Toelatingsnummer 12845 N
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 HERREGISTRATIE TOELATING
Gelet op de aanvraag d.d. 29 juli 2008 (20080706 THG) van
BASF Nederland B.V.
Groningensingel 1
6835 EA ARNHEM
tot herregistratie van de toelating als bedoeld in artikel 80, vijfde lid Verordening (EG) 1107/2009
juncto artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden voor het
gewasbeschermingsmiddel, op basis van de werkzame stoffen pyraclostrobine en boscalid
Bellis
gelet op artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 39, eerste lid, Wet
gewasbeschermingsmiddelen en biociden,
BESLUIT HET COLLEGE als volgt:
1.1 Herregistratie toelating
1 De toelating van het gewasbeschermingsmiddel Bellis, welke expireert op 1 augustus
2013 wordt voor de in bijlage I genoemde toepassingen verlengd onder nummer 12845.
Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.
2 De toelating geldt tot 1 juli 2023.
1.2 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als
waarvoor de toelating is verleend.
1.3 Gebruik
Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I bij dit
besluit is voorgeschreven.
Bellis
12845 N
1
1.4 Classificatie en etikettering
Gelet op artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 29, eerste lid, sub d,
Wet gewasbeschermingsmiddelen en biociden,
1. De aanduidingen die op de verpakking moeten worden vermeld, worden hierbij
vastgesteld als volgt:
aard van het preparaat: Water dispergeerbaar granulaat
werkzame stof:
pyraclostrobine
boscalid
gehalte:
12,8 %
25,2 %
letterlijk en zonder enige aanvulling:
andere zeer giftige, giftige, bijtende of schadelijke stof(fen):
gevaarsymbool:
Xn
N
aanduiding:
Schadelijk
Milieugevaarlijk
Waarschuwingszinnen:
R22
R50/53
-Schadelijk bij opname door de mond.
-Zeer vergiftig voor in het water levende organismen; kan in het
aquatisch milieu op lange termijn schadelijke effecten
veroorzaken.
Veiligheidsaanbevelingen:
S21
S46
S60
S61
-Niet roken tijdens gebruik.
-In geval van inslikken onmiddellijk een arts raadplegen en
verpakking of etiket tonen.
-Deze stof en de verpakking als gevaarlijk afval afvoeren.
-Voorkom lozing in het milieu. Vraag om speciale instructies /
veiligheidsgegevenskaart.
Specifieke vermeldingen:
DPD01
-Volg de gebruiksaanwijzing om gevaar voor mens en milieu te
voorkomen.
2. Behalve de onder 1. bedoelde voorgeschreven aanduidingen en vermeldingen moeten
op de verpakking voorkomen:
a. letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.
Bellis
12845 N
2
b. hetzij letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede
bestrijding mits deze niet met die tekst in strijd zijn.
c. bij het toelatingsnummer een cirkel met daarin de aanduiding W.3.
2 DETAILS VAN DE AANVRAAG EN TOELATING
2.1 Aanvraag
Het betreft een aanvraag tot herregistratie van de toelating van het middel Bellis (12845 N),
een middel op basis van de werkzame stoffen pyraclostrobine en boscalid. De herregistratie
wordt aangevraagd voor de toelating als schimmelbestrijdingsmiddel in de teelt van appel en
peer. Tevens betreft het een verzoek tot uitbreiding met de toepassing in de teelt van
vruchtbomen en vruchtboomonderstammen.
2.2 Informatie met betrekking tot de stof
De werkzame stof pyraclostrobine is bij Richtlijn 2004/30/EG d.d. 10 maart 2004 van de
Europese Commissie van de Europese Gemeenschappen opgenomen in Bijlage I van Richtlijn
91/414/EEG. De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009
(Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011).
De werkzame stof boscalid is bij Richtlijn 2008/44/EC d.d. 4 april 2008 van de Europese
Commissie van de Europese Gemeenschappen opgenomen in Bijlage I van Richtlijn
91/414/EEG. De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009
(Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011).
2.3 Karakterisering van het middel
Bellis is een preventief werkend combinatieproduct op basis van pyraclostrobin en boscalid.
Pyraclostrobin behoort tot de groep van de strobilurinen. Enkele werkzame stoffen binnen deze
groep zijn kresoxim-methyl, azoxystrobin, famoxadone en trifloxystrobin. Pyraclostrobin remt de
mitochondrische ademhaling. Het middel remt de kieming van schimmelsporen en de groei van
de kiembuis op het bladoppervlak. Pyraclostrobin is niet systemisch. Het Fungicide Resistance
Action Committee (FRAC) geeft aan dat strobilurinen in hoge mate resistentiegevoelig zijn.
Boscalid behoort tot de chemische groep van de carboxamiden. Enkele werkzame stoffen
binnen deze groep zijn o.a. flutolanil, mepronil, carboxin, fenfuram en thifluzamide. Boscalid
remt de ademhaling in de mitochondria in de schimmel, waardoor essentiële bouwstenen niet
meer worden gevormd (succinate dehydrogenase) en de schimmelgroei wordt geremd. Het
middel remt tevens de kieming van de schimmelsporen. Boscalid werkt preventief en
systemisch en heeft een grote translaminaire mobiliteit. Boscalid is een “single site inhibitor’’ en
is matig resistentiegevoelig.
2.4 Voorgeschiedenis
De aanvraag is op 29 juli 2008 ontvangen; op 25 juli 2008 zijn de verschuldigde
aanvraagkosten ontvangen. Bij brief d.d. 4 juni 2009 is de aanvraag in behandeling genomen.
3 RISICOBEOORDELINGEN
De beoordeling is confonform beoordelingskader RGB (Hoofdstuk 2) bestaande uit de
werkinstructies RGB (tox en mil) en voor de overige aspecten HTB 1.0.
Bellis
12845 N
3
3.1 Fysische en chemische eigenschappen
De aard en de hoeveelheid van de werkzame stoffen en de in toxicologisch en ecotoxicologisch
opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De
identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het
middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar
geacht (artikel 28, eerste lid, sub c en e, Wet gewasbeschermingsmiddelen en biociden).
De beoordeling van de evaluatie van het middel en de stof staat beschreven in Hoofdstuk 2,
Physical and Chemical Properties, in Bijlage II bij dit besluit.
3.2 Analysemethoden
De geleverde analysemethoden voldoen aan de vereisten. De residuen die het gevolg zijn van
geoorloofd gebruik die in toxicologisch opzicht of vanuit milieu oogpunt van belang zijn, kunnen
worden bepaald met algemeen gebruikte passende methoden (artikel 28, eerste lid, sub d, Wet
gewasbeschermingsmiddelen en biociden).
De beoordeling van de evaluatie van de analysemethoden staat beschreven in Hoofdstuk 3,
Methods of Analysis, in Bijlage II bij dit besluit.
3.3 Risico voor de mens
Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale
omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik,
geen directe of indirecte schadelijke uitwerking heeft op de gezondheid van de mens. De
voorlopige vastgestelde maximum residugehalten op landbouwproducten zijn aanvaardbaar
(artikel 28, eerste lid, sub b, onderdeel 4 en sub f, Wet gewasbeschermingsmiddelen en
biociden).
Het profiel humane toxicologie inclusief de beoordeling van het risico voor de toepasser staat
beschreven in Hoofdstuk 4 Mammalian Toxicology, in Bijlage II bij dit besluit.
Het residuprofiel, de vastgestelde maximum residugehalten en de beoordeling van het risico
voor de volksgezondheid staan beschreven in Hoofdstuk 5, Residues in bijlage II behorende bij
dit besluit.
3.4 Risico voor het milieu
Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale
omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik,
geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt
gehouden met de volgende aspecten:
- de plaats waar het middel in het milieu terechtkomt en wordt verspreid, met name voor wat
betreft besmetting van het water, waaronder drinkwater en grondwater,
- de gevolgen voor niet-doelsoorten.
(artikel 28, eerste lid, sub b, onderdeel 4 en 5, Wet gewasbeschermingsmiddelen en biociden).
De beoordeling van het risico voor het milieu staat beschreven in Hoofdstuk 6, Environmental
Fate and Behaviour, en Hoofdstuk 7, Ecotoxicology, in Bijlage II bij dit besluit.
3.5 Werkzaamheid
Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale
omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik,
voldoende werkzaam is en geen onaanvaardbare uitwerking heeft op planten of plantaardige
producten (artikel 28, eerste lid, sub b, onderdelen 1 en 2, Wet gewasbeschermingsmiddelen
en biociden).
De beoordeling van het aspect werkzaamheid staat beschreven in Hoofdstuk 8, Efficacy, in
Bijlage II bij dit besluit.
Bellis
12845 N
4
3.6 Eindconclusie
Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Bellis op
basis van de werkzame stoffen pyraclostrobine en boscalid voldoende werkzaam en heeft het
geen schadelijke uitwerking op de gezondheid van de mens en het milieu.
Wageningen, 7 maart 2014
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN,
ir. J.F. de Leeuw
voorzitter
Bellis
12845 N
5
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE I bij het besluit d.d. 7 maart 2014 tot herregistratie van de toelating van het middel
Bellis, toelatingnummer 12845 N
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Toegestaan is uitsluitend het gebruik als schimmelbestrijdingsmiddel toegepast door middel
van een gewasbehandeling in de teelt van:
a.
Appel en peer;
b.
Vruchtbomen en vruchtboomonderstammen van appel en peer.
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel en
peer op perceelranden die grenzen aan oppervlaktewater uitsluitend toegestaan voor 1 mei
wanneer:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en venturidoppen
(Lechler ID 90-015C).
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel en
peer op perceelranden die grenzen aan oppervlaktewater uitsluitend toegestaan na 1 mei
wanneer:
•
het middel wordt verspoten met een tunnelspuit of:
•
in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt
met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het perceel
bespoten dient te worden, of:
•
er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste
bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en venturidoppen
(Lechler ID 90-015C).
Resistentiemanagement
Dit middel bevat de werkzame stoffen pyraclostrobin en boscalid. Pyraclostrobin behoort tot
demethoxy-carbamaten. De Frac code is 11. Boscalid behoort tot de pyridine-carboxamiden.
De Frac code is 7. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van
resistentiemanagement dient u de adviezen die gegeven worden in de
voorlichtingsboodschappen, op te volgen.
De kans op het ontstaan van resistentie tegen de groep van de strobilurinen en carboxamiden
kan niet worden uitgesloten.
Daarom per teelt in totaal maximaal vier behandelingen met het middel in een kalenderjaar
uitvoeren volgens één van de volgende mogelijkheden:
- Een blok uitvoeren van drie toepassingen van Bellis, gevolgd door twee toepassingen
van een middel met een ander werkingmechanisme, gevolgd door één toepassing van
Bellis;
- Eén toepassing van Bellis, gevolgd door twee toepassingen van een middel met een
ander werkingsmechanisme, gevolgd door een blok van drie toepassingen van Bellis;
- Eén blok van twee toepassingen van Bellis, gevolgd door twee toepassingen van een
middel met een ander werkingsmechanisme, gevolgd door een blok van twee
toepassingen van Bellis;
- Bellis toepassen in afwisseling met een middel met een ander werkingsmechanisme.
Bellis
12845 N
1
Veiligheidstermijn
De termijn tussen de laatste toepassing en de oogst mag niet korter zijn dan:
7 dagen voor appel en peer.
Dit middel is uitsluitend bestemd voor professioneel gebruik.
B.
GEBRUIKSAANWIJZING
Bellis is een schimmelbestrijdingsmiddel met een preventieve werking en bevat de werkzame
stoffen pyraclostrobin en boscalid. Pyraclostrobin behoort tot de chemische groep van de
strobilurinen en boscalid tot de carboxamiden.
Het middel dient te worden toegepast op een droog gewas.
Toepassingen
Appel en peer, ter bestrijding van schurft (Venturia inaequalis en Venturia pirina)
Toepassen in een interval in 7-10 dagen vanaf het groene knopstadium.
Dosering: 0,08% (80 gram middel per 100 liter water) met een maximum van 0,8 kg middel/ha
Appel en peer, ter bestrijding van echte meeldauw (Podosphaera leucotricha)
Toepassen in een interval van 7-10 dagen vanaf het roze knopstadium tot aan het einde van de
ascosporenuitstoot.
Dosering: 0,08% (80 gram middel per 100 liter water) met een maximum van 0,8 kg middel/ha
Appel en peer, ter voorkoming van vruchtrot veroorzaakt door Gloeosporium spp. en
Penicillium spp.
Toepassen in een interval van 7-10 dagen vanaf ± 6 weken voor de oogst.
Dosering: 0,08% (80 gram middel per 100 liter water) met een maximum van 0,8 kg middel/ha
Appel en peer, ter voorkoming van bewaarschurft (Venturia inaequalis en Venturia pirina).
Toepassen in een interval van 7-10 dagen vanaf ± 6 weken voor de oogst.
Dosering: 0,08% (80 gram middel per 100 liter water) met een maximum van 0,8 kg middel/ha
In de teelt van vruchtboomonderstammen en vruchtbomen van appel en peer, ter bestrijding
van schurft (Venturia inaequalis en Venturia pirina)
Toepassen in een interval van 7-10 dagen vanaf het groene knopstadium.
Dosering: 0,08%; (80 gram middel per 100 liter water) met een maximum van 0,8 kg middel/ha
In de teelt van vruchtboomonderstammen en vruchtbomen van appel en peer, ter bestrijding
van echte meeldauw (Podosphaera leucotricha)
Toepassen in een interval van 7-10 dagen vanaf het roze knopstadium tot aan het einde van de
ascosporen uitstoot.
Dosering: 0,08%; (80 gram middel per 100 liter water) met een maximum van 0,8 kg middel/ha
Bellis
12845 N
2
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE II bij het besluit d.d. 7 maart 2014 tot herregistratie van de toelating van het middel
Bellis, toelatingnummer 12845 N
RISKMANAGEMENT
Contents
Page
1. Identity of the plant protection product ...................................................................... 3
2. Physical and chemical properties ............................................................................... 4
3. Methods of analysis ................................................................................................... 10
4. Mammalian toxicology ............................................................................................... 15
5. Residues ..................................................................................................................... 26
6. Environmental fate and behaviour ............................................................................ 34
7. Ecotoxicology ............................................................................................................. 64
8. Efficacy ....................................................................................................................... 98
9. Conclusion ................................................................................................................ 101
10.
Classification and labelling.................................................................................. 101
Appendix 1 Table of authorised uses ................................................................................ 1
Appendix 2 Reference list................................................................................................... 2
pag. 2
1. Identity of the plant protection product
1.1
Applicant
BASF Nederland B.V.
Groningensingel 1
6835 EA ARNHEM
1.2
Identity of the active substances
Common name
Boscalid
Name in Dutch
Boscalid
Chemical name
2-Chloro-N-(4'-chlorobiphenyl-2-yl)nicotinamide (IUPAC name)
CAS no
188425-85-6
EC no
Not assigned
The active substance boscalid was included on August 1st, 2008 in Annex I of Directive
91/414/EEC. From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance
is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC.
Common name
Name in Dutch
Chemical name
CAS no
EC no
Pyraclostrobin
Pyraclostrobine
methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) Nmethoxy carbamate (IUPAC)
175013-18-0
not assigned
The active substance pyraclostrobin was included on June 1st 2004 in Annex I of Directive
91/414/EEC. From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance
is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC.
1.3
Identity of the plant protection product
Name
Bellis
Formulation type
WG
Content active substance
25.2% pure boscalid
12.8% pure pyraclostrobin
The formulation was not part of the assessment of the active substances for inclusion in Annex
I of Directive 91/414/EEC.
1.4
Function
Bellis is a fungicide.
1.5
Uses applied for
See GAP (Appendix I).
With the reregistration, the GAP is extended with the use in apple and pear nursery stock and
root stock of apple and pear.
1.6
Background to the application
The application is a re-registration.
1.7
Packaging details
pag. 3
1.7.1 Packaging description
Material:
HDPE
Capacity:
1, 2, 5 or 10L
Type of closure and size 42mm (1 and 2L) of 54mm (5 and 10L) opening with PP screw cap and
of opening:
HF-seal.
Other information
UN/ADR compliant.
1.7.2 Detailed instructions for safe disposal
See application form and MSDS (no particular recommendations)
2. Physical and chemical properties
2.1
Active substance: boscalid
Data on the identity and the physical and chemical properties is taken from the List of
Endpoints (Draft Review Report, January 2008 – SANCO/3919/2007 – rev. 4). Changes and/or
additions are taken up in italics.
Common name (ISO)
Boscalid
Development Code
BAS 510 F
Chemical name (IUPAC)
2-Chloro-N-(4'-chlorobiphenyl-2-yl)nicotinamide
Chemical name (CA)
2-Chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl)-3pyridinecarboxamide
CIPAC No
673
CAS No
188425-85-6
EEC No
not assigned
FAO SPECIFICATION
not assigned
Minimum purity
960 g/kg
Identity of relevant impurities (of
None
toxicological, environmental and/or
other significance) in the active
substance as manufactured (g/kg)
Molecular formula
C18H12Cl2N2O
Molecular mass
343.21 g/mol
Structural formula
O
N
H
N
Cl
Cl
Physical-chemical properties
Melting point
Boiling point
Appearance
Relative density
Surface tension
143 – 144 °C (capillary method, 99.7 %)
145 °C (DSC method, 99.7 %)
none (decomposition occurs at 300 oC. No boiling point
was determined).
white crystalline solid, odourless (min 99.4 %)
20
d 4 = 1.381 (99.7 %)
66.0 mN/m 0.5 % (w/w) and
pag. 4
Vapour pressure
Henry's law constant
Solubility in water
Solubility in organic solvents
Partition co-efficient (log Pow)
Hydrolytic stability (DT50)
Dissociation constant
UV/VIS absorption (max.)
Photostability in water (DT50)
Quantum yield of direct phototransformation in water at λ >290 nm
Flammability
Explosive properties
Oxidising properties
61.7 mN/m 1.0 % (w/w)
(98.16 %, both at 20 °C)
72.1 mN/m 0.5 % (w/w) and
72.4 mN/m 1.0 % (w/w)
(99.7 %, both at 20 °C)
7.2 x 10-7 Pa at 20 °C
5.178 x 10-5 Pa m³/mol
4.6 mg/L at 20 °C (99.4 %)
No dissociation in water, therefore no pH dependency
Solubility at 20°C in g/L (99.4 %)
n-Heptane
< 10 g/L
Toluene
20-25 g/L
Dichloromethane
200-250 g/L
Methanol
40-50 g/L
Acetone
160-200 g/L
Ethyl acetate
67-80 g/L
N,N-Dimethylformamide
> 250 g/L
Acetonitrile
40-50 g/L
1-Octanol
< 10 g/L
2-Propanol
< 10 g/L
olive oil
< 10 g/L
2.96 (pH 7.1, 21 °C)
No dissociation in water, therefore no pH dependency
Stable between pH 4 and pH 9
No dissociation in water
207 nm (ε 31534)
228 nm (ε 19834)
290 nm (ε 1529)
300 nm (ε 531)
Stable, no degradation observed
Smaller than 2.45 x 10-4
not highly flammable
No auto-flammability was observed up to 400 °C
None (statement)
The chemical structure of the active substance gives no
evidence of oxidising properties
2.2
Active substance: pyraclostrobin
Data on the identity and the physical and chemical properties are taken from the List of
Endpoints (EFSA Review Report September 2004). Changes and/or additions are taken up in
italics.
Pyraclostrobin
Active substance (ISO Common
Name)
methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3Chemical name (IUPAC)
yl]oxymethyl}phenyl) N-methoxy carbamate
carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3Chemical name (CA)
yl]oxy]methyl]phenyl]methoxy-, methyl ester
CIPAC No
657
CAS No
175013-18-0
EEC No (EINECS or ELINCS)
not assigned
FAO Specification (including year of
not applicable, new active substance
pag. 5
publication)
Minimum purity of the active
substance as manufactured (g/kg)
975
Identity of relevant impurities (of
toxicological, environmental and/or
other significance) in the active
substance as manufactured (g/kg)
max. 0.001 dimethyl sulfate (DMS)
Molecular formula
C19 H18 Cl N3 O4
Molecular mass
387.82 g/mol
Structural formula
Cl
N
O
N
O
N
O
O
Physical-chemical properties
Melting point (state purity)
Boiling point (state purity)
Temperature of decomposition
Appearance (state purity)
Relative density (state purity)
Surface tension
Vapour pressure (in Pa, state
temperature)
Henry’s law constant (in Pa·m3·mol-1)
Solubility in water (in g/l or mg/l, state
temperature)
Solubility in organic solvents (in g/l or
mg/l, state temperature)
Partition co-efficient (log Pow) (state
pH and temperature)
Hydrolytic stability (DT50) (state pH
and temperature)
63.7-65.2 °C (99.8 %)
no boiling point up to decomposition at 200°C, (99.8 %)
200°C (99.8 %)
white to light beige cristaline solid (99.8 %)
Density: 1.367 g/cm3 (99.8 %, 20 °C)
71.8 mN/m at 0.5 % (w/w) (20 °C)
71.5 mN/m at 2.0 % (w/w) (20 °C) (98.5 %)
2.6 x 10-8 (20°C)
5.307 x 10-6
19 ± 1.7 g/L at 20 °C in deionised water (pH of 5.8)
There is no dissociation in water therefore pH dependence
on solubility is not applicable.
In g/l at 20 °C
n-heptane : 3.7
2-propanol : 30.0
octanol: 24.2
olive oil: 28.0
methanol:100.8
acetone: >500
ethyl acetate: >500
acetonitrile: >500
dichloromethane: >500
toluene: >500
3.99 (20 °C, 99.8 %)
Effect of pH was not investigated since there is no
dissociation in water.
pH 5: stable
pH 7: stable
pH 9: stable (very slow degradation observed)
In the DAR, temperatures at which the tests were
pag. 6
Dissociation constant
UV/VIS absorption (max.) (if
absorption >290 nm state ε at
wavelength)
Photostability (DT50) (aqueous,
sunlight, state pH)
Quantum yield of direct phototransformation in water at λ > 290 nm
Photochemical oxidative degradation
in air
Flammability
Auto-flammability
Oxidative properties
Explosive properties
performed were not stated.
not applicable. No indication of dissociation in water.
2.5 x 104 L mol-1 cm-1 at 205 nm
2.4 x 104 L mol-1 cm-1 at 275 nm (22°C, 99.8 %)
DT50 < 2 h (mean value of tolyl- and chlorophenyl-label) at
22°C
2.17 x 10-1
Half-life = 1.87 h
not considered highly flammable;
autoflammability: 510 °C
Not oxidising
no potential for explosivity as evident from the structural
formula
2.3
Plant protection product: Bellis
The range of the application concentration of the plant protection product is 0.05 - 0.16 %
Section
(Annex
point)
B.2.2.1
(IIIA 2.1)
B.2.2.2
(IIIA 2.1)
B.2.2.3
(IIIA 2.1)
B.2.2.4
(IIIA 2.2)
B.2.2.5
(IIIA 2.2)
B.2.2.6
(IIIA 2.3)
B.2.2.7
(IIIA 2.3)
B.2.2.8
(IIIA 2.3)
B.2.2.9
(IIIA 2.4)
B.2.2.10
(IIIA 2.4)
B.2.2.11
(IIIA 2.5)
Study
Guidelines Findings
and GLP
Evaluation and
conclusion
Appearance:
physical state
Appearance:
colour
Appearance:
odour
Explosive
properties
Oxidising
properties
Flammability
GLP
Visual
GLP
Visual
GLP
Olfactory
GLP
OECD 113
GLP
EC A17
GLP
EC A10
GLP
EC A16
Solid granule
Acceptable
Brown
Acceptable
Moderate smoky
Acceptable
Not explosive (< 500 J/g)
Acceptable
Not oxidising
Acceptable
Not highly flammable
Acceptable
328 oC
Acceptable
Autoflammability
Flash point
Acidity /
alkalinity
pH
Surface
tension
Not applicable
Not applicable
GLP
CIPAC
MT75.3
GLP
OECD 115
In CIPAC D:
0.02%: 6.3
0.67%: 6.8
1.0%: 6.8
In pure water:
0.02%: 6.8
0.67%: 7.0
1.0%: 7.0
0.02%: 46.4 mN/m
0.67%: 26.2 mN/m
pag. 7
Acceptable
Acceptable
Section
(Annex
point)
B.2.2.12
(IIIA 2.5)
B.2.2.13
(IIIA 2.6)
Study
B.2.2.14
(IIIA 2.6)
Bulk (tap)
density
B.2.2.15
(IIIA 2.7)
Storage
stability
B.2.2.16
(IIIA 2.7)
Guidelines Findings
and GLP
Viscosity
Relative
density
Shelf life
Not applicable
GLP
OECD 109
(EC A3)
GLP
CIPAC
MT186
GLP
CIPAC
MT46
GLP
Density at 20 oC = 1.509 g/cm3 Acceptable
D420 = 1.509
Loose density: 598 g/L
Tapped density: 689 g/L
Acceptable
Stable for 2 weeks at 54 oC.
Acceptable
Properties determined before
and after storage: a.i. content.
Stable for 2 years at 20 oC in
1L (HD)PE.
Properties determined before
and after storage: a.i. content,
appearance, pH, wettability,
foam persistence,
suspensibility, spontaneity of
dispersion, dry sieve, wet
sieve residue, particle size
distribution (laser diffraction),
dust content, caking, water
content, packaging.
Stable for 2 years at 30 oC in
1L (HD)PE.
B.2.2.17
(IIIA 2.8)
Wettability
B.2.2.18
(IIIA 2.8)
Persistent
foaming
Evaluation and
conclusion
GLP
CIPAC
MT53.3.1
GLP
CIPAC
MT47.2
GLP
Ross-miles
Properties determined before
and after storage: a.i. content,
appearance, pH, wettability,
foam persistence,
suspensibility, spontaneity of
dispersion, dry sieve, wet
sieve residue, particle size
distribution (laser diffraction),
dust content, caking, water
content, packaging.
0 seconds
Acceptable
Acceptable
Acceptable
0.02% in CIPAC D: no foam
0.67% in CIPAC D: no foam
Acceptable
0.02% in CIPAC D: no foam
0.67% in CIPAC D: no foam
Acceptable
pag. 8
Section
(Annex
point)
B.2.2.19
(IIIA 2.8)
Study
Guidelines Findings
and GLP
Evaluation and
conclusion
Suspensibility
GLP
CIPAC
MT184
Acceptable study.
B.2.2.20
(IIIA 2.8)
Spontaneity of
dispersion
B.2.2.21
(IIIA 2.8)
B.2.2.22
(IIIA 2.8)
Dilution
stability
Dry sieve test
B.2.2.23
(IIIA 2.8)
Wet sieve test
B.2.2.24
(IIIA 2.8)
Particle size
distribution
B.2.2.25
(IIIA 2.8)
Content of
dust/fines
B.2.2.26
(IIIA 2.8)
Attrition and
friability
B.2.2.27
(IIIA 2.8)
Emulsifiability,
reemulsifiability
and emulsion
stability
No to GLP
CIPAC
MT184
GLP
CIPAC
MT174
0.2% in CIPAC D
Boscalid: 56%
Pyraclostrobin: 61%
0.67% in CIPAC D
Boscalid: 60%
Pyraclostrobin: 65%
0.05% in CIPAC D:
Boscalid: 93%
Pyraclostrobin: 93%
In CIPAC D (1%), gravimetric:
90%
Suspensibility of Bellis is
low. However, of a grand
total of 8 measurements,
only one result is below
60%. Therefore, it is
considered advisable to
agitate the spray fluid,
but the label does not
require instructions for
continuous agitation.
See below for more test
results.
Acceptable
Acceptable
Not applicable
GLP
CIPAC
MT170
GLP
CIPAC
MT185
GLP
Laser
diffraction
GLP
CIPAC
MT171
GLP
CIPAC
MT178.2
Sieve x
Residues rx
(µm)
(%)
3350
0
2000
0.1
1000
2.2
500
97.5
250
0.2
125
0
75
0
0% on a 75 µm sieve
d10% (µm) = 0.73
d10% (µm) = 2.74
d10% (µm) = 9.66
0.7 mg (0.002%). Classified as
nearly dust-free.
100%
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Deviation from protocol:
no glass beads used
during the test.
Not applicable
pag. 9
Section
(Annex
point)
B.2.2.28
(IIIA 2.8)
B.2.2.29
(IIIA 2.8)
B.2.2.30
(IIIA 2.8)
B.2.2.31
(IIIA 2.8)
B.2.2.32
(IIIA 2.8)
2.9.1
2.9.2
Study
Stability of
dilute
emulsion
Flowability
Guidelines Findings
and GLP
Not applicable
GLP
CIPAC
MT172
Pourability
(rinsibility)
Dustability
Adherence
and
distribution to
seeds
Physical
compatibility
with other
products
Chemical
compatibility
with other
products
Evaluation and
conclusion
Spontaneous.
Acceptable
Not applicable
Not applicable
Not applicable
Not to GLP
Modified
ASTM
E1518-93
Bellis was mixed in CIPAC D
water with various other
products at representative
spray concentrations. For all
mixtures a running agitator is
required.
Products tested: Polyram DF
(WG), Delan 75 SC (SC),
Malvin (WP), Masai (WP),
Insegar (WP), Confidor WG 70
(WG), Pirimor (GR), Kumulus
WG (WG), Regalis (WG),
Cascade 100 DC (DC).
See 2.9.1
Acceptable
Acceptable
Conclusion
The physical and chemical properties of the active substance and the plant protection product
are sufficiently described by the available data. Neither the active substance nor the product
has any physical or chemical properties, which would adversely affect the use according to the
proposed use and label instructions.
2.3
Data requirements
None.
3. Methods of analysis
3.1.
Analytical methods in technical material and plant protection product
3.1.1 Boscalid
Description and data on the analytical methods are taken from the List of Endpoints of boscalid
(DAR, November 2007). Changes and/or additions are taken up in italics.
pag. 10
Technical as (principle of method)
HPLC-UV
Impurities in technical as (principle
of method)
HPLC-UV; GC/MS
Preparation (principle of method)
HPLC-UV method F-111 for the determination of boscalid
and pyraclostrobin in Bellis.
3.1.2 Pyraclostrobin
Description and data on the analytical methods are taken from the List of Endpoints of
pyraclostrobin (DAR, November 2003). Changes and/or additions are taken up in italics.
Technical as (principle of method)
HPLC-UV; reversed phase column
Impurities in technical as (principle HPLC-UV; reversed phase column. GC-FID
of method)
Preparation (principle of method)
HPLC-UV method F-111 for the determination of boscalid
and pyraclostrobin in Bellis.
3.1.3 Conclusion
The analytical method are considered to be acceptable. The analytical methods for the
technical grade active ingredients have been assessed in their respective DARs. The method
for determination of the active ingredients in the formulation is fully validated for the plant
protection product Bellis.
