van landbouwerwten;

f)        in de teelt van landbouwstambonen;

g)      in de teelt van veldbonen;

h)      in de teelt van graszaad en graszoden alsmede in weiland en sportvelden;

i)        in de teelt van blauwmaanzaad, karwij, vezelvlas, lijnzaad en zomer- en winterkoolzaad;

j)        in de teelt van bladrammenas, bladkool en stoppelknollen;

k)      in de onbedekte teelt van rode bessen, zwarte bessen en kruisbessen;

l)        in de teelt van aardbeien;

m)   in de onbedekte teelt van bramen en frambozen;

n)      in de teelt van sla (met uitzondering van veldsla), de onbedekte teelt van andijvie en de onbedekte teelt van spinazie;

o)      in de teelt van peulvruchten;

p)      in de teelt van aubergines, komkommers, meloenen, paprika's, Spaanse peper, tomaten en de bedekte teelt van augurken en courgette;

q)      in de teelt van rode kool, savooie kool, spitskool, witte kool, bloem­kool, broccoli, spruitkool en koolrabi;

r)       in de teelt van koolraap, knolraap (consumptieraap), de onbedekte teelt van radijs en de teelt van rammenas;

s)      in de teelt van zaaiuien, 1e-jaars plantuien, 2e-jaars plantuien, zilveruien, picklers, sjalotten, knoflook en prei;

t)        in de teelt van asperges mits toegepast na het steken;

u)      in de teelt van paddestoelen;

v)    in de teelt van bloembol- en bolbloemgewassen;

w)    in de teelt van bloemisterijgewassen, vaste planten en boomkwekerijge­wassen (waarbij voor de onbedekte teelt geldt dat uitsluitend toepassingen waarbij neerwaarts wordt bespoten zijn toegestaan).

 

2.2 Informatie met betrekking tot de stof

De werkzame stof deltamethrin is bij Richtlijn 2003/5/EG, d.d. 10 januari 2003 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

De werkzame stof in Decis EC is deltamethrin. Deltamethrin behoort tot de groep van de pyrethroiden. Deltamethrin is een snel werkend niet-systemisch insecticide met een contact- en maagwerking. Het blokkeert het functioneren van de natriumkanalen, zodat er geen overdracht van zenuwimpulsen plaatsvindt. Deltamethrin heeft binnen een aantal minuten effect op insecten, wat resulteert in de beëindiging van vraat aan de planten. De insecten sterven in een later stadium. Vanwege de lipofiele eigenschappen van de stof wordt deze zeer snel geabsorbeerd in de lipiden-rijke cuticula (opperhuid) van de insecten wat met name het knock-down effect geeft.

In Nederland zijn diverse producten gebaseerd op deltamethrin toegelaten voor toepassingen in diverse gewassen, bossen, parken en tuinen, tegen een breed spectrum aan insecten.

 

2.4 Voorgeschiedenis

De aanvraag is op 28 oktober 2005 ontvangen; op 31 oktober 2005 zijn de verschuldigde aanvraagkosten ontvangen.

 

 

3  RISICOBEOORDELINGEN

 

De beoordeling van deze aanvraag is conform HTB 1.0.

 

3.1  Fysische en chemische eigenschappen

De aard en de hoeveelheid van de werkzame stoffen en de in toxicologisch 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 van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht (artikel 28, eerste lid, sub c en e, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van de evaluatie van het middel en de stof staat beschreven in Hoofdstuk 2, Physical and Chemical Properties, in Bijlage II bij dit besluit.

 

3.2  Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten. De residuen die het gevolg zijn van geoorloofd gebruik die in toxicologisch opzicht of vanuit milieu oogpunt van belang zijn, kunnen worden bepaald met algemeen gebruikte passende methoden (artikel 28, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van de evaluatie van de analysemethoden staat beschreven in Hoofdstuk 3, Methods of Analysis, in Bijlage II bij dit besluit.

 

3.3  Risico voor de mens

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen directe of indirecte schadelijke uitwerking heeft op de gezondheid van de mens. De voorlopige vastgestelde maximum residugehalten op landbouwproducten zijn aanvaardbaar (artikel 28, eerste lid, sub b, onderdeel 4 en sub f, Wet gewasbeschermingsmiddelen en biociden).
Het profiel humane toxicologie inclusief de beoordeling van het risico voor de toepasser staat beschreven in Hoofdstuk 4 Mammalian Toxicology, in Bijlage II bij dit besluit.

Het residuprofiel, de vastgestelde maximum residugehalten en de beoordeling van het risico voor de volksgezondheid staan beschreven in Hoofdstuk 5, Residues in bijlage II behorende bij dit besluit.

 

3.4  Risico voor het milieu

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met de volgende aspecten:

-          de plaats waar het middel in het milieu terechtkomt en wordt verspreid, met name voor wat betreft besmetting van het water, waaronder drinkwater en grondwater,

-          de gevolgen voor niet-doelsoorten.

(artikel 28, eerste lid, sub b, onderdeel 4 en 5, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het risico voor het milieu staat beschreven in Hoofdstuk 6, Environmental Fate and Behaviour, en Hoofdstuk 7, Ecotoxicology, in Bijlage II bij dit besluit.

 

3.5  Werkzaamheid

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, voldoende werkzaam is en geen onaanvaardbare uitwerking heeft op planten of plantaardige producten (artikel 28, eerste lid, sub b, onderdelen 1 en 2, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het aspect werkzaamheid staat beschreven in Hoofdstuk 8, Efficacy, in Bijlage II bij dit besluit.

 

3.6  Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Decis EC op basis van de werkzame stof deltamethrin voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu.

 

 


4  AFLEVER- EN OPGEBRUIKTERMIJN

 

Er is een aflever- en opgebruiktermijn vastgesteld (zie 1.5).

 

 

 

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden 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, 18 januari 2013

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,





ir. J.F. de Leeuw

voorzitter


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 18 januari 2013 tot herregistratie van de toelating van het middel Decis EC, toelatingnummer 7774 N

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als insectenbestrijdingsmiddel:

a)      in de teelt van consumptieaardappelen, zetmeelaardappelen en pootaardappelen;

b)      in de teelt van suikerbieten en voederbieten;

c)      in de teelt van granen;

d)      in de teelt van maïs;

e)      in de teelt van landbouwerwten;

f)        in de teelt van landbouwstambonen;

g)      in de teelt van veldbonen;

h)      in de teelt van graszaad en graszoden alsmede in weiland en sportvelden;

i)        in de teelt van blauwmaanzaad, karwij, vezelvlas, lijnzaad en zomer- en winterkoolzaad;

j)        in de teelt van bladrammenas, bladkool en stoppelknollen;

k)      in de onbedekte teelt van rode bessen, zwarte bessen en kruisbessen;

l)        in de teelt van aardbeien;

m)   in de onbedekte teelt van bramen en frambozen;

n)      in de teelt van sla (met uitzondering van veldsla), de onbedekte teelt van andijvie en de onbedekte teelt van spinazie;

o)      in de teelt van peulvruchten

p)      in de teelt van aubergines, komkommers, meloenen, paprika's, Spaanse peper, tomaten en de bedekte teelt van augurken en courgette;

q)      in de teelt van rode kool, savooie kool, spitskool, witte kool, bloem­kool, broccoli, spruitkool en koolrabi;

r)       in de teelt van koolraap, knolraap (consumptieraap), de onbedekte teelt van radijs en de teelt van rammenas;

s)      in de teelt van zaaiuien, 1e-jaars plantuien, 2e-jaars plantuien, zilveruien, picklers, sjalotten, knoflook en prei;

t)        in de teelt van asperges mits toegepast na het steken;

u)      in de teelt van paddestoelen;

v)    in de teelt van bloembol- en bolbloemgewassen;

w)    in de teelt van bloemisterijgewassen, vaste planten en boomkwekerijge­wassen (waarbij voor de onbedekte teelt geldt dat uitsluitend toepassingen waarbij neerwaarts wordt bespoten zijn toegestaan).

 

Per teeltseizoen mogen maximaal 3 toepassingen met Decis EC worden uitgevoerd, tenzij anders aangegeven.

 

Om in het water levende organismen te beschermen is toepassing uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater gebruik wordt gemaakt van:

 

- minimaal 75% driftreducerende spuitdoppen in de volgende teelten:

aardappelen (alle toepassingen), landbouwerwten, landbouwstambonen, veldbonen, bladrammenas, bladkool en stoppelknollen, rode bessen, zwarte bessen, kruisbessen, bramen en frambozen, sla, andijvie, spinazie, peulvruchten, rode kool, savooie kool, spitskool, witte kool, bloemkool, broccoli, spruitkool, koolraap, knolraap (consumptieraap), radijs, rammenas, zaaiuien, 1e-jaars plantuien, 2e-jaars plantuien, zilveruien, picklers, sjalotten, knoflook, prei, asperges, bloembol- en bolbloemgewassen (met uitzondering van gladiool), vaste planten; en

- minimaal 75% driftreducerende spuitdoppen in de teelt van boomkwekerijgewassen,waarbij geldt dat toepassing uitsluitend door middel van een neerwaartse bespuiting mag plaatsvinden.

- minimaal 90% driftreducerende spuitdoppen in de volgende teelten:

koolrabi, gladiool, bloemisterijgewassen, mais

 

Gevaarlijk voor bijen en hommels. Om de bijen en andere bestuivende insecten te beschermen mag u dit product niet gebruiken op in bloei staande gewassen of op niet-bloeiende gewassen wanneer deze actief bezocht worden door bijen en hommels. Gebruik dit product niet wanneer bloeiende onkruiden aanwezig zijn. Gebruik is wel toegestaan op bloeiende planten in de kas mits er geen bijen of hommels in de kas actief naar voedsel zoeken. Voorkom dat bijen en andere bestuivende insecten de kas binnenkomen, bijvoorbeeld door alle openingen met insectengaas af te sluiten.

 

Let op: dit middel kan schadelijk zijn voor bestuivers in kasteelten. Raadpleeg uw leverancier van bestuivers over het gebruik van dit middel in combinatie met het gebruik van bestuivers en over de in acht te nemen wachttijden.

 

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.

 

Behandelde percelen mogen niet tijdens en binnen 30 dagen na toepassing worden beweid of gemaaid ten behoeve van voederdoeleinden.

 

VEILIGHEIDSTERMIJNEN

De termijn tussen de laatste toepassing en de oogst mag niet korter zijn dan:

3 dagen voor aardbeien, aubergines, augurken, courgettes, komkom­mers, meloenen,

paprika's, Spaanse peper, tomaten, paddestoelen.

7 dagen voor aardappelen, landbouwerwten, landbouwstambonen, veldbonen, peulvruchten bladrammenas, bladkool, stoppelknollen, rode bessen, zwarte bessen, kruisbessen, bramen, frambozen, sla (met uitzondering van veldsla), de onbedekte teelt van andijvie, de onbedekte teelt van spinazie, rode kool, savooienkool, spitskool, witte kool, bloem­kool, broccoli, spruitkool, koolrabi, koolraap, knolraap (consumptieraap), de onbedekte teelt van radijs, rammenas, zaaiuien, 1e-jaars plantuien, 2e-jaars plantuien, zilveruien, picklers, sjalotten, knoflook, asperge en prei.

30 dagen voor granen, maïs, suiker- en voederbieten.

45 dagen voor zomer- en winterkoolzaad en karwij

60 dagen voor blauwmaanzaad, lijnzaad en vezelvlas

 

Dit middel is uitsluitend bestemd voor professioneel gebruik.

 

 

B.

GEBRUIKSAANWIJZING

 

Decis EC is geformuleerd als emulgeerbaar concentraat (EC). Het middel werkt als een contact‑ en maaggif, de werking is bijzonder snel. Decis EC werkt niet systemisch, heeft geen dampwerking en dringt niet in het blad door, wel dringt het middel diep in de waslaag door. Decis EC bezit in de aangegeven doserin­gen geen fytotoxische eigenschap­pen.

Decis EC is werkzaam tegen vele insecten.

 

 


TOEPASSINGEN

 

Consumptieaardappelen, zetmeelaardappelen en pootaardap­pelen, ter bestrijding van larven van de Colorado­kever.

