Toelatingsnummer 14643 N
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 WEDERZIJDSE ERKENNING
Gelet op de aanvraag d.d. 15 november 2011 (20111015 NLWERG) van
Sharda Europe b.v.b.a.
Jozef Mertensstraat 142
B-1702 DILBEEK
BELGIË
tot verkrijging van een wederzijdse erkenning van de toelating in het Verenigd Koninkrijk van
het gewasbeschermingsmiddel op basis van de werkzame stof glyfosaat,
Shyfo
gelet op artikel 40, lid 1 van de Verordening (EG) 1107/2009,
BESLUIT HET COLLEGE als volgt:
1.1 Toelating
1. Het middel Shyfo is toegelaten voor de in bijlage I genoemde toepassingen onder
nummer 14643 N met ingang van datum dezes. Voor de gronden van dit besluit wordt
verwezen naar bijlage II bij dit besluit.
2. De toelating geldt tot 31 december 2016.
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 bij dit
besluit is voorgeschreven.
1.4 Classificatie en etikettering
Gelet op artikel 31 en artikel 65 van de Verordening EG/1107/2009 worden voorschriften
gegeven.
Shyfo
14643 N
1
Dit leidt tot de volgende voorschriften:
De aanduidingen, welke moeten worden vermeld, worden hierbij vastgesteld als volgt:
aard van het preparaat: Met water mengbaar concentraat
werkzame stof:
glyfosaat
gehalte:
360 g/l
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
geethoxyleerde talkvet alkylamines
PICTOGRAM(MEN)
pictogram:
GHS05-corrosief
GHS07-schadelijk
SIGNAALWOORD
Gevaar
Gevarenaanduidingen
H318
H332
Veroorzaakt ernstig oogletsel
Schadelijk bij inademing.
Voorzorgsmaatregelen
SP 1
-Zorg ervoor dat u met het product of zijn verpakking geen water
verontreinigt.
P261
Inademing van stof/rook/gas/nevel/damp/spuitnevel vermijden.
P273
Voorkom lozing in het milieu.
P280
Beschermende handschoenen/beschermende
kleding/oogbescherming/gelaatsbescherming dragen.
P305 + P351 + P338 BIJ CONTACT MET DE OGEN: voorzichtig afspoelen met
water gedurende een aantal minuten; contactlenzen verwijderen,
indien mogelijk. Blijven spoelen.
P310
Onmiddellijk een ANTIGIFCENTRUM/arts/... raadplegen.
P391
Gelekte/gemorste stof opruimen.
P501
Inhoud/verpakking afvoeren naar inzamelpunt voor gevaarlijk of
bijzonder afval.
Aanvullende etiketelementen
EUH401
Shyfo
14643 N
Volg de gebruiksaanwijzing om gevaar voor de menselijke
gezondheid en het milieu te voorkomen.
2
Behalve de voorgeschreven aanduidingen en vermeldingen moet op de verpakking voorkomen:
a. letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I.
2 DETAILS VAN DE AANVRAAG
Het betreft een aanvraag tot verkrijging van een toelating van het middel Shyfo (14643 N), een
middel op basis van de werkzame stof glyfosaat. Het middel wordt aangevraagd als
onkruidbestrijdingsmiddel, doodspuitmiddel en middel voor de behandeling van stobben van
afgezaagde bomen en struiken.
2.2 Informatie met betrekking tot de stof
Er zijn in Nederland reeds andere middelen op basis van de werkzame stof glyfosaat
toegelaten.
De werkzame stof glyfosaat is op 1 juli 2002 opgenomen in bijlage I van Richtlijn 91/414/EEG
(03/31/EG).
De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening
(EU) No 540/2011 d.d. 25 mei 2011) en geplaatst als stof 25 in de bijlage.
2.3 Karakterisering van het middel
Het middel Shyfo bevat de werkzame stof glyfosaat. Glyfosaat behoort tot de chemische groep
van glycines en is geformuleerd als glyfosaat-trimesium- of glyfosaat-ammonium-zout.
Het werkingsmechanisme van glyfosaat, na opname via de bladeren en transport in de plant,
bestaat uit het verhinderen van de biosynthese van essentiële aromatische aminozuren zoals
phenylalanine, tyrosine en tryptofaan. De eiwitsynthese wordt hierdoor geremd met als gevolg
dat de aminozuren glutamine en glutaminezuur zich ophopen in de plant. De plant sterft binnen
enkele weken volledig af. Zodra glyfosaat in contact komt met de bodem, wordt de werkzame
stof geïnactiveerd. Opname door de wortels via de grond vindt niet plaats. Wel kan bij direct
wortelcontact (vergroeiing van de wortels), het middel van de ene plant naar de andere plant
getransporteerd worden.
2.4 Voorgeschiedenis
De aanvraag is op 30 november 2011 ontvangen; op 28 november 2011 zijn de verschuldigde
aanvraagkosten ontvangen. Bij brief d.d. 18 september 2012 is de aanvraag in behandeling
genomen.
3 RISICOBEOORDELINGEN
De aanvraag is beoordeeld conform Rgb d.d. 13 juni 2011 en Evaluation Manual 1.1.
3.1
Inleiding
Gezien de aard van de wederzijdse erkenning wordt ervan uitgegaan dat de beoordeling door
het Verenigd Koninkrijk is uitgevoerd conform de Uniforme Beginselen (annex VI bij richtlijn
91/414/EEG). Voor de beoordeling van de aspecten fysische en chemische eigenschappen,
analysemethoden, werkzaamheid en delen van de aspecten risico voor de mens en risico voor
het milieu refereert het Ctgb aan het toelatingsbesluit in het Verenigd Koninkrijk. Op een aantal
hieronder weergegeven voor de Nederlandse situatie specifieke punten, toetst het Ctgb zelf
inhoudelijk.
Shyfo
14643 N
3
3.2
Risico voor de mens
De volgende aspecten worden nationaal ingevuld:
• Arbeidsomstandigheden - nationale modellen en arbeidshygiënische strategie
• Volksgezondheid - de criteria voor residuen in volggewassen.
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
beoordeling van het risico voor de toepasser staat beschreven in Hoofdstuk 4 Mammalian
Toxicology, van Bijlage II bij dit besluit.
3.3
Risico voor het milieu
De volgende aspecten worden nationaal ingevuld:
• Uitspoeling naar grondwater
• Drift naar oppervlaktewater; van toepassing op: Waterorganismen, vogels, zoogdieren, nietdoelwitplanten, niet-doelwitarthropoden en oppervlaktewater bestemd voor de bereiding van
drinkwater
• Drinkwatercriterium oppervlaktewater.
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.
3.4
Eindconclusie
Bij gebruik volgens het Wettelijk Gebruiksvoorschrift is het middel Shyfo op basis van de
werkzame stof glyfosaat voldoende werkzaam en heeft het geen schadelijke uitwerking op de
gezondheid van de mens en het milieu.
Bezwaarmogelijkheid
Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage
2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet
bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een
bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en
biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid
van het elektronisch indienen van een bezwaarschrift opengesteld.
Wageningen, 7 november 2014
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN,
ir. J.F. de Leeuw
voorzitter
Shyfo
14643 N
4
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE I bij het besluit d.d. 7 november 2014 tot toelating van het middel Shyfo, toelatingnummer 14643 N
Wettelijk Gebruiksvoorschrift
Toegestaan is uitsluitend het professionele gebruik als:
- onkruidbestrijdingsmiddel,
- doodspuitmiddel,
- middel voor de behandeling van stobben van afgezaagde bomen en struiken,
in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde
toepassingsvoorwaarden
Toepassingsgebied
Type
behandeling
Te bestrijden organisme
Dosering
(middel) per
toepassing
Maximale
dosering
(middel) per
toepassing
Maximaal aantal
behandelingen per
teeltcyclus of per 12
maanden
Maximaal
aantal liter
middel per ha
per teeltcyclus
of per 12
maanden
Veiligheidstermijn in
dagen of uiterst
gewasstadium waarop
toegepast mag worden
Suikerbiet
Voor opkomst
Eenjarige onkruiden
1,5 l/ha
1,5 l/ha
1 per teeltcyclus
1,5 l/ha per
teeltcyclus
-
Wintertarwe
Voor opkomst
Voor de oogst
(BBCH 89, rijping volledig)
Eenjarige onkruiden
Kweek 1
1,5 l/ha
2-4 l/ha
1,5 l/ha
4 l/ha
Overige overblijvende
onkruiden
Eenjarige onkruiden
4 l/ha
4 l/ha
1.5 l/ha
1,5 l/ha
Wintergerst
Voor opkomst
Voor de oogst
(BBCH 89, rijping volledig)
Zomertarwe
Zomergerst
Shyfo
14643 N
Voor opkomst
Voor de oogst
(BBCH 89, rijping volledig)
Voor opkomst
Voor de oogst
(BBCH 89, rijping volledig)
Kweek
1
2-4 l/ha
4 l/ha
Overige overblijvende
onkruiden
Eenjarige onkruiden
Kweek 1
4 l/ha
4 l/ha
1,5 l/ha
2-4 l/ha
1,5 l/ha
4 l/ha
Overige overblijvende
onkruiden
Eenjarige onkruiden
Kweek 1
4 l/ha
4 l/ha
1,5 l/ha
2-4 l/ha
1,5 l/ha
4 l/ha
Overige overblijvende
onkruiden
4 l/ha
4 l/ha
1 per teeltcyclus
4 l/ha per
teeltcyclus
1 per teeltcyclus
4 l/ha per
teeltcyclus
1 per teeltcyclus
4 l/ha per
teeltcyclus
1 per teeltcyclus
4 l/ha per
teeltcyclus
7
7
7
7
5
Toepassingsgebied
Type
behandeling
Te bestrijden organisme
Dosering
(middel) per
toepassing
Maximale
dosering
(middel) per
toepassing
Haver
Voor opkomst
Voor de oogst
(BBCH 89, rijping volledig)
Eenjarige onkruiden
Kweek 1
1,5 l/ha
2-4 l/ha
1,5 l/ha
4 l/ha
Overige overblijvende
onkruiden
Eenjarige onkruiden en
graanopslag
Kweek 1
4 l/ha
4 l/ha
1,5 l/ha
1,5 l/ha
3-4 l/ha
4 l/ha
Overige overblijvende
onkruiden
Eenjarige onkruiden en
graanopslag
Kweek 1
4 l/ha
4 l/ha
1,5 l/ha
1,5 l/ha
3-4 l/ha
4 l/ha
Overige overblijvende
onkruiden
Eenjarige onkruiden en
graanopslag
Kweek 1
4 l/ha
4 l/ha
1,5 l/ha
1,5 l/ha
3-4 l/ha
4 l/ha
Overige overblijvende
onkruiden
Eenjarige onkruiden en
graanopslag
Kweek 1
4 l/ha
4 l/ha
1,5 l/ha
1,5 l/ha
3-4 l/ha
4 l/ha
Overige overblijvende
onkruiden
Eenjarige onkruiden en
graanopslag
Kweek 1
4 l/ha
4 l/ha
1,5 l/ha
1,5 l/ha
3-4 l/ha
4 l/ha
Overige overblijvende
onkruiden
Gras en onkruiden
4 l/ha
4 l/ha
3-6 l/ha
6 l/ha
Droog te oogsten
erwten
Voor opkomst
Voor de oogst
(BBCH 89, rijping volledig)
Lijnzaad
Voor opkomst
Voor de oogst
(BBCH 89, rijping volledig)
Mosterd
Voor opkomst
Voor de oogst
(BBCH 89, rijping volledig)
Koolzaad
Voor opkomst
Voor de oogst
(BBCH 89, rijping volledig)
Veldboon (voor
Ensilage)
Voor opkomst
Voor de oogst
(BBCH 89, rijping volledig)
Voedergrasland
Shyfo
14643 N
Doodspuiten
Maximaal aantal
behandelingen per
teeltcyclus of per 12
maanden
Maximaal
aantal liter
middel per ha
per teeltcyclus
of per 12
maanden
1 per teeltcyclus
4 l/ha per
teeltcyclus
1 per teeltcyclus
4 l/ha per
teeltcyclus
1 per teeltcyclus
4 l/ha per
teeltcyclus
Veiligheidstermijn in
dagen of uiterst
gewasstadium waarop
toegepast mag worden
7
7
14
1 per teeltcyclus
4 l/ha per
teeltcyclus
8
1 per teeltcyclus
4 l/ha per
teeltcyclus
14
1 per teeltcyclus
1 per 12 maanden
4 l/ha per
teeltcyclus
6 l/ha per 12
maanden
7
5 dagen tussen
toepassing en beweiden
en/of maaien
6
Toepassingsgebied
Type
behandeling
Te bestrijden organisme
Dosering
(middel) per
toepassing
Maximale
dosering
(middel) per
toepassing
Maximaal aantal
behandelingen per
teeltcyclus of per 12
maanden
Maximaal
aantal liter
middel per ha
per teeltcyclus
of per 12
maanden
Veiligheidstermijn in
dagen of uiterst
gewasstadium waarop
toegepast mag worden
Appel
Tussen het gewas
Meerjarige onkruiden en
wortelopslag
5 l/ha
5 l/ha
1 per 12 maanden
5 l/ha per 12
maanden
Peer
Tussen het gewas
Meerjarige onkruiden en
wortelopslag
5 l/ha
5 l/ha
1 per 12 maanden
5 l/ha per 12
maanden
Kers (onbedekte teelt)
Tussen het gewas
Meerjarige onkruiden en
wortelopslag
5 l/ha
5 l/ha
1 per 12 maanden
5 l/ha per 12
maanden
Pruim (onbedekte
teelt)
Tussen het gewas
Meerjarige onkruiden en
wortelopslag
5 l/ha
5 l/ha
1 per 12 maanden
5 l/ha per 12
maanden
Erwt zonder peul
Voor opkomst
1,5 l/ha
1,5 l/ha
1 per teeltcyclus
Knolraap
Voor opkomst
1,5 l/ha
1,5 l/ha
1 per teeltcyclus
Koolraap
Voor opkomst
1,5 l/ha
1,5 l/ha
1 per teeltcyclus
Uien
Voor opkomst
1,5 l/ha
1,5 l/ha
1 per teeltcyclus
Asperge (onbedekte
teelt)
Prei (onbedekte teelt)
Voor opkomst
1,5 l/ha
1,5 l/ha
1 per teeltcyclus
1,5 l/ha
1,5 l/ha
1 per teeltcyclus
Boomkwekerijgewassen (onbedekte
teelt), bosbouw
Voor uitplanten
Eenjarige onkruiden en
graanopslag
Eenjarige onkruiden en
graanopslag
Eenjarige onkruiden en
graanopslag
Eenjarige onkruiden en
graanopslag
Eenjarige onkruiden en
graanopslag
Eenjarige onkruiden en
graanopslag
Onkruiden
4-5 l/ha
5 l/ha
1 per 12 maanden
1,5 l/ha per
teeltcyclus
1,5 l/ha per
teeltcyclus
1,5 l/ha per
teeltcyclus
1,5 l/ha per
teeltcyclus
1,5 l/ha per
teeltcyclus
1,5 l/ha per
teeltcyclus
5 l/ha per 12
maanden
Gesloten bloemknoppen
zichtbaar
(BBCH 55)
Gesloten bloemknoppen
zichtbaar
(BBCH 55)
Gesloten bloemknoppen
zichtbaar
(BBCH 55)
Gesloten bloemknoppen
zichtbaar
(BBCH 55)
-
Voor opkomst
Shyfo
14643 N
-
Tussen het gewas
Alleen met
handspuitapparatuur
Onkruiden
3-6 l/ha
6 l/ha
1 per 12 maanden
6 l/ha per 12
maanden
-
Behandeling van stobben
Stobben van
afgezaagde bomen en
struiken
Chemisch dunnen van
bomen en struiken
Onkruiden
20% (1 liter
middel in 4 liter
water)
2 ml per 10cm
diameter boom
1,5-3 l/ha
8 l/ha
1 per 12 maanden
8 l/ha per 12
maanden
-
6 ml per boom
1 per 12 maanden
6 ml per boom
-
3 l/ha
1 per 12 maanden
3 l/ha per 12
maanden
-
Doodspuiten (Injecteren)
Naaldhout
-
Over het gewas
7
Toepassingsgebied
Type
behandeling
Te bestrijden organisme
Dosering
(middel) per
toepassing
Maximale
dosering
(middel) per
toepassing
Maximaal aantal
behandelingen per
teeltcyclus of per 12
maanden
Maximaal
aantal liter
middel per ha
per teeltcyclus
of per 12
maanden
Veiligheidstermijn in
dagen of uiterst
gewasstadium waarop
toegepast mag worden
Tijdelijk onbeteeld
terrein
Terrein behandeling voor
zaaien of uitplanten
Eenjarige onkruiden en
granen3
1,5-3 l/ha
3 L/ha
1 per 12 maanden
4 l/ha per 12
maanden
-
Kweek1
Overige overblijvende
grassen en
aardappelopslag
Overblijvende
tweezaadlobbige
onkruiden
3-4 l/ha
4 l/ha
4 l/ha
4 l/ha
4-5 l/ha
5 l/ha
Doodspuiten
Dekvruchten
3-6 l/ha
6 l/ha
Permanent onbeteeld
terrein
Terrein behandeling
Eenjarige onkruiden
Overblijvende onkruiden
1,5 l/ha
4-5 l/ha
1,5 l/ha
5 l/ha
1 per 12 maanden
5 liter per ha
per 12
maanden
-
Akkerbouw-gewassen,
fruitgewassen,
groenteteelt,
kruidenteelt,
sierteeltgewassen,
cultuurgrasland,
bosbouw en in
openbaar groen
Doodspuiten
Gewassen uit
fytosanitaire overweging
1,5 l/ha3
1,5 l/ha3
1 per 12 maanden
5 liter per ha
per 12
maanden
-
1,5-5,0 l/ha3
-
5,0 l/ha3
1
kweek (Elytrigia repens)
met behulp van onkruidstrijkers, mits de toepassing zodanig plaatsvindt dat het gewas niet wordt geraakt met het middel, de apparatuur niet
druipt en de vloeistof niet van de behandelde onkruiden afloopt
3
Na toepassing van Shyfo in een dosering van 1,5 l/ha op tijdelijk onbeteeld terrein of voor doodspuiten van gewassen uit fytosanitaire
overwegingen in akkerbouwgewassen, fruitgewassen, groenteteelt, kruidenteelt, sierteeltgewassen, cultuurgrasland, bosbouw en in openbaar
groen, dient minimaal 2 dagen gewacht te worden met zaaien of uitplanten van nieuwe gewassen. Na toepassing van hogere doseringen dient
2
Shyfo
14643 N
8
minimaal 5 dagen gewacht te worden met zaaien of uitplanten van nieuwe gewassen. Graszaad kan 5 dagen na toepassing gezaaid worden.