3.2
Residue analytical methods
3.2.1 Boscalid
Description and data on the analytical methods are taken from the List of Endpoints of boscalid
(DAR, November 2007). Changes and/or additions are taken up in italics.
Food/feed of plant origin (principle
GC-MS method for the determination of boscalid only
LOQ:
of method and LOQ for methods
for monitoring purposes)
0.01 mg/kg (wheat, lemon, tomato, cabbage, lettuce) 0.02
mg/kg (oil rape seed)
0.05 mg/kg (hops, recovery = 63 %)
Confirmatory method: 3 mass fragments
ILV: yes
Food/feed of animal origin
(principle of method and LOQ for
methods for monitoring purposes)
Soil (principle of method and LOQ)
LC-MS/MS method for the determination of boscalid only
LOQ:
0.05 mg/kg (apple, cherry, grapes, strawberry, carrot, onions,
tomato, broccoli, cabbage, leek, dwarf beans, oilseed rape)
Confirmatory method: not required for HPLC-MS/MS
methods.
ILV: no
GC-ECD
LOQ = 0.01 mg/kg (milk) and 0.025 mg/kg (muscle, liver,
kidney, fat, egg)
Methods for nicobifen (boscalid) and metabolite M510F01
confirmation: GC-MS
ILV: GC-ECD
GC-MS method for the determination of boscalid only
LOQ: 0.01 mg/kg
Confirmatory method: 4 mass fragments
pag. 11
Water (principle of method and
LOQ)
Air (principle of method and LOQ)
Body fluids and tissues (principle of
method and LOQ)
GC-MS method for the determination of boscalid only
LOQ: 0.05 µg/L (drinking water)
LOQ: 0.5 µg/L (surface water)
Confirmatory method: 4 mass fragments
LC-MS/MS method L0127/01 for the determination of
boscalid in surface water and drinking water.
LOQ = 0.03 µg/kg (surface and drinking water)
Confirmatory method: not required for LC-MS/MS
GC-MS method for the determination of boscalid only
LOQ = 1.5 µg/m3
Confirmatory method : 3 mass fragments
Not required, not classified as (very) toxic
Based on the proposed use of the plant protection product analytical methods for determination
of residues in food/feed of plant origin are required for watery matrices (apple, pear).
Definition of the residue and proposed MRLs for boscalid
Matrix
Proposed definition of the residue for
Proposed MRL
monitoring
Food/feed of plant
Boscalid
Please refer to the residue
origin
section.
Food/feed of animal
Boscalid and M510F01
Please refer to the residue
origin
section.
Required LOQ
Soil
Drinking water
Boscalid
Boscalid
Surface water
Air
Boscalid
Boscalid
Body fluids and
tissues
The active substance is not classified as
(very) toxic thus no definition of the
residue is proposed.
0.05 mg/kg (default)
0.1 µg/L (Dutch drinking water
guideline)
0.1 µg/L
0.03 mg/m3 (derived from the
AOEL [0.1 mg/kg/d] according to
SANCO/825/00)
No requirements.
The residue analytical methods, included in the abovementioned List of Endpoints, are suitable
for monitoring of the MRLs.
The residue analytical methods for soil and air, evaluated in the DAR, are acceptable and
suitable for monitoring of residues in the environment. For surface water, the residue analytical
method in the DAR was insufficiently validated: the LOQ is higher than the required 0.1 µg/L.
Therefore, the applicant provided an additional acceptably validated LC-MS/MS method with a
LOQ of 0.03 µg/kg.
3.2.2 Pyraclostrobin
Description and data on the analytical methods are taken from the List of Endpoints of
pyraclostrobin (DAR, November 2003). Changes and/or additions are taken up in italics.
Food/feed of plant origin (principle
LC-MS/MS method for determination of pyraclostrobin and
of method and LOQ for methods
metabolite BF 500-3
pag. 12
for monitoring purposes)
Food/feed of animal origin
(principle of method and LOQ for
methods for monitoring purposes)
Soil (principle of method and LOQ)
Water (principle of method and
LOQ)
Air (principle of method and LOQ)
Body fluids and tissues (principle of
method and LOQ)
LOQ: 0.02 mg/kg (wheat, grapes, peanut, HPLC-UV
orange)
Confirmatory method: not required for HPLC-MS/MS
ILV: yes
HPLC-UV method for the determination of pyraclostrobin only
LOQ: 0.01 mg/kg (milk) and 0.05 mg/kg (muscle, liver,
kidney, fat and eggs)
Confirmatory method: HPLC-UV with different column
ILV: yes
GCMS or LC/MSMS method for the determination of
pyraclostrobin and metabolite BF 500-10
LOQ: 0.01 mg/kg (milk) and 0.05 mg/kg (muscle, liver,
kidney, fat and eggs)
Confirmatory method: for milk both GC-MS and HPLCMS/MS methods were validated. For other matrices no
confirmatory method is required (HPLC-MS/MS)
ILV: no
LC-MS/MS or HPLC-UV
LOQ: 0.01 mg/kg (pyraclostrobin, BF500-3, BF500-7 and
BF500-6)
Confirmatory method: HPLC-API-MS
LC-MS/MS
LOQ: 0.05 µg/L (drinking and surface water, pyraclostrobin
only)
Conf irmatory method: not requir ed for HPLCMS/ MS
HPLC-UV method for the determination of pyraclostrobin only
LOQ = 0.3 µg/m3
Confirmatory method: LC-MS
HPLC-UV 0.05 mg/kg (liver, kidney)
HPLC-UV 0.05 mg/kg (blood)
Determined analytes: pyraclostrobin
Confirmatory method: different column type
Based on the proposed use of the plant protection product analytical methods for determination
of residues in food/feed of plant origin are required for watery matrices (apple, pear).
Definition of the residue and MRLs for pyraclostrobin
Matrix
definition of the residue for monitoring
Proposed MRL
Food/feed of plant
pyraclostrobin
Please refer to the residue
origin
section.
Food/feed of animal
pyraclostrobin
Please refer to the residue
origin
section.
Required LOQ
Soil
Drinking water
pyraclostrobin, BF500-3, BF500-7 and
BF500-6
Pyraclostrobin
Surface water
Air
Pyraclostrobin
Pyraclostrobin
pag. 13
0.05 mg/kg (default)
0.1 µg/L (Dutch drinking water
guideline)
0.1 µg/L
0.0045 mg/m3 (derived from the
Body fluids and
tissues
AOEL [0.015 mg/kg bw]
according to SANCO/825/00)
The active substance is classified as toxic No requirements.
pyraclostrobin
The residue analytical methods, included in the abovementioned List of Endpoints, are suitable
for monitoring of the MRLs.
The residue analytical methods for water, soil and air, evaluated in the DAR, are acceptable
and suitable for monitoring of residues in the environment.
3.2.3 Conclusion
The submitted analytical methods meet the requirements. The methods are specific and
sufficiently sensitive to enable their use for enforcement of the MRLs and for monitoring of
residues in the environment.
3.3
Data requirements
None.
3.4
Physical-chemical classification and labelling
Proposal for the classification and labelling of the formulation concerning physical
chemical properties
Substances, present in the formulation, which should be mentioned on the label by their
chemical name (other very toxic, toxic, corrosive or harmful substances):
Symbol:
Indication of danger:
R phrases
S phrases
S21
When using do not smoke.
Special provisions:
DPD-phrases
Child-resistant fastening obligatory?
Not applicable
Tactile warning of danger obligatory?
Not applicable
Explanation:
Hazard symbol:
Risk phrases:
Safety phrases:
Other:
S21 is assigned to products containing halogenated compounds
which can form toxic fumes when incinerated or burned.
-
Supported shelf life of the formulation: 2 years
The proposed labelling above is equal to the previous decision regarding the labelling of the
plant protection product Bellis (dated March, 7th, 2004).
In the GAP/instructions for use the following has to be stated:
None.
pag. 14
4. Mammalian toxicology
List of Endpoints
Boscalid
Boscalid is a new active substance, included in Annex I of 91/414/EEC. The final List of
Endpoints presented below is taken from the final review report on boscalid
(SANCO/3919/2007 –rev 5, d.d. 21 January 2008). Where relevant, some additional
remarks/information are given in italics.
Absorption, distribution, excretion and metabolism in mammals
Rate and extent of absorption:
Approx. 44 % (based on bile excretion within
48 h and urinary excretion within 6 h, low dose)
Distribution:
Widely distributed. Highest residues in liver and
adipose tissue (8-h, low dose)
In high-dose females, highest residues were
observed in thyroid and kidney
Potential for accumulation:
No evidence
Rate and extent of excretion:
Complete excretion of low dose within 48 h (approx.
20 % via urine and 80 % via faeces)
Toxicologically significant compounds:
Parent and metabolites
Metabolism in animals:
Extensive (< 1 % of absorbed dose excreted as
parent via urine or bile), 38 metabolites identified in
rat matrices. Major pathway was hydroxylation at the
diphenyl moiety and subsequent O-glucuronidation
Acute toxicity
Rat LD50 oral
Rat LD50 dermal
Rat LC50 inhalation
Skin irritation
Eye irritation
Skin sensitization (test method used and result)
> 5000 mg/kg bw
> 2000 mg/kg bw
> 6.7 mg/l air (nose-only dust exposure)
Non-irritant
Non-irritant
Not a skin sensitiser (M&K test)
Short term toxicity
Target / critical effect
Lowest relevant oral NOAEL / NOEL
Lowest relevant dermal NOAEL / NOEL
Lowest relevant inhalation NOAEL / NOEL
Liver, thyroid
Dog 1-yr: 800 ppm (22 mg/kg bw/d)
Rat 28-day: 1000 mg/kg bw/d
No studies submitted, not required.
Genotoxicity
No genotoxic potential
1
Boscalid was negative in the Ames test, gene mutation test with mammalian cells, chromosome abberation test
with CHO cells, and a UDS test with primary rat hepatocytes in vitro, and also in the micronucleus test in mice in
vivo.
Long term toxicity and carcinogenicity
Target / critical effect
Lowest relevant NOAEL / NOEL
Carcinogenicity
Liver, thyroid
Rat 2-yr: 100 ppm (4.4 mg/kg bw/d)
Slight increase of thyroid follicular cell adenomas; not
pag. 15
relevant to man. No classification and labelling
necessary.
Reproductive toxicity
Reproduction target / critical effect
Lowest relevant reproductive NOAEL / NOEL
Developmental target / critical effect
Lowest relevant developmental NOAEL / NOEL
Slightly reduced viability and decreased pup wt
during lactation in the presence of parental adverse
effects
2
10000 ppm ( 1165 mg/kg bw/d)
Delayed ossification in rabbits and rats in the
presence of maternal toxicity at the limit dose
3
Rat & rabbit: 300 mg/kg bw/d
2
NOAEL for parental- and offspring toxicity: 11 mg/kg bw/d. Effects on reproduction were not observed (NOAEL≥
1165 mg/kg bw/d).
3
NOAEL for developmental and maternal toxicity.
Delayed neurotoxicity
No studies submitted, not required.
Other toxicological studies
Mechanism studies:
Boscalid is an inducer of cytochrome P450; T3 and
T4 levels are decreased and TSH is increased. The
increased metabolism of T4 via hepatic enzyme
conjugation appeared to be responsible for the
increased TSH.
Studies performed on metabolites or impurities:
Para-chlorobenzoic acid (degradation product in
aquatic environment): literature survey data indicates
that para-chlorobenzoic acid exhibits higher acute
oral toxicity than nicobifenboscalid. No concern from
limited in-vitro genotoxicity data.
Acute oral toxicity studies and bacterial reverse
mutation assays for impurities 107371, 398794,
4060018 and 4060017 resulted in LD50 values >
2000 mg/kg bw and no evidence for a genotoxic
potential.
Immunotoxicity:
No toxic potential on cellular and humoral immune
functions.
Medical data
No data (new compound)
Summary
ADI
Value
0.04 mg/kg bw
AOEL systemic
0.1 mg/kg bw/d
ARfD (acute reference dose)
Not allocated
Study
Safety factor
Rat 2-yr oral
100
feed
Dog 1-yr oral
100*
feed; corrected
for 44 % oral
absorption
Not necessary, based on low
acute toxicity and lack of
developmental toxicity concerns
* corrected for 44% oral absorption
pag. 16
Formulation (BAS 510 01 F):
Rat in vivo: 7 %;
rat/human in-vitro dermal penetration ratio: 1
7 % human dermal absorption proposed for use in
4
exposure calculations
Dermal absorption
4
The dermal absorption studies are performed with the formulation with code BAS 510 01F. This product is a water
dispersable granulate with 50% boscalid. In the in vivo study the animals were exposed to a high dose level of 1
2
2
mg/cm and a low dose of 0.01 mg/cm . The potential absorbed dose for the high dose was 2-3% (exposure period
10 hours) and for the low, most relevant dose 7%. The in-vitro absorption through rat epidermal membranes was the
same as through human epidermal membranes at low and intermediate dose levels (0.01 and 0.1 mg/cm²) and
approx. 4-fold greater at the high concentration level (1.00 mg/cm²). The results obtained for the low and
intermediate concentrations were considered to be the most relevant, because these concentration levels fall in the
range of the expected operator exposure.
Pyraclostrobin
Pyraclostrobin is a new active substance, included in Annex I of 91/414/EEC. The final List of
Endpoints presented below is taken from the final review report on pyraclostrobin
(SANCO/1420/2001 – final, d.d. 8 September 2004). Where relevant, some additional
remarks/information are given in italics.
Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)
Rate and extent of absorption
Rapid absorption: Tmax ~1 hour; 50% (based on
urinary and biliary excretion within 48 hours)
Distribution
Widely, highest concentrations in the liver
Potential for accumulation
None
Rate and extent of excretion
Complete within 5 d; mainly via faeces (80-90 %,
biliary excretion amounting to 35 %), via urine 11-15
%
Toxicologically significant compounds
Parent compound and metabolites
(animals, plants and environment)
Metabolism in animals
Extensive (> 95 %) with nearly 50 metabolites
occurring
Main metabolic pathways included Ndemethoxylation, hydroxylation, cleavage of ester
bond and further oxidation of the resulting molecule
parts, conjugation with glucoronic acid or sulphate
Acute toxicity (Annex IIA, point 5.2)
Rat LD50 oral
Rat LD50 dermal
Rat LC50 inhalation
Skin irritation
Eye irritation
Skin sensitization (test method used and result)
> 5000 mg/kg bw
(Mouse: mortality at ≥ 300 mg/kg bw)
> 2000 mg/kg bw
1
0.69 mg/L
Irritating
Not irritating
Not sensitising (M&K maximisation test)
1
0.69 mg/L is based on a pyraclostrobin solution in acetone. A 40% solution in Solvesso results in 4.07 < LC50 <
7.3 mg/L and a classification with Xn, R20
Short term toxicity (Annex IIA, point 5.3)
Target / critical effect
Lowest relevant oral NOAEL / NOEL
Lowest relevant dermal NOAEL / NOEL
Lowest relevant inhalation NOAEL / NOEL
2
Reduced body weight, gastrointestinal tract, red
blood cells; diarrhoea (dog); hepatocellular
hypertrophy (rat); white blood cells and lymphatic
organs (mouse)
2
90-day mouse: 30 ppm (4 mg/kg bw/d)
28 day rat: > 250 mg/kg bw/d (systemic)
No data - not required
(because of physical and chemical properties)
based on effects on body weight after 90 days in the carcinogenicity study in male mice
pag. 17
Genotoxicity (Annex IIA, point 5.4)
No genotoxic potential
3
3
Pyraclostrobin was negative in the following in vitro tests: Ames test, CHO/HPRT-test, chromosome abberation test
with CHO V79 cells, and a UDS-test with rat hepatocytes. Pyraclostrobin was negative in an in vivo micronucleus
test in mice.
Long term toxicity and carcinogenicity (Annex IIA, point 5.5)
Target / critical effect
Reduced body weight; (rat & mouse); liver cell
necrosis (rat)
Lowest relevant NOAEL / NOEL
Chronic rat (75 ppm) 3 mg/kg bw/d
Carcinogenicity
No carcinogenic potential
Reproductive toxicity (Annex IIA, point 5.6)
Reproduction target / critical effect
Lowest relevant reproductive NOAEL / NOEL
Developmental target / critical effect
Lowest relevant developmental NOAEL / NOEL
Lowest relevant maternal NOAEL / NOEL
Reduced pup body weight gain in the presence of
parental toxicity
4
75 ppm (8.2 mg/kg bw/d)
Developmental effects in rats and embryotoxicity
(including malformations) in rabbits at maternally
toxic doses
5
5 mg/kg bw/d (rabbit)
5
3 mg/kg bw/d (rabbit)
4
The NOAEL for parental toxicity was 8.2 mg/kg bw/d (based on decreased food intake and decreased body
weight gain at 25 mg/kg bw/d).
5
The effects are not statistically significant when compared to controles. Statistical significance was noted when
compared to historical control values. Malformations were noted at doses were severe maternal toxicity was noted.
Therefore, no classification with R63. The NOAEL for maternal toxicity in the rabbit was 3 mg/kg bw/day (based on
decreased food intake and decreased body weight gain at 5 mg/kg bw/day).
Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 5.7)
No neurotoxic potential (rat, acute and 13wk studies)
Other toxicological studies (Annex IIA, point 5.8)
Three water metabolites (BF500-11, 500-13, 500-14)
proved negative in the Ames test
Medical data (Annex IIA, point 5.9)
Limited data (new compound); no human health
problems identified
Summary (Annex IIA, point 5.10)
Value
ADI
AOEL systemic
ARfD (acute reference dose)
0.03 mg/kg
bw
0.015 mg/kg
bw
0.03 mg/kg
bw
Study
Chronic rat study
Rabbit, developmental
toxicity study (maternal
toxicity; 50% oral
absorption)
Rabbit, developmental
toxicity study (maternal
toxicity)
Safety
factor
100
100
100
Dermal absorption (Annex IIIA, point 7.3)
EC formulation (BAS 500 F): 2.6% (rat, in vivo); in
vitro data suggest much lower permeability of human
skin; 1% used for calculation based on in vitro/in vivo
6
data
pag. 18
6
2
Dermal absorption was studied in an in vivo study with rats at doses of 0.015, 0.075 en 0.375 mg/cm . Doses of
2
0.015-0.075 mg/cm are equivalent to doses at mixing and loading. At 0.075 mg/cm2 the highest dermal absorption
was noted: 2.6%. From in vitro dermal absorption data, it was concluded that the dermal absorption through rat skin
was 12 times higher than through human skin. The dermal absorption in humans is therefore maximally 2.6/12 =
0.22%. The notifier and RMS proposed to use the value of 1% for dermal absorption.
Local effects
Boscalid: Boscalid does not produce local effects, neither after a single nor repeated exposure
Pyraclostrobin: Pyraclostrobin produces local effects after a single exposure (skin irritation),
but these local effects are covered in the risk assessment/management by means of
assignment of R- and S-phrases, if necessary (the formulation Bellis is not irritating to the skin
after a single exposure). In a dermal 28-day study with rats, the NOAEL for systemic toxicity
was 250 mg/kg bw/d, the highest dose tested, but signs of dermal irritation were observed at all
dose levels (40, 100, and 250 mg/kg bw/d). At 40 mg/kg bw/d epidermal thickening was
observed in 5 females (10 females were tested). At higher doses, epidermal thickening,
hyperkeratosis, scale formation and slight erythema were observed. For the overall risk
assessment, the local effects are however less critical than the systemic effects.
Data requirements active substance
Boscalid and pyraclostrobin: No additional data requirements are identified.
4.1
Toxicity of the formulated product (IIIA 7.1)
The formulation Bellis needs to be classified as R22 ‘Harmful if swallowed ’, based on the acute
oral toxicity (LD50 rat 1459 mg/kg bw).
The formulation Bellis does not need to be classified on the basis of its dermal (LD50 rat > 2000
mg/kg bw) and inhalation toxicity (LC50 rat > 5.4 mg/L).
The formulation Bellis is not classifiable as a skin or eye irritant.
The formulation Bellis does not have sensitising properties in a modified Buehler test (in guinea
pig)
4.1.1 Data requirements formulated product
Boscalid and pyraclostrobin: No additional data requirements are identified.
4.2
Dermal absorption (IIIA 7.3)
Boscalid
For the current assessment a WG formulation with a lower concentration boscalid in the
concentrate, but comparable concentrations of spray dilution is considered, compared to the
formulation studied in the DAR. As the undiluted formulation is a WG, it can be assumed that
the difference in percentage active substance (25% compared to 50% in the formulation
studied in the DAR) is of limited influence on the dermal absorption. Therefore, for the current
assessment a dermal absorption of 7% for both the undiluted and the spray formulation is
considered (see List of Endpoints).
Pyraclostrobin
It can be assumed that the dermal absorption of pyraclostrobin in an EC formulation (evaluated
in the DAR) is worst case to the dermal absorption of pyraclostrobin in an WG formulation
Bellis. Therefore, for the current assessment 1% is used for the concentrate and spray dilution
(see List of endpoints).
4.3
Available toxicological data relating to non-active substances (IIIA 7.4)
The available toxicological data relating to non-active substances will be taken into account in
the classification and labelling of the formulated product.
pag. 19
4.4
Exposure/risk assessments
4.4.1 Operator exposure/risk
According to the Dutch Plant Protection Products and Biocides Regulations the risk
assessment is performed according to a tiered approach. There are four possible tiers:
Tier 1: Risk assessment using the EU-AOEL without the use of PPE
Tier 2: Risk assessment using the NL-AOEL without the use of PPE
Tier 3: Refinement of the risk assessment using new dermal absorption data
Tier 4: Prescription of PPE
Boscalid
Tier 1
Calculation of the EU-AOEL / Tolerable Limit Value (TLV)
For boscalid no TLV has been set. The AOEL will be used for the risk assessment.
Since boscalid is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.1 mg/kg
bw/day (= 7 mg/day for a 70-kg operator/worker), based on the 1-year dog study, is applied
(see List of Endpoints). Since the AOEL is based on a 1-year dog study, the AOEL also covers
operator exposure that might exceed three months, but in practice, the application period of
Bellis will not exceed three months (including contract workers).
Exposure/risk
Exposure to boscalid during mixing and loading and application of Bellis 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.
Table T.1 Internal operator exposure to boscalid and risk assessment for the use of
Bellis
Route
Estimated internal
Systemic
Risk-index b
exposure a (mg /day)
EU-AOEL
(mg/day)
Mechanical downward spraying on tree nursery (apple and pear) 0.8 kg/ha
Mixing/
Loadingc
d
Application
Respiratory
0.04
7.0
0.01
Dermal
0.35
7.0
0.05
Respiratory
0.02
7.0
< 0.01
Dermal
0.42
7.0
0.06
Total
0.83
7.0
0.12
Mechanical upward spraying on apple, pear and tree nursery (apple and pear) 0.8 kg/ha
Mixing/
Loadingc
d
Application
Respiratory
0.04
7.0
0.01
Dermal
0.35
7.0
0.05
Respiratory
0.04
7.0
0.01
Dermal
6.44
7.0
0.92
Total
6.87
7.0
0.98
pag. 20
Route
Systemic
EU-AOEL
(mg/day)
Manual downward spraying on tree nursery (apple and pear) 0.8 kg/ha
Mixing/
Loadingc
f
Application
Estimated internal
exposure a (mg /day)
Risk-index b
Respiratory
0.04
7.0
0.01
Dermal
0.35
7.0
0.05
Respiratory
0.06
7.0
< 0.01
Dermal
3.66
4.11
7.0
7.0
0.52
0.59
Total
Manual upward spraying on tree nursery (apple and pear) 0.8 kg/ha
Mixing/
Loadingc
Respiratory
0.04
7.0
0.01
Dermal
0.35
7.0
0.05
Applicatione
Respiratory
0.24
7.0
0.03
Dermal
7.85
8.48
7.0
1.12
7.0
1.21
Total
a
b
c
d
e
f
Internal exposure was calculated with:
• biological availability via the dermal route: 7% (concentrate) and 7% (spray dilution) (see 4.2)
• biological availability via the respiratory route: 100% (worst case)
The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
External exposure is estimated with NL-model.
External exposure is estimated with EUROPOEM.
th
External exposure is estimated with German model (90 percentile).
External exposure is estimated with UK model.
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 EU-AOEL for
which a standard factor of 100 is applied.
The calculation of the systemic AOEL for semi-chronic exposure is based on the NOAEL of 34
mg/kg bw/d in the 90-day toxicity study with rats. Calculations from other studies result in
higher AOELs. The NOAEL of 11 mg/kg bw/day from the two generation reproduction toxicity
study is not used as the effects at the LOAEL of 113 mg/kg bw/day (histopathological changes
in the liver and pupsweight decrease) were marginal. Therefore, the NOAEL of the 90-day rat
study is considered more representative for the semi-chronic NOAEL of the rat.
Safety factors are used to compensate for the uncertainties, which arise, for example, from
extrapolation from the tested species to humans and the differences between experimental
circumstances, and to ensure that at the acceptable exposure level no adverse health effects
will occur.
Used factors are:
• extrapolation rat→ human on basis of caloric demand
• other interspecies differences:
• intraspecies differences: (professional use)
pag. 21
4
3
3
• biological availability via oral route:
• weight of professional operator/worker:
44%*
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: 34 x 0.44 x 70 / (4 x 3 x 3) = 29 mg/day
Exposure/risk
Table T.2 Internal operator exposure to boscalid and risk assessment for the use of
Bellis
Route
Estimated internal
Systemic
Risk-index b
a
exposure (mg /day)
NL-AOEL
(mg/day)
Manual upward spraying on tree nursery (apple and pear) 0.8 kg/ha
Mixing/
Loadingc
d
Application
Respiratory
0.04
29.0
< 0.01
Dermal
0.35
29.0
0.01
Respiratory
0.24
29.0
< 0.01
Dermal
7.85
8.48
29.0
0.27
29.0
0.29
Total
a
b
c
d
Internal exposure was calculated with:
• biological availability via the dermal route: 7% (concentrate) and 7% (spray dilution) (see 4.2)
• biological availability via the respiratory route: 100% (worst case)
The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
External exposure is estimated with NL-model.
th
External exposure is estimated with German model (90 percentile).
Since the NL-AOEL is not exceeded without the use of PPE, a higher tier assessment is not
required.
Pyraclostrobin
Tier 1
Calculation of the EU-AOEL / Tolerable Limit Value (TLV)
For pyrastroclobin no TLV has been set. The AOEL will be used for the risk assessment.
Since pyraclostrobin is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.015
mg/kg bw/d (=1.05 mg/day for a person of 70 kg), based on the developmental toxicity study in
rabbit, is applied (see List of Endpoints). Furthermore, the semi-chronic EU-AOEL can also be
considered as a chronic AOEL since the chronic study has the same NOAEL (3 mg/kg bw/d).
Exposure/risk
Exposure to pyraclostrobin during mixing and loading and application of Bellis 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.
pag. 22
Table T.1 Internal operator exposure to pyraclostrobin and risk assessment for the use
of Bellis.
Route
Estimated internal
Systemic
Risk-index b
a
exposure (mg /day)
EU-AOEL
(mg/day)
Mechanical downward spraying on tree nursery (apple and pear) 0.8 kg/ha
Mixing/
Loadingc
d
Application
Respiratory
0.02
1.05
0.02
Dermal
0.03
1.05
0.03
Respiratory
0.01
1.05
0.01
Dermal
0.03
1.05
0.03
Total
0.09
1.05
0.09
Mechanical upward spraying on apple, pear and tree nursery (apple and pear) 0.8 kg/ha
Mixing/
Loadingc
d
Application
Respiratory
0.02
1.05
0.02
Dermal
0.03
1.05
0.03
Respiratory
0.02
1.05
0.02
Dermal
0.47
1.05
0.44
Total
0.54
1.05
0.51
Manual downward spraying on tree nursery (apple and pear) 0.8 kg/ha
Mixing/
Loadingc
f
Application
Respiratory
0.02
1.05
0.02
Dermal
0.03
1.05
0.03
< 0.01
1.05
< 0.01
0.04
0.09
1.05
0.04
0.09
Respiratory
Dermal
Total
1.05
Manual upward spraying on tree nursery (apple and pear) 0.8 kg/ha
Mixing/
Loadingc
e
Application
Respiratory
0.02
1.05
0.02
Dermal
0.03
1.05
0.03
Respiratory
0.12
1.05
0.11
Dermal
0.57
0.74
1.05
0.54
1.05
0.70
Total
a
b
c
d
e
f
Internal exposure was calculated with:
• biological availability via the dermal route: 1% (concentrate) and 1% (spray dilution) (see 4.2)
• biological availability via the respiratory route: 100% (worst case)
The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
External exposure is estimated with NL-model.
External exposure is estimated with EUROPOEM.
th
External exposure is estimated with German model (90 percentile).
External exposure is estimated with UK model
Since the EU-AOEL is not exceeded without the use of PPE, a higher tier assessment is not
required.
4.4.2 Bystander exposure/risk
Boscalid and Pyraclostrobin
The bystander exposure is only a fraction of the operator exposure. Based on the risk-index for
the operator, no exposure calculations are performed for bystanders.
pag. 23
4.4.3
Worker exposure/risk
Boscalid
Tier 1
Shortly after application 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.3 the estimated internal
exposure is compared with the systemic EU-AOEL.
Table T.3 Internal worker exposure to boscalid and risk assessment after application of
Bellis
Route
Estimated internal
Systemic
Risk-index b
a
exposure (mg /day)
EU-AOEL
(mg/day)
Re-entry activities in apple, pear and tree nursery (apple and pear)
Respiratoryc
a
b
c
-
7.0
-
Dermal
1.14
7.0
0.16
Total
1.14
7.0
0.16
External exposure was estimated with EUROPOEM II. Internal exposure was calculated with:
• biological availability via the dermal route: 7% (see 4.2)
• biological availability via the respiratory route: 100% (worst case)
The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
No model available
Since the EU-AOEL is not exceeded without the use of PPE, a higher tier assessment is not
required.
Pyraclostrobin
Tier 1
Shortly after application 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. 2 the estimated internal
exposure is compared with the systemic EU-AOEL.
Table T.2 Internal worker exposure to pyraclostrobin and risk assessment after
application of Bellis
Route
Estimated internal
Systemic
Risk-index b
a
exposure (mg /day)
EU-AOEL
(mg/day)
Re-entry activities in apple, pear and tree nursery (apple and pear)
Respiratoryc
a
b
c
-
1.05
-
Dermal
0.08
1.05
0.08
Total
0.08
1.05
0.08
External exposure was estimated with EUROPOEM II. Internal exposure was calculated with:
• biological availability via the dermal route: 1% (see 4.2)
• biological availability via the respiratory route: 100% (worst case)
The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
No model available
Since the EU-AOEL is not exceeded without the use of PPE, a higher tier assessment is not
required.
pag. 24
4.4.4 Re-entry
Boscalid and Pyraclostrobin
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 no adverse health effects are expected
for the unprotected operator after dermal and respiratory exposure to pyraclostrobin and
boscalid as a result of the application of Bellis in apple, pear and tree nursery (of apple and
pear).