Een behandeling uitvoeren zodra de larven de grootte van een tarwekor­rel hebben bereikt.

Dosering: 300 ml per ha.

 

Pootaardappelen, ter voorkoming van virusoverdracht (o.a. bladrolvirus) door bladluizen.

Toepassen zodra 90% van de planten is opgekomen. De behandeling 14 dagen later herhalen.

Dosering: 400 ml per ha.

 

Pootaardappelen, ter voorkoming van virusoverdracht van het Yn-virus door bladluizen.

Toepassen in de periode vanaf de opkomst van het gewas tot één week voor de rooidatum. In de beheersingsstrategie kan Decis EC maximaal 3x worden ingezet.

Dosering: 200 ml per hectare in combinatie met minerale olie.

Voor de dosering van de minerale olie raadplege men de publicaties van o.a. de DLV. Het middel toepassen in combinatie met minerale olie.

 

Consumptie- en zetmeelaardappelen, ter bestrijding van bladluizen ter voorkoming van zuigschade.

Een behandeling uitvoeren wanneer gemiddeld meer dan 50 bladluizen per samengesteld blad voorkomen.

Dosering: 200 ml per ha.

 

Suiker‑ en voederbieten, ter bestrijding van tripsen en rupsen.

De bestrijding van trips kan het beste worden uitge­voerd wanneer de tripsen op de jonge plant­jes worden waar­geno­men.

Rupsen, die in de maand augustus hier en daar worden aange­troffen, kunnen soms een aanzienlijke hoeveel­heid blad wegvreten. De schade valt doorgaans mee. In een enkel geval kan bestrijding gewenst zijn.

Dosering: 300 ml per ha.

 

Granen, ter bestrijding van bladluizen.

Een bespuiting uitvoeren als tenminste 70% van de halmen met bladluizen is bezet.

Een toepassing in het najaar kan ook noodzakelijk zijn bij veel bladluizen op de jonge halmen.
Een gecombineerde bestrijding van bladluizen en afrijpingsziekten is verantwoord wanneer bij begin bloei tenminste 30% van de halmen met bladluizen is bezet.

Dosering: 250 ml per ha.

 

Maïs, ter bestrijding van de maïswortelkever (Diabrotica virgifera virgifera).

Toepassingsinterval: ca. twee weken

Dosering: 500 ml per ha

 

Landbouwerwten, ter bestrijding van tripsen en de erwtenpeulboor­der.

Dosering: 300 ml per ha

 

Landbouwerwten en veldbonen, ter bestrijding van bladrandkever.

Zodra vreterij van de bladrandkever aan de blaadjes van de jonge planten wordt waargenomen een behandeling uitvoeren.

Dosering: 300 ml per ha

 

Landbouwstambonen (bruine bonen, witte bonen, gele bonen, kievitsbonen), ter bestrijding van tripsen.

Dosering: 300 ml per ha

 

Graszaadteelt, graszodenteelt, sportvelden en in weiland, ter bestrijding van de larven van de rouw­vlieg.

Bij voorkeur spuiten met veel water; regen kort na de toepassing heeft een gunstig effect op de bestrij­ding.

De behandeling dient in de herfst te worden uitge­voerd.

Om de kans op contact van het middel met de larven te vergroten, verdient het aanbeveling het weiland eerst te slepen en geen drijfmest kort voor de bespui­ting aan te brengen.

N.B.: Het middel heeft geen effect op emelten.

Dosering: 300 ml per ha.

 

Graszaadteelt van veldbeemd, ter bestrijding van de graszaadgal­mug.

De 1e bespuiting dient circa één week na het begin van de eiafzetting te worden uitgevoerd; op overja­rige perce­len dient de bespuiting na 14 dagen te worden herhaald. Op 1e‑jaars percelen kan met één bespui­ting worden volstaan, na verwijdering van de dekvrucht.

Dosering: 500 ml per ha.

 

Vezelvlas, lijnzaad en blauwmaanzaad, ter bestrijding van trips.

Een behandeling uitvoeren zodra aantasting wordt waarge­nomen.

Dosering: 300 ml per ha.

 

Zomer– en winterkoolzaad, ter bestrijding van de koolzaadglanske­ver.

Zodra vóór de bloei van het gewas gemiddeld 3‑5 glanske­vers per plant aanwezig zijn, een behandeling uitvoe­ren.

Als het gewas bloeit, is een bestrijding niet zinvol meer.

Dosering: 200 ml per ha.

 

Zomer– en winterkoolzaad, ter bestrijding van de koolzaadsnuitkever.

Vanaf het moment dat de eerste hauwen gevormd zijn, een behandeling uitvoeren zodra per plant 1 of meer snuitke­vers aanwezig zijn.

Nadat alle hauwen zijn gevormd, is een bestrijding niet zinvol meer.

Dosering: 200 ml per ha.

 

Karwij, ter bestrijding van de karwijmot.

Zodra de eerste rupsjes zich in de schermen inspinnen een behandeling uitvoeren.

Dosering: 200 ml per ha.

 

Bladrammenas, bladkool en stoppelknollen, ter bestrijding van rupsen.

Een behandeling uitvoeren zodra aantasting wordt waargenomen.

Dosering: 300 ml per ha.

 

Fruitgewassen

 

De onbedekte teelt van rode bessen, zwarte bessen en kruisbessen, ter bestrijding van rupsen van bonte bessenvlin­der, blad­rollers en de bastaardrups van de bes­se­blad­wesp. De toepassing dient kort voor de bloei en na de bloei plaats te vinden als de eispiegels uitkomen.

De bestrijding van wantsen dient plaats te vinden bij het verschijnen van de larven.

Het is vrijwel zeker dat bij het juiste bestrijdingsmo­ment van deze  insecten sommige bessen in bloei staan. Dat betekent dat een bespui­ting vóór de bloei moge­lijk te vroeg is en direct na de bloei herhaald moet worden.

Dosering: 0,02% (20 ml per 100 liter water).

 

Aardbeien, ter bestrijding van aardbeibloesemkever, trips en rupsen.

Dosering: 0,02% (20 ml per 100 liter water) met een maximale hoeveelheid spuitvloeistof van 1000 liter per hectare

 

De onbedekte teelt van bramen en frambozen, ter bestrijding van aardbeibloesemkever en frambozekever. Eén keer spuiten 10‑14 dagen vóór de bloei en/of één keer spuiten kort vóór de bloei gevolgd door één keer spuiten vlak na de bloei.

Dosering: 0,02% (20 ml per 100 liter water)

 

De onbedekte teelt van bramen en frambozen, ter bestrijding van rupsen (o.a. bladrollers) toepassen vóór de bloei en eventueel op het tijdstip van de eerste generatie van de vrucht­bladrol­ler (± half juni).

Dosering: 0,02% (20 ml per 100 liter water)

 

De onbedekte teelt van bramen en frambozen, ter bestrijding van wantsen vóór de bloei spui­ten bij het uitkomen van de eieren.

Dosering: 0,02% (20 ml per 100 liter water)

 

Groentegewassen

 

Sla (met uitzondering van veldsla), onbedekte teelt van andijvie en de onbedekte teelt van spinazie, ter bestrij­ding van rupsen.

Dosering: 0,05% (50 ml per 100 liter water)

 

Peulvruchten (stamslaboon, stamsnijboon, boterboon, flageolet, stokslaboon, stoksnijboon, spekboon, pronkboon, peulen, asperge-erwt, doperwt, kapucijner, suikererwt, kouseband, tuinboon, sojaboon, limaboon, cowpea), ter bestrijding van tripsen.

Dosering: 300 ml per ha

 

Aubergines, komkommers, meloenen, papri­ka's, Spaanse peper en tomaten en de bedekte teelt van augurken en courgettes, ter bestrij­ding van rupsen, bladrollers, ­witte­vlieg, mi­neervlieg en trips.

De behandeling enige malen (maximaal 3 keer) herhalen met een inter­val van plm. 7 dagen.

Dosering: 0,05% (50 ml per 100 liter water) met een maximale hoeveelheid spuitvloeistof van 1400 liter per hectare

 

Rode kool, savooie kool, spitskool, witte kool, bloemkool, broccoli, spruitkool, en koolrabi, ter bestrijding van koolrupsen, koolmot en bladrollers. Spuiten zodra eerste vrete­rij zicht­baar wordt.

Ter bestrij­ding van koolgalmug het middel toepassen zodra de eerste eitjes zijn afgezet. De bespui­ting zonodig herhalen.

Dosering: 300 ml per ha.

 

Koolraap en knol­raap (con­sumptieraap) de onbedekte teelt van radijs en rammenas (rettich), ter bestrijding van rupsen en trips.

Zodra aantas­ting optreedt dient met de bespuiting begonnen te worden.

Dosering: 300 ml per ha.

 

Zaaiuien, 1e-jaars plantuien, 2e-jaars plantuien, zilver­uien, pick­lers, sjalotten, knoflook en prei, ter bestrijding van preimot, trips en mineervlieg.

Dosering: 300 ml per ha.

 

Asperges, ter bestrijding van aspergekever en asperge­vlieg.

  in 1‑ en 2‑jarige velden:

   zodra de stengels boven de grond komen;

  in productievelden:

   direct na de oogst. De behandeling desgewenst herha­len.

Dosering: 300 ml per ha.

 

Paddestoelenteelt, ter bestrijding van champignonvliegen en ‑mu­ggen.

 

Spuitbehandeling

Het is aan te bevelen Decis EC op de bedden onder lage druk en in de rest van de cel onder hoge druk toe te passen.

Tijdstip van toepassing: Ná het afdekken tot en met de oogst met in achtname van de veiligheidstermijn.

Dosering: 3 ml in 50-100 liter water per 100 m² teeltoppervlak.

Hiervan ongeveer twee‑derde gedeelte op de bedden en één‑derde gedeelte voor de rest van de cel (vloer, plafond, bekisting en muren).

 

Ruimtebehandeling

Toelichting:

Tijdens de behandeling en enige tijd daarna moeten de champig­nons droog blijven. Vanaf het moment van de behandeling dient de ventilatie en de circulatie geduren­de 1 uur stopgezet te worden en dient de verlich­ting ingescha­keld te zijn.

Dosering: 3 ml per 100 m3 celinhoud door middel van ruimtebehandelingsapparatuur (Puls- of Swingfog of electrische verdampers).

 

Bloemisterij‑, boomkwekerij‑, bolbloem- en bloembolge­wassen en vaste planten

 

Bloembol- en bolbloemgewassen, ter bestrij­ding van rupsen, bladrollers, mineer­vlieg, trips, wit­te vlieg en dop en schildluizen.

Dosering: 0,05% (50 ml per 100 liter water)

                

Gladiolen, ter bestrijding van trips (gewas­bespuiting).

Dosering: 300 ml per ha.

 

Tulp en hyacint, ter beperking van verspreiding van non-persistente virussen.

Toepassen in de periode vanaf mei . Bij tulpen de bespuitingen voortzetten tot de derde week van juni en bij hyacinten tot één week voor het rooien. In de beheersingsstrategie kan Decis EC maximaal 2x worden ingezet.

Dosering: 400 ml per ha.

 

Lelie, ter beperking van verspreiding van non-persistente virussen.

Toepassen in de periode vanaf kort na opkomst tot kort voor rooien. In de beheersingsstrategie kan Decis EC maximaal 2x worden ingezet. Gecombineerde toepassing met minerale olie kan het effect verbeteren.

Dosering: 400 ml per ha.

    

Bloemisterijgewassen, ter bestrijding van rupsen, bladrollers, mineer­vlieg, trips, wit­te vlieg en dop en schildluizen.

Behandeling herhalen met een interval van 7 dagen.

Dosering: 0,05% (50 ml per 100 liter water) met een maximale hoeveelheid spuitvloeistof van 1000 liter per hectare in bedekte teelten

 

Boomkwekerijgewassen en vaste planten, ter bestrijding van diverse rupsen (o.a. spin­selmotten, bas­taardsa­tijnvlinder, bladrol­lers), trips, bladmi­neer­ders, eiketop­gal­mug en dennelotrups.

Spuiten zodra de aantasting optreedt. Bij rupsen van de bas­taardsatijnvlinder eventueel ook spuiten in de nazomer vóórdat de rupsen zich inspinnen.