Voor de andere gebruiken geldt dat na toepassing minimaal 2 dagen moet worden gewacht met zaaien of uitplanten van nieuwe gewassen en
7 dagen met het uitplanten van bomen, struiken etc.
Bij toepassing op een afgerijpt gewas in de teelt van granen, droog te oogsten erwten, veldboon (voor ensilage) en lijnzaad, en bij een
behandeling over het gewas in naaldhout, het middel toepassen in 80-250 liter water per ha.
Bij toepassing op een afgerijpt gewas in de teelt van mosterd en koolzaad het middel toepassen in 100-250 liter water per ha.
Bij gebruik op grasland en bij het doodspuiten van dekvruchten het middel toepassen in 150-250 liter water per ha.
Bij gebruik in de teelt van appel, peer, pruim en kers, het middel toepassen in 200-400 liter water per ha.
Bij toepassing tussen het gewas in boomkwekerijgewassen, bosbouw of bij doodspuiten van gewassen uit fytosanitaire overwegingen, het
middel toepassen in 200-250 liter water per ha.
Bij een behandeling voor opkomst of uitplanten en bij een terrein behandeling op tijdelijk onbeteeld terrein, het middel toepassen in 80-250 liter
water per ha.
Bij een toepassing op permanent onbeteeld terrein, het middel toepassen in 80-400 l/ha.
Bij toepassing op een afgerijpt gewas in de teelt van granen, droog te oogsten erwten en lijnzaad, bij gebruik op grasland, bij het doodspuiten
van dekvruchten en bij een behandeling voor zaaien of uitplanten op tijdelijk onbeteeld terrein, kan bij gebruik van een schijfvernevelaar het
middel worden toegepast in 40 liter water per ha.
Toepassingsvoorwaarden
Om niet tot de doelsoorten behorende planten te beschermen is de toepassing van het product in de teelt van suikerbieten, gerst, haver, tarwe,
droog te oogsten erwten, lijnzaad, mosterd, koolzaad, veldboon, voedergrasland, erwt zonder peul, knolraap, koolraap, uien, asperge, prei,
groenbedekking op land niet gebruikt voor gewasproductie voor cultivatie (dekvrucht), tijdelijk onbeteeld terrein, permanent onbeteeld terrein,
alle eetbare en niet-eetbare gewassen (stobben, voor het planten, doodspuiten) en boomkwekerijgewassen (bosbouw, onkruidbestrijding voor
het planten) uitsluitend toegestaan indien gebruik wordt gemaakt van één van de volgende maatregelen:
. lage spuitboomhoogte (30 cm boven de top van het gewas) in combinatie met een driftarme Venturidop en een kantdop, of,
. sleepdoek in combinatie met minimaal 50% driftreducerende spuitdoppen en een kantdop; of
. overkapte beddenspuit.
Om niet tot de doelsoorten behorende planten te beschermen is de toepassing van het product in de teelt van appel, peer, kers, pruim en
boomkwekerijgewassen (bosbouw, tussen de gewassen) uitsluitend toegestaan indien gebruik wordt gemaakt van minimaal 50%
driftreducerende spuitdoppen in combinatie met een kantdop.
Shyfo
14643 N
9
In appel, peer, kers en pruim toepassen voor BBCH 55 (Gesloten bloemknoppen zichtbaar) of na de oogst.
In de bosbouw mag het middel alleen worden toegepast mits niet op vruchtdragende bomen en struiken wordt gespoten en geen bramen en/of
bosbessen worden geraakt.
Toepassing van dit middel op half-open en gesloten verhardingen is uitsluitend toegestaan volgens de ‘criteria voor toepassing van
onkruidbestrijdingsmiddelen op basis van glyfosaat op verhardingen’ volgens de DOB- methode (Duurzaam OnkruidBeheer op verhardingen,
zie www.dob-verhardingen.nl).
Bij de toepassing op tijdelijk onbeteeld terrein mogen sloottaluds niet gespoten worden.
Bij gebruik van een spuitvernevelaar dient de diameter van de spuitdruppels tussen de 200 en 300 µm te liggen.
Shyfo niet toepassen in gewassen bedoeld voor zaadteelt.
Bij gebruik in de teelt van appel, peer, pruim en kers, dienen de bomen minstens 2 jaar oud te zijn.
Resistentiemanagement
Dit middel bevat de werkzame stof glyfosaat. Glyfosaat behoort tot de glycines. De Hrac code is G. Bij dit product bestaat er kans op
resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op
te volgen.
Gewassen uit fytosanitaire overweging mogen alleen bestreden worden op aanwijzing van de hoofdinspecteur van de Divisie Landbouw en
Natuur van de Nederlandse Voedsel en Waren Autoriteit.
Shyfo
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10
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE II bij het besluit d.d.7 november 2014 tot toelating van het middel Shyfo,
toelatingnummer 14643 N
Contents
Page
1
Identity of the plant protection product
2
Physical and chemical properties
3
Methods of analysis
4
Mammalian toxicology
5
Residues
6
Environmental fate and behaviour
7
Ecotoxicology
8
Efficacy
9
Conclusion
Classification and labelling
Appendix 1
Appendix 2
Shyfo
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12
13
13
13
18
19
41
51
52
52
Table of authorised uses
Reference List
11
1. Identity of the plant protection product
1.1
Applicant
Sharda Europe b.v.b.a.
Jozef Mertensstraat 142
B-1702 DILBEEK
BELGIË
1.2
Identity of the active substance
Common name
Glyphosate
Name in Dutch
Glyfosaat
Chemical name
N-(phosphonomethyl)-glycin (IUPAC)
CAS no
1071-83-6
EC no
213-997-4
The active substance was included in Annex I of Directive 91/414/EEC on 1 July 2002. 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.
The active substance is formulated as its variant glyphosate, isopropylamine salt and is
considered equivalent to the active substance as evaluated for inclusion in Annex I of
Directive 91/414/EEC.
1.3
Identity of the plant protection product
Name
Shyfo
Formulation type
SL
Content active substance
360 g/L pure active substance
For the assessment of the formulation and its proposed use we refer to the member state of
the original authorisation (United Kingdom).
1.4
Function
Herbicide and desiccant.
1.5
Uses applied for
See GAP (Appendix I).
1.6
Background to the application
Application for mutual recognition of an authorisation of a plant protection product.
The application for Shyfo is based on the authorisation for Shyfo in the United Kingdom
(MAPP 15040).
1.7
Packaging details
1.7.1 Packaging description
Material:
PET
Capacity:
1L
Type of closure and size Screw cap with induction seal, diameter 45 mm.
of opening:
Other information
ADR compliant and UN certified.
1.7.2 Detailed instructions for safe disposal
No particular recommendations.
Shyfo
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12
2. Physical and chemical properties
For the assessment of the physical and chemical properties of Shyfo we refer to the member
state of the original authorisation (United Kingdom).
3. Methods of analysis
For the assessment of the methods of analysis required for Shyfo we refer to the member
state of the original authorisation (United Kingdom).
Supported shelf life of the formulation: two years in HDPE.
4. Mammalian toxicology
4.1
Toxicity of the formulated product (IIIA 7.1)
For the evaluation of the toxicity of the formulated product Shyfo, we refer to the member
state of the original authorisation (UK).
It should be noted that no toxicity studies of the formulated product are included in the
original authorisation by the UK.
4.2
Dermal absorption (IIIA 7.3)
In the original authorisation the UK did not perform any operator, bystander or worker
exposure assessment. Instead the UK states this was not required as “formulation was
comparable to the referenced products”. The referenced products were Glyphosate 360 and
Glyphogan.
As the current application requires an exposure assessment with the Dutch specific models a
dermal absorption value of 3% will be used. This is the dermal absorption value that was
derived for Roundup SL in the DAR for glyphosate and has also been used in the
Netherlands for the authorisation of Glyphogan.
4.3
Available toxicological data relating to non-active substances (IIIA 7.4)
For toxicological data relating to non-active substances we refer to the registration report
written by the UK.
4.4
Exposure/risk assessments (Dutch specific aspect)
Overview of the intended uses
An application (request for mutual recognition) has been submitted for the authorisation of
the plant protection product Shyfo, a herbicide based on the active substance glyphosate.
Shyfo is a SL formulation and contains 485 g/L of the isopropylamine salt of glyphosate (=
360 g/L glyphosate).
The formulation Shyfo is applied by mechanical downward spraying, manual downward
spraying, brushing and injection. The formulation is applied in many crops during the whole
year with a maximum dose of 8 L formulation / ha. Therefore, a chronic exposure duration is
applicable for the operator (including contract workers).
Shyfo
14643 N
13
4.4.1 Operator exposure/risk
Calculation of the EU-AOEL / Tolerable Limit Value (TLV)
For glyphosate no TLV has been set.
In the EU, a semi-chronic AOEL is derived. For the current application, a chronic AOEL
should be derived. The calculation of the systemic AOEL for chronic exposure is based on
the NOAEL of 31 mg/kg bw/d in the 2-year study with the rat, and a safety factor of 100,
corrected for an oral absorption of 30%. This results in a systemic AOEL of 0.093 mg/kg
bw/day (= 6.5 mg/day for a 70-kg operator/worker).
Exposure/risk
Exposure to glyphosate during mixing and loading and application of Shyfo is estimated with
models. The exposure is estimated for the unprotected operator. In general, mixing and
loading and application is performed by the same person. Therefore, for the total exposure,
the respiratory and dermal exposure during mixing/loading and application have to be
combined.
In the Table below the estimated internal exposure is compared with the systemic EU-AOEL.
For manual downward spraying on tree nursery the actual area treated per day for manual
downward spraying is lower than the default 1 ha; as only the area under the trees is
sprayed, not the between the rows, hence the treated area is estimated to be 0.5 ha.
For the patch treatment with a paintbrush (tree stump treatment), no exposure is expected
during application. Therefore the exposure is estimated for mixing and loading only. For the
application via injection operator exposure is expected to be negligible. For each application
method, the exposure is only estimated with the highest dose.
Table T.1 Internal operator exposure to glyphosphate and risk assessment for the use
of Shyfo
Route
Estimated internal
Systemic
Risk-index b
exposure a (mg /day)
EU-AOEL
(mg/day)
Mechanical downward spraying on the intended crops, maximum dose 6 L/ha (uncovered)
Mixing/
Loadingc
c
Application
Respiratory
0.11
6.5
0.02
Dermal
12.96
6.5
1.99
Respiratory
0.17
6.5
0.03
Dermal
1.94
6.5
0.30
Total
15.18
6.5
2.34
Manual downward spraying on the tree nursery crops and forestry between crops,
maximum dose 6 L/ha (uncovered)
Mixing/
Respiratory
<0.01
6.5
<0.01
Loadingd
Dermal
4.21
6.5
0.65
Applicatione
Respiratory
0.65
6.5
0.10
Dermal
16.52
6.5
2.54
Total
21.39
6.5
3.29
Application via paintbrush on tree stump, maximum dose 8 L/ha (uncovered)
Mixing/
Loadingd
Shyfo
14643 N
Respiratory
<0.01
6.5
<0.01
Dermal
1.12
6.5
0.17
Total
1.12
6.5
0.17
14
a
b
c
d
e
Internal exposure was calculated with:
• biological availability via the dermal route: 3% (concentrate) and 3% (spray dilution) (see 4.2)
• biological availability via the respiratory route: 100% (worst case)
The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
External exposure is estimated with EUROPOEM.
External exposure is estimated with EUROPOEM (dermal) and NL-model (respiratory).
External exposure is estimated with UK POEM.
Since the EU-AOEL is exceeded without the use of PPE, a tier 2 assessment has to be
performed using the NL-AOEL.
Tier 2
Calculation of the NL-AOEL
The risk index calculated with the EU-AOEL is >1. Therefore, the Plant Protection Products
and Biocides Regulations (NL: Rgb) prescribes the calculation of the risk with an AOEL
based on allometric extrapolation (known as the NL-AOEL). This method takes into account
the caloric demand of the species studied and results in a more specific value than the EUAOEL for which a standard factor of 100 is applied.
The calculation of the systemic AOEL for chronic exposure is based on the NOAEL of 31
mg/kg bw/day in the 2yr study with the rat. Calculations from other studies result in higher
AOELs.
Safety factors are used to compensate for the uncertainties, which arise, for example, from
extrapolation from the tested species to humans and the differences between experimental
circumstances, and to ensure that at the acceptable exposure level no adverse health effects
will occur.
Used factors are:
• extrapolation rat → human on basis of caloric demand
• other interspecies differences:
• intraspecies differences: (professional use)
• biological availability via oral route:
• weight of professional operator/worker:
4
3
3
30%*
70 kg
* If the absorbed dose is significantly lower (<80%) than the administered dose, this is adjusted by a correction
factor equal to the percentage absorption.