Bystander exposure
Based on the risk assessment, it can be concluded that no adverse health effects are expected
for the unprotected bystander due to exposure to pyraclostrobin and boscalid during application
of Bellis in apple, pear and tree nursery (of apple and pear).
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
apple, pear and tree nursery (of apple and pear) due to exposure to pyraclostrobin and boscalid
after application of Bellis.
These conclusions are also valid for the simultaneous exposure to boscalid and pyraclostrobin.
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
Based on this evaluation, no additional data requirements are identified.
4.7
Combination toxicology
The formulation Bellis is a mixture of two active substances. The combined toxicological
effect of these two active substances has not been investigated with regard to repeated dose
toxicity.
Possibly, the combined exposure to these active substances may lead to a different
toxicological profile than the profile that is based on the individual substances. For boscalid the
liver is the critical target organ (enzyme induction). Pyraclostrobin has other critical effects and
the most important critical effect is reduced body weight. The mechanism of the liver effects of
pyraclostrobin is not clear, but it does not seem to be enzyme induction (at lower dose levels,
liver weight was decreased instead of increased, while hepatocellular hypertrophy was
observed). Based on the toxicological profiles, an additive effect is therefore not expected.
Furthermore, for application on apple, pear and tree nursery (of apple and pear) the risk indices
for both substances are low, and therefore no risks are expected even if an additive effect
would be induced by the simultaneous exposure to both substances.
In conclusion, an additive effect is not expected, but even if an additive effect would be
induced, no risks are expected.
4.8
Mammalian toxicology classification and labelling
Proposal for the classification and labelling of the formulation concerning health
pag. 25
Based on the profile of the substance, the provided toxicology of the preparation, the
characteristics of the co-formulants, the method of application and the risk assessment for the
operator, as mentioned above, the following labelling of the preparation is proposed:
Substances, present in the formulation, which should be mentioned on the label by
their chemical name (other very toxic, toxic, corrosive or harmful substances):
Symbol:
Xn
Indication of danger:
Harmful
R phrases
R22
Harmful if swallowed.
S phrases
S46
If swallowed, seek medical advice
immediately and show this container or label.
Special provisions:
DPD-phrases
Plant protection
DPD01
To avoid risk for man and the environment,
products phrase:
comply with the instructions for use
DPD-phrase
Child-resistant fastening obligatory?
n/a
Tactile warning of danger obligatory?
n/a
Explanation:
Hazard symbol:
Risk phrases:
Safety phrases:
Other:
S2, S13 and S20 are no longer invariably assigned to
formulations intended for professional use only.
-
5. Residues
Boscalid
Boscalid is a new active substance, included in Annex I of Directive 91/414/EEC. The List of
Endpoints is dated 12-11-2007, the last revision before publishing the review report.
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)
Plant groups covered
grapes (fruit), lettuce (leaf vegetables), beans
(pulses)
Rotational crops
radish, lettuce, wheat
Metabolism in rotational crops similar to
metabolism in primary crops?
yes
Processed commodities
no hydrolytic decomposition during simulation of
pasteurisation (pH 4, 90°C), baking, boiling,
brewing (pH 5, 100°C) or during sterilisation (pH 6,
120°C)
Residue pattern in processed commodities
similar to residue pattern in raw commodities?
yes
Plant residue definition for monitoring
Boscalid
Plant residue definition for risk assessment
Boscalid
pag. 26
Conversion factor (monitoring to risk
assessment)
not applicable
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
Animals covered
goat, hen
Time needed to reach a plateau concentration
in milk and eggs
6 days for eggs
Animal residue definition for monitoring
Boscalid and the hydroxylated metabolite M510F01
(including its conjugates), expressed as boscalid
Boscalid and M510F01 (including its conjugates)
expressed as boscalid
Bound residues in liver and minor metabolites in
milk (as M510F53)
Animal residue definition for risk assessment
14 days for milk (cow feeding study)
Conversion factor (monitoring to risk
assessment)
not applicable
Metabolism in rat and ruminant similar (yes/no)
Yes
Fat soluble residue: (yes/no)
yes (log Pow = 2.96), in livestock feeding study
residues in fat and cream at 1x dose
Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
after application of 2.1 kg as/ha to bare soil and
PBIs of 30, 120, 270, 365 days the major residue in
following crops was parent boscalid, except for
wheat grain.
Residues of parent: 0.014 - 0.146 mg/kg (lettuce);
0.09 - 0.30 mg/kg (radish leaf), 0.01 - 0.09 mg/kg
(radish root) 0.005 - 0.028 mg/kg (wheat grain),
0.19 - 1.47 mg/kg (wheat forage), 0.81 - 7.99 mg/kg
(wheat straw)
From the results it cannot be excluded that residues
above the LOQ (0.05 mg/kg) may occur in
succeeding crops. This is confirmed by the results
of a field test with residues of boscalid in wheat
plants at 0.10 mg/kg and in wheat straw at 0.75
mg/kg.
The potentiality of residues in succeeding crops is
accounted for in the dietary risk assessment and in
the setting of MRLs by setting 0.5 mg/kg for
commodities not covered by residue or rotational
crop trials.
pag. 27
Stability of residues (Annex IIA, point 6 Introduction, Annex IIIA, point 8 Introduction)
Food of animal origin: (milk, muscle, liver) boscalid
and metabolite M510F01 stable for 5 months under
frozen conditions
Food of plant origin (Wheat plant, wheat grain,
wheat straw, oilseed rape seed, sugar beet, white
cabbage, peach, pea) boscalid stable for at least 24
months under frozen conditions
Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)
Ruminant:
Poultry:
Pig:
Conditions of requirement of feeding studies
Expected intakes by livestock ≥ 0.1 mg/kg diet
(dry weight basis) (yes/no - If yes, specify the
level)
yes
22 mg/kg diet
(beef cattle)
yes
1.6 mg/kg diet
yes
2.9 mg/kg diet
no
10 mg/kg diet
(dairy cws)
Potential for accumulation (yes/no):
no
no
Metabolism studies indicate potential level of
residues ≥ 0.01 mg/kg in edible tissues (yes/no)
yes
yes
Feeding studies (Specify the feeding rate in cattle
and poultry studies considered as relevant)
20 mg/kg DM for beef, 1 mg/kg DM for hen
Residue levels in matrices : Mean (max) mg/kg
Muscle
< 0.05 (high
< 0.05 (low
< 0.05
dose)
dose)
(extrapol.
from
ruminants)
Liver
0.18 (high dose)
< 0.1 (low dose)
< 0.1
Kidney
0.24 (high dose)
not applicable
< 0.1
Fat
0.27 (high dose)
< 0.1 (low dose)
< 0.1
Milk
0.05 (high dose)
Eggs
< 0.02
Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)
Crop/ process/ processed product
Number of
studies
Processing factors
Transfer
factor
Yield
factor
Grapes
must, cold
1 (4 trials)
must, after short time heating
1 (4 trials)
pag. 28
0.32–
0.52
0.45–
-
Amount
transferred (%)
(Optional)
must, after mash heating
1 (4 trials)
wine, from must, cold
1 (4 trials)
wine from must, after short time heating
1 (4 trials)
Wine from must, after mash heating
1 (4 trials)
wet pomace
1 (4 trials)
0.48
0.09–
0.18
0.26–
0.47
0.36–
0.46
0.08–
0.12
1.95–
3.41
-
0.50
-
0.43
-
-
-
Peas
Peas/Washed peas
Peas/Wash water
Cooked peas,
canned peas,
boiled water,
vegetable stock
1 (4 trials) only
one trial with
RAC residues >
LOQ
residues in RAC
< LOQ
(0.05 mg/kg)”
< 0.36
(residues
in
processe
d product
< 0.05
mg/kg)
-
Pyraclostrobin
Pyraclostrobin is a new active substance included in Annex I of directive 91/414/EEC by
Directive 04/30/EC d.d. March 10th, 2004. The List of Endpoints is dated November 2003.
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)
Plant groups covered
wheat (cereals), grapes (fruit), potatoes (root
and tuber vegetable)
Rotational crops
radish, lettuce, wheat
Plant residue definition for monitoring
Pyraclostrobin
Plant residue definition for risk
Pyraclostrobin
assessment
Conversion factor (monitoring to risk
None
assessment)
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
Animals covered
lactating goat, laying hen
Animal residue definition for monitoring
Pyraclostrobin
Animal residue definition for risk
liver (except poultry liver) and milk fat only:
assessment
Pyraclostrobin and its metabolites containing
the 1-(4-chlorophenyl)-1H-pyrazole - or the 1(4-chloro-2-hydroxyphenyl)-1H-pyrazole
moiety, sum expressed as pyraclostrobin
Conversion factor (monitoring to risk
cream: 6
assessment)
liver: not applicable, no pyraclostrobin in liver
to be expected
Metabolism in rat and ruminant similar
Yes
(yes/no)
Fat soluble residue: (yes/no)
yes (Log Po/w 3.99)
pag. 29
Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
30, 120, 365 days plant back interval after
application of 0.9 kg a.s./ha: TRR in the edible
parts for human consumption are very low
(radish roots, lettuce: < 0.040 mg/kg; wheat
grain: < 0.089 mg/kg).
No accumulation of Pyraclostrobin or its
degradation products [radish, lettuce < 0.0106
mg/kg; wheat straw < 0.0147 mg/kg; wheat
grain: not detectable]
Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)
Food of animal origin: Pyraclostrobin stable for
8 month
Metabolite BF 500-10 (model compound) with
slow degradation but stable enough to
evaluate the submitted feeding study (analysed
within 6 month).
Plant (peanut nutmeat, peanut oil, wheat grain,
wheat straw, sugarbeet tops, sugarbeet roots,
tomatoes, grape juice): Pyraclostrobin,
metabolite BF 500-3 stable for 18 month
Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)
Ruminant:
Poultry:
Pig:
Intakes by livestock ≥ 0.1 mg/kg diet/day:
yes/no
yes/no
yes/no
7.0 mg/kg dry 0.3 mg/kg dry 0.3 mg/kg
feed
feed
dry feed
Muscle
< 0.05
< 0.05
< 0.05
Liver
< 0.05
< 0.05
< 0.05
Kidney
< 0.05
< 0.05
< 0.05
Fat
< 0.05
< 0.05
< 0.05
Milk
< 0.01
not applicable not
applicable
Eggs
not applicable
< 0.05
not
applicable
Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)
Crop/processed crop
Number of
Transfer
studies
factor
grapes / must, juice, wine
4 trials
0.03
grapes / wet pomace
4 trials
3.9
grapes / rasins
1 (2 trials)
2.7
barley/pot barley
1 trial
0.7
barley/pearling dust
1 trial
11
barley/malt
4 trials
1.2
barley/malt germs
1 trial
2.3
barley/spent grain
1 trial
10
barley/trubs (flocs)
1 trial
0.7
barley/beer yeast
1 trial
0.7
barley/beer
4 trials
0.7
wheat/flour, middlings, shorts
1
0.6
wheat/ germ
1
0.8
pag. 30
% Transference
*
* Calculated on the basis of distribution in the different portions, parts or products as determined through balance
studies.
Comments on/additions to List of Endpoints
No additional comments
5.1
Summary of residue data
5.1.1 Metabolism in plants
Boscalid
Metabolism was studied in grapes, lettuce and beans. Metabolism was also investigated in
rotational crops lettuce, radish and wheat. In all cases, the main metabolite was boscalid.
Metabolism was found to be essentially the same in the different crop categories, and covers
the intended use.
Pyraclostrobin
Metabolism was studied in wheat, grapes and potatoes. Main metabolite was pyraclostrobin.
Metabolism was found to be essentially the same in the different crop categories, and covers
the intended use.
5.1.2 Metabolism in livestock
Boscalid
Metabolism was investigated in lactating goat and laying hen.
Main metabolites were boscalid (all matrices) and M510F01 (milk, liver). Metabolism was found
to be essentially the same in goat, hen and rat. Therefore, no study in pig is required.
Pyraclostrobin
Metabolism was investigated in lactating goat and laying hen. Main metabolite was
pyraclostrobin. Metabolism was found to be essentially the same in goat, hen and rat.
Therefore, no study in pig is required.
5.1.3 Residue definition (plant and animal)
Boscalid
The residue definition in plants is ‘boscalid parent’, for monitoring and risk assessment. Since
metabolism in grapes, lettuce and beans (primary crops) and lettuce, radish and wheat
(rotational crops) is similar, the residue definition applies to all crops.
The residue definition in animal products is boscalid and the hydroxylated metabolite M510F01
(including its conjugates), expressed as boscalid for monitoring.
The residue definition for risk assessment is boscalid and M510F01 (including its conjugates)
expressed as boscalid, including bound residues in liver and minor metabolites in milk (as
M510F53).
Pyraclostrobin
The residue definition in plants is ‘pyraclostrobin parent’, for monitoring and risk assessment.
Since metabolism in wheat, grapes and potatoes is similar, the residue definition applies to all
crops.
It was found that low residues will only occur in milk fat and liver of ruminants. Next to
pyraclostrobin, also its metabolites containing the 1-(4-chlorophenyl)-1H-pyrazole - or the 1-(4chloro-2-hydroxyphenyl)-1H-pyrazole moiety are relevant residues. For the sake of simplicity
the residue definition for all animal products is ‘pyraclostrobin parent’ for monitoring, although
no pyraclostrobin was found in liver. For risk assessment, a conversion factor should be
derived for milk fat and liver. For milk fat a conversion factor of 6 is proposed. Since no
pyraclostrobin is found in liver, no conversion factor could be set. However, since no residues
above LOQ (0.05 mg/kg) are expected, this is considered acceptable.
pag. 31
5.1.4 Stability of residues
Boscalid
Food of animal origin: (milk, muscle, liver) boscalid and Metabolite M510F01 stable for 5
months.
Food of plant origin (Wheat plant, wheat grain, wheat straw, oilrape seed, sugar beet, white
cabbage, peach, pea): boscalid stable for 24 months.
Pyraclostrobin
Food of animal origin: Pyraclostrobin stable for 8 months.
Metabolite BF 500-10 (model compound) with slow degradation but stable enough to evaluate
the submitted feeding study (analysed within 6 months).
Plant (peanut nutmeat, peanut oil, wheat grain, wheat straw, sugarbeet tops, sugarbeet roots,
tomatoes, grape juice): Pyraclostrobin, metabolite BF 500-3 stable for 18 months.
5.1.5 Supervised residue trials
Apple & pear
(cGAP-NL: 4x 0.0202 kg boscalid and 0.0102 kg pyraclostrobin/hL, interval: 7 days, PHI: 7
days)
Thirteen supervised residue trials in apple in Northern Europe have been submitted, which are
summarised in TNO report CTB-2005-007-B and Ctgb document (September 2005)The trials
were performed according to GLP and according to the intended use. For this assessment the
residues values at PHI of 7 days were chosen. Apple is a major crop, therefore, a minimum of 8
trials are required. A sufficient number of residue trials are available. The residue levels
selected are presented in table R1. Trials with apple can be extrapolated to pear. The residue
levels show sufficiently that the apple and pear EU-MRL of 2 mg/kg for boscalid and 0.3 for
pyraclostrobin are not exceeded.
Table R1: Selected residue levels from supervised residue trials at PHI between 6-8 days
Crop
Apple à pear
Boscalid
Residue levels
(mg/kg)
0.14,
0.15,0.24,0.29,
0.32,0.32,0.339
0.36,0.37,0.39,
0.42,0.55, 1.24
STMR
(mg/kg)
0.34
Pyraclostrobin
HR
Residue levels
(mg/kg (mg/kg)
)
1.24
0.034,0.05,
0.058,0.07, 0.08,
0.081,0.095, 0.1,
0.101, 0.14 ,
0.118,0.131, 0.163
STMR
(mg/kg)
HR
(mg/kg)
0.1
0.163
à = extrapolation
5.1.6 Residues in succeeding crops
Boscalid
Boscalid shows some degree of persistency. The substance also appears in numerous
secondary (rotational) crops.
In Addendum 2, d.d. May 2006, the rapporteur evaluated a statement: from all the known
residue data in primary as well as rotation crops, it can be deduced that residues in rotational
crops are never higher than 0.5 mg/kg. Therefore, it is proposed to set a value of 0.5 mg/kg for
those crops which will not have an intended use in the European Union, being a default MRL
for rotational crops for boscalid. This MRL has been taken up in Annex IIIa of Regulation (EC)
396/2005. The value will be used in the risk assessment below.
Pyraclostrobin
No detectable residues are expected in rotational crops.
5.1.7 Residues from livestock feeding studies
pag. 32
Boscalid
Dietary intake of beef cattle was calculated using the data form the draft assessment report
(oilseeds: 0.15 mg/kg, cabbage: 0.10 mg/kg, carrot 0.25 mg/kg and the residue data on
cereals: 3 mg/kg for grain and 30 mg/kg for straw). Dietary intake for cattle was maximally 21.5
mg/kg dry feed.
In a feeding study with lactating cows the residues (28-day average) of boscalid + M510F01 +
M510F02 in milk at dose levels of 20.2 mg/kg dry diet was 0.035 mg/kg.
The average residues of boscalid + M510F01 + M510F02 after 28 days in muscle, fat, liver and
kidney at a dose level of 20.2 mg/kg dry diet was <0.05, 0.27, 0.18 and 0.24 mg/kg respectively
(highest residue values were not reported except for muscle: a single value of 0.058 mg/kg).
Dietary intake for poultry was calculated using the data from the draft assessment report
(carrot: 0.25 mg/kg), oil seeds: 0.15 mg/kg and the data on cereal grain: 3 mg/kg).
Dietary intake was calculated to be maximally 2.8 mg/kg dry feed.
No feeding study was available, but from the available metabolism study with hen performed at
12 mg/kg dry feed (4.3 N) TRR was found to be 0.058 mg/kg in egg, 0.0025 mg/kg in meat,
0.025 mg/kg in fat and 0.1687 mg/kg in liver. At the expected feeding rate of 2.8 mg/kg dry feed
residues (TRR) for all products are expected to be < 0.05 mg/kg.
These values are covered by the proposed tMRLs of 0.5 mg/kg for mammalian products
including milk and of 0.5 mg/kg for poultry products except eggs for which an MRL of 0.05
mg/kg is proposed.
Pyraclostrobin
The results from the livestock feeding studies were based on a dietary intake calculation as
presented in the Draft Assessment Report which was adopted unchanged in the MRL
harmonisation report presented to the Pesticide Residue Working Group in January 2005 (See
List of Endpoints).
5.1.9 Calculation of the ADI and the ARfD
Boscalid
The ADI was based on the NOAEL of 4 mg/kg bw/d from the 2-year oral rat study giving rise to
effects in the thyroid and liver at the near higher dose group. Using a safety factor of 100, the
ADI was established at 0.04 mg/kg bw/d. (see List of Endpoints human toxicology)
An ARfD was not allocated, since boscalid shows no acute toxic properties at the expected
dose level.
Pyraclostrobin
The ADI was based on the NOAEL of 3 mg/kg bw/d from developmental studies giving rise to
developmental effects in rats and embryotoxicity (including malformations) in rabbits at
maternally toxic doses. Using a safety factor of 100, the ADI was established at 0.03 mg/kg
bw/d.
The ARfD was based on the NOAEL of 3 mg/kg bw/d from developmental studies giving rise to
developmental effects in rats and embryotoxicity (including malformations) in rabbits at
maternally toxic doses. Using a safety factor of 100, the ARfD was established at 0.03 mg/kg
bw/d.
The ADI and ARfD were taken from the most recent List of Endpoints on Human Toxicology,
from the final review report (SANCO/1420/2001-final d.d. 08.09.2004).
5.2
Maximum Residue Levels
MRLs for both boscalid and pyraclostrobin are established in Regulation (EC) 396/2005. The
product complies with the MRL Regulation (see 5.1.5), notification of revised MRLs is not
necessary.
pag. 33
5.3
Consumer risk assessment
Boscalid
Risk assessment for chronic exposure through diet
A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA
PRIMo rev. 2.0, containing all available Member State diets, and the temporary EU-MRLs and
the STMR values proposed in EFSA Reasoned Opinion: Modification of the existing MRLs for
boscalid in various crops: (EFSA Journal 2010;8(9):1780). The maximum TMDI is 77.6 % of the
ADI for the German child. The TMDI is 34% and 72.2% of the ADI for the Dutch general
population and Dutch children ages 1-6, respectively.
Risk assessment for acute exposure through diet
A calculation of the Estimated Short Term Intake (ESTI) was not carried out since an ARfD was
not established (not necessary).
Pyraclostrobin
Risk assessment for chronic exposure through diet
A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA
PRIMo rev. 2.0, containing all available Member State diets, and the EU-MRLs available in
Annex II of Regulation (EC) 396/2005. The maximum TMDI is 65.8 % of the ADI for the
German child. The TMDI is 28.2% and 54.9% of the ADI for the Dutch general population and
Dutch children ages 1-6, respectively.
Risk assessment for acute exposure through diet
A calculation of the Estimated Short Term Intake (ESTI) was carried out using EFSA PRIMo
rev. 2.0 and the harmonised EU-MRLs of the intended uses. The highest percentage of the
ESTI is 98 % of the ARfD for apple for the UK infant. ESTI values for the other commodities in
all other consumer diets are all lower.
Conclusion
No risk is foreseen for consumers when authorising Bellis with regard to boscalid and
pyraclostrobin.
The product complies with the Uniform Principles.
5.4
Data requirements
None
6. Environmental fate and behaviour
The Plant Protection Products and Biocides Regulations (RGB) published in the Government
Gazette (Staatscourant) 188 of 28 September 2007 came into effect on 17 Oktober 2007, while
repealing the Uniform Principles Decree on Plant Protection Products (BUBG) and the
Regulation elaborating the uniform principles for plant protection products (RUUBG).
Risk assessment is done in accordance with Chapter 2 of the RGB for products based on
- active substances which have already been included in Annex I of directive 91/414/EEC
- “new” active substances;
or
Risk assessment is done in accordance with Chapter 10 of the RGB for products based on
- active substances which have not been included in Annex I of directive 91/414/EEC.
This means that for the current application of Bellis, risk assessment is done in accordance with
Chapter 2 of the RGB.
pag. 34
For boscalid, the List of Endpoints of November 2007 (new format for LoEP) is used. The most
recent LoEP (draft LoEP from EFSA conclusion of 01/2008, old format) cannot be used, since
this list lacks important relevant details for fate and behaviour (no or less information on higher
tier studies, no individual endpoint values). The values presented in the scientific content of this
list are the same as the values presented in the LoEP of 01/2008.
Pyraclostrobin is a new substance, included in Annex I (June,1, 2004; final LoEP on Circa is
from EFSA Review Report September 2004). For the risk assessment the final List of
Endpoints is used.
List of Endpoints Fate/behaviour Boscalid (November 2007)
Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)
Mineralisation after 100 days ‡
14
8 % after 119 d, [diphenyl- C]-label (n = 1)
14
15% after 119 d, [pyridine- C]-label (n = 1)
Non-extractable residues after 100 days ‡
14
49 % after 119 d, [diphenyl- C]-label (n = 1)
14
33 % after 119 d, [pyridine- C]-label (n = 1)
Metabolites requiring further consideration ‡
- name and/or code, % of applied (range and
maximum)
No major metabolites
Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)
Anaerobic degradation ‡
Mineralisation after 100 days
14
74 % after 120 d, [diphenyl- C-X]-label (n = 1)
14
77 % after 120 d, [pyridine- C-Y]-label (n = 1)
Non-extractable residues after 100 days
14
16 % after 120 d, [diphenyl- C-X]-label (n = 1)
14
14 % after 120 d, [pyridine- C-Y]-label (n = 1)
Metabolites that may require further
consideration for risk assessment - name
and/or code, % of applied (range and
maximum)
No major metabolites
Soil photolysis ‡
Metabolites that may require further
consideration for risk assessment - name
and/or code, % of applied (range and
maximum)
No major metabolites
(after 15 d: 91 % parent, 6 % bound residues, 0.2 %
CO2, DT50: 135 d)
pag. 35
Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)
Laboratory studies ‡
Parent
Aerobic conditions
Soil type
X
1
pH
o
t. C / % MWHC DT50 /DT90
(d)
DT50 (d)
St.
20 °C
pF2/10kPa
(r )
Method of
calculation
2
st
Bruch West
20 °C / 40 %
108 / 360
--
--
1 order
Li 35 b
20 °C / 40 %
322 / nr
--
--
1 order
Lufa 2.2
20 °C / 40 %
384 / nr
--
--
1 order
US soil
20 °C / 40 %
376 / nr
--
--
1 order
Minto (Canada)
20 °C / 40 %
133 / 442
--
--
1 order
geom.
mean
232 / 399
--
Geometric mean/median
st
st
st
st
median
322 / -nr
not reported
Field studies ‡
Parent
Aerobic conditions
Soil type (indicate Location
if bare or cropped (country or
soil was used).
USA state).
Stetten (3
replicates)
DU2/15/97
Germany
X
1
pH
Depth DT50 (d)
(cm)
actual
DT90(d) St.
actual
2
(r )
Norm.
7.5
0-10
28
47
90
> 365
Germany
5.4
0-10
147
175
208
106
> 365
1
Best fit
0.875
0.943
0.956
arithm.
mean
176.7
Manzanilla
ALO/05/98
Alcala del Rio
ALO/06/98
Grossharrie
D05/03/98
Method
of
calculatio
n
Best fit
0.952
0.968
0.988
arithm.
mean
55.7
Schifferstadt (3
replicates)
DU3/06/97
DT50
(d)
212
Spain
7.4
0-10
27
> 365
0.88
98
Best fit
Spain
7.7
0-10
78
> 365
0.81
-*
Best fit
Germany
6.1
0-10
144
> 365
0.87
-*
Best fit
× This column is reserved for any other property that is considered to have a particular impact on the degradation rate.
pag. 36
Field studies ‡
Parent
Aerobic conditions
Soil type (indicate Location
if bare or cropped (country or
soil was used).
USA state).
X
1
pH
Depth DT50 (d)
(cm)
actual
DT90(d) St.
actual
2
(r )
DT50
(d)
Norm.
Geometric mean /median
arithm.
mean
96.3
> 365
geom.
mean,
78.3
Method
of
calculatio
n
arithm.
mean
139
geom.
mean
130
median
78.0
*
because of the high standard deviations of the degradation rate, a reasonable calculation of the half-life is not
possible
Met 1
No major metabolites
Soil type
Location
pH
Depth DT50
(cm)
(d)
actual
DT90 (d) St.
actual
(r2)
DT50
(d)
Norm.
Method
of
calculatio
n
Geometric mean/median
pH dependence ‡
(yes / no) (if yes type of dependence)
No
Accumulation study
a) Germany, loamy sand/sandy loam
1998-2003, application to vines
Annual application rate: 3 × 700 g as/ha
(2100 g as/ha)
Plateau reached after approx. 3 years according to
ModelMaker evaluation
ModelMaker assessment:
minimum plateau: 2000 g as/ha (95 % of AR)
maximum plateau: 3100 g as/ha (148 % of AR)
measured concentrations:
June 2002, June 2003 (representing minimum
plateau): mean 2608 g as/ha (124 % of AR)
October 2001, October 2002, August 2002
(representing maximum plateau): mean 2900 g
as/ha (138 % of AR)
b) Germany, sandy loam
1998-2004 and ongoing, 3-year crop rotation with
vegetables and cereals
1998, 2001, 2004:
2 × 300 g as/ha and 3 × 500 g as/ha , vegetables
(2100 g as/ha)
1999, 2002:
3 × 300 g as/ha and 2 × 400 g as/ha, vegetables
pag. 37
(1700 g as/ha)
2000, 2003:
no application , spring wheat
Overall average annual application rate:
1270 g as/ha
ModelMaker assessment (based on data until 2004)
minimum plateau: 1200 g as/ha (95 % of AR)
maximum plateau: 2200 g as/ha (174 % of AR)
measured concentrations (data until 2004):
after the last application in 2002: 2545 g as/ha (150
% of applied rate in the preceeding year)
before the first application in 2004: 1096 g as/ha
Soil accumulation and plateau concentration
a) PECsoil for upper 5 cm layer based on data from
soil accumulation studies
vines:
modelled concns. – 0.551 mg/kg (413 g as/ha)
measured concns. – 0.277 mg/kg (208 g as/ha)
beans:
meas. + mod. concns. – 0.944 mg/kg (708 g as/ha)
measured concns. – 0.640 mg/kg (480 g as/ha)
b) Minimum and maximum plateau concentration
predicted with the simulation model FOCUS-PEARL
1.1.1 for the scenarios Hamburg and Châteaudun.
vines with application of 1 × 600 g as/ha per year
and crop interception of 50 %
vegetables with application of 2 × 500 g as/ha per
year and crop interception of 70 %.
Both use maximum standardised field half-life
(DT50 of 212 d) for calculation.
vines:
Hamburg – min. 0.52 mg/kg (390 g as/ha), max.
0.91 mg/kg (680 g as/ha)
Châteaudun – min. 0.39 mg/kg (290 g as/ha), max.
0.79 mg/kg (590 g as/ha)
beans:
Hamburg – min. 0.52 mg/kg (390 g as/ha), max.
0.90 mg/kg (680 g as/ha)
Châteaudun – min. 0.40 mg/kg (300 g as/ha), max.
0.78 mg/kg (590 g as/ha)
Scenario
Interceptio
n (%)
Crop
type
Min.
Max.
Plateau
Plateau
[kg/ha]
[kg/ha]
Jokioinen
80
Beans
0.31
0.50
Hamburg
80
Beans
0.18
0.37
Sevilla
80
Beans
0.05
0.25
Hamburg
85
Vines
0.08
0.17
Piacenza
85
Vines
0.03
0.12
pag. 38
Laboratory studies ‡
Parent
Anaerobic conditions
Soil type
X
Bruch West
99/060/01
(silty sand)
Bruch West
98/060/02
(sandy loam)
2
pH
o
t. C / % MWHC DT50 / DT90 (d) DT50 (d)
20 °C
pF2/10kP
a
(r )
Method of
calculation
St.
2
st
diphe 7.2
nyllabel
20 °C/ flooded
261 / n.r.
--
--
1 order
pyridi 7.5
nelabel
20 °C/ flooded
345 / n.r.
--
--
1 order
geom. mean
300 / --
--
St.