Het verdient aanbeveling door middel van een proefbespuiting vast te stellen of het gewas de behandeling verdraagt.

Dosering: 0,02% (20 ml per 100 liter water).

Gecombineerd toepassen met minerale olie kan het effect verbeteren.

Voor de dosering van minerale olie raadpleegt men de voorlichting.

 

 

 


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 18 januari 2013 tot herregistratie van de toelating van het middel Decis EC, toelatingnummer 7774 N

 

 

 Contents                                                                                                                            Page

           

1          Identity of the plant protection product                                                                 15

2          Physical and chemical properties                                                                           16

3          Methods of analysis                                                                                                              20

4          Mammalian toxicology                                                                                               24

5          Residues                                                                                                                     30

6          Environmental fate and behaviour                                                                         43

7          Ecotoxicology                                                                                                             60

8          Efficacy                                                                                                                      111

9          Conclusion                                                                                                               112

10        Classification and labelling                                                                                    113

 

Appendix 1    Table of authorised uses

 


1.      Identity of the plant protection product

 

1.1       Applicant

Bayer CropScience B.V.

Energieweg 1

3641 RT  MIJDRECHT

 

1.2       Identity of the active substance

Common name

Deltamethrin

Name in Dutch

Deltamethrin

Chemical name

(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate
or
(S)-
α-cyano-3-phenoxybenzyl (1R)-cis-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate [IUPAC]

CAS no

52918-63-5

EEG no

2582566

 

The active substance was included on November 1st 2003 in Annex 1 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

Decis EC

Formulation type

EC

Content active substance

25 g/L pure deltamethrin

 

The formulation was not part of the assessment of the active substance for inclusion in the Annex I list of Directive 91/414/EEC.

 

1.4       Function

Insecticide.

 

1.5       Uses applied for

See GAP (Appendix I).

Finally some of the originally claimed uses in this application were withdrawn or modified by the applicant. Only where relevant for the risk assessment, updates were made. Only the uses given in the legal instructions for use and GAP table are authorized.   

 

1.6       Background to the application

It concerns a re-registration.

 

1.7       Packaging details

Material:

HDPE/PA

Capacity:

1, 5 or 10L

Type of closure and size of opening:

Bottle: Coed HDPE innerlined PA

Cap: HDPE or Ppcopolymer (HF seal)

Other information

ADR/UN compliant

 

1.7.2    Detailed instructions for safe disposal

See application form and MSDS.

 

 

2.      Physical and chemical properties

 

2.1              Active substance: deltamethrin

Data on the identity and the physical and chemical properties is taken from the List of Endpoints (July 2002). Changes and/or additions are taken up in italics.

 

Identity

Active substance (ISO Common Name)

Deltamethrin

Chemical name (IUPAC)

(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate
or
(S)-
α-cyano-3-phenoxybenzyl (1R)-cis-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate

Chemical name (CA)

(S)-cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate

CIPAC No

333

CAS No

52918-63-5

EEC No (EINECS or ELINCS)

2582566

FAO Specification (including year of                                publication)

980 g/kg; technical product is a single stereoisomer (1991)

Minimum purity of the active substance as manufactured (g/kg)

985

Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg)

None

Molecular formula

C22H19Br2NO3

Molecular mass

505.2

Structural formula

 

 

Physical-chemical properties

Melting point (state purity)

100-102°C (373-375°K), (technical grade)*

Boiling point (state purity)

Decomposes before reaching boiling point (technical grade)

Temperature of decomposition

»270°C

Appearance (state purity)

Off-white solid powder (technical grade)*

Relative density (state purity)

0.550 g/cm3 (bulk density) (technical grade)*

Surface tension

Not required based on low water solubility

Vapour pressure (in Pa, state temperature)

1.24 x 10-8 Pa, 25ºC

Henry’s law constant (in Pa·m3·mol-1)

3.1 x 10-2  Pa×m3/mol, 25ºC

Solubility in water (in g/l or mg/l, state                                   temperature)

0.0002 mg/l, 25ºC; solubility not pH dependent, determined at pH 7.49-7.85

< 0.005 mg/l, 20ºC by column elution method, pH 6.2

Solubility in organic solvents (in g/l or  mg/l, state temperature)

Highly soluble in most organic solvents at room temperature:

1,2-dichloroethane     >600 g/l, 20ºC

acetone                      300-600 g/l, 20ºC

dimethylsulfoxide        200-300 g/l, 20ºC

ethyl acetate               200-300 g/l, 20ºC

p-xylene                      150-200 g/l, 20ºC

xylene                         175 g/l, 25ºC

acetonitrile                  60-75 g/l, 20ºC

methanol                    8.15 g/l, 20ºC

n-heptane                   2.47 g/l, 20ºC

Partition co-efficient (log Pow) (state pH and temperature)

4.6, 25ºC, pH 7.6 (not pH dependent)

Hydrolytic stability (DT50) (state pH and temperature)

pH___5___: Hydrolysis is negligible (25°)

pH___7___: Hydrolysis is negligible (25°)

pH___9___: DT50 = 2.5 days (mean value) (25°)

Dissociation constant

Does not dissociate

UV/VIS absorption (max.) (if absorption >290 nm state ε at wavelength)

Abs. maxima at 267, 271 and 278 nm

Low to very low absorption at 290-300 nm

Photostability (DT50) (aqueous, sunlight, state pH)

Direct phototransf. t½ 48 days; indirect phototransf.

t½ = 4 days, (benzyl-labelled deltamethrin)

Quantum yield of direct photo-

transformation in water at λ > 290 nm

8.72 x 10-4 (calculated)

Photochemical oxidative degradation in air

Half-life for reaction with OH-radicals, given a 24-h concentration of 0.5 x 106 OH/cm3, was calculated to 16.4 hours

Flammability

Not highly flammable (purity >98%)

Auto-flammability

270 oC (purity >98%)

Oxidative properties

Not oxidising (statement)

Explosive properties

Not explosive (98.4% TGAI)

*) The values for melting point, appearance and relative density are determined with technical grade active ingredient instead of the pure active ingredient. This should be taken into account with the European re-evaluation of the active substance.

 

2.2              Plant protection product: Decis EC

Decis EC is an emulsifiable concentrate. Data on the plant protection product are taken from studies submitted by the notifier.

The range of the application concentration of the plant protection product is 0.02-0.05%.

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

visual

Clear liquid

Acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

visual

Yellow

Acceptable

 

B.2.2.3 (IIIA 2.1)

Appearance: odour

organoleptic

Aromatic

Acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

GLP:yes

EEC A.14

No danger of explosion

Acceptable

 

B.2.2.5 (IIIA 2.2)

Oxidising properties

Theoretical assessment

No oxygen compound at significant concentration

Acceptable, no glp at statement

 

B.2.2.6 (IIIA 2.3)

Flammability

 

Not applicable

 

B.2.2.7 (IIIA 2.3)

Auto-flammability

EEC A.15

460°C

Acceptable

B.2.2.8 (IIIA 2.3)

Flash point

glp:yes

EEC A.9

48 °C

Acceptable.

As R10 at label as formulation is flammable.

B.2.2.9 (IIIA 2.4)

Acidity / alkalinity

 

Not applicable

 

B.2.2.10 (IIIA 2.4)

pH

CIPAC MT 75

1% solution; pH=5 in distilled water

Acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

EEC A.5

27.3 mN/m at 40 °C

Acceptable.

Non-essential information.

B.2.2.12 (IIIA 2.5)

Viscosity

DIN 51562

Kinematic viscosity:

1.09 mm2/s at 40 °C

Acceptable.

Non-essential information.

B.2.2.13 (IIIA 2.6)

Relative density

EEC A.3

Density 0.89 g/mL at 20 °C

Acceptable

 

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

Not applicable to EC formulations.

 

B.2.2.14 (IIIA 2.7)

Storage stability

CIPAC MT46

 

 

 

 

 

 

 

CIPAC MT 39.1

Properties determined before and after storage: appearance, a.i. content, packaging suitability, pH (1%), emulsifiability (5%), emulsion characteristics (CIPAC MT36.3), foam persistence.

 

 

No separation of oil or solid matter occurred at 0 °C.

Acceptable

The product is stable for 14 days at 54 °C in PE innerlined PA bottles.

 

 

 

Acceptable

B.2.2.15 (IIIA 2.7)

Shelf life

 

Properties determined before and after storage: appearance, a.i. content, packaging suitability, pH (1%), emulsifiability (5%), emulsion characteristics (CIPAC MT36.3), foam persistence.

Acceptable.

The product has a shelf life of 2 years at RT in PE innerlined PA bottles.

B.2.2.16

(IIIA 2.8)

Wettability

 

Not applicable to EC formulations.

 

B.2.2.17 (IIIA 2.8)

Persistent foaming

CIPAC MT 47.2

At 0.03%: 7 ml after 1 min

At 0.18%: 8 ml after 1 min

Both in CIPAC water D

Acceptable. However Persistent foaming was not determined at the highest proposed concentration.

B.2.2.18

(IIIA 2.8)

Suspensibility

 

Not applicable to EC formulations.

 

B.2.2.19

(IIIA 2.8)

Spontaneity of dispersion

 

Not applicable to EC formulations.

 

B.2.2.20

(IIIA 2.8)

Dilution stability

 

Not applicable to EC formulations.

 

B.2.2.21

(IIIA 2.8)

Dry sieve test

 

Not applicable to EC formulations.

 

B.2.2.22

(IIIA 2.8)

Wet sieve test

 

Not applicable to EC formulations.

 

B.2.2.23

(IIIA 2.8)

Particle size distribution

 

Not applicable to EC formulations.

 

B.2.2.24

(IIIA 2.8)

Content of dust/fines

 

Not applicable to EC formulations.

 

B.2.2.25

(IIIA 2.8)

Attrition and friability

 

Not applicable to EC formulations.

 

B.2.2.26 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

CIPAC MT 36.1

Tests in both CIPAC A and CIPAC D water at 5% dilution in each water type showed 1ml cream without oil after 120 min but complete re-emulsification after 24 hours

Acceptable.

The lower proposed concentration is not tested. However in HTB 1.0 this is not required

B.2.2.27

(IIIA 2.8)

Stability of dilute emulsion

 

See B.2.2.26

No further tests are considered required.

B.2.2.28

(IIIA 2.8)

Flowability

 

Not applicable to EC formulations.

 

B.2.2.29

(IIIA 2.8)

Pourability (rinsibility)

 

Not applicable to EC formulations.

 

B.2.2.30

(IIIA 2.8)

Dustability

 

Not applicable to EC formulations.

 

B.2.2.31

(IIIA 2.8)

Adherence and distribution to seeds

 

Not applicable to EC formulations.

 

2.9.1

Physical compatibility with other products

 

Not applicable as no tank mixes are recommended on the labels

Acceptable.

 

2.9.2

Chemical compatibility with other products

 

Not applicable as no tank mixes are recommended on the labels

Acceptable.

 

 

No mixing with other plant protection products or adjuvants is proposed. No information is available on the behaviour of this product when mixed. Mixing with another product or adjuvant can therefore result in unexpected behaviour.

 

Conclusion

The physical and chemical properties of the active substance and the plant protection product are sufficiently described by the available data. Neither the active substance 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.

 

 

3.      Methods of analysis

 

Description and data on the analytical methods is taken from the List of Endpoints (July 2002). Changes and/or additions are taken up in italics.

 

3.1.            Analytical methods in technical material and plant protection product

Technical as (principle of method)

The sample was dissolved in an organic solvent, and deltamethrin was determined by HPLC-UV.

Impurities in technical as (principle of method)

Deltamethrin was separated from its enantiomer, and the three other pairs of enantiomers by HPLC-UV. Other impurities are detected by the same method.

Preparation (principle of method)

LC-UV method AL003/99-2 for determination of deltamethrin in emusifiable concentrates.

 

Conclusion

The analytical methods regarding the technical active ingredient have been assessed during the evaluation of the active substance for inclusion in Annex 1 of 91/414/EEC. The methods are therefore acceptable.

The submitted validated method for the formulation is considered acceptable.