AOELsystemic: 31 x 0.3 x 70 / (4 x 3 x 3) = 18.1 mg/day
Exposure/risk
Table T.2 Internal operator exposure to glyphosate and risk assessment for the use of
Shyfo
Systemic
Risk-index b
NL-AOEL
(mg/day)
Mechanical downward spraying on the intended crops, maximum dose 6 L/ha (uncovered)
Route
Mixing/
Loadingc
c
Application
Shyfo
14643 N
Estimated internal
exposure a (mg /day)
Respiratory
0.11
18.1
0.01
Dermal
12.96
18.1
0.72
Respiratory
0.17
18.1
0.01
Dermal
1.94
18.1
0.11
Total
15.18
18.1
0.84
15
Systemic
Risk-index b
NL-AOEL
(mg/day)
Manual downward spraying on the tree nursery crops and forestry, maximum dose 6 L/ha
(uncovered)
Mixing/
Respiratory
<0.01
18.1
<0.01
Loadingd
Dermal
4.21
18.1
0.23
Route
Applicatione
a
b
c
d
e
Estimated internal
exposure a (mg /day)
Respiratory
0.65
18.1
0.04
Dermal
16.52
18.1
0.91
Total
21.39
18.1
1.18
Internal exposure was calculated with:
• biological availability via the dermal route: 3% (concentrate) and 3% (spray dilution) (see 4.2)
• biological availability via the respiratory route: 100% (worst case)
The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
External exposure is estimated with EUROPOEM.
External exposure is estimated with EUROPOEM (dermal) and NL-model (respiratory).
External exposure is estimated with UK POEM.
Since the NL-AOEL is exceeded for the manual downward treatment without the use of PPE,
a tier 3 assessment has to be performed.
Tier 3
Since the results of acceptable dermal absorption studies were already used in tier 1 and 2,
a further refinement with additional dermal absorption data is not considered relevant and a
tier 4 assessment will be performed.
Tier 4
The NL-AOEL is exceeded without the use of PPE and dermal absorption data have already
been taken into account in the risk assessment. Therefore, in Tier 4 a risk assessment is
performed with and without the use of PPE.
Table T.3 Internal operator exposure to glyphosate and risk assessment for the use of
Shyfo
Route
Estimated internal
Systemic
Risk-index b
a
exposure (mg /day)
NL-AOEL
(mg/day)
without
with
without
with
PPE
PPE
PPE
PPE
Manual downward spraying on the tree nursery crops and forestry, maximum dose 6 L/ha
(uncovered)
Mixing/
Respiratory
<0.01
(<0.01)
18.1
<0.01
(<0.01)
Loadingc
Dermal
4.21
(4.21)
18.1
0.23
(0.23)
Applicationc/d
a
b
c
d
e
Respiratory
0.65
(0.65)
18.1
0.04
(0.04)
Dermal
16.52
1.65
18.1
0.91
0.09
Total
21.39
6.52
18.1
1.18
0.36e
Internal exposure was calculated with:
• biological availability via the dermal route: 3% (concentrate) and 3% (spray dilution) (see 4.2)
• biological availability via the respiratory route: 100% (worst case)
The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
External exposure is estimated with EUROPOEM (dermal) and NL-model (respiratory).
External exposure is estimated with UK POEM.
PPE: gloves and coverall during application
Shyfo
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16
4.4.2 Bystander exposure/risk
The exposure is estimated for the unprotected bystander. In Table T.4 the estimated internal
exposure is compared with the systemic EU-AOEL.
Table T.4 Internal bystander exposure to glyphosate and risk assessment during
application of Shyfo
Route
Estimated internal
Risk-index b
Systemic
a
exposure (mg /day)
EU-AOEL
(mg/day)
Bystander exposure during application in the intended crops, maximum 6 L/ha.
a
b
Respiratory
2.03
6.5
0.31
Dermal
0.07
6.5
0.1
Total
2.09
6.5
0.32
External exposure was estimated with EUROPOEM II. Internal exposure was calculated with:
• biological availability via the dermal route: 3% (see 4.2)
• biological availability via the respiratory route: 100% (worst case)
The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
4.4.3 Worker exposure/risk
Tier 1
Shortly after application it is not necessary to perform any re-entry activities for most
intended uses. However, after application on coniferous trees (over the crop) it is possible to
perform re-entry activities during which intensive contact with the treated crop will occur.
Therefore, worker exposure is calculated.
The exposure is estimated for the unprotected worker. In Table T.5 the estimated internal
exposure is compared with the systemic EU-AOEL.
Table T.5 Internal worker exposure to glyphosate and risk assessment after
application of Shyfo
Route
Estimated internal
Systemic
Risk-index b
a
exposure (mg /day)
EU-AOEL
(mg/day)
Re-entry activities in coniferous trees, 3 L/ha
Respiratory
a
b
-
-
-
Dermal
2.92
6.5
0.45
Total
2.92
6.5
0.45
External exposure was estimated with EUROPOEM II. Internal exposure was calculated with:
• biological availability via the dermal route: 3% (see 4.2)
The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
4.4.4 Re-entry
See 4.4.3 Worker exposure/risk.
Overall conclusion of the exposure/risk assessments of operator, bystander, and
worker
The product complies with the Uniform Principles.
Operator exposure
Based on the risk assessment, it can be concluded that for mechanical downward application
no adverse health effects are expected for the unprotected operator after dermal and
respiratory exposure to glyphosate as a result of the application of Shyfo in the intended
crops.
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17
For the unprotected operator, adverse health effects after dermal/respiratory exposure to
glyphosate as a result of the manual downward application of Shyfo in tree nursery and
forestry cannot be excluded. Correct use of personal protective equipment will reduce the
dermal exposure results in a sufficient reduction of the exposure to glyphosate for the
application of Shyfo in the intended crops.
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 glyphosate during application of
Shyfo in the intended crops.
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 intended crops due to exposure to glyphosate after application of Shyfo.
4.5
Appropriate mammalian toxicology and operator exposure end-points relating
to the product and approved uses
See List of Endpoints.
4.6
Data requirements
None.
4.7
Combination toxicology
Shyfo contains only one active substance and it is not described that it should be used in
combination with other formulations.
5. Residues
For the aspect ‘Residues’, and risk for consumers we refer to the member state of the
original authorisation (UK), except for the aspect ‘residues in succeeding crops’.
5.1
Summary of residue data
5.1.6 Residues in succeeding crops
For rotational crop studies reference can be made to the Draft Assessment Report (DAR)
prepared by the RMS Germany and the final List of Endpoints, d.d. October 2000. Rotational
crop studies were conducted with carrots, lettuce and barley. Only very low levels of
glyphosate and AMPA are present in the soil and plant tissues of rotational crops. Residues
in emergency replant and rotational crops will be less than those found in the primary crop.
Conclusion
The product complies with the Uniform Principles.
Data requirements
None.
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6. Environmental fate and behaviour
Risk assessment is done in accordance with Chapter 2 of the RGB.
Glyphosate was included on Annex I on July 1st, 2002 (2001/99/EG, 20-11-2001). On the
basis of the proposed and supported uses, the following particular issues have been identified
as requiring particular and short term attention from all Member States, in the framework of any
authorisations to be granted, varied or withdrawn, as appropriate:
-
Groundwater: Member States must pay particular attention to the protection of the
groundwater in vulnerable areas, in particular with respect to non-crop uses.
The LoEP (d.d. May 11th, 2001) from the final review report (6511/VI/99-final, 21 January
2002) is used for the current assessment. The List of Endpoints contains both the endpoints
for glyphosate as well as glyphosate trimesium. Only the endpoints for glyphosate are used
since the amount of active substance in the formulation is expressed as pure glyphosate
(formulated as potassium salt). For the sake of completeness the endpoints of glyphosate
trimesium are listed as well. The final list of endpoints (final review report of January 2002) is
used for risk assessment. Remarks and recalculations (based on LoEP data) by Ctgb are
added to the LoEP in italics.
The underlying risk assessment is based on the final list of endpoints for glyphosate and on
the UK authorisation for Shyfo. For the Dutch specific aspects data from recent assessments
is used.
List of Endpoints Fate/behaviour (May 11th, 2001 as included in the final review report
of January 2002)
Fate and behaviour in soil
Route of degradation
Aerobic:
Mineralization after
different periods of time
(%):
Non-extractable residues
after different periods of
time (%):
Glyphosate
Glyphosate trimesium
3 soils, 3 different 14C labels: 46.8
– 55.3 (28 d); 5.8 – 9.3 (112 d);
34.7 – 41.4 (84 d)
2 soils: 69.7 – 80.1 (150 d)
1 soil: 32.7 (112 d)
1 soil: 79.6 (100 d)
3 soils, 3 different 14C labels: 8.5 –
40.3 (28 d); 4.6 – 13.5 (112 d);
16.7 – 33.9 (84 d)
2 soils: 5.1 – 8.8 (150 d)
1 soil: 13.9 (112 d)
1 soil: 8.4 (100 d)
Glyphosate
2 soils: 37 (21 d), 75 (150 d)
TMS:
2 soils: 46 (9 d), 74 (150 d)
Glyphosate
2 soils: 32 (21 d), 20 (150 d)
TMS:
2 soils: 26 (9 d), 10 (150 d)
Major metabolites above
10 % of applied, name
and/or code,
% of applied (range and
maximum)
Aminomethylphosphonic acid
(AMPA) 26-29% after 14 days
Aminomethylphosphonic acid
(AMPA) 15.4% after 21 days (only
in one study detected), no further
degradation within 70 days.
Supplemental studies
Glyphosate
Glyphosate trimesium
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19
Supplemental studies
Glyphosate
Glyphosate trimesium
Anaerobic degradation
Mineralization after different
periods of time (%):
3 soils, 3 different 14C labels: 33.5
– 51.4 (28 d); 1.4 – 5.0 (112 d);
24.2 – 38.6 (84 d)
1 soil, < 1 (120 d)
Mineralization after different
periods of time (%):
Glyphosate: 43 (63 d)
TMS: 57 (63d)
Non-extractable residues after
different periods of time (%):
3 soils, 3 different 14C-labels: 12.8
– 29.7 (28d); 0.4 – 12.0 (112 d);
15.1 – 31.6 (84d)
1 soil, 20 (120 d)
Non-extractable residues after
different periods of time (%):
Glyphosate: 24 (63 d)
TMS: 16 (63d)
Soil photolysis:
DT50: 96 (90 d dark); 101 d
(1236 d dark)
DT50 200 hours (50 ° N)
AMPA: max. 24 % DT50 200
hours;No metabolites of TMS
detected.
Remarks:
None.
None.
Laboratory studies
Glyphosate
DT50lab (20 °C, aerobic):
DT50lab (20°C, aerobic): 4 – 180 d
(20°C), mean 49 d, n=7 (first order
kinetic)
Ctgb: individual values 4, <7, 8, 9,
25, 110 and 180 days. Geometric
mean = 19.3 (days)
Glyphosate trimesium
Glyphosate: 3- 62 d , mean 29 d,
n=8 (first order kinetic)
TMS: 3-15 d, mean 7 d, n=8 (first
order kinetic)
Rate of degradation
DT90lab (20 °C, aerobic):
DT90lab (20°C, aerobic): 40 – 280 d Glyphosate: 81- 207 d n= 4(first order
(20°C), mean 159 d,n=4 (first order kinetic)
TMS: 37-85 d (TMS anion), n= 4 (first
kinetic)
order kinetic)
Glyphosate:67d
DT50lab (10 °C, aerobic): DT50lab (10°C, aerobic):
TMS: 70 d (8°C)
not submitted (see field studies)
No significant degradation.
DT50lab (20°C, anaerobic): DT50lab (20°C, anaerobic):
comparable to aerobic (study one);
(waterphase) 3 d, (system) 1699 d
(study two)
Field studies (country or Glyphosate
region)
DT50f (best fit):
DT50f from soil
Germany 5 (Menslage); 12 (Bad
dissipation studies:
Krozingen) d; Switzerland 7
(Diegten); 21d (Egerkingen); USA:
1 d (Texas), 7 d (Ohio), 9 d
(Georgia), 12 d (California), 17 d
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14643 N
Glyphosate trimesium
DT50f (best fit):
Germany: 9, 15, 17, 23, 34,34d;
USA: 1.5, 1.8, 15 and 17 d
20
Glyphosate trimesium
Field studies (country or Glyphosate
region)
(Arizona), 31 d (Minnesota), 106 d
(New York), 130 d (Iowa);
Canada: 11 d (Manitoba), 16 d
(Ontario), 63 d (Alberta)
AMPA DT50f (first order kinetic) :
AMPA DT50f (best fit):
Germany: 134, 242, 316, 362,
Germany 218 d (Menslage);
449, 875 d ;
Switzerland 135; 139 d;
USA: 13, 23, 37,147d .
USA: 76 d (Ohio), 93 d (Texas),
103 d (Arizona), 145 d (New York),
170 d (Georgia), 174 d (Minnesota),
240 d (California); Canada: 128 d
(Manitoba), 185 d (Ontario)
Ctgb: the above endpoints for field
degradation of glyphosate and
AMPA cannot be traced back to
the studies described in the DAR
(due to recalculation/kinetic fitting?)
For the assessment, the bold
values from this final LoEP are
relied on.
not calculated; see DT50f
DT90f from soil
dissipation studies:
DT90f:
Germany: 76, 89, 113, 124, 166,
326 d;
USA: 24, 48, 61, 68 d
AMPA DT90f:
Germany: 445, 804, 1050, 1203,
1491, 2907 d;
USA: 42, 77, 124, 489d
Soil accumulation and
plateau concentation
Remarks:
e.g. effect of soil pH on
degradation rate
Glyphosate
Glyphosate trimesium
Plateau concentration for AMPA:
5.62 mg/kg (mean DT50f: 697 d
(first order kinetic))
Plateau concentration for AMPA:
0.91 mg/kg (mean DT50f
(Germany): 396 d (first order
kinetic))
None.
None.
Adsorption/desorption
Glyphosate
Kf / Koc:
Kd
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14643 N
soil type
1/n
Koc
Kd
soil
type
1/n
Glyphosate trimesium
Kd
Koc
Kd
Koc
1/n
21
silty clay
loam
1.16 60000 900
silt
loam
0.98 25100
427
0.89 1179 20
silt loam
0.8
loam
0.93 2860
66
0.89 530
loamy
sand
0.92 22300 245
sandy 0.88 7880
loam
39
0.84 1758 9
sand
*)
32830 263
clay
sand loam *)
50660 810
sandy clay *)
loam
3598
50
3800
34
loamy
sand
*)
884
5.3
silt loam
*)
3404
47
1.1
12
180000 2340 0.93 1659 22
*)
17819 510
loam
(sediment)
*)The advanced adsorption
isotherm test wasn't conducted
because in the screening test
equilibrium was not reached
after 72 hours
No pH-dependence
pH
dependence:
No pH dependence.
AMPA
Kf / Koc:
Kd
soil type
1/n
Koc
Kd
clay loam 0.786
3640
76
sand
0.904
8310
1554
sand
0.752
1160
15
clay loam 0.791
3330
30
loamy
sand
0.769
6920
111
sand
0.788
24800
74
No pH-dependence
pH
dependence:
Mobility
Column leaching:
Aged residue leaching:
Shyfo
14643 N
Glyphosate
1. 0.12 – 1.45% as of applied in
leachate (3 soils)
2. 0.03 – 6.56% as of applied in
leachate (7 soils)
1.56, 0.22 and 0.02 % 14Cactivity in leachates
65.2, 59.0 and 2.1 % evolved as
CO2
30.3, 40.4 and 97.5 % 14C in the
Glyphosate trimesium
< 2 % as in leachate
(BBA standard soils)
14
C distribution after 30 days:
Glyphosate-14C: 52 %
extractable (AMPA 26 %), 12 %
unextractable, 33 % CO2; TMS14
C: 10 % extractable, 21 %
22
Glyphosate
upper 2 cm of columns
Glyphosate trimesium
unextractable, 57 % CO2
0.1 % Glyphosate and 0.5% TMS in
leachate, total radioactivity in
leachate not given.
Lysimeter/Field leaching Not submitted.
studies:
Not submitted.
Remarks:
None.
None.