Method of
calculation
Geometric mean/median
st
median:
-- / -n.r. not reported
Met 1
No major metabolites
Soil type
X
1
pH
o
t. C / %
MWHC
DT50/ DT90 f. f. DT50 (d)
(d)
kdp/k 20 °C
f
pF2/10kPa
2
(r )
Geometric mean/median
Soil adsorption/desorption (Annex IIA, point 7.1.2)
Parent ‡
Soil Type
OC %
Soil
pH
Kd
(mL/g)
Koc
Kf
Kfoc
(mL/g)
(mL/g)
(mL/g)
LUFA 2.2
2.5
5.8
--
--
27.8
1110
0.875
Bruch West
1.5
7.5
--
--
7.6
507
0.870
Li 35 b
1.1
6.5
--
--
6.5
594
0.839
USA
538-30-5
0.4
5.8
--
--
3.9
987
0.887
USA
538-31-2
0.5
5.2
--
--
3.3
655
0.886
CAN-95024
3.4
7.5
--
--
776
0.851
arithm.mea
n
9.8
arithm.mea
n
771
arithm.
mean
0.868
median
6.5
median
715
Arithmetic mean/median
pH dependence, Yes or No
2
1/n
--
No
× This column is reserved for any other property that is considered to have a particular impact on the de26.4gradation rate.
pag. 39
Metabolite 1 ‡ No major metabolites
Soil Type
OC %
Soil pH
Kd
(mL/g)
Koc
Kf
Kfoc
1/n
(mL/g)
(mL/g)
(mL/g)
Arithmetic mean/median
pH dependence (yes or no)
Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)
Column leaching ‡
Not required
Aged residues leaching ‡
0 % radioactivity in leachate
Lysimeter/ field leaching studies ‡
Not required, no leaching expected.
See also PECgw
Route and rate of degradation in water (Annex IIA, point 7.2.1)
Hydrolytic degradation of the active substance
and metabolites > 10 % ‡
pH 4: stable (no major metabolites)
pH 7: stable (no major metabolites)
pH 9: stable (no major metabolites)
Photolytic degradation of active substance and
metabolites above 10 % ‡
DT50 : not reported (stable)
(no major metabolites)
Quantum yield of direct phototransformation in
water at Σ > 290 nm
< 2.45 * 10-4
Readily biodegradable ‡
(yes/no)
No
Degradation in water / sediment
Parent
water: 17.4 % after 100 d
sediment: 79.9 % after 100 d
Water /
sediment
system
pH
pH t. C DT50 St.
DT90 whole (r2)
water sed.
sys. (d)
phase
DT50 - DT90 St.
System A
8.5
9 / 133
Kellmetschweiher
o
6.8
20
Values by
far
exceeding
--
pag. 40
Water (d)
2
(r )
DT50 DT90
St.
2
(r )
Method of
calculation
sed. (d)
--
Values by
far
exceeding
--
graphical
determinat
ion after
System B
8.1
7.5
20
Berghäuser
Altrhein
Geometric mean/median
Accumulation
the
-duration of
the
experimen
t, for both
systems
and both
labelling
positions Reliable
extrapolati
on of DT90
not
possible
3 / 43
--
geom.mea
n
5.2 / 75.6
the
-duration of
the
experimen
t, for both
systems
and both
labelling
positions Reliable
extrapolati
on of DT90
not
possible
--
fitting of
compartm
ent model
--
plateau after 8 yr: 217 % (calculation)
Metabolite 1
No major metabolites
Water /
sediment
system
pH
pH t. C DT50 St.
water sed.
DT90 whole (r2)
phase
sys.
o
DT50 DT90
r
2
Water
DT50 DT90
St.
2
(r )
Method of
calculation
sed.
Geometric mean/median
Mineralisation and non extractable residues
Water /
sediment
system
pH
water
pH
sed.
Mineralisation
x % after n d (end
of the study)
Non-extractable
Non-extractable residues
residues in sed. max in sed. max × % after n d
× % after n d
(end of the study)
System A
8.5
6.8
0.5 % after 100 d
13 % after 100 d
--
8.1
7.5
0.5 % after 100 d
10 % after 100 d
--
phase
Kellmetschweiher
System B
Berghäuser
Altrhein
Degradation in water / sediment (outdoor study*)
Parent
water: 19.8 % after 103 d
sediment: 28.2 % after 103 d
Water /
sediment
system
pH
System A
8.8
Kellmetschweiher
Accumulation
water
phase
o
pH
t. C DT50 - DT90 St.
sed.
whole sys. (r2)
DT50 DT90
St.
2
(χ )
Water
n.r.
~20
110 / 370
0.79
(46 % of as
after 120
days in
water and
sediment)
St.
(χ )
Method of
calculation
--
First order
16.7
Best fit
2
sed.
32 / n.r.
2.7
16 / n.r.
--
plateau after 8 yr: 27.2 % (calculation)
pag. 41
DT50 DT90
66 / n.r.
(graphical
determinat
ion)
*
non-standardised test, considered as additional information,
not used for standard PEC-calculation, used for higher-tiered PEC calculation with consideration of
accumulation in soil
n.r. not reported
Recalculated kinetics for the total system, DT50 of 90 days used for risk assessment by Ctgb:
Water / sediment pH
system
water
phase
System A
8.8
pH sed. t.
o
C
n.r.
2
DT50 DT90
whole
sys.
χ
DT50 - St. DT50 St. Method of
2
DT90 (χ2) (χ ) calculation
DT
90
Water
sed.
~20 90/289
10.0
Kellmetschweiher
-
-
-
-
(M0
90.3, k
0.008)
Metabolite 1:
M510F64:
water: max. 9.0 % at 14 d and 9.4 % at 30 d
Water /
sediment
system
pH
pH t. C DT50 St.
water sed.
DT90 whole (r2)
phase
sys.
DT50 DT90
System A
8.8
8 / n.r.
o
n.r.
~20
--
r
2
water
--
First order
FOCUS kinetics
spreadsheet,
visual
acceptable
DT50 DT90
St.
(r )
Method of
calculation
--
First order
2
sed.
--
--
Kellmetschweiher
Geometric mean/median
--
8 / n.r.
--
Mineralisation and non extractable residues
Water /
sediment
system
pH
water
System A
8.8
pH
sed.
Mineralisation
x % after n d (end
of the study)
Non-extractable
Non-extractable residues
residues in sed. max in sed. max × % after n d
× % after n d
(end of the study)
n.r.
26.8 5 after 120 d*
48.3 % after 103 d
phase
20.5 % after 120 d
Kellmetschweiher
*
calculated as material balance difference
Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)
Direct photolysis in air ‡
Photolytically stable in water. Photolysis in air not
expected. Not stable under influence of radicals,
(see DT50 photochemical oxidative degradation).
Quantum yield of direct phototransformation
< 2.45 × 10
Photochemical oxidative degradation in air ‡
DT50: < 1.1 d
-4
5
AOPWIN Version 1.88, [OH radicals] = 8 × 10 cm
Volatilisation ‡
from plant surfaces:about 1 % in 24 hours
from soil: about 0.5 % in 24 hours
Metabolites
None
pag. 42
-3
Residues requiring further assessment
Environmental occurring metabolite requiring
further assessment by other disciplines
(toxicology and ecotoxicology).
Soil: parent (default)
Surface Water: parent (default)
Sediment: parent (default)
Ground water: parent (default)
Air: parent (default)
Monitoring data, if available (Annex IIA, point 7.4)
Soil (indicate location and type of study)
None
Surface water (indicate location and type of
study)
None
Ground water (indicate location and type of
study)
None
Air (indicate location and type of study)
None
Points pertinent to the classification and proposed labelling with regard to fate and
behaviour data
R 53
List of Endpoints Fate/behaviour pyraclostrobin (October 2003)
Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)
Mineralisation after 100 days
4 % after 87 d (tolyl-label, route study)
5 % after 91 d (chlorophenyl-label, route study)
Non-extractable residues after 100
54.3 % after 87 d (tolyl-label, route study)
days
56.1 % after 91 d (chlorophenyl-label, route study)
Major metabolites - name and/or code,
BF 500-6, max. 31 % after 120 days (rate studies)
% of applied (range and maximum)
BF 500-7, max. 13 % after 62 days (rate studies)
Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)
Anaerobic degradation
no residues of the parent after 120 days,
bound residues:
61 % (tolyl-label), 37 % (chlorophenyl-label).
Major metabolite BF 500-3: max 95.8 % after 14 d
(tolyl-label), 80 % after 14 d (chlorophenyl-label)
Soil photolysis
after 15 days: 64-74 % parent, 12 % bound
residues, 2 % CO2, no major metabolites (> 10 %)
Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)
Method of calculation
ModelMaker 3.0.3/3.0.4 (Cherwell Scientific
(Notifier)
Publishing Limited)
Laboratory studies (range or median,
DT50lab as (20 °C, aerobic): 12-101 days
with n value, with r2 value)
(5 soils)
DT50lab BF 500-6 (tolyl-label, route study):
129 d
DT50lab BF 500-6 (chlorphenyl-label, route study):
166 d
pag. 43
Field studies (state location, range or
median with n value)
Method of calculation
(Rapporteur)
Field studies (state location, range or
median with n value)
DT50lab BF 500-7 (tolyl-label, route study):
112 d
DT50lab BF 500-7 (chlorphenyl-label, route study):
159 d
DT90lab as (20 °C, aerobic): 143-163 days
(5 soils)
DT90lab BF 500-6 (tolyl-label, route study):
428 d
DT90lab BF 500-6 (chlorphenyl-label, route study):
552 d
DT90lab BF 500-7 (tolyl-label, route study):
372 d
DT90lab BF 500-7 (chlorphenyl-label, route study):
529 d
DT50lab (5 °C, aerobic): > 120 days
DT50lab (20 °C, anaerobic): 3 days
degradation in the saturated zone: not relevant
DT50f : 2 – 37 days, 6 locations (3 Germany, 2
Spain, 1 Sweden)
DT90f : 83-230 days
Timme and Frehse, 1st order kinetics
DT50f : 8 - 55 days, 6 locations (3 Germany, 2
Spain, 1 Sweden).
DT50 of 34.4 d considered as realistic worst case
and used for PECsoil calculations
Metabolites not found in amounts above the limit
of quantification. BF 500-6 found sporadically.
DT90f : 83 - 230 days
Soil adsorption/desorption (Annex IIA, point 7.1.2)
Active substance
Kf /Koc
(14C-Chlorphenol-ring)
Kd
soils: 3 German, 2 US, 1 Canadian
Koc 6000 – 16000 (no average value calculated
because of extremely high range)
pH dependence (yes / no) (if yes type
Kd 30 – 368
of
1/n = 0.861 – 1.025 (arithmetic mean: 0.95
dependence)
(calculated from DAR)
No
BF 500-6
Koc = 3200 – 71000
1/n not available.Due to low water solubility only
one concentration considered.
BF 500-7
Koc = 4020 – 149900
1/n not available. Due to low water solubility only
one concentration considered.
Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)
Column leaching
0 % in leachate, all radioactivity in top soil layer
Aged residues leaching
0 % in leachate, all radioactivity in top soil layer
pag. 44
Lysimeter/ field leaching studies
based on Koc and DT50 values, no leaching
expected
Studies not available, not required.
Route and rate of degradation in water (Annex IIA, point 7.2.1)
Hydrolysis of active substance and major
pH 5, 25 °C: stable
metabolites (DT50) (state pH and
temperature)
pH 7, 25 °C: stable
pH 9, 25 °C: stable
Photolytic degradation of active substance DT50 parent : 1-2 days
and major metabolites
BF 500-11:max. 45 % after 21 days
BF 500-13:max. 17 % after 6 days
BF 500-14:max. 21 % after 3 hours
BF 500-15:max. 27 % after 1 day
500M58:max. 23 % after 1 day
Readily biodegradable (yes/no)
No
Best fit
Degradation in
- DT50 water
pond system: 3 days; river system: 1 day
water/sediment
- DT90 water
pond system: 41 days; river system: 9 days
-DT50 sediment
pond system: 33 days; river system: 9 days
-DT90 sediment
pond system: 105 days; river system: no
calc.possible
pond system: 27 days; river system: 29 days**
- DT50 whole system
pond system: 89 days; river system: 96 days**
- DT90 whole system
** = low r² value (0.5593) (added from EU
evaluation and authoriation site (final decision
report))
Degradation in
water/sediment
- DT50 water
- DT90 water
- DT50 entire system
- DT90 entire system
Mineralisation
Non-extractable residues
1st-order (Timme and Frehse)
pond system: 8.7 days; river system: 1 day
pond system: 28.9 days; river system: not
extrap.
pond system: 26.8 days; river system: 29
days**
pond system: 89 days; river system: 96 days**
** = low r² value (0.5593)
NB: Ctgb cannot retrieve the system values
from the DAR or the addenda. A first order fit
on the total of a.s. in water and sediment was
performed using the FOCUS kinetics excel
sheet (using Solver)
Whole system (SFO):
-pond system (A): DT50 25.6 d; DT90 85.0 d
(chi2 6.5, M0 91.6, k 0.027))
-river system (B): DT50 7.4 d; DT90 24.6 d
(chi2 10.0, M0 98.9, k 0.094)
geomean DT50system of 13.8 days used for Risk
assessment
0.7 – 7.5 % in 100 days
51 - 66 %
pag. 45
100 days
Distribution in water / sediment systems
(active substance)
pond system: sediment max. 53 % after 14
days, decreasing to 7 % after 100 days
river system: sediment max. 62 % after 2 days,
decreasing to 10 % after 100 days
BF 500-3:
in water: max. 2 %,
in sediment: max. 12 %
(pond system) after 100 days;
max. 66 % (river system) after 14 days,
decreasing to 29 % after 100 days
BF 500-6:
(only in pond system) in
sediment max. 7 % after 61 days
BF 500-7:
(only in pond system) in
sediment max. 6 % after 61 days
Distribution in water / sediment systems
(metabolites)
Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)
Direct photolysis in air
see photochemical oxidative degradation
Quantum yield of direct
phototransformation
2.17 x 10-1
Photochemical oxidative degradation in air
(DT50)
< 2 hours
(According to Atkinson, AOP)
Volatilisation
from plant surfaces: about 3 % in 24 hours
from soil: < 1 % in 24 hours
Definition of the Residue (Annex IIA, point 7.3)
Soil: parent, BF500-6, BF500-7
Relevant to the environment
Groundwater: parent, BF500-6, BF500-7
Surface water including sediment: parent,
BF500-3, BF 500-11, BF 500-13
Monitoring data, if available (Annex IIA, point 7.4)
Soil (indicate location and type of study)
None
Surface water (indicate location and type
of study)
Ground water (indicate location and type
of study)
Air (indicate location and type of study)
None
None
None
Appendix A: Metabolite names, codes and other relevant information of the plant
protection product Bellis with a.s. boscalid and pyraclostrobin.
The compounds shown below were found in one or more studies involving the metabolism
and/or environmental fate of boscalid and pyraclostrobin. The parent compound structure of
boscalid and pyraclostrobin is shown first in this list and followed by degradate or related
compounds.
Compound Code
IUPAC name
name
number
Structural
formula
Structure
pag. 46
Molecular Observed in
Weight
study (% of
[g/mol]
occurrence/
Boscalid
188425
-85-6
(CAS
no)
2-Chloro-N-(4'chlorobiphenyl2yl)nicotinamide
C18H12Cl2N2O
343.21
O
N
H
N
formation)
Parent, all
compartments
Cl
Cl
M510F64
Pyraclostrobin
175013
-18-0
(CAS
no)
methyl N-(2-{[1- C19H18ClN3O4
(4chlorophenyl)1H-pyrazol-3yl]oxymethyl}
phenyl) Nmethoxy
carbamate
387.82
Cl
BF500-6
BF500-7
6.1
N
O
N
O
N
9.0-9.4 % in
surface
water
Parent, all
compartments
O
O
641.55
625.55
31 % in soil
13 % in soil
Fate and behaviour in soil
6.1.1 Persistence in soil
Article 2.8 of the Plant Protection Products and Biocides Regulations (RGB) describes the
authorisation criterion persistence. If for the evaluation of the product a higher tier risk
assessment is necessary, a standard is to be set according to the MPC-INS3 method. Currently
this method equals the method described in the Technical Guidance Document (TGD).
Additional guidance is presented in RIVM4-report 601782001/20075.
For the current application this means the following:
Boscalid
The following first order laboratory DT50 values are available for the active substance boscalid:
108, 322, 384, 376, 133 days (geomean 232 days).
There are no major metabolites.
Due to the exceeding of the threshold value of 60 days for the mean DT50 (lab) for boscalid, it
must be demonstrated by means of field dissipation studies that the field DT50 is < 90 days.
There are field data provided in the List of Endpoints. The Dutch assessment is based on the
non-normalised DT50 values of representative sites. In this case, it means that the German
trials are used and the Spanish sites are excluded from the calculation of the geomean.
Individual values are 55.7 (arithmetic mean of 3 replicates, Stetten), 176.7 (arithmetic mean of
3 replicates, Schifferstadt), and 144 days, leading to a geomean value of 112.3 days (best fit
kinetics).
From the results it is shown that the mean field DT50 is > 90 days. Based on the above, the
proposed applications of the plant protection product Bellis do not meet the standards for
persistence. Because the field DT50 is > 90 days and the field DT90 is > 1 year, it has to be
3
INS: international and national quality standards for substances in the Netherlands.
RIVM: National institute of public health and the environment.
5
601782001/2007: P.L.A. van Vlaardingen and E.M.J. Verbruggen, Guidance for the derivation of
environmental risk limits within the framework of 'International and national environmental quality
standards for substances in the Netherlands' (INS). Revision 2007’.
4
pag. 47
demonstrated that application of the plant protection product does not lead to accumulation of
the a.s. boscalid to the extent that it will have an unacceptable effect on non-target organisms.
In order to prevent this, the sum of the concentrations in which boscalid is present 2 years after
the last application after 10 years of annual application in the upper 20 cm of the soil where the
plant protection product has been applied (Gp,10) (see Table M.3), should not exceed the
MPC-INS value for soil organisms. See (next) section on MPC-INS.
Pyraclostrobin
The following laboratory DT50 values are available for the active substance pyraclostrobin: 12,
101, 50, 38 and 86 days (geomean 45.6 days). The mean DT50-value of the a.s. can thus be
established to be <90 days. Furthermore it can be excluded that after 100 days there will be
more than 70% of the initial dose present as bound (non-extractable) residues together with the
formation of less than 5% of the initial dose as CO2. Field studies indicate a realistic worst-case
DT50 field value of 34.4 days.
Herewith, the standards for persistence are met for the active substance pyraclostrobin.
Metabolites BF500-6 (max. observed 31 %) and BF500-7 (13 %) are formed in major amounts
in the laboratory degradation studies.
For the metabolite BF500-6 the following DT50-values are available: 129 and 166 days
(geomean 146.3 days).
For the metabolite BF500-7 the following DT50-values are available: 112 and 159 days
(geomean 133.4 days).
Due to the exceeding of the threshold value of 60 days for the mean DT50 (lab) for metabolites
BF 500-6 and BF 500-7, it has to be demonstrated by means of field dissipation studies that the
field DT50 is < 90 days. The following field data are provided: In field experiments performed on
four locations in Europe (each relevant for the Dutch situation), metabolite BF500-7 was not
found, BF 500-6 was found sporadically and at concentrations just above the detection limit. It
is not likely that long term accumulation will take place and that effects on non- target
organisms will occur.
From the results it is shown that the metabolites are not major under field conditions. Therefore,
the standards for persistence are met.
MPCsoil
In RIVM report 11189 the Maximum Permissible Concentration (MPC; MTR in Dutch) for soil is
derived for boscalid.
Data sources
The derivation of the MPC for boscalid is based on the data available in the EU-dossier and
RIVM report 09378a01. In addition, an on-line literature search was performed on TOXLINE
(literature from 1985 to 2001) and Current Contents (literature from 2001 to 2007). This search
did not result in any references from which an endpoint could be derived.
Ecotoxicological effect data
Laboratory data
Table M.1 shows the ecotoxicological data available in the dossier for boscalid. Since chronic
data are available for different trophic levels, acute data are not taken into account.
pag. 48
Table M.1 Available chronic laboratory toxicity data for derivation of the MPC soil.
Endpoints
NOEC in test soil
NOEC in standard soil (10% o.m.)
[mg a.s./kg]
[mg a.s./kg]
Microbial processes
Respiration
>8.06* (NOECrespiration)
>17.1
Nitrification
Fungi
Chaetomium globosum
Fusarium oxysporium
Mucor circinelloides
Trichoderma viride
Phytophthora nicotianae var.
parasitica
Annelida
Eisenia fetida
Collembola
Folsomia candida
Macrophyta
Allium cepa
>8.06* (NOECnitrification)
>17.1
25
25
1.57
1.57
>100
192
192
12.1
12.1
>769
1.13* (NOECreproduction)
2.39
58.8* (NOECmortality)
>470* (NOECreproduction)
125
>1000
>2.57* (NOEC)
>5.14
*NOEC based on 4.7% o.m.
Field data
Two long term field studies with natural occurring populations of earthworms were available. In
both field studies (on different soil types), the formulation was applied as 3 x 0.3 and 3 x 0.6 kg
a.s./ha. The results of these studies show that effects are found on earthworm populations.
However, effects of the lowest treatment are < 30% and recovery occurs one year after last
treatment. In the higher treatment in one of the field studies effects were >30% one year after
application.
When these studies should be used for standard-setting, however, a number of aspects render
the study not useful. A first and crucial point is, that a MPC should be protective for a chronic
exposure to a substance in soil. In the case of the earthworm field studies, the compound was
applied to the soil surface, not mixed through the soil and concentrations in soil were not
measured. When it would be assumed that the total dose applied in the field study would be
distributed over the upper 5 cm of soil, this would result in a concentration of 2.4 mg/kg soil,
corrected for a standard soil with 10% o.m. 7.5 mg/kg soil. However, it is not clear how the
compound is distributed over the soil, and how exposure is over time. Therefore it is practically
impossible to determine the long-term exposure of the earthworms in the soil, and therefore no
endpoint for exposure in soil can be derived.
Another aspect is that recovery cannot be taken into account for standard setting.
Apart from these field studies with earthworms, two litterbag studies are available. In these
studies litterbags are buried in the soil (at 5 cm depth) before spraying, in the same test as
described above in the earthworm field studies. After that the soil is sprayed with 3 x 0.6 kg
a.s./ha in the one experiment and 1 x 1.8 kg a.s./ha in the other. Effects on litter breakdown
were studied till 6 months after last application. In the first study a small significant effect (6.5%
reduction of o.m. weight loss) was found on the last sampling dates only. In the second study
significant effects of < 20% were found on all sampling dates. For registration purposes it was
concluded that no unacceptable risk for organic matter breakdown could be demonstrated. For
the use for standard setting the same problem as with the earthworms occur: the exposure in
soil is not known. For this reason no NOEC can be derived from this study.
pag. 49
MPCeco, soil – ecotoxicity data
Based on the laboratory data it can be stated that chronic toxicity data are available for at least
three trophic levels. According to the TGD this would result in an assessment factor of 10 on
the lowest NOEC (Eisenia fetida), resulting in an MPC of 0.24 mg a.s./kg for standard soil (10%
o.m.).
Although it is clear that the NOEC for Eisenia fetida is the lowest, the NOEC for soil fungi is
within a factor 10 of that of Eisenia fetida. Therefore, and from the mode of action of the
compound (fungicide) it cannot be concluded that earthworms are the most sensitive group,
and therefore a field study with earthworms cannot be used to lower the assessment factor
(apart from the above mentioned point of the unknown exposure in soil). The rough estimation
of the exposure in soil of 7.5 mg/kg indicates that there is no reason to use a higher safety
factor on the laboratory data.
The results of the litterbag study cannot be used to lower the safety factor of an MPC based on
Eisenia fetida. When it would be assumed that the total dose applied in the field study would be
distributed over the upper 5 cm of soil this would result in a concentration of 2.4 mg/kg soil,
corrected for a standard soil with 10% o.m. 7.5 mg/kg soil. This result also indicates that there
is no reason to use a higher safety factor on the laboratory data.
MPCsp, soil – secondary poisoning
Since the logKow < 3 the trigger for bioconcentration and biomagnification is not exceeded and
it is not expected that a risk for bioconcentration and biomagnification will occur. A BCF value
for soil organisms is not available. However, since the LogKow is determined using the HPLC
method, ionisation to NH+ cannot be excluded, and calculated values of LogKow are >3, it is
decided to estimate the risk of bioconcentration for the terrestrial route. For this aim the NOAEL
of 300 mg/kg feed for Colinus virginianus, 100 mg/kg feed for Rattus norvegicus, and 1000
mg/kg feed for Anas platyrhynchos are used to calculate the MPC for secondary poisoning. For
each species the MPCoral is calculated, and the lowest is used to calculate the MPC for
bioconcentration and biomagnification. In this case the NOEC for reproduction for Rattus
norvegicus of 100 mg/kg f d-1 is taken as the lowest MPC. Then the MPC soil is calculated
using Eqs. 27 and 28. Default values for Fgut, RHOsoil and Fsolidsoil are given in Table 31 of
Report 601501031. The BCFearthworm is calculated using Eq. 8, using the highest calculated
LogKow of 5.01 and the RHO earthworm of Table 31 from Report 601501031. Ksoil-water is
calculated using equations 59, 57 and 69 of Report 601501031. The thus calculated MPC for
bioconcentration and biomagnification is 1.2934. After normalisation to Dutch standard soil
according to Eq. 65 of Report 601501031the MPCsoil sp, st_soil_dw is 3.80 mg.kgdw st soil-1, based on
the highest calculated LogKow of 5.01 (XLogP).
MPChuman, soil – human exposure
For boscalid the MPChuman, soil is calculated according to Section 3.3.6 of the INS-Guidance,
using the ADI of 0.04 mg.kgbw-1.d-1 as input. Other input parameters needed for the
(intermediate) calculations are the Kow (912) and Koc (743) and Henry’s law constant and water
solubility. Using the defaults as given in Table 31 of the INS-Guidance, the following results are
obtained (for intermediate results, see Table M.2):
MPChuman,soil leaf
1.105E-07 kg/kgwwt soil
MPChuman,soil root
6.911E-07 kg/kgwwt soil
MPChuman,soil milk
4.813E-04 kg/kgwwt soil
MPChuman,soil meat
2.836E-04 kg/kgwwt soil
The most critical MPChuman, soil for exposure via leaf crops (1.105E-07 kg/kgwwt soil) is equivalent
to 0.3685 mg/kg dw for standard soil at 10% OM.
The thus calculated MPCHUMAN, SOIL is 0.37 mg/kg soil dw.
pag. 50
Table M.2 Intermediate results MPChuman, soil
-1
ALPHA
3.548E-02
[d ]
BAFmeat
2.291E-05
[d.kgmeat ]
BAFmilk
7.244E-06
[d.kgmilk ]
BETAagric
5.796E-06
[kgc.m .d ]
Cair
Cagric,porew
leaf_temp
Cagric,porew
root_temp
Cagric,porew
leaf
Cagric,porew
root
0.000E+00
[kgc.m ]
8.356E-06
[kgc.m ]
5.224E-05
[kgc.m ]
8.356E-06
[kgc.m ]
5.224E-05
[kgc.m ]
Cleaf
2.333E-07
[kgc.kgwwt ]
Cmeat
9.302E-07
[kgc.kgwwt ]
Cmilk
4.991E-07
[kgc.kgwwt ]
Croot
7.292E-07
[kgc.kgwwt ]
-1
-1
-3
-1
-3
-3
-3
-3
-3
-1
-1
-1
-1
pag. 51
Fassaer
0.000E+00
[-]
ICgrass
6.760E+01
[kgwwt.d ]
ICsoil
Kair-water
kelimplant
Kleaf-air
Kplant-water
Kp soil
Ksoil-water
Q milk
Q meat
TSCF
MPChuman,soil
leaf SI
MPChuman,soil
root SI
MPChuman,soil
milk SI
MPChuman,soil
meat SI
4.647E-01
2.185E-08
0.000E+00
4.471E+08
9.770E+00
1.486E-02
2.249E+01
5.243E+01
5.243E+01
1.387E+00
[kgwwt.d ]
3
-3
[m .m ]
[d-1]
3
-3
[m .m ]
3
-3
[m .m ]
3
-1
[m .kg ]
3
-3
[m .m ]
1.105E-07
[kg.kgwwt ]
6.911E-07
[kg.kgwwt ]
4.813E-04
[kg.kgwwt ]
2.836E-04
[kg.kgwwt ]
-1
-1
[-]
-1
-1
-1
-1
Conclusion
The MPC based on human toxicological data is 0.37 mg/kg. This means that the MPC of
0.24 mg/kg based on ecotoxicological data is also protective for human uptake. The MPC
based on secondary poisoning is 3.80 mg/kg. This means also that the MPC based on
ecotoxicological data is protective, and the overall MPC is 0.24 mg/kg for a standard soil with
10% om.
PECsoil
The concentration of boscalid, pyraclostrobin, and its metabolites in soil is needed to assess
the risk for soil organisms (earthworms, micro-organisms). The PECsoil is calculated for the
upper 5 cm of soil using a soil bulk density of 1500 kg/m3.
The logPow is almost > 3 (2.96) for boscalid. Moreover, since the LogKow is determined
using the HPLC method, ionisation to NH+ cannot be excluded, and calculated values of
LogKow are >3 (for details see MPC-section secondary poisoning). The logKow of
pyraclostrobin is 3.99. Therefore, PEC21d is calculated for both substances to address
secondary poisoning of birds and mammals through the consumption of earthworms. For the
metabolites of pyraclostrobin the logKow is unknown. As a conservative approach, the
PEC21d is calculated to enable risk assessment for secondary poisoning.
As boscalid is a persistent substance, an accumulation PEC is calculated based on Gp,10
assuming a homogeneous distribution in the top 20 cm. The fraction remaining in the soil one
year after application (R%) is calculated using the Dutch standard scenario with a dose of 1
kg/ha in Pearl and amounts to 39.7% for boscalid.
The following input data are used for the calculation:
PEC soil:
Active substance boscalid:
Maximum (relevant) field DT50 for degradation in soil: 176.7 days
Page 52
Molecular weight: 343.21 g/mol
Active substance pyraclostrobin:
Maximum field DT50 for degradation in soil: 34.4 days
Molecular weight: 387.82 g/mol
Metabolite BF500-6:
Maximum DT50 for degradation in soil (20°C): 166 days
Molecular weight: 641.55 g/mol
Correction factor: 0.31 (maximum observed fraction) * 1.65 (relative molar ratio = M
metabolite/M parent) = 0.512
Metabolite BF500-7:
Maximum DT50 for degradation in soil (20°C): 159 days
Molecular weight: 625.55 g/mol
Correction factor: 0.13 (maximum observed fraction) * 1.62 (relative molar ratio = M
metabolite/M parent) = 0.212
The Gp,10 of a.s. boscalid is derived based on a R% of 39.7%.