 

3.2       Residue analytical methods

Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes)

Method 00855 for the determination of deltamethrin residues in plant material:

LOQ = 0.01 mg/kg dry, watery, fat matrices

Confirmatory method: GC-MS/MS

Method 00855/M002 (GC/MSMS) and

Method 00855/M003 (LC/MSMS)

for the determination of deltamethrin residues in plant material:

LOQ=0.01 mg/kg

ILV: although both laboratories are from Bayer, it is acceptable that the second study can be regarded as the ILV, as the first laboratory was not involved in the validation of the second.

 

Method DFG S-19 GC-MS applying three ions monitoring as confirmation, LOQ = 0.01 mg/kg (tomato, orange, dried bean, barley and oilseed rape.

ILV: yes

Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes)

Multiresidue method (main method); determination by GC-ECD.

LOQ 0.02 mg/kg (milk, egg, meat, fat, liver, kidney).

ILV: yes

 

Confirmatory method DFG S19: acetone/water extraction followed by liquid-liquid partition using ethyl acetate/cyclohexane and GPC cleaning, analysis by GC-MS: LOQ 0.01 mg/kg in milk, egg, bovine muscle, liver, kidney and fat.

ILV: yes

Soil (principle of method and LOQ)

Method 1: Samples were extracted with water/aceto­nitrile/hexane. The hexane layer was evaporated to dry­ness, re-dissolved in hexane, purified on diol Bond Elut cartridge and analysed by GC-ECD.

LOQ = 0.001 mg/kg.

 

Method 2: Samles were extracted with hexane/acetone and filtered. The extract was evaporated, purified on silica gel cartridge, concentrated and analysed by GC-ECD. LOQ = 0.002 mg/kg.

 

Confirmatory method 00877 extraction by acetonitrile/water with ammonium acetate, LC-MS/MS analysis of cis-, trans- and alpha-R-deltamethrin. LOQ 0.1 mg/kg

Water (principle of method and LOQ)

Drinking water: extraction with hexane, analysis by GC-ECD. LOQ 0.05 µg/l.

Confirmatory method : GC-MS/MS (surface water method)

Surface water: acidified samples are extracted by solid phase extraction. The dried cartridge is eluted with hexane/dichloromethane. The eluate is concentrated, and determined by GC-ECD, with confirmatory GC/MS/MS. LOQ = 0.003 µg/l

Air (principle of method and LOQ)

A volume of air was drawn through a Tenax tube. Deltamethrin was eluted with ethyl acetate and analysed by GC-ECD. LOQ = 0.27 mg/m3.

Confirmatory method : GC-MS (3 mass-fragments)

Body fluids and tissues (principle of method and LOQ)

Samples of human plasma were acidified, extracted with acetonitrile, evaporated to dryness, re-dissolved in hexane, cleaned-up on silca cartridge, evaporated to dryness, re-dissolved in hexane and analysed by GC-ECD. LOQ = 20 ng/ml

To samples of urine were added sodium chloride solution and methanol. The sample was extracted with diethyl ether, evaporated to dryness, re-dissolved in hexane and analysed by GC-ECD.

LOQ = 10 ng/ml

 

Confirmatory method 01127, acetonitrile extraction, LC-MS/MS analysis. LOQ 50 mg/L (cattle blood)

                                                                                                                   

Based on the proposed use of the plant protection product analytical methods for determination of residues in food/feed of plant origin are required for dry, watery and fat matrices (corn, broccoli, seed).

 

Definition of the residue and proposed MRL’s for deltamethrin

Matrix

Definition of the residue for monitoring

MRL

Food/feed of plant origin

Deltamethrin

0.02 mg/kg (LOQ) *

Food/feed of animal origin

Deltamethrin

0.02 mg/kg (LOQ) *

 

Required LOQ

Soil

Deltamethrin

0.05 mg/kg

Drinking water

Deltamethrin

0.1 µg/L (Dutch drinking water guideline)

Surface water

Deltamethrin

0.1 µg/L

Air

Deltamethrin

0.0064 mg/m3 (derived from the AOEL (1.5 mg/person/d) according to SANCO/825/00)

Body fluids and tissues

Deltamethrin

0.05 mg/l (blood)

0.1 mg/kg (tissues; meat or liver)

* for further information, please refer to the residue section

 

The residue analytical methods, included in the abovementioned List of Endpoints, are suitable for monitoring of the MRL’s.

 

The residue analytical methods for water, soil and air, evaluated in the Draft Assessment Report (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 MRL’s and for monitoring of residues in the environment.

 

3.3              Data requirements

None.

 

3.4       Physical-chemical classification and labelling

 

Proposal for the classification of deltamethrin (symbols and R phrases)
(EU classification) concerning physical chemical properties

 

Symbol(s):

-

Indication(s) of danger: -

 

Risk phrase(s)

R10

Flammable

 

Proposal for the classification and labelling of Decis EC concerning physical chemical properties

 

Regarding the physical and chemical properties of the formulation, the method of application and the further information on the plant protection product, the following labelling of the preparation is proposed (professional use only):

 

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

Solvent naphtha (petroleum), light aromatic

Symbol:

-

Indication of danger:

-

R phrases

R10

Flammable

 

R65

Harmful: may cause lung damage if swallowed

S phrases

S21

When using do not smoke.

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

R10 is assigned to products that are flammable.

R65 contains more then 10% hydrocarbons

Safety phrases:

S21 is assigned to products that contain halogenated compounds which may form toxic fumes when incinerated or burned.

Other:

-

 

 

 

 

 

4.      Mammalian toxicology

 

List of Endpoints

Deltamethrin is an existing active substance, included in Annex I of 91/414/EEC. The final List of Endpoints (dated July 2002) presented below is taken from the final review report on deltamethrin (6504/VI/99-final, d.d. 17 October 2002). 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 (around 75 %). Based on urine and bile excretion in a low oral dose and a iv. dose study in rat.

Distribution

Widely distributed. (Highest residue levels in fat after 7 days).

Potential for accumulation

No evidence of accumulation. (Half-life > 24 h in fat).

Rate and extent of excretion

Rapid. 75 % within 24 hours. Equivalent amounts in urine and faeces.

Toxicologically significant compounds

Parent compound and metabolites.

Metabolism in animals

Moderately metabolised. Cleavage of ester bound, hydoxylation and conjugation.

 

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral

87 mg/kg bw                                                R25

Rat LD50 dermal

>2000 mg/kg bw

Rat LC50 inhalation

0.6 mg/l (6 hour whole-body exposure, dust particulate aerosol).                                     R23

Skin irritation

Non irritant

Eye irritation

Non irritant

Skin sensitisation (test method used and result)

Non sensitising (M&K, Buehler)

 

Short term toxicity (Annex IIA, Point 5.3)   

Target/critical effect

Nervous system (neurological effects).

Lowest relevant oral NOAEL / NOEL

NOAEL: 1 mg/kg bw/day (90-d oral test in rat, and a 1-y dog study)

Lowest relevant dermal NOAEL / NOEL

NOAEL: 1000 mg/kg bw/day (based on a 21-day dermal test in rat)

Lowest relevant inhalation NOAEL / NOEL

NOAEL: < 3 mg/l (based on a 14-d inhalation study in rat)

 

Genotoxicity (Annex IIA, point 5.3)

No genotoxic potential 1

1  The genotoxic potential of deltamethrin was investigated in five in vitro studies (two Ames tests, growth inhibition test in E. Coli, mammalian cytogenetic test in Chinese hamster ovary cells, mammalian cell DNA repair test in primary rat hepatocytes) and in three in vivo studies (micronucleus test in mouse bone marrow, dominant lethal assay in the mouse, cytogenetic analysis of bone marrow of mouse).

 

Long term toxicity (Annex IIA, point 5.5)    

Target/critical effect

Nervous system (neurological effects)

Lowest relevant NOAEL/NOEL

25 ppm or 1 mg/kg bw/d (2 year rats)

Carcinogenicity

No carcinogenic potential

 

 

Reproductive toxicity (AnnexIIA, point 5.6)           

Reproductive target /critical effect

Increased pup mortality and increased pup weight at parental toxic dose levels.

Lowest relevant reproductive NOAEL / NOEL

NOEL 80 ppm or 4.2 mg/kg bw/d, rat, adults and offspring.

Developmental target/critical effect

Rat; No developmental toxicity at maternal toxic doses.

Mouse; No developmental toxicity at maternal toxic doses.

Rabbit; No developmental toxicity at maternal toxic doses.

Lowest relevant developmental NOAEL / NOEL

Rat; Maternal toxicity NOAEL 2.5 mg/kg bw/d. Developmental toxicity NOEL > 5 mg/kg bw/d (in another study NOAEL determined to 10 mg/kg bw/d).

 

Neurotoxicity/ delayed neurotoxicity (Annex IIA, point 5.7)

 

Evidence of neurotoxic effects in supplemented short- and long-term studies.

NOEL 50 ppm (4 mg/kg bw/d). Based on 13-week feeding study in rat.

 

Non-standard studies indicated developmental neurotoxicity but no NOAEL was determined. Further confirmatory data on developmental neurotoxicity to be generated for pyrethroids. 2

2  The notifier performed a developmental neurotoxicity study. See below ‘data requirements active substance’.

 

Other toxicological studies (Annex IIA, point 5.8)

No data required

 

Medical data (Annex IIA, point 5.9)

Cases of subjected facial and occupational intoxication due to inappropriate handling of the substance.

 

Summary (Annex IIA, point 5.10)

 

Value

Study

Safety factor

ADI

0.01 mg/kg bw/d

1 year dog

90 days dog

100

AOEL systemic

0.0075 mg/kg bw/d

1 year dog

90 days dog

100

ARfD (acute reference dose)

0.01  mg/kg bw/d (As the ADI)

Provisional estimates (toddlers): for the vast majority of commodities no exceedence of ARfD.

 

Dermal absorption (Annex IIIA, point 7.3)                                        

No data submitted - a 10 % default value used in calculations.

 

Data requirements active substance

Deltamethrin is included in Annex I of Directive 91/414/EEC, but the following is stated in the List of Endpoints:

Further confirmatory data on developmental neurotoxicity to be generated for pyrethroids (when internationally agreed testing protocols are available).

A DNT-study (developmental neurotoxicology) has been provided. The study has been conducted in accordance with OECD guideline 426. A Scientific Opinion of the Panel on Plant Protection Products and their Residues (PPR) has been published and was adopted on 9 December 2008 (The EFSA Journal (2009) 921, 2-34). The PPR Panel concluded that the study is acceptable and that deltamethrin has been adequately tested for developmental neurotoxicity and that the available data do not indicate that deltamethrin is a developmental neurotoxic agent.

The PPR Panel concludes that the existing health-based guidance values (AOEL, ADI and ARfD) provide adequate protection against any potential developmental neurotoxicity of deltamethrin that would, anyhow, occur only at doses causing severe systemic toxicity. The health-based guidance values do not need to be adjusted.

 

4.1       Toxicity of the formulated product (IIIA 7.1)

The formulation Decis EC needs to be classified R22 ‘Harmful if swallowed’, based on the acute oral toxicity (LD50 rat 431 mg/kg bw) and R20 ‘Harmful by inhalation, based on the acute inhalation toxicity (LC50 rat 2.6 mg/L).

The formulation Decis EC does not need to be classified on the basis of its acute dermal toxicity (LD50 rat > 2000 mg/kg bw).

The formulation Decis EC is considered irritating to skin and severely irritating to eyes and needs to be classified as R38 ‘Irritating to skin’ and R41 ‘Risk of serious damage to eyes’.

The formulation Decis EC does not need to be classified for skin sensitisation (modified Buehler and maximisation test).

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 

4.2       Dermal absorption (IIIA 7.3)

In the List of Endpoints, a default value of 10% is used for dermal absorption. For the current application, two dermal absorption studies were submitted, one in vivo study with rats and one comparative in vitro study with human and rat skin, both with deltamethrin formulated as Decis EC 25. Based on the results of the in vivo study, dermal absorption of deltamethrin (formulated as Decis EC 25) is considered to be 4% for the concentrate (area dose is 240 µg/cm2) and 5% for the spray dilution (area dose is 1.1 µg/cm2). Using the human : rat ratios from the comparative in vitro study (with comparable area doses and also with deltamethrin formulated as Decis EC 25) this results in a dermal absorption value of 0.2% for the concentrate and the spray dilution.