Fate and behaviour in water
Abiotic degradation
Hydrolytic degradation:
Glyphosate
pH__5____: stable (25°C)
pH__7____: stable (25°C)
pH__8____: stable (25°C)
Photolytic degradation:
Glyphosate trimesium
pH___5___: stable; 25 and 40
°C (glyphosate and TMS)
pH___7___: stable; 25 and 40
°C (glyphosate and TMS)
pH___9___: stable; 25 and 40
°C (glyphosate and TMS)
DT50: 33 d (pH 5), 69 d (pH 7),
77 d (pH 9).
Glyphosate:
DT50: 81 d (pH 7) 37°N
TMS: stable
Glyphosate
Glyphosate trimesium
No.
No.
1 and 4 days (Möllerfeld and
Römbke)
Glyphosate: 14 and 24 d;
TMS: 4 and 3 d
not calculated
Glyphosate: 46 and 80 d;
TMS: 13 and11 d
Biological degradation
Readily biodegradable:
Water/sediment study:
DT50 water:
DT90 water:
DT50 whole system:
Shyfo
14643 N
27 and 146 days (Möllerfeld and Glyphosate: 21 and
Römbke),
202 (extrapol.) d;
Ctgb: recalculation to SFO with TMS: 5 and 7 d
FOCUS Degradation Kinetics
spreadsheet gives:
DT50: 86.1 d chi2: 9.5
DT50: 37.7 d chi2: 11.7
23
Glyphosate
Glyphosate trimesium
31 and 124 days (Muttzall)
Ctgb: recalculation to SFO with
FOCUS Degradation Kinetics
spreadsheet gives:
DT50: 439.9 d chi2: 4.4
DT50: 52.6 d chi2: 7.1
Geomean 4 systems : 93.1 days,
used in exposure assessment
DT90 whole system:
Not calculated
Glyphosate: 69 d;
TMS: 18 and 23 d
Mineralization
18 and 24 % after 100 days
(Möllerfeld and Römbke),
6 and 26 % after 91 days
(Muttzall)
Glyphosate: 48 and 6 % after
100 days;
TMS: 67 and 68 % after 100
days
Non-extractable
residues
14 and 22 % after 100 days
(Möllerfeld and Römbke),
31 and 35 % after 91 days
(Muttzall)
Glyphosate: 14 and 17 % after
100 days;
TMS: 7 and 8 % after 100 days
Distribution in water /
sediment systems
(active substance)
after 1 day: 47-64% in water, 31- Glyphosate water: 1 and 5 %;
44% in sediment;
sediment: 4 and 58 %
after 100 days 3% in water, 29TMS water: < 1%; sediment: 2
44% in sediment.
and 5 %
In sediment: maximum 50-60% after
7 and 14 days, resp.
and 30-50% after 100 days.
Distribution in water /
sediment systems
(major metabolites)
AMPA: if found, only in the water AMPA water: 4 and < 1 %:
phase: maximum 16% after
AMPA sediment: 18 and 3 %
14 days and 0.5 % after 100 days.
Water/sediment studies with 14CAMPA (Knoch and Spirlet):
1 st system:
waterphase:
101% day 0; 4% day 100;
sediment:
max. 41% day 59; 20% day 100;
2 nd system
waterphase:
100% day 0; 1% day 59;
sediment:
max. 46% day 14; 32% day 100
Ctgb: no DT50 values were
derived for AMPA. Based on the
data presented in Addendum 2
(Knoch & Spirlet), the following
SFO DT50 system values were
calculated using the FOCUS
Degradation Kinetics spreadsheet:
Shyfo
14643 N
24
Glyphosate
Glyphosate trimesium
- system 1: 47.8 d (chi2 5.9)
- system 2: 32.8 d (chi2 11.6)
geomean: 39.6 days
Accumulation in water
and/or sediment:
No accumulation
No accumulation
Glyphosate
Glyphosate trimesium
Not submitted.
Not submitted.
None.
None.
Degradation in the
saturated zone
Remarks:
Fate and behaviour in air
Volatility
Vapour pressure:
Glyphosate
1.31 ⋅ 10-5 Pa (25 °C, acid)
Glyphosate trimesium
Henry's law constant:
2.1 ⋅ 10-7 Pa m3 mol-1
< 1 ⋅ 10-11 Pa (20 °C)
< 2 ⋅ 10-9 Pa m3 mol-1
Glyphosate
No absorption for wavelengths
> 290 nm.
DT50 (water):33d (pH 5), 69 d
(pH 7), 77 d (pH 9)
Glyphosate
Glyphosate trimesium
No absorption for wavelengths
> 290 nm.
DT50 (water): 81 d (pH 7) 37°N
(stable for TMS)
Glyphosate trimesium
Photolytic degradation
Direct photolysis in air:
Photochemical oxidative DT50: 1.6 d (Atkinson estimation)
degradation in air
DT50:
from plant surfaces: no
Volatilisation:
significant
volatilization
from soil: no significant
volatilization
from plant surfaces: negligible
(glyphosate and TMS)
Remarks:
None.
None.
DT50: about 1.4 hours
from soil: negligible (glyphosate
and TMS)
Appendix A: Metabolite names, codes and other relevant information of the pesticide
Shyfo with a.s. glyphosate.
The compounds shown below were found in one or more studies involving the metabolism
and/or environmental fate of glyphosate. The parent compound structure of glyphosate is
shown first in this list and followed by degradate or related compounds.
Shyfo
14643 N
25
Compound IUPAC name
name
Structural
formula
Structure
Glyphosate NC3H8NO5P
(phosphonomethyl)glycin
O
NH
HO
AMPA
6.1
-
O
CH6NO3P
CH2
OH
Molecular Observed
Weight
in study (%
[g/mol]
of
occurrence/
formation)
169.1
parent
P
CH2
OH
111.0
29 % in
soil, 16 %
in water
Fate and behaviour in soil
6.1.1 Persistence in soil
The risk assessment of persistence in soil is not a Dutch specific aspect. For the risk
assessment we refer to the member state of the original authorization (UK).
6.1.2 Leaching to shallow groundwater (Dutch specific aspect)
Leaching to shallow ground water is a Dutch specific aspect. For the current application for
mutual recognition this means that the UK risk assessment for leaching to ground water
cannot be used for mutual recognition and a national risk assessment has to be performed.
Article 2.9 of the Plant Protection Products and Biocides Regulations (RGB) describes the
authorisation criterion leaching to groundwater.
The leaching potential of the active substance (and metabolites) is calculated in the first tier
using Pearl 4.4.4 and the FOCUS Kremsmünster scenario. Input variables are the actual
worst-case application rate [0.18 -2.88 kg/ha], the crop [Oilseed rape, Linseed (scenario
KREMoilseed is used), Field bean, Peas, Leek, Asparagus (scenario KREMfldbeans is
used), Sugar beet, Mustard, Swede, Turnip, Fodder grassland (scenario KREMsugarbeet is
used), Apple, Pear, Cherry, Plum (scenario KREMapples is used), Tree nursery (scenario
KREM wcereals (worst case)), (un)cultivated land (scenario fallow soil), Cereals, Onion] and
an interception value appropriate to the crop stage of 0 – 0.8 (depending on BBCH of use).
Date of yearly application is May 25th for spring application and November 1st for autumn
applications. For metabolites all available data concerning substance properties are
regarded. Metabolite AMPA is included in the calculations. No other metabolites occurred
above > 10 % of AR, > 5 % of AR at two consecutive sample points or had an increasing
tendency. The following input data are used for the calculation:
PEARL:
Active substance glyphosate:
Geometric mean DT50 for degradation in soil (20°C): 19.3 days (laboratory data, n=7).
Arithmetic mean Kom (pH-independent): 12868 L/kg (n=8, excluding the sediment data)
Arithmetic mean 1/n: 0.96 (n=3, only for studies in which a 1/n was determined)
Saturated vapour pressure: 1.31 x 10-5 Pa (25 °C, acid, LoEP phys-chem properties)
Solubility in water: 10.5 ± 0.2 g/l (pH 2, 20 °C, 9 95 g/kg, LoEP phys-chem properties)
Molecular mass: 169.1 g/mol
Q10: 2.2
Plant uptake factor: 0.5 (systemic active substance)
Shyfo
14643 N
26
Metabolite AMPA:
Geometric mean field DT50 for degradation in soil (20°C): 139.5 days (no lab data available,
geomean of 7 acceptable field data points)
Arithmetic mean Kom (pH-independent): 4,656 L/kg (n=6)
Arithmetic mean 1/n: 0.80 (n=6)
Maximum fraction of occurrence: 0.29
Saturated vapour pressure: 1.31 x 10-5 Pa (25°C; parent)
Solubility in water: 10.5 ± 0.2 g/l (20°C; parent)
Molecular mass: 111.0 g/mol
Q10: 2.2
Plant uptake factor: 0.0 (default for metabolites)
Other parameters: standard settings of PEARL 4.4.4
The following concentrations are predicted for the a.s. glyphosate and the metabolite AMPA
following the realistic worst case GAP, see Table M.2
Table M.2 Leaching of active substance glyphosate and metabolite AMPA as predicted
by PEARL 4.4.4
Frequency Fraction
PEC
Use
Scenario Substance Rate
substanc Interval
Intercepted* groundwater
used
e [kg/ha] [days]
[µ
µg/L]
spring autum
n
Cereals
KREMGlyphosate
0.54
0
1/<
< 0.001
wcereals
AMPA
**
0.001
Linseed,
KREMGlyphosate
0.54
0
1/<
< 0.001
oilseed
woilseed
AMPA
**
0.001
Field beans,
KREMGlyphosate
0.54
0
1/<
< 0.001
pea without
fldbeans
AMPA
**
0.001
pod,
asparagus,
leek, dry
harvested
peas
Sugarbeet,
cereals,
mustard,
rape,swede,
turnip,
Onions
Permanently
uncultivated
land (excluding
(semi)hardene
d surfaces) ,
All edible
crops,
(stubble,
before
Shyfo
14643 N
KREMsugarbeet
Glyphosate
AMPA
0.54
**
1/-
0
<
0.001
< 0.001
KREMonions
fallow soil
Glyphosate
AMPA
Glyphosate
AMPA
0.54
**
0.54
**
1/-
0
< 0.001
1/-
0
<
0.001
<
0.001
< 0.001
27
Use
planting,
destruction)
Coniferous
trees (over the
crop),
Temporarily
uncultivated
land.
Barley, Oats,
Wheat,
Dry harvested
peas, field
beans
Linseed,
oilseed rape,
Mustard
Scenario
used
Fraction
Intercepted*
PEC
groundwater
[µ
µg/L]
spring autum
n
Glyphosate
AMPA
1.08
**
1/-
0
<
0.001
< 0.001
Glyphosate
AMPA
1.08
**
1.-
0
<
0.001
< 0.001
KREMwcereals
KREMfldbeans
Glyphosate
AMPA
Glyphosate
AMPA
1.44
**
1.44
**
1/-
0.9
< 0.001
1/-
0.7
<
0.001
<
0.001
KREMwoilseed
KREMsugarbeet
fallow soil
Glyphosate
AMPA
Glyphosate
AMPA
Glyphosate
AMPA
1.44
**
1.44
**
1.44
**
1/-
0.8
1/-
0.9
1/-
0
KREMapples
Glyphosate
AMPA
1.80
**
1/-
KREM-vines Glyphosate
AMPA
Cherry, Plum,
KREMGlyphosate
Tree nursery
wcereals
AMPA
crops, Forestry
(default)
Temporary
fallow soil
Glyphosate
uncultivated
AMPA
land,
Permanently
uncultivated
land (excluding
(semi)hardene
d surfaces), All
edible crops
(stubble before
planting,
destruction)
Fodder
KREMGlyphosate
grassland,
sugarbeet
AMPA
Tree nursery
crops,
Forestry,
between
crops, Green
1.80
**
1.80
**
Temporary
uncultivated
land
Apple, Pear,
Cherry, Plum,
Tree nurserry
Crops,
Forestry, All
edible crops
(stubble before
planting,
destruction)
Shyfo
14643 N
KREMwcereals
(default)
fallow soil
Substance Rate
Frequency
substanc Interval
e [kg/ha] [days]
< 0.001
<
0.001
<
0.001
<
0.001
< 0.001
0
<
0.001
< 0.001
1/-
0
< 0.001
1.-
0
<
0.001
<
0.001
1.80
**
1/-
0
<
0.001
< 0.001
2.16
**
1/-
0
<
0.001
< 0.001
< 0.001
< 0.001
< 0.001
28
Use
cover, on land
not being used
for crop
production
before
cultivation
(dekvrucht)
Tree nursery
crops, Forestry
(stump
application) –
injection
Tree nursery
crops,
Forestry,
(chemical
thinning)Brushing
(Semi)
hardened
surfaces
(spotwise
treatment)
Scenario
used
Substance Rate
Frequency
substanc Interval
e [kg/ha] [days]
Fraction
Intercepted*
PEC
groundwater
[µ
µg/L]
spring autum
n
Not relevant, no leaching from application method injection to tree stumps.
fallow soil
Glyphosate
AMPA
2.88
**
1/-
0
<
0.001
< 0.001
fallow soil
Glyphosate
AMPA
0.18***
**
1/-
0
<
0.001
< 0.001
*interception values derived from Table 1.6 in “generic guidance for FOCUS groundwater scenarios”.
Interception values were appropriate for respective BBCH codes; No interception for BBCH 00/ Application
before planting, interception of 0.7-0.9 for applications from BBCH 89.
** calculated using transformation scheme
*** based on spotwise treatment of 10 % of the acreage resulting in a factor 10 lower dose rate per hectare; the
application rate of 0.18 kg a.s..ha covers the also proposed lower application for the same use (0.054 kg/ha).
Results of Pearl 4.4.4 using the Kremsmünster scenario are examined against the standard
of 0.01 µg/L. This is the standard of 0.1 µg/L with an additional safety factor of 10 for
vulnerable groundwater protection areas (NL-specific situation).
From Table M.2 it reads that the expected leaching based on the PEARL-model calculations
for the a.s. glyphosate and its metabolite AMPA is smaller than 0.01 µg/L for all proposed
applications. Hence, the applications meet the standards for leaching as laid down in the
RGB.
Non-relevant metabolites
AMPA is the major metabolite of glyphosate in soil and water. For this metabolite it has been
demonstrated that it is toxicologically non-relevant for the assessment for leaching to
groundwater (refer to Decision of the Board of 12 June 2002).
For AMPA the following applies:
• Efficacy: The metabolite AMPA has no properties concerning efficacy.
• Human toxicology: Regarding the results of the available tests the metabolite AMPA
is considered toxicologically non-relevant. (For further details see the List of
Endpoints for human toxicology).
• Ecotoxicology:
o Aquatic organisms:
Shyfo
14643 N
29
Algae: NOEC = 79.7 mg/L (complies with criterion: NOEC >1 mg/L)
Aquatic invertebrates: EC50 = 691 mg/L (complies with criterion: EC50
>100 mg/L)
Fish: LC50 = 520 mg/L (complies with criterion: LC50 >100 mg/L)
o Earthworms:
There is no study available addressing the acute toxicity of AMPA to earthworms,
but a 56-d chronic study is provided: NOEC ≥ 28.1 mg/kg. This value is
approximately 40 times higher than the maximum PEC0 for AMPA in soil.
Furthermore for glyphosate the acute 14-d LC50 >1000 mg/kg. In this study also
considerable amounts of AMPA were formed (peak concentrations of AMPA are
reached after 14 days in soil degradation studies). Consequently AMPA is
assumed to be non-toxic to earthworms.
o Soil micro-organisms:
There is no study available addressing the toxicity of AMPA to soil microorganisms, but from studies with the active ingredient glyphosate it shows that at
relevant concentrations following use there are no effects on soil micro-organisms.
In this study also considerable amounts of AMPA were formed (peak
concentrations of AMPA are reached after 14 days in soil degradation studies).
Consequently AMPA is assumed to be non-toxic to soil micro-organisms at
relevant concentrations following use.
o Birds:
There are acute and sub-acute studies addressing the acute toxicity of AMPA to
birds submitted, which show that AMPA is very slightly toxic to birds.