This R% is the result of a PEARL 3.3.3 calculation of an application in maize of 1 kg/ha on May
25th with the Dutch standard scenario based on:
Boscalid
Geometric mean lab DT50 for degradation in soil (20°C): 232 days*
Arithmetic mean Kom (pH-independent): 447 L/kg (771/1.724)
1/n: 0.868
Saturated vapour pressure: 7.2 x 10-7 Pa at 20 °C
Solubility in water: 4.6 mg/L at 20 °C
Molecular weight: 343.21 g/mol
* it is not clear if field data for boscalid are normalised according to FOCUS (first order kinetics) since ‘best fit’ is
indicated. The DAR does not clarify whether SFO or other first order kinetics was applied either. Therefore the
assessment is done with the geomean of the lab data, in line with earlier Dutch assessments.
See Table M.3 for other input values and results.
Table M.3 PECsoil calculations (5 cm and 20 cm)
Substance Correction Rate Freq. Interval Fraction PIECsoil
factor
[kg
[days] on soil * 5 cm
a.s./ha]
[mg
a.s./kg]
Apple
and
pear
Boscalid
Pyraclostrobin
BF500-6
BF500-7
0.512
0.212
0.2016 4
0.1024
0.0524
0.0217
Page 53
7
0.35
0.361
0.157
0.094
0.039
PECsoil
21 days
[mg
a.s./kg]
0.347
0.128
0.090
0.037
PECsoil
20 cm
(Gp,10)
[mg
a.s./kg]
0.0246
-
Pome
fruit
nursery
stock
and
pome
fruit
root
stock
Boscalid
Pyraclostrobin
BF500-6
BF500-7
0.512
0.212
0.2016 4
0.1024
0.0524
0.0217
7
0.35
0.361
0.157
0.094
0.039
0.347
0.128
0.090
0.037
0.0246
-
* fraction on soil is detemined as 1 – interception value; interception values derived from Table 1.5 in “generic
guidance for FOCUS groundwater scenarios” BBCH 56 corresponds to flowering, therefore an interception value
of 0.65 is considered appropriate.
The acute and short-term (21 days) exposure concentrations are examined against
ecotoxicological threshold values in section 7.5. The Gp,10 is examined against the overall
MPC soil. See next section.
Risk assessment
The highest Gp,10 is 0.0246 mg/kg soil. The overall MPC is 0.24 mg/kg for a standard soil
with 10% OM. This value has to be corrected to 4.7 % OM (representative for agricultural
soil). Hence, the corrected MPC is 0.113 mg/kg.
Since the Gp,10 is lower than the highest MPCsoil for a.s. boscalid, it is concluded that the
standards for persistence as laid down in the RGB are met.
6.1.2 Leaching to shallow groundwater
Article 2.9 of the Plant Protection Products and Biocides Regulations (RGB) describes the
authorisation criterion leaching to groundwater.
The leaching potential of the active substances boscalid and pyraclostrobin and metabolites
is calculated in the first tier using Pearl 3.3.3 and the FOCUS Kremsmünster scenario. Input
variables are the actual worst-case application rate, the crop and an interception value
appropriate to the crop stage. First date of yearly application is May 25th (default). Autumn
applications are also relevant (applications can last up to and including September) and
hence an appropriate date (September 1st) is chosen (see Table M.4).
For metabolites all available data concerning substance properties are regarded. Major
metabolites BF500-6 and BF500-7 are included in the calculations. No other metabolites
occurred above > 10 % of AR, > 5 % of AR at two consecutive sample points or had an
increasing tendency.
The following input data are used for the calculation:
PEARL:
Active substance boscalid:
Geometric mean lab DT50 for degradation in soil (20°C): 232 days*
Arithmetic mean Kom (pH-independent): 447 L/kg (771/1.724)
1/n: 0.868
Saturated vapour pressure: 7.2 x 10-7 Pa at 20 °C
Solubility in water: 4.6 mg/L at 20 °C
Molecular weight: 343.21 g/mol
Active substance pyraclostrobin:
Geometric mean lab DT50 for degradation in soil (20°C): 45.6 days
Mean Kom (pH-independent): 5473 L/kg.
1/n: 0.95
Page 54
Saturated vapour pressure: 2.6 x 10-8 Pa (20°C)
Solubility in water: 19000 mg/L (at 20 °C in deionised water (pH of 5.8))
Molecular weight: 387.82 g/mol
Metabolite BF 500-6:
Geometric mean lab DT50 for degradation in soil (20°C): 146.3 days
Mean Kom (pH-independent): 22324 L/kg.
1/n: 1 (default for metabolites in absence of data)
Saturated vapour pressure: see parent
Solubility in water: see parent
Molecular weight: 641.55 g/mol
Formation fraction: 31 % maximum observed
Metabolite BF 500-7:
Geometric mean lab DT50 for degradation in soil (20°C): 133.4 days
Mean Kom (pH-independent): 36630 L/kg.
1/n: 1 (default for metabolites in absence of data)
Saturated vapour pressure: see parent
Solubility in water: see parent
Molecular weight: 626.55 g/mol
Formation fraction: 13 % maximum observed
Other parameters: standard settings of PEARL 3.3.3
* it is not clear if field data for boscalid are normalised according to FOCUS (first order kinetics) since ‘best fit’ is
indicated. The DAR does not clarify whether SFO or other first order kinetics was applied either. Therefore the
assessment is done with the geomean of the lab data, in line with earlier Dutch assessments.
The following concentrations are predicted for the a.s. boscalid, pyraclostrobin and
metabolites BF500-6 and BF500-7 following the realistic worst-case GAP, see Table M.4a.
For boscalid an extended simulation of 60 years is performed because it appeared that the
front of the leaching did not reach the groundwater at 1 m depth after 20 years of simulation.
Table M.4a Leaching of a.s. boscalid, pyraclostrobin and metabolites BF500-6 and
BF500-7 as predicted by PEARL 3.3.3
Use
Substance
Rate Frequenc Interval Fraction
PEC
subst y
[days] Intergroundwater [µ
µg/L]
ance
cepted *
[kg/h
a]
Spring
autumn
st
(1 app. (1st app.
May 25th Septembe
)
r 1st)
Apple and
Boscalid
0.201 4
7
0.65
0.0052
0.0057
pear;
Pyraclostrobin 6
< 0.001 < 0.001
Pome fruit
BF500-6
0.102
< 0.001 < 0.001
nursery stock BF500-7
4
< 0.001 < 0.001
and pome
- **
fruit root stock
- **
*
**
interception values derived from Table 1.5 in “generic guidance for FOCUS groundwater scenarios”.
BBCH 56 corresponds to flowering, therefore an interception value of 0.65 is considered appropriate.
application rate for metabolites is calculated via the transformation scheme
Page 55
Results of Pearl 3.3.3 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).
The expected leaching based on the PEARL-model calculations for the a.s. boscalid,
pyraclostrobin and its metabolites BF500-6 and BF500-7 is smaller than 0.01 µg/L for the
proposed applications. Hence, the applications meet the standards for leaching as laid down
in the RGB.
Hence, the active substances meet the standards laid down in the RGB for the proposed
applications.
Monitoring data
Boscalid
There are no data available regarding the presence of the substance boscalid in
groundwater.
Pyraclostrobin
There are no data available regarding the presence of the substance pyraclostrobin in
groundwater.
Regarding the presence of metabolites BF500-6 and BF500-7 no monitoring data are
available.
Conclusions
The proposed application(s) of the product complies with the requirements laid down in the
RGB concerning persistence and leaching in soil.
6.2
Fate and behaviour in water
6.2.1 Rate and route of degradation in surface water
The exposure concentrations of the active substance boscalid and pyraclostrobin in surface
water and sediment 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. Drift mitigation measures are proposed by the
applicant:
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer op perceelranden die grenzen aan oppervlaktewater uitsluitend toegestaan voor 1
mei wanneer:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C).
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer op perceelranden die grenzen aan oppervlaktewater uitsluitend toegestaan na 1 mei
wanneer:
•
het middel wordt verspoten met een tunnelspuit of:
•
in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt
met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het
perceel bespoten dient te worden, of:
•
er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste
bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of:
Page 56
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C).
Concentrations in surface water are calculated using the model TOXSWA.
For boscalid, there is no first tier DT50system to use for PEC calculations. In the DAR and the
Addendum of May 2006, calculations are based on the DT50 in water (9 days). This is not in
line with the current guidance from FOCUS surface water Guidance Document, which states
that system values are needed (unless it is proven that the DT50 water and sediment represent
real degradation values instead of dissipation values).
A total system DT50 value for boscalid is available from a higher tier outdoor (irradiated) watersediment study. This study is described in the DAR: The water/sediment system taken for this
study was of the same origin as one of the systems used for the aerobic aquatic metabolism
(Kellmetschweiher). The water/sediment systems were placed in big isolated plastic tanks,
filled to a distinct level with water in order to simulate a bigger water body with respective
temperature compensation. The tanks were located outdoors in order to have outdoor
temperature and light conditions (treatment date July 5th, 2000).
This value of 110 days was derived by graphical estimation, which is not according to the latest
guidance, and hence was recalculated to 90 days according to the FOCUS degradation
kinetics guidance by Ctgb. This value is used for risk assessment, which deviates from the
earlier approach of using the water DT50 of 21 days.
Metabolite M510F64 of boscalid occurred in water at max. 9.0 % at 14 d and 9.4 % at 30 d
and hence is a minor metabolite in water. In the DAR it is stated that this metabolite
remained below 10% TAR and was of transient nature, and that additionally this compound is
of no toxicological and ecotoxicological relevance.
Since there are no DT50 values for the total system and there are also no ecotox data, no
exposure concentrations are calculated and no risk assessment is performed. Since the
expected concentration in water is lower than boscalid (formation 9%) and public literature
papers indicate that this substance is several orders of magnitude less toxic than the parent,
no further evaluation is performed. This is in line with the DAR (NL has not commented on
this approach).
In the aqueous photolysis study, the following metabolites of pyraclostrobin were found: BF
500-11 (max. 45 % after 21 days), BF 500-13 (max. 17 % after 6 days), BF 500-14 (max. 21
% after 3 hours), BF 500-15 (max. 27 % after 1 day, transient) and 500M58 (max. 23 % after
1 day, transient). Metabolites BF 500- 11, BF 500-13 and BF 500-14 might hence be relevant
in the natural aquatic environment. No PEC values are calculated, since the concentration in
water will be lower than the concentration of the parent pyraclostrobin (based on formation
%) and the toxicity is much lower for the metabolites than for the active substance.
Metabolites BF 500-15 and 500M58 are formed within 1 day. It is assumed that the toxicity of
these metabolites are included in the tests for the parent pyraclostrobin.
Pyraclostrobin metabolite BF500-3 is observed in a maximum percentage of 66 % of A.R. in
river sediment. However, it is not mentioned in the ecotox LoEP and no substance properties
are available. Furthermore, parent pyraclostrobin is already assessed for the risk to sediment
organisms which is expected to cover the risk for BF500-3. Therefore, no PEC values are
calculated. Major soil metabolites BF500-6 and –7 are found in minor quantities in the watersediment study and do not need an aquatic risk assessment under the present framework
(only drift entry).
The following input data are used for the calculation:
Page 57
TOXSWA:
Active substance boscalid:
DT50 for degradation in water at 20°C: 90 days (n=1, total system DT50 in higher tier outdoor
study, recalculated by Ctgb)
DT50 for degradation in sediment at 20°C: 1000 days (default).
Mean Kom for suspended organic matter: 447 L/kg
Mean Kom for sediment: 447 L/kg
1/n: 0.868
Saturated vapour pressure: 7.2 x 10-7 Pa at 20 °C
Solubility in water: 4.6 mg/L at 20 °C
Molecular weight: 343.21 g/mol
Active substance pyraclostrobin:
Geomean DT50 for degradation in water at 20°C: 13.8 (recalculated by Ctgb on the basis of the
study in the DAR)
DT50 for degradation in sediment at 20°C: 1000 days (default)
Kom for suspended organic matter: 5473 L/kg
Kom for sediment: 5473 L/kg
1/n: 0.95
Saturated vapour pressure: 2.6 x 10-8 Pa (20°C)
Solubility in water: 19 g/L (at 20 °C in deionised water (pH of 5.8))
Molecular weight: 387.82 g/mol
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.5a, the drift percentages and calculated surface water concentrations for the
active substance boscalid and pyraclostrobin for each intended use are presented. The
emission via drift reduction is higher for apple and pear use than for pome fruit nursery stock
and pome fruit root stock use. The drift reducing measures are proposed for both apple and
pear use and pome fruit nursery stock and pome fruit root stock use. Therefore, only for
apple and pear use the PECsw are calculated as these will result in highest PECsw.
Table M.5a Overview of surface water concentrations for active substance boscalid and
pyraclostrobin following spring application in the edge-of-field ditch
Use
Substance
Rate
Freq. Inter- Drift PIEC PEC21 PEC28
Apple and pear
Wanner equipment with
reflection shield and venturi
nozzles (Lechler ID 90-015C)
st
before May 1
Boscalid
Pyraclostrobin
a.s.
[kg/ha]
val
0.2016 4
0.1024
7
Page 58
*
*
[µ
µg/L] [µ
µg/L] [µ
µg/L]
0.98 3.15
2.58
2.39
1.07
0.74
0.69
[%]
*
Use
Substance
Apple and pear
st
Tunnel sprayer from May 1
onwards
Apple and pear
Windbreak + onesided
st
spraying last row from May 1
onwards
Apple and pear
Venturi nozzle + onesided
st
spraying last row from May 1
onwards
Apple and pear
Wanner equipment with
reflection shield and venturi
nozzles (Lechler ID 90-015C)
st
from May 1 onwards
Boscalid
Pyraclostrobin
Rate
Freq. Inter- Drift PIEC PEC21 PEC28
a.s.
val
*
*
*
[kg/ha]
[%] [µ
µg/L] [µ
µg/L] [µ
µg/L]
0.2016 4
7
1
3.20
2.62
2.43
0.1024
1.09
0.76
0.71
Boscalid
Pyraclostrobin
0.2016 4
0.1024
7
0.7
2.24
0.76
1.83
0.53
1.69
0.49
Boscalid
Pyraclostrobin
0.2016 4
0.1024
7
0.8
2.56
0.87
2.09
0.60
1.94
0.56
Boscalid
Pyraclostrobin
0.2016 4
0.1024
7
0.21
0.66
0.23
0.54
0.16
0.50
0.15
*
calculated according to TOXSWA
PECsediment
To address the risk to sediment organisms, a PEC sediment value is needed for boscalid.
The PECsediment values calculated with TOXSWA are expressed in g a.s./m3 sediment.
This PECsed has to be converted to mg a.s./kg sed dw by dividing it by the dry weight (DW)
bulk density.
It is assumed that the substance will be present mainly in the top 1 cm layer. This layer has a
dry weight bulk density of 80 kg/m3. The maximum PEC value in sediment in the top 1 cm of
sediment is reached at day 28 after the first application. See Table M.5b for calculation of
PECsediment.
Table M.5b Maximum sediment concentration for active substance boscalid following
spring application in the edge-of-field ditch
Use
Substance Rate
drift PECsediment
3
a.s.
[%]
[g a.s./m
*
[kg/ha]
sediment]
Boscalid
0.2016 0.98 1.57E-02
Apple and pear
Wanner equipment with reflection
shield and venturi nozzles (Lechler
st
ID 90-015C) before May 1
Apple and pear
Boscalid
0.2016 1
0.160E-01
st
Tunnel sprayer from May 1
onwards
Apple and pear
Boscalid
0.2016 0.7 0.115E-01
Windbreak + onesided spraying
st
last row from May 1 onwards
Apple and pear
Boscalid
0.2016 0.8 0.130E-01
Venturi nozzle + onesided spraying
st
last row from May 1 onwards
Apple and pear
Boscalid
0.216
0.21 3.84E-03
Wanner equipment with reflection
shield and venturi nozzles (Lechler
st
ID 90-015C) from May 1 onwards
* TOXSWA output
3
3
** calculated as (PECsed in g/m / 80 kg/m )*1000 (conversion of g/kg to mg/kg)
PECsediment
[mg a.s./kg
**
sediment DW]
0.196
0.200
0.144
0.163
0.048
The exposure concentrations in surface water and sediment are compared to the
ecotoxicological threshold values in section 7.2.
Page 59
Monitoring data
The Pesticide Atlas on internet (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl) is
used to evaluate measured concentrations of plant protection products in Dutch surface
water, and to assess whether the observed concentrations exceed threshold values.
Dutch water boards have a well-established programme for monitoring plant protection
product 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 plant protection product contamination of Dutch surface waters against
environmental standards.
Recently, the new version 2.0 was released. This new version of the Pesticide Atlas does not
contain the land use correlation analysis needed to draw relevant conclusions for the
authorisation procedure. Instead a link to the land use analysis performed in version 1.0 is
made, in which the analysis is made on the basis of data aggregation based on grid cells of
either 5 x 5 km or 1 x 1 km.
Data from the Pesticide Atlas are used to evaluate potential exceeding of the authorisation
threshold and the MPC (ad-hoc or according to INS) threshold.
For examination against the drinking water criterion, another database (VEWIN) is used,
since the drinking water criterion is only examined at drinking water abstraction points. For
the assessment of the proposed applications regarding the drinking water criterion, see next
section.
Boscalid
The active substance boscalid was observed in the surface water (most recent data from
2011). In Table M.6a the number of observations in the surface water are presented.
In the Pesticide Atlas, surface water concentrations are compared to the authorisation
threshold value of 12.5 µg/L (28-06-2007, consisting of first or higher tier acute or chronic
ecotoxicological threshold value, including relevant safety factors, which is used for risk
assessment, in this case 0.1*NOEC fish from ELS test) and to the indicative Maximum
Permissible Concentration (MPC) of 0.55 µg/L as presented in the Pesticide Atlas (data
source for the MPC: Zoeksysteem normen voor het waterbeheer,
http://www.helpdeskwater.nl/normen_zoeksysteem/normen.php).
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.6a Monitoring data in Dutch surface water (from www.pesticidesatlas.nl,
version 2.0)
Total no of locations
n>
n > indicative/ad hoc
n > MPC-INS
(2011)
authorisation
MPC threshold
threshold *
threshold
204**
0
3 locations exceed MPC
with factor 2-5.
n.a.
* n.a.: no MPC-INS available.
** the number of observations at each location varies between 1 and 30, total number of measurements is 1421 in
2011
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
Page 60
data. However, this is the best available information and therefore it is used in this
assessment.
In this case, there were no exceedings in 2005-2006 and therefore no land use correlation
can be performed. Furthermore, since there are only three locations with an exceeding, no
statistically sound analysis of a relationship with land use can be made.
Therefore, no consequences can be drawn from the observed exceedings.
Pyraclostrobin
The active substance/metabolite pyraclostrobin was observed in the surface water (most
recent data from 2007). In Table M.6b 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 0.8 µg/L (07-12-2012, consisting of first or higher tier acute or chronic
ecotoxicological threshold value, including relevant safety factors, which is used for risk
assessment, in this case 0.1*NOEC mesocosm) and to the indicative Maximum Permissible
Concentration (MPC) of 0.023 µg/L as presented in the Pesticide Atlas (data source for the
MPC: Zoeksysteem normen voor het waterbeheer,
http://www.helpdeskwater.nl/normen_zoeksysteem/normen.php).
For substance pyraclostrobin, an MPC-INS value of 0.023 µg/L is available (RIVM report
11925, November 2009, see section 7.2 for details).
This value is identical to the value presented in the Pesticide Atlas. Therefore, if threshold
exceedings are correlated to the proposed use, this may have consequences for the
authorisation.
Table M.6b Monitoring data in Dutch surface water (from www.pesticidesatlas.nl,
version 2.0)
Total no of
n > authorisation
n > indicative/ad hoc
n > MPC-INS
locations
threshold
MPC threshold
threshold
(2011)
104*
1 (exceeding the
5 x exceeding the threshold 5 x exceeding
threshold with a factor with a factor between 2- 5
the threshold
> 5)
1 x exceeding the threshold with a factor
with a factor > 5
between 2- 5
1 x exceeding
the threshold
with a factor > 5
*
the number of observations at each location varies between 14 and 30, total number of
measurements is 728 in 2011
On one location (Upper part of Noord-Holland) the authorisation threshold is exceeded. In
view of the very localized single exceeding, this might be related to a point source.
It is noted that the authorisation threshold has been re-evaluated and now is 1.75 µg/L for
fish and 8.0 µg/L for other organisms (hence, the safety factor on the NOEC of the
mesocosm is removed). The new threshold value has not yet been included in the Pesticide
Atlas. Therefore the observed exceeding of the authorisation threshold in the Pesticide Atlas
might not exist based on the new endpoints. On several locations in the upper part of NoordHolland the ad-hoc MPC (equalling the MPC-INS) is exceeded.
The correlation of exceeding of the MPC 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.
However, the observed exceeding (in 2005-2006) could not be correlated to any use since
there are too few exceeding data to perform the correlation analysis. It is noted however that
Page 61
in some regions not monitored yet in 2005-2006, several exceedings occur. At this moment
no information on relation with land use is available. However the locations with exceeding
are not typically fruit growing areas (apple and pear).
Therefore, no consequences can be drawn for the current application for authorisation.
Drinking water criterion
It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005
(Awb 04/37 (General Administrative Law Act)) that when considering an application, Ctgb
should, on the basis of the scientific and technical knowledge and taking into account the
data submitted with the application, also judge the application according to the drinking water
criterion ‘surface water intended for drinking water production’. No mathematical model for
this aspect is available. This means that any data that is available cannot be adequately
taken into account. It is therefore not possible to arrive at a scientifically well-founded
assessment according to this criterion. Ctgb has not been given the instruments for testing
surface water from which drinking water is produced according to the drinking water criterion.
In order to comply with the Court’s decision, however - from which it can be concluded that
Ctgb should make an effort to give an opinion on this point – and as provisional measure, to
avoid a situation where no authorisation at all can be granted during the development of a
model generation of the data necessary, Ctgb has investigated whether the product under
consideration and the active substance could give cause for concern about the drinking
water criterion.
Boscalid
Boscalid has been on the Dutch market for > 3 years (authorised since 12-12-2003). This
period is sufficiently large to consider the market share to be established. Further, earlier
calculations provided for the applicant have shown that the sum of the predicted
concentrations at surface water abstraction points of all earlier authorised uses remains
below the trigger value. Finally, no exceeding of the trigger at water abstraction points has
been observed in routine water quality monitoring.
Hence, from the general scientific knowledge collected by Ctgb about the product and its
active substance, Ctgb concludes that there are in this case no concrete indications for
concern about the consequences of this product for surface water from which drinking water
is produced, when used in compliance with the directions for use. Ctgb does under this
approach expect no exceeding of the drinking water criterion. The standards for surface
water destined for the production of drinking water as laid down in the RGB are met.
Pyraclostrobin
Pyraclostrobin has been on the Dutch market for > 3 years (authorised since 12-12-2003).
This period is sufficiently large to consider the market share to be established. Further,
earlier calculations provided for the applicant have shown that the sum of the predicted
concentrations at surface water abstraction points of all earlier authorised uses remains
below the trigger value. Finally, no exceeding of the trigger at water abstraction points has
been observed in routine water quality monitoring.
Hence, from the general scientific knowledge collected by Ctgb about the product and its
active substance, Ctgb concludes that there are in this case no concrete indications for
concern about the consequences of this product for surface water from which drinking water
is produced, when used in compliance with the directions for use. Ctgb does under this
approach expect no exceeding of the drinking water criterion. The standards for surface
water destined for the production of drinking water as laid down in the RGB are met.
6.3
Fate and behaviour in air
Route and rate of degradation in air
Boscalid
The vapour pressure is 7.2 x 10-7 Pa at 20 °C. The Henry constant is 5.18 x 10-8 kPa m³/mol
at 20°C. The half-life in air is < 1.1 d.
Page 62
Pyraclostrobin
The vapour pressure is 2.6 x 10-8 Pa at 20°C. The Henry constant is 5.307 x 10-6 kPa m³/mol
at 20°C. The half-life in air is < 2 hours.
Since at present there is no framework to assess fate and behaviour in air of plant protection
products, for the time being this issue is not taken into consideration.
6.4
Appropriate fate and behaviour endpoints relating to the product and approved
uses
See List of Endpoints.
6.5
Data requirements
None.
The following restriction sentences were proposed by the applicant:
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer op perceelranden die grenzen aan oppervlaktewater uitsluitend toegestaan voor 1
mei wanneer:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C).
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer op perceelranden die grenzen aan oppervlaktewater uitsluitend toegestaan na 1 mei
wanneer:
•
het middel wordt verspoten met een tunnelspuit of:
•
in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt
met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het
perceel bespoten dient te worden, of:
•
er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste
bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C).
Based on the current assessment, the following has to be stated in the legal
instructions for use:
Om in het water levende organismen te beschermen is de toepassing voor 1 mei in de teelt
van appel en peer op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan
wanneer het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C). (to be confirmed by ecotox)
Om in het water levende organismen te beschermen is de toepassing vanaf 1 mei in de teelt
van appel en peer op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan
wanneer:
•
het middel wordt verspoten met een tunnelspuit of:
•
in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt
met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het
perceel bespoten dient te worden, of:
•
er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste
bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C).
(to be confirmed by ecotox)
Page 63
6.6
Overall conclusions fate and behaviour
It can be concluded that:
1. the active substances boscalid, pyraclostrobin and metabolites BF500-6 and BF500-7
meet the standards for persistence in soil as laid down in the RGB.
2. all proposed applications of the active substances boscalid, pyraclostrobin and
metabolites BF500-6 and BF500-7 meet the standards for leaching to the shallow
groundwater as laid down in the RGB.
3. all proposed applications of the active substances boscalid and pyraclostrobin meet
the standards for surface water destined for the production of drinking water as laid
down in the RGB.
7. Ecotoxicology
For the current application of Bellis, risk assessment is done in accordance with Chapter 2 of
the RGB.
Boscalid is a new substance, included in Annex I since 08/2008. For the risk assessment, the
List of Endpoints of 11/2007 is used. The most recent LoEP (draft LoEP from EFSA
conclusion of 01/2008) cannot be used, since this list is incomplete for ecotoxicology (no
information on higher tier studies, no information on non-target plants and activated sludge,
no information on metabolites, no information on formulations). The list is updated to the
information that is available in the LoEP of 01/2008.
Pyraclostrobin is a new substance, included in Annex I (June 2004). RMS is Germany. For
the risk assessment the final List of Endpoints (September 2004) is used.
Additions and/or clarifications to the LoEP by Ctgb are added in italics.
Studies submitted for Dutch registration were evaluated and summarized by RIVM, report
12804a00, 01/2011
List of Endpoints Ecotoxicology
Boscalid (November 2007, updated to January 2008)
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)
Species
Test substance
Time
scale
Endpoint
Endpoint
(mg/kg
bw/day)
(mg/kg feed)
Birds ‡
Colinus virginianus
As
Acute
LD50 > 2000
Colinus virginianus
As
Short-term
LD50 > 1094.3
LC50 > 5000
Colinus virginianus
as
Long-term*
NOAEDD 24.1
NOAEL300
rat.
As
Acute
LD50 > 5000
rat
As
Long-term*
NOEAEDD 67
Mammals ‡
NOEAEC 1000
Additional higher tier studies ‡
--
* Option for refinement long-term risk: For boscalid the half-life on plant material (lettuce) was
determined to be 1.6-2.7 days (geometric mean 2.09, n = 8).
Page 64
Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA,
point 8.2, Annex IIIA, point 10.2)
Group
Test
substance
Time-scale
Endpoint
O. mykiss.
as
static – 96 h
Mortality, EC50
2.7
O. mykiss
as
flow-through – 97
d (ELS)
NOEC
0.125
O. mykiss
BAS 501 01 F
static – 96 h
LC50
100
as
static – 48 h
EC50
(Test type)
Toxicity
(mg/L)
Laboratory tests ‡
Fish
Aquatic invertebrate
D. magna
5.33
1.25*
D. magna
as
semistatic – 21 d
NOEC
1.31
D. magna
BAS 501 01 F
static – 48 h
EC50
50
static – 28 d
NOEC
1.0
static – 28 d
NOEC
23.26 mg/kg
ErC50
3.75
EbC50
1.34
ErC50
4.50
EbC50
3.37
Sediment dwelling organisms
C. riparius
as
C. riparius
as
spiked sediment
Algae
P. subcapitata
as
static – 96 h
as
P. subcapitata
BAS 501 01 F
static – 72 h
Higher plant - none
Microcosm or mesocosm tests
Not required
*
According to the LoEP of 01/2008. This is incorrect. The value should be 5.33 mg/L as given in the
LoEP of 11/2008.
Bioconcentration
log PO/W
1
Active substance
Metabolite 1
2.96
No major metabolites
Bioconcentration factor (BCF) ‡
92
Annex VI Trigger for the bioconcentration
factor
> 100 for non readily
biodegradable substances
Clearance time (days) (CT50)
Max. 1.0 d
(CT90)
Max. 3.3 d
Level and nature of residues (%) in
organisms after the 14 day depuration
phase
n.r.
1
only required if log PO/W > 3.
14
* based on total C or on specific compounds
Page 65
Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)
Test substance
Acute oral toxicity
(LD50 µg/bee)
Acute contact toxicity
(LD50 µg/bee)
as ‡
166 µg as/bee
200 µg as/bee
100 µg prep./bee
LD50 = 100 µg
prep/bee
1
Preparation
Field or semi-field tests
Not required
1
for preparations indicate whether endpoint is expressed in units of as or preparation
Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)
Laboratory tests with standard sensitive species
Species
Test
Endpoint
Substance
Effect
(LR50 g as/ha)
Typhlodromus pyri ‡
BAS 510 01 F
Mortality
> 1800
Aphidius rhopalosiphi ‡
BAS 510 01 F
Mortality
> 1800
Page 66
Further laboratory and extended laboratory studies J
Species
Life
stage
Test substance,
substrate and
duration
Typhlodromus
Proto-
BAS 510 01 F
pyri
nymphs
Typhlodromus
Proto-
pyri
nymphs
Typhlodromus
Proto-
pyri
nymphs
Typhlodromus
Proto-
pyri
nymphs
Typhlodromus
Proto-
pyri
nymphs
Aphidius
Imag-
rhopalosiphi
ines
Aphidius
Imag-
rhopalosiphi
ines
Aphidius
Imag-
rhopalosiphi
ines
Aphidius
Imag-
rhopalosiphi
ines
Aphidius
Imag-
rhopalosiphi
ines
Chrysopa carnea
Larvae
Dose (g
as/ha)
Endpoint
46
Mortality
% effect
Trigger
value
0
30 %
0
30 %
Mortality
0
30 %
Fecundity
+14
Mortality
0
Fecundity
3
Mortality
0
Fecundity
+3
Mortality
0
30 %
0
30 %
0
30 %
30 %
Fecundity
BAS 510 01 F
115
Mortality
Fecundity
BAS 510 01 F
288
BAS 510 01 F
700
BAS 510 01 F
1800
BAS 510 01 F
355.5
30 %
30 %
Fecundity
BAS 510 01 F
533.5
Mortality
Fecundity
BAS 510 01 F
800
Mortality
Fecundity
BAS 510 01 F
1200
Mortality
11
Fecundity
25
BAS 510 01 F
1800
Mortality
11
Fecundity
34
Mortality
2
Fecundity
11
BAS 510 01 F
1200
30 %
30 %
Pardosa spp.