 

4.3       Available toxicological data relating to non-active substances (IIIA 7.4)

Other formulants: no reason for concern.

 

4.4       Exposure/risk assessments

 

4.4.1    Operator exposure/risk

Exposure to deltamethrin during mixing and loading and application of Decis EC is estimated with models. The exposure is estimated for the unprotected operator. In the Table below the estimated internal exposure is compared with the systemic AOEL. 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.

 

 

 

 

 

 

Table T.1 Internal operator exposure to deltamethrin and risk assessment for the use of Decis EC

 

Route

Estimated internal exposure (mg /day)

Systemic

AOEL

(mg/day)

Risk-index f

Mechanical upward spraying on pome and stone fruit, grapes, and berries, outdoors a,e

Mixing/

Loading

Respiratory

<0.001

0.525

<0.01

Dermal

0.002

0.525

<0.01

Application

Respiratory

0.001

0.525

<0.01

Dermal

0.007

0.525

0.01

 

Total

0.010

0.525

0.02

Manual upward spraying on pome and stone fruit, grapes, and berries, outdoors c,e

Mixing/

Loading

Respiratory

<0.001

0.525

<0.01

Dermal

0.002

0.525

<0.01

Application

Respiratory

0.009

0.525

0.02

Dermal

0.008

0.525

0.02

 

Total

0.017

0.525

0.03

Mechanical downward spraying on maize, strawberries, root and tuber vegetables, brassicaceae, kohlrabi, lettuce, endive, spinach, legume vegetables, peas, asparagus, onion, shallots, garlic, leek, oilseeds, caraway, potatoes, beets, cereals, grass-seed, grassland, sportfields, flax, linseed, poppy seed, ornamentals, tree nurseries and perennials, outdoors .a,e

Mixing/

Loading

Respiratory

<0.001

0.525

<0.01

Dermal

0.005

0.525

0.01

Application

Respiratory

0.001

0.525

<0.01

Dermal

<0.001

0.525

<0.01

 

Total

0.007

0.525

0.01

Manual up- and downward spraying on e.g. mushrooms, pepper, tomato, tree nurseries and perennials, indoors b,e

Mixing/

Loading and Application

Respiratory

0.075

0.525

0.14

Dermal

0.030

0.525

0.06

 

Total

0.105

0.525

0.20

Manual up- and downward spraying of floors, walls, ceilings etc in mushroom cells d,e

Mixing/

Loading and Application

Respiratory

0.001

0.525

<0.01

Dermal

<0.001

0.525

<0.01

 

Total

0.001

0.525

0.01

a       External exposure was estimated by  EUROPOEM I

b       External exposure was estimated by  the Dutch greenhouse model (manual indoors).

c       External exposure was estimated by  EUROPOEM and Dutch model (resp dermal and inhalation during mixing and loading) and German model, 90 percentile (application).

d       TNsG biocide Spraying model 2: Mixing and loading liquids in reservoir for powered spray application at 4 to 7 bar pressure as a coarse or medium spray, indoors, overhead and downwards.  Scenario - medium pressure spray applications, e.g. for remedial biocides.

e       Internal exposure was calculated with:

·       biological availability via the dermal route:   0.2% (see 4.2)

·       biological availability via the respiratory route:   100% (worst case)

f        The risk-index is calculated by dividing the internal exposure by the systemic AOEL.

 

4.4.2    Bystander exposure/risk

The bystander exposure is only a fraction of the operator exposure. Based on the low risk-index for the operator, no exposure calculations are performed for bystanders.

 

4.4.3    Worker exposure/risk

The exposure is estimated for the unprotected worker. In the Table below the estimated internal exposure is compared with the systemic AOEL. The worker exposure in mushrooms is considered to be a worst case scenario, taking into account the high application rate and the relatively high transfer coefficient for mushrooms used in the model.

Table T.2  Internal worker exposure to deltamethrin and risk assessment after application of Decis EC

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Re-entry activities in ornamentals, pome and stone fruit, grapes, (straw)berries, (arable) vegetables, mushrooms

 

Respiratory

0.025

0.525

0.05

Dermal

0.008

0.525

0.02

 

Total

0.033

0.525

0.06

a       External exposure was estimated by EUROPOEM II. Internal exposure was calculated with:

·       biological availability via the dermal route:   0.2% (see 4.2)

·       biological availability via the respiratory route:   100% (worst case)

b       The risk-index is calculated by dividing the internal exposure by the systemic AOEL.

 

Re-entry activities in the other crops applied for in this reregistration are normally performed by tractor mounted devices or no direct contact with the crop is expected shortly after application, and therefore, no worker exposure is expected.

 

4.4.4    Re-entry

Re-entry exposure can occur after application on sportfields. In the table below the estimated internal exposure as a result of dermal exposure is compared with the systemic AEL. There is no model available to estimate respiratory exposure, but it is expected that this will be negligible.

 

Table T.3  Internal re-entry exposure to deltamethrin and risk assessment after application of Decis EC

 

Route

Estimated internal exposure a (mg /day)

Systemic

AEL

(mg/day)

Risk-index b

Re-entry sportfields

Adult (sporting)

Dermal

0.00045

0.47 C

<0.01

a       External exposure was estimated by the “RIVM re-entry model” . Internal exposure was calculated with:

·       biological availability via the dermal route: 0.2% (see 4.2)

b       The risk-index is calculated by dividing the internal exposure by the systemic AEL.

c       From the systemic AOEL of 0.0075 mg/kg bw/day a specific AEL is derived for adults (63 kg bw).

 

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 deltamethrin as a result of the application of Decis EC in the crops mentioned in the re-registration request.

 

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 deltamethrin during application of Decis EC in the crops mentioned in the re-registration request.

 

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 re-entry activities in the crops mentioned in the re-registration request due to exposure to deltamethrin after application of Decis EC.

 

4.5       Appropriate mammalian toxicology and operator exposure endpoints relating to
the product and approved uses

See List of Endpoints.

 

4.6       Data requirements

No additional data requirements are identified.

 

4.7       Combination toxicology

Decis EC contains only one active substance and it is not described that it should be used in combination with other formulations.

 

4.8       Mammalian toxicology classification and labelling

 

Proposal for the classification and labelling of the formulation concerning health

 

The current classification and labelling (Xn, R20/22, R37/38, R41, S23d, S24, S26, S39a, S51), which is prepared in conformity with Directive 1999/45/EC, can be maintained.

 

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

Xn

Indication of danger:

Harmful

R phrases

R20/22

Harmful by inhalation and if swallowed.

 

R37/38

Irritating to respiratory system and skin.

 

R41

Risk of serious damage to eyes.

S phrases

S23d

Do not breathe spray.

 

S24

Avoid contact with skin.

 

S26

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

 

S39a

Wear eye protection.

 

S51

Use only in well-ventilated areas.

Special provisions:
DPD-phrases

-

-

Plant protection products phrase:
DPD-phrase

DPD01

To avoid risk for man and the environment, comply with the instructions for use

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

 

5.      Residues

 

Deltamethrin is an existing active substance, included in Annex I of 91/414/EEC and approved under Regulation (EC) No 1107/2009 according to Reg. (EU) 540/2011. The List of Endpoints presented below is the most recent (July 2002) obtained from the final review report. Where relevant, some additional remarks/information are given in italics.

 

List of Endpoints

 

Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)

Plant groups covered

fruits, leafy crops, cereals *

Rotational crops

carrots, radishes, lettuce, spinach, barley

Plant residue definition for monitoring

deltamethrin

Plant residue definition for risk assessment

deltamethrin

Conversion factor (monitoring to risk assessment)

-

* Metabolism was studied in apple and tomato (fruits), corn (cereals), and cotton (pulses & oilseeds, also valid for leafy crops)

 

Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)

Animals covered

cow, hen

Animal residue definition for monitoring

deltamethrin

Animal residue definition for risk assessment

deltamethrin

Conversion factor (monitoring to risk assessment)

-

Metabolism in rat and ruminant similar (yes/no)

yes

Fat soluble residue: (yes/no)

yes (log Pow = 4.6)

 

Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)

cereal straw

...............……………......................................

~0.2 mg/kg at ³2X, otherwise no significant residues (>0.01 mg/kg) are expected in succeeding crops

 

Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)

lettuce.........................................................

hops and beer.............................................

stable for 8 months at -15±5°C

stable for 5.5 months at -20°C

ginned cotton seeds...................................

stable for at least 38 months at -12°C to -27°C

crude cotton oil and soapstock...................

stable for 24 months at -12°C to -27°C

cotton hull....................................................

stable for 13 months at -12°C to -27°C

corn, rice, sorghum and wheat grain..........

stable (>80%) for 3 months at -20 and -30°C

corn, rice, sorghum and wheat grain..........

stable for at least 9 months at -23°C to -27°C

Eggs............................................................

stable for at least 13 months at -12°C to -27°C

Fat...............................................................

stable for at least 12 months at -23°C to -27°C

Muscle.........................................................

stable for at least 9 months at -23°C to -27°C

 

Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)

Intakes by livestock ³ 0.1 mg/kg diet/day:

Ruminant:

yes

Poultry:

Yes

Pig:

yes

Muscle

0.01

<0.002

0.003

Liver

<0.01

<0.02

<0.002

Kidney

<0.01

-

0.03

Fat

0.04

0.003

-

Milk

0.02

-

-

Eggs

-

0.037

-

 

Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)

Crop/processed crop

Number of studies

Transfer factor

% Trans-ference*

Fruits and vegetables/jam, syrup and cooking (see specification below) 1

1

0.33-0.85

 

strawberries (jam)

-

0.67

 

peaches (in syrup)

-

0.25

 

apricots (in syrup)

-

0.33

 

cherries (in syrup)

-

not possible to determine, as the original residue was <0.01

 

leek (cooking)

-

0.85

 

aubergines (cooking)

-

not possible to determine, as the original residue was <0.01

 

lettuce (cooking)

-

0.5

 

spinach (cooking) 2

-

0.75

 

haricot verts (cooking)

-

0.5

 

peas (cooking)

-

0.5

 

carrots (cooking)

-

not possible to determine, as the original residue was <0.01

 

artichokes (cooking)

-

0.33

 

Apples

1

 

 

wet pomace

 

5.7

 

juice

 

0.09

 

Tomatoes/dry pomace

1

7

 

Tomatoes/wet pomace, puree, ketchup, paste, juice

1

£1

 

Tomatoes/ketchup

1

”concentration”

 

Tomatoes

1

 

 

paste

 

0.4

 

puree

 

0.4

 

Pulses/cooking

1

0.1

 

Hops/beverage

1

0.01

 

Tea/beverage

1

0.01

 

Potatoes/peeled potatoes

 

1

0 (no detectable residues in processed products)

 

washed potatoes

2

0.86

 

cooked potatoes

4

0.62

 

Coffee/roasting

 

1

0 (no detectable residues in processed products)

 

Wheat/flour, bread

1

0.2

 

Barley/malt, beer

 

1

0 (no detectable residues in processed products)

 

Maize/oil

1

20

 

Rape seed/oil

1

10

 

Soya bean/oil

1

10

 

Sunflower seed/oil

1

10

 

Olives/oil

1

1.6

 

* Calculated on the basis of distribution in the different portions, parts or products as determined through balance studies; 1 Extracted from review paper with limited background information; no data available regarding number of studies; 2 Since ARfD is exceeded, a further processing study is required on 'cooking vegetable in water'.