Based on the data listed above it can be concluded that the metabolite AMPA can be
considered as non-relevant for leaching (although the more recent stepwise approach from
the GD on non-relevant metabolites was not exactly followed). Only a first tier leaching
assessment is performed. For the currently proposed uses, there was no exceeding of the
trigger.
Lysimeter/field leaching studies
No lysimeter studies are available for glyphosate or its metabolite AMPA.
Monitoring data
The active substance glyphosate and its metabolite AMPA were observed in the groundwater
of sampling points around a groundwater abstraction point [Bannink, 19991]. No residues of
glyphosate or AMPA were found at the filter depth, which ranged from 6 to 32 m below soil
surface. In Table M.3a observed concentrations in the shallow groundwater are presented.
Table M.3a Monitoring data for glyphosate in groundwater (1999)
Location/year
Detection
a/n*
Mean conc.
limit [µg/L]
[µ
µg/L]
Groundwater protection
area Helmond, 1999
0.05
0 / n**
<0.05
Maximum
conc. [µ
µg/L]
<0.05
* number of observations above detection limit (a)/total number observations (n).
** the total number of samples could not be retrieved.
More recent data are presented in RIVM Rapport 607310001/2007. Monitoring data were
collected in 2006 in the framework of groundwater monitoring for the WFD starting situation
(so-called nulmeting) in the Dutch provinces Drenthe, Flevoland, Friesland, Gelderland,
Groningen, Noord-Holland, Overijssel, Utrecht and Zeeland. See Table M.3b.
1
Bannink, A. (1999) Bestrijdingsmiddelen in het grondwaterbeschermingsgebied Helmond 1999. ’s
Hertogenbosch, The Netherlands: N.V. Waterleidingmaatschappij Oost-Brabant. Report no. WOB.BI2803, (in
Dutch) 49pp.
Shyfo
14643 N
30
Table M.3b Monitoring data for glyphosate in groundwater (2006)
Location/year
Detection
a/n*
Mean
Maximum
limit [µg/L]
conc.
conc. [µ
µg/L]
[µ
µg/L]
P90
conc.
[µ
µg/L]
The Netherlands, 2006
< 0.20
Varies
between 0.1
and 1.5
4/691
0.01
4.74
* number of observations above detection limit (a)/total number observations (n).
It must be noted that (page 19 of the report, translated by Ctgb) “no check was performed on
the measurements as is required for use of the data in registration assessment, as this was
not included in the current project remit. Presented values can therefore not be used as such
in registration procedures.”
As the P90 value given is below the detection limit (which is 0.2 µg/L for the deep
groundwater samples) and the data cannot be considered entirely suitable for use in the
registration process, no consequences are drawn from the data.
Conclusions
The proposed applications of the product comply with the requirements laid down in the RGB
concerning leaching to groundwater.
6.2
Fate and behaviour in water
6.2.1 Rate and route of degradation in surface water (Dutch specific aspect)
Since the Netherlands has its own national drift values, the exposure concentrations of the
active substance glyphosate and metabolite AMPA in surface water have been estimated for
the various proposed uses using calculations of surface water concentrations (in a ditch of 30
cm depth), which originate from spray drift during application of the active substance. The
spray drift percentage depends on the use.
No drift reducing measures are proposed by the applicant.
For the use on temporarily uncultivated land the applicant proposes the following restriction
Bij de toepassing op tijdelijk onbeteeld terrein mogen sloottaluds niet gespoten worden.
However, it is never allowed to treat ditch slopes as laid down in other Dutch law and
regulation (LOTV/Activiteitenbesluit). Hence in fact the restriction sentence is redundant. For
glyphosate containing products it is nonetheless maintained on the labels since formerly
(before 2006) there was an authorisation for use in dry ditches.
The several uses are grouped and calculated by group. Because the application timing is
variable within each group, both a spring and autumn scenario is calculated. Injection and
brushing are no drift applications and are therefore not included in the calculations. The use on
permanently uncultivated land may include hardened surfaces. However, because the
emission route run-off from hardened surfaces is not an NL-specific route, this specific
emission due to the use on hardened surfaces will not be taken into account.
Concentrations in surface water are calculated using the model TOXSWA. The following input
data are used for the calculation:
TOXSWA:
Active substance:
Geometric mean DT50 for degradation in water at 20°C: 91.3 days (geomean of 4 SFO system
values in the LoEP, endpoints recalculated by Ctgb using the study data in the DAR)
DT50 for degradation in sediment at 20°C: 1000 days (default).
Shyfo
14643 N
31
Arithmetic mean Kom for suspended organic matter: 12868 L/kg (n=8, excluding the sediment
data)
Arithmetic mean Kom for sediment: 12868 L/kg (n=8, excluding the sediment data)
Arithmetic 1/n: 0.96 (n=3, only for studies in which a 1/n was determined)
Saturated vapour pressure: 1.31 x 10-5 Pa (25°C, acid, LoEP phys-chem properties)
Solubility in water: 10.5 ± 0.2 g/l (pH 2, 20°C, 99 5 g/kg, LoEP phys-chem properties)
Molecular mass: 169.1 g/mol
Q10: 2.2
Metabolite AMPA
Geometric mean: DT50 for degradation in water at 20°C: 39.6 days (geomean of 2 systems,
endpoints calculated by Ctgb from LoEP data)
DT50 for degradation in sediment at 20°C: 1000 days (default).
Arithmetic mean Kom for suspended organic matter: 4656 L/kg (n=6)
Arithmetic mean Kom for sediment: 4656 L/kg (n=6)
Arithmetic mean 1/n: 0.80 (n=6)
Saturated vapour pressure: 1.31 x 10-5 Pa (25°C, parent)
Solubility in water: 10.5 ± 0.2 g/l (20°C, parent)
Molecular mass: 111.0 g/mol
Correction factor: 0.16 (max. % observed) x 0.66 (relative molar ratio = M metabolite/ M parent)
= 0.11
Q10: 2.2
Other parameters: standard settings TOXSWA
When no separate degradation half-lives (DegT50 values) are available for the water and
sediment compartment (accepted level P-II values), the system degradation half-life
(DegT50-system, level P-I) is used as input for the degrading compartment and a default
value of 1000 days is to be used for the compartment in which no degradation is assumed.
This is in line with the recommendations in the FOCUS Guidance Document on Degradation
Kinetics.
For metabolites, the level M-I values are used (system DegT50 value) only, since level M-II
criteria have not been fully developed under FOCUS Degradation Kinetics.
In Table M.4, the drift percentages and calculated surface water concentrations for the active
substance glyphosate and its metabolite AMPA for each intended use are presented.
Metabolite AMPA is modelled as parent using the application rate of the parent multiplied by
the the correction factor and the parameters for AMPA as described in the input box.
Table M.4 Overview of surface water concentrations for active substance glyphosate
and metabolite AMPA in the edge-of-field ditch following spring/autumn application
Use*
Substance Rate
Freq./
Drift
a.s.
Interval [%]
[kg/ha]
Group 1
Glyphosate
Shyfo
14643 N
0.54
1/-
1
PIEC
**
[µ
µg/L]
PEC21
**
[µ
µg/L]
PEC28
**
[µ
µg/L]
Spring autumn spring autumn spring autumn
2.352 2.352 1.229
0.315
1.123
0.238
32
Use*
Substance Rate
Freq./
Drift
a.s.
Interval [%]
[kg/ha]
AMPA
0.06
Group 2
Glyphosate 1.08
AMPA
0.12
Group 3
Glyphosate 1.44
AMPA
0.16
Temporary Glyphosate 1.44
uncultivated AMPA
0.16
land
Group 4
Glyphosate
1.8
AMPA
0.20
Group 5
Glyphosate 2.16
AMPA
0.24
Permanently Glyphosate 0.18***
uncultivated
AMPA
0.02***
land; only
(semi)
hardened
surfaces,
1/-
1
1/-
1
1/-
1
1/-
1
1/-
1
1/-
1
PIEC
**
[µ
µg/L]
PEC21
**
[µ
µg/L]
PEC28
**
[µ
µg/L]
Spring autumn spring autumn spring autumn
0.273 0.273 0.151
0.036
0.138
0.027
4.715 4.715 2.476
0.632
2.265
0.478
0.545 0.545 0.312
0.073
0.286
0.055
6.293 6.293 3.312
0.844
3.029
0.638
0.735 0.735 0.422
0.098
0.387
0.074
6.293 6.293 3.312
0.844
3.029
0.638
0.735 0.735 0.422
0.098
0.387
0.074
7.872
0.911
9.452
1.105
0.781
0.090
7.872
0.911
9.452
1.105
0.781
0.0901
4.151
0.527
4.990
0.644
0.405
0.048
1.056
0.122
1.269
0.148
0.110
0.012
3.798
0.484
4.567
0.592
0.370
0.044
0.799
0.092
0.959
0.112
0.079
0.009
* Uses are grouped as follows:
Group 1: Sugarbeet, barley, oats, wheat, dry harvested peas, linseed, mustard, oilseed rape, field
beans, pea without pod, swede, turnip, onions, asparagus, leek, permanently uncultivated land (with the
exception of (semi) hardenend surfaces), All edible crops, (stubble, before planting, destruction)
Group 2: Coniferous trees (over the crop), temporarily uncultivated land.
Group 3: Barley, oats, wheat, dry harvested peas, linseed, mustard, oilseed rape, field beans.
Group 4: Apple, pear, cherry, Plum, tree nurserry crops, forestry, temporary uncultivated crops,
Permanently uncultivated land (with the exception of (semi)hardenened surfaces), All edible crops (stubble before
planting, destruction).
Group 5: Fodder grassland, tree nursery crops, forestry, between crops, green cover, on land not being
used for crop production before cultivation (dekvrucht)
** calculated according to TOXSWA
*** based on spotwise treatment of 10% of the acreage resulting in a factor 10 lower dose rate per hectare; the
application rate of 0.18 kg a.s..ha covers the also proposed lower application for the same use (0.054 kg/ha). ).
The exposure concentrations in surface water are compared to the ecotoxicological threshold
values in section 7.2.
Monitoring data
The Pesticide Atlas on internet (www.pesticidesatlas.nl,
www.bestrijdingsmiddelenatlas.nl) is used to evaluate measured concentrations of
pesticides in Dutch surface water, and to assess whether the observed concentrations
exceed threshold values.
Dutch water boards have a well-established programme for monitoring pesticide
contamination of surface waters. In the Pesticide Atlas, these monitoring data are processed
into a graphic format accessible on-line and aiming to provide an insight into measured
pesticide contamination of Dutch surface waters against environmental standards.
The current version 2.0 of the Pesticide Atlas does not contain a land use correlation
analysis, which may indicate probable or causal relationships with land use. Instead a link to
the land use analysis performed in version 1.0 is made, in which the analysis is made on the
basis of data aggregation based on grid cells of either 5 x 5 km or 1 x 1 km.
Data from the Pesticide Atlas are used to evaluate potential exceeding of the authorisation
threshold and the MPC (ad-hoc or according to INS) threshold.
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For examination against the drinking water criterion, another database (VEWIN) is used,
since the drinking water criterion is only examined at drinking water abstraction points. For
the assessment of the proposed applications regarding the drinking water criterion, see next
section.
Active substance glyphosate
The active substance glyphosate was observed in the surface water (most recent data from
2009). In Table M.5a the number of observations in the surface water are presented.
In the Pesticide Atlas, surface water concentrations are compared to the authorisation
threshold value of 64 µg/L (27/07/2005, consisting of first or higher tier acute or chronic
ecotoxicological threshold value, including relevant safety factors, which is used for risk
assessment, in this case 0.1*EC50 algae) and to the indicative Maximum Permissible
Concentration (MPC) of 77 µg/L as presented in the Pesticide Atlas
Currently, this MPC value is not harmonised, which means that not all available
ecotoxicological data for this substance are included in the threshold value. In the near future
and in the framework of the Water Framework Directive, new quality criteria will be
developed which will include both MPC data as well as authorisation data.
The currently available MPC value is reported here for information purposes. Pending this
policy development, however, no consequences can be drawn for the proposed applications.
Table M.5a. Monitoring data in Dutch surface water (from www.pesticidesatlas.nl,
version 2.0) of glyphosate.
n > indicative/ad hoc
n > MPC-INS
Total no of locations
n>
MPC threshold
threshold *
(2010)
authorisation
threshold
293 **
0
0
n.a.
* n.a.: no MPC-INS available. < : exceeding expected to be lower than with indicative/ad hoc MPC value; >
: exceeding expected to be higher than with indicative/ad hoc MPC value
** the number of observations at each location varies between 1 and 30, total number of measurements is
1421 in 2010.
As there are no exceedings of thresholds, the monitoring data have no consequences for the
proposed uses of the product.
AMPA (metabolite of glyphosate)
The metabolite AMPA was observed in the surface water (most recent data from 2010). In
Table M.5b the number of observations in the surface water are presented.
In the Pesticide Atlas, surface water concentrations are compared to the authorisation
threshold value of 8980 µg/L (27/06/2002, consisting of first or higher tier acute or chronic
ecotoxicological threshold value, including relevant safety factors, which is used for risk
assessment, in this case 0.1*EC50 algae) and to the indicative Maximum Permissible
Concentration (MPC) of 79.7 µg/L as presented in the Pesticide Atlas.
Currently, this MPC value is not harmonised, which means that not all available
ecotoxicological data for this substance are included in the threshold value. In the near future
and in the framework of the Water Framework Directive, new quality criteria will be
developed which will include both MPC data as well as authorisation data. The currently
available MPC value is reported here for information purposes. Pending this policy
development, however, no consequences can be drawn for the proposed applications.
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Table M.5b. Monitoring data in Dutch surface water (from www.pesticidesatlas.nl,
version 2.0) of AMPA.
Total no of locations
n>
n > indicative/ad hoc
n > MPC-INS
(2010)
authorisation
MPC threshold
threshold *
threshold
293 **
0
0
n.a.
* n.a.: no MPC-INS available. < : exceeding expected to be lower than with indicative/ad hoc MPC value; > :
exceeding expected to be higher than with indicative/ad hoc MPC value
** the number of observations at each location varies between 1 and 30, total number of measurements is 1374
in 2010.
The correlation of exceedings with land use is derived from the 1.0 version of the Pesticide
Atlas. Hence, the correlation is not based on the exact same monitoring data. However, this
is the best available information and therefore it is used in this assessment.
As there is no exceeding of the ad hoc MPC or the authorisation threshold, the monitoring
data have no consequences for the proposed uses of the product.
.
Drinking water criterion
Assessment of the drinking water criterion is in principle not a Dutch specific aspect however
the interpretation is done in a Dutch specific way.
It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005
(Awb 04/37 (General Administrative Law Act)) that when considering an application, the Ctgb
should, on the basis of the scientific and technical knowledge and taking into account the
data submitted with the application, also judge the application according to the drinking water
criterion ‘surface water intended for drinking water production’.
The assessment methodology followed is developed by the WG implementation drinking
water criterion and outlined in Alterra report 16352.
Substances are categorized as new substances on the Dutch market (less than 3 years
authorisation) or existing substances on the Dutch market (authorised for more than 3 years).
- For new substances, a preregistration calculation is performed.
- For existing substances, the assessment is based on monitoring data of VEWIN
(drinking water board).
o If for an existing substance based on monitoring data no problems are
expected by VEWIN, Ctgb follows this VEWIN assessment.
If for an existing substance based on monitoring data a potential problem is identified by
VEWIN, Ctgb assesses whether the 90th percentile of the monitoring data meet the drinking
water criterion at each individual drinking water abstraction point
Glyphosate has been on the Dutch market for > 3 years (authorised since 25-02-1990). This
period is sufficiently large to consider the market share to be established. The existing active
substance glyphosate -and also its metabolite AMPA- is included in the most recent list of
substances of concern due to its presence in surface water at drinking water abstraction
points as established by VEWIN/Ctgb. Therefore, an adequate risk assessment is needed.