Adults
BAS 510 01 F
1200
Mortality
0
30 %
Poecilus cupreus
Imagin
es
BAS 510 01 F
1200
Food uptake
Mortality
Food uptake
5
0
5
30 %
Field or semi-field tests
Test material
(%)
Species
Test
No. of
Dosage per appl.
Effect
appl.
(g as/ha)
Final bonitation*
-----------------------------------------------------------------------------------------------------------------------------------Predatory mites
BAS 510 01 F
T. pyri
Field
3
600
0/0
BAS 510 01 F
T. pyri
Field
3
30
0/6
BAS 510 01 F
T. pyri
Field
3
600
39.7 / 2.8
BAS 510 01 F
T. pyri
Field
3
30
33.6 / 5.0
BAS 510 01 F
T. pyri
Field
3
600
21 / 9
BAS 510 01 F
T. pyri
Field
3
30
12 / 9
-----------------------------------------------------------------------------------------------------------------------------------* 7 / 27 days resp. 29 days after last application
Page 67
Effects on earthworms, other soil macro-organisms and soil micro-organisms (Annex
IIA, points 8.4 and 8.5, Annex IIIA, points 10.6 and 10.7)
Test organism
1
Test substance
Time scale
Endpoint
Eisenia fetida
as ‡
Acute 14 days
LC50 > 1000 mg boscalid / kg
(corrected > 500 mg as/kg)
Eisenia fetida
Preparation
Acute
LC50 > 1000 mg BAS 510 01 F
/ kg (corrected > 500 mg
form./kg)
Eisenia fetida
Preparation
Chronic
NOEC 3.6 kg BAS 510 01 F
Earthworms
/ha
(corrected 1.8 kg form./ha;
equivalent to 1.197 mg
boscalid/kg)
--
Metabolite 1
Acute
No major metabolite
--
as ‡
Chronic
NOEC mg as/kg d.w.soil (mg
as/ha)
Folsomia candida
Preparation**
Chronic
NOEC 125 mg form./kg soil
(mortality)
Collembola
NOEC > 1000 mg form./kg soil
(reproduction)
--
Metabolite 1
Soil micro-organisms
Nitrogen mineralisation
as ‡
No effects up to 12 kg BAS 510 01 F/ha
(equivalent to 6 kg as/ha or 8 mg as/kg soil)
Carbon mineralisation
Metabolite 1
No major metabolite
as ‡
No effects up to 12 kg BAS 510 01 F/ha
(equivalent to 6 kg as/ha or 8 mg as/kg soil)
Metabolite 1
Field studies
No major metabolite
2, *
Two field tests on the formulation BAS 510 01 F 3 were conducted with 3 × 0.6 kg/ha and 3 × 1.2
kg/ha. One year after the last application there was a not significant reduction in abundance and
biomass of earthworms of about 30 % in case of the higher application rate. No long-lasting effects on
overall abundance and biomass of earthworms were observed for the lower test concentration.
However for both test concentrations effects on single species of about 30 % in comparison to control
still exist one year after the last application.
1
indicate where endpoint has been corrected due to log Po/w > 2.0 (e.g. LC50corr)
litter bag, field arthropod studies not included at 8.3.2/10.5 above and earthworm field studies
3
BAS 510 01F = 500 g boscalid /kg
* studies are also summarized in RIVM report 09378a01 d.d. 30-03-2004
** formulation is BAS 510 01 F, content of nicobifen (boscalid) 500 g/kg (added from DAR)
2
Page 68
Effects on soil fungi*
Chaetomium globosum
NOEC: 25 mg a.s./kg soil
Fusarium oxysporium
NOEC: 25 mg a.s./kg soil
Mucor circinelloides
NOEC: 1.57 mg a.s./kg soil
Trichoderma viride
NOEC: 1.57 mg a.s./kg soil
Phytophthora nicotianae var. parasitica
NOEC: >100 mg a.s./kg soil
* data submitted for Dutch application for authorisation for another formulation based on boscalid
(Cantus).
Effects on non-target plants (Annex IIA, point 8.6, Annex IIIA, point 10.8)
Preliminary screening data
Limit test:
No phytotoxicity effects > 5 %, max. 8.8 % weight reduction up to 1800 g as/ha
Terrestrial non-target plants *
Avena sativa, Daucus carota,
NOEC: 3.6 kg BAS 510 01 F/ha = 2,57 mg w.s./kg
Brassica oleracea, Pisum
sativum,Zea mais,Allium cepa
*Data from DAR added to the List of Endpoints by Ctgb, copied from C-165.3.10
Effects on biological methods for sewage treatment (Annex IIA, point 8.7)
Test type/organism
endpoint
Activated sludge
static – 0.5 h
Respiration rate
> 1000 mg/L
Ecotoxicologically relevant compounds (consider parent and all relevant metabolites
requiring further assessment from the fate section)
Compartment
soil
Boscalid (default)
water
Boscalid (default)
sediment
Boscalid (default)
groundwater
Boscalid (default)
Classification and proposed labelling with regard to ecotoxicological data (Annex IIA,
point 10 and Annex IIIA, point 12.3)
RMS/peer review proposal
Active substance
N, R 51/53
Active substance Pyraclostrobin
Pyraclostrobin is a new substance, included in Annex I (June 2004). RMS is Germany. For
the risk assessment the final List of Endpoints (September 2004) is used.
Page 69
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)
Acute toxicity to mammals
LD50 > 5000 mg/kg bw (rat)
Long-term toxicity to mammals
NOAEL 75 ppm (rat multi-generation study)
(DAR: This is equal to 8.2 mg/kg bw/d)
Acute toxicity to birds
LD50 > 2000 mg/kg bw (bobwhite quail)
Dietary toxicity to birds
LC50 > 5000 ppm (bobwhite quail and mallard
duck)
LC50 > 1176 mg/kg bw/d (bobwhite quail)
LC50 > 1320 mg/kg bw/d (mallard duck)
Reproductive toxicity to birds
NOEL 1000 ppm (bobwhite quail and mallard
duck)
NOEL: 105 mg/kg bw/d (bobwhite quail)
NOEL: 128 mg/kg bw/d (mallard duck)NOEL
1000 ppm
Toxicity data for aquatic species (most sensitive species of each group)
(Annex IIA, point 8.2, Annex IIIA, point 10.2)
Group
Test substance
Time-scale
Endpoint
Toxicity
(mg as/L)
BAS 500 F
(pyraclostrobin)
static - 96 h
LC50
0.006
flow-through 28 d
ELS - 98 d
static – 48 h
semi-static – 21
d
static – 28 d
static – 96 h
Static – 0.5 h
Static - 96 h
NOEC
0.005
NOEC
EC50
NOEC
0.002
0.016
0.011
NOEC
EbC50
EC20
LC50
0.04
0.152
> 1000
0.014
Static - 48 h
Static - 72 h
Static - 96 h
EC50
EbC50
LC50
0.065
1370
≥100
Static – 48 h
Static – 72 h
Static - 96 h
EC50
ErC50
LC50
> 100
> 100
≥100
Static – 48 h
Static – 72 h
Static - 96 h
EC50
EbC50
LC50
> 100
66
> 100
Static – 48 h
Static – 72 h
EC50
EbC50
> 100
46
Laboratory tests
O. mykiss
O. mykiss
O. mykiss
D. magna
D. magna
C. riparius
P. subcapitata
Activated sludge
O. mykiss
D. magna
P. subcapitata
O. mykiss
D. magna
S. subspicatus
O. mykiss
D. magna
S. subspicatus
O. mykiss
BAS 500 00 F
(formulated
product)
BF 500-11
(metabolite)
BF 500-13
(metabolite)
BF 500-14
(metabolite)
D. magna
S. subspicatus
Microcosm or mesocosm tests
Page 70
Group
Test substance
Toxicity
(mg as/L)
A mesocosm study was conducted with the formulated product BAS 500 00 F. Four
concentration levels ranging from 0.9 µg as/L to 24 µg as/L simulating a vineyard situation
with 8 applications in 14 d intervals were investigated. Approximately 260 different taxa of
aquatic invertebrates were determined in the study. In most cases only insignifcant transient
effects were observed. Affected populations usually recovered until the end of the study. For
the mollusc species Bithynia tentaculata and Valvata spec and the mussel species
Dreissena polymorpha treatment related effects were observed in the highest treatment
level. The NOEC was determined to be 8 µg as/L.
Bioconcentration (Log POW : 3.99)
Bioconcentration factor (BCF)
Annex VI Trigger for the bioconcentration
factor
Clearance time
(CT50)
(CT90)
Level of residues (%) in organisms after
the 14 day depuration phase
Time-scale
Endpoint
675 (whole fish, chlorophenyl label)
736 (whole fish tolyl label)
> 100 for non readily biodegradable
substances
<1d
2.3 – 3.2 d
Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)
Acute oral toxicity
(as)
LD50 > 73.1 µg/bee
Acute contact toxicity
(as)
LD50 > 100 µg/bee
Multiple Dose Test
Acute oral toxicity
Acute contact toxicity
(formulation)
(formulation)
LD50 = 76.9 µg as/ bee
LD50 > 100 µg as/bee
Field or semi-field tests
Not required
Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)
Species
Stage
Test
Dose
Endpoint Adverse
Annex VI
Substance (kg
effects
Trigger
1
as/ha)
%
%
Laboratory tests
T. pyri
Protonymphs BAS 500 00 0.320
Mortality
47
30
F
Fertility
99
30
A.
Adults
BAS 500 00 0.320
Mortality
30
30
rhopalosiphi
F
Fertility
80
30
C. carnea
Larvae
BAS 500 00 0.320
Mortality
79
30
F
Fertility
0
30
C. septemLarvae
BAS 500 00 0.320
Mortality
100
30
punctata
F
P. cupreus
Adults
BAS 500 00 0.320
Mortality
0
30
F
Food
11
30
uptake
Pardosa spp
Adults
BAS 500 00 0.320
Mortality
0
30
F
Food
9.9
30
Page 71
uptake
Extended laboratory tests
A.
Adults
rhopalosiphi
C. carnea
Adult/LC
C. septempunctata
Adults/LC
BAS 500 00
F
BAS 500 00
F
BAS 500 00
F
0.320
0.160
0.064
Mortality
Fertility
Mortality
Fertility
Mortality
Fertility
0
0
27
80
0
3.1
acceptable
acceptable
acceptable
1
Adverse effect means:
x % effect on mortality = x % increase of mortality compared to control
y % effect on a sublethal parameter = y % decrease of sublethal parameter compared to
control
(sublethal parameters are e.g. reproduction, parasitism, food consumption)
When effects are favourable for the test organisms, a + sign is used for the sublethal
effectpercentages (i.e. increase compared to control) and a – sign for mortality
effectspercentages (i.e. decrease compared to control).
Field tests with BAS 500 00 F
Predatory mites
Species
Details of uses
Dosage per application
Total dosage
Effects
T. pyri 8 applications 0.16-0.4 kg product/ha
2.64 kg product/ha/year
0.0 / 0.0
T. pyri 8 applications 0.16-0.6 kg product/ha
3.14 kg product/ha/year
0.0 / 12
T. pyri 8 applications 0.24-0.6 kg product/ha
3.12 kg product/ha/year
58.1/ 0.0
Summary:
Three field tests with T. pyri clearly demonstrated recovery of affected populations within at
latest 8 weeks.
Effects on earthworms (Annex IIA, point 8.4, Annex IIIA, point 10.6)
Acute toxicity
LC50 = 567 mg a.s./kg
Acute toxicity (formulation BAS 500 00 F)
Reproductive toxicity (formulation BAS
500 00 F)
LC50 = 282 mg form./kg
NOEC = 1 L product/ha (=0,357 mg w.s./kg)
Acute toxicity (metabolite BF 500-6)
Acute toxicity (metabolite BF 500-7)
LC50 > 1000 mg/kg soil
LC50 > 1000 mg/kg soil
Field tests with BAS 500 00 F and BAS 500 01 F
Two field tests were conducted with BAS 500 00 F 0.03 and 0.06 kg as/ha. In one field test
there was no adverse effect on number and biomass of earthworms, on feeding activity
(bait-lamina) and on overall abundance of collembola. In the second field test a slight effect
with the full application rate was observed, but is regarded acceptable. One field test was
conducted with BAS 500 01 F with an application rata of 2 x 0.25 kg as/ha. No long lasting
effects on earthworm populations were observed.
Page 72
Effects on soil micro-organisms (Annex IIA, point 8.5, Annex IIIA, point 10.7)
Nitrogen mineralisation
No effects up to 10 L product/ha (respective 2.5
kg as/ha)
BAS 500-6: No effect up to 750 g/ha
BAS 500-7: No effect up to 375 g/ha
Carbon mineralisation
No effects up to 10 L product/ha (respective 2.5
kg as/ha)
BAS 500-6: No effect up to 750 g/ha
BAS 500-7: No effect up to 375 g/ha
Formulation Bellis
Several studies with the formulaton Bellis (BAS 516 04 F = 12.8% pyraclostrobin, 25.2%
boscalid) are available. The studies are summarized and evaluated by TNO (report no: CTB2005-007-B)
Toxicity aquatic organisms
Algae
Substance Species
Method
Pseudokirchneriella
subcapitata
Bellis
static
Duration
[h]
72
Criterion
ErC50
Value form. Value
[mg/ L]
[mg a.s/L]
4.99
1.90
EbC50
1.62
Criterion
Value form. Value a.s.
[mg/ L]
[mg/ L]
0.08
0.024
0.50
Invertebrates
Substance
Species
Method
Bellis
Daphnia magna
static
Substance
Species
Method
Bellis
Oncorhynchus mykiss
Duration
[h]
48
EC50
Fish
Criterion
static
Duration
[h]
96
Method
Duration
Criterion
oral
contact
[h]
48
48
LD50
LD50
LC50
Value form. Value a.s.
[mg/ L]
[mg/ L]
0.024
0.013
Toxicity terrestrial organisms
(Bumble)bees
Substance
Species
Bellis
Apis mellifera
Value
a.s.
[µg/bee]
>43.71
>100
Non-target arthropods
1
Form. Species
Bellis
Bellis
1
Typhlodromus pyri
Aphidius
rhopalosiphi
Method Dose
Dose
[kg total
[kg/ha] a.s./ha]
Lab.test 5.7
2.166
Lab.test 2.523 0.959
Parameter Adverse
2
effects
[%]
Mortality 10.2
Mortality 50
Formulation Bellis = BAS 516 00 F (12.8% pyraclostrobin +25.2% boscalid)
2
Adverse effect means:
x % effect on mortality = x % increase of mortality compared to control
Page 73
LR50
[kg
as/ha]
>2.166
0.959
y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to control
(sublethal parameters are e.g. reproduction, parasitism, food consumption)
When effects are favourable for the test organisms, a + sign is used for the sublethal effectpercentages (i.e. increase
compared to control) and a – sign for mortality effectspercentages (i.e. decrease compared to control).
Earthworms
Substance
Species
Soil type
OM
Criterion
Bellis
Eisenia fetida
artificial
[%]
10
LC50
Dose
a.s.
[kg/ha]
326
Micro-organisms
Substance
Bellis
Dose
product
[kg a.s./ha]
Dose
a.s.
[mg a.s./kg]
Duration
7.6
10.1
28
Process
Maximal
effect
[%]
Respiration
Mineralisation
< 25%
< 25%
[d]
Non-target plants
Daucus carota, Brassica napus, Pisum sativum,
Helianthus annuus, Avena sativa, Allium cepa
Effect
at end
> 25%
at day 28
[Y/N]
N
N
No effects at 7.5 L/ha (2.25 kg a.s./ha)
Additional information
In reaction on the assessment in C.171.3.3, the applicant submitted a DT50 foliage calculation
performed by BASF. The calculation was summarized and checked by the CTB in August
2007.
First order non-linear fit DT50 values Signum
Crop
Boscalid DT50
r2
Pyraclostrobin DT50
[days]
[days]
Lettuce 2.2
1
1.8
Lettuce 2.1
0.998 1.6
Lettuce 2.7
1
1.4
Lettuce 2.1
0.998 2
Lettuce 2.5
0.996 1.5
Lettuce 1.8
0.879 1
Lettuce 2.1
Lettuce 1.9
Lettuce 1.6
Geometric mean:
2.09
0.996 1.5
1
1.3
0.999 1.7
Geometric mean: 1.51
Page 74
r2
1
0.999
1
1
1
0.961
Visual fit
Good
Good
Good
Good
Good
Bad for both
compounds
0.999 Good
1
Good
1
Good
Additional information, summarized and evaluated by RIVM, report 12804a00, 01/2011)
Species
Location
earthworm Southern
field fauna Germany
Soil
type
OM Dose
Time of
Duration Criterion
[%] product application [months]
[kg/ha]
silt,
4.5- 1.5, 3.0
sand- 6.0 and 4.5
clay
16 April
2009
6
Significant
effects
> 50 %
Y/N
abundance N
biomass
In a reliable field study the effects of application of BAS 51607 F (6.5% pyraclostrobin, 26.9%
boscalid) on bare soil on earthworm populations were studied. An average of 199.2
individuals/m2 was found at study initiation. Analysis of boscalid in the upper 10 cm of the soil
surface showed a variation of 64 - 138% of the nominal concentrations for all replicates. On
average, 78% was found in the 1.5 kg product/ha treatment, 80% in the 3.0 kg product/ha
treatment and 99% in the 4.5 kg product/ha treatment. From the study it can be concluded
that BAS 516 07 F at rates of 1.5, 3.0 and 4.5 kg product/ha did not cause any significant
adverse effects on total earthworm abundance and biomass, or on individual species or
ecological groups of earthworms at 39 and 179 days after treatment. Toxic reference showed
significant effects >50%.
Combination toxicology
Combination toxicology is assessed for formulations containing more than one active
substance, and for combinations of products, which are made according to the Instructions
for Use as a tank mixture. Based on the precautionary principle, concentration-addition is
assumed.
For plant protection products the TER (Toxicity-Exposure Ratio) is used as a standard in the
risk assessment (except for bees and other non-target arthropods, where HQ-values are
calculated). The TER must be higher than a trigger value to comply with the standards.
For the combination risk assessment of formulations containing more than one active
substance and for tank mixtures the following formula is used:
triggersubstance 1 /TERsubstance 1 + triggersubstance 2 /TERsubstance 2 + triggersubstance i/TERsubstance i .
When for each substance the trigger values are equal, the combined TER value can be
calculated according to:
o TERcombi = trigger/((trigger/TERsubstance 1)+(trigger/TERsubstance 2)+( trigger/TERsubstance 3))
An acceptable risk is expected when TERcombi > trigger.
In case of unequal triggers, the combined TER value can be calculated using the following
formula:
o
o
Triggercombi = triggersubstance 1/triggersubstance 2/triggersubstance i
TERcombi = triggercombi /((triggersubstance 1 /TERsubstance 1)+(triggersubstance 2 /TERsubstance 2)+(
triggersubstance i /TERsubstance i))
An acceptable risk is expected when TERcombi > triggercombi.
In this formula, ‘triggers’ are the trigger values as mentioned in the corresponding chapter of
the HTB (v1.0).
In case toxicity of the formulation has been measured, the TER-value of the formulation is
calculated with the PEC of the formulation and the toxicity value of the formulation. The PEC
of the formulation is the sum of the PECs of the individual active substances. The toxicity
Page 75
value of the formulation is expressed in total amount active substance. Trigger/TER must be
smaller than 1.
In the risk assessment, the risk of combination toxicology is assessed using the highest
trigger/TER-value from the one based on the sum of the individual substances and the one
based on formulation studies. When the standard of 1 is breached, the product is not
permissable, unless an adequate risk assessment shows that there are no unacceptable
effects under field conditions after application of the product according to the proposed GAP.
7.1
Effects on birds
Birds can be exposed to the active substances boscalid and pyraclostrobin via natural food
(sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning. For
indoor applications no exposure through natural food is expected.
The threshold value for birds is based on the trigger from the RGB. This means that ToxicityExposure Ratio’s (TERs) for acute and short-term exposure should be ≥ 10 and TER for
chronic exposure should be ≥ 5.
Table E.1 presents an overview of toxicity data.
Table E.1 Overview of toxicity data for birds for substances boscalid and
pyraclostrobin
Endpoint
Value
Boscalid
LD50
Acute toxicity to birds:
>2000 mg a.s./kg bw
Dietary toxicity to birds:
LC50
>1094 mg a.s./kg bw/d
Reproductive toxicity to birds:
NOEL
24.1 mg a.s./kg bw/d
Acute toxicity to birds:
LD50
>2000 mg a.s./kg bw
Dietary toxicity to birds:
LC50
> 1176 mg a.s./kg bw/d
Reproductive toxicity to birds:
NOEL
105 mg a.s./kg bw/d
Pyraclostrobin
7.1.1 Natural food and drinking water
Sprayed products
Procedures for risk assessment for birds comply with the recommendations in the Guidance
Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC
(SANCO/4145/2000).
For the current application, uses can be categorized as orchard, vine, hops. Depending on
the crop category, different indicator species are chosen. Table E.2 shows which indicator
species are relevant for which uses.
Table E.2 Indicator species per use
Use
Crop
Apple, pear, Pome fruit nursery Orchard
stock and pome fruit root stock
Indicator species
insectivorous
Table E.3a-c show the TER values for birds. The estimated daily uptake values (ETE,
Estimated Theoretical Exposure) of both active substances for acute, short-term and longterm exposure are calculated using the Food Intake Rate of the indicator species (FIR)
divided by the body weight of the indicator species (bw), the Residue per Unit Dose (RUD), a
Page 76
time-weighted-average factor (fTWA, only for long term) and the application rate. For uses with
frequency > 1, a MAF (Multiple Application Factor) may be applicable. The ETE is calculated
as application rate * (FIR/bw) * RUD * MAF [* fTWA, only for long term]. The ETE is compared
to the relevant toxicity figure. TER should be above the trigger for an acceptable risk.
Table E.3a Acute risk for birds
Substance
FIR / bw RUD
Application rate
MAF
(kg
a.s./ha)
AcuteLD50
TER
term ETE (mg/kg
bw/d)
(mg/kg
(trigger
10)
bw/d)
Apple and pear &: insectivorous bird
Boscalid
1.04
52
0.2016
Pyraclostrobin
1.04
52
0.1024
combination
Table E.3b Short-term risk for birds
Substance
FIR / bw RUD Application rate
MAF
(kg
a.s./ha)
Apple and pear: insectivorous bird
Boscalid
1.04
29
0.2016
Pyraclostrobin
1.04
29
0.1024
combination
Table E.3c Long-term risk for birds
Substance
FIR / bw RUD Applica- MAF
tion rate
(kg
a.s./ha)
Apple and pear: insectivorous bird
Boscalid
1.04
29
0.2016
Pyraclostrobin
1.04
29
0.1024
combination
10.90
5.54
>2000
>2000
>183
>361
>122
Shortterm ETE
LC50
(mg/kg
bw/d)
TER
(mg/kg
bw/d)
6.08
3.09
ftwa
(trigger
10)
>1094
>1176
>180
>381
>122
Long- NOEL
TER
term ETE (mg/kg
bw/d)
(mg/kg
(trigger
bw/d)
5)
6.08
3.09
24.1
105
3.96
34.0
3.55
Taking the results in Table E.3 into account, it appears that an acceptable acute and shortterm risk is expected. For the long-term TER is below the trigger of 5. A further refinement is
required.
Refinement insectivorous birds
For refinement for insectivorous birds the applicant refers to results from field trials
conducted by ECPA member companies (Schabacker et al, 2005). However, these data are
incorporated in the new guidance document for bird and mammals risk assessment, in which
new RUD values for insects are available. This GD currently still has a draft status.
Therefore, it cannot be used in general yet. A PPR-opinion of the GD by the PPR-panel was
published in June 2008 (Question No EFSA-Q-2006-064. The EFSA Journal (2008) 734:1181). Based on the state of the art Ctgb agrees to use the revised arthropod residue data as
evaluated in the new GD as a higher tier in national risk assessment now that this PPR
Page 77
opinion has become available. (NB: Other aspects of the new GD will not be used until
official approval of the GD on national level.)
The revised RUD values for arthropods are given in the Table below (data taken from
Appendix 14 to the PPR-opinion). These values can be used for risk assessment.
Crop/category of insects
Ground dwelling invertebrates
without interception1
Ground dwelling invertebrates
with interception2
Insects (foliar dwelling
invertebrates3)
Crop stage
ground directed
applications
applications directed to
crop canopies
whole season
mean
7.5
90th percentile
13.8
3.5
9.7
21.0
54.1
1
applications on bare soil, or ground directed applications up to principle growth stage 3, ground directed
applications in orchards/vines (e.g. herbicides)
2
applications directed to crop canopies (orchards/vines), ground directed applications on top of crops with
principle growth stage of 4 or greater
3
no data are available for canopy dwelling invertebrates in winter or before the leaves appear (interception would
be less)
For the proposed uses, foliar dwelling invertebrates may be present, so the mean RUD of
21.0 can be used for the revised long-term risk assessment.
Furthermore, the PPR-opinion indicates that the default DT50 of 10 days which is applied to
plant-like food items can also be used for insects. Multiple applications on the same
individual insect are not expected, therefore the exposure is equal for single and multiple
uses. This implies that the ftwa of 0.53 (currently only used for herbivorous species) can also
be used for insects.
The refined risk assessment is performed in Table E.4
Table E.4 Refined long-term risk for birds
Substance
FIR / bw RUD Applica- MAF
tion rate
(kg
a.s./ha)
Apple and pear: insectivorous bird
Boscalid
1.04
21
0.2016
Pyraclostrobin
1.04
21
0.1024
combination
ftwa
0.53
0.53
Long- NOEL
TER
term ETE (mg/kg
bw/d)
(mg/kg
(trigger
bw/d)
5)
2.33
1.15
24.1
105
10.3
91.2
9.28
Based on the risk assessment given in the table above, a low risk is expected for the
proposed uses.
Drinking water
The risk from exposure through drinking surface water is calculated for a small bird with body
weight 10 g and a DWI (daily water intake) of 2.7 g/d. Surface water concentrations are
calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is
taken into account.
Page 78
Boscalid
The highest PIECwater is 3.20 µg/L. It follows that the risk of drinking water is (LD50 * bw) /
(PIEC*DWI) = (>2000 * 0.010) / (0.00320 * 0.0027) = >100000
Since TER ≥ 10, the risk is acceptable.
Pyraclostrobin
The highest PIECwater is 1.09 µg/L. It follows that the risk of drinking water is (LD50 * bw) /
(PIEC*DWI) = (>2000 * 0.010) / (0.001.09 * 0.0027) = >100000
Since TER ≥ 10, the risk is acceptable.
Considering the large TER values, no combined risk is expected.
7.1.2 Secondary poisoning
The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and
worms.
Examination takes place against the threshold value for chronic exposure of 0.2 times the
NOEC value. This means that the TER should be ≥ 5.
Fish
Boscalid
For boscalid a BCF of 92 L/kg is available.
The highest PECwater(21) (taken from paragraph 6.2.1.) amounts 2.62 µg/L = 0.00262 mg/L.
Indicator species is a 1000-g bird eating 206 g fresh fish per day.
The TER is then calculated as NOEL / (PECwater(21) * BCFfish * (FIR/bw) = 24.1 / (0.00262 * 92 *
0.21) = 476. Since this is > 5, the risk for birds as a result of consumption of contaminated fish
is considered to be small.
Pyraclostrobin
For pyraclostrobin a BCF of 736 L/kg is available. The highest PECwater(21) (taken from
paragraph 6.2.1.) amounts 0.76 µg/L = 0.00076 mg/L.
Indicator species is a 1000-g bird eating 206 g fresh fish per day.
The TER is then calculated as NOEL / (PECwater(21) * BCFfish * (FIR/bw) = 105 / (0.00076 * 736 *
0.21) = 894. Since this is > 5, the risk for birds as a result of consumption of contaminated fish
is considered to be small.
Combination
Considering the high TER values calculated for the separate a.s., the combined risk from
secondary poisoning via fish is considered low.
Earthworms
Boscalid
Since there are no experimental data the bioconcentration factor for earthworms (BCFworm) is
calculated according to the following formula: BCF = (0.84 + 0.01 * Kow) / foc * Koc.
The logKow of boscalid is 2.96, which leads to a BCFworm = 0.66 kg soil/kg worm.
The highest PECsoil(21) (taken from paragraph 6.1.1) amounts to 0.347 g/kg soil.
Indicator species is a 100-g bird eating 113 g fresh worms per day.
The risk is then calculated as NOEL / PECsoil(21) * BCFworm * (FIR/bw) = 24.1/ (0.347*0.66*1.1)
= 95.7. Since this is > 5, the risk for birds as a result of consumption of contaminated worms is
considered to be small.
Pyraclostrbin
Since there are no experimental data the bioconcentration factor for earthworms (BCFworm) is
Page 79
calculated according to the following formula: BCF = (0.84 + 0.01 * Kow) / foc * Koc.
The logKow of pyraclostrobin is 3.99 and the Koc is 9304 L/kg, which leads to a BCFworm =
0.53 kg soil/kg worm.
The highest PECsoil(21) (taken from paragraph 6.1.1) amounts 0.128 mg/kg soil.
Indicator species is a 100-g bird eating 113 g fresh worms per day.
The risk is then calculated as NOEL / PECsoil(21) * BCFworm * (FIR/bw) = 105 / (0.128 * 0.53 *
1.1) = 1407. Since this is > 5, the risk for birds as a result of consumption of contaminated
worms is considered to be small.
Combination
Considering the high TER values calculated for the separate a.s., the combined risk from
secondary poisoning via earthworms is considered low.
Metabolites:
Soil metabolites of pyraclostrobin: BF 500-6 and BF 500-7: In field experiments performed on
four locations in Europe (each relevant for the Dutch situation), metabolite BF500-7 was not
found, BF 500-6 was found sporadically and at concentrations just above the detection limit.
In addition, the available ecotoxicity data (earthworms and soil micro-organisms) show no
toxicity of these metabolites.
Taking the results for secondary poisoning through fish and earthworms into account, the
proposed uses meet the standards for secondary poisoning as laid down in the RGB.
Conclusions birds
The product complies with the RGB.
7.2
Effects on aquatic organisms
7.2.1 Aquatic organisms
The risk for aquatic organisms is assessed by comparing toxicity values with surface water
exposure concentrations from section 6.2. Risk assessment is based on toxicity-exposure
ratio’s (TERs).
Toxicity data for aquatic organisms are presented in Table E.5.