 

Comments on/additions to List of Endpoints

From the evaluation table (Doc. 6488/VI/99 rev. 13 (16.07.2002)) it can be concluded that at the time of Annex I inclusion, several open points remained to be dealt with at member state level:

a.      Residue trials for citrus fruit in S-EU are required.

b.      Residue trials for tree nuts are required.

c.      Residue trials for pome fruit in S-EU are required.

d.      Residue trials for cherries and plums are required.

e.      Residue trials for grapes, strawberries in N-EU, for raspberries in N-EU and gooseberries in N-EU are required.

f.        Residue trials for olives in S-EU are required.

g.      Residue trials for carrots and radishes in S-EU are required.

h.      Residue trials for spring onions are required.

i.         Residue trials for field tomatoes in N-EU, glasshouse tomatoes, field cucumbers in S, glasshouse cucumbers, field melons in N, glasshouse melons and sweet corn are required.

j.         Residue trials for cauliflower, head brassica and leaf brassica are required.

k.       Residue trials for glasshouse lettuce, spinach in S-EU and witloof in N are required.

l.         Residue trials for beans with pods in S-EU, peas with pods in S-EU and peas without pods in S-EU are required.

m.    Residue trials for globe artichokes and leek in N-EU are required.

n.      Residue trials for fungi are required.

o.      Residue trials for rapeseed in S-EU, cotton in S-EU and sunflower are required.

p.      Residue trials for potatoes (pre-harvest) in S-EU are required.

q.      Residue trials for hops (import) are required.

r.        Residue trials on sugar beet roots and fodder crops may be required, depending on the outcome of the evaluation of the data already submitted.

Crops in recorded in bold are relevant for the current application for authorisation. Several MRL proposals by RMS Sweden have been discussed in the Standing Committee on Food Chain and Animal Health (SCoFCAH) Pesticide Residues in Brussels. EU-MRLs for deltamethrin have been adopted in Regulation (EC) 396/2005.

 

5.1       Summary of residue data

This evaluation of residue data is based on the Draft Assessment Report (DAR) and addenda for deltamethrin, on data submitted by the applicant and summarised in Ctgb report 20060203-sava-res-V01 of 14-06-2007, and on the document “Deltamethrin – Re-evaluation of MRLs and proposal for amendments” of January 2009 by RMS Sweden, drafted in the framework of art 12.2 of Regulation (EC) 396/2005.

 

5.1.1    Metabolism in plants

In the DAR the metabolism is reported in three crop groups: fruit, cereals, and pulses and oilseeds/leafy crops. Furthermore, a translocation study was reported showing little translocation. Because the metabolism is similar in these crop groups, it is also considered to be similar in the other crop groups.

The intended use for Decis EC includes crops in the crop categories fruit, leaf vegetables, root and tuber vegetables, cereals and pulses/oilseed. There is no need for separate metabolism studies in roots and tubers or leaf vegetables.

 

5.1.2    Metabolism in livestock

In the DAR the metabolism is reported in cow and hen. No further data required.

 

5.1.3    Residue definition (plant and animal)

Residue definition for monitoring and risk assessment of plant products is deltamethrin and for monitoring and risk assessment of animal products is deltamethrin (cis-deltamethrin) (see Directive 2006/59/EC).

 

5.1.4    Stability of residues

See List of Endpoints.

 

5.1.5    Supervised residue trials

Supervised residue trials have been submitted in strawberries (grown indoors) and maize, these have been summarized by Ctgb. For the crops in the intended use, the applicant refers to the EU dossier. Summaries from the residue trials in the EU-dossier are available in MRL proposals of December 2006, October 2005, June 2005, June 2004 and September 2003 (revised February 2004) by RMS Sweden. These proposals contain the supervised residue trials from the DAR and addenda to the DAR. All these proposals have been included in the document “Deltamethrin – Re-evaluation of MRLs and proposal for amendments” of January 2009 – revision of December 2010.

 

Fruits

Apple and Pear

Eighteen supervised residue trials in apple performed in Northern Europe (N-EU) were deemed acceptable for setting of the EU-MRL. The cGAP-NL (3x 0.5 g as/hL, PHI = 7d) is less critical than the cGAP-EU (3x 2.5 g as/hL, PHI = 7 days).

The results of the trials, together with 12 trials in Southern Europe (S-EU), have been used to set the EU-MRL of 0.2 mg/kg. The results from the N-EU trials lead to an STMR of 0.045 mg/kg and HR of 0.08 mg/kg.

Residues in apples can be extrapolated to pears, as the same GAP applies to both apple and pear. Nevertheless, an EU-MRL of 0.1 mg/kg has been established for pear. Apple and pear are no longer supported by the applicant/registration holder.

 

Cherries

Six supervised residue trials in cherry performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (3x 0.5 g as/hL, PHI = 7d) is less critical than the cGAP-EU (3x 1.25 g as/hL, PHI = 7 days).

The results of the trials, together with eight trials in S-EU, have been used to set the EU-MRL of 0.2 mg/kg. The results from the N-EU trials lead to an STMR of 0.03 mg/kg and HR of 0.04 mg/kg. Cherries are no longer supported by the applicant/registration holder.

 

Plums

Six supervised residue trials in plum performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (3x 0.5 g as/hL, PHI = 7d) is less critical than the cGAP-EU (3x 1.25 g as/hL, PHI = 7 days).

The results of the trials, together with five trials in S-EU, have been used to set the EU-MRL of 0.1 mg/kg. The results from the N-EU trials lead to an STMR of 0.012 mg/kg and HR of 0.028 mg/kg. Plums are no longer supported by the applicant/registration holder.

 

Red and black currants, gooseberries and blueberries (outdoor)

A minimum of four residue trials in black currants and up to a total of eight trials with currants in totality are needed to set an MRL for the group “other small fruits and berries” to which red and black currants, gooseberries, and blueberries belong.

Seven supervised residue trials in black currant performed in N-EU were deemed acceptable for setting of an EU-MRL. The cGAP-NL (3x 6 g as/ha, PHI = 7d) for currants is less critical than the cGAP-EU (3x 12.5 g as/ha, PHI = 7 days). The results from the N-EU trials lead to an STMR of 0.08 mg/kg and HR of 0.3 mg/kg and an EU-MRL of 0.5 mg/kg for currants.

 

No EU-GAP is available for gooseberry, and no trials are available in this crop. However, an EU-MRL of 0.2 mg/kg is set for gooseberry. The cGAP-NL for currants is less critical than the EU-cGAP, for blackcurrants; results from blackcurrants trials can be extrapolated to gooseberry. RMS Sweden proposes a revised MRL of 0.5 mg/kg.

 

Grapes (outdoor)

The cGAP for table and wine grapes in N-EU is worst case compared to the cGAP-NL with 3x 12.5 g as/ha and PHI 7d vs. 3x 7.5 g as/ha and PHI 7d.

Four supervised residue trials in wine grapes and five in table grapes performed in N-EU were deemed acceptable for setting of the EU-MRL.

The results of the trials, together with 11 trials in S-EU, have been used to set the EU-MRL of 0.2 mg/kg. The results from the N-EU trials lead to an STMR of 0.05 mg/kg and HR of 0.11 mg/kg. Grapes are no longer supported by the applicant/registration holder.

 

Blackberries and raspberries (outdoor)

Two supervised residue trials in raspberries performed in N-EU are available. The results of these trials were pooled with results of three trials in S-EU in raspberries. Acceptable trials in blackberries are not available. The cGAP-NL (3x 6 g as/ha, PHI = 7d) for raspberries and blackberries is less critical than the cGAP-EU (3x 12.5 g as/ha, PHI = 7 days). The results from the trials were in the range of <0.02 to 0.06 mg/kg. The existing of MRL 0.5 mg/kg is based on an old use that is, to the RMS knowledge, no longer supported. Therefore, an MRL of 0.1 g/kg was proposed.

 

 

 

 

Strawberry (outdoor)

Nine supervised residue trials in strawberry performed outdoors in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (2x 3 g as/ha, PHI = 3d) is less critical than the cGAP-EU (2x 12.5 g as/ha, PHI = 3 days).

The results from the N-EU trials lead to an STMR of 0.02 mg/kg and HR of 0.03 mg/kg. The CODEX MRL of 0.2 mg/kg was adopted as the EU-MRL for deltamethrin in strawberry.

 

Strawberry (indoor)

Eight supervised residue trials in strawberry performed indoors in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (2x 5 g as/ha, PHI = 3d) is less critical than the cGAP-EU (3x 12.5 g as/ha, PHI = 3 days).

The results from the indoor trials lead to an STMR of 0.01 mg/kg and HR of 0.03 mg/kg. The CODEX MRL of 0.2 mg/kg was adopted as the EU-MRL for deltamethrin in strawberry.

 

Melons

Four supervised residue trials in melons performed indoor are available. The trials were performed according to GLP. The trials were performed according to the intended use within a 25% margin. The cGAP-NL is equal to the cGAP-EU (3x 17.5 g as/ha, PHI = 3 days).

The analysed residue values amount all <0.01 mg/kg but the results of the trials have not been used to set the EU-MRL. The Codex MRL of 0.2 mg/kg has been adopted. STMR and HR of the residue trials are 0.01 mg/kg. This CODEX MRL however exceeds the ARfD. Therefore, RMS Sweden proposes an MRL of 0.02* mg/kg is based on outdoor and indoor use.

 

Vegetables

Radish

Eight supervised residue trials in radish performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (3x 7.5 g as/ha, PHI 7d) is less critical than the cGAP-EU (3x 12.5 g as/ha, PHI = 7 days).

The results of the trials have been used to set the EU-MRL of 0.02* mg/kg. The results from the N-EU trials lead to an STMR of 0.013 mg/kg and HR of 0.02 mg/kg.

 

Sugar- and fodder beets, swedes, turnip

The cGAP-NL (3x 7.5 g as/ha, PHI 30d) is more critical than the cGAP-EU (1x 12.5 g as/ha, PHI = 7 days).

For the MRL proposal, nine trials in sugar beet in accordance with the cGAP-EU were evaluated

The analysed residue values amount to 4x <0.01 and 5x <0.02 mg/kg in the root and 0.01. <0.02 (2x), 0.02 (2x), 0.03 (2x), 0.04 (2x) mg/kg in leaves with tops.

 

An EU-MRLs has been established for sugar beet root of 0.5 mg/kg.

Residues in sugar beets can be extrapolated to fodder beet, swede and turnip, as the same GAP applies to these crops. For swedes and turnips, an EU-MRL of 0.05* mg/kg has been established. RMS Sweden proposes a revised MRL of 0.05* mg/kg based on available data.

 

Onions, garlic and shallots

Eleven supervised residue trials in onions performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (3x 7.5 g as/ha, PHI 7d) is less critical than the cGAP-EU (3x 12.5 g as/ha, PHI = 7 days).

The results of the trials, together with nine trials in S-EU, have been used to set the EU-MRL of 0.1 mg/kg. The results from the N-EU trials lead to an STMR of 0.02 mg/kg and HR of 0.03 mg/kg. Results in bulbonions can be extrapolated to garlic and shallots. RMS Sweden proposes a revised MRL of 0.06 mg/kg based on available data.

 

 

Cauliflower and broccoli

The cGAP-NL (3x 7.5 g as/ha, PHI 7d) for broccoli and cauliflower is the same as the cGAP for N-EU. Ten supervised residue trials in cauliflower performed in N-EU were deemed acceptable for setting of the EU-MRL. No trials in broccoli are available. The results of the trials have been used to adopt the CODEX MRL of 0.1 mg/kg as the EU-MRL. The results from the N-EU trials lead to an STMR of 0.01 mg/kg and HR of 0.01 mg/kg. Results from the cauliflower trials can be extrapolated to broccoli.

 

Brussels sprouts

The cGAP-NL (2x 7.5 g as/ha, PHI 7d) is less critical than the cGAP-EU (2x 12.5 g as/ha, PHI = 7 days).

Five supervised residue trials performed in accordance with the cGAP-EU were deemed acceptable for setting of the EU-MRL of 0.1 mg/kg, although the trials resulted in residue levels of <0.01 mg/kg. The results from the N-EU trials lead to an STMR of 0.01 mg/kg and HR of 0.01 of 0.01 mg/kg. RMS Sweden proposes a revised MRL of 0.02* mg/kg based on the available data.

 

Head cabbage

Six supervised residue trials in white cabbage performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (2x 7.5 g as/ha, PHI 7d) is less critical than the cGAP-EU (2x 12.5 g as/ha, PHI = 7 days).

The results of the trials, together with six trials in S-EU, have been used to set the EU-MRL of 0.1 mg/kg. The results from the N-EU trials lead to an STMR of 0.02 mg/kg and HR of 0.06 mg/kg. Trials with white cabbage can be extrapolated to all types of head cabbage.