2
Adriaanse et al. (2008). Development of an assessment methodology to evaluate agricultural use ofplant
protection products for drinking water production from surface waters - A proposal for the registration procedure
in the Netherlands. Alterra-Report 1635
Shyfo
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There are monitoring data concerning the presence of glyphosate at drinking water
abstraction points.
In earlier assessments for re-registration of glyphosate-based products the monitoring data
set of 2001-2004 was evaluated. The following was concluded:
There are monitoring data concerning the presence of glyphosate in drinking water
abstraction points located in the Rhine and Meuse river. Based on the fact that in almost one
third of all samples the 0.1 µg/L threshold is exceeded and also the 90th percentile is above
the threshold (overall 90th-percentile value: 0.192 µg/L), it is expected that there is concern
for drinking water. In the re-registration of nine glyfosate-containing products this issue was
addressed. The outcome is given below: Restriction to DOB on hardened surfaces will meet
the threshold for drinking water. Therefore Ctgb decides to allow professional use on
hardened surfaces only via DOB or a similar certified system.
For formulations for which application on hardened surfaces is not applied for, no restrictions
for the use on hardened surfaces have to be included on the label. In the assessment of the
re-registration of Roundup Evolution (Decision of the Board d.d. 16 May 2008) this issue is
completely assessed.
Hence, the formulations based on glyphosate were allowed to stay on the market provided
that for the professional uses on hardened surface restrictions in the use were included. At
that time, the certification of the aimed application technique (DOB) was not yet possible and
therefore the restriction could not be set very stringent yet (techniques in line with DOB or
other certified techniques were put on the label). Several years have now passed since the
implementation of the new label with restrictions and new monitoring data are available.
There are indications from specific monitoring campaigns that the threshold value is not met
yet. Recently therefore, an analysis was made of the available monitoring data after the entry
into force of the restrictions for hardened surfaces, to evaluate whether this restricted use
has led to meeting the standards (policy advice of Ctgb by decree of the Ministry of Spatial
Planning, Housing and the Environment, dated October 2009).
On the basis of the monitoring campaign, which was the incentive for performing the above
analysis, it has been decided (in February 2010) to restrict the professional uses on
hardened surface to certified DOB practice, in order to achieve the expected improvement of
the water quality at drinking water abstraction points. The certification became obligatory in
February 2011. After the decision on appeal (June 2013), however, the demand for
certification could not be maintained. In the mean time, the rules for applying in accordance
with DOB have become more stringent (max 360 g a.s./ha per year, max. 216 gram a.s/ha
per application, DOB version 2.0). As the applied for use of Shyfo falls within these
boundaries there is no objection to the use of the same restriction as for Roundup Evolution.
For Roundup Evolution the restriction currently is: Toepassing van dit middel op half-open en
gesloten verhardingen is uitsluitend toegestaan volgens de ‘criteria voor toepassing van
onkruidbestrijdingsmiddelen op basis van glyfosaat op verhardingen’ volgens de DOBmethode (Duurzaam OnkruidBeheer op verhardingen, zie www.dob-verhardingen.nl).
This same restriction is therefore valid for Shyfo.
The currently available dataset of RIWA-Rhine/Meuse and Waterbedrijf Groningen (at the
time of the original assessment of Shyfo these were the data from 2007- 2010) indicate that
concentrations at drinking water abstraction points have decreased substantially on almost
every abstraction point, but the 90th percentile of several abstraction points is still above 0.1
µg/L. See Table M.6a.
Table M.6a Monitoring data for glyphosate at drinking water abstraction points from
surface water in the period 2007 – 2010 (after implementing restrictions for
professional use on hardened surfaces)
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Abstraction point
Andijk
Nieuwegein
Amsterdam-Rijn kanaal
(Nieuwersluis)
Brakel
Heel
Petrusplaat/Keizersveer
Scheelhoek/Stellendam
Drentsche Aa (De Punt)
Number of
measurements above
detection limit/
Number of
measurements
[n/N]
19/92
60/118
67/117
25/87
61/70
92/124
31/59
21/122
Number of
measurements above
drinking water limit/
Number of
measurements
[n/N]
0/92
8/118
8/117
6/87
43/70
32/124
3/59
15/122
Overall
90percentile
[µg/L]
0.060
0.080
0.090
0.080
0.191
0.160
0.072
0.109
For the appeal against the implementation of the certified DOB restriction for professional
use on hardened surfaces (appeal no. 2010-08/09, date treated at Advisory Board 23 March
2011) it was again analysed if the monitoring data demonstrate an improvement of the water
quality at drinking water abstraction points.
It was concluded that for all abstraction points an improvement was found when comparing
the 2007-2009 analysis with the 2007-2010 analysis. Furthermore, the exceeding at De Punt
(Drentsche Aa catchment) can be fully attributed to one anomalous year (2008). This
probably is caused by non-GAP application but it cannot be substantiated which use or user
group is responsible (it seems likely that it is due to the use on pavements because of the
observed relation with weather conditions, personal communication Waterbedrijf Groningen).
Most proposed uses are not expected to contribute to the drinking water problem as they are
not on paved areas. One of the proposed uses does imply professional treatment on
permanently uncultivated land, including paved areas.
Since it has been demonstrated that the exceeding of the drinking water criterion by
glyphosate is due to the professional use on hardened surfaces, this use cannot be
authorised as such.
However, in an earlier assessment for professional use of glyphosate on paved areas Ctgb
concluded that when complying to the DOB principles, the maximum amount of a.s.
glyphosate is regulated. This does not depend on which formulation is used. Hence the total
amount of the active substance glyphosate is not allowed to exceed the DOB instructions.
This means that the authorisation of Shyfo will not lead to a higher overall use of glyphosate
on hardened surfaces, since the use of DOB is legally binding by the inclusion on the
instructions for use (WG).
It is considered that –in view of earlier assessments that the overall use on paved areas will
not increase, combined with the observed downward trend (data of 2010 show less
exceeding than earlier years) - although the standards for surface water destined for the
production of drinking water as laid down in the RGB are not met for glyphosate, the
proposed applications can be authorised, provided that the following restriction sentence is
included in the WG, to ensure that application takes place in accordance with DOB when
treating hardenened surfaces:
Toepassing van dit middel op half-open en gesloten verhardingen is uitsluitend toegestaan
volgens de ‘criteria voor toepassing van onkruidbestrijdingsmiddelen op basis van glyfosaat
op verhardingen’ volgens de DOB- methode (Duurzaam OnkruidBeheer op verhardingen, zie
www.dob-verhardingen.nl).
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AMPA
The VEWIN has included AMPA on the list of substances of concern for drinking water.
The same new data set (after introduction of the restrictions for use on hardened surfaces)
as available for glyphosate is also available for AMPA. An analysis of the data (2007-2010)
shows that the 90th percentile is above the drinking water limit at all drinking water
abstraction points. See Table M.6b.
Table M.6b Monitoring data for AMPA at drinking water abstraction points from
surface water in the period 2007 – 2010 (after implementing restrictions for
professional use on hardened surfaces)
Abstraction point
Number of
Number of
90measurements above measurements above percentile
[µg/L]
detection limit/
drinking water limit/
Number of
Number of
measurements
measurements
[n/N]
[n/N]
0.310
Andijk
71/92
71/92
0.616
Nieuwegein
132/132
132/132
0.678
Amsterdam-Rijn kanaal
116/117
116/117
(Nieuwersluis)
1.200
Brakel
87/87
87/87
2.500
Heel
70/70
70/70
1.800
Petrusplaat/Keizersveer
103/104
103/104
0.772
Scheelhoek/Stellendam
59/59
57/59
Drentsche Aa (De Punt)
3/115
0/115
0.025
It must be noted that the detection limit for most abstraction points is 0.1 µg/L. Furthermore
AMPA is known to have more sources than only glyphosate (e.g., detergents). Again, also for
AMPA the exposure is governed almost entirely by the use of glyphosate on hardened
surfaces, and it has been analysed that applications to crop and/or bare soil hardly contribute
to the observed surface water concentrations at drinking water abstraction points.
Additionally, the metabolite is declared non-relevant for groundwater. The groundwater
assessment is in fact a drinking water assessment, hence the non-relevance could in
principle be extrapolated to surface water destined for the production of drinking water. This
is sustained by the Guidance Document (GD) on non-relevant metabolites where it is stated
in the introduction that: “This guidance document focuses on groundwater, though the general
approach may also be applicable for the regional management of surface water resources
intended for the abstraction of drinking water in Member States.”
For the proposed uses there is no exceeding of the “normal” groundwater limit of 0.1 µg/L
(leaching assessment). In contrast, the monitoring data at abstraction points show that for
surface water the 90th percentile concentration is 1.30 µg/L, which is above 0.75 µg/L and
below 10 µg/L.
The determination of non-relevance depends on the level of exposure concentrations.
Several “threshold of concern values” are included in the step-wise procedure in the
Guidance document for non-relevance of metabolites. These threshold values consist of a
concentration of 0.75 µg/L (above which a full consumer exposure assessment has to be
made) and a concentration of 10 µg/L (above which the decision for allowing the substance
is a risk managers’ responsibility). This means that for AMPA a consumer risk assessment
has to be made according to Step 5 of the GD: “Metabolites which have passed steps 1 to 3
and for which levels of estimated concentrations of metabolites in groundwater (as defined in
Shyfo
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38
Step 2) lie between 0.75 µg/L (from Step 4) and 10 µg/L3 will require a refined assessment of
their potential toxicological significance for consumers.
[….]
As provided [..] for step 4, also in step 5 the question must be addressed whether there are
other sources of exposure for consumers but groundwater. The permissible exposure of
consumers via water is calculated on the basis of a daily consumption of 2 L/day and taking
into account exposure from all other routes, if appropriate.”
The consumer exposure calculation for AMPA is based on the following input parameters:
Weight adult population: 63 kg
Weight child 1—6 years: 17 kg
ADI for AMPA: 0.3 mg/kg BW day-1 (derived from glyphosate)
Intake of drinking water: 2 L for adults, for children both a 1 L (realistic estimate) and a 2 L
(extreme worst-case) assessment is made
yields:
- a TMDI (Theoretical Maximum Daily Intake) of 2.6 µg/adult a day, equivalent to 0.041 µg/kg
BW day-1. This is 0.014 % of the ADI;
- a TMDI (Theoretical Maximum Daily Intake) of 1.3 µg/child a day, equivalent to 0.076 µg/kg
BW day-1. This is 0.025 % of the ADI;
- a TMDI (Theoretical Maximum Daily Intake) of 2.6 µg/child a day, equivalent to 0.153 µg/kg
BW day-1. This is 0.051 % of the ADI.
The exposure is negligible. Hence there is no concern from a consumer exposure
perspective.
Based on the results of the consumer risk assessment, it can be concluded that metabolite
AMPA is also non-relevant for surface water destined for the production of drinking water.
On the basis of al the above arguments, the proposed uses meet the standards for drinking
water with regard to AMPA.
Conclusion drinking water criterion
The original registration in UK was not assessed against the drinking water criterion.
Conclusion risk assessment according to RGB: all proposed applications of the product
comply with the RGB, provided that for the use on (half-open and closed) hardened surfaces
a restriction sentence is included on the label.
6.3
Fate and behaviour in air
Route and rate of degradation in air
Assessment of fate and behaviour in air is not a Dutch specific aspect. For the risk
assessment we refer to the member state of the original authorization (UK).
At present there is no framework to assess fate and behaviour in air of plant protection
products.
3
This limit value of 10 µg/L is selected for pragmatic reasons. It is also the current limit value defined in the
Drinking Water Directive for chlorinated aliphatic hydrocarbons such as trichlorethene. Some degradation
products of pesticides may belong into this chemical category. Note that some other products may also belong to
other defined categories in Drinking Water Directive and are, therefore, subject to a different limit.
Shyfo
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6.4
Appropriate fate and behaviour end-points relating to the product and approved
uses
See List of End-points.
6.5
Data requirements
None
The following restriction sentences were proposed by the applicant:
Toepassing van dit middel op verhardingen is uitsluitend toegestaan onder certificaat
volgens de ‘criteria voor toepassing van onkruidbestrijdingsmiddelen op basis van glyfosaat
op verhardingen’ van de Barometer duurzaam Terreinbeheer of een door het Ctgb
vergelijkbaar verklaard certificatiesysteem.
Bij de toepassing op tijdelijk onbeteeld terrein mogen sloottaluds niet gespoten worden.
Based on the current assessment, the following has to be stated in the GAP/legal
instructions for use (WG):
Toepassing van dit middel op half-open en gesloten verhardingen is uitsluitend toegestaan
volgens de ‘criteria voor toepassing van onkruidbestrijdingsmiddelen op basis van glyfosaat
op verhardingen’ volgens de DOB- methode (Duurzaam OnkruidBeheer op verhardingen, zie
www.dob-verhardingen.nl).
Bij de toepassing op tijdelijk onbeteeld terrein mogen sloottaluds niet gespoten worden.
6.6
Overall conclusions fate and behaviour
It can be concluded that:
1. all proposed applications of the active substance glyphosate meet the standards for
leaching to the shallow groundwater as laid down in the RGB.
2. all proposed applications of metabolite AMPA meet the standards for leaching to
shallow groundwater as laid down in the RGB.
3. UK did not assess the product with regard to the standards for surface water destined
for the production of drinking water, however, the proposed applications of the
product complies with the RGB with regard to the standards for surface water
destined for the production of drinking water, in case a restriction sentence is placed
on the label:
Toepassing van dit middel op half-open en gesloten verhardingen is uitsluitend
toegestaan volgens de ‘criteria voor toepassing van onkruidbestrijdingsmiddelen op
basis van glyfosaat op verhardingen’ volgens de DOB- methode (Duurzaam
OnkruidBeheer op verhardingen, zie www.dob-verhardingen.nl).
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7. Ecotoxicology
The Plant Protection Products and Biocides Regulations (RGB) published in the Government
Gazette (Staatscourant) 188 of 28 September 2007 came into effect on 17 October 2007,
while repealing the Uniform Principles Decree on Plant Protection Products (BUBG) and the
Regulation elaborating the uniform principles for plant protection products (RUUBG).
Risk assessment is done in accordance with Chapter 2 of the RGB for products based on:
- active substances which have already been placed on Annex I of directive 91/414/EEC
- “new”active substances;
This means that for the current application of mutual recognition of Shyfo, risk assessment is
done in accordance with Chapter 2 of the RGB.
The underlying risk assessment is based on the final list of endpoints for glyphosate and on
the UK authorisation for Shyfo (MAPP 15040). For the Dutch specific aspects data from
previous assessment is used.
Glyphosate is an existing active substance, included in Annex I (2001/99/EG).
List of Endpoints Ecotoxicology
Glyphosate
The environmental risk assessment is based on, the EU List of Endpoints from the EU review
report Glyphosate 6511/VI/99-final d.d. 21 January 2002 and data from the monograph on
Glyphosate. The List of Endpoints contains both the endpoints for glyphosate as well as
glyphosate trimesium. This assessment is only based on the endpoints of glyphosate. For
the sake of completeness also the endpoints of glyphosate trimesium are listed, but these
remain unused.
Sharda submitted acute toxicity studies in carp, daphnia and algae. These studies were
evaluated and summarised by Ctgb in December 2012 and are included in the LoEP (in
italics).
Terrestrial Vertebrates
Glyphosate
Glyphosate-trimesium
Acute toxicity to
mammals:
LD50 > 2000 mg/kg bw
lowest LD50 748 mg/kg bw
Acute toxicity to birds:
LD50 > 2000 mg/kg bw
AMPA > 2250 mg/kg bw
lowest LD50 950 mg/kg bw
Dietary toxicity to birds:
LC50 >4640 ppm (1624 mg/kg bw/d)*
AMPA >5620 ppm (1967 mg/kg
bw/d)*
LC50 > 5000 ppm
Reproductive toxicity to
birds:
NOEC 200 ppm (30 mg/kg bw/d)*
NOEC 712 ppm
Short term oral toxicity
to mammals:
NOAEL/NOEL 150 mg/kg bw/d (90 d,
rat)
NOAEL/NOEL 25 mg/kg
bw/d (90 d, rat)
* Recalculated to daily dose based on default factors for dietary and reproduction studies of 0.35 and 0.15 resp.