Table E.5 Overview toxicity endpoints for aquatic organisms
Substance
Organism
Lowest
L(E)C50
NOEC
[mg/L]
[mg/L]
Boscalid
Acute
Algae
1.34
Daphnids
5.33
Fish
2.7
Chronic
Daphnids
1.31
Fish
0.125
Pyraclostrobin
Acute
Algae
0.152
Daphnids
0.016
Fish
0.006
Chronic
Daphnids
0.011
Fish
0.002
Page 80
Toxicity value
[µ
µg/L]
1340
5330
2700
1310
125
152
16
6
11
2
Bellis (expressed as
total a.s.)
Acute
Algae
Daphnids
Fish
0.50
0.024
0.013
500
24
13
These toxicity values are compared to the surface water concentrations calculated in section
6.2. Trigger values for acute exposure are 100 for daphnids and fish (0.01 times the lowest
L(E)C50-value) and 10 for algae (0.1 times the lowest EC50-value). Trigger values for chronic
exposure are 10 for daphnids and fish (0.1 times the lowest NOEC-values).
For acute and chronic risk, the initial concentration is used (PIEC) for TER calculation.
In table E.6. TER values for aquatic organisms are shown. Additional drift reducing measures
have been added. These measures have a higher reduction than the existing measures, and
are therefore not included in the calculations.
Table E.6a TER values: acute
use
Substance
Apple and pear
st
Tunnel sprayer after May 1
Boscalid
Pyraclostrobin
Combination
Bellis
Boscalid
Pyraclostrobin
Combination
Bellis
Boscalid
Pyraclostrobin
Combination
Bellis
Apple and pear
Windbreak + onesided spraying last row after
st
May 1
Apple and pear
Venturi nozzle + onesided spraying last row
st
after May 1
TERst
(trigger
10)
Algae
419
139
105
117
598
200
150
167
523
175
131
146
TERst
(trigger
100)
Daphnid
1666
14.7
14.6
5.59
2379
21.1
20.9
8.00
2082
18.4
18.2
7.00
TERst
(trigger
100)
Fish
844
5.50
5.47
3.03
1205
7.89
7.84
4.33
1055
6.90
6.85
3.79
Table E.6b TER values: chronic
use
Substance
Apple and pear
st
Tunnel sprayer after May 1
Boscalid
Pyraclostrobin
Combination
Boscalid
Pyraclostrobin
Combination
Boscalid
Pyraclostrobin
Combination
Apple and pear
Windbreak + onesided spraying last row after
st
May 1
Apple and pear
Venturi nozzle + onesided spraying last row
st
after May 1
TERlt
(trigger 10)
Daphnid
409
10.1
9.85
585
14.5
14.1
512
12.6
12.3
TERlt
(trigger 10)
Fish
39.1
1.83
1.75
55.8
2.63
2.51
48.8
2.30
2.19
Taking the results in Table E.6a and b into account, it appears that for boscalid the TERs are
above the relevant triggers for all proposed uses. For pyraclostrobin, however, only and
acceptable risk is expected for algae. For this substance a further refinement of the risk
should be performed.
Page 81
Higher tier risk assessment (refinement of the risk assessment)
A mesocosm study was conducted with the formulated product BAS 500 00 F containing only
pyraclostrobin. Four concentration levels ranging from 0.9 µg as/L to 24 µg as/L simulating a
vineyard situation with 8 applications in 14 d intervals were investigated. Approximately 260
different taxa of aquatic invertebrates were determined in the study. In most cases only
insignifcant transient effects were observed. Affected populations usually recovered until the
end of the study. For the mollusc species Bithynia tentaculata and Valvata spec and the
mussel species Dreissena polymorpha treatment related effects were observed in the
highest treatment level. The NOEC was determined to be 8 µg as/L. This can be used as
refined endpoint for aquatic invertebrates.
Because only one micro-/mesocosm study is available, conducted on only one site during
one time period, the spatio-temporal variation must be taken into account. From research
done by Alterra, it became clear that this variation depends on the toxicity endpoint, which is
used for risk assessment. If the NOEC-value is taken as the relevant endpoint, the variation
in space and time is in general not large. However, if recovery is taken into account and a
NOEAEC-value is established, the spatio-temporal variation is much greater. In that case a
safety factor is necessary. Based on available data from Alterra a safety factor of 3 has to be
applied to the NOEAEC-value. This value is in most cases sufficiently protective.
Fish were not included in the mesocosm, but they were included in a parallel pond study.
Only 1 species was tested (C. caprio), which is not the most sensitive fish species. Therefore
a final safety factor (trigger) of 10 is used on the NOEC of 8 µg/L, when regarding the risk to
fish.
In C-190.3.1 (02/2008), the applicant came with a statement to come to a higher endpoint.
Statement applicant
The applicant does not agree with the final endpoint of 0.8 µg/L for fish.
In the monograph of pyraclostrobin, acute toxicity laboratory studies of seven different fish
species are available. From this data it appears that the rainbow trout is the most sensitive
species, but the carp (species tested in the mesocosm) is not the least sensitive species.
From these studies also appears that pyraclostrobin shows a very steep concentration
response relationship for all species. Furthermore, the difference in endpoints of acute
toxicity tests is close to the endpoints from chronic tests (i.e. 6.2 µg/L v.s. 4.5 µg/L for
rainbow trout.)
The applicant proposes an endpoint based on the HC5 or HC1 value, calculated from the
NOEC values from acute toxicity studies described in the monograph.
Table E.7 Available LC50 values for pyraclostrobin
Species
LC50 NOEC
[µg/L] [µg/L]
Oncorhynchus mykiss
6.16 4.5
Lepomis macrochirus
25.4 10.9
Cyprinus carpio
17.7 12.1
Pimephales promelas
16.1 7.0
Oryzias latipes
53.3 16.5
Brachydanio rerio
61.9 23.4
Leuciscus idus melanotus 19.1 13.5
HC5
5.9
4.2
HC1
2.8
2.4
Page 82
Since the acute to chronic toxicity rate is narrow and pyraclostrobin is not stable in water, the
NOEC from acute toxicity tests should also cover the chronic risk.
For the reasons mentioned above, the applicant proposes an endpoint of 2.4 µg/L for fish.
Reaction Ctgb
Ctgb agrees that since more fish species were tested, the safety factor of 10 is too
conservative. The difference in sensitivity between Oncorhynchus mykiss (the most sensitive
test species) and Lepomis macrochirus is about a factor 4-5 and a sensitivity factor of about
5 is considered protective enough. This leads to an endpoint of 1.6 µg/L.
Using the HC5 method is an acceptable refinement method in the Dutch assessment.
However, still the small differences between acute endpoints and chronic endpoints should
be taken into account. It is therefore proposed to use the lower limit of the HC5 value, based
on the NOEC values.
After recalculation of the endpoints available, a HC5 of 4.34 µg/L is calculated, with a lower
limit of 1.75 µg/L.
Comparing the endpoint based on the mesocosm study and based on the lower limit of the
HC5 calculation, it appears that these values are close together. Therefore the endpoint of
1.75 µg/L for fish is acceptable and can be used for risk assessment.
For the other aquatic organisms the derived NOEC value of 8 µg/L from the mesocosm study
can be used for risk assessment. No safety factor is required.
The most critical endpoint (pyraclostrobin) for aquatic organisms is 1.75 µg/L.
In Table E.8 the refined TERs and the combined toxicity with boscalid is calculated. Only the
risk for fish is calculated, since the other organisms are at least a factor of 10 less sensitive
for boscalid and a factor of 2 for pyraclostrobin.
Table E. 8b. Refined TER values: chronic
Use
Substance
Apple and pear
st
Tunnel sprayer after May 1
Apple and pear
st
Windbreak + onesided spraying last row after May 1
Apple and pear
st
Venturi nozzle + onesided spraying last row after May 1
TERlt
TERlt
(trigger 1) (trigger 10)
Fish*
Fish*
Boscalid
39.1
Pyraclostrobin
1.61
16.1
Combination
11.4
Boscalid
55.8
Pyraclostrobin
2.30
23.0
Combination
16.3
Boscalid
48.8
Pyraclostrobin
2.01
20.1
Combination
14.2
Based on the results presented in the table above, an acceptable risk is expected for the
proposed uses, provided that the following restriction sentences are placed on the label:
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer voor 1 mei op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan
wanneer:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C).
Page 83
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer vanaf 1 mei op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan
wanneer:
•
het middel wordt verspoten met een tunnelspuit of:
•
in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt
met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het
perceel bespoten dient te worden, of:
•
er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste
bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C)
7.2.2 Risk assessment for bioconcentration
Boscalid
For the active substance a BCF-value of 92 L/kg is available.
Since this value is below 100 L/kg, the risk for bioconcentration is small. Therefore the active
substance boscalid meets the standards for bioconcentration as laid down in the RGB.
Pyraclostrobin
For the active substance a BCF-value of 736 L/kg is available.
Since the BCF is above 100 L/kg and the substance pyraclostrobin is not ready
biodegradable, there is a risk for bioconcentration.
According to the guidance document on aquatic ecotoxicology the following points should be
checked:
1) Direct long-term effects in fish due to bioconcentration;
2) Secondary poisoning for birds and mammals;
3) Biomagnification in aquatic food chains
Ad 1) An ELS study should be available if 100 < BCF < 1000 and EC50 a.s. < 0.1 mg/L.
These triggers are exceeded for pyraclostrobin and an ELS study is available. The long term
NOEC is 2 µg/L. The risk assessment in section 7.2.1 above showed a chronic risk to fish
based on first-tier assessment. In the refinement an acceptable risk for fish was expected
(see higher tier risk assessment for aquatic organisms in section 7.2.1. edge of field
assessment).
Ad 2) From the assessment of birds and mammals it should appear that there is no risk on
secondary poisoning through fish, which is the case for the proposed uses.
Ad 3) When the BCF > 1000 and the elimination in the BCF study within 14 days is < 95%
and the DT90 water or sediment > 100 days, a higher tier exposure assessment with regard
to the potential for biomagnification in the aquatic food chain should be conducted. These
triggers are not exceeded for pyraclostrobin.
Hence, the active substance pyraclostrobin meets the standards for bioconcentration as laid
down in the RGB for the edge of field.
7.2.3 Risk assessment for sediment organisms
Boscalid
The NOEC for Daphnia for boscalid is >0.1 mg/L, but the a.s. is found in more than 10% of
AR in the sediment of a water/sediment study and toxicity endpoints for sediment dwelling
organisms is available. The water-based NOEC value for Chironomus is 1.0 mg a.s./L. When
this value is examined against the highest PIEC in water of 0.00320 mg a.s./L, the TER value
is 313 and the trigger value of 10 is met.
The sediment-based NOEC value for Chironomus is 23.26 mg a.s./kg. When this value is
examined against the highest PIEC in sediment of 0.200 mg a.s./kg, the TER value is 116
Page 84
and the trigger value of 10 is met.
Pyraclostrobin
The NOEC value for Chironomus is 0.04 mg a.s./L. When this value is examined against the
highest PIEC in water of 0.00109 mg/L, the TER value is 36.7 and the trigger value of 10 is
met.
Combination
The combined TER from the water-spiked tests is 32.8, which is above the relevant trigger of
10. Therefore an acceptable risk is expected.
Therefore, proposed uses meet the standards for sediment organisms as laid down in the
RGB.
Conclusions aquatic organisms
The proposed applications meets the standards for aquatic organisms.
7.3
Effects on terrestrial vertebrates other than birds
Mammals can be exposed to the active substances boscalid and pyraclostrobin via natural
food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning.
For indoor applications no exposure through natural food is expected
The threshold value for mammals is based on the trigger from the RGB. This means that the
Toxicity-Exposure Ratio (TER) for acute exposure should be ≥ 10 and TER for chronic
exposure should be ≥ 5. Dietary toxicity is not taken into account for mammals.
Table E.9 presents an overview of toxicity data.
Table E.9 Overview of toxicity data for mammals
Endpoint
Value
Boscalid
LD50
Acute toxicity to mammals:
>5000 mg a.s./kg bw
NOEL
Reproductive toxicity to mammals:
67 mg a.s./kg bw/d
Pyraclostrobin
Acute toxicity to mammals:
LD50
>5000 mg a.s./kg bw
Reproductive toxicity to mammals:
NOEL
8.2 mg a.s./kg bw/d
7.3.1 Natural food and drinking water
Sprayed products
Procedures for risk assessment for mammals comply with the recommendations in the
Guidance Document on Risk Assessment for Birds and Mammals under Council Directive
91/414/EEC (SANCO/4145/2000).
For the current application, uses can be categorized as orchard, vine, hops. Depending on
the crop category different indicator species are chosen. Table E.10 shows which indicator
species are relevant for which uses.
Page 85
Table E.10 Indicator species per use
Use
Crop
Apple, pear, Pome fruit
Orchard
nursery stock and pome fruit
root stock
Indicator species
Small herbivorous
Table E.11a-b show the estimated daily uptake values (ETE, Estimated Theoretical
Exposure) for acute and long-term exposure, using the Food Intake Rate of the indicator
species (FIR) divided by the body weight of the indicator species (bw), the Residue per Unit
Dose (RUD), a time-weighted-average factor (fTWA, only for long term) and the application
rate. For uses with frequency of > 1, a MAF (Multiple Application Factor) may be applicable.
The ETE is calculated as application rate * (FIR/bw) * RUD * MAF [* fTWA, only for long term].
The ETE is compared to the relevant toxicity figure. TER should be above the trigger for an
acceptable risk.
Table E.11a Acute risk for mammals
Substance
FIR / bw RUD
Application rate
MAF
(kg a.s./ha)
Apple and pear: small herbivorous mammal
Boscalid
1.39
85
0.2016
Pyraclostrobin
1.39
85
0.1024
combination
1.8
1.8
Table E.11b Long-term risk for mammals
Substance
FIR / bw RUD Applica- MAF
tion rate
(kg
a.s./ha)
Apple and pear: small herbivorous mammal
Boscalid
1.39
46
0.2016
Pyraclostrobin
1.39
46
0.1024
combination
2.4
2.4
ftwa
0.53
0.53
AcuteLD50
term ETE (mg/kg
bw/d)
(mg/kg
bw/d)
40.9
21.8
>5000
>5000
TER
(trigger
10)
>117
>230
>77.3
LongNOEL
TER
term ETE (mg/kg
bw/d)
(mg/kg
(trigger
bw/d)
5)
16.4
8.33
67
8.2
4.09
0.98
0.79
Taking the results in Table E.11 into account, it appears that the acute risk is acceptable, but
that the long-term risk should be further refined.
Refinement small herbivorous mammals
RUD data
For boscalid, the applicant refers to the available residue data in cereals, which was
submitted for the registration of Venture. After recalculation, Ctgb comes to a mean RUD of
28.6 mg a.s./kg. This value can be used in risk assessment.
For pyraclostrobin, the applicant refers to the DAR to the residue studies on cereals. In the
DAR 56 studies are available, in which residues on whole plants were measured, directly
after application (DALA = 0). Residues of metabolite BF 500-3 were also included. Most of
the studies were performed in Northern Europe, but also studies from southern Europe were
included. This is acceptable, since the RUD is measured directly after application.
The applicant proposed a mean RUD of 24.64 mg a.s./kg. After recalculation, Ctgb comes to
Page 86
a mean RUD (including metabolite BF 500-3) of 24.79 mg a.s./kg. This value can be used in
risk assessment.
Since the application concerns a fungicide, a deposition factor of 0.6 (40% interception) can
be used for the use in apple and pear. The RUD for boscalid is 17.16 mg/kg and for.
pyraclostrobin 14.87.
DT50 data
The applicant uses the same DT50 as determined for the leafy crops. However, this value
cannot be extrapolated to grasses. DT50 values should be derived from grasses or cereals.
Endpoint pyraclostrobin
Statement applicant:
The NOAEL for reproductive performance and fertility was set to 300 ppm, since
reproductive parameters such as oestrous cycle, mating behaviour, conception, gestation,
parturition, lactation and weaning as well as sperm parameters, sexual organ weight gross
and histopathological findings were similar between test item treated rats and the control
rats.
The NOAEL for general systemic toxicity was 75 ppm (8.2 mg/kg bw) for F0 and F1 parental
animals and the developmental toxicity was 75 ppm for F1 and F2 pups. This was based on
decreased food consumption in F0 and F1 parental males as well as in F0 and F1 parental
females during pre-mating and gestation (F1 only). The F0 parental females during premating and gestation (up to 5%) and lactation (up to 4%) and the F1 males showed reduced
body weights during main phases of treatment period (up to 9%) and after weaning (up to
6%). The F0 females showed reduced body weight gain during pre-mating (up to 12%) and
lactation (up to 50%) while this effect was seen in the F0 males during pre-mating weeks 910 (about 25%).
Test item reduced signs of developmental toxicity included reduced mean body weights in F1
pups (about 10%) and F2 pups (about 13%) until weaning (both sexes combined); reduced
body weight gains in F1 and F2 pups from day 4 post partum up to weaning (about 12% and
about 15% respectively) both sexes combined. Additionally, a delay in vaginal opening in the
F1 female animals only was observed indicating a delay in physical development. This effect
is related to the reduced body weight development and not indicative of a selective effect of
the test substance.
Test substance related signs of developmental toxicity were observed in progeny of the F0
and F1parents at 300 ppm. Developmental toxicity was characterised by impairments in body
weight/ body weight gain, which were similar to the effects noted in parental animals. The
changes in a few pus organ weights, absolute (reduced) and relative (increased), are
considered to be caused by the reduced pup weights. Furthermore, a delay in vaginal
opening in the selected F1 females was noted as a sign of a general delay in physical
development, which is also assumed to be related to the retardation in body weight
development.
With respect to wild mammal risk evaluation - based on ecologically relevant aspects – it is
thus concluded that a level of 300 ppm (32.6 mg/kg b.w./day) should be derived from the
results of the two-generation study BAS 500 F in rats to constitute the NOAEL.
Also based on a weight of evidence approach, the following can be concluded: The general
systemic and developmental toxicity effects were directly connected with the reduced feed
consumption of the parental animals. The effects observed are considered to be ecologically
Page 87
non-relevant, as in natural habitat animals might switch to other food items which is not
possible in the course of a worst-case laboratory study. In addition, the magnitude of effects
observed at up to 300 ppm in the same strain of animals kept under highly controlled
homogeneous conditions in the two-generation reproduction study, would probably be within
the normal variation of free living animals.
Reaction Ctgb:
The chronic endpoint for pyraclostrobin was determined during the EU process. Deviation
from this endpoint should be well supported. Although the effects on body weight gain might
not be ecologically relevant, also effect on body weight itself was found (up to 13%). This can
very well be ecologically relevant. The argument that this is caused by a decreased food
consumption, which might not be relevant in the natural habitat since mammals might switch
to other food sources, is not strong enough to deviate from the European decision.
Based on the accepted refinements, the long-term ETE and TER for the use in berries is
calculated and given in Table E.12.
Table E.12 Refined long-term risk for mammals
Substance
FIR / bw RUD Applica- MAF
tion rate
(kg
a.s./ha)
Apple and pear: small herbivorous mammal
Boscalid
1.39
17.2 0.2016 2.4
Pyraclostrobin
1.39
14.9 0.1024 2.4
combination
ftwa
0.53
0.53
Long- NOEL
TER
term ETE (mg/kg
bw/d)
(mg/kg
(trigger
bw/d)
5)
6.13
2.70
67
8.2
10.9
3.04
2.38
Based on the risk assessment presented in the table above, the long-term TERs are still
below the trigger of 5. A further refinement is required (i.e. a relevant residue decline study,
or a well supported PT or PD refinement).
The applicant provided a refined risk assessment based on residue decline data for
pyraclostrobin in pea and wheat. The calculation was summarized and checked by the Cgtb.
The residue decline of BAS 500 F - pyraclostrobin on young peas and young wheat plants
has been studied at a range of field trials at different sites in Northern Europe during the
growing season of the year 2012. In total 8 trials for each crop were performed in Northern
Europe, each with 3 plots.
The results of the evaluation by Ctgb are summarized in the table below.
DT50 values for pyroclostrobin and results of the statistical analysis-scaled error (ε)
for first-order kinetic model.
Plant
wheat
wheat
wheat
wheat
wheat
wheat
wheat
trial
L120103*
L120103*
L120103*
L120103
L120104
L120104
L120105
plot
P2
P2
P3
P3
P2
P3
P2
Kinetic
model
SFO
FOMC
SFO
FOMC
SFO
SFO
SFO
Page 88
DT50
[days]
0.95
1.19**
1.36
1.68**
1.40
1.97
2.18
ε [%]
30.5
14.6
19.9
11.7
11.2
12.5
9.3
t-prob.
3.4E-4
0.003/0.1***
2.4E-5
0.0043/0.04***
2.20E-07
1.60E-06
2.80E-07
wheat
wheat
wheat
wheat
wheat
wheat
wheat
peas
peas
peas
peas
peas
peas
peas
peas
peas
peas
L120105
L120106*
L120106*
L120106
L120437
L120437*
L120437
L120073
L120073
L120074
L120074
L120075
L120075
L120076*
L120076*
L120076*
L120076
P3
P2
P2
P3
P2
P3
P3
P2
P3
P2
P3
P2
P3
P2
P2
P3
P3
SFO
1.56 10.2
1.80E-07
SFO
0.80 43.8
0.0028
FOMC
0.54** 27.9
0.04/0.4
SFO
1.25
7.9
1.30E-08
SFO
1.38 13.2
1.0E-6
SFO
1.08 15.6
2.3E-6
FOMC
1.28**
7.0
7.2E-4/0.007***
SFO
1.28
7
5.90E-09
SFO
1.50
9.9
1.60E-07
SFO
1.91
8.4
8.10E-08
SFO
1.55
8.3
3.70E-08
SFO
3.76
5.1
2.30E-08
SFO
2.50 12.6
6.00E-06
SFO
1.67 26.9
4.9E-4
FOMC
1.16** 21.9
0.064/0.18***
SFO
2.05
16
0.035
FOMC****
2.74**
6.6
8.2E-4/0.01***
Minimum
1.25
Maximum
3.76
Average
1.86
Geomean
1.77
Median
1.56
* no acceptable fit; value excluded from the calculation of the geomean/median DT50 value;
** DT50 back calculated from DT90 value (i.e. DT50 = DT90/3.32);
*** probability for parameter estimate of α en β respectively;
**** third data point removed from the fit
Three field trials (L120076 (P2), L120103 (P2),L120106 (P2)), which were included in the
kinetic evaluation by the applicant after removal of outliers, were omitted by Ctgb because no
justification could be found for the removal of the data points. No acceptable fit could be
found for the whole dataset for these trials. In addition, results from 1 trial (L120437 (P2 and
P3)) were not included in the evaluation by the applicant. As the data from this trial was
judged to be acceptable by the residue expert, Ctgb also included this trial in the evaluation.
Finally, for some trials Ctgb performed also a kinetic fit for a bi-phasic model for trials where
the error% for the SFO fit was larger than 15%.
The average and median DT50 in wheat is lower (1.59 / 1.48) than that in peas (2.2 / 1.91).
It should be noted that there is still a large amount of uncertainty, since this means
extrapolation for residues on wheat in an early stages; to grass vegetation in orchards.
However, by including the higher DT50 values for peas, the refinement is considered to be
acceptable. Thsu the geometric mean DT50 of 1.77 will be used in risk assessment
The TERlt for pyraclostrobin, based on a MAF and ftwa calculated based on a DT50 of 1.77
days, is 8.2 / (1.39 * 14.9 * 0.1024 * 1.07 * 0.34) = 10.6. This results in a combination TER of
5.4. Although there are some uncertainties considering the use of the DT50, the risk
assessment is still worst case since no PT or PD refinements were used. . Therefore, the
long term risk is considered to be acceptable.
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.
Page 89
Boscalid
The highest PIECwater is 3.20 µg/L. It follows that the risk of drinking water is (LD50 * bw) /
(PIEC*DWI) = (>5000 * 0.010) / (0.00320 * 0.00157) = >100000
Since TER ≥ 10, the risk is acceptable.
Pyraclostrobin
The highest PIECwater is 0.157 µg/L. It follows that the risk of drinking water is (LD50 * bw) /
(PIEC*DWI) = (>5000 * 0.010) / (0.000157 * 0.00157) = >100000
Since TER ≥ 10, the risk is acceptable.
Considering the high TER values, no combined risk is expected.
7.3.2 Secondary poisoning
The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and
worms.
Examination takes place against the threshold value for chronic exposure of 0.2 times the
NOEC value. This means that the TER should be ≥ 5.
Fish
Boscalid
For boscalid a BCF of 92 L/kg is available.
The highest PECwater(21) (taken from paragraph 6.2.1 amounts 2.62 µg/L = 0.00262 mg/L.
Indicator species is a 3000-g mammal eating 390 g fresh fish per day.
The TER is then calculated as NOEL / (PECwater(21) * BCFfish * (FIR/bw) = 67 / (0.00262* 92 *
0.13) = 2138. Since this is > 5, the risk for mammals as a result of consumption of
contaminated fish is considered to be small.
Pyraclostrobin
For pyraclostrobin a BCF of 736 L/kg is available. The highest PECwater(21) (taken from
paragraph 6.2.1.) amounts 0.76 µg/L = 0.00076 mg/L.
Indicator species is a 1000-g mammal eating 206 g fresh fish per day.
The TER is then calculated as NOEL / (PECwater(21) * BCFfish * (FIR/bw) = 8.2 / (0.00076 * 736 *
0.13) = 113. Since this is > 5, the risk for mammals as a result of consumption of contaminated
fish is considered to be small.
Combination
The combined TER is 107. Since this is > 5, the risk for mammals as a result of consumption of
contaminated fish is considered to be small.
Earthworms
Boscalid
Since there are no experimental data the bioconcentration factor for earthworms (BCFworm) is
calculated according to the following formula: BCF = (0.84 + 0.01 * Kow) / foc * Koc.
The logKow of boscalid is 2.96, which leads to a BCFworm = 0.347 kg soil/kg worm.
The highest PECsoil(21) (taken from paragraph 6.1.1) amounts to 0.90 mg/kg soil.
Indicator species is a 10-g mammal eating 14 g fresh worms per day.
The risk is then calculated as NOEL / PECsoil(21) * BCFworm * (FIR/bw) = 67/(0.347*0.66*1.4) =
209. Since this is > 5, the risk for mammals as a result of consumption of contaminated worms
is considered to be small.
Pyraclostrbin
Page 90
Since there are no experimental data the bioconcentration factor for earthworms (BCFworm) is
calculated according to the following formula: BCF = (0.84 + 0.01 * Kow) / foc * Koc.
The logKow of pyraclostrobin is 3.99 and the Koc is 9304 L/kg, which leads to a BCFworm =
0.53 kg soil/kg worm.
The highest PECsoil(21) (taken from paragraph 6.1.1) amounts 0.128 mg/kg soil.
Indicator species is a 100-g mammal eating 113 g fresh worms per day.
The risk is then calculated as NOEL / PECsoil(21) * BCFworm * (FIR/bw) = 8.2 / (0.128 * 0.53 *
1.4) = 86.3. Since this is > 5, the risk for mammals as a result of consumption of contaminated
worms is considered to be small.
Combination
The combined TER is 61. Since this is > 5, the risk for mammals as a result of consumption of
contaminated worms is considered to be small.
Metabolites:
Soil metabolites of pyraclostrobin: BAS 500-6 and BAS 500-7: In field experiments performed
on four locations in Europe (each relevant for the Dutch situation), metabolite BF500-7 was
not found, BF 500-6 was found sporadically and at concentrations just above the detection
limit. In addition, the available ecotoxicity data (earthworms and soil micro-organisms) show
no toxicity of these metabolites.
Taking the results for secondary poisoning through fish and earthworms into account, the
proposed uses meet the standards for secondary poisoning as laid down in the RGB.
Conclusions mammals
The product does comply with the RGB.
7.4
Effects on bees
The risk assessment for bees is based on the ratio between the highest single application
rate and toxicity endpoint (LD50 value). An overview of the risk at the proposed uses is given
in Table E.13
Table E.13 Risk for bees
Use
Substance
Apple, pear,
Pome fruit
nursery stock
and pome fruit
root stock
Application
rate
[g a.s./ha]
Boscalid
201.6
Pyraclostrobin 102.4
Combination
Bellis
304
LD50
[µg/bee]
166
>73.1
>43.71
Rate/LD50
1.21
<1.40
<2.61
<6.95
Trigger
value
50
Since the ratio rate/LD50 is below 50, the risk for bees is considered to be low. Hence, all
proposed uses meet the standards for bees as laid down in the RGB.
Conclusions bees
The product complies with the RGB.
Page 91
7.5
Effects on any other organisms (see annex IIIA 10.5-10.8)
7.5.1 Effects on non-target arthropods
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 in-field and 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). Hazard Quotients should
be below the trigger value of 2 to meet the standards. The resulting Hazard Quotients are
presented in Table E.14. For the first assessment, only the worst-case uses in Apple and
pear (application before May 1st) is calculated.
Table E.14 HQ-values for A. rhopalosiphi and T. pyri
Application rate MAF1 Drift factor/
(kg a.s./ha)
Vegetation factor2
Apple and pear (early application)
In-field
A. rhopalosiphi 0.304
2.7
T. pyri
0.304
2.7
Off-field
A. rhopalosiphi 0.304
2.7
0.0375
T. pyri
0.304
2.7
0.0375
Safety LR50
HQ
factor2 (kg a.s./ha)
-
>2.17
0.959
<0.38
<.86
10
10
>2.17
0.959
<0.14
0.32
1
: Multiple Application Factor
st
: off-field: drift factor = 37.5% for orchards, application before May 1 , vegetation dilution factor = 10,
safety factor = 10 (default values)
2
As the above table shows, both in- and off-field HQ values are below the trigger value of 2.
The proposed application of the product therefore meets with the standards as laid down in
the RGB.
7.5.2 Earthworms
Indoor uses
For glasshouse uses, management practice includes regular sterilisation of the soil, which
prevents the formation of a natural soil organism community within glasshouses. Exposure to
natural soils is not expected. Therefore no risk assessment is performed for soil organisms.
Field uses
The acute risk for earthworms is calculated as TER-value (trigger value 10). Since the
logPow of the active substances >2, a correction to the reference soil containing 4.7 %
organic matter is necessary. Exposure is expressed as the initial PEC soil. PEC soil is
calculated in section 6.1.1. Table E.15 presents endpoints, PECsoil and TER values.
Table E.15 Overview of soil concentrations and acute TERs for earthworms
Use.
Substance
LC50corr
PIEC soil
TER
Trigger
[mg/kg]
[mg/kg]
value
Apple, pear, Pome Boscalid
>470
0.361
>1302
10
fruit nursery stock Pyraclostrobin
266
0.157
1694
and pome fruit root Combination
>736
stock
Bellis
>153
0.518
>295
Page 92
In view of the results presented in Table E.15, a low acute risk for earthworms is expected at
all proposed uses. Metabolites BF 500-6 and BF 500-7 are less toxic than the parent
pyraclostrobin. The expected concentrations in soil are also lower. Therefore the risk for
these metabolites is low.