 

Kale

Five supervised residue trials in kale performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (is equal to the cGAP-EU (3x 7.5 g as/ha, PHI 7d). The results of the trials have been used to set the EU-MRL of 0.5 mg/kg. The results from the N-EU trials lead to an STMR of 0.32 mg/kg and HR of 0.39 mg/kg. The MRL and the HR result in an exceeded ARfD (see 5.3). Therefore, RMS Sweden proposes an MRL of 0.02* mg/kg as there is no safe use. Kale needs to be removed from the label of Decis EC.

 

Kohlrabi

Four supervised residue trials in kohlrabi performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (3x 7.5 g as/ha, PHI 7d) is less critical than the cGAP-EU (3x 12.5 g as/ha, PHI 7d). The results of the trials have been used to set the EU-MRL of 0.05* mg/kg. The results from the N-EU trials lead to an STMR of 0.005 mg/kg and HR of 0.005 mg/kg. RMS Sweden proposes an MRL of 0.02* mg/kg.

 

Lettuce (except lamb’s lettuce) and endive (outdoor)

The cGAP-NL (2 3x 10 g as/ha, PHI 7d) is less critical than the cGAP for N-EU (3x 12.5 g as/ha, PHI 7d). Twenty-eight trials with lettuce grown outdoors were deemed acceptable for setting of the EU-MRL. The results of the trials, together with nine trials in S-EU, have been used to set the EU-MRL of 0.5 mg/kg. The results from the N-EU trials lead to an STMR of 0.03 mg/kg and HR of 0.1 mg/kg. Residues in lettuce can be extrapolated to endive, as the same GAP applies to both crops. RMS Sweden proposes an MRL of 0.4 mg/kg, based in the indoor trials.

 

Lettuce (except lamb’s lettuce) and endive (indoor)

Eight supervised residue trials performed in accordance with the new proposed cGAP-NL (2 3x 12.5 g as/ha, PHI 7d) in protected lettuce were submitted is less critical than the results from the indoor trials, lead to an STMR of 0.07 mg/kg and HR of 0.24 mg/kg. Residues in lettuce can be extrapolated to endive, as the same GAP applies to both crops. This use is covered by the EU-MRL of 0.5 mg/kg. RMS Sweden proposes an MRL of 0.4 mg/kg.

 

The MRL and the HR result in an exceeding of the ARfD for endive (see 5.3). Therefore, RMS Sweden proposes an MRL of 0.1 mg/kg for endive based on results from outdoor grown lettuce. Trials in indoor grown lettuce result in higher residue levels and consequently in exceeding the ARfD. Endive (protected) needs to be removed from the label of Decis EC. 

 

Spinach (outdoor)

The cGAP-NL (2 3x 10 g as/ha, int 14d, PHI 7 3d) is less critical than the cGAP-EU (3x 12.5 g as/ha, PHI 3d). Ten trials according to the cGAP-EU are available. The results from the outdoor trials in accordance with the cGAP-EU, lead to an STMR of 0.4 mg/kg and HR of 1.0 mg/kg. An MRL of 2 mg/kg was calculated with these results, but cannot be proposed as the MRL and the HR result in an exceeding of the ARfD (see 5.3). Therefore, applicant submitted six supervised residue trials in conducted in Northern Europe in 2009 and 2010. At PHI 7 days, levels of deltamethrin were: 0.07, 0.02, 0.04, 0.04, 0.06, 0.02 mg/kg, resulting in an STMR of 0.07 mg/kg and HR 0.07 mg/kg.

The current EU-MRL is 0.5 mg/kg. The proposed GAP is covered by this EU-MRL. RMS Sweden proposes an MRL of 0.6 mg/kg.

 

Spinach (indoor)

No trials in spinach cultivated indoors are available. Extrapolation from lettuce is not possible as cGAPs are different (cGAP indoor spinach 2x 0.1 kg as/ha, int 14d, PHI 7d). Authorisation on spinach grown indoors cannot be granted and needs to be removed from the label.

 

Peas (fresh), with and without pods

Four supervised residue trials in peas with pods and seven in peas without pods performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (2x 7.5 g as/ha, PHI 7d) is less critical than the cGAP-EU (2x 12.5 g as/ha, PHI = 7 days). The results of the trials, together with a total of six trials in S-EU in peas with or without pods, have been used to set the EU-MRL of 0.2 mg/kg, based on the CODEX MRL. The results from the N-EU trials lead to an STMR of 0.01 mg/kg and HR of 0.14 mg/kg.

 

Beans with pods

Nine supervised residue trials in beans with pods performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (2x 7.5 g as/ha, PHI 7d) is less critical than the cGAP-EU (2x 12.5 g as/ha, PHI 7d). The results of the trials, together with eight trials in S-EU, have been used to set the EU-MRL of 0.2 mg/kg, based on the CODEX MRL. The results from the N-EU trials lead to an STMR of 0.01 mg/kg and HR of 0.14 mg/kg.

 

Beans without pods

Eleven supervised residue trials in beans without pods performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (2x 7.5 g as/ha, PHI 7d) is less critical than the cGAP-EU (2x 12.5 g as/ha, PHI 7d). The results of the trials prove that the use on beans with pods is worst-case and the EU-MRL of 0.2 mg/kg is based on the CODEX MRL. The results from the N-EU trials lead to an STMR of 0.01 mg/kg and HR of 0.14 mg/kg.

 

Peas and beans (dry)

No trials with dry harvested peas and beans performed in accordance with cGAP-NL are available. In The MRL Evaluation by Sweden (2010), only trials representing a post-harvest treatment are available. As this can be considered worst-case to a pre-harvest treatment, a sufficient number of trials in pulses are available. The post-harvest treatment trials result in an STMR of 0.65 mg/kg and a HR of 0.85 mg/kg.

 

Asparagus

The cGAP-NL (3x 7.5 g as/ha) is comparable to the cGAP-EU (2x 12.5 g as/ha). No studies are available. Studies are not considered necessary as the harvestable parts of asparagus grow mostly under the soil surface. Asparagus are harvested when the plants have not yet developed green parts (i.e. leaves and stems). When harvest ceases (May-June), the remaining stems that grow afterwards constitute the green parts and only at this moment insecticidal sprays are part of the GAP. Furthermore, deltamethrin is non-systemic and is therefore not likely to translocate into the roots. A pre-harvest interval is not of concern, as spraying occurs after harvest. Therefore, no detectable residue levels are expected in the consumable parts of asparagus. An EU-MRL of 0.05* mg/kg has been set. RMS Sweden proposes an MRL of 0.02* mg/kg.

           

Leek

Eight supervised residue trials in leek performed in N-EU were deemed acceptable for setting of the EU-MRL. The cGAP-NL (3x 7.5 g as/ha, PHI 7d) is less critical than the cGAP-EU (3x 12.5 g as/ha, PHI 7d). The results of the trials, together with five trials in S-EU, have been used to set the EU-MRL of 0.2 mg/kg. The results from the N-EU trials lead to an STMR of 0.07 mg/kg and HR of 0.13 mg/kg.

 

Edible mushrooms

Fungi are a minor crop. Five supervised residue trials in cultivated mushrooms performed indoors were accepted for setting of the EU-MRL. The cGAP-NL (2x 0.075 g as/100 m37,5 g as/ha, PHI 3d) is equal to the cGAP-EU (2x 7.5 g as/ha, PHI 3d). The five trials used for MRL setting correspond to the cGAP-EU. The results of the trials have been used to set the EU-MRL of 0.05* mg/kg, an STMR of 0.02 mg/kg and HR of 0.02 mg/kg. RMS Sweden proposes an MRL of 0.02* mg/kg.

 

Potatoes

The cGAP-NL (3x 10 g as/ha, PHI 7d) is more critical than the cGAP-EU (3x 7.5 g as/ha, PHI 7d). Thirteen supervised residue trials in potatoes performed in N-EU were considered acceptable for setting of the EU-MRL. These trials were performed with application rates worst-case to the cGAP-NL and cGAP-EU. The results from the N-EU trials lead to an STMR of 0.01 mg/kg and HR of 0.01 mg/kg. The MRL is 0.2 mg/kg, based on a post-harvest use.

 

Oilseeds

Poppy seed, caraway, rapeseed and flax (linseed)

Trials with rapeseed can be extrapolated to linseed with applications up or close to harvest. At least four trials with two of the following crops: cottonseed, rapeseed, soybean and sunflower, can be used to extrapolate to minor “unlisted” oilseeds; caraway and poppy seed can be classified to this category.

Six supervised residue trials in rapeseed performed in N-EU were considered acceptable for setting of the EU-MRL, no trials in S-EU are available; an EU-MRL of 0.1 mg/kg was set based on these studies.

Nine supervised residue trials in sunflower performed in N-EU and eight in S-EU were considered acceptable for setting of the EU-MRL; an EU-MRL of 0.05* mg/kg was set based on these studies.

The EU-cGAP for rapeseed is 3x 7.5 g asha, PHI 45d, for sunflower 1x 7.5 g as/ha and PHI 60d and for cotton 2x 17, 5 g as/ha and PHI 30d. The cGAP-NL for linseed and poppy seed is the same as the EU-cGAP for sunflower. The cGAP-NL for rapeseed and caraway is 1x 5 g as/ha and PHI 45d.

For mustard seed an MRL of 0.1 mg/kg has been established alongside an MRL of 0.05* mg/kg for all other oilseeds, except rapeseed: 0.1 mg/kg.

The EU-MRL covers the intended use of Decis EC on rapeseed. It is also expected, based on the results with sunflower, that no detectable residues will be present in linseed and poppy seed after application of Decis EC in accordance with the cGAP-NL. The same can be concluded for caraway, based on the available trials with both sunflower and rapeseed.

 

RMS Sweden concluded that the use on poppy seed cannot be extrapolated from rapeseed but extrapolation from rapeseed to linseed is possible and proposed MRLs of 0.05* and 0.1 mg/kg for poppy seed and linseed, respectively. Furthermore, Sweden proposes to lower the MRL for mustard seed to 0.02* mg/kg.

 

Fruiting vegetables (indoor)

Tomatoes

Eight residue trials in greenhouse were performed in tomato. Deltamethrin was applied as a 25 g/l emulsifiable concentrate formulation. In all trials, four applications at a nominal rate of 17,5 (up to 19) g as/ha were made. In all trials, tomato fruit was sampled on days 0, 2, and 3 after the last spray application. These conditions comply with the indoor cGAP-EU (4x 17.5 g as/ha, PHI 3d) and are more critical than the cGAP-NL (3x 17.5 g as/ha, PHI 3d).

The residues of deltamethrin found in tomato three days after the last application were between <0.01 mg/kg (LOQ) and 0.2 mg/kg. An MRL of 0.5 mg/kg was calculated with these results, but cannot be proposed as the MRL and the HR result in an exceeding of the ARfD (see 5.3). Therefore, RMS Sweden proposed an MRL of 0.04 mg/kg is based on data from tomatoes outdoor in S-EU and a new GAP with 4x 12.5 g as/ha, PHI 3d. The current EU-MRL is 0.3 mg/kg. The N-EU use is sufficiently covered by this EU-MRL. Authorisation on tomatoes can be granted until revision of the EU-MRLs. Once the MRL is revised, the cGAP of Decis EC in tomatoes needs to be amended.

 

Aubergines

Aubergines are extrapolated from tomatoes. No trials in aubergines are available. The cGAP-EU (4x 17.5 g as/ha, PHI 3d) of aubergines is less critical than the cGAP-NL of tomatoes (see tomatoes). RMS Sweden proposes a revised MRL of 0.5 mg/kg. The current EU-MRL is
0.3 mg/kg.

 

Cucumbers, courgettes, gherkins

Eight residue trails in greenhouse were performed on cucumbers. Trials were performed with 3 or 4 applications of 17.5 g as/ha with. The indoor cGAP-EU (4x 17.5 g as/ha, PHI: 3d) is more critical than the cGAP-NL (3x 17.5 g as/ha, PHI 3d), however, the deviation falls within the 25% margin. The eight trials were used to set the EU-MRL of 0.2 mg/kg. Trials with 3 applications are considered suitable for MRL setting, because the contribution of early applications to the final residue level is expected to be very low on fast growing commodities like cucumber. Residue levels observed at three days after harvest were between <0.01*mg/kg and
0.03 mg/kg. STMR is 0.02 mg/kg and the HR is 0.03 mg/kg.