(based on EFSA-opinion on azinphos-methyl)
Aquatic Organisms
GlyphosateIPA
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14643 N
Glyphosatetrimesium
Glyphosate
st
acid (1
metabolite)
(= a.s.)
AMPA
41
Acute toxicity fish: EC50
>1000 mg /L
1800 mg/L
38 mg/L
Long term toxicity fish:
NOEC
917 mg /L
50 mg/L
25 mg/L
Bioaccumulation fish:
Not relevant
Not relevant
Not relevant
Acute toxicity invertebrate:
EC50
930 mg /L
12 mg/L
40 mg/L
Chronic toxicity invertebrate:
NOEC
455 mg /L
1.1 mg/L
30 mg/L
Chronic toxicity algae EC50
72.9 mg/L
0.72 mg/L
0.64 mg/L
(168 h)
Chronic toxicity sediment
dwelling organism:
Not tested
Not tested
Not tested
Long-term toxicity aquatic
plants: EC50
53.6 mg/L
1.0 mg/L
12 mg/L
>180
>180
89.8
Honeybees
Glyphosate
Glyphosate-trimesium
Acute oral toxicity:
LD50: 100 µg as/bee
LD50: > 400 µg as/bee
Acute contact toxicity:
LD50: > 100 µg as/bee
LD50: > 400 µg as/bee
Other arthropod species
Test species
Test method
Glyphosate
% Effect
Glyphosate-trimesium
% Effect
Typhlodromus pyri
Lab on inert substrate
Lifecycle: 100 % mortality (3.6 kg
as/ha)
Lifecycle: 100 % mortality (5.760
kg as/ha)
LR50: 0.211 kg as/ha
Typhlodromus pyri
Lab natural substrate
on leaves
Lifecycle: 89 % mortality (7.720 kg
as/ha)
LR50: 5.089 kg as/ha
Typhlodromus pyri
Lab natural substrate
on plants
Lifecycle: 30 % mortality; 0 %
effect on fertility (3.708 kg as/ha)
---
Aphidius rhopalosiphi
Lab on inert substrate
Adult: 100 % mortality
Adults: 100 % mortality (5.76 kg
as/ha)
LR50: 0.043 kg as/ha
Aphidius rhopalosiphi
Lab natural substrate
on plants
Adult: 25 % mortality; 6 % effect on
fertility (3.720 kg as/ha)
---
Aphidius rhopalosiphi
Lab natural substrate
on leaves
---
LR50:> 8.4 kg as/ha
Orius insidiosus
Lab on inert substrate
---
Lifecycle: 95 % mortality (5.760 kg
as/ha)
Chrysoperla carnea
Lab on inert substrate
Larval stage: 53 % mortality (0.712
kg as/ha)
---
Chrysoperla carnea
Larval stage: 59 % mortality; 20 %
---
Shyfo
14643 N
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Test species
Test method
Lab on inert substrate
Glyphosate
% Effect
Glyphosate-trimesium
% Effect
Drino inconspicua
Lab on inert substrate
---
Adults: 56 % mortality; 76 % effect
on parasitization (2.4 kg as/ha)
Pterostichus
melaniarius
Lab on inert substrate
---
Adults: 26.7% mortality (3.6 kg
as/ha)
Adults: 10% mortality (7.2 kg
as/ha)
Aleochara bilineata
Lab on inert substrate
Lifecycle: 1% parasitation capacity
(1.63 kg as/ha)
---
Bembidion lampros
Semifield
Adult: 0% mortality (4,890 kg
as/ha)
---
Poecilus cupreus
Lab on inert substrate
Adult: 0% mortality; 31% effect on
food uptake (3.6 kg as/ha)
---
Trechus quadristriatus
Lab on inert substrate
Adult: 14% mortality (3.6 kg as/ha)
---
Pardosa spp.
Lab on inert substrate
Earthworms
Adult: 56% mortality (3.7 kg as/ha)
Adults: 4 % mortality (3.6 kg as/ha)
Adults: 0% mortality (7.2 kg as/ha)
Glyphosate
Glyphosate trimesium
Acute toxicity:
LC50 > 480 mg as/kg
LC50 > 1000 mg as/kg
Reproductive toxicity:
Soil micro-organisms
NOEC 28.79 mg/kg (IPA-salt)
NOEC 28.79 mg/kg (IPA-salt)
Glyphosate
Glyphosate-trimesium
Nitrogen mineralization:
No effects up to 18 kg as/ha
No effects up to 18 kg as/ha
Carbon mineralization:
No effects up to 18 kg as/ha
No effects up to 18 kg as/ha
effect on fertility (3.708 kg as/ha)
Non-target organisms to believed at risk (Flora en fauna)
No data available.
Effects on waste water treatment
Glyphosate has no effect on respiration of activated sludge, EC50 is > 100 mg/L.
Effects on non target plants (taken from DAR)
Seven dicotyl and 4 monocotyl weed species were tested according to UP EPA guidelines
on seed germination and seedling emergence. Also a test on vegetative vigour was carried
out on 10 species. In the seedling emergence test no effects > 50% were found at the
highest dose tested. The EC50 is > 5.7 kg a.s./ha. In the vegetative vigour test, significant
effects were found in plant height and plant weight at 5.1 kg a.s./ha.
The lowest ER50 values in a vegetative vigour test after 21 days was observed for
tomato plants and the endpoint was calculated to be 0.146 kg a.s./ha for dry weight.
Shyfo
14643 N
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Soil non-target micro-organisms (taken from DAR)
Substance Medium type Duration pH T
Species
[h]
[°C]
Glyphosate growth medium 16
Effect Value Remarks
[mg/L]
n.a. 27 ± 5 Pseudomonas putida IC50
>100
NOEC 100
None
Formulation Shyfo
The applicant submitted a several new studies for the formulation Shyfo. These studies were
summarized and evaluated by Ctgb in December 2012.
Aquatic organisms
Test substance
Glyphosate 41% SL
(41% glyphosate;
12.5% surfactant)
Organism
Carp (Cyprinus carpio)
Endpoint
96-hour LC50
Daphnia magna
48-hour EC50
Pseudokircheneriella
subcapitata
48-hour EbC50
(A)
48-hour ErC50
(A)
48-hour EyC50
(A)
Value
18.5 mg product/L
(7.59 mg a.s./L)
62.3 mg product/L
(25.5 mg a.s./L)
15.9 mg product/L
(6.52 mg a.s./L)
47.7 mg product/L
(19.6 mg a.s./L)
17.2 mg product/L
(7.05 mg a.s./L)
(A) Endpoint based on 48-hour exposure period as validity criterion for control growth was met for 48 hours but
not for 72 hours. It should be noted that 72-hour endpoints were slightly higher than 48-hour endpoints.
7.1
Effects on birds (Dutch specific aspect)
The risk assessment for birds from exposure via sprayed natural food and secondary
poisoning via earthworms is not a Dutch specific aspect. For the risk assessment we refer to
the member state of the original authorisation (UK).
The risk assessment for birds via surface water (drinking water and secondary poisoning via
fish) is a Dutch specific aspect, since surface water concentrations are calculated based on
national drift values.
Drinking water
The risk from exposure through drinking surface water is calculated for a small bird with body
weight 10 g and a DWI (daily water intake) of 2.7 g/d. Surface water concentrations are
calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is
taken into account. The highest PIECwater is 9.452 µg/L. It follows that the risk of drinking
water is (LD50 * bw) / (PIEC*DWI) = (>2000 * 0.010) / (0.009452 * 0.0027) = >8E+05. Since
TER ≥ 10, the risk is acceptable.
7.1.2 Secondary poisoning
Since the log Pow of glyphosate < 3 (-2.8) the potential for bioaccumulation is considered low
and no further assessment is deemed necessary. The logPow of metabolite AMPA is also low
(<2) and no further risk assessment is necessary.
Conclusions birds
The application for mutual recognition of the product complies with the RGB for exposure of
birds via surface water and secondary poisoning.
Shyfo
14643 N
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7.2
Effects on aquatic organisms (Dutch specific aspect)
7.2.1 Aquatic organisms
Since the Netherlands have their own national drift values, the exposure concentrations in
surface water have been estimated based on these drift values (see PECsw in section 6.2).
The risk for aquatic organisms is assessed by comparing toxicity values with surface water
exposure concentrations from section 6.2. Risk assessment is based on toxicity-exposure
ratio’s (TERs).
Toxicity data for aquatic organisms are presented in Table E.1. Because the application for
authorisation concerns a herbicide, also the effects on macrophytes (aquatic plants) are
evaluated .
Table E.1 Overview toxicity endpoints for aquatic organisms
Substance
Organism
Lowest
Toxicity value
L(E)C50 NOEC
[µ
µg/L]
[mg/L] [mg/L]
glyphosate
Acute
Algae
0.64
640
Invertebrates
40
40000
Fish
38
38000
Macrophytes
12
12000
Chronic
Invertebrates
30
30000
Fish
25
25000
AMPA
Shyfo
(expressed as
a.s.)
Acute
Algae
Invertebrates
Fish
Macrophytes
Acute
Algae
Invertebrates
Fish
89.8
>180
>180
89800
>180 000
>180 000
6.52
25.5
7.59
6520
25500
7590
During the completeness check of the application for mutual recognition, the applicant was
requested to address the long-term risk of the formulation to aquatic organisms, based on
concern for long-term effects due to the co-formulant POEA (Polyoxyethylene amine (Berol
907), containing tallow alkylamine ethoxylate). The applicant submitted acute toxicity studies
with the product Shyfo. For fish, daphnia and algae, the difference in endpoints for the active
substance and the product Shyfo is less than a factor of 10, which is considered a trigger for
requirement of long-term studies with the product. For fish, the difference may be higher than
10, since the study with the product was conducted with carp, which is generally a less
sensitive species than trout. However, data for other glyphosate formulations (see e.g. 6483
N for Roundup) indicate comparable endpoints for fish as for Shyfo, when based on the
active substance. As a consequence, long-term studies with the product are not required.
The toxicity values are compared to the highest surface water concentrations calculated in
section 6.2 (i.e. those for group 5: Fodder grassland, tree nursery crops, forestry, between
crops, green cover, on land not being used for crop production before cultivation
(dekvrucht)). Note that the use on hardened surfaces is not taken into account, as the
emission route run-off from hardened surfaces is not an NL-specific route.
Shyfo
14643 N
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Trigger values for acute exposure are 100 for invertebrates and fish (0.01 times the lowest
L(E)C50-value) and 10 for algae and macrophytes (0.1 times the lowest EC50-value). Trigger
values for chronic exposure are 10 for invertebrates and fish (0.1 times the lowest NOECvalues).
For acute and chronic risk, the initial concentration is used (PIEC).
In table E.2 TER values for aquatic organisms are shown.
Table E.2a TER values: acute
TERst
Use
Substance PECsw
TERst
TERst
TERst
(trigger 10)
(trigger 100)
(trigger 100)
(trigger 10)
[µ
µg
a.s./L]
Algae
Invertebrates
Fish
Macrophytes
Group Glyphosate 9.452
68
4232
4020
1270
5 (A)
AMPA
1.105
8E+04
2E+05
2E+05
Group 5 : Fodder grassland, tree nursery crops, forestry, between crops, green cover, on
land not being used for crop production before cultivation (dekvrucht)
Table E.2b TER values: chronic
Use
Substance
PECsw
[µ
µg a.s./L]
TERlt
TERlt
(trigger 10)
(trigger 10)
Invertebrates
Fish
(A)
Group 5
Glyphosate
9.452
3174
2645
Group 5: Fodder grassland, tree nursery crops, forestry, between crops, green cover, on land
not being used for crop production before cultivation (dekvrucht)
Taking the results in Table E.2a and b into account, the acute TERs for fish and
invertebrates are above the relevant Annex VI triggers of 100 and the acute TERs for algae
and Lemna are above the relevant Annex VI triggers of 10. The chronic TERs for fish and
invertebrates are above the relevant Annex VI triggers of 10. Thus, it appears that the
proposed uses meet the standards for aquatic organisms as laid down in the RGB.
7.2.2 Risk assessment for bioconcentration
Since the log Kow value is –2.8, the risk for bioconcentration is small and is considered not
relevant. Therefore the active substance meets the standards for bioconcentration.
7.2.3 Risk assessment for sediment organisms
There are no data regarding the toxicity of glyphosate for sediment organisms. Since the
NOEC for daphnids is over 0.1 mg/L the risk for sediment organisms is considered to be low.
Therefore these data are not necessary.
AMPA is acute less toxic than glyphosate. Since for glyphosate no risk for sediment
organisms is expected, the risk for sediment organisms for metabolite AMPA is considered to
be low as well. Therefore, the active substance meets the standards for sediment organisms.
Conclusions aquatic organisms
The proposed applications meet the standards for aquatic organisms.
7.3
Effects on terrestrial vertebrates other than birds (Dutch specific aspect)
The risk assessment for mammals via natural food and secondary poisoning via earthworms
is not a Dutch specific aspect. For the risk assessment we refer to the member state of the
original authorisation (UK).
Shyfo
14643 N
46
The risk assessment for mammals via surface water (drinking water and secondary
poisoning via fish) is a Dutch specific aspect, since surface water concentrations are
calculated based on national drift values.
Drinking water
The risk from exposure through drinking from surface water is calculated for a small mammal
with body weight 10 g and a DWI (daily water intake) of 1.57 g/d. Surface water
concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance,
acute exposure is taken into account. The highest PIECwater is 9.452 µg/L. It follows that the
risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>2000* 0.010) / (0.009452 * 0.00157) =
>1E+06. Since TER > 10, the risk is acceptable.
7.3.2 Secondary poisoning
Since the log Pow of glyphosate < 3 (-2.8) the potential for bioaccumulation is considered low
and no further assessment is deemed necessary. The logPow of metabolite AMPA is also low
(<2) and no further risk assessment is necessary.
Conclusions mammals
The application for mutual recognition of the product complies with the RGB for exposure of
mammals via surface water and secondary poisoning.
7.4
Effects on bees
The risk assessment for bees is not a Dutch specific aspect. For the risk assessment we
refer to the member state of the original authorization (UK).
7.5
Effects on any other organisms (see annex IIIA 10.5-10.8)
7.5.1 Effects on non-target arthropods (Dutch specific aspect)
In-field
The in-field risk assessment for non-target arthropods in accordance with ESCORT2 is not
based on drift values and is therefore not a Dutch specific aspect. For the risk assessment
we refer to the member state of the original authorisation (UK).
Off-field (Dutch specific aspect)
For the off-field risk assessment on non-target arthropods in accordance with ESCORT2,
drift values are used to estimate the off-crop risk for the two standard species A. rhopalosiphi
and T. pyri. Since the Netherlands have their own national drift values, the off-field risk
assessment is a national specific aspect. As the intended uses in tree nursery crops
(forestry) as stump application and chemical thinning (by injection) do not result in off-field
exposure, these uses are not considered.
The risk for non-target arthropods is assessed by calculating Hazard Quotients. For this,
Lethal Rate values (LR50) are needed. Based on LR50-values from studies with the two
standard species Aphidius rhopalosiphi and Typhlodromus pyri an off-field Hazard Quotient
(HQ) can be calculated according to the assessment method established in the
SETAC/ESCORT 2 workshop and described in the HTB (v 1.0).