In the subchronic risk assessment for earthworms, a long-term TER-value is calculated.
Examination of the PIEC takes place against the trigger of 0.2*NOEC. See Table E.16.
Table E.16 Overview of soil concentrations and chronic TERs for earthworms
PIEC soil
TER
Trigger
Use
Substance
NOECcorr
[mg/kg]
[mg/kg]
value
3.32
Apple,
Boscalid
1.197
0.361
5
1.07
pear,
Pyraclostrobin
0.168
0.157
0.81
Pome
Combination
fruit
nursery
stock
and
pome
fruit root
stock
The chronic threshold value for earthworms resulting from exposure to both the active
substances is exceeded. The applicant refers to a sublethal toxicity study with the
formulation Bellis, showing an acceptable risk. This study is however not available at Ctgb
and can therefore not be used in risk assessment.
A refined risk assessment based on field studies is performed.
Boscalid
The following studies are described in the LoEP: Two field tests on the formulation BAS 510
01 F (500 g boscalid /L) were conducted with 3 × 0.6 kg form./ha and 3 × 1.2 kg form./ha..
One year after the last application there was a not significant reduction in abundance and
biomass of earthworms of about 30 % in case of the higher application rate. No long-lasting
effects on overall abundance and biomass of earthworms were observed for the lower test
concentration. However for both test concentrations effects on single species of about 30 %
in comparison to control still exist one year after the last application.
These studies were also evaluated and summarized by RIVM (report no. 09378, 2004).
Studies were considered less reliable since there were only 4 replicates and the used
method (electrical octett) shows moderate results. It was concluded that at the low
application rate (3x0.3 kg a.s./ha) no effects are expected. At the high rate (3x0.6 kg a.s./ha)
however, long-term effects cannot be ruled out.
There have been several discussions between applicant and evaluator about the validity and
the interpretation of the results of these studies. See C-165.3.10 for detailed description (in
Dutch). The validity in terms of replication and method was concluded to be acceptable.
In terms of the interpretation of the results, a discussion on the interception values was held.
For the proposed use assessed in C-165.3.10, cutting flowers, an interception value of 0.4
was used, while for the field studies an interception value of 0.5 was assumed (grassland).
However, according to the FOCUS groundwater guidance, the interception on established
turf/grasslands is 0.9. This means that, on the basis of the current figures, only 10 % of the
application rates in the field studies actually reached the soil. This means that the NOEC
(3x0.3 kg a.s./ha) should actually read 3x0.03 kg a.s./ha reaching the soil.
Page 93
If the field study application of 3x0.3 kg a.s/ha and 3 x 0.6 kg a.s./ha is translated to a
PECsoil value (assuming a soil bulk density of 1500 kg/m3, depth 5 cm, fraction intercepted
0.9, interval 21 days, worst-case DT50 for boscalid) then PECs of 0.111 and 0.222 mg a.s./kg
soil are calculated. Considering the uncertainties in effects at 3 x 0.6 kg a.s./ha, and the
worst-case assumptions for interception, the concentration of 0.222 mg a.s./kg soil is
considered to be safe. This concentration is at the same level as the chronic NOEC including
the assessment factor.
This NOEC is lower than the calculated PIEC of 0.361 mg/kg. Therefore a further refinement
of the risk assessment is required.
Pyraclostrobin
Two field tests were conducted with 8 applications with increasing concentrations of 0.03 and
0.06 kg as/ha and a maximum total concentration of 0.76 kg a.s./ha. In one field test there
was no adverse effect on number and biomass of earthworms, on feeding activity (baitlamina) and on overall abundance of collembola. In the second field test a slight effect with
the full application rate was observed, but is regarded acceptable. A third field test was
conducted with an application rata of 2 x 0.25 kg as/ha. No long lasting effects on earthworm
populations were observed.
Since application rates, frequencies and interception values differ between the available field
studies and the proposed applications, extrapolation is difficult. For the third field test, the
DAR indicates that the study was performed in cereal, with in interval of almost a month.
With this information, the application rate from the field study can be transformed to a
PECsoil from the study. When assuming a soil bulk density of 1500 kg/m3, depth 5 cm,
fraction intercepted 0.9, interval 28 days, worst-case DT50 for pyraclostrobin of 34 days, then
a PEC of 0.052 mg a.s./kg soil is calculated.
For the other studies, the data is limited; no intervals or individual application rates are
mentioned. The maximum application rate is 0.76 kg a.s./ha. When assuming a soil bulk
density of 1500 kg/m3, depth 5 cm and fraction intercepted 0.9, then a PEC of 0.104 mg
a.s./kg soil is calculated. This value disregards the possible degradation between
applications, but on the other hand, interception values are worst case. Therefore this
concentration will be used for risk assessment.
This NOEC is lower than the calculated PIEC of 0.157 mg/kg. Therefore a further refinement
of the risk assessment is required.
Formulation
A field study with the formulation Signum (BAS 516 00 F =67 g pyraclostrobin/kg, 267 g
boscalid/kg) was provided earlier and evaluated and summarized by RIVM (see LoEP). The
study concerns both active substances, but in a different ratio (more boscalid compared to
pyraclostrobin). Furthermore, the study can be considered worst case, since the application
was made to bare soil. Finally, the study is more easily to be extrapolated, since the
frequency in the study is 1, at high application rates.
No effects were found at an application of 4.5 kg product/ ha (1.5 kg total a.s./ha). This
results in 301.5 g pyraclostrobin and 1201.5 g boscalid per hectare. The applicant stated that
with the application Bellis, 4 applications of in total 500 g pyraclostrobin and 1000 g boscalid
are requested. Including interception, a maximum of 50% of this dose will reach the soil
(based on the Generic guidance for Focus groundwater scenarios).
Page 94
Ctgb agrees, with a slight correction as with the application Bellis, 4 applications of in total
410 g pyraclostrobin and 806 g boscalid are requested.
When the field study application is translated to a PECsoil value (assuming a soil bulk
density of 1500 kg/m3, depth 5 cm, fraction intercepted 0.9) then for boscalid the application
rate of 1201.5 g/ha results in a PEC of 1.60 mg a.s./kg, and for pyraclostrobin 301 g/ha =
0.401 mg a.s./kg. These values are higher than the calculated PIECs of 0.361 mg
boscalid/kg and 0.157 mg pyraclostrobin/kg.
Hence, the application in Bellis is covered by this study with Signum, and the risk to
earthworms is considered to be acceptable.
7.5.3 Effects on soil micro-organisms
Boscalid
No effects were found after 28 days on the nitrogen transformation and carbon mineralization
at doses up to 6 kg a.s./ha (= 8 mg/kg soil).
Pyraclostrobin
No effects were found after 28 days on the nitrogen transformation and carbon mineralization
at doses up to 2.5 kg a.s./ha. For metabolites BF 500-6 and BF 500-7 no effects were found
at relevant doses of 750 g/ha and 375 g/ha respectively.
Bellis
In the tested soils (loamy sand and sandy loam soil ), no effects >25% were observed on
carbon mineralisation and ammonium and nitrate formation at application rate of 10.1 mg
total a.s./kg after 28 days. Since the reduction percentage is below 25% after 28 days, the
standards regarding soil micro-organisms are met.
Therefore, the proposed applications of the product meet the standards for micro-organisms.
7.5.4 Effects on activated sludge
An EC50 value of >1000 mg/L is available for both pyraclostrobin and boscalid.
Field uses
For the proposed uses no exposure of activated sludge is expected. Therefore, the proposed
applications comply with the standards for activated sludge as laid down in the RGB.
7.5.5 Effects on non-target plants
The risk assessment for non-target plants is based on an off-crop situation with a drift
percentage depending on the crop. The exposure thus equals drift* the application rate. The
worst-case drift is 37.5% for orchards, application before May 1st. The worst-case use is
therefore the application in plum, cherry and Morello cherry.
A TER is calculated with the lowest EC50 value from a laboratory test with higher plants and
the exposure concentration. lowest EC50 is > 1.804 kg a.s./ha for all six species tested. See
table E.17 for TER calculation.
Page 95
Table E.17: Overview of exposure concentration and TER for non-target plants for the
worst-case use
TER Trigger
Use
Substance Dose MAF. Drift% (off- Exposure EC50
[kg
[kg
value
field
(kg
a.s./ha]
a.s.
exposure)
a.s./ha)
/ha]
37.5
0.308
>7.3 5
Apple, pear,
Bellis
0.304 2.7
>2.25
Pome fruit
nursery stock
and pome fruit
root stock
The ratio between EC50 and the exposure concentration is > 5. Therefore, the risk for nontarget plants is considered to be low.
Conclusions any other organisms
The product complies with the RGB for the aspects non-target arthropods, earthworms, soil
micro-organisms, activated sludge and non-target plants.
7.6
Appropriate ecotoxicological endpoints relating to the product and approved
uses
See List of Endpoints.
7.7
Data requirements
None.
7.8
Classification and Labelling
Proposal for the classification and labelling of the formulation concerning the
environment
Symbol:
N
R phrases
R50/53
S phrases
S60
S61
Special provisions
(DPD-phrases) :
Explanation:
Hazard symbol:
Risk phrases:
Safety phrases:
Other:
-
Indication of danger:
Dangerous for the
environment.
Very toxic to aquatic organisms, may cause
long-term adverse effects in the aquatic
environment.
This material and its container must be
disposed of as hazardous waste.
Avoid release to the environment. Refer to
special instructions/safety data sheets.
-
Based on the toxicity for the formulation to aquatic
organisms
Based on the toxicity for the formulation to aquatic
organisms
S60 and S61 are assigned to products for professional
use carrying N and R50/53.
-
Page 96
The following restriction sentences were proposed by the applicant:
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer op perceelranden die grenzen aan oppervlaktewater uitsluitend toegestaan voor 1
mei wanneer:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C).
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer op perceelranden die grenzen aan oppervlaktewater uitsluitend toegestaan na 1 mei
wanneer:
•
het middel wordt verspoten met een tunnelspuit of:
•
in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt
met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het
perceel bespoten dient te worden, of:
•
er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste
bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C).
Based on the current assessment, the following has to be stated in the legal
instructions for use:
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer voor 1 mei op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan
wanneer:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C).
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer vanaf 1 mei op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan
wanneer:
•
het middel wordt verspoten met een tunnelspuit of:
•
in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt
met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het
perceel bespoten dient te worden, of:
•
er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste
bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C)
7.9
Overall conclusions regarding ecotoxicology
It can be concluded that:
1. all proposed applications of the formulated product Bellis meet the standards for birds
as laid down in the RGB.
2. all proposed applications of the formulated product Bellis meet the standards for
aquatic organisms as laid down in the RGB.
3. the active substances boscalid and pyraclostrobin meet the standards for
bioconcentration as laid down in the RGB.
4. all proposed applications of the formulated product Bellis meet the standards for
mammals as laid down in the RGB.
5. all proposed applications of the formulated product Bellis meet the standards for bees
as laid down in the RGB.
Page 97
6. all proposed applications of the formulated product Bellis meet the standards for nontarget arthropods as laid down in the RGB.
7. all proposed applications of the formulated product Bellis meet the standards for
earthworms as laid down in the RGB.
8. all proposed applications of the formulated product Bellis meet the standards for soil
micro-organisms as laid down in the RGB.
9. all proposed applications of the formulated product Bellis meet the standards for
activated sludge as laid down in the
10. all proposed applications of the formulated product Bellis meet the standards for nontarget plants as laid down in the RGB
8. Efficacy
Efficacy assessment is partially based on the summary and evaluation of Bellis prepared by
Linge Agroconsultancy (report Bellis).
This application concerns a re-registration. The claimed uses and the corresponding dose
rates remain the same and no changes in circumstances have occurred (cultivation systems,
application methods, resistance development). The dose and effectiveness were evaluated
in some uses to confirm this unchanged situation.
Use in fruit tree nursery cultivation of apple and pear is an extension.
Dose justification
Scab (Venturia inaequalis) in apple
Bridging trials are done with Bellis WG and Bellis SE. Bellis WG 0,8 kg/ha contains the same
amount of active ingredients as Bellis SE 1 l/ha.
Effectiveness of 0.8 kg/ha Bellis WG was comparable to effectiveness of 1 l/ha Bellis SE.
In 2 trials Bellis WG was applied in 0.6 and 0.8 kg/ha (claimed dose rate). In 6 trials in 2000
and 1 trial in 2002 Bellis SE was tested in 0.75 and 1 l/ha.
Effectiveness of 0.8 kg/ha Bellis WG was better than effectiveness of 0.6 kg/ha Bellis.
Effectiveness of 1 l/ha Bellis SE was better than effectiveness of 0.75 l/ha Bellis SE.
Powdery mildew (Podosphaere leucoticha) in apple
Effectiveness of 0.8 kg/ha Bellis WG was comparable tot effectiveness of Bellis SE in 1 l/ha.
In 2 trials Bellis WG was applied in 0.6 and 0.8 kg/ha (claimed dose rate) and Bellis SE in
0.75 and 1 l/ha.
Effectiveness of Bellis WG 0.8 kg/ha was better than effectiveness of 0.6 kg/ha Bellis.
Effectiveness of Bellis SE 1 l/ha was better than effectiveness of 0.75 l/ha Bellis SE.
Fungi causing storage rots (Gloeosporium spp. and Penicillium spp.) in apple
In 2 trials Bellis SE was applied in 0.75 and 1 l/ha to test effectiveness against Gloeosporium
spp. In 1 trial Bellis SE was applied in 0.75 and 1 l/ha to test effectiveness against Penicillium
spp. Effectiveness of 1 l/ha Bellis SE was significantly better than effectiveness of 0.75 l/ha
Bellis SE.
Fungi causing storage rots (Botrytis spp. and Penicillium spp.) in pear
In 2 trials Bellis (SE) was applied in 0.75 and 1 l/ha to test effectiveness against Botrytis spp.
and Penicilllium spp. Effectiveness of 1 l/ha Bellis SE was better than effectiveness of 0.75
l/ha Bellis SE.
Page 98
Effectiveness
Scab (Venturia inaequalis) in apple and scab (Venturia pirina) pear and powdery mildew
(Podosphaere leucoticha) in apple
From 2000 till 2003 18 trials (Belgium) have been conducted to assess the effectiveness of
Bellis in controlling scab in apple, 5 trials have been conducted to assess effectiveness of
Bellis in controlling scab in pear and 11 trials have been conducted to asses effectiveness of
Bellis in controlling powdery mildew in apple.
Bellis was tested in a SE-formulation in 2000, 2001, 2002 and 2003 and in de claimed WGformulation in 2003. The trials in 2003 are bridging trials for the trials done in 2000, 2001 and
2002. Effectiveness of 0.8 kg/ha Bellis WG was comparable to effectiveness of 1 l/ha Bellis
SE. Trials done with BellisSE can be used to assess effectiveness of Bellis (WG). The
number of trials is sufficient.
Effectiveness of Bellis (WG, 0.8 kg/ha, 2 trials) and Bellis (SE, 1l/ha, 18 trials) was good in
controlling scab in apple on leaves and fruits and comparable to effectiveness of the
standard product based on kresoxim-methyl and trifloxystrobin.
Effectiveness of Bellis (WG, 0.8 kg/ha, 2 trials) and Bellis (SE, 1l/ha, 5 trials) was good in
controlling scab in pear on leaves and fruits and comparable to effectiveness of the standard
product based on kresoxim-methyl and trifloxystrobin and thiram.
Effectiveness of Bellis (WG, 0.8 kg/ha, 2 trials) and Bellis (SE, 1l/ha, 11 trials) was good in
controlling powdery mildew in apple on leaves and twigs (resp. primary and secondary
infection) and comparable to effectiveness of the standard product based on kresoximmethyl and trifloxystrobin.
Storage scab in apple
In 4 trials effectiveness of Bellis (SE, 1 l/ha) was good in controlling storage scab in apple
and comparable to effectiveness of the standard product based on kresoxim-methyl and
trifloxystrobin. Because of the good control of scab in the field and in storage this number of
trials is sufficient.
Fungi causing storage rots (Gloeosporium spp. and Penicillium spp.) in apple and
Fungi causing storage rots (Botrytis spp. and Penicillium spp.) in pear
From 1999 till 2002 7 trials (Belgium) have been conducted to assess the effectiveness of
Bellis in controlling storage rots in apple. In 1 trials different species of storage rots occurred.
Gloeosporium spp occurred in 7 trials and Penicillium spp in 2 trials.
To test storage rot in pear 2 trials have been conducted. Botrytis spp. and Penicillium spp.
occurred in 2 trials. The number of trials is sufficient.
Effectiveness of Bellis (SE, 1 l/ha) in controlling Gloeosporium spp and Penicillium spp in
apple varied from moderate to good, but effectiveness of Bellis (SE, 1 l/ha) was better than
the effectiveness of the standard product based on captan, carbendazim/diethofencarb, and
thiofanaat-methyl.
Effectiveness of Bellis (SE, 1 l/ha) in controlling Botrytis spp and Penicillium spp in pear
varied from moderate to good, but in general effectiveness of Bellis (SE, 1 l/ha) was better
than the effectiveness of the standard product based on carbendazim/diethofencarb and
tolyfluanide.
Combination product
In 2 trials (1999 and 2000), in which effectiveness of Bellis against storage rot was
conducted, also a tank mix with pyraclostrobin and boscalid was used. Dose rate of
pyraclostrobin and boscalid was the same as in Bellis (WG, 0.8 kg/ha). Also 2 trials with
pyraclostrobin and 1 trial with boscalid sec were conducted in the same dose rate as used in
de tank mix. In general effectiveness of the tank mix (pyraclostrobin and boscalid) in
Page 99
controlling scab was better than the effectiveness of pyraclostrobin sec and boscalid sec.
In general effectiveness of the tank mix (pyraclostrobin and boscalid) in controlling powdery
mildew was better than the effectiveness of pyraclostrobin sec.
In 3 trials (2 in 2001 and 1 in 2002), in which effectiveness of Bellis (SE, 1 l/ha) against scab
and powdery mildew was tested, also pyraclostrobin sec was used. Dose rate of pyraclostrobin was the same as in Bellis (SE, 1 l/ha). Effectiveness of Bellis (SE, 1 l/ha) in controlling
scab was better or the same as effectiveness of pyraclostrobin. Effectiveness of Bellis (SE, 1
l/ha) in controlling powdery mildew was better than effectiveness of pyraclostrobin.
Against scab and powdery mildew in apple a better effectiveness of the combination product
was shown. Also from resistance management a combination product had a benefit;
pyraclostrobin and boscalid have different mode of actions. Therefore the risk on crossresistance is low and the combination product will lower the risk on resistance.
Extrapolation
Since it concerns a re-registration extrapolation is possible from the tested uses to the
non-tested uses.
In conformity with the document ‘options for the extrapolation of data on the efficacy and
phytotoxicity of plant protection products (CTB, version 2.0 May 2004) and on basis of
expert judgement the following relevant extrapolations are possible:
- Scab and powdery mildew in cultivation of apple and pear to scab and powdery
mildew in fruit tree nursery cultivation of apple and pear.
- Phytotoxicity in apple to phytotoxicity in fruit tree nursery cultivation of apple
- Phytotoxicity in pear to phytotoxicity in fruit tree nursery cultivation of pear
Conclusion
The product complies with the Uniform Principles because in accordance with article 2.1 it
controls scab, powdery mildew and fungi causing storage rots in apple and pear and scab
and mildew in fruit tree nursery cultivation of apple and pear.
8.2
Harmful effects
8.2.1 Phytotoxicity
Phytotoxicity was assessed during the effectiveness trials. In apple trials were done with
Bellis SE with dose rate n and 2n. No negative effects were seen, except the background
colour of fruits. Fruits treated with Bellis SE as well as fruits treated with the standard product
had a more yellow background colour than untreated fruits. Differences were acceptable.
In pear no negative effects were seen in the trials with Bellis SE in dose rate n and 2n.
Bellis (WG) in apple was tested in 0.8 kg/ha (4 trials) and 1.6 kg (3 trials) and in pear in 0.8
l/ha (2 trials). In none of these trials negative effects were observed.
8.2.2 Yield
Yield was assessed during the effectiveness trials. In apple trials were done with Bellis SE
with dose rate n and 2n. No negative effects on yield were seen.
In pear no negative effects were seen in the trials with Bellis SE in dose rate n and 2n.
Bellis WG in apple was tested in 0.8 kg/ha (4 trials) and 1.6 kg (3 trials) and in pear in 0.8
l/ha (2 trials). In none of this trials negative effects on yield were observed
8.2.3 Effects on succeeding crops or substitution crops
Both pyraclostrobin and boscalid have no negative effect on succeeding crops. In apple
and pear succeeding crops are no item, in the tree nursery of apple and pear succeeding
crops are possible. Pyraclostrobin and boscalid are very selective fungicides so succeeding
crops will not have a negative impact by the use of Bellis.
Page 100
8.2.4 Effects on plants or plant products to be used for propagation
Tree nursery cultivation is regarded as plants to be used for propagation. No phytotoxicity
was found in apple and pear. Since phytotoxicity can be extrapolated from apple and pear
to tree nursery cultivation of apple and pear, no negative effects are expected.
8.2.5 Effects on adjacent crops
Studies show that Bellis has no negative effect on the vegetative vigour of non-target plants.
This similar experience from 3 year of practice no negative impact of Bellis on adjacent crops
was observed.
Conclusion
The product complies with the Uniform Principles because it does not, in accordance with
article 2.2., induce any unacceptable side effects on plants or plant products, when used and
applied in accordance with the proposed label.
8.3
Resistance
Pyraclostrobin consist to the group of Qol-fungicides. This group of fungicides is sensitive to
resistance. According to the FRAC (Fungicide resistance action committee) the resistance
risk for the target pathogen Venturia inaequalis is assessed as being high to Qol-fungicides.
Also for Venturia perina resistance is mentioned. An unrestricted use pattern would not be
acceptable. Podosphaera leucotricha is assessed to present a moderate risk of resistance to
Qol-fungicides.
A modified use pattern in a resistance management strategy is necessary.
For the active ingredient boscalid no reports on resistance are available at the moment.
Boscalid is a “single site inhibitor’’ and is moderate sensitive tot resistance.
Since there is a risk of resistance development, a resistance strategy should be placed on
the label.
Conclusion
The product complies with the Uniform Principles, article 2.1.3 as the level of control on the
long term is not influenced by the use of this product because of the possible build up of
resistance.
8.4
For vertebrate control agents: impact on target vertebrates
Because no vertebrates are controlled, this point is not relevant.
8.5
Any other relevant data / information
None.
9. Conclusion
The product complies with the Uniform Principles.
The evaluation is in accordance with the Uniform Principles laid down in appendix VI of
Directive 91/414/EEC. The evaluation has been carried out on basis of a dossier that meets
the criteria of appendix III of the Directive.
10. Classification and labelling
Proposal for the classification and labelling of the formulation
Page 101
Based on the profile of the substance, the provided toxicology of the preparation, the
characteristics of the co-formulants, the method of application and the risk assessments, the
following labelling of the preparation is proposed:
Substances, present in the formulation, which should be mentioned on the label by
their chemical name (other very toxic, toxic, corrosive or harmful substances):
Symbol:
N
Indication of danger:
Dangerous for the
environment.
Xn
Indication of danger:
Harmful
R phrases
R22
Harmful if swallowed.
R50/53
Very toxic to aquatic organisms, may cause
long-term adverse effects in the aquatic
environment.
S phrases
S21
When using do not smoke.
S46
If swallowed, seek medical advice
immediately and show this container or label.
S60
This material and its container must be
disposed of as hazardous waste.
S61
Avoid release to the environment. Refer to
special instructions/safety data sheets.
Special provisions:
DPD-phrases
DPD01
To avoid risk for man and the environment,
Plant protection
products phrase:
comply with the instructions for use
DPD-phrase
Child-resistant fastening obligatory?
n/a
Tactile warning of danger obligatory?
n/a
Based on the current assessment, the following has to be stated in the legal
instructions for use:
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer voor 1 mei op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan
wanneer:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C).
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel
en peer vanaf 1 mei op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan
wanneer:
•
het middel wordt verspoten met een tunnelspuit of:
•
in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt
met een Venturidop, waarbij de laatste bomenrij éénzijdig in de richting van het
perceel bespoten dient te worden, of:
•
er de combinatie is van een windhaag op de rand van het rijpad, waarbij de laatste
bomenrij éénzijdig in de richting van het perceel bespoten dient te worden, of:
•
het middel wordt verspoten met een Wannerspuit met reflectiescherm en
venturidoppen (Lechler ID 90-015C)
Page 102
Appendix 1 Table of authorised uses
PPP (product name/code): Bellis
Active substance(s) (name and content, g/L or g/kg): 12.8% pyraclostrobin, 25.2% boscalid
Formulation type: WG
1
UseNo.
2
Member
state(s)
3
4
Crop and/
or situation
F
G
or
I
5
Pests or Group of
pests controlled
6
7
8
Application
Method /
Kind
Timing / Growth
stage of crop &
season
10
11
12
Application rate per treatment
Number /
(min. Interval
between
applications)
kg product g as/ha
/ ha
Water L/ha
13
14
Remarks:
PHI
(days) a) max. no. of applications per crop
and season
b) Maximum product rate per season
min / max
c) additional remarks
1
NL
Apple
F
Venturia inaequalis
Spray
Podosphaera
leucotricha
MarchSeptember BBCH
56-87
4/7
MarchSeptember BBCH
56-87
4/7
MarchSeptember BBCH
56-87
4/7
max 0.8
102.4
1000-1500
pyraclostrobin
7
201.6
boscalid
Gloeosporium spp
Maximum of 4 applications per crop per
season.
Application rate 0.08% with a maximum
of 0.8 kg/ha per application
Penicillium spp.
NL
Pear
F
Venturia pirina
Spray
Podosphaera
leucotricha
max 0.8
102.4
1000-1200
pyraclostrobin
7
201.6
boscalid
Gloeosporium spp
Maximum of 4 applications per crop per
season.
Application rate 0.08% with a maximum
of 0.8 kg/ha per application
Penicillium spp.
New uses
2
NL
Apple and pear nursery F
stock and root stock of
apple and pear
Venturia inaequalis
Venturia pirina
Podosphaera
leucotricha
Spray
Page 1
max 0.8
102.4
500-1000
pyraclostrobin
201.6
boscalid
nr
Maximum of 4 applications per crop per
season.
Application rate 0.08% with a maximum
of 0.8 kg/ha per application
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.
Product Name: Bellis
Active Substance: pyraclostrobin + boscalid
Application no: Date: 03-03-2009
Applicant: BASF
Part B - List of Annex III data submitted in support of the evaluation
Annex
point
6/1
6.1.1/1
6.1.2/1
6.1.3/1
6.1.4/1
6.1.4.1/1
6.1.4.2/1
6.1.4.3/1
6.2.1/1
6.2.4/1
6.2.5/1
6.2.6/1
6.2.7/1
6.2.8/1
6.5/1
6.6/1
6.7/1
Year
2004
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Data
protection
claimed Y/N
Owner
Bellis (BAS 516 01 F) - Biological assessment
dossier - Control of Venturia
inaqualis/Venturia pirina en Podosphaera
leucotricha in apples and pears.
BASF Belgium; Brussles; Belgium
2004/1026615
No
unpublished
Y
BASF
Page 2
Application
number*
20050009 TG
Date of
submission*
14-1-2005
Annex
point
6/2
6.1.1/2
6.1.2/2
6.1.3/2
6.1.4/2
6.1.4.1/2
6.1.4.2/2
6.1.4.3/2
6.2.1/2
6.2.4/2
6.2.5/2
6.2.6/2
6.2.7/2
6.2.8/2
6.5/2
6.6/2
6.7/2
6/3
6.1.1/3
6.1.2/3
6.1.3/3
6.1.4/3
6.1.4.1/3
6.1.4.2/3
6.1.4.3/3
6.2.1/3
6.2.4/3
6.2.5/3
6.2.6/3
6.2.7/3
6.2.8/3
6.5/3
6.6/3
6.7/3
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Data
protection
claimed Y/N
Owner
2004
Bellis (BAS 516 01 F) - Biological assessment
dossier - Control of storage diseases in
apples and pears (Gloeosporium, Botrytis,
Alternaria and Penecillium).
BASF Belgium; Brussles; Belgium
2004/1026616
No
unpublished
Y
BASF
20050009 TG
14-1-2005
2004
Bellis (BAS 516 04 F) - Bridging study BAS 516
01 F - BAS 51 604 F - Control of Ventruria
inaqualis/Venturia pirina and Podosphaera
leucotricha in apples and pears.
BASF Belgium; Brussles; Belgium
2004/1026617
No
unpublished
Y
BASF
20050009 TG
14-1-2005
Year
Page 3
Application
number*
Date of
submission*
Annex
point
6/4
6.1.1/4
6.1.2/4
6.1.3/4
6.1.4/4
6.1.4.1/4
6.1.4.2/4
6.1.4.3/4
6.2.1/4
6.2.4/4
6.2.5/4
6.2.6/4
6.2.7/4
6.2.8/4
6.5/4
6.6/4
6.7/4
6/6
6.1.1/6
6.1.2/6
6.1.3/6
6.1.4/6
6.1.4.1/6
6.1.4.2/6
6.1.4.3/6
6.2.1/6
6.2.4/6
6.2.5/6
6.2.6/6
6.2.7/6
6.2.8/6
6.5/6
6.6/6
6.7/6
KIIIA 10.3/2
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Data
protection
claimed Y/N
Owner
2008
Dossier for the evaluation of the plant protection
product BAS 516 04 F containing pyroclostrobin
and boscalid.
BASF Netherland BV; Arnhem; The Netherlands
No
unpublished
Y
BASF
20080706 THG
29-7-2008
2008
Dossier for the evaluation of the plant protection
product BAS 516 04 F containing pyroclostrobin
and boscalid.
BASF Netherland BV; Arnhem; The Netherlands
No
unpublished
Y
BASF
20080706 THG
24-11-2008
Study on the residue behaviour of pyraclostrobin
(BAS 500 F) on pea (young plants) after
application of BAS 500 06 F under field
conditions in France (North), Germany, United
Kingdom, Italy and Spain, 2012)
Agrologia S.L.U., Utrera, Spain.
2013/1044539
Yes
unpublished
Y
BASF
Year
2013
Page 4
Application
number*
Date of
submission*
Annex
point
Year
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Data
protection
claimed Y/N
Owner
KIIIA 10.3/3
2013
Study on the residue behaviour of pyraclostrobin
(BAS 500 F) on wheat (young plants) after
application of BAS 500 06 F under field
conditions in North and South Europe, season
2012.
Agricultura y ensayo SL, Seville, Spain.
2013/145207
Yes
unpublished
Y
BASF
* in case of an earlier submission (for an earlier application
Page 5
Application
number*
Date of
submission*

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