Trials with cucumbers can be extrapolated to courgettes and gherkins. The current and proposed EU-MRL is 0.2 mg/kg.

 

(Sweet) Peppers

Eight residue trails in greenhouse were performed on peppers were considered acceptable for setting an EU-MRL. The indoor cGAP-EU (4x 17.5 g as/ha, PHI 3d) is more critical than the cGAP-NL (3x 17.5 g as/ha, PHI 3d). Residue levels observed at three days after harvest were between <0.02* mg/kg and 0.07 mg/kg, with an STMR of 0.03 mg/kg and a HR of 0.07 mg/kg. These residue levels are in compliance with the harmonised EU-MRL of 0.2 mg/kg.

Trials with peppers can be extrapolated to chilli peppers.

 

Cereals

Cereals except maize

Trials with foliar treatments in N-EU with barley, wheat and oats are available. The EU-cGAP is 2x 6.25 g as/ha with PHI 30d. The cGAP-NL is equal to the cGAP-EU with 2 applications of 6 g as/ha and PHI 30d.

Four trials in barley, oats and wheat each were performed in accordance with the cGAP. These results can also be used for rye and triticale.

Residue levels found in these trials amounted to <0.01 (4x), 0.01, <0.02 (4x), 0.03 (2x) and 0.05 mg/kg in grain.

There is a cGAP-EU for post-harvest treatment of cereals (1x 1 g as/ton, PHI n.a.)

The EU-MRL of 2 mg/kg for cereals was based on a post-harvest treatment, which is not part of the intended use for Decis EC.

 

Maize

No supervised residue trials in maize after foliar treatment are available. As it can be concluded from the results in wheat, oats and barley after foliar application, that the post-harvest treatment is worst case, trials are not considered necessary. The EU-MRL of 2 mg/kg for cereals applies to maize.

 

Forage crops

Fodder radish, forage rape, turnip (grown as catch crop)

No trials in these crops are available, and are not required as these crops are grown exclusively as livestock feed. The residue levels in these crops to which livestock is exposed, is covered by supervised residue trials in sugar beet.

 

Grass from grass-seed production and meadow grass

For the use on rye grass, four trials in NEU are available which were evaluated by RMS Sweden. The applied GAP was 2x 6.25 g as/ha, withholding period 14d. This cGAP is less critical than cGAP-NL, with 2x 12.5 g as/ha and 14d withholding. Residue levels in fresh grass were 0.08, 0.09, 0.31 and 0.34 mg/kg. Re-calculated to dry weight (20% dry matter): 0.40, 0.45, 1.55, 1.7 mg/kg. These values were used in the livestock dietary intake calculations (see 5.1.7). As the cGAP-NL contains a higher dose rate, residue levels in fresh grass and hay will be higher. The theoretical intake by cattle and pigs will be higher. As no residue trials are available at the cGAP-NL, it cannot be calculated what the livestock dietary burden will be and whether the proposed MRLs for animal products cover the use on grass. Hence, a feeding restriction needs to be applied to these crops/products and a withholding period for pastures of 30 days needs to be prescribed.

 

5.1.6    Residues in succeeding crops

See List of Endpoints.

 

5.1.7    Residues from livestock feeding studies

Grasses, potato, sugar beet, fodder beet, kale/cabbage, pome fruit, cereals, forage rape, pulses and maize are all used as livestock feed. Because the evaluation of animal metabolism in the DAR does not state how fast the plateau is reached, the livestock intake was calculated using HR levels mentioned under 5.1.5. RMS Sweden performed dietary intake calculations for the MRL review. The derived theoretical intake were 0.07, 0.09, 0.10, and 0.07 mg/kg bw/d for dairy cattle, beef cattle, poultry, and pigs, respectively using the EFSA calculator. The highest contributing commodity is grass hay for dairy and meat cattle, wheat grain for poultry and cabbage for pigs

 

In the DAR two feeding studies in dairy cattle were evaluated, of which one cannot be used due to uncertainties in the dose levels. In the other the lowest dose level was 29 mg/animal/day, corresponding to 0.052 mg/kg bw/d for 28 days. The highest dose rate was 144 mg/animal/day, corresponding to 0.26 mg/kg bw/d. The calculated maximum dietary burden for dairy and beef cattle are 0.073 mg/kg bw/day and 0.086 mg/kg bw/day, respectively. This is in between the intake levels used in the livestock feeding study and an estimation of the residues in tissue and milk was made by interpolation between the feeding levels. Proposed MRLs were then derived by rounding the HRs up to the closest MRL class. 

 

A feeding study in poultry was summarised in the DAR. The doses in the study were 0.093, 0.278 and 0.927 mg/kg bw/day. The calculated maximum dietary burden for poultry is 0.096 mg/kg bw/day which corresponds to the highest dose level in the poultry feeding study. The study resulted in residue levels of <0.02 mg/kg for muscle and liver, <0.05 mg/kg for fat and <0.015 mg/kg for eggs.

 

A feeding study in pigs was summarised in the DAR. The dose in the studies was approximately 0.017 mg/kg bw. The intake corresponds to 0.023 mg/kg bw/day.

Calculated maximum dietary burden is 0.071 mg/kg bw/day, which is 309-418% more than in the livestock feeding study. Consequently, the feeding study is not relevant for estimation of residue levels in tissues resulting from the dietary burden. Based on metabolism studies in livestock the metabolic pattern in rat and ruminant is similar and a feeding study with pig is in fact not required. The calculated dietary burden for pigs is in line with the calculated dietary burden for dairy and beef cattle and extrapolation from this study has been done. There is no need for demanding a new feeding study with pig.

 

5.1.8    Processing factors

See List of Endpoints, no additional studies submitted.

 

5.1.9    Calculation of the ADI and the ARfD

Both the ADI and the ARfD are based on the NOAEL of 1 mg/kg bw/d in the 1-year and 90-day dog study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI and ARfD of 0.01 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).

 

A DNT-study (developmental neurotoxicology) has been provided. The study has been conducted in accordance with OECD guideline 426. A Scientific Opinion of the Panel on Plant Protection Products and their Residues (PPR) has been published and was adopted on 9 December 2008 (The EFSA Journal (2009) 921, 2-34). The PPR Panel concluded that the study is acceptable and that deltamethrin has been adequately tested for developmental neurotoxicity and that the available data do not indicate that deltamethrin is a developmental neurotoxic agent.

The PPR Panel concludes that the existing health-based guidance values (AOEL, ADI and ARfD) provide adequate protection against any potential developmental neurotoxicity of deltamethrin that would, anyhow, occur only at doses causing severe systemic toxicity. The health-based guidance values do not need to be adjusted.

 

5.2       Maximum Residue Levels

Harmonised and temporary EU-MRLs are present in Annex II and IIIb of Regulation (EC) 396/2005.

Review of all existing MRLs by EFSA is currently ongoing. The product complies with the MRL Directives/Regulation. Notification of revised MRLs is not necessary, as this was already done by RMS Sweden.

 

5.3       Consumer risk assessment

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 and harmonised EU-MRLs. The maximum TMDI is 323% of the ADI for WHO Cluster diet B. The TMDI is 93.5% and 189% of the ADI for the Dutch general population and Dutch children ages 1-6, respectively.

 

A refinement of the risk assessment by performing a EDI calculation using the STMR values and processing factors instead of the MRLs provides a substantial reduction of the estimated intake.

The theoretical daily intake is reduced to 13.2% and 34.5% of the ADI for the general population and for children, respectively.

 

Risk assessment for acute exposure through diet

A calculation of the International Estimated Short Term Intake (IESTI) was carried out using EFSA PRIMo rev. 2.0 and the proposed EU-MRLs (see 5.1.5, can be current MRL when no revised MRL was proposed) and accompanying HRs.

 

The ARfD is exceeded when using the HR for in IESTI 1[1]:

Kale:

263.6%

Dutch Diet

Endive (protected):

209.8%

Dutch Diet

Tomatoes:

116.3%

Belgian Diet

 

The ARfD is exceeded when using the HR for in IESTI 2[2]:

Endive (protected):

209.8%

Kale:

188.4%

 

An attempt to refine the acute intake calculation was performed by using the Dutch NESTI spreadsheet.

Crop/commodity

Input

%ARfD general population

%ARfD children 1-6 years

Endive (protected):

HR 0.24 mg/kg

No data, large portion 426 g/person/day

No data, large portion 299 g/person/day

Kale:

HR 0.39 mg/kg

No data, large portion 294 g/person/day

No data, large portion 166 g/person/day

Tomatoes:

HR 0.2 mg/kg

23.5%

63.4%

 

No data can be generated for kale as certain info is not available. However, comparing the LP weight to other brassica vegetables and leaf vegetables, it seems very likely that the ARfD for deltamethrin will be exceeded with the available LP weights and HRs.

As no further refinement can be applied to kale, use of Decis EC cannot be authorised in kale.

For endive (protected), the HR results in an exceeded ARfD. However, using the HR for endive (unprotected), the ARfD is not exceeded. The use of Decis EC in protected endive cannot be granted.

 

Conclusion

The product complies with the Uniform Principles, except for the use on kale, protected endive, protected spinach and grass from grass seed production and meadow grass.

The use on protected endive and on kale lead to an unacceptable risk for the consumer. For spinach grown indoors, a data requirement was identified. Therefore, these three applications need to be removed from the label. For grass from grass seed production and meadow grass, a feeding restriction needs to be applied to these crops/products and a withholding period for pastures of 30 days needs to be prescribed: Behandelde percelen mogen niet tijdens en binnen 30 dagen na toepassing worden beweid of gemaaid ten behoeve van voederdoeleinden.  

 

5.4              Data requirements

None.

 

 

6.      Environmental fate and behaviour

 

The Plant Protection Products and Biocides Regulations (RGB) published in the Government Gazette (Staatscourant) 188 of 28 September 2007 came into effect on 17 Oktober 2007, while repealing the Uniform Principles Decree on Plant Protection Products (BUBG) and the Regulation elaborating the uniform principles for plant protection products (RUUBG).

For applications for formulations received and taken into the assessment procedure before 17-10-2007 containing active substances of the following category

- active substances which have already been included in Annex I of directive 91/414/EEC

- “new” active substances;

risk assessment is done in accordance with HTB 1.0.

This means that for the current application of Decis EC, risk assessment is done in accordance with HTB 1.0.

 

Deltamethrin is an existing substance listed on Annex I. The risk assessment is based on the review report of deltamethrin 6504/VI/99-rev. 3 (18 August 2002) and the registration report of the UK of Decis and Decis forte (November 2006). New data submitted for the current application were evaluated in the registration report of the UK. Relevant parts of the registration report are taken into account in this assessment and added in italics to the List of Endpoints.

 

After the first assessment (27 May 2009), the following data requirements were set in the ecotox assessment:

 

- Aquatic organisms: a refined risk assessment.

 

In response to these data requirements a new GAP/WGGA was proposed by the applicant. As a result of the new GAP the application for use in apple, pear, grapes and cherries is withdrawn. Moreover, for several other uses, number and interval of application has changed. The changes in the GAP were such that the PECsoil and PECgw measurements calculated in the initial risk assessment remain worst case. These changes therefore only affect the PECsw calculations.   

 

List of Endpoints Fate/behaviour (final review report, August 2002, LoEP dated July 2002)

 

Fate and behaviour in the environment

 

Fate and behaviour in soil

Route of degradation

 

Aerobic:

 

Mineralization after 100 days:

90 d: 52% (benzyl-14C), 36 % (gem-14C)
123/128 d: 62-69% (cyano-14C), 52-58% (phenoxy-14C)
64 d: 62% (cyano-14C), 60 % (vinyl-14C)
64 days: 50-70% (vinyl-14C), 61-65% (benzyl-14C)

Non-extractable residues after 100 days:

90 d: 18% (benzyl-14C), 48% (gem-14C)
123/128 d: 10-17% (cyano-14C), 24-31% (phenoxy-14C)
64 d: 20%