Data for Shyfo have not been submitted. Therefore, the assessment is based on the data for
glyphosate from the LoEP. In the LoEP, LR50 values are not provided for laboratory tests,
but it can be concluded that they must be below the tested dose, which was 3.6 kg a.s./ha for
T. pyri and probably also for A. rhopalosiphi. As the LR50 values are < values, the resulting
HQ values will be > values and the risk assessment will not be conclusive. Therefore, the risk
assessment is based on the data from extended studies on plants (LR50 values >3.708 kg
a.s./ha for T. pyri and >3.720 kg a.s./ha for A. rhopalosiphi). Hazard Quotients should be
below the trigger value of 1 to meet the standards.
Shyfo
14643 N
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The resulting Hazard Quotients are presented in Table E.3.
Table E.3 HQ-values for A. rhopalosiphi and T. pyri
Use*
Application MAF(A) Drift
rate
fraction
(kg a.s./ha)
Off-field
Group A.
2.16
1
0.10 (B)
1
rhopalosiphi
T. pyri
2.16
1
0.10 (B)
Group A.
1.8
1
0.022 (C)
2
rhopalosiphi
T. pyri
1.8
1
0.022 (C)
Group A.
2.16
1
0.063 (D)
3
rhopalosiphi
T. pyri
2.16
1
0.063 (D)
Group A.
1.8
1
0.10 (B)
4
rhopalosiphi
T. pyri
1.8
1
0.10 (B)
*
Vegetation Safety LR50
HQ
Factor (kg
factor (E)
(F)
a.s./ha)
1
5
>3.720 <0.29
1
1
5
5
>3.708 <0.29
>3.720 <0.05
1
1
5
5
>3.708 <0.05
>3.720 <0.18
1
1
5
5
>3.708 <0.18
>3.720 <0.2
1
5
>3.708 <0.2
Uses are grouped as follows:
Group 1: Sugar beet, barley, oats, wheat, dry harvested peas, linseed, mustard, oilseed rape, field bean,
fodder grassland, pea without pod, swede, turnip, onions, asparagus, leek, green cover on land
not being used for crop production before cultivation (dekvrucht), temporarily uncultivated land,
permanently uncultivated land (open surfaces), all edible crops, all non edible crops (stubble,
before planting, destruction), tree nursery crops (forestry, weed control before planting).
Group 2: Apple, pear, cherry, plum
Group 3: Tree nursery crops (forestry, between crops), coniferous trees (over the crop)
Group 4: (Semi) hardened surfaces
(A) Multiple Application Factor
(B) Default value for field crops
(C) Default value for herbicide spraying in large fruit, standard flat fan nozzle
(D) Default value for tree nursery crops, widely spaced
(E) Vegetation distribution factor is 1 when using results from extended studies on 3D structures
(F) Safety factor is 5 when using results from extended studies
As the above table shows, off-field HQ values are expected to be the trigger value of 1.
The proposed application of the product therefore meets with the standards as laid down in
the RGB.
7.5.2 Earthworms
The risk assessment for earthworms is not a Dutch specific aspect. For the risk assessment
we refer to the member state of the original authorisation (UK).
7.5.3 Effects on soil micro-organisms
The risk assessment for soil micro-organisms is not a Dutch specific aspect. For the risk
assessment we refer to the member state of the original authorisation (UK).
7.5.4 Effects on activated sludge
The risk assessment for activated sludge is not a Dutch specific aspect. For the risk
assessment we refer to the member state of the original authorisation (UK).
7.5.5 Effects on non target-plants (Dutch specific aspect)
According to the Terrestrial guidance document (Sanco/10329/2002) spray drift is considered
to be the key exposure route for non-target plants in the off-field area. Since the Netherlands
have their own national drift values, the risk assessment for non-target plants is a national
specific aspect. The risk assessment for non-target plants is performed below.
Shyfo
14643 N
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The risk assessment for non-target plants is based on an off-crop situation with a drift
percentage of 4.7% for field crops, 2.2% for herbicide spraying in large fruit (standard flat fan
nozzle) and 1.4% for tree nursery crops (herbicide use). The exposure equals drift *
application rate * MAF (in case of multiple application). MAF is 1 for single applications.
A TER is calculated with the lowest ER50 value, based on the available data for the a.s. The
lowest ER50 is 0.146 kg a.s./ha (tomato). See table E.4 for TER calculation.
Table E.4 Overview of exposure concentrations and TERs for non target plants
Use
Dose
MAF Drift% (offExposure EC50
TER Trigger
[kg a.s.
field
(kg
[kg
value
/ha]
exposure)
a.s./ha)
a.s./ha]
1.5
Group 1 2.16
1
4.7
0.10
0.146
5
3.7
Group 2 1.8
1
2.2
0.040
0.146
5
4.8
Group 3 2.16
1
1.4
0.0302
0.146
5
1.7
Group 4 1.8
1
4.7
0.085
0.146
5
*
Uses are grouped as follows:
Group 1: Sugar beet, barley, oats, wheat, dry harvested peas, linseed, mustard, oilseed rape, field bean,
fodder grassland, pea without pod, swede, turnip, onions, asparagus, leek, green cover on land
not being used for crop production before cultivation (dekvrucht), temporarily uncultivated land,
permanently uncultivated land (open surfaces), all edible crops, all non edible crops (stubble,
before planting, destruction), tree nursery crops (forestry, weed control before planting).
Group 2: Apple, pear, cherry, plum
Group 3: Tree nursery crops (forestry, between crops), coniferous trees (over the crop)
Group 4: (Semi) hardened surfaces
From table E.4 it appears that a risk for non-target plants cannot be excluded for all groups.
However, as studies have shown that the toxicity of formulations with glyphosate can
be more toxic (typically about a factor of 3) to non-target terrestrial plants than the active
substance as such, a study with the formulation Shyfo should be required. Because this
study is not available the risk assessment will be based for the time being on the assumption
that the toxicity is enhanced with a factor of 3. The TER values are presented in table E.6.
Table E.6 Overview of exposure concentrations and TERs for non target plants, based
on the lowest EC50 value with an additional safety factor of 3
Use
Dose
MAF Drift% (offExposure EC50/3 TER Trigger
[kg a.s.
field
(kg
[kg
value
/ha]
exposure)
a.s./ha)
a.s./ha]
0.49 5
Group 1 2.16
1
4.7
0.10
0.049
1.23 5
Group 2 1.8
1
2.2
0.040
0.049
1.62 5
Group 3 2.16
1
1.4
0.0302
0.049
0.58 5
Group 4 1.8
1
4.7
0.085
0.049
*
Uses are grouped as follows:
Group 1: Sugar beet, barley, oats, wheat, dry harvested peas, linseed, mustard, oilseed rape, field bean,
fodder grassland, pea without pod, swede, turnip, onions, asaparagus, leek, green cover on land
not being used for crop production before cultivation (dekvrucht), temporarily uncultivated land,
permanently uncultivated land (open surfaces), all edible crops, all non edible crops (stubble,
before planting, destruction), tree nursery crops (forestry, weed control before planting).
Group 2: Apple, pear, cherry, plum
Group 3: Tree nursery crops (forestry, between crops), coniferous trees (over the crop)
Group 4: (Semi) hardened surfaces
From table E.6 it appears that a high risk is indicated for all groups. The risk can be reduced
to an acceptable level by the following drift reduction measures (in Dutch):
- Group 1:
. lage spuitboomhoogte (30 cm boven de top van het gewas) in combinatie met een
Shyfo
14643 N
49
driftarme Venturidop en een kantdop, of,
. sleepdoek in combinatie met minimaal 50% driftreducerende spuitdoppen en een
kantdop; óf
. overkapte beddenspuit.
-Group 2 and 3:
. minimaal 50% drifreducerende spuitdoppen in combinatie met een kantdop.
- Group 4: In the fate assessment for drinking water (see section 6.2.1) a restriction
sentence is included to ensure that only DOB certified users are allowed to treat
hardened surfaces. It is expected that the remaining drift percentage is so low that an
acceptable risk is reached for terrestrial non-target plants (in some cases hand held
equipment is used which will give higher drift, above 1%, but this will be very locally and
no population effects on terrestrial non-target plants are expected).
Conclusions any other organisms
The proposed applications of the product comply with the RGB for the aspect non-target
arthropods (off-field). The proposed applications of the product comply with the RGB for the
aspect terrestrial non-target plants for all uses, provided that drift reduction measures are
applied.
7.6
Appropriate ecotoxicological end-points relating to the product and approved
uses
See List of Endpoints.
7.7
Data requirements
None.
7.8
Restriction sentences
Based on the current assessment, the following has to be stated in the GAP/legal
instructions for use:
In the WG (legal instructions):
(restrictiezin)
Om niet tot de doelsoorten behorende planten te beschermen is de toepassing van het
product in de teelt van suikerbieten, gerst, haver, tarwe, droog te oogsten erwten,
lijnzaad, mosterd, koolzaad, veldboon, voedergrasland, erwt zonder peul, knolraap,
koolraap, uien, asperge, prei, groenbedekking op land niet gebruikt voor gewasproductie
voor cultivatie (dekvrucht), tijdelijk onbeteeld terrein, permanent onbeteeld terrein, alle
eetbare en niet-eetbare gewassen (stobben, voor het planten, doodspuiten) en
boomkwekerijgewassen (bosbouw, onkruidbestrijding voor het planten) uitsluitend
toegestaan indien gebruik wordt gemaakt van één van de volgende maatregelen:
. lage spuitboomhoogte (30 cm boven de top van het gewas) in combinatie met een
driftarme Venturidop en een kantdop, of,
. sleepdoek in combinatie met minimaal 50% driftreducerende spuitdoppen en een
kantdop; of
. overkapte beddenspuit.
Om niet tot de doelsoorten behorende planten te beschermen is de toepassing van het
product in de teelt van appel, peer, kers, pruim en boomkwekerijgewassen (bosbouw,
tussen de gewassen) uitsluitend toegestaan indien gebruik wordt gemaakt van minimaal
50% driftreducerende spuitdoppen in combinatie met een kantdop.
Shyfo
14643 N
50
7.9
Overall conclusions regarding the environment
It can be concluded that:
1. for the risk assessment for birds via natural food and secondary poisoning via
earthworms, Ctgb refers to the member state of the original authorisation (UK).
2. all proposed applications of the active substance glyphosate meet the standards for
birds (exposure via surface water; secondary poisoning via fish) as laid down in the
RGB.
3. all proposed applications of the active substance glyphosate meet the standards for
aquatic organisms as laid down in the RGB.
4. the active substance glyphosate meets the standards for bioconcentration as laid down
in the RGB.
5. for the risk assessment for mammals via natural food and secondary poisoning via
earthworms, Ctgb refers to the member state of the original authorisation (UK)
6. all proposed applications of the active substance glyphosate meet the standards for
mammals (exposure via surface water; secondary poisoning via fish) as laid down in
the RGB.
7. for the risk assessment for bees, Ctgb refers to the member state of the original
authorisation (UK).
8. for the risk assessment for non-target arthropods in-field, Ctgb refers to the member
state of the original authorisation (UK).
9. all proposed applications of the active substance glyphosate meet the standards for
non-target arthropods (off-field) as laid down in the RGB.
10. for the risk assessment for earthworms, Ctgb refers to the member state of the original
authorisation (UK).
11. for the risk assessment for soil micro-organisms, Ctgb refers to the member state of the
original authorisation (UK).
12. for the risk assessment for activated sludge, Ctgb refers to the member state of the
original authorisation (UK).
13. The proposed applications of the active substance glyphosate meet the standards for
non-target plants as laid down in the RGB, provided that drift reduction measures are
applied.
8. Efficacy
The product is authorised in the UK for the use in sugar beet, wheat, barley, oats, dry
harvested peas, linseed, mustard, oilseed rape, field bean, fodder grassland, apple, pear,
cherry, plum, pea without pod, swede, turnip, onions, asparagus, leek, tree nursery crops,
forestry, coniferous crops, green cover on land not being used for crop production before
cultivation, temporarily and permanently uncultivated land and all edible and non edible
crops. Climatological and environmental circumstances relevant for the aspect efficacy in the
claimed uses in The Netherlands are comparable to those in the UK. The cultivation method
in claimed uses is similar in both countries and there are no country-specific situations for the
use of Shyfo as a herbicide in the claimed uses.
8.1
Efficacy evaluation
For the evaluation of the aspect ‘Efficacy’ we refer to the evaluation of the member state of
the original authorisation (UK).
8.2
Harmful effects
For the evaluation of the aspect ‘Harmful effects’ we refer to the evaluation of the member
state of the original authorisation (UK).
8.3
Resistance
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On the label for resistance management the following text is added:
Resistentiemanagement
Dit middel bevat de werkzame stof glyfosaat. Glyfosaat behoort tot de glycines. De Hrac
code is G. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van
resistentiemanagement dient u de adviezen die gegeven worden in de
voorlichtingsboodschappen, op te volgen.
8.4
For vertebrate control agents: impact on target vertebrates
Because no vertebrates are controlled, this point is not relevant.
8.5
Any other relevant data / information
None.
9. Conclusion
The authorisation of the product is based on mutual recognition of the authorisation in the
United Kingdom of the product Shyfo approval number MAPP 15040. For the evaluation is
referred to the original authorisation as the United Kingdom have adopted the Uniform
Principles.
The evaluation of the Dutch specific aspects is in accordance with the Uniform Principles laid
down in appendix VI of Directive 91/414/EEC. The evaluation has been carried out on basis
of a dossier that meets the criteria of appendix III of the Directive.
The product is considered to comply with the Uniform Principles.
Classification and labelling
The identity of all substances in the mixture that contribute to the classification of the
mixture *:
glyphosate, tallow alkylamine ethoxylate
Pictogram:
GHS05
Signal word:
danger
GHS07
H-statements:
H318
Causes serious eye damage.
H332
Harmful if inhaled.
P-statements:
P261
Avoid breathing
dust/fume/gas/mist/vapours/spray.
P273
Avoid release to the environment.
P280
Wear protective gloves/protective clothing/eye
protection/face protection.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for
several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
P310
Immediately call a POISON
CENTER/doctor/…
P391
Collect spillage.
P501
Dispose of contents/container to hazardous or
special waste collection point.
Supplemental Hazard EUH401
To avoid risks to human health and the
information:
environment, comply with the instructions for
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SP1 statement
SP1
(gewas)
Child-resistant fastening obligatory?
Tactile warning of danger obligatory?
Explanation:
Pictogram:
use.
Do not contaminate water with the product or
its container.
Not applicable
Not applicable
No GHS09 necessary as H411 is not applied
H-statements:
H411 does not need to be applied; classification
according to Reg. (EC) 1272/2008 and based on:
• acute ecotoxicity data for the formulation (lowest
LC50 of 15.9 mg form/L for algae submitted by
the applicant, M factor not applicable)
• chronic data for the active substance (rapidly
degradable, lowest NOEC of 25 mg/L for fish
from EU List of Endpoints from the EU review
report Glyphosate 6511/VI/99-final d.d. 21
January 2002 and data from the monograph on
Glyphosate, M factor not applicable)
• chronic data for one co-formulant (rapidly
degradable, lowest NOEC of 7.5 mg/L for fish
from EPA Ecotox database, M factor not
applicable)
P-statements:
From the P-statements proposed by the applicant with
respect to human toxicology only the highly
recommended and recommended statements for
professional use were selected (note that P280 also
follows from the risk assessment) in order to reduce the
number of P-satements.
the P-statements proposed by the applicant with respect
to ecotoxicology were accepted.
Other:
SP1 according to Reg. (EU) No 547/2011.
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
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Appendix 1 Table of authorized uses
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Appendix 2 Reference list
This appendix serves only to give an indication of which data have been used for decision
making for the first time; as a result of concurring applications for authorisations, the data
mentioned here may have been used for an earlier decisions as well. Therefore, no rights
can be derived from this overview.
Deze appendix geeft een indicatief overzicht van de gegevens die voor het eerst gebruikt zijn
ten behoeve van een besluit; het kan echter voorkomen dat (onder andere) door een
samenloop van aanvragen, de hier opgenomen gegevens al eens eerder gebruikt zijn. Aan
dit overzicht kunnen dan ook geen rechten ontleend worden.
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1-2-3 - PDT-PHYTOS-VN.123